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pdfVoluntary National Retail Food
Regulatory Program Standards
2017
Self-Assessment and Audit Manual
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
College Park, MD 20740
Voluntary National Retail Food Regulatory Program Standards – January 2017
INTRODUCTION
Achieving national uniformity among regulatory programs responsible for retail food protection in the
United States has long been a subject of debate among the industry, regulators and consumers.
Adoption of the FDA Food Code at the state, local and tribal level has been a keystone in the effort to
promote greater uniformity. However, a missing piece has been a set of widely recognized standards for
regulatory programs that administer the Food Code. To meet this need FDA has developed the
“Voluntary National Retail Food Regulatory Program Standards” (Retail Program Standards) through
ideas and input from federal, state, and local regulatory officials, industry, trade and professional
associations, academia and consumers on what constitutes a highly effective and responsive retail food
regulatory program.
In March of 1996, the FDA hosted a meeting to explore ways in which its retail food protection program
could be improved. Participants in the meeting included FDA Retail Food Specialists, FDA
headquarters personnel, state and local regulatory officials from the six FDA regions, the president of
the Association of Food & Drug Officials, and industry representatives. Following that meeting, FDA
established a National Retail Food Team comprised of the Regional Retail Food Specialists, CFSAN
personnel and other FDA personnel directly involved in retail food protection. A Retail Food Program
Steering Committee was established and tasked with leading the team to respond to the direction given
by the participants in the meeting, i.e. providing national leadership, being equal partners, being
responsive, providing communication and promoting uniformity.
The Steering Committee was charged with developing a five-year operational plan for FDA’s retail food
program. The Steering Committee was also charged with ensuring the operational plan was in keeping
with the goals and mission of the President’s Food Safety Initiative. FDA solicited input from the
regulatory community, industry and consumers in developing the plan. The resulting Operational Plan
charted the future of the National Retail Food Program and prompted a reassessment of the respective
roles of all stakeholders and how best to achieve program uniformity.
From the goals established in that first Operational Plan, two basic principles emerged on which to build
a new foundation for the retail program:
•
•
Promote active managerial control of the risk factors most commonly associated with foodborne
illness in food establishments, and
Establish a recommended framework for retail food regulatory programs within which the active
managerial control of the risk factors can best be realized.
These principles led to the drafting of standards that encourage voluntary participation by the regulatory
agencies at the state, local, and tribal level. The Program Standards were developed with input obtained
through a series of meetings over a two-year period including: the 1996 stakeholders meeting, FDA
Regional Seminars, meetings with state officials hosted by the Retail Food Specialists, and six
Grassroots Meetings held around the country in 1997. Valuable input from industry associations,
associations of regulatory officials, and others was also obtained. The Retail Program Standards were
Voluntary National Retail Food Regulatory Program Standards – January 2017
provided to the Conference for Food Protection for further input and to achieve broad consensus among
all stakeholders.
In developing the Retail Program Standards, FDA recognized that the ultimate goal of all retail food
regulatory programs is to reduce or eliminate the occurrence of illnesses and deaths from food produced
at the retail level and that there are different approaches toward achieving that goal. Federal, state, local,
and tribal agencies continue to employ a variety of mechanisms with differing levels of sophistication in
their attempt to ensure food safety at retail.
While the Retail Program Standards represent the effective, focused food safety program to which we
ultimately aspire, they begin by providing a foundation and system upon which all regulatory programs
can build through a continuous improvement process. The Standards encourage regulatory agencies to
improve and build upon existing programs. Further, the Standards provide a framework designed to
accommodate both traditional and emerging approaches to food safety. The Retail Program Standards
are intended to reinforce proper sanitation (good retail practices) and operational and environmental
prerequisite programs while encouraging regulatory agencies and industry to focus on the factors that
cause and contribute to foodborne illness, with the ultimate goal of reducing the occurrence of those
factors.
PURPOSE
The Retail Program Standards serve as a guide to regulatory retail food program managers in the design
and management of a retail food regulatory program and provide a means of recognition for those
programs that meet these standards. Program managers and administrators may establish additional
requirements to meet individual program needs.
The Retail Program Standards are designed to help food regulatory programs enhance the services they
provide to the public. When applied in the intended manner, the Program Standards should:
•
•
•
•
•
•
Identify program areas where an agency can have the greatest impact on retail food safety
Promote wider application of effective risk-factor intervention strategies
Assist in identifying program areas most in need of additional attention
Provide information needed to justify maintenance or increase in program budgets
Lead to innovations in program implementation and administration
Improve industry and consumer confidence in food protection programs by enhancing uniformity
within and between regulatory agencies
Each Standard has one or more corresponding worksheets, forms and guidance documents. Regulatory
agencies may use existing, available records or may choose to develop and use alternate forms and
worksheets that capture the same information.
SCOPE
The Retail Program Standards apply to the operation and management of a retail food regulatory
program that is focused on the reduction of risk factors known to cause or contribute to foodborne
illness and to the promotion of active managerial control of these risk factors. The results of a self-
Voluntary National Retail Food Regulatory Program Standards – January 2017
assessment against the Standards may be used to evaluate the effectiveness of food safety interventions
implemented within a jurisdiction. The Standards also provide a procedure for establishing a database
on the occurrence of risk factors that may be used to track the results of regulatory and industry efforts
over time.
HISTORY
The Retail Program Standards were pilot tested in each of the five FDA regions in 1999. Each
regulatory participant reported the results at the 2000 Conference for Food Protection. Improvements to
the Standards were incorporated into the January 2001 version based on input from the pilot participants.
Further refinements to the Standards were made in subsequent drafts leading up to the endorsement of
the March 2002 version of the Retail Program Standards by the 2002 Conference for Food Protection.
Subsequent changes and enhancements have been made following concurrence of the stakeholders at the
biennial meetings of the Conference for Food Protection.
In maintaining these standards, FDA intends to allow for and encourage new and innovative approaches
to the reduction of factors that are known to cause foodborne illness. Program managers and other
health professionals participating in this voluntary program who have demonstrated means or methods
other than those described here may submit those to FDA for consideration and inclusion in the Retail
Program Standards. Improvements to future versions of the Standards will be made through a process
that includes the Conference for Food Protection to allow for constant program enhancement and
promotion of national uniformity.
IMPACT ON PROGRAM RESOURCES
During pilot testing of the Retail Program Standards in 1998, some jurisdictions reported that the selfassessment process was time consuming and could significantly impact an agency’s resources.
Collection, analysis, and management of information for the database Occurrence of Risk Factor Studies
were of special concern. However, participating jurisdictions also indicated that the resource
commitment was worthwhile and that the results of the self-assessment were expected to benefit their
retail food protection program. Advance planning is recommended before beginning the data collection
process in order to use resources efficiently. In addition, changes to the Standards now allow
jurisdictions to use routine inspection data for analysis on the occurrence of risk factors, significantly
reducing the resource requirements for separate data collection.
It is further recommended that jurisdictions not attempt to make program enhancements during the selfassessment process. A better approach is to use the self-assessment to identify program needs and then
establish program priorities and plans to address those needs as resources become available.
COMMENTS AND INQUIRIES
To promote uniform and reasonable application of these Standards, interested persons are invited to
submit comments and inquiries to their FDA Regional Retail Food Specialist or to the Retail Food
Protection Team in the FDA Center for Food Safety and Applied Nutrition at:
[email protected].
Voluntary National Retail Food Regulatory Program Standards – January 2017
Administrative Procedures for Participation in the
Voluntary National Retail Food Regulatory Program Standards
Table of Contents
OVERVIEW OF THE PROGRAM STANDARDS ..................................................................................................... 2
PURPOSE OF THIS DOCUMENT ............................................................................................................................. 2
ENROLLING IN THE PROGRAM STANDARDS .................................................................................................... 3
MAINTENANCE IN THE PROGRAM STANDARDS .......................................................................................... 3
CONDUCTING THE SELF-ASSESSMENT ...................................................................................................................... 3
VERIFYING THE SELF-ASSESSMENT .......................................................................................................................... 4
REPORTING THE RESULTS OF SELF-ASSESSMENTS AND VERIFICATION AUDITS TO FDA .......................................... 5
DISPUTE RESOLUTION PROCESS FOR NON-CONFIRMING AUDITS ............................................................. 6
RETAIL FOOD PROGRAM STANDARDS CLEARINGHOUSE CONTACT ......................................................... 8
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Administrative Procedures for Participation in the
Voluntary National Retail Food Regulatory Program Standards
Overview of the Program Standards
The purpose of the Voluntary National Retail Food Regulatory Program Standards (hereafter referred to
as the Retail Program Standards) is to establish best practices for regulatory programs that license and
inspect foodservice and retail food establishments. Jurisdictions are encouraged to use the Retail
Program Standards to improve program management and to implement best practices that enhance the
quality of public health services provided to stakeholders. Effective use of the Retail Program Standards
will enable a jurisdiction to make lasting programmatic improvements to their retail food protection
program.
Purpose of this Document
This document describes the general procedures for enrolling in the Program Standards, remaining in
active participant in the Program Standards, and resolving issues associated with the interpretation and
application of the Program Standards. This document is divided into the following sections:
1. Enrollment in the Retail Program Standards
2. Maintenance in the Program Standards
a. Self-assessment of a retail food regulatory program against the criteria in each of the 9
Program Standards;
b. Confirmation of the accuracy of the Self-Assessment and demonstration of an enrolled
jurisdiction’s progress in reducing the occurrence of foodborne illness risk factors;
c. Reporting to FDA the status of the self-assessment and verification audit; and
3. Dispute resolution process for non-confirming audits.
For additional information, the reader may refer to the FDA website for more detailed documentation on
the Program Standards. Detailed information along with the most recent version of the Program
Standards can be found on the following website: http://www.fda.gov/RetailProgramStandards.
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Enrolling in the Program Standards
Enrollment in the Retail Program Standards conveys an eligible jurisdiction’s intent to actively use the
Retail Program Standards as a tool to assess and improve its retail food regulatory program.
Government agencies and organizations responsible for regulation or oversight of the food
establishments that sell, serve or vend food directly to the public are eligible to enroll in the Retail
Program Standards.
A jurisdiction initiates the enrollment process by notifying their FDA Regional Retail Food Specialist of
its intent to enroll in the Retail Program Standards. To enroll, a jurisdiction must complete and sign the
related sections on the FDA National Registry Report (FDA Form 3958) and submit these forms to the
FDA Regional Specialist.
Upon submission of the completed enrollment form, FDA will add the jurisdiction to its on-line Listing
of Jurisdictions Enrolled in the Voluntary National Retail Food Regulatory Program Standards. The
listing is organized by State and contains basic information about the jurisdiction, the key contact
person, and the Retail Program Standards milestones achieved by the jurisdiction.
Maintenance in the Retail Program Standards
FDA encourages enrolled jurisdictions to actively participate in the Retail Program Standards. Active
participation means that a jurisdiction takes action to:
1. Periodically assess its program using the criteria in the nine Retail Program Standards;
2. Have its self-assessment verified by an independent audit (for Standards that the jurisdiction
reports meeting); and
3. Report the status of the program self-assessment and verification audit to FDA.
Conducting the Self-Assessment
Description of the Self-Assessment
The Self-Assessment is an internal review by program management to determine if the existing
retail food protection program conforms to the criteria in the Retail Program Standards.
Frequency of the Self-Assessment
A self-assessment against the criteria in each of the nine (9) Retail Program Standards shall be
completed at the following frequency:
1. Within 12 months of the date of enrollment; and
2. Following the initial self-assessment, the complete self-assessment cycle must be
repeated at a minimum every 60 months.
A jurisdiction may, and is encouraged to, complete a self-assessment update at any time during
the 60-month interval to reflect the most current information on its program accomplishments as
reflected by comparison against one or more of the individual Standards.
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Required Documents for the Self-Assessment
The most recent version of the Retail Program Standards must be used when completing a
required self-assessment.
A self-assessment update can be made using the version of the Retail Program Standards
effective at the jurisdiction’s previous required self-assessment or a more recent version of the
Retail Program Standards, at the jurisdiction’s discretion.
Individuals conducting a self-assessment are encouraged to use the provided worksheets to
complete the self-assessment. These worksheets are designed to assist the assessor in identifying
and recording program accomplishments and gaps, and to document the location of quality
records and source documents.
Documents containing equivalent summary information can be used in lieu of the provided
worksheets.
Documenting the Assessment of Individual Standards
To support a determination that a Retail Program Standard has been met, a jurisdiction shall
retain documents used during the self-assessment and have them available for use during the
verification audit, including:
1. Complete the corresponding worksheets. Alternatively, provide documents containing
equivalent summary information for that Standard in preparation of the verification audit;
and
2. Establish, identify, and maintain quality records specified as requirements in each of the
Retail Program Standards. The quality records must be maintained in such a manner that
an auditor can be provided information necessary to verify that a Standard’s criteria have
been met.
If a self-assessment indicates that the jurisdiction does not meet a Standard, the jurisdiction should
identify any deficiencies in meeting the Standards criteria.
Verifying the Self-Assessment
Description of the Verification Audit
The Verification Audit is a systematic, independent examination by an external party to confirm
the accuracy of the Self-Assessment that claims one or more Standard(s) as met.
A verification audit may be conducted by an authorized city, county, district, state, federal, tribal
or other third party person who has no responsibilities for the day-to-day operations of the
jurisdiction requesting the verification audit. The auditor shall complete the verification audit.
Frequency of the Verification Audit
The program manager, or a designated representative, must request a verification audit within
three (3) months of the completion of the self-assessment or self-assessment update in which one
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or more Standard(s) is claimed as met. The verification audit must be completed within six (6)
months of that self-assessment or self-assessment update.
Verification audits shall be conducted at the following frequency:
1. After the initial self-assessment (conducted within 12 months of enrollment), if the
jurisdiction claims conformance with one or more Standards; and
2. After each subsequent self-assessment (conducted every 60 months), if the jurisdiction
claims conformance with one or more Standards.
Selecting an Auditor
The jurisdiction is responsible for arranging for an individual to conduct the verification audit. If
the jurisdiction is unable to arrange for an individual to serve as an auditor, the jurisdiction
should contact their FDA Regional Retail Food Specialist for further guidance.
Role of the Auditor during the Verification Audit
During the verification audit, the auditor will:
1. Review the quality records and confirm that the self-assessment accurately reflects the
program’s achievement status with each criterion for the version of the Retail Program
Standards that was used when completing the self-assessment or a self-assessment
update;
2. Determine if the quality records specified as requirements in each of the Retail Program
Standards have been established, identified, and maintained. If the quality records for a
specific program element provide inadequate information upon which to make a
determination of conformance with the Standard or to enable a verification audit, that
Standard is not met; and
3. In instances where the auditor determines that the jurisdiction does not conform with the
Standard(s), review the reasons for the non-conforming finding with the Program
Manager and identify the elements necessary for the jurisdiction to meet the Standard.
The auditor will convey the results of the verification audit by providing a written report to the
jurisdiction. The written report shall consist of the Self-Assessment and Verification Audit Form
for each Standard that is audited. The form must clearly indicate whether the verification audit
confirms or disputes the Self-Assessment’s findings with regard to conformance for each
individual Standard. If the auditor disputes the findings from the Self-Assessment, the auditor
must provide written comments on the Self-Assessment and Verification Audit Form to support
the auditor’s findings.
Reporting the Results of Self-Assessments and Verification Audits to FDA
Timeframe for Reporting Results from a Self-Assessment or Verification Audit
The program manager, or a designated representative, must report the status of the selfassessment, self-assessment update, and the verification audit to their FDA Regional Retail Food
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Specialist:
1. within 30 days following a self-assessment (regardless of whether any Standard(s) are
claimed as met);
2. within 30 days following a self-assessment update (only if the achievement status for a
Standard has changed); and
3. within 30 days following any verification audit.
Method for Reporting Results from a Self-Assessment or Verification Audit
Reports must be submitted on the FDA National Registry Report (FDA Form 3958).
Report forms should be marked to show attainment of each applicable Standards achieved at the
time of submission. Dates showing current attainment for each Standard should be recorded on
each submission in order to accurately reflect the program’s history. All applicable Standards
should be marked with their most recent attainment dates to ensure that accurate information is
posted on the Listing of Jurisdictions Enrolled in the Voluntary National Retail Food Regulatory
Program Standards.
Dispute Resolution Process for Non-Confirming Audits
Under the Standards process, the auditor acts as the verifier of facts. The auditor certifies the accuracy
of a jurisdiction’s assessment of its conformance with the Retail Program Standards. In the event that a
jurisdiction disagrees with the auditor’s findings at the end of a verification audit, the following is the
process for resolving such differences.
Report Results of a Non-Confirming Audit
1. If a verification audit does not confirm the results of a self-assessment for one or more of
the Standards, it is the jurisdiction’s responsibility to contact their FDA Regional Retail
Food Specialist within ten business days of the close of the audit. The jurisdiction and
the FDA Regional Retail Food Specialist must discuss the steps necessary to reconcile
any discrepancies and to establish a correction plan if it wishes to retain the self-reported
information on the national web listing or to remove any incorrect self-reported data.
2. An action plan and timeline for correcting any element deficiencies must be developed by
the jurisdiction. The plan should include specific milestones to ensure that the full
criteria can be met by an established target date, not to exceed one year. The jurisdiction
must review the plan and timeline with the FDA Regional Retail Food Specialist.
3. The results of the jurisdiction’s self-assessment remain on the Listing of Jurisdictions
Enrolled in the Voluntary National Retail Food Regulatory Program Standards during
the correction period identified in the Action Plan.
4. If the jurisdiction does not wish to institute an action plan with milestones for correcting
deficiencies, the listing will be changed to reflect the results of the verification audit. The
jurisdiction can then work without time constraints to meet any non-confirmed standards
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and submit a new FDA National Registry Report (FDA Form 3958) when the standard is
achieved.
Dispute Resolution
FDA has established a Retail Food Program Standards Clearinghouse (Clearinghouse). The
Clearinghouse is composed of:
• Two FDA Regional Retail Food Specialists;
• One member of the FDA Center of Food Safety and Applied Nutrition Retail Food Policy
Team;
• One representative from the Conference for Food Protection Program Standards
Committee; and
• Representatives from five jurisdictions enrolled in the Standards.
The Clearinghouse was established to answer questions about the Standards and to give
interpretations based on the existing Standards language. The Clearinghouse is also available to
assist in resolving differences that arise as a result of a verification audit.
Written Request for Assistance
1. A jurisdiction seeking the assistance of the Clearinghouse must submit a request in
writing to the Clearinghouse. Contact information for the Standards Clearinghouse is
provided below. The request must include an explanation of the issues in dispute or
interpretations in question, and a copy of the verification audit report. The jurisdiction
may include any supporting information relevant to the results of the self-assessment or
verification audit. The written request must be made within 30 calendar days of the close
of the audit.
2. The Clearinghouse Chair will inform the auditor of the jurisdictions request. The auditor
may also supply additional written materials within 30 calendar days from the time they
are notified.
Assistance Process
1. The Clearinghouse will set a date and time to hear the facts from each side via conference
call.
2. The jurisdiction and the auditor will be provided the opportunity to speak in support of
the materials they submitted in writing. Clearinghouse members may ask questions of
each side.
3. The Clearinghouse will then confer in private before providing clarification on the issue.
Decisions
1. After conferring in private, the Clearinghouse will provide a written response to the
jurisdiction and the auditor within 10 business days following the conference call.
2. The interpretation of the Clearinghouse panel is final.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Retail Food Program Standards Clearinghouse Contact
Robert Sudler, Jr. MS, CP-FS
Consumer Safety Officer
FDA/CFSAN/Office of Food Safety
Retail Food Protection Staff / Retail Food Policy Team
5001 Campus Drive
Mail Stop HFS-320, Room 3B-018
College Park, MD. 20740
Phone: 240-402-1943
Fax: 301-436-2672
E-Mail: [email protected]
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Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 1
REGULATORY FOUNDATION
Table of Contents
REQUIREMENT SUMMARY ......................................................................................................................................... 2
DESCRIPTION OF REQUIREMENT................................................................................................................................ 2
A. FDA Food Code Interventions and Risk Factor Control Measures ............................................................... 2
B. Good Retail Practices .................................................................................................................................... 2
C. Compliance and Enforcement........................................................................................................................ 3
OUTCOME.................................................................................................................................................................. 3
DOCUMENTATION ..................................................................................................................................................... 3
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Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 1
REGULATORY FOUNDATION
This standard applies to the regulatory foundation used by a retail food program. Regulatory foundation
includes any statute, regulation, rule, ordinance, or other prevailing set of regulatory requirements that
governs the operation of a retail food establishment.
Requirement Summary
The regulatory foundation includes provisions for:
1. The public health interventions contained in the current published edition of the Food Code
or one of the two most recent previous editions of the Food Code;
2. Control measures for the risk factors known to contribute to foodborne illness;
3. Good Retail Practices (GRP’s) at least as stringent as the Food Code edition as specified in 1
above; and
4. Compliance and enforcement at least as stringent as the selected provisions from Food Code
and Annex 1 of the Food Code edition as specified in 1 above.
Description of Requirement
A. Food Code Interventions and Risk Factor Control Measures
The regulatory foundation contains provisions that are at least as stringent as the public health
interventions and the provisions that control risk factors known to contribute to foodborne illness
contained in the current published edition of the Food Code or one of the two most recent previous
editions of the Food Code. Jurisdictions that meet Standard 1 but who may become noncompliant due
to the release of a new edition of the Food Code are considered to continue meeting the Standard for a
period of two years from the release date of the new Food Code edition in order to complete the process
of updating its regulations.
To meet this element of the Standard, regulations must have a corresponding requirement for the Food
Code sections as listed and summarized in the Standard 1: Self-Assessment Worksheet for Part I, from
#1 “Demonstration of Knowledge” through #11 “Highly Susceptible Populations.” For initial listing, the
regulatory foundation must contain at least 9 of the 11 interventions and risk factor controls. In order to
meet fully the requirements of the Standard, the regulatory foundation must meet all 11 of the
interventions and risk factor controls by the third audit.
B. Good Retail Practices
The regulations contain provisions that address Good Retail Practices that are at least as stringent as
those described in the edition of the Food Code as specified in A. To meet this element of the Standard,
regulations must have a corresponding requirement for 95 percent of the Food Code sections as listed
and summarized in the Standard 1: Self-Assessment Worksheet for Part II, from #12 “Personnel”
through #37 “Variance for Smoking.”
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C.Compliance and Enforcement
The regulations contain provisions that address Compliance and Enforcement requirements that are at
least as stringent as those contained in the edition of the Food Code as specified in A. To meet this
element of the Standard, regulations must have a corresponding requirement for each of the Food Code
sections as listed in the Standard 1: Self-Assessment Worksheet for Part III, items 1 through 12; except
item 12 pertaining to “Legal Remedies,” where only one of the sections pertaining to criminal,
injunctive, or civil penalties is required.
Outcome
The desired outcome of this standard is the adoption of a sound, science-based regulatory foundation for
the public health program and the uniform regulation of industry.
Documentation
The quality records needed for this standard include:
1. The statute, regulation, rule, ordinance or other prevailing set of regulatory requirements that
govern the operation of a retail food establishment; and
2. The completed Standard 1: Program Self-Assessment and Verification Audit Form.
3. The completed Standard 1: Self-Assessment Worksheet for:
• Part I – Food Code Intervention and Risk Factor Controls
• Part II – Good Retail Practices
• Part III – Compliance and Enforcement
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INSTRUCTIONS FOR COMPLETING
THE PROGRAM SELF-ASSESSMENT AND VERIFICATION AUDIT FORM
STANDARD 1 - REGULATORY FOUNDATION
Program Self-Assessment and Verification Audit Form
The Standard 1: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process. The form is included at the end of
these instructions. Whether one is performing a program self-assessment or conducting a verification
audit, it is recommended that the form be available as a reference to the Standard 1 criteria.
Using the Program Self-Assessment and Verification Audit Form
Documenting the Findings from the Self-Assessment
Jurisdictions conducting a self-assessment of the Regulatory Foundation component must indicate on the
form if each of the listed Standard 1 criteria are met. These responses are recorded under the column
“Jurisdiction’s Self-Assessment.”
Jurisdictions are not obligated to use this form. An equivalent form or process is acceptable provided
that the results of the jurisdiction’s self-assessment for the specific Standard 1 criteria listed on this form
are available for review.
The Standard 1: Program Self-Assessment and Verification Audit Form is divided into four sections:
1. Assessment of the Program's Regulatory Foundation;
2. Food Code Interventions and Risk Factors;
3. Good Retail Practices; and
4. Compliance and Enforcement.
The self-assessor must review each Standard 1 criterion and determine if the jurisdiction’s source
documents confirm that the Standard criteria are met. If the criteria are met, the self-assessor must place
an “X” in the “YES” box under the “Jurisdiction’s Self-Assessment” column of the Standard 1: Program
Self-Assessment and Verification Audit Form.
If a review of the jurisdiction’s source documents does not confirm that the Standard 1 criteria are met,
the self-assessor must place an “X” in the “NO” box under the “Jurisdiction’s Self-Assessment” column
of the Standard 1: Program Self-Assessment and Verification Audit Form. The self-assessor may specify
why the criteria are not met in the box provided.
The self-assessor should review the findings on the Standard 1: Program Self-Assessment and
Verification Form to ensure accuracy. The jurisdiction must provide the auditor with their completed
Standard 1: Program Self-Assessment and Verification Audit Form and any worksheets or documents
used to support and demonstrate that the Standard 1 criteria have been met.
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Once all the criteria have been reviewed and documented on the form, the self-assessor must complete
the Program Self-Assessment Summary section on page one of the Standard 1: Program SelfAssessment and Verification Audit Form. The self-assessor must:
•
Enter their contact information;
•
Document if the jurisdiction met the Standard 1 criteria in the appropriate boxes; and
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 1 criteria.
Documenting the Findings from the Verification Audit
The self-assessor must provide their completed Standard 1: Program Self-Assessment and Verification
Audit Form to the auditor for review. The auditor must indicate on the Standard 1: Program SelfAssessment and Verification Audit Form if the criteria were met.
If a review of the jurisdiction’s source documents confirms the self-assessment conclusion that the
Standard criteria are met, the verification auditor places an “X” in the “YES” box under the “Auditor’s
Verification” column of the form.
If a review of the jurisdiction’s source documents does not confirm the self-assessment conclusion that
the Standard criteria are met, the verification auditor places an “X” in the “NO” box under the
“Auditor’s Verification” column on the form. The verification auditor must specify why the criterion is
not met in the box provided. Supplemental pages may be used to explain findings.
The verification auditor must discuss their findings with the program manager or their appointed
representative and provide constructive feedback at the conclusion of the on-site visit. In particular, any
Standard 1 criteria for which the auditor cannot confirm through a review of the self-assessment should
be thoroughly discussed. Ample time should be allotted to ensure that there is a clear understanding of
the reasons for the “non-conforming” finding. The auditor should be prepared to identify the elements
required for the jurisdiction to meet the Standard.
Once the close out interview has been conducted, the auditor must complete the Verification Audit
Summary section located on page one of the Standard 1: Program Self-Assessment and Verification
Audit Form. The auditor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 2 criteria in the appropriate boxes; and
•
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 1 criteria if the auditor does not confirm the self-assessment
findings.
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FAX:
FAX:
Signature of the Verification Auditor:
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I affirm that the information represented in the Verification Audit of Standard 1 is true and correct
Verification Audit indicates that the Jurisdiction MEETS the Standard 1 criteria: YES
Date the Verification Audit of Standard 1 was Completed:
Auditor’s Jurisdiction Address:
Phone:
Auditor’s Jurisdiction Name:
Verification Auditor’s Title:
NO
NO
VERIFICATION AUDIT SUMMARY
Printed Name of the Person who conducted the Verification Audit:
Signature of the Self-Assessor:
I affirm that the information represented in the Self-Assessment of Standard 1 is true and correct
Self-Assessment indicates that the Jurisdiction MEETS the Standard 1 criteria: YES
Date the Standard 1 Self-Assessment was Completed:
Jurisdiction Address:
Phone:
Jurisdiction Name:
Self-Assessor's Title:
Printed Name of the Person who conducted the Self-Assessment:
E-mail:
E-mail:
PROGRAM SELF-ASSESSMENT SUMMARY
Standard 1: Regulatory Foundation
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
Part I - Self-Assessment Worksheet
Part I - Verification Audit Worksheet
a) The jurisdiction’s initial Food Code assessment
indicates that the agency's regulatory requirements contain
at least 9 of the 11 FDA Food Code intervention and risk
factor controls. By the third verification audit the
jurisdiction's assessment indicates that the agency's
regulatory requirements contain all 11 of the FDA Food
Code intervention and risk factor controls.
2. Food Code Interventions and Risk Factors
c) The regulatory foundation assessment clearly identifies
the jurisdiction's corresponding requirement to the
applicable Code section. The assessment provides a
determination as to whether a specific provision in the
jurisdiction's regulation meets the intent of the
corresponding FDA Food Code section.
b) The jurisdiction’s side-by-side comparison includes an
assessment of major Food Code Interventions and Risk
Factors, Good Retail Practices, and Compliance/
Enforcement Administrative requirements
a) The jurisdiction has documentation that it has
performed a side-by-side comparison of its prevailing
statutes, regulations, rules, and other pertinent
requirements against the current published edition of the
FDA Food Code or one of the two most recent previous
editions of the FDA Food Code.
1-7
Self-Assessor's General Comments
Jurisdiction's Self-Assessment
1. Assessment of the Program's Regulatory Foundation
Criteria
Jurisdiction Name:
YES
NO
Standard 1: Regulatory Foundation
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
If no, auditor is to specify why criterion is
not met
Auditor's Verification
Part III - Self Assessment Worksheet
Part III - Verification Audit Worksheet
NOTE: Auditor's random selection of Compliance and
Enforcement Code Sections confirms the jurisdiction's
assessment that a corresponding requirement is contained
in the agency's code or statutes. Documentation from:
a) The jurisdiction's Food Code assessment indicates that
regulatory requirements contain ALL the FDA Food Code
Compliance and Enforcement Sections identified in the
Standard.
4. Compliance and Enforcement
Part II - Self-Assessment Worksheet
Part II - Verification Audit Worksheet
NOTE: Auditor's random selection of Good Retail Practices
Code Sections confirms the jurisdiction's assessment that a
corresponding requirement is contained in the agency's
code or statutes. Documentation from:
a) The jurisdiction's Food Code assessment indicates that
regulatory requirements contain at least 95 percent of
the FDA Food Code Good Retail Practices Sections.
3. Good Retail Practices
NOTE: Auditor's random selection of Food Code
Intervention and Risk Factor Control Sections confirms the
jurisdiction's assessment that a corresponding requirement
is contained in the agency's rules, regulations, ordinances,
code, or statutes.
b) The jurisdiction’s Food Code assessment indicates
that the agency has a corresponding requirement for
ALL FDA Food Code provisions related to the
interventions and risk factor controls.
Criteria
YES
NO
1-8
Self-Assessor's General Comments
Jurisdiction's Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If no, auditor is to specify why criterion is
not met
Auditor's Verification
1-9
General Notes Pertaining to the Program Self-Assessment or the Verification Audit
Standard 1: Regulatory Foundation
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards
DEFINITIONS
The following definitions apply in the interpretation and application of these Standards.
1. Active Managerial Control – The purposeful incorporation of specific actions or procedures by
industry management into the operation of a business to attain control over foodborne illness risk
factors.
2. Auditor – Any authorized city, county, district, state, federal, tribal or other third party person
who has no responsibilities for the day-to-day operations of that jurisdiction and is charged with
conducting a verification audit, which confirms the accuracy of the self-assessment.
3. Baseline Survey – See Risk Factor Study.
4. Candidate - A regulatory officer whose duties include the inspection of retail food
establishments.
5. Compliance and Enforcement – Compliance includes all voluntary or involuntary conformity
with provisions set forth by the regulatory authority to safeguard public health and ensure that
food is safe. Enforcement includes any legal and/or administrative procedures taken by the
regulatory authority to gain compliance.
6. Confirmed Foodborne Disease Outbreak – means a foodborne disease outbreak in which
laboratory analysis of appropriate specimens identifies a causative agent and epidemiologic
analysis implicates the food as the source of the illness or epidemiological analysis alone
implicates the food as the source of the illness.
7. Direct Regulatory Authority (DRA) – The organizational level of government that is
immediately responsible for the management of the retail program. This may be at the city,
county, district, state, federal, territorial, or tribal level.
8. Enforcement Actions – Actions taken by the regulatory authority such as, but not limited to,
warning letters, revocation or suspension of permit, court actions, monetary fines, hold orders,
destruction of food, etc., to correct a violation found during an inspection.
9. Follow-up Inspection – An inspection conducted after the initial routine inspection to confirm
the correction of a violation(s).
10. Food Code Interventions – the preventive measures to protect consumer health stated below:
1. management's demonstration of knowledge;
2. employee health controls;
3. controlling hands as a vehicle of contamination;
4. time / temperature parameters for controlling pathogens; and
5. consumer advisory.
11. Food-Related Injury – Means an injury from ingesting food containing a physical hazard such
as bone, glass, or wood.
12. Foodborne Disease Outbreak – The occurrence of two or more cases of a similar illness
resulting from the ingestion of a common food.
13. Good Retail Practices (GRP's) – Preventive measures that include practices and procedures to
effectively control the introduction of pathogens, chemicals, and physical objects into food, that
are prerequisites to instituting a HACCP or Risk Control Plan and are not addressed by the FDA
Food Code interventions or risk factors.
14. Hazard – A biological, chemical or physical property that may cause food to be unsafe for
4
Voluntary National Retail Food Regulatory Program Standards – January 2017
human consumption.
15. National Registry of Retail Food Protection Programs (National Registry) – A listing of
retail food safety programs that have voluntarily enrolled as participants in the Voluntary
National Retail Food Regulatory Program Standards.
16. Person in charge (PIC) – The individual present at a food establishment who is responsible for
the operation at the time of inspection.
17. Program Element – One of the program areas for which a National Standard has been
established such as regulations, training, inspection system, quality assurance, foodborne illness
investigation, compliance and enforcement, industry and consumer relations, and program
resources.
18. Program Manager – The individual responsible for the oversight and management of a retail
food regulatory program.
19. Quality Records – Documentation of specific elements of program compliance with the
National Standards as specified in each Standard.
20. Risk Control Plan (RCP) – a concisely written management plan developed by the retail or
food service operator with input from the health inspector that describes a management system
for controlling specific out-of-control risk factors.
21. Risk Factors – the improper employee behaviors or improper practices or procedures in retail
food and food service establishments stated below which are most frequently identified by
epidemiological investigation as contributing to foodborne illness or injury:
1. improper holding temperature;
2. inadequate cooking;
3. contaminated equipment;
4. food from unsafe source; and
5. poor personal hygiene.
22) Risk Factor Study (formerly Baseline Survey) – A study on the occurrence of foodborne illness
risk factors within institutional, foodservice, restaurants, and retail food facility types under a
jurisdiction’s regulatory authority. Criteria for a Risk Factor Study are detailed in Standard 9,
including at a minimum:
1. Data Collection, analysis, and a written report;
2. A collection instrument with data items pertaining to the five foodborne illness risk
factors;
3. A collection instrument that uses the convention of IN, OUT, NA and NO to
document observations;
4. All facility types identified by FDA’s national study that are under the jurisdiction’s
regulatory authority; and
5. Studies subsequent to the initial study repeated at 5-year intervals.
23) Routine Inspection – A full review and evaluation of a food establishment's operations and
facilities to assess its compliance with Food Safety Law, at a planned frequency determined by
the regulatory authority. This does not include re-inspections and other follow-up or special
investigations.
24) Self-Assessment – An internal review by program management to determine whether the
existing retail food safety program meets the Voluntary National Retail Food Regulatory
Program Standards.
25) Self-Assessment Update – Comparison of one or more program elements against the Voluntary
National Retail Food Regulatory Program Standards between the required 60-month periodic
5
Voluntary National Retail Food Regulatory Program Standards – January 2017
self-assessment.
26) Standardization Inspection – An inspection used to demonstrate a candidate's knowledge,
communication skills, and ability to identify violations of all regulatory requirements and to
develop a risk control plan for identified, uncontrolled risk factors.
27) Suspect Foodborne Outbreak – Means an incident in which two or more persons experience a
similar illness after ingestion of a common food or eating at a common food
establishment/gathering.
28) Trainer – An individual who has successfully completed the following training elements as
outlined in Steps 1 – 3, Standard 2, and is recognized by the program manager as having the field
experience and communication skills necessary to train new employees.
1. Satisfactory completion of the prerequisite curriculum;
2. Completion of a field training process similar to that contained in Appendix B-2; and
3. Completion of a minimum of 25 independent inspections and satisfactory completion
of the remaining course curriculum.
29) Training Standard – An individual who has successfully completed the following training
elements AND standardization elements in Standard 2 and is recognized by the program
manager as having the field experience and communication skills necessary to train new
employees. The training and standardization elements include:
1. Satisfactory completion of the prerequisite curriculum;
2. Completion of a field training process similar to that contained in Appendix B-2;
3. Completion of a minimum of 25 independent inspections and satisfactory completion
of the remaining course curriculum;
4. Successful completion of a standardization process based on a minimum of eight
inspections that includes development of HACCP flow charts, completion of a risk
control plan, and verification of a HACCP plan, similar to the FDA standardization
procedures;
5. Completion of a minimum of 20 contact hours of continuing education in food safety
every 36 months after the initial training is completed as outlined in Standard 2; and
6. Standardization maintained every three (3) years as outlined in Standard 2.
30) Verification Audit – A systematic, independent examination by an external party to confirm the
accuracy of the Self-Assessment.
6
Submit by Email
Print Form
Form Approved
OMB Number 0910-0621
Expiration Date: xx/xx/xxxx
(See Public Reporting Burden
Statement on page 2.)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Voluntary National Retail Food Regulatory Program Standards
FDA NATIONAL REGISTRY REPORT
1. Information about the Jurisdiction
Name of Jurisdiction Reporting
This Information
Address
City
State
Title for Contact Person
Contact Person for Jurisdiction
ZIP Code
Phone Number for Jurisdiction's
Contact Person
E-Mail Address for Jurisdiction's Contact Person
Jurisdiction is willing to serve as an auditor
for another jurisdiction:
Website Link for Jurisdiction
Yes
2. Information about Enrollment
No
Enrollment Date (DD/MM/YYYY)
Please enroll this jurisdiction in the Retail Program Standards
Please remove this jurisdiction from the Listing of Enrolled Jurisdictions
Update Results for the
Self-Assessment.
Other - Please explain
3. Information about Self-Assessment Findings and Verification Audit Findings
Completion Date for Self-Assessment
Program
Standard
Number
Instructions for Completing this Section
** If the jurisdiction's self-assessment indicates
conformance with any Standards, please mark
the applicable Standards. Only enter a date
if it differs from that of the self-assessment
completion date (i.e. a self-assessment update
was conducted)
*** If the jurisdiction's verification audit
confirms conformance with any Standards,
please mark the applicable Standards and
indicate the completion date.
**** All dates should be entered in the
MM/DD/YYYY format.
Self-Assessment**
Verification Audit***
Program Standard Met
(Mark all that apply)
Verification Audit Confirmed
(Mark all that apply and enter the
date confirmed for each)
1
2
3
4
5
6
7
8
9
4. Permission to Publish Information on the FDA Website
Permission is granted to publish the following information in the Listing of Jurisdictions Enrolled in the Voluntary National Retail Food
Regulatory Program Standards:
Enrollment information
Authorized Individual (Printed)
FORM FDA 3958 (11/16)
Title
Self-assessment findings
Signature
Page 1 of 2
Verification audit findings
Date (mm/dd/yyyy)
PSC Publishing Services (301) 443-6740
EF
Instructions for Completing FDA National Registry Report - Form 3958
The FDA National Registry Report must be completed and submitted to the appropriate FDA Regional Retail Food Specialist (Retail
Food Specialist) within 30 days following completion of the self-assessment, self-assessment update, or verification audit. The Listing
of Jurisdictions Enrolled in the Voluntary National Retail Food Regulatory Program Standards will be updated using data contained in
this report.
This form may be completed online and printed for submission to the appropriate Retail Food Specialist. Alternatively, this form may be
completed online and submitted electronically to the appropriate Retail Food Specialist. A listing of Retail Food Specialists, by state,
can be found on FDA's Retail Program Standards website (www.fda.gov/RetailProgramStandards).
Part 1: Information about the Jurisdiction
1. Enter the jurisdiction name, and the jurisdiction address.
2. Enter the name and contact information for the contact person for this jurisdiction. This is the individual to whom Retail Program
Standards correspondence will be sent.
3. Enter the jurisdiction's website address.
4. Indicate if the jurisdiction is willing to serve as an auditor for another jurisdiction.
Part 2: Information about Enrollment
1. Select the first box to indicate that the jurisdiction is a new enrollee. Please also enter the enrollment date.
2. Select the second box to indicate that you would like to remove this jurisdiction from the Listing of Jurisdictions Enrolled in the
Voluntary National Retail Food Regulatory Program Standards.
3. Select the third box to indicate that you are updating the findings from your self-assessment or verification audit. If you are
updating this information please select the relevant self-assessment.
4. If the first three options are not applicable, select "Other" and provide additional information.
Part 3: Information about Self-Assessment Findings and Verification Audit Findings
1. Enter the date that the self-assessment was completed.
2. Check the applicable boxes to indicate which Standards were met, as determined by the self-assessment. For each box that is
checked, do not enter a date unless the self-assessment date for that Standard is different than the date that the self-assessment
was completed (i.e. a self-assessment update was completed for Standard X after the self-assessment was completed.)
3. Check the applicable boxes in the third column to indicate which Standards were met, as verified by a verification audit. For each
box that is checked, a date should be entered to indicate the date that the verification audit was completed for that Standard.
Part 4: Permission to Publish Information on FDA's Website
1. With your permission, information submitted on this form will be published on FDA's Listing of Jurisdictions Enrolled in the
Voluntary National Retail Food Regulatory Program Standards. Check the appropriate box(es) to indicate what information FDA
may publish on the website.
After completing Parts 1-4, the Program Manager must:
1. Enter the name of the Authorized Individual. This may be the Program Manager or another individual authorized to submit this
information.
2. Provide the signature of the Authorized Individual for the reporting jurisdiction.
a. If the form is completed electronically, click the signature box to provide an electronic signature.
b. If the form is completed by hand, sign your name in the signature box.
3. Enter the date that the form is signed.
FOR INTERNAL FDA USE ONLY (To be completed by FDA Regional Retail Food Specialist)
The Listing of Enrolled Jurisdictions should reflect the following changes:
New Enrollment
Remove jurisdiction from Listing of Enrolled Jurisdictions (please attach an explanation)
New/Updated Jurisdiction Contact Information
New/Updated Jurisdiction Website Address
Updated Results for the indicated Self-Assessment Period
Reviewed By
Submitted By
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
This section applies only to the requirements of the Paperwork Reduction Act of 1995: The public reporting burden time for this
collection of information is estimated to average 12 minutes per response, including the time to review instructions, search existing data
sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden
estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
[email protected]
FORM FDA 3958 (11/16)
Do not send your completed form to the PRA Staff email address to the left.
“An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it
displays a currently valid OMB number.”
Page 2 of 2
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A SELF-ASSESSMENT
STANDARD 1 - REGULATORY FOUNDATION
Part I – Food Code Interventions and Risk Factor Controls
STEP 1 – Review Food Code Interventions and Risk Factor Controls
The jurisdiction’s regulatory foundation must contain requirements that are at least as stringent as
the public health interventions/risk factor provisions contained in the FDA Food Code. Part I of the
Standard 1: Self-Assessment Worksheet, included at the end of these instructions, contains 11 public
health interventions and risk factor controls:
1. Demonstration of Knowledge
2. Employee Health
3. Consumer Advisory
4. Approved Source
5. Time/Temperature
6. Protection from Contamination
7. Control of Hands as a Vehicle of Contamination
8. Good Hygienic Practices
9. Chemical
10. Conformance with Approved Procedures
11. Highly Susceptible Populations
To meet any one of the 11 elements described above, the self-assessment must indicate that the
jurisdiction’s regulatory requirements address each Food Code section listed under that element.
STEP 2 - Conduct the Self-Assessment for Part I
The self-assessor must compare the jurisdiction’s code, regulation or ordinance with the Food Code
sections grouped under each of the 11 public health interventions and risk factor control measures listed
in Part I of the Standard 1: Self-Assessment Worksheet. For each Food Code section, the self-assessor
must:
• Record the corresponding jurisdiction requirement; and
• Document his/her determination:
- If Full Intent of the Food Code section is met, place an "X" in the appropriate column.
- If Partial Intent of the Food Code section is met, identify language that is not included
with the jurisdiction's requirement. Indicate whether the language is addressed in
another jurisdiction statute, ordinance, or regulatory requirement.
- If No corresponding regulation exists, indicate "No Compliance" in the appropriate
column and provide any information that may explain why it is not part of the
jurisdiction's current requirements.
1-10
Voluntary National Retail Food Regulatory Program Standards – January 2017
STEP 3 – Document the Self-Assessment Results for Part I
A summary table is provided in Part I of the Standard 1: Self-Assessment Worksheet to document the
results of the self-assessment for each of the 11 public health intervention and risk factor control
measures. For each public health intervention and risk factor control measure, the self-assessor must
record the findings from the self-assessment. If each Food Code section listed under an Intervention/
Risk Factor has a check in the “Full Intent is Met” column, the Standard criteria is met. Place an “X” in
the Self-Assessment Results “YES” column.
If any of the Food Code sections are missing, or the jurisdiction's regulatory requirements only partially
meet the intent of the language, place an “X” in the Self-Assessment Results “NO”
column for that intervention/risk factor control measure.
At the bottom of Part I of the Standard 1: Self-Assessment Worksheet, the self-assessor must record the
jurisdiction’s name and the number of interventions/risk factors that are met. For initial participation
and listing purposes, the jurisdiction’s self-assessment must indicate conformance with at least 9 of the
11 intervention/risk factor categories. By the third verification audit, the jurisdiction must meet 11 of
the 11 intervention/risk factor control categories in order to meet the Standard 1 criteria.
Examples of documents that may be reviewed:
The jurisdiction’s statute, regulation, rule, ordinance or other prevailing set of regulatory
requirements that govern the operation of its food establishments
Version of the Food Code that was used for the self-assessment
Completed Standard 1: Self-Assessment Worksheet
* Part I – Food Code Interventions and Risk Factor Controls
If applicable, documents discussing or comparing code provisions excepted if adoption was
made by reference with exceptions.
1-11
2-102.11 – Demonstration
2-102.12 – Certified Food Protection Manager
2-103.11 – Person in Charge
2
3
4
Food Code
Section
2-201.11 – Responsibility of Permit Holder, Person
in Charge, and Conditional Employees
Item
No.
5
SECTION 2 – EMPLOYEE HEALTH
2-101.11 – Assignment
Food Code
Section
1
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
SECTION 1 – DEMONSTRATION OF KNOWLEDGE
1-12
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
PART I – 2017 Food Code: Interventions and Risk Factor Controls
Standard 1: Regulatory Foundation
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
2-201.13 – Removal, Adjustment, or Retention of
Exclusions and Restrictions
2-501.11– Clean-up of Vomiting and Diarrheal
Events
7
8
Food Code
Section
3-603.11 – Consumption of Animal Foods that are
Raw, Undercooked, or Not Otherwise Processed to
Eliminate Pathogens
Item
No.
9
SECTION 3 – CONSUMER ADVISORY
2-201.12 – Exclusions and Restrictions
Food Code
Section
6
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-13
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
3-201.11 – Compliance with Food Law
3-201.12 – Food in a Hermetically Sealed
Container
3-201.13 – Fluid Milk and Milk Products
3-202.13 – Eggs
3-202.14 – Eggs and Milk Products, Pasteurized
5-101.13 – Bottled Drinking Water
3-201.14 – Fish
3-201.15 – Molluscan Shellfish
11
12
13
14
15
16
17
Food Code
Section
10
Item
No.
SECTION 4 – APPROVED SOURCE
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-14
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
3-201.16 – Wild Mushrooms
3-201.17 – Game Animals
3-101.11 – Safe, Unadulterated, and Honestly
Presented
3-202.11 – Temperature
3-202.15 – Package Integrity
3-202.18 – Shellstock Identification
3-203.12 – Shellstock, Maintaining Identification
3-402.11 – Parasite Destruction
19
20
21
22
23
24
25
Food Code
Section
18
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-15
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
3-202.110 – Juice Treated
27
3-401.11 – Raw Animal Foods
3-401.12 – Microwave Cooking
3-401.14 – Non-Continuous Cooking of Raw
Animal Foods
3-403.11 – Reheating for Hot Holding
29
30
31
Food Code
Section
28
Item
No.
SECTION 5 – TIME/TEMPERATURE
3-402.12 – Records, Creation, and Retention
Food Code
Section
26
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-16
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
3-501.19 – Time as a Public Health Control
3-501.17 – Ready-to-Eat, Time/Temperature
Control for Safety Food, Date Marking
35
37
3-501.16 – Time/Temperature Control for Safety
Food, Hot and Cold Holding
34
3-501.18 – Ready-to-Eat, Time/Temperature
Control for Safety Food, Disposition
3-501.15 – Cooling Method
33
36
3-501.14 – Cooling
Food Code
Section
32
Item
No.
SECTION 5 – TIME/TEMPERATURE
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-17
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Food Code
Section
3-301.12 – Preventing Contamination When Tasting
3-302.11 – Packaged/Unpackaged Food –
Separation, Packaging, and Segregation
3-304.11 – Food Contact with Equipment and
Utensils
3-306.14 – Returned Food and Re-Service of Food
3-701.11 – Discarding or Reconditioning Unsafe,
Adulterated,or Contaminated Food
4-201.12 – Food Temperature Measuring Devices
4-501.111 – Manual Warewashing Equipment, Hot
Water Sanitization Temperatures
4-501.112 – Mechanical Warewashing Equipment,
Hot Water Sanitization Temperatures
Item
No.
38
39
40
41
42
43
44
45
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
SECTION 6 – PROTECTION FROM CONTAMINATION
Partial Compliance
1-18
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Food Code
Section
4-501.113 – Mechanical Warewashing Equipment,
Sanitization Pressure
4-501.114 – Manual and Mechanical Warewashing
Equipment, Chemical Sanitization – Temperature,
pH, Concentration, and Hardness
4-501.115 – Manual Warewashing Equipment,
Chemical Sanitization Using Detergent-Sanitizers
4-601.11 – Equipment, Food-Contact Surfaces,
Non Food-Contact Surfaces, and Utensils
4-602.11 - Equipment Food-Contact Surfaces and
Utensils
4-602.12 – Cooking and Baking Equipment
4-702.11 – Before Use After Cleaning
4-703.11 – Hot Water and Chemical
Item
No.
46
47
48
49
50
51
52
53
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-19
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
2-301.11 – Clean Condition
2-301.12 – Cleaning Procedure
2-301.14 – When to Wash
2-301.15 – Where to Wash
2-301.16 – Hand Antiseptics
3-301.11 – Preventing Contamination from Hands
5-203.11 – Handwashing Sinks (Numbers/
Capacities)
5-204.11 – Handwashing Sinks (Location/
Placement)
55
56
57
58
59
60
61
Food Code
Section
54
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
1-20
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
SECTION 7 – CONTROL OF HANDS AS A VEHICLE OF CONTAMINATION
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
6-301.11 – Handwashing Cleanser, Availability
6-301.12 – Hand Drying Provision
6-301.13 – Handwashing Aids and Devices,
Use Restrictions
6-501.18 – Cleaning of Plumbing Fixtures
63
64
65
66
67
Item
No.
2-401.11 - Eating, Drinking, or Using Tobacco
Food Code
Section
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
SECTION 8 – GOOD HYGIENIC PRACTICES
5-205.11 – Using a Handwashing Sink
Food Code
Section
62
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
1-21
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
SECTION 7 – CONTROL OF HANDS AS A VEHICLE OF CONTAMINATION
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
2-401.13 - Bandage, Finger Cot, Stall
69
3-202.12 – Additives
3-302.14 – Protection from Unapproved Additives
7-207.11 – Restriction and Storage
7-207.12 – Refrigerated Medicines, Storage
7-208.11 – Storage (First Aid Supplies)
71
72
73
74
Food Code
Section
70
Item
No.
SECTION 9 – CHEMICAL
2-401.12 – Discharges from the Eyes, Nose,
and Mouth
Food Code
Section
68
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-22
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
7-209.11 – Storage (Personal Care Items)
7-101.11 – Identifying Information, Prominence
7-102.11 – Common Name
7-201.11 – Separation
7-202.11 – Restriction
7-202.12 – Conditions of Use
7-203.11 – Poisonous or Toxic Material Containers
7-204.11 – Sanitizers, Criteria
76
77
78
79
80
81
82
Food Code
Section
75
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-23
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
7-204.12 – Chemicals for Washing, Treatment,
Storage and Processing Fruits and Vegetables,
Criteria
7-204.13 – Boiler Water Additives, Criteria
7-204.14 – Drying Agents, Criteria
7-205.11 – Incidental Food Contact, Criteria
7-206.11 – Restricted Use Pesticides, Criteria
7-206.12 – Rodent Bait Stations
7-206.13 – Tracking Powders, Pest Control and
Monitoring
7-301.11 – Separation (Retail Sale)
84
85
86
87
88
89
90
Food Code
Section
83
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-24
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Food Code
Section
3-502.12 – Reduced Oxygen Packaging Without a
Variance, Criteria
94
Item
No.
3-801.11 – Pasteurized Foods, Prohibited
Reservice, and Prohibited Foods
Food Code
Section
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
SECTION 11 – HIGHLY SUSCEPTIBLE POPULATIONS
93
92 3-502.11 – Variance Requirement
91 3-404.11 – Treating Juice
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-25
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
List what is not covered
(Additional sheets can be used for
explanations and comments)
SECTION 10 – CONFORMANCE WITH APPROVED PROCEDURES
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Consumer Advisory
Approved Sources
Time/Temperature
Protection from Contamination
Control of Hands as a Vehicle of
Contamination
Good Hygienic Practices
Chemical
Conformance with Approve Procedures
Highly Susceptible Populations
3
4
5
6
7
8
9
10
11
(regulatory agency)
Employee Health
2
Assessment of
Demonstration of Knowledge
Section Description
1
Food
Code
Section
NO
1-26
indicates conformance with
Standard Standard
Criteria Criteria
Met
Not Met
YES
(# Met)
out of the 11 Intervention/Risk Factor Categories
Self-Assessor's General Comments
Part I – 2017 Food Code: Interventions and Risk Factor Controls
Self-Assessment Results
Standard 1: Regulatory Foundation
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A SELF-ASSESSMENT
STANDARD 1 - REGULATORY FOUNDATION
Part II – Good Retail Practices
STEP 1 – Review Good Retail Practices
The jurisdiction’s regulatory foundation must have corresponding requirements for 95 percent of the
FDA Food Code sections listed in Part II – Good Retail Practices of the Standard 1: Self-Assessment
Worksheet. This worksheet is included at the end of these instructions. Part II of the Standard 1: SelfAssessment Worksheet contains several categories, beginning with #12 “Personnel” through #36
“Presence of Insects / Rodents Minimized, Outer Openings Protected, etc.”
STEP 2 - Conduct the Self-Assessment for Part II
The self-assessor must compare the jurisdiction’s code, regulation or ordinance with the corresponding
Food Code section for each of the Good Retail Practices (GRPs) provision listed in Part II of the
Standard 1: Self-Assessment Worksheet. For each Food Code section:
• Record the corresponding jurisdiction requirement; and
• Document his/her determination:
- If Full Intent of the Food Code section is met, place an "X" in the appropriate column.
- If Partial Intent of the Food Code section is met, identify language that is not included
with the jurisdiction's requirement. Indicate whether the language is addressed in
another jurisdiction statute, ordinance, or regulatory requirement.
- If No corresponding regulation exists, indicate "No Compliance" in the appropriate
column and provide any information that may explain why it is not part of the
jurisdiction's current requirements.
STEP 3 – Document the Self-Assessment Results for Part II
The summary table is provided at the end of Part II on the Standard 1: Self-Assessment Worksheet to
document the results of the self-assessment for the Good Retail Practices Food Code provisions. For
each Good Retail Practice category, the self-assessor will record the total number of Food Code
sections for which the jurisdiction’s regulations have a corresponding requirement. This number is
obtained from the totals documented at the end of each of the Good Retail Practice categories.
At the bottom of Part II of the Standard 1: Self-Assessment Worksheet, record the number of Good
Retail Practices that are met. Divide the total number of provisions met (last line of table) by 247 and
multiple by 100 to determine the percentage of the Good Retail Practices provisions contained in the
jurisdiction’s code or regulation. A percentage equal to or greater than 95% meets the Regulatory
Foundation for Sections 12 – 36.
1-27
Voluntary National Retail Food Regulatory Program Standards – January 2017
Examples of documents that may be reviewed
The jurisdiction’s statute, regulation, rule, ordinance or other prevailing set of regulatory
requirements that govern the operation of its food establishments
Version of the FDA Food Code that was used for the self-assessment
Completed Standard 1: Self-Assessment Worksheet
* Part II – Good Retail Practices
If applicable, documents discussing or comparing code provisions excepted if adoption
was made by reference with exceptions.
1-28
2-303.11 - Prohibition
2-301.11 - Clean Condition
2-402.11 - Effectiveness
6-301.14 - Handwashing
Signage
2
3
4
5
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
3-202.16 - Ice
3-202.17 - Shucked Shellfish, Packaging and
Identification
7
Food Code
Section
6
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
SECTION 13 – FOOD & FOOD PROTECTION
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 12 PROVISIONS MARKED “YES”:
2-302.11 - Maintenance
Food Code
Section
1
Item
No.
SECTION 12 – PERSONNEL
1-29
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
(Section 12 has a total of 5 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
Part II – 2017 Food Code: Good Retail Practices
Standard 1: Regulatory Foundation
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
3-203.11 - Molluscan Shellfish, Original
Container
3-302.12 - Food Storage Containers,
Identified with Common Name of Food
3-302.13 - Pasteurized Eggs, Substitute for
Raw Shell Eggs for Certain Recipes
3-305.13 - Vended Time/Temperature
Control for Safety Food, Original Container
9
10
11
12
16 3-602.12 - Other Forms of Information
15 3-602.11 - Food Labels
14 3-601.12 - Honestly Presented
13 3-601.11 - Standards of Identity
3-202.19 - Shellstock, Condition
Food Code
Section
8
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-30
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Food Code
Section
Full
Intent
Is Met
YES
3-401.13 - Plant Food Cooking for Hot
Holding
Food Code
Section
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 14 PROVISIONS MARKED “YES”:
18
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Partial Compliance
1-31
(Section 14 has a total of 1 provision)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
(Section 13 has a total of 12 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
SECTION 14 – PLANT FOOD COOKING FOR HOT HOLDING
TOTAL NUMBER OF SECTION 13 PROVISIONS MARKED “YES”:
17 6-404.11 - Segregation and Location
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Food Code
Section
3-302.12 - Storage or Display of Food In
Contact with Water and Ice
3-304.11 - Food Contact with Equipment
and Utensils
21
22
27 3-306.12 - Condiments, Protection
26 3-306.11 - Food Display
25 3-305.14 - Food Preparation
24 3-305.12 - Food Storage, Prohibited Areas
23 3-305.11 - Food Storage
3-303.11 - Ice Used as Exterior Coolant,
Prohibited as Ingredient
20
19 3-302.15 - Washing Fruits and Vegetables
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
SECTION 15 – PROTECTION FROM CONTAMINATION
Partial Compliance
1-32
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
3-307.11 - Miscellaneous Sources of
Contamination
29
Full
Intent
Is Met
YES
(Section 15 has a total of 11 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
4-301.11 - Cooling, Heating, and Holding
Capacities
31
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 16 PROVISIONS MARKED “YES”:
3-501.11 - Frozen Food
Food Code
Section
30
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
1-33
(Section 16 has a total of 2 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
SECTION 16 – FACILITIES / METHODS TO CONTROL PRODUCT TEMPERATURE
TOTAL NUMBER OF SECTION 15 PROVISIONS MARKED “YES”:
3-306.13 - Consumer Self-Service
Operations
Food Code
Section
28
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
3-501.12 - Time / Temperature Control for
Safety Food, Slacking
3-501.13 - Thawing
32
33
Full
Intent
Is Met
YES
(Section 17 has a total of 2 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
4-204.13 - Dispensing equipment,
Protection of Equipment and Food
4-204.14 - Vending Machine Vending
Stage Closure
35
36
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 17 P8OVISIONS MARKED “YES”:
3-304.12 - In-Use Utensils, Between-use
Storage
Food Code
Section
34
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
1-34
(Section 17 has a total of 3 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
SECTION 18 – DISPENSING OF FOOD / UTENSILS PROPERLY STORED
TOTAL NUMBER OF SECTION 17 PROVISIONS MARKED “YES”:
Food Code
Section
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
SECTION 17 – TIME / TEMPERATURE CONTROL FOR SAFETY FOOD - PROPERLY THAWED
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
4-203.12 - Temperature Measuring
Devices, Ambient Air and Water
4-204.112 - Temperature Measuring
Devices
4-302.12 - Food Temperature Measuring
Devices
38
39
40
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 19 PROVISIONS MARKED “YES”:
4-203.11 - Temperature Measuring
Devices
Food Code
Section
37
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Partial Compliance
1-35
(Section 19 has a total of 4 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
SECTION 19 – THERMOMETERS PROVIDED AND CONSPICUOUS
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
3-304.16 - Using Clean Tableware for
Second Portions and Refills
3-304.17 - Refilling Returnables
4-101.11 - Characteristics
4-101.12 - Cast Iron, Use Limitation
4-101.13 - Lead, Use Limitation
(In Ceramic, China, and Crystal)
4-101.14 - Copper, Use Limitation
4-101.15 - Galvanized Metal, Use
Limitation
42
43
44
45
46
47
Food Code
Section
41
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-36
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
DESIGNED, CONSTRUCTED, MAINTAINED,
List what is not covered.
(Additional sheets can be used for explanations
and comments)
SECTION 20 – FOOD AND NONFOOD CONTACT SURFACES:
INSTALLED, LOCATED, OPERATED, CLEANABLE
Voluntary National Retail Food Regulatory Program Standards – January 2017
4-101.17 - Wood, Use Limitation
4-101.18 - Nonstick Coatings, Use
Limitation
4-101.19 - Nonfood-Contact Surfaces
4-102.11 - Characteristics
4-201.11 - Equipment and Utensils
4-202.11 - Food-Contact Surfaces
4-202.12 - CIP Equipment
4-202.13 - "V" Threads, Use Limitation
4-202.14 - Hot Oil Filtering Equipment
49
50
51
52
53
54
55
56
Food Code
Section
48
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-37
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
4-202.15 - Can Openers
4-202.16 - Nonfood-Contact Surfaces
4-202.17 - Kick Plates, Removable
4-204.12 - Equipment Openings,
Closures, and Deflectors
4-204.15 - Bearings and Gear Boxes,
Leakproof
4-204.16 - Beverage Tubing, Separation
4-204.17 - Ice Units, Separation of Drains
4-204.18 - Condenser Unit, Separation
4-204.19 - Can Openers on Vending
Machines
58
59
60
61
62
63
64
65
Food Code
Section
57
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-38
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
4-204.110 - Molluscan Shellfish Tanks
4-204.111 - Vending Machines,
Automatic Shutoff
4-204.121 - Vending Machines, Liquid
Waste Products
4-204.122 - Case Lot Handling
Equipment, Moveability
4-204.123 - Vending Doors and Openings
4-302.11 - Utensils, Consumer Self-Service
4-401.11 - Equipment, Clothes Washers
and Dryers and Storage Cabinets,
Contamination Prevention
4-402.11 - Fixed Equipment, Spacing or
Sealing
4-402.12 - Fixed Equipment, Elevation or
Sealing
67
68
69
70
71
72
73
74
Food Code
Section
66
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-39
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
4-501.11 - Good Repair and Proper
Adjustment
4-501.12 - Cutting Surfaces
4-501.13 - Microwave Ovens
4-502.11 - Good Repair and Calibration
4-601.11(B - C) - Equipment, Food-Contact
Surfaces, Nonfood-Contact Surfaces,
Utensils
4-602.13 - Nonfood-Contact Surfaces
4-604.11 - Dry Cleaning
4-902.11 - Food-Contact Surfaces
76
77
78
79
80
81
82
Food Code
Section
75
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-40
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
4-902.12 - Equipment
Food Code
Section
Partial Compliance
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Food Code
Section
4-303.11 - Cleaning Agents and Sanitizer,
Availability
4-203.13 - Pressure Measuring Devices,
Mechanical Warewashing Equipment
4-204.113 - Warewashing Machine, Data
Plate Operating Specifications
4-204.114 - Warewashing Machines,
Temperature, Measuring Devices
4-204.115 - Warewashing Machines,
Temperature, Measuring Devices
Item
No.
84
85
86
87
88
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
1-41
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
SECTION 21 – WAREWASHING FACILITY: DESIGNED CONSTRUCTED, INSTALLED, LOCATED, OPERATED,
CLEANABLE, USED
(Section 20 has a total of 43 provisions)
Full
List what is not covered.
Intent (Additional sheets can be used for explanations
Is Met
and comments)
YES
TOTAL NUMBER OF SECTION 20 PROVISIONS MARKED “YES”:
83
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Voluntary National Retail Food Regulatory Program Standards – January 2017
4-204.116 - Manual Warewashing
Equipment, Heaters and Baskets
4-204.117 - Warewashing Machines,
Automatic Dispensing of Detergents and
Sanitizer s
4-204.118 - Warewashing Machines, Flow
Pressure Device
4-204.119 - Warewashing Sinks and
Drainboards, Self-Draining
4-204.120 - Equipment Compartments,
Drainage
4-301.12 - Manual Warewashing, Sink
Compartment Requirements
4-301.13 - Drainboards
4-302.13 - Temperature Measuring
Devices, Manual Warewashing
4-302.14 - Sanitizing Solutions, Testing
Devices
90
91
92
93
94
95
96
97
Food Code
Section
89
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-42
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
4-501.14 - Warewashing Equipment,
Cleaning Frequency
4-501.15 - Warewashing Machines,
Manufacturer's Operating Instructions
4-501.16 - Warewashing Sinks, Use
Limitation
4-501.17 - Warewashing Equipment,
Cleaning Agents
4-501.18 - Warewashing Equipment,
Clean Solutions
4-501.19 - Manual Warewashing
Equipment, Wash Solution Temperature
4-501.110 - Mechanical Warewashing
Equipment, Wash Solution Temperature
4-501.116 - Warewashing Equipment,
Determining Chemical Sanitizer
Concentration
4-603.12 - Precleaning
99
100
101
102
103
104
105
106
Food Code
Section
98
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-43
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
4-603.14 - Wet Cleaning
4-603.15 - Washing, Procedures for
Alternative Manual Warewashing
Equipment
4-603.16 - Rinsing Procedures
4-904.14 - Rinsing Equipment and
Utensils After Cleaning and Sanitizing
108
109
110
111
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 21 PROVISIONS MARKED “YES”:
4-603.13 - Loading of Soiled Items,
Warewashing Machines
Food Code
Section
107
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Partial Compliance
1-44
(Section 21 has a total of 28 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
3-304.13 - Linens and Napkins, Use
Limitation
3-304.14 - Wiping Cloths, Use Limitation
3-304.15 - Gloves, Use Limitation
4-101.16 - Sponges, Use Limitation
4-801.11 - Clean Linens
4-802.11 - Specifications
4-803.11 - Storage of Soiled Linens
4-803.12 - Mechanical Washing
4-901.12 - Wiping Cloths, Air Drying
Locations
113
114
115
116
117
118
119
120
Food Code
Section
112
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
1-45
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
SECTION 22 – WIPING CLOTHS, LINENS, NAPKINS, GLOVES, SPONGES: PROPERLY USED, STORED
Voluntary National Retail Food Regulatory Program Standards – January 2017
4-903.12 - Equipment
Food Code
Section
Full
Intent
Is Met
YES
(Section 22 has a total of 10 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
4-901.11 - Equipment and Utensils, AirDrying Required
4-903.11 - Equipment, Utensils, Linens,
and Single-Service and Single-Use
Articles
4-903.12 - Prohibitions
4-904.11 - Kitchenware and Tableware
4-904.12 - Soiled and Clean Tableware
123
124
125
126
Food Code
Section
122
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
1-46
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
SECTION 23 – STORAGE, HANDLING OF CLEAN EQUIPMENT, UTENSILS
TOTAL NUMBER OF SECTION 22 PROVISIONS MARKED “YES”:
121
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
4-904.13 - Preset Tableware
127
Full
Intent
Is Met
YES
(Section 23 has a total of 6 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
4-502.12 - Single-Service and Single-Use
Articles, Required Use
4-502.13 - Single-Service and Single-Use
Articles, Use Limitation
4-502.14 - Shells, Use Limitation
128
129
130
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 24 PROVISIONS MARKED “YES”:
Food Code
Section
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
1-47
(Section 24 has a total of 3 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
SECTION 24 – SINGLE-SERVICE / SINGLE-USE ARTICLES: STORAGE, DISPENSING, USE, NO REUSE
TOTAL NUMBER OF SECTION 23 PROVISIONS MARKED “YES”:
Food Code
Section
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Voluntary National Retail Food Regulatory Program Standards – January 2017
5-102.11 - Standards
5-102.12 - Nondrinking Water
5-102.13 - Sampling
5-102.14 - Sample Report
5-103.11 - Capacity
5-103.12 - Pressure
5-104.11 - System
5-104.12 - Alternative Water Supply
132
133
134
135
136
137
138
139
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 25 PROVISIONS MARKED “YES”:
5-101.11 - Approved System
Food Code
Section
131
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
1-48
(Section 25 has a total of 9 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
SECTION 25 – SAFE WATER SOURCE, HOT AND COLD UNDER PRESSURE, ADEQUATE QUANTITY
Voluntary National Retail Food Regulatory Program Standards – January 2017
5-101.12 - System Flushing and
Disinfection
5-201.11 - Approved
5-202.11 - Approved System and
Cleanable Fixtures
5-202.12 - Handwashing Facility,
Installation
5-202.15 - Conditioning Device, Location
5-203.13 - Service Sink
5-204.13 - Conditioning Device, Location
5-205.13 - Scheduling Inspection and
Service for a Water System Device
5-205.14 - Water Reservoir of Fogging
Devices, Cleaning
141
142
143
144
145
146
147
148
Food Code
Section
140
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
SECTION 26 – PLUMBING: INSTALLED, MAINTAINED
Partial Compliance
1-49
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
5-205.15 - System Maintained in Good
Repair
5-301.11 - Approved
5-302.11 - Enclosed System, Sloped to
Drain
5-302.12 - Inspection and Cleaning Port,
Protected and Secured
5-302.13 - "V" Type Threads, Use
Limitation
5-302.14 - Tank Vent, Protected
5-302.15 - Inlet and Outlet, Sloped to
Drain
5-302.16 - Hose, Construction and
Identification
5-303.11 - Filter, Compressed Air
5-303.12 - Protective Cover or Device
150
151
152
153
154
155
156
157
158
Food Code
Section
149
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-50
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
5-304.11 - System Flushing and
Disinfection
5-304.12 - Using a Pump and Hoses,
Backflow Prevention
5-304.13 - Protecting Inlet, Outlet, and
Hose Fitting
5-304.14 - Tank, Pump, and Hoses,
Dedication
160
161
162
163
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 26 PROVISIONS MARKED “YES”:
5-303.13 - Mobile Food Establishment
Tank Inlet
Food Code
Section
159
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Partial Compliance
1-51
(Section 26 has a total of 24 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
5-202.13 - Backflow Prevention, Air Gap
5-202.14 - Backflow Prevention Device,
Design Standard
5-203.14 - Backflow Prevention Device,
When Required
5-203.15 - Backflow Prevention Device,
Carbonator
5-204.12 - Backflow Prevention Device,
Location
5-205.12 - Prohibiting a Cross Connection
164
165
166
167
168
169
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 27 PROVISIONS MARKED “YES”:
Food Code
Section
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
1-52
(Section 27 has a total of 6 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
SECTION 27 – CROSS CONNECTION, BACK SIPHONAGE, BACKFLOW PREVENTION
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
6-402.11 - Convenience and Accessibility
171
Full
Intent
Is Met
YES
(Section 28 has a total of 2 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
6-202.14 - Toilet Rooms, Enclosed
6-302.11 - Toilet Tissue Availability
6-501.19 - Closing Toilet Room Doors
173
174
175
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 28 PROVISIONS MARKED “YES”:
5-501.17 - Toilet Room Receptacle,
Covered
Food Code
Section
172
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
1-53
(Section 28 has a total of 4 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
SECTION 29 – TOILET ROOMS ENCLOSED, SELF CLOSING DOORS; FIXTURES GOOD REPAIR,
CLEAN PROPER WASTE RECEPTACLES
TOTAL NUMBER OF SECTION 28 PROVISIONS MARKED “YES”:
5-203.12 - Toilets and Urinals
Food Code
Section
170
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
SECTION 28 – TOILET FACILITIES: CONVENIENT, ACCESSIBLE, DESIGNED, INSTALLED
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
5-402.11 - Backflow Prevention
5-402.12 - Grease Trap
5-402.13 - Conveying Sewage
5-402.14 - Removing Mobile Food
Establishment Wastes
4-502.15 - Flushing a Waste Retention
Tank
5-403.11 - Approved Sewage Disposal
System
5-403.12 - Other Liquid Wastes and
Rainwater
177
178
179
180
181
182
183
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 30 PROVISIONS MARKED “YES”:
5-401.11 - Capacity and Drainage
Food Code
Section
176
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
SECTION 30 – SEWAGE AND WATER WASTE DISPOSAL
Partial Compliance
1-54
(Section 30 has a total of 8 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
5-501.11 - Outdoor Storage Surface
Food Code
Section
5-501.14 – Receptacles in Vending
Machines
5-501.18 – Cleaning Implements and
Supplies
190
192
5-501.110 – Storing Refuse, Recyclables,
and Returnables
Handling Units Location
191 Machines, Receptacles and Waste
5-501.19 – Storage Areas, Redeeming
5-501.16 – Storage Areas, Rooms, and
Receptacles, Capacity and Availability
189
188 5-501.15 – Outside Receptacles
187
186 5-501.13 – Receptacles
185 5-501.12 - Outdoor Enclosure
184
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
1-55
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
SECTION 31 – GARBAGE AND REFUSE DISPOSAL – CONTAINERS OR RECEPTACLES: COVERED, ADEQAUTE NUMBER,
INSECT / RODENT PROOF, FREQUENCY OF REMOVAL, CLEAN, AREA PROPERLY CONSTRUCTED, NECCESSARY
IMPLEMENTS, SUPPLIES
Voluntary National Retail Food Regulatory Program Standards – January 2017
5-501.111 – Areas, Enclosures, and
Receptacles, Good Repair
Food Code
Section
5-501.115 – Maintaining Refuse Areas and
Enclosures
201
5-503.11 – Community or Individual
Facility
200 5-502.12 – Receptacles or Vehicles
199 5-502.11 – Frequency
198 5-501.116 – Cleaning Receptacles
197
196 5-501.114 – Using Drain Plugs
195 5-501.113 –Covering Receptacles
194 5-501.112 –Outside Storage Prohibitions
193
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-56
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
6-202.110 - Outside Refuse Areas, Curbed
and Graded to Drain
202
Full
Intent
Is Met
YES
(Section 31 has a total of 19 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
6-101.11 - Surface Characteristics
6-102.11 - Surface Characteristics
6-201.11 - Floors, Walls, and Ceilings
6-201.12 - Floors, Walls, and Ceilings,
Utility Lines
6-201.13 - Floors and Wall Junctures,
Coved, and Enclosed or Sealed
204
205
206
207
Food Code
Section
203
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
1-57
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
SECTION 32 – PHYSICAL FACILITY, FLOORS, WALLS, CEILINGS: DESIGNED, CONSTRUCTED, MAINTAINED, CLEAN
TOTAL NUMBER OF SECTION 31 PROVISIONS MARKED “YES”:
Food Code
Section
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Voluntary National Retail Food Regulatory Program Standards – January 2017
6-201.14 - Floor Carpeting,
Restrictions and Installation
6-201.15 - Floor Covering, Mats and
Duckboards
6-201.16 - Wall and Ceiling Coverings
and Coatings
6-201.17 - Walls and Ceilings,
Attachments
6-201.18 - Walls and Ceilings, Studs,
Joists, and Rafters
6-202.17 - Outdoor Food Vending
Areas, Overhead Protection
6-202.18 - Outdoor Servicing Areas,
Overhead Protection
6-501.11 - Repairing
6-501.12 - Cleaning, Frequency and
Restrictions
209
210
211
212
213
214
215
216
Food Code
Section
208
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
Partial Compliance
1-58
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
6-501.17 - Absorbent Materials on
Floors, Use Limitation
218
Full
Intent
Is Met
YES
(Section 32 has a total of 16 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
Food Code
Section
4-202.18 - Ventilation Hood Systems,
Filters
4-204.11 - Ventilation Hood Systems,
Drip Preventions
4-301.14 - Ventilation Hood Systems,
Adequacy
6-202.11 - Light Bulbs, Protective
Shielding
Item
No.
219
220
221
222
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
1-59
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
SECTION 33 – LIGHTING, VENTILATION, DRESSING ROOMS / DESIGNATED AREAS MAINTAINED
TOTAL NUMBER OF SECTION 32 PROVISIONS MARKED “YES”:
6-501.13 - Cleaning Floors, Dustless
Methods
Food Code
Section
217
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Voluntary National Retail Food Regulatory Program Standards – January 2017
6-202.12 - Heating, Ventilating, Air
Conditioning System Vents
Food Code
Section
6-501.14 - Cleaning Ventilation
Systems, Nuisance and Discharge
Prohibition
6-501.110 - Using Dressing Rooms
and Lockers
228
229
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 33 PROVISIONS MARKED “YES”:
6-403.11 - Designated Areas
227
226 6-305.11 - Designation
225 6-304.11 - Mechanical
224 6-303.11 - Intensity
223
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Partial Compliance
1-60
(Section 33 has a total of 11 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
6-501.15 - Cleaning Maintenance
Tools, Preventing Contamination
231
6-501.114 - Maintaining Premises,
Unnecessary Items and Litter
234
Full
Intent
Is Met
YES
(Section 34 has a total of 5 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
Food Code
Section
235 4-301.15 - Clothes Washers and Dryers
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
1-61
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
SECTION 35 – COMPLETE SEPARATION FROM LIVING / SLEEPING QUARTERS; LAUNDRY
TOTAL NUMBER OF SECTION 34 PROVISIONS MARKED “YES”:
6-501.113 - Storing Maintenance
Tools
233
232 6-501.16 - Drying Mops
6-202.19 - Outdoor Walking and
Driving Surfaces, Graded to Drain
Food Code
Section
230
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
SECTION 34 – PREMISES MAINTAINED FREE OF LITTER, UNNECESSARY ARTICLES, CLEANING AND MAINTENANCE
EQUIPMENT PROPERLY STORED
Voluntary National Retail Food Regulatory Program Standards – January 2017
Food Code
Section
6-202.11 - Private Homes and Living
or Sleeping Quarters, Use Prohibition
6-202.112 - Living or Sleeping
Quarters, Separation
238
239
Full
Intent
Is Met
YES
(Section 35 has a total of 5 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Food Code
Section
241
6-202.13 - Insect Control Device,
Design and Installation
240 2-403.11 - Handling Prohibition
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Full
Intent
Is Met
YES
1-62
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Partial Compliance
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
SECTION 36 – PRESENCE OF INSECTS / RODENTS MINIMIZED, OUTER OPENINGS PROTECTED, ANIMALS AS
ALLOWED
TOTAL NUMBER OF SECTION 35 PROVISIONS MARKED “YES”:
4-803.15 - Use of Laundry Facilities
237
4-401.11 - Equipment Clothes
236 Washers and Dryers, and Storage
Cabinets, Contamination Prevention
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Voluntary National Retail Food Regulatory Program Standards – January 2017
Food Code
Section
6-501.111 - Controlling Pests
6-501.112 - Removing Dead or
Trapped Birds, Insects, Rodents, and
other Pests
6-501.115 - Prohibiting Animals
244
245
246
Full
Intent
Is Met
YES
TOTAL NUMBER OF SECTION 36 PROVISIONS MARKED “YES”:
6-202.16 - Exterior Walls and Roofs,
Protective Barrier
243
242 6-202.15 - Outer Openings Protected
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, Etc.
Partial Compliance
1-63
(Section 36 has a total of 7 provisions)
List what is not covered.
(Additional sheets can be used for explanations
and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with FDA Food Code is not Met
(Indicate the Situation)
NO
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 1: REGULATORY FOUNDATION
SELF-ASSESMENT WORKSHEET
PART II – 2017 Food Code: Good Retail Practices
SELF-ASSESSMENT RESULTS
Section Number
Number of Provisions
Met (Identified as "YES"
on worksheet)
Section Description
12
Personnel
13
Food and Food Protection
14
Plant Cooking for Hot Holding
15
Protection from Contamination
16
Facilities / Methods to Control Product Temperature
17
Time/Temperature Control for Safety Food Properly Thawed
18
Dispensing Food / Utensils Properly Stored
19
Food Equipment
20
Food and Nonfood-Contact Surfaces
21
Warewashing Facilities; Designed, Constructed, Installed, Located, Operated, etc.
22
Wiping Cloths, Linens, Napkins, Gloves, Sponges: Properly Used, Stored
23
Storage, Handling of Clean Equipment, Utensils
24
Single-Service / Single Use Articles: Storage, Dispensing, Use, no Reuse
25
Safe Water Source, Hot and Cold Under Pressure, Adequate Quantity
26
Plumbing: Installed, Maintained
27
Cross Connection, Back Siphonage, Backflow Prevention
28
Number, Convenient, Accessible, Designed, Installed
29
Toilet Rooms Enclosed, Self-Closing Doors; Fixtures, Good Repair, Clean, etc.
30
Sewage and Waste Water Disposal
31
Garbage and Refuse Disposal - Containers or Receptacles: Covered, etc.
32
Physical Facility - Floors, Walls, Ceiling: Designed, Constructed, Maintained, etc.
33
Lighting, Ventilation, Dressing Rooms / Designated Areas Maintained
34
Premises Maintained Free of Litter, Unnecessary Articles
35
Complete Separation from Living / Sleeping Quarters; Laundry
36
Presence of Insects / Rodents Minimized, Outer Openings Protected, etc.,
TOTAL NUMBER OF PROVISIONS MET – (Add Column 2)
Divide the total number of provisions met (last line of table) by 246 and multiple by 100 to determine
the percentage of the Good Retail Practices provisions contained in your code regulation.
%
A percentage equal to or greater than 95% meets the Regulatory Foundation for Sections 12 thru 36.
1-64
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A SELF-ASSESSMENT
STANDARD 1 - REGULATORY FOUNDATION
Part III – Compliance and Enforcement
STEP 1 – Review Compliance and Enforcement Administrative Provisions
Part III of the Standard 1: Self-Assessment Worksheet contains 12 Compliance and Enforcement areas
within a regulatory retail food program. This worksheet is included at the end of these instructions. To
meet this element of Standard 1, the jurisdiction’s regulatory requirements must have a corresponding
requirement for the Food Code sections listed in Items 1 through 11. For Item 12 pertaining to “Legal
Remedies,” a jurisdiction need only demonstrate that its regulatory foundation provides the authority to
implement one of the legal remedies pertaining to criminal, injunctive, or civil penalties.
STEP 2 - Conduct the Self-Assessment for Part III
The self-assessor must compare the jurisdiction’s code, regulation or ordinance against with the FDA
Food Code Compliance and Enforcement provisions listed on the self-assessment worksheets. For each
Food Code section:
• Record the corresponding jurisdiction requirement; and
• Document his/her determination:
- If Full Intent of the Food Code section is met, place an "X" in the appropriate column.
- If Partial Intent of the Food Code section is met, identify language that is not included
with the jurisdiction's requirement. Indicate whether the language is addressed in
another jurisdiction statute, ordinance, or regulatory requirement.
- If No corresponding regulation exists, indicate "No Compliance" in the appropriate
column and provide any information that may explain why it is not part of the
jurisdiction's current requirements.
STEP 3 – Document the Self-Assessment Results for Part III
A summary table is provided at the end of Part III on the Standard 1: Self-Assessment Worksheet to
document the results of the regulatory foundation self-assessment for the Compliance and Enforcement
Food Code provisions. At the bottom of Part III on the Standard 1: Self-Assessment Worksheet, record
the number of Compliance and Enforcement categories that are met. To meet the Standard 1, Part III
criteria, the jurisdiction must have a “YES” response for all 12 of the listed Compliance and
Enforcement categories.
Examples of documents that may be reviewed
The jurisdiction’s statute, regulation, rule, ordinance or other prevailing set of regulatory
requirements that govern the operation of its food establishments
Version of the FDA Food Code that was used for the self-assessment
Completed Standard 1: Self-Assessment Worksheet
* Part III – Compliance and Enforcement
If applicable, documents discussing or comparing code provisions excepted if adoption was
made by reference with exceptions.
1-65
Food Code
Section
Hold orders, Embargo, and Destruction of Food
8-901.10 – Conditions Warranting Remedy
Hold orders, Embargo, and Destruction of Food
8-903.10 – Hold Order, Justifying Conditions and
Removal of Food
Hold orders, Embargo, and Destruction of Food
8-903.30 – Hold Order, Contents
Permit / License Required; Right to Deny
8-301.11 – Prerequisite for Operation
Permit / License Required; Right to Deny
8-304.20 – Permits Not Transferable
Plan Review / Pre-operational inspections
8-201.11 – When Plans are Required
Item
No.
1a
1b
1c
2a
2b
3
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
1-66
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
Part III – 2013 Food Code: Compliance and Enforcement Summary
Standard 1: Regulatory Foundation
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Inspection Authority / Right to Access
8-402.20 – Refusal, Notification of Right to Access,
and Final Request for Access
4
Authority to Require HACCP Plans
8-201.13 – When a HACCP Plan is Required
Granting of Variances
8-103.10 – Modifications and Waivers
Granting of Variances
8-103.11 – Documentation of Proposed Variance
and Justification
Granting of Variances
8-103.12 – Conformance with Approved
Procedures
6
7a
7b
7c
Information Authority; Restriction / Exclusion
of Employees
5c 8-501.30 – Restriction or Exclusion Order: Warning
or Hearing Not Required, Information Required
in Order
Information Authority; Restriction / Exclusion
of Employees
5b
8-501.20 – Restriction or Exclusion of Food
Employee, or Summary Suspension of Permit
Information Authority; Restriction / Exclusion
of Employees
5a 8-501.10 – Obtaining Information: Personal
History of Illness, Medical Examination, and
Specimen Analysis
Food Code
Section
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
Partial Compliance
1-67
List what is not covered
(Additional sheets can be used for
explanations and comments)
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Jurisdiction Does NOT Issue Variances
Food Code
Section
Timely Correction of Critical Violations
8-405.11 – Timely Correction
Timely Correction of Critical Violations
8-406.11 – Time Frame for Correction
Imminent Health Hazard (Summary of
Suspension)
8-904.10 – Conditions Warranting Action
License Suspension / Revocation
10a 8-905.10 – Response to Notice of Hearing or
Request for Hearing, Basis and Time Frame
9b
Imminent Health Hazard (Summary of
9a Suspension)
8-404.12 – Resumption of Operations
8c
Timely Correction of Critical Violations
8b 8-405.20 – Verification and Documentation of
Correction
8a
Variances Prohibited
7d (Variances Prohibited)
Item
No.
YES
Jurisdiction's
Corresponding
Full
Code Section,
Intent
Rule, etc.
is Met
1-68
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
Voluntary National Retail Food Regulatory Program Standards – January 2017
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
Food Code
Section
Institution of Proceedings
8-910.10 - Institution of Proceedings
Full
Intent
is Met
YES
List what is not covered
(Additional sheets can be used for
explanations and comments)
Partial Compliance
Compliance with the Food Code section is
NOT Met
(Indicate the Situation)
NO
1-69
NOTE:
1. Meeting the Standard #1 criteria for the “Compliance and Enforcement” component requires a “Yes” for all Food Code Sections listed in Items 1 through 11.
2. For Item 12 pertaining to legal remedies, the jurisdiction needs to demonstrate a corresponding regulatory requirement for only one of the sections pertaining
to criminal, injunctive, or civil penalties.
Civil Penalties Provided
12c 8-913.10 - Petitions, Penalties and
Continuing Violations
12b 8-912.10 - Petitions for Injunction
Criminal Penalties
12a 8-911.10 - Authorities, Methods, Fines
and Sentences
11a
License Suspension / Revocation
8-905.20 - Response to Notice of Hearing
10b
or Request for Hearing, Required Form
and Contents
Item
No.
Jurisdiction's
Corresponding
Code Section,
Rule, etc.
Voluntary National Retail Food Regulatory Program Standards – January 2017
Inspection Authority / Right to Access
Information Authority; Restriction / Exclusion
of Employees
Authority to Require HACCP Plans
Granting of Variances / Variances Prohibited
Timely Correction of Critical Violations
Imminent Health Hazard
(Summary of Suspension)
License Suspension / Revocation
Highly Susceptible Populations
Legal Remedies
4
5
6
7
8
9
10
11
12
(Regulatory Agency)
Plan Review / Pre-operational Inspections
3
YES
Standard
Criteria
is Met
NO
Standard
Criteria
is not Met
indicates conformance with
Permit / License Required; Right to Deny
2
Assessment of
Hold Orders, Embargo, and Destruction
of Food
Compliance and Enforcement
Program Description
1
Compliance
and
Enforcement
Area
1-70
(# Met)
out of the 12 Compliance and Enforcement Categories
Self-Assessor's General Comments
Part III – Compliance and Enforcement
Self-Assessment Results
Standard 1: Regulatory Foundation
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A VERIFICATION AUDIT
STANDARD 1 - REGULATORY FOUNDATION
Part I – Food Code Interventions and Risk Factor Controls
STEP 1 – Confirm Completion of the Self-Assessment for the Program’s Regulatory Foundation
The jurisdiction’s review of its food code against the Food Code should include documentation that a
that a side-by-side comparison of its prevailing statutes, regulations, rules, and other pertinent
requirements was completed. If a jurisdiction adopted the current published edition or one of the two
most recent editions of the Food Code by reference, a side-by-side comparison of the language is not
necessary. Adoption by reference meets the criteria of the Standard.
The jurisdiction’s side-by-side comparison must include an assessment of the following items:
1. The major Food Code Public Health Intervention and Risk Factor control measures;
2. Good Retail Practices;
3. Compliance and Enforcement administrative requirements.
The side-by-side comparison should clearly identify the jurisdiction's corresponding requirements to the
applicable Food Code section.
STEP 2 – Determine Food Code Interventions and Risk Factor Controls Sections to Review
The verification auditor must randomly select Food Code sections to review. The auditor should only
review public health interventions and risk factor control categories that the jurisdiction reported as
meeting on Part I of their Standard 1: Self-Assessment Worksheet. Part I of the jurisdiction's Standard
1: Self-Assessment Worksheet contains 93 Food Code sections pertaining to Public Health Interventions
and Risk Factor Controls. Each of these Food Code sections has been assigned a number from 1 to 93.
For Part I, the verification auditor must randomly select 15 Food Code sections for the review. A list of
random numbers can be obtained from the following web link: www.randomizer.org. Using the
jurisdiction's Standard 1: Self-Assessment Worksheet, the verification auditor must identify the Food
Code sections that correspond to the randomly selected numbers recorded on the verification audit
worksheet. This worksheet is included at the end of these instructions.
The auditor should only review those Food Code sections that the jurisdiction indicates were met. If a
Public Health Intervention or Risk Factor Control Food Code section is selected that the jurisdiction
indicated was not met, the verification auditor should select a substitute Food Code section to review.
STEP 3 – Confirm Findings for Food Code Interventions and Risk Factor Controls
The auditor must review the randomly selected regulatory requirements. The auditor must compare
the language in each of the selected jurisdiction code sections to verify that it is at least as stringent
1-71
Voluntary National Retail Food Regulatory Program Standards – January 2017
as the corresponding Food Code section language. The language may be more stringent, but not less
stringent. Record an "X" in the appropriate box on the Standard 1: Verification Audit Worksheet based
on the determination.
Yes - Full Intent is Met
or
No - Full Intent is not Met
In instances where the verification auditor has determined that the jurisdiction’s language does not
meet the criterion, an explanation must be provided on the Standard 1: Verification Audit Worksheet.
Record the explanation under the column “If No, Auditor is to specify why the criterion is not met.”
STEP 4 – Document the Verification Audit Results for Part I
Part I of the Standard 1: Self-Assessment Worksheet, included at the end of these instructions, contains
11 public health interventions and risk factor controls:
1. Demonstration of Knowledge
2. Employee Health
3. Consumer Advisory
4. Approved Source
5. Time/Temperature
6. Protection from Contamination
7. Control of Hands as a Vehicle of Contamination
8. Good Hygienic Practices
9. Chemical
10. Conformance with Approved Procedures
11. Highly Susceptible Population
To meet any one of the 11 public health intervention and risk factor controls identified under the
self-assessment process, the self-assessment must indicate that the jurisdiction’s regulatory
requirements address all Food Code sections listed for that area. For initial listing, the jurisdiction's
regulatory foundation must contain at least 9 of the 11 public health interventions and risk factor
controls. In order to fully meet the requirement of the Standard, the regulatory foundation must meet all
11 of the interventions and risk factor controls by the third verification audit cycle.
If four or more of the 15 selected code sections reviewed during the audit process do not meet the
stringency of language criteria, the Standard 1, Part I element fails to meet the criteria, and no further
sampling is necessary. If one, two or three of the 15 selected code sections do not meet the stringency of
the language criteria but the jurisdiction continues to meet the required number of interventions and risk
factor controls to meet the Standard, then randomly select an additional 15 Food Code sections. No
more than three total disagreements are acceptable in the thirty (30) Code sections drawn for comparison
in order for the audit to confirm the Part I element of Standard 1 as met. In addition, at least 9 out of the
11 interventions and risk factor controls must still be met at the end of the first audit after the
disagreements are taken into account, and the jurisdiction must meet 11 out of the 11 interventions and
risk factor controls by the third regular audit in order to meet the Standard 1 criteria.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Examples of documents that may be reviewed:
The jurisdiction’s statute, regulation, rule, ordinance or other prevailing set of regulatory
requirements that govern the operation of its food establishments
Version of the FDA Food Code that was used for the self-assessment
Completed Standard 1: Self-Assessment Worksheet, Part I – Food Code Interventions and
Risk Factor Controls
If applicable, documents discussing or comparing code provisions excepted if adoption was
made by reference with exceptions.
1-73
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
Number of
Sections
Reviewed
Jurisdiction's
Corresponding
Code Section,
Rule, etc.
YES
Full
Intent
is Met
NO
Full
Intent is
not Met
If no, auditor must specify why criterion is not met
1-74
NOTES
1. If there is Agreement that ALL 15 selected code sections meet the stringency of the language criteria in the FDA Food Code, proceed to Part II.
2. If one, two or three of the 15 selected code sections do not meet the stringency of the language criteria in the FDA Food Code, then complete the
Supplemental Part I Section of the Worksheet by randomly selecting another 15 Interventions and Risk Factor code sections to review.
3. If four or more of the 15 selected code sections do not meet the stringency of the language criteria in the FDA Food Code, then the jurisdiction does
not meet the Standard 1 criteria for Food Code Interventions and Risk Factors.
Corresponding Food Code
Randomly
Chapter from Part I
Selected
Interventions and Risk Factors
Number
Self-Assessment Worksheet
Part I – Interventions and Risk Factors
Part I – Food Code Interventions and Risk Factor Controls
Standard 1: Regulatory Foundation
Verification Audit Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
Number of
Sections
Reviewed
Jurisdiction's
Corresponding
Code Section,
Rule, etc.
YES
Full
Intent
is Met
NO
Full
Intent is
not Met
If no, auditor must specify why criterion is not met
1-75
NOTES
1. If more than three of the 30 total selected code sections do not meet the stringency of the language criteria in the FDA Food Code, then the jurisdiction
does not meet the Standard 1 criteria for Food Code Interventions and Risk Factors.
Corresponding Food Code
Randomly
Chapter from Part I
Selected
Interventions and Risk Factors
Number
Self-Assessment Worksheet
Part I – Interventions and Risk Factors
Supplement to Part I – Food Code Interventions and Risk Factor Controls
Standard 1: Regulatory Foundation
Verification Audit Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A VERIFICATION AUDIT
STANDARD 1 - REGULATORY FOUNDATION
Part II – Good Retail Practices
STEP 1 – Review the Self-Assessment conducted for Good Retail Practices
To meet the Standard 1 criteria for Good Retail Practices, a jurisdiction’s regulations must have a
corresponding requirement for 95 percent of the Food Code sections listed in Part II of the SelfAssessment Worksheet. The auditor must examine the jurisdiction’s Standard 1: Self-Assessment
Worksheet to verify that an assessment has been made for each of the 246 Good Retail Food Practices
Food Code sections. The auditor must determine if the jurisdiction identified at least 234 Food Code
sections (95%) that meet the criteria for stringency of language compared to the Food Code.
STEP 2 – Determine Good Retail Practices Sections to Review
The verification auditor must randomly select 13 Food Code sections as part of the Part II review
process for Good Retail Practices. A list of random numbers can be obtained from the "Randomizer"
web link: www.randomizer.org. Using the jurisdiction's self-assessment worksheet, the verification
auditor must identify the Food Code sections that correspond to the randomly selected numbers recorded
on the Part II - Good Retail Practices Verification Audit Worksheet. The worksheet is included at the
end of the instructions.
The auditor should only review those Food Code sections that the jurisdiction indicated were met. If a
Good Retail Practice Food Code section is selected that the jurisdiction indicated was not met, the
verification auditor should select a substitute Food Code section to review.
STEP 3 – Confirm Findings for Good Retail Practices
The auditor must review the randomly selected Food Code sections. The auditor must compare the
language in each of the selected jurisdiction food code sections to verify that it is at least as stringent as
the corresponding FDA Food Code section language. The language may be more stringent, but not less
stringent. Record an “X” in the appropriate box based on the determination.
Yes - Full Intent is Met
or
No - Full Intent is not Met
In instances where the verification auditor determined that the jurisdiction’s language does not meet the
criterion, an explanation must be provided on the Verification Audit Worksheet. The auditor must
record the explanation under the column “If No, Auditor is to specify why the criterion is not met.”
STEP 4 – Document the Verification Audit Results for Part I
To meet the Part II – Good Retail Practices element of Standard 1, the jurisdiction’s regulatory
requirements must have a corresponding requirement for 95 percent of the FDA Food Code sections
listed in Part II of the Standard 1: Self-Assessment Worksheet.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
If four or more of the 13 selected Food Code sections do not meet the stringency of language criteria,
the Part II element fails to meet the criteria, and no further sampling is necessary. If one, two or three of
the 13 selected food code sections do not meet the stringency of the language criteria, then the auditor
must randomly select an additional 13 Food Code sections. No more than three total disagreements are
acceptable in the twenty-six (26) food code sections drawn for comparison in order for the audit to
confirm that the Part II element of Standard 1 was met.
Examples of documents that may be reviewed:
The jurisdiction’s statute, regulation, rule, ordinance, or other prevailing set of regulatory
requirements that govern the operation of its food establishments
Version of the Food Code that was used for the self-assessment
Completed Standard 1: Self-Assessment Worksheet
* Part II – Good Retail Practices
If applicable, documents discussing or comparing code provisions excepted if adoption was
made by reference with exceptions.
1-77
13
12
11
10
9
8
7
6
5
4
3
2
1
Number of
Sections
Reviewed
Corresponding Food Code
Chapter from Part II
Good Retail Practices
Self-Assessment Worksheet
Jurisdiction's
Corresponding
Code Section,
Rule, etc.
YES
Full
Intent
is Met
NO
Full
Intent is
not Met
If no, auditor must specify why criterion is not met
1-78
1. If there is agreement that ALL 13 selected code sections meet the stringency of the language criteria in the FDA Food Code, proceed to Part III.
2. If one, two or three of the 13 selected code sections do not meet the stringency of the language criteria in the FDA Food Code, then complete the Supplemental Part II section
of the worksheet by randomly selecting another 13 Good Retail Food Practices code sections to review.
3. If four or more of the 13 selected code sections do not meet the stringency of the language criteria in the Food Code, then the jurisdiction does not meet the Standard 1 criteria
for Part II Good Retail Food Practices.
NOTES
Randomly
Selected
Number
Part II – Good Retail Practices
Standard 1: Regulatory Foundation
Verification Audit Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
13
12
11
10
9
8
7
6
5
4
3
2
1
Number of
Sections
Reviewed
Jurisdiction's
Corresponding
Code Section,
Rule, etc.
YES
Full
Intent
is Met
NO
Full
Intent is
not Met
If no, auditor must specify why criterion is not met
1-79
1. If more than three of the 26 total selected code sections do not meet the stringency of the language criteria in the Food Code, then the jurisdiction does not meet the
Standard 1 criteria for Good Retail Practices.
NOTES
Corresponding Food Code
Randomly
Chapter from Part I
Selected
Interventions and Risk Factors
Number
Self-Assessment Worksheet
Supplement to Part II – Good Retail Practices
Standard 1: Regulatory Foundation
Verification Audit Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A VERIFICATION AUDIT
STANDARD 1 - REGULATORY FOUNDATION
Part III – Compliance and Enforcement
STEP 1 – Review the Self-Assessment conducted for Compliance and Enforcement Food Code
provisions
The jurisdiction’s self-assessment of their Compliance and Enforcement provisions must indicate that
it has a corresponding regulatory requirement for the Food Code sections listed in Items 1 through 12
on Part III of the Standard 1: Self-Assessment Worksheet. For Items 1 through 11, a jurisdiction must
demonstrate its regulations have a corresponding provision or language for all the Food Code sections
listed. For Item 12, a jurisdiction need only demonstrate that its regulatory foundation provides the
authority to implement one of the following three Food Code legal remedies pertaining to criminal,
injunctive, or civil penalties:
8-911.10 – Authorities, Methods, Fines and Sentences
8-912.10 – Petitions for Injunction
8-913.10 – Petitions, Penalties and Continuing Violations
STEP 2 – Determine Food Code Compliance and Enforcement Sections to Review
The verification auditor must randomly select five Compliance and Enforcement areas for the review
process. A list of random numbers can be obtained from the “Randomizer” web link: www.randomizer.
org. Using Part III of the jurisdiction’s Standard 1: Self-Assessment Worksheet, the verification auditor
will identify the Food Code sections that correspond to the randomly selected number recorded on Part
III of the Standard 1: Verification Audit Worksheet. This worksheet is included at the end of these
instructions.
When conducting a verification audit, the auditor will randomly select 5 of the 11 compliance and
enforcement areas to review. For each selected area, the jurisdiction must demonstrate its regulations
have a corresponding provision(s) or language for each Food Code section listed under that area.
In the case of Item 12, pertaining to "Legal Remedies", three Food Code sections comprise this
Compliance and Enforcement area. A jurisdiction must demonstrate a corresponding regulatory
requirement for one one of the Food Code sections pertaining to criminal, injunctive, or civil penalties.
STEP 3 – Confirm Findings for Food Code Compliance and Enforcement Sections
The auditor must review the randomly selected Food Code sections. The auditor must compare the
language in each of the selected jurisdiction code sections to verify that it is at least as stringent as the
corresponding Food Code section language. The language may be more stringent, but not less stringent.
Record an “X” in the appropriate box based on the determination.
Yes - Full Intent is Met
or
No - Full Intent is not Met
1- 80
Voluntary National Retail Food Regulatory Program Standards – January 2017
In instances where the verification auditor determined that the jurisdiction’s language does not meet
the criterion, an explanation must be provided on the Verification Audit Worksheet. The auditor must
record the explanation under the column “If No, Auditor is to specify why the criterion is not met.”
Examples of documents that may be reviewed:
The jurisdiction’s statute, regulation, rule, ordinance, or other prevailing set of regulatory
requirements that govern the operation of its food establishments
Version of the FDA Food Code that was used for the self-assessment
Completed Standard 1: Self-Assessment Worksheet, Part III – Compliance and Enforcement
If applicable, documents discussing or comparing code provisions excepted if adoption was
made by reference with exceptions.
Summary for the Standard 1 – Regulatory Foundation Verification Audit
At the conclusion of the verification audit process, the jurisdiction’s Verification Audit Worksheet
must indicate that it meets the criteria in all three Parts of the Standard in order to fully meet the
Standard I requirement.
Part 1: Control of Foodborne Illness Public Health Interventions and Risk Factor Controls
Part II: Good Retail Practices
Part III: Compliance and Enforcement Administrative Provisions
1-81
Randomly
Selected
Number
Corresponding Food Code Chapter
from Part III
Compliance and Enforcement
Self-Assessment Worksheet
Jurisdiction's
Corresponding
Code Section,
Rule, etc.
YES
Full
Intent
is Met
NO
Full
Intent is
not Met
If no, auditor must specify why criterion is not met
1-82
1. Some Compliance and Enforcement Areas contain multiple Food Code Sections. List all the pertinent Food Code Sections listed on the Self-Assessment Worksheet for
each of the Compliance and Enforcement areas that are randomly selected.
2. Meeting the Standard 1 criteria for the "Compliance and Enforcement" component requires a "Yes" for all Food Code sections listed in Items 1 through 11. For Item 12 pertaining to
legal remedies, the jurisdiction needs to demonstrate a corresponding regulatory requirement for only one of the sections pertaining to criminal, injunctive, or civil penalties.
3. If there is agreement that ALL code sections within the 5 selected "Compliance and Enforcement" components meet the stringency of the language criteria in the FDA Food Code, the
Standard 1 criteria is met for Part III.
4. If one or more of the code sections within the 5 selected "Compliance and Enforcement" components do not meet the stringency of the language criteria in the FDA Food Code, the
the jurisdiction does not meet the Standard 1 criteria for Part III.
NOTE
5
4
3
2
1
Number of
Sections
Reviewed
Part III – Compliance and Enforcement
Standard 1: Regulatory Foundation
Verification Audit Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 2
TRAINED REGULATORY STAFF
Table of Contents
REQUIREMENT SUMMARY ......................................................................................................................................... 2
DESCRIPTION OF REQUIREMENT ................................................................................................................................ 2
Step 1: Pre-Inspection Curriculum...................................................................................................................... 3
Step 2: Initial Field Training and Experience ..................................................................................................... 4
Step 3: Independent Inspections and Completion of ALL Curriculum Elements .................................................6
Step 4: Food Safety Inspection Officer – Field Standardization .........................................................................7
Step 5: Continuing Education and Training........................................................................................................ 8
OUTCOME.................................................................................................................................................................. 9
DOCUMENTATION ..................................................................................................................................................... 9
2-1
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 2
TRAINED REGULATORY STAFF
This Standard applies to the essential elements of a training program for regulatory staff.
Requirement Summary
The regulatory retail food program inspection staff (Food Safety Inspection Officers - FSIO) shall have
the knowledge, skills, and ability to adequately perform their required duties. The following is a
schematic of a 5-step training and standardization process to achieve the required level of competency.
STEP 1
Completion of curriculum courses designated as “Pre” in Appendix B-1 prior to conducting and
independent routine inspections.
STEP 2
Completion of the following:
• A minimum of 25 joint field training inspections (or a sufficient number of joint inspections
determined by the trainer and verified through written documentation that the FSIO has
demonstrated all performance elements and competencies to conduct independent inspections of
retail food establishments); and
• Successful completion of the jurisdiction’s FSIO Field Training Plan similar to the process
outlined in Appendix B-2: Conference for Food Protection (CFP) Field Training Manual.
STEP 3
Completion of the following:
• A minimum of 25 independent inspections; and
• Remaining course curriculum (designated as “post” courses) outlined in Appendix B-1:
Curriculum for Retail Food Safety Inspection Officers.
STEP 4
Completion of a standardization process similar to the FDA standardization procedures.
STEP 5
Completion of 20 contact hours of continuing food safety education every 36 months after the initial
training is completed.
Description of Requirement
Ninety percent (90 %) of the regulatory retail food program inspection staff (Food Safety Inspection
Officers - FSIO) shall have successfully completed the required elements of the 5-step training and
standardization process:
• Steps 1 through 4 within 18 months of hire or assignment to the retail food regulatory program.
• Step 5 every 36 months after the initial 18 months of training.
2-2
Voluntary National Retail Food Regulatory Program Standards – January 2017
Step 1: Pre-Inspection Curriculum
Prior to conducting any type of independent field inspections in retail food establishments, the FSIO
must satisfactorily complete training in pre-requisite courses designated with a “Pre” in Appendix B-1,
for the following curriculum areas:
1.
Prevailing statutes, regulations, ordinances (specific laws and regulations to be addressed
by each jurisdiction);
2.
Public Health Principles;
3.
Food Microbiology; and
4.
Communication Skills.
There are two options for demonstrating successful completion of the pre-inspection curriculum.
OPTION 1: Completion of the pre-inspection curriculum may be demonstrated by successful
completion of the following:
• FDA ORA U pre-requisite courses identified as “Pre” in Appendix B-1; and
• Training on the jurisdiction’s prevailing statutes, regulations, and/or ordinances.
Note: The estimated contact time for completion of the FDA ORA U pre-requisite (“Pre”)
courses is 42 hours.
OPTION 2: Completion of the pre-inspection curriculum may be demonstrated by successful
completion of the following:
• Successful completion of courses deemed by the regulatory jurisdiction’s food
program supervisor or training officer to be equivalent to the FDA ORA U prerequisite (Pre”) courses; and
• Training on the jurisdiction’s prevailing statutes, regulations, and/or ordinances; and
• Successful passing of one of the four written examination options (described later in
this Standard) for determining if a FSIO has a basic level of food safety knowledge.
A course is deemed equivalent if it can be demonstrated that it covers at least 80% of the learning
objectives of the comparable ORA U course AND verification of successful completion is provided.
The learning objectives for each of the listed ORA U courses are available from the web site link at:
http://www.fda.gov/Training/ForStateLocalTribalRegulators/ucm121831.htm
Note: While certificates issued by course sponsors are the ideal proof of attendance, other
official documentation can serve as satisfactory verification of attendance. The key to a
document’s acceptability is that someone with responsibility, such as a trainer/food program
manager who has first-hand knowledge of employee attendance at the session, keeps the
records according to an established protocol. An established protocol can include such items
as:
• Logs/records that are completed based on sign-in sheets; or
• Information validated from the certificate at the time-of-issuance; or
• A college transcript with a passing grade or other indication of successful
completion of the course; or
• Automated attendance records, such as those currently kept by some
professional associations and state agencies, or
2-3
Voluntary National Retail Food Regulatory Program Standards – January 2017
• Other accurate verification of actual attendance.
Regulatory retail food inspection staff submitting documentation of courses equivalent to the FDA ORA
U courses – OPTION 2 – must also demonstrate a basic level of food safety knowledge by successfully
passing one examination from the four written examination categories specified herein.
1.
The Certified Food Safety Professional examination offered by the National Environmental
Health Association; or
2.
A state sponsored food safety examination that is based on the current version of the FDA
Food Code (and supplement) and is developed using methods that are psychometrically
valid and reliable; or
3.
A food manager certification examination provided by an ANSI/CFP accredited
certification organization; or
4.
A Registered Environmental Health Specialist or Registered Sanitarian examination offered
by the National Environmental Health Association or a State Registration Board.
Note: Written examinations are part of a training process, not a standardization/certification
process. The examinations listed are not to be considered equivalent to each other. They are
to be considered as training tools and have been incorporated as part of the Standard because
each instrument will provide a method of assessing whether a FSIO has attained a basic level
of food safety knowledge. Any jurisdiction has the option and latitude to mandate a particular
examination based on the laws and rules of that jurisdiction.
Step 2: Initial Field Training and Experience
The regulatory staff conducting inspections of retail food establishments must conduct a minimum of 25
joint field inspections with a trainer who has successfully completed all training elements (Steps 1 – 3)
of this Standard. The 25 joint field inspections are to be comprised of both “demonstration” (trainer led)
and “training” (trainee led) inspections and include a variety of retail food establishment types available
within the jurisdiction.
If the trainer determines that the FSIO has successfully demonstrated the required performance elements
and competencies, a lower minimum number of joint field training inspections can be established for
that FSIO provided there is written documentation, such as the completion of the CFP Field Training
Plan in Appendix B-2, to support the exception.
Note: The CFP Field Training Manual is available for the Conference for Food Protection
web site: http://www.foodprotect.org/ and is located under the icon titled “Conference
Developed Guides and Documents.”
Demonstration inspections are those in which the jurisdiction’s trainer takes the lead and the candidate
observes the inspection process. Training inspections are those in which the candidate takes the lead
and their inspection performance is assessed and critiqued by the trainer. The jurisdiction’s trainer is
2-4
Voluntary National Retail Food Regulatory Program Standards – January 2017
responsible for determining the appropriate combination of demonstration and training inspections based
on the candidate’s food safety knowledge and performance during the joint field inspections.
The joint field inspections must be conducted using a field training process and forms similar to ones
presented in the CFP Field Training Manual included as Appendix B-2. The CFP Field Training
Manual consists of a training plan and log, trainer’s worksheets, and procedures that may be
incorporated into any jurisdiction’s retail food training program. It is a national model upon which
jurisdictions can design basic field training and provides a method for FSIOs to demonstrate
competencies needed to conduct independent inspections of retail food, restaurant and institutional
foodservice establishments.
Jurisdictions are not required to use the forms or worksheets provided in the CFP Field Training
Manual. Equivalent forms or training processes can be developed. To meet the intent of the Standard,
documentation must be maintained that confirms FSIOs are trained on, and have demonstrated, the
performance element competencies needed to conduct independent inspections of retail food and/or
foodservice establishments.
Note: The CFP Field Training Manual is designed as a training approach providing a
structure for continuous feedback between the FSIO and trainer on specific knowledge, skills,
and abilities that are important elements of effective retail food, restaurant, and institutional
foodservice inspections.
• The CFP Field Training Manual is NOT intended to be used for certification or
licensure purposes.
• The CFP Field Training Manual is NOT intended to be used by regulatory
jurisdictions for administrative purposes such as job classifications, promotions,
or disciplinary actions.
FSIOs must successfully complete a joint field training process, similar to that presented in the CFP
Field Training Manual, prior to conducting independent inspections and re-inspections of retail food
establishments in risk categories 2, 3, and 4 as presented in Appendix B-3 (taken from Annex 5, Table 1
of the 2013 FDA Food Code). The jurisdiction’s trainer/food program manager can determine if the
FSIO is ready to conduct independent inspections of risk category 1 establishments (as defined in
Appendix B-3) at any time during the training process.
Note: The criterion for conducting a minimum of 25 joint field training inspections is intended
for new employees or employees new to the food safety program. In order to accommodate an
experienced FSIO, the supervisor/training officer can in lieu of the 25 joint field inspections:
• Include a signed statement or affidavit in the employee’s training file explaining
the background or experience that justifies a waiver of this requirement; and
• The supervisor/training officer must observe experienced FSIOs conduct
inspections to determine any areas in need of improvement. An individual
corrective action plan should be developed outlining how any training
deficiencies will be corrected and the date when correction will be achieved.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Step 3: Independent Inspections and Completion of ALL Curriculum Elements
Within 18 months of hire or assignment to the regulatory retail food program, Food Safety Inspection
Officers must complete a minimum of 25 independent inspections of retail food, restaurant, and/or
institutional foodservice establishments.
• If the jurisdiction’s establishment inventory contains a sufficient number of facilities, the FSIO
must complete 25 independent inspections of food establishments in risk categories 3 and 4 as
described in Appendix B-3.
• For those jurisdictions that have a limited number of establishments which would meet the risk
category 3 and/or 4 criteria, the FSIO must complete 25 independent inspections in food
establishments that are representative of the highest risk categories within their assigned
geographic region or training area.
In addition, all coursework identified in Appendix B-1, for the following six curricula areas, must be
completed within this 18 month time frame.
1. Prevailing statutes, regulations, ordinances (all courses for this element are part of the prerequisite curriculum outlined in Step 1);
2. Public health principles (all courses for this element are part of the pre-requisite curriculum
outlined in Step 1);
3. Communication skills (Step 1);
4. Food microbiology (some of the courses for this element are part of the pre-requisite
curriculum outlined in Step 1);
5. Epidemiology;
6. Hazard Analysis Critical Control Points (HACCP);
7. Allergen Management
8. Emergency Management
All courses for each of the curriculum areas must be successfully completed within 18 months of hire or
assignment to the regulatory retail food program in order for FSIOs to be eligible for the Field
Standardization Assessment.
Note: The estimated contact time for completion of the FDA ORA U “post” courses is 26
hours. The term “post” refers to those courses in Appendix B-1 that were not included as part
of the pre-requisite coursework. This includes all the courses in Appendix B-1 that do not have
the designation “Pre” associated with them. All courses in Appendix B-1 must be successfully
completed prior to conducting field standardizations.
As with the pre-requisite inspection courses, the coursework pertaining to the above six curriculum areas
can be successfully achieved by completing the ORA U courses listed under each curriculum area OR
by completing courses, deemed by the regulatory jurisdiction’s food program supervisor or training
officer to be equivalent to the comparable FDA ORA U courses.
A course is deemed equivalent if it can be demonstrated that it covers at least 80% of the learning
objectives of the comparable ORA U course AND verification of successful completion can be
provided. The learning objectives for each of the listed ORA U courses are available from the FDA
website: http://www.fda.gov/Training/ForStateLocalTribalRegulators/ucm121831.htm
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Step 4: Food Safety Inspection Officer – Field Standardization
Within 18 months of employment or assignment to the retail food program, staff conducting inspections
of retail food establishments must satisfactorily complete four joint inspections with a “training
standard” using a process similar to the “FDA Standardization Procedures.” The jurisdiction’s “training
standard” must have met all the requirements for conducting field standardizations as presented in the
definition section of these Standards. The standardization procedures shall determine the inspector’s
ability to apply the knowledge and skills obtained from the training curriculum, and address the five
following performance areas:
1.
2.
3.
4.
5.
Risk-based inspections focusing on the factors that contribute to foodborne illness;
Good Retail Practices;
Application of HACCP;
Inspection equipment; and
Communication.
Continuing standardization (re-standardization) shall be maintained by performing four joint inspections
with the "training standard" every three years.
Note: The field standardization and continuing standardization (re-standardization) criteria
described in Step 4 is intended to provide a jurisdiction the flexibility to use their own
regulation or ordinance. In addition, the reference to using standardization procedures similar
to the FDA Procedures for Standardization of Retail Food Inspection Training Officers, is
intended to allow the jurisdiction the option to develop its own written protocol to ensure that
personnel are trained and prepared to competently conduct inspections. Any written
standardization protocol must include the five performance areas outlined above in Step 4.
It is highly beneficial to use the FDA Food Code, standardization forms and procedures even
when a jurisdiction has adopted modifications to the Food Code. Usually regulatory
differences can be noted and discussed during the exercises, thereby enhancing the knowledge
and understanding of the candidate. The scoring and assessment tools presented in the FDA
standardization procedures can be used without modification regardless of the Food Code
enforced in a jurisdiction. The scoring and assessment tools are, however, specifically tied to
the standardization inspection form and other assessment forms that are a part of the FDA
procedures for standardizations.
FDA’s standardization procedures are based on a minimum of 8 inspections. However to meet
Standard 2, a minimum of 4 standardization inspections must be conducted.
Jurisdictions that modify the limits of the standardization process by reducing the minimum
number of inspections from 8 to 4 are cautioned that a redesign of the scoring assessment of
the candidate’s performance on the field inspections is required. This sometimes proves to be a
very difficult task. A jurisdiction must consider both the food safety expertise of its staff, as
well as the availability of personnel versed in statistical analysis before it decides to modify the
minimum number of standardization inspections. The jurisdiction’s standardization
procedures need to reflect a credible process and the scoring assessment should facilitate
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Voluntary National Retail Food Regulatory Program Standards – January 2017
consistent evaluation of all candidates.
The five performance areas target the behavioral elements of an inspection. The behavioral
elements of an inspection are defined as the manner, approach and focus which targets the
most important public health risk factors, and communicates vital information about the
inspection in a way that can be received, understood and acted upon by retail food
management. The goal of standardization is to assess not only technical knowledge but also an
inspector’s ability to apply his or her knowledge in a way that ensures the time and resources
spent within a facility offer maximum benefit to both the regulatory agency and the consuming
public. Any customized standardization procedure must continue to meet these stated targets
and goals.
Should a jurisdiction fall short of having 90% of its retail food program inspection staff successfully
complete the Program Standard 2 criteria within the 18 month time frame, a written protocol must be
established to provide a remedy so that the Standard can be met. This protocol would include a
corrective action plan outlining how the situation will be corrected and the date when the correction will
be achieved.
Step 5: Continuing Education and Training
A FSIO must accumulate 20 contact hours of continuing education in food safety every 36 months after
the initial training (18 months) is completed. Within the scope of this standard, the goal of continuing
education and training is to enhance the FSIO’s knowledge, skills, and ability to perform retail food and
foodservice inspections. The objective is to build upon the FSIO’s knowledge base. Repeated
coursework should be avoided unless justification is provided to, and approved by, the food program
manager and/or training officer.
Training on any changes in the regulatory agency’s prevailing statutes, laws and/or ordinances must be
included as part of the continuing education (CE) hours within six months of the regulatory change.
Documentation of the regulatory change date and date of training must be included as part of the
individual’s training record.
The candidate qualifies for one contact hour of continuing education for each clock hour of participation
in any of the following nine activities that are related specifically to food safety or food inspectional
work:
1.
2.
3.
4.
5.
Attendance at FDA Regional seminars / technical conferences;
Professional symposiums / college courses;
Food-related training provided by government agencies (e.g., USDA, State, local);
Food safety related conferences and workshops; and
Distance learning opportunities that pertain to food safety, such as:
• Web based or online training courses (e.g., additional food safety courses offered
though ORA U, industry associations, universities); and
• Satellite Broadcasts.
A maximum of ten (10) contact hours may be accrued from the following activities:
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Voluntary National Retail Food Regulatory Program Standards – January 2017
6. Delivering presentations at professional conferences;
7. Providing classroom and/or field training to newly hired FSIOs, or being a course instructor
in food safety; or
8. Publishing an original article in a peer-reviewed professional or trade association
journal/periodical.
Contact hours for a specified presentation, course, or training activity will be recognized only one time
within a 3-year continuing education period 1.
Note: Time needed to prepare an original presentation, course, or article may be included as
part of the continuing education hours. If the FSIO delivers a presentation or course that has
been previously prepared, only the actual time of the presentation may be considered for
continuing education credit.
A maximum of four (4) contact hours may be accrued for:
9. Reading technical publications related to food safety.
Documentation must accompany each activity submitted for continuing education credit. Examples of
acceptable documentation include:
• certificates of completion indicating the course date(s) and number of hours attended or CE
credits granted;
• transcripts from a college or university;
• a letter from the administrator of the continuing education program attended;
• a copy of the peer-reviewed article or presentation made at a professional conference; or
• documentation to verify technical publications related to food safety have been read
including completion of self-assessment quizzes that accompany journal articles, written
summaries of key points/findings presented in technical publications, and/or written book
reports.
Note: The key to a document’s acceptability is that someone with responsibility, such as a
training officer or supervisor, who has first-hand knowledge of employee’s continuing
education activities, maintains the training records according to an established protocol
similar to that presented in Step 1 for assessing equivalent courses.
Outcome
The desired outcome of this Standard is a trained regulatory staff with the skills and knowledge
necessary to conduct quality inspections.
Documentation
The quality records needed for this standard include:
1. Certificates or proof of attendance from the successful completion of all the course elements
identified in the Program Standard curriculum (Steps 1 and 3);
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Voluntary National Retail Food Regulatory Program Standards – January 2017
2. Documentation of field inspection reports for twenty-five each joint and independent
inspections (Steps 2 and 3);
3. Certificates or other documentation of successful completion of a field training process
similar to that presented in Appendix B-2. NOTE: The CFP Field Training Manual is
available for the Conference for Food Protection web site: http://www.foodprotect.org/ and is
located under the icon titled “Conference Developed Guides and Documents.”
4. Certificates or other records showing proof of satisfactory standardization (Step 4);
5. Contact hour certificates or other records for continuing education (Step 5);
6. Signed documentation from the regulatory jurisdiction’s food program supervisor or training
officer that food inspection personnel attended and successful completed the training and
education steps outlined in this Standard.
7. Date of hire records or assignment to the retail food program; and
8. Summary record of employees’ compliance with the Standard.
The Standard 2: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process for Standard 2.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS FOR COMPLETING
THE PROGRAM SELF-ASSESSMENT AND VERIFICATION AUDIT FORM
STANDARD 2 – TRAINED REGULATORY STAFF
Program Self-Assessment & Verification Audit Form
The Standard 2: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process for Standard 2. The form is included
at the end of these instructions. Whether one is performing a program self-assessment or conducting a
verification audit, it is recommended that the form be available as a reference to the Standards 2 criteria.
Using the Program Self-Assessment and Verification Audit Form
Documenting the Findings from the Self Assessment
Jurisdictions conducting a self-assessment of the “Trained Regulatory Staff” component of their retail
food protection program must indicate on the form if each of the Standard 2criterion is met. These
responses are recorded under the column, “Jurisdiction’s Self-Assessment.”
Jurisdictions are not obligated to use the form. An equivalent form or process is acceptable provided
that the results of the jurisdiction’s self-assessment for the specific Standard 2 criteria listed are
available for review.
The self-assessor will review each Standard 2 criterion and determine if the jurisdiction’s source
documents confirm that the Standard criteria are met. If the criteria are met, the self-assessor must place
an “X” in the “YES” box under the “Jurisdiction’s Self-Assessment”column of the Standard 2: Program
Self-Assessment and Verification Audit Form.
If a review of the jurisdiction’s source documents does not confirm that the Standard 2 criteria are met,
the self-assessor must place an “X” in the “NO” box under the “Jurisdiction’s Self-Assessment” column
of the Standard 2: Program Self-Assessment and Verification Audit Form. The self-assessor may
specify why the criteria are not met in the box provided.
The self-assessor should review the findings on the Standard 2: Program Self-Assessment and
Verification Form to ensure accuracy. The jurisdiction will be required to provide the auditor with their
completed Program Self-Assessment and Verification Audit Form and any documents used to support
and demonstrate that the Standard 2 criteria have been met.
Once all the Standard 2 criteria have been reviewed and staff training records documented on the form,
the self-assessor must complete the Program Self-Assessment Summary section on page one of the
Standard 2: Program Self-Assessment and Verification Audit Form. The self-assessor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 2 criteria in the appropriate boxes; and
•
Sign the form where indicated.
•
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Voluntary National Retail Food Regulatory Program Standards – January 2017
It then will be up to the jurisdiction to determine its action plan and time frame for correcting
any deficiencies in order to meet the Standard 2 criteria.
Documenting the Findings from the Verification Audit
The jurisdiction requesting the verification audit must provide their completed Standard 2: Program
Self-Assessment and Verification Audit Form to the auditor for review. Auditors must indicate on
the Standard 2: Program Self-Assessment and Verification Audit Form if each of the criterion were
met.
If a review of the jurisdiction’s source documents confirms the self-assessment conclusion that
the Standard criteria are met, the verification auditor places an “X” in the “YES” box under the
“Auditor’s Verification” column of the form.
If a review of the jurisdiction’s source documents does not confirm the self-assessment
conclusion that the Standard criteria are met, the verification auditor places and “X” in the
“NO” box under the “Auditor’s Verification” column of the form. The verification auditor
must specify why the criterion is not met in the box provided. Supplemental pages may be
used to explain findings.
To meet the Standard criteria, the jurisdiction must have demonstrated that 90% of their staff
assigned responsibilities for retail food and/or foodservice inspections successfully completed
the training curriculum, field training, field standardization, and continuing education requirements.
The verification auditor must discuss their findings with the program manager or their
appointed representative and provide constructive feedback at the conclusion of the on-site
visit. In particular, any Standard 2 criteria for which the auditor cannot confirm through a
review of the self-assessment should be thoroughly discussed. Ample time should be allotted
to ensure that there is a clear understanding of the reasons for the “non-conforming” finding.
The auditor should be prepared to identify the elements required for the jurisdiction to meet the
Standard.
Once the close out interview has been conducted, the auditor must complete the Verification
Audit Summary section located on the first page of the Standard 2: Program Self-Assessment and
Verification Audit Form. The auditor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 2 criteria in the appropriate boxes; and
•
•
Sign the form where indicated.
It then will be up to the jurisdiction to determine its action plan and time frame for correcting
any deficiencies in order to meet the Standard 2 criteria if the auditor does not confirm the selfassessment findings.
2-12
FAX:
FAX:
Signature of the Verification Auditor:
2-13
I affirm that the information represented in the Verification Audit of Standard 2 is true and correct
Verification Audit indicates that the Jurisdiction MEETS the Standard 2 criteria: YES
Date the Verification Audit of Standard 2 was Completed:
Auditor’s Jurisdiction Address:
Phone:
Auditor’s Jurisdiction Name:
Verification Auditor’s Title:
NO
NO
VERIFICATION AUDIT SUMMARY
Printed Name of the Person who conducted the Verification Audit:
Signature of the Self-Assessor:
I affirm that the information represented in the Self-Assessment of Standard 2 is true and correct
Self-Assessment indicates that the Jurisdiction MEETS the Standard 2 criteria: YES
Date the Standard 2 Self-Assessment was Completed:
Jurisdiction Address:
Phone:
Jurisdiction Name:
Self-Assessor's Title:
Printed Name of the Person who conducted the Self-Assessment:
E-mail:
E-mail:
PROGRAM SELF-ASSESSMENT SUMMARY
Standard 2: Trained Regulatory Staff
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
a) The jurisdiction maintains a written training record
that provides confirmation that each employee
completed a minimum of 25 joint field training
inspections of retail food and/or foodservice
establishments (if less than 25 joint field training
inspections are performed, written documentation on
file that FSIO has successfully demonstrated all
required inspection competencies) PRIOR to
conducting retail food or foodservice inspections.
2. Initial Field Training
b) The jurisdiction written training record provides
documentation that each employee has completed the
Standard 2 prerequisite ("Pre") training curriculum
PRIOR to conducting independent retail food or
foodservice inspections.
a) The jurisdiction maintains a written training record
for each employee that includes the date or hire or
assignment to the agency's retail food protection
program.
1. Employee Training Records
Criteria
Jurisdiction Name:
YES
NO
2-14
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
Standard 2: Trained Regulatory Staff
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
Self-Assessor's
General Comments
a) The jurisdiction maintains a written training record
that provides documentation that each employee
successfully completed a Standardization process
similar to the FDA Procedures for Standardization
within 18 months of hire or assignment to the retail
food protection program.
4. Field Standardization
b) The jurisdiction's written training record provides
documentation that each employee has completed
ALL aspects of the Standard #2 training curriculum
("Pre") and ("Post") courses prior to field
standardization.
a) The jurisdiction maintains a written training record
that provides confirmation that each employee
completed a minimum of 25 independent retail food
and/or foodservice inspections PRIOR to field
standardization.
2-15
3. Independent Inspections / Completion of ALL Curriculum Requirements
b) The jurisdiction maintains a written training record
that provides confirmation that each employee
successfully completed a field training process
similar to that contained in the CFP Field Training
Manual provided in Appendix B-2, Standard 2,
PRIOR to conducting independent inspections of
retail food and/or foodservice establishments.
Criteria
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
a) The jurisdiction maintains a written training record
that provides document that each employee
conducting retail food and/or foodservice inspections
has accumulated 20 hours of continuing education
every 36 months after the initial training (18) months
is completed.
5. Continuing Education and Training
a) The jurisdiction maintains a written training record
that provides documentation that each standardized
employee has maintained their standardization by
performing a minimum of 4 joint inspections with a
"training standard" every 3 years.
Criteria
YES
NO
2-16
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
2-17
GENERAL NOTES PERTAINING TO THE PROGRAM SELF-ASSESSMENT OR THE VERIFICATION AUDIT
Standard 2: Trained Regulatory Staff
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A SELF-ASSESSMENT
STANDARD 2 – TRAINED REGULATORY STAFF
STEP 1 – Document Employee Training Records
The jurisdiction should document and retain a training record for each employee. The training record
must include the date of hire or assignment to the retail food program. The Standard 2: Self-Assessment
Worksheet may be used by the jurisdiction as a training record. The worksheet is included at the end of
these instructions. In lieu of the Standard 2 Self-Assessment Worksheet, other manual forms or
automated records may be used by the jurisdiction to retain training records related to the selfassessment as long as the information required in the Standard 2 criteria is documented in some manner.
STEP 2 – Document Employees Completion of Pre-Requisite “Pre” Training Curriculum
Standard 2 requires the FSIO to complete the pre-requisite coursework listed in Appendix B-1 prior to
conducting independent inspections of retail food establishments. The program areas covered in the
pre-requisite coursework include training on prevailing statutes, regulations, ordinances; public health
principles; communication skills, and microbiology. The date each employee fully completed the
Standard 2 pre-requisite curriculum must berecorded on the Standard 2 Self-Assessment Worksheet.
STEP 3 – Document Employees Completion of Initial Field Training
Standard 2 requires a minimum of 25 joint field training inspections to be conducted with a trainer who
has successfully completed all the Standard 2 training elements (Steps 1 – 3). The joint field training
inspections must be completed prior to conducting independent inspections of retail food establishments.
The joint field inspections must be conducted using a field training process, established by the
jurisdiction, similar to the one presented in the CFP Field Training Manual. The CFP Field Training
Manual is included as Appendix B-2. The date each employee completed the Standard 2 field training
requirement must be recorded on the Standard 2 Self-Assessment Worksheet.
STEP 4 – Document Employees Completion of Independent Inspections / All Curriculum
Requirements
Standard 2 requires a minimum of 25 independent retail food establishment inspections to be conducted
by employees in various establishment types. These independent inspections must be completed prior to
field standardization. In addition, all “Post” curriculum courses identified in Appendix B-1 must be
successfully completed for FSIOs to be eligible for the Field Standardization Assessment. The date each
employee completed 25 independent inspections AND the Standard 2 “Post” curriculum training
requirement must be recorded on the Standard 2 Self-Assessment Worksheet.
STEP 5 – Document Employees Completion of Field Standardization
Within 18 months of employment or assignment to the retail food program, staff conducting inspections
of retail food establishments must satisfactorily complete four joint inspections
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Voluntary National Retail Food Regulatory Program Standards – January 2017
with a “training standard” using a process similar to the “FDA Standardization Procedures.” The
procedure used for standardization does not have to be identical to the FDA Procedures for
Standardization of Retail Food Inspection/Training Officers. However, it must include a determination
of the the following:
1. The inspector’s ability to apply the knowledge and skills obtained from the training
curriculum; and
2. The inspector’s ability in the following five performance areas:
Conducting risk-based inspections (i.e. primary focus on the risk factors that
contribute to foodborne illness),
Recognizing good retail practice requirements,
Applying HACCP principles to the inspection process,
Demonstrating knowledge and use of essential inspection equipment, and
Communicating in an effective manner.
NOTE: For new hires or employees newly assigned to the retail food protection program, the date
recorded in the “Completion of Field Standardization” column must be within 18 months of the date
recorded in the “Date of Hire or Assignment to the Retail Food Protection Program.”
For experienced employees, however, the completion date for standardization may be in excess of 18
months of their date of hire. This is because the jurisdiction may not have been standardizing their retail
food protection program staff prior to enrollment in the Program Standards. Keep in mind that the
Standard 2 language was written to establish a training and standardization process for new employees.
As long as the experienced FSIO has successfully completed standardization at the time of the selfassessment the Standard 2criteria is met.
The date each employee successfully completes field standardization must be recorded on the
Standard 2: Self-Assessment Worksheet.
STEP 6 – Document Employee Continuing Education and Training
Each employee must accumulate 20 contact hours of continuing education training every 36 months.
For employees newly hired or newly reassigned to the retail food program, the 36 month period does not
begin until after the first 18 months of training. For existing employees, the 36 month period does not
begin until a jurisdiction enrolls as a participant in the Standards. The date each employee accumulated
20 contact hours of continuing education within the 36 months of their most current standardization/restandardization cycle must be recorded on the Standard 2 Self-Assessment Worksheet.
STEP 7 – Document the Self-Assessment Results
The self-assessor must document if each of the listed employees met the Standard 2 criteria. The
self-assessors response should be recorded in the Self-Assessment Worksheet under the column “Meets
the Standard 2 Criteria YES or NO.” A jurisdiction meets the Standard 2 criteria if ninety percent
(90%) of the retail food program inspection staff fulfilled all the training and standardization
requirements within the specified time frames.
2-19
12
11
10
9
8
7
6
5
4
3
2
1
No.
2-20
NOTE:
1. Ninety percent (90%) of the staff must meet each training element for the Jurisdiction to meet Standard 2 – Trained Regulatory Staff.
2. Based on the documentation from this worksheet, record your findings for each of the items on the Standard 2: Program Self-Assessment and
Verification Audit Form.
Employee
Name
Completion of a Minimum of 25 Completion of a Minimum Completion of Field Number of
Meets the
Completion of Training
Standardization*
Education
Standard 2
Joint Field Training Inspections* 25 Independent Inspections
Date of Hire
Pre-requisite ("Pre")
(within 18 months Contact Hours Criteria
AND
AND
or Assignment
Curriculum*
of hire or
(Minimum of
Successful completion of a field "Post" Curriculum Courses*
to the Retail
(Prior to conducting
assignment
to
the
20 Contact
training process similar to the
YES
(within 18 months of hire
Food Program
independent
Retail Food
Hours Every
CFP Field Training Manual in
or
or assignment to the Retail
inspections)
Program)
3 Years)
No
Appendix B-2
Food Program
(* indicates completion date required)
Training Record for Each Employee
Standard 2: Trained Regulatory Staff
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
12
11
10
9
8
7
6
5
4
3
2
1
No.
Meets the
Completion of a Minimum of 25 Completion of a Minimum Completion of Field Number of
Completion of Training
Education
Standardization*
Standard 2
Joint Field Training Inspections* 25 Independent Inspections
Pre-requisite ("Pre")
Date of Hire
(within 18 months Contact Hours
Criteria
AND
AND
Curriculum*
or Assignment
(Minimum of
of hire or
Successful completion of a field "Post" Curriculum Courses*
(Prior to conducting
to the Retail
20 Contact
assignment to the
YES
training process similar to the
(within 18 months of hire
independent
Food Program
Hours
Every
Retail Food
or
CFP Field Training Manual in
or assignment to the Retail
inspections)
3 Years)
Program)
No
Appendix B-2
Food Program
(* indicates completion date required)
Training Record for Each Employee
2-21
NOTE:
1. Ninety percent (90%) of the staff must meet each training element for the Jurisdiction to meet Standard 2 – Trained Regulatory Staff.
2. Based on the documentation from this worksheet, record your findings for each of the items on the Standard 2: Program Self-Assessment and
Verification Audit Form.
Employee
Name
ADDITIONAL STANDARD 2 SELF-ASSESSMENT WORKSHEET (if needed)
Standard 2: Trained Regulatory Staff
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A VERIFICATION AUDIT
STANDARD 2 – TRAINED REGULATORY STAFF
STEP 1 – Verify Employees Training Records
The jurisdiction should document and retain a training record for each employee. The training record
must include the date of hire or assignment to the retail food program. The Standard 2 Self-Assessment
Worksheet may be used by the jurisdiction as a training record. The worksheet is included at the end of
these instructions. In lieu of the Standard 2 Self-Assessment Worksheet, other manual forms or
automated records may be used by the jurisdiction to retain training records related to the selfassessment as long as the information required in the Standard 2 criteria is documented in some manner.
STEP 2 – Verify Jurisdiction’s Worksheet Percentage Calculation
Review the jurisdiction’s Standard 2 Self-Assessment Worksheet, or equivalent documentation, to
determine if the results of the jurisdiction’s self-assessment indicate that ninety percent (90%) of the
retail food program staff successfully completed all the Standard 2 training and standardization
elements within the required time frames. If audit calculations result in a percentage that is less than
90%, the auditor can conclude that the jurisdiction does not meet the Standard 2 criteria. If this
conclusion is reached, the audit process for Standard 2 is completed. There is no need to randomly
select and review individual employee training records.
STEP 3 – Determine the Number of Employee Training Records to Review
If the jurisdiction used the Standard 2: Self-Assessment Worksheet, the employees will be
listed in numerical order. The verification auditor must use a random selection method to determine
which employees’ training records will be reviewed. Employees should be eliminated from the random
selection process if they meet one of the following criteria:
1. The employee has been employed or worked in the retail food program for less than
18 months; or
2. The employee is no longer assigned to the retail food program; or
3. The self-assessor indicated on the Self-Assessment Worksheet that the employee did
not meet each Standard 2 element.
The number of training records that must be randomly selected is based on the number of employees
conducting retail food establishment inspections. Use the chart below to determine the number of
employee training records to review.
Number of Employees Number of Files to Select
5 or less
All
20 or less
5
21 or more
25 percent
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Voluntary National Retail Food Regulatory Program Standards – January 2017
STEP 4 – Obtain Random Numbers
A list of random numbers can be obtained from the following web site: www.randomizer.org
Record the random numbers generated from the web site (or from an alternate random number selection
process) on the Standard 2 Verification Audit Worksheet. The worksheet is included at the end of these
instructions.
STEP 5 – Select Employee Training Records to Review
Using the jurisdiction’s Standard 2 Self-Assessment Worksheet, or equivalent documentation, the
verification auditor must identify the employee training records that correspond to the randomly
selected numbers recorded on the Standard 2 Verification Audit Worksheet. Record the employee’s
name adjacent to the corresponding random number on the Standard 2 Verification Audit Worksheet.
Only those employees’ training records that the jurisdiction reports as meeting all the Standard 2
training and standardization elements are to be reviewed. If an employee is randomly selected but the
jurisdiction indicated that employee does not meet the Standard 2 criteria, the verification auditor
should randomly select a substitute employee training record to review.
STEP 6 – Verify Documentation of the Completion of the Standard Training Criteria
The verification auditor must review the training file for each of the randomly selected employees to
confirm completion of the following items:
coursework related to the Standard 2 Pre-requisite (“Pre”) curriculum;
a minimum of 25 joint field training inspection, including documentation that
confirms Food Safety Inspection Officers (FSIOs) are trained on, and have
demonstrated, the performance element competencies needed to conduct independent
inspections of retail food and/or foodservice establishments;
a minimum of 25 independent inspections and ALL the Standard 2 (“Post”)
curriculum requirements;
field standardization within 18 months of hire or re-standardization every three years
after initial standardization, and
20 hours of food safety related continuing education every three years
NOTE: For new hires or employees newly assigned to the retail food protection program, the date
recorded in the “Completion of Field Standardization” column must be within 18
months of the date recorded in the “Date of Hire or Assignment to the Retail Food Protection
Program.”
For experienced employees, however, the completion date for standardization may be in excess of 18
months of their date of hire. This is because the jurisdiction may not have been standardizing their retail
food protection program staff prior to enrollment in the Program Standards. Keep in mind that the
Standard 2 language was written to establish a training and standardization process for new employees.
As long as the experienced FSIO has successfully completed standardization at the time of the selfassessment the Standard 2 criteria is met.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
STEP 7 – Making a Determination Based on the Results of the Audit
For each employee training file reviewed, the verification auditor must mark the appropriate box
on the Standard 2 Verification Audit Worksheet. The auditor must indicate “YES –Standard 2
criteria are met” or “NO” – Standard 2 criteria is not met.” If the verification auditor determines an
employee training record did not meet the Standard 2 criteria, an explanation must be provided noting
any deficiencies. A jurisdiction meets the Standard 2 criteria if ninety percent (90%) of the retail food
program inspection staff fulfilled all the training and standardization requirements within the specified
time frames.
2-24
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
No.
Employee Name
Yes
Standard 2
Criteria are Met
No
Standard 2
Criteria are
Not Met
If NO, auditor is to specify why criterion is not met
2-25
NOTE:
1. All randomly selected employee training records must contain documentation that the Standard 2 training and standardization elements
have been successfully completed.
2. Based on the documentation from this worksheet, record your determination for each of the items on the jurisdiction’s Standard 2:
Program Self-Assessment and Verification Audit Form.
Randomly
Selected
Number
Standard 2: Trained Regulatory Staff
Verification Audit Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
No.
Employee Name
Yes
Standard 2
Criteria are Met
No
Standard 2
Criteria are
Not Met
If NO, auditor is to specify why criterion is not met
2-26
NOTE:
1. All randomly selected employee training records must contain documentation that the Standard 2 training and standardization elements
have been successfully completed.
2. Based on the documentation from this worksheet, record your determination for each of the items on the jurisdiction’s Standard 2:
Program Self-Assessment and Verification Audit Form.
Randomly
Selected
Number
ADDITIONAL STANDARD 2 VERIFICATION AUDIT WORKSHEET (if needed)
Standard 2: Trained Regulatory Staff
Verification Audit Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
Program Standard #2
APPENDIX B-1: Curriculum for Retail Food Safety Inspection Officers
For state, local & tribal regulators to register on-line for free access to web courses, go to:
http://www.fda.gov/Training/ForStateLocalTribalRegulators/ucm120925.htm
Pre-requisite (“Pre”) curriculum courses
(to be completed during the 25 joint inspection period AND prior to conducting any independent inspections)
PUBLIC HEALTH PRINCIPLES
1. Public Health Principles (90) FDA36
MICROBIOLOGY
Food Microbiological Control (series):
1. Overview of Microbiology (60) MIC01
2. Gram-Negative Rods (60) MIC02
3. Gram-Positive Rods & Cocci (90) MIC03
4. Foodborne Viruses (60) MIC04
5. Foodborne Parasites (90) MIC05
6. Mid-Series Exam (30) MIC16
7. Controlling Growth Factors (90) MIC06
8. Control by Refrigeration & Freezing (60) MIC07
9. Control by Thermal Processing (90) MIC08
10. Control by Pasteurization (90) MIC09
11. Aseptic Sampling (90) MIC13
12. Cleaning & Sanitizing (90) MIC15
PREVAILING STATUTES, REGULATIONS, ORDINANCES
1. Basic Food Law for State Regulators (60) FDA35
2. Basics of Inspection: Beginning an Inspection (90) FDA38
3. Basics of Inspection: Issues & Observations (90) FDA39
4. An Introduction to Food Security Awareness (60) FD251 (ORA U internet site)
5. FDA Food Code
NOTE: Specific state/local laws & regulations to be addressed by each jurisdiction
COMMUNICATION SKILLS
1. Communication Skills for Regulators (Course can be accessed through
(http://www.accessdata.fda.gov/ORAU/CommRegulators/)
Curriculum (“Post”) courses
(to be completed any time prior to Food Code Standardization AND
within 18 months of hire or assignment to the regulatory retail food program)
MICROBIOLOGY
Food Microbiological Control (series):
1. Control by Retorting (90) MIC10
2. Technology-Based Food Processes (120) MIC11
3. Natural Toxins (90) MIC12
ALLERGEN MANAGEMENT
1. Food Allergens (60) FD252 (Course can be accessed
through http://class.ucanr.edu/)
HACCP
Basics of HACCP (series):
1. Overview of HACCP (60) FDA16
2. Prerequisite Programs & Preliminary Steps (60) FDA17
3. The Principles (60) FDA18
EPIDEMIOLOGY
Foodborne Illness Investigations (series):
1. Collecting Surveillance Data (90) FI01
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Voluntary National Retail Food Regulatory Program Standards – January 2017
2.
3.
4.
5.
6.
Beginning the Investigation (90) FI02
Expanding the Investigation (90) FI03
Conducting a Food Hazard Review (90) FI04
Epidemiological Statistics (90) FI05
Final Report (30) FI06
FEMA – Incident Command System and National Incident
Management System: Course available from FEMA web
link. – http://training.fema.gov/IS/NIMS.asp
1. IS-100.a, Introduction to Incident Command System,
(180) ICS-100 or IS-100 for FDA
2. IS-200.a, ICS for Single Resources and Initial Action
Incidents, (180) ICS-200
3. IS-700.a, NIMS an Introduction, (180) ICS 700
EMERGENCY MANAGEMENT
( ) Average time in minutes required to take the course, 60 minutes equals .1 CEU, 90-120 minutes equals .2 CEUs
Estimated total hours for “Pre” courses are 42 hours.
Estimated total hours for “Post” courses are 26 hours.
Estimated total hours for completion of all Program Standard #2 coursework are 68 hours
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Program Standard #2
APPENDIX B-1: Curriculum for Retail Food Safety Inspection Officers
“Application” Courses and “Hands-On” Training
To provide application and transfer of web instruction to the FSIO’s work environment, a jurisdiction’s training
program (inclusive of both classroom instruction and field training inspections) for staff newly hired or newly assigned
to the retail food protection program must include a minimum of eighty percent (80%) of the learning objectives
contained in the ORA U course FD170: Application of Inspection and Investigation Techniques. A jurisdiction may
use any one of the following options to address learning objectives not covered in their existing training programs.
1. FD170: Application of Inspection and Investigation Techniques (available at www.ifpti.org/).
2. Courses and/or field training exercises developed by regulatory jurisdictions or other entities that contain
learning objectives and exercises equivalent to Option 1 above.
3. Discussions, questions and exercises (conducted in the office or during the 25 joint inspections) that contain
learning objectives and exercises equivalent to Option 1 above.
The learning objectives for the ORA U course FD170: Application of Inspection and Investigation Techniques are
included below:
FD170: Application of Inspection and Investigation Techniques
Applying Knowledge and Principles to the Real World of Inspection and Investigation of Food Establishments
Learning Objectives: Upon completion of this course, participants will be able to:
1. Explain prerequisite knowledge, skills, and abilities required for inspection and investigation.
2. Apply laws, codes, and guidance documents.
3. Select and use inspection and investigation equipment and tools.
4. Identify the potential hazards present in an establishment.
5. Identify the steps of a focused food safety inspection.
6. Explain different types of investigations.
7. Write descriptive, accurate, and unbiased reports.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
APPENDIX B-2: CFP Field Training Manual
Background
The Conference for Food Protection (CFP) has progressed through multiple stages in the development of a nationally
recognized model for training and standardizing regulatory Food Safety Inspection Officers (FSIO) responsible for
conducting food safety inspections. Research conducted by CFP revealed that existing training and standardization
programs were nearly as varied as the number of regulatory jurisdictions throughout the country. In response, a model
multi-tiered approach for training and standardizing FSIOs was developed using the FDA Voluntary National Retail
Food Regulatory Program Standards, Standard 2 – Trained Regulatory Staff.
This Field Training Manual focuses on two components of this multi-tiered approach contained in Standard 2 – the
pre-requisite coursework and the field training model for preparing newly hired FSIOs or individuals newly assigned
to the regulatory retail food protection program to conduct independent food safety inspections. The instructions and
worksheets provided in this manual constitute a training process, not a certification or audit process.
The model developed through the CFP process, consists of a training plan, trainer’s worksheets, and procedures that
may be used by any regulatory retail food protection program. Jurisdictions do not have to be enrolled in the FDA
Voluntary National Retail Food Regulatory Program Standards to use, and benefit from, this training structure for
preparing FSIOs to conduct independent food safety inspections. This manual was developed to assist jurisdictions that
do not have the available staff resources and funding necessary to develop a comprehensive training process. The
training model presented in this manual can be readily integrated into existing regulatory retail food protection
programs.
The work within this document represents the culmination of years of research and review by subject matter experts
comprised of psychometricians and representatives from state and local regulatory retail food protection programs;
industry trade associations; retail food and foodservice operations; academia; and the FDA’s Office of Regulatory
Affairs University (ORA U). The coursework and training process are the basis for much of the criteria that is
contained in Steps 1 and 2 of Standard 2 – Trained Regulatory Staff, FDA Voluntary National Retail Food Regulatory
Program Standards. This manual is a working document and improvements will be made through the CFP Committee
process.
Overview of the Field Training Manual
All new employees or individuals new to the regulatory retail food protection program should complete pre-requisite
coursework and a field training process similar to that presented in this document. The national research conducted by
CFP has been used to identify the minimum performance element competencies needed to conduct effective regulatory
retail food safety inspections. The CFP Training Plan and Log along with the Field Training Worksheets provided in
this manual are based on these minimum performance element competencies.
Flexibility has been built into the process to allow regulatory jurisdictions the opportunity to customize training
content and methods to represent a jurisdiction’s own administrative policies, procedures, and inspection protocol. As
you read through this manual, it is important to keep in mind that jurisdictions are not obligated to use the forms;
equivalent forms or training processes can be developed. The ultimate objective is to ensure FSIOs are trained on, and
provided an opportunity to successfully demonstrate, the performance element competencies that are a vital part of
their job responsibilities.
Where to Access the Field Training Manual
A copy of the CFP Field Training Manual can be accessed from the Conference for Food Protection’s website
(http://www.foodprotect.org/).
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Voluntary National Retail Food Regulatory Program Standards – January 2017
APPENDIX B-3: Risk Categorization of Food Establishments
2017 FDA Food Code – Annex 5, Conducting Risk-based Inspections
Table 1
Risk
Category
Description
Frequency
#/Year
1
Examples include most convenience store operations, hot dog carts, and coffee
shops. Establishments that serve or sell only pre-packaged, non time/
temperature control for safety (TCS) foods. Establishments that prepare only
non-TCS foods. Establishments that heat only commercially processed TCS
foods for hot holding. No cooling of TCS foods. Establishments that would
otherwise be grouped in Category 2 but have shown through historical
documentation to have achieved active managerial control of foodborne
illness risk factors.
1
2
Examples may include retail food store operations, schools not serving a highly
susceptible population, and quick service operations. Most products are
prepared/cooked and served immediately. May involve hot and cold holding
of TCS foods after preparation or cooking. Complex preparation of TCS foods
requiring cooking, cooling, and reheating for hot holding is limited to only a
few TCS foods. Establishments that would otherwise be grouped in Category 3
but have shown through historical documentation to have achieved active
managerial control of foodborne illness risk factors. Newly permitted
establishments that would otherwise be grouped in Category 1 until history of
active managerial control of foodborne illness risk factors is achieved and
documented.
2
3
An example is a full service restaurant. Extensive menu and handling of raw
ingredients. Complex preparation including cooking, cooling, and reheating
for hot holding involves many TCS foods. Variety of processes require hot and
cold holding of TCS food. Establishments that would otherwise be grouped in
Category 4 but have shown through historical documentation to have
achieved active managerial control of foodborne illness risk factors. Newly
permitted establishments that would otherwise be grouped in Category 2 until
history of active managerial control of foodborne illness risk factors is achieved
and documented.
3
4
Examples include preschools, hospitals, nursing homes, and establishments
conducting processing at retail. Includes establishments serving a highly
susceptible population or that conduct specialized processes (i.e. smoking and
curing, reduced oxygen packaging for extended shelf-life).
4
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Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 3
INSPECTION PROGRAM BASED ON HACCP PRINCIPLES
Table of Contents
REQUIREMENT SUMMARY ......................................................................................................................................... 2
DESCRIPTION OF REQUIREMENT................................................................................................................................ 2
OUTCOME.................................................................................................................................................................. 2
DOCUMENTATION ..................................................................................................................................................... 2
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Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 3
INSPECTION PROGRAM BASED ON HACCP PRINCIPLES
This standard applies to the utilization of HACCP principles to control risk factors in a retail food
inspection program.
Requirement Summary
An inspection program that focuses on the status of risk factors, determines and documents compliance,
and targets immediate- and long-term correction of out-of-control risk factors through active managerial
control.
Description of Requirement
Program management:
1. Implements the use of an inspection form that is designed for:
a) The identification of risk factors and interventions.
b) Documentation of the compliance status of each risk factor and intervention (i.e. a form with
notations indicating IN compliance, OUT of compliance, Not Observed, or Not Applicable
for risk factors)
c) Documentation of all compliance and enforcement activities and
d) Requires the selection of IN, OUT, NO, or NA for each risk factor.
2. Develops and uses a process that groups food establishments into at least three categories based
on potential and inherent food safety risks.
3. Assigns the inspection frequency based on the risk categories to focus program resources on food
operations with the greatest food safety risk.
4. Develops and implements a program policy that requires:
a) On-site corrective actions* as appropriate to the type of violation.
b) Discussion of long-term control** of risk factor options, and
c) Follow-up activities.
5. Establishes and implements written polices addressing code variance requests related to risk
factors and interventions.
6. Establishes written polices regarding the verification and validation of HACCP plans when a
plan is required by the code.
Outcome
The desired outcome of this standard is a regulatory inspection system that uses HACCP principles to
identify risk factors and to obtain immediate- and long-term corrective action for recurring risk factors.
Documentation
The quality records needed for this standard include:
1. Inspection form that requires the selection of IN, OUT, NO, or NA,
2. Written process used for grouping establishments based on food safety risk and the
inspection frequency assigned to each category,
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Voluntary National Retail Food Regulatory Program Standards – January 2017
3.
4.
5.
6.
Policy for on-site correction and follow-up activities,
Policy for addressing code variance requests related to risk factors and interventions,
Policy for verification and validation of HACCP plans required by code, and
Policy requiring the discussion of food safety control systems with management when out of
control risk factors are recorded on subsequent inspections.
*Note: On-site corrective action as appropriate to the violation would include such things as:
a. Destruction of foods that have experienced extreme temperature abuse,
b. Embargo or destruction of foods from unapproved sources,
c. Accelerated cooling of foods when cooling time limits can still be met,
d. Reheating when small deviations from hot holding have occurred,
e. Continued cooking when proper cooking temperatures have not been met.
f. Initiated use of gloves, tongs, or utensils to prevent hand contact with ready-to-eat foods, or
g. Required hand washing when potential contamination is observed.
**Note: Long-term control of risk factors requires a commitment by managers of food establishments
to develop effective monitoring and control measures or system changes to address those risk factors
most often responsible for foodborne illness. Risk control plans, standard operating procedures, buyer
specifications, menu modification, HACCP plans and equipment or facility modification may be
discussed as options to achieve the long-term control of risk factors.
3-3
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS FOR COMPLETING
THE PROGRAM SELF-ASSESSMENT AND VERIFICATION AUDIT FORM
STANDARD 3 – INSPECTION PROGRAM BASED ON HACCP PRINCIPLES
Program Self-Assessment & Verification Audit Form
The Standard 3: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process for Standard 3. The form is
included at the end of these instructions. Whether one is performing a program self-assessment or
conducting a verification audit, it is recommended that the form be available as a reference to the
Standards 3 criteria.
Using the Program Self-Assessment and Verification Audit Form
Documenting the Findings from the Self Assessment
Jurisdictions conducting a self-assessment of Standard 3 must indicate on the form if each of the listed
criteria is met. These responses are recorded under the column “Jurisdiction’s Self Assessment.”
Jurisdictions are not obligated to use this form. An equivalent form or process is acceptable provided
that the results of the jurisdiction’s self-assessment for the specific Standard 3 criteria listed on this form
are available for review.
The Standard 3: Program Self-Assessment and Verification Audit Form is the only form a jurisdiction
needs to use to record the results of their self-assessment. Standard 3 requires inspection policies to be
established, written, and implemented. A policy without documentation of implementation does not
meet the Standard 3 criteria.
The Standard 3: Program Self-Assessment and Verification Audit Form divides the Standard 3 criteria
into six steps:
1. Inspection Form Design
a. The jurisdiction's inspection form identifies foodborne illness risk factors and Food Code
interventions.
b. The jurisdiction's inspection form documents actual observations using the convention
IN, OUT, NA, and NO.
c. The jurisdiction's inspection form documents compliance and enforcement activities.
2. Risk Assessment Categories
a. A risk assessment is used to group food establishments into at least 3 categories based on
their potential and inherent food safety risks.
3. Inspection Frequency
a. The jurisdiction's inspection frequency is based on assigned risk categories.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
4. Corrective Action Policy
a. The jurisdiction has a written and implemented policy that requires on-site corrective
action for foodborne illness risk factors observed to be out of compliance.
b. The jurisdiction has a written and implemented policy that requires discussion for longterm control of foodborne illness risk factors.
c. The jurisdiction has a written and implemented policy that requires follow-up activites on
foodborne illness risk factor violations.
5. Variance Request Policy
a. The jurisdiction has a written and implemented policy on variance requests related to
foodborne illness risk factors and Food Code interventions.
6. Verification and Validation of HACCP Plan Policy
a. The jurisdiction has a written and implemented policy for the verification and validation
of HACCP plans, when a HACCP plan is required by the Food Code.
The self-assessor must review each Standard 3 criterion and determine if the jurisdiction’s source
documents confirm that the Standard criteria are met. If the criteria are met, the self-assessor must place
an “X” in the “YES” box under the “Jurisdiction’s Self-Assessment” column of the Standard 3:
Program Self-Assessment and Verification Audit Form.
If a review of the jurisdiction’s source documents does not confirm that the Standard 3 criteria are met,
the self-assessor must place an “X” in the “NO” box under the “Jurisdiction’s Self-Assessment” column
of the Standard 3: Program Self-Assessment and Verification Audit Form. The self-assessor may
specify why the criteria are not met in the box provided.
The self-assessor should review the findings on the Standard 3: Program Self-Assessment and
Verification Form to ensure accuracy. The jurisdiction will be required to provide the auditor with their
completed Standard 3: Program Self-Assessment and Verification Audit Form and any documents used
to support and demonstrate that the Standard 3 criteria have been met.
Once all the criteria have been reviewed and documented on the form, the self-assessor must complete
the Program Self-Assessment Summary section on page one of the Standard 3: Program SelfAssessment and Verification Audit Form. The self-assessor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 3 criteria in the appropriate boxes; and
•
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 3 criteria.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Documenting the Findings from the Verification Audit
The jurisdiction requesting the verification audit must provide their completed Standard 3: Program
Self-Assessment and Verification Audit Form to the auditor for review. The auditor must indicate on the
Standard 3: Program Self-Assessment and Verification Audit Form if the criteria were met.
If a review of the jurisdiction’s source documents confirms the self-assessment conclusion that the
Standard criteria are met, the verification auditor places an “X” in the “YES” box under the “Auditor’s
Verification” column of the form.
If a review of the jurisdiction’s source documents does not confirm the self-assessment conclusion that
the Standard criteria are met, the verification auditor places and “X” in the “NO” box under the
“Auditor’s Verification” column of the form. The verification auditor must specify why the criterion is
not met in the box provided. Supplemental pages may be used to explain findings.
The jurisdiction must meet all six program performance criteria outlined in Standard 3.
The verification auditor must discuss their findings with the program manager or their appointed
representative and provide constructive feedback at the conclusion of the on-site visit. In particular, any
Standard 3 criteria for which the auditor cannot confirm through a review of the self-assessment should
be thoroughly discussed. Ample time should be allotted to ensure that there is a clear understanding of
the reasons for the “non-conforming” finding. The auditor should be prepared to identify the elements
required for the jurisdiction to meet the Standard.
Once the close out interview has been conducted, the auditor must complete the Verification Audit
Summary section located on the first page of the Standard 3: Program Self-Assessment and Verification
Audit Form. The auditor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 3 criteria in the appropriate boxes; and
•
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 3 criteria if the auditor does not confirm the self-assessment
findings.
3-6
FAX:
FAX:
Signature of the Verification Auditor:
3-7
I affirm that the information represented in the Verification Audit of Standard 3 is true and correct.
Verification Audit indicates that the Jurisdiction MEETS the Standard 3 criteria: YES
Date the Verification Audit of Standard 3 was Completed:
Phone:
Auditor’s Jurisdiction Address:
Auditor’s Jurisdiction Name:
Verification Auditor’s Title:
NO
NO
VERIFICATION AUDIT SUMMARY
Printed Name of the Person who conducted the Verification Audit:
Signature of the Self-Assessor:
I affirm that the information represented in the Self-Assessment of Standard 3 is true and correct.
Self-Assessment indicates that the Jurisdiction MEETS the Standard 3 criteria: YES
Date the Standard 3 Self-Assessment was Completed:
Phone:
Jurisdiction Address:
Jurisdiction Name:
Self-Assessor's Title:
Printed Name of the Person who conducted the Self-Assessment:
E-Mail:
E-Mail:
PROGRAM SELF-ASSESSMENT SUMMARY
Standard 3: Inspection Program Based On HACCP Principles
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
b) The jurisdiction has a written and implemented
policy that requires discussion for long-term control
of foodborne illness risk factors.
a) The jurisdiction has a written and implemented policy
that requires on-site corrective action for foodborne
illness risk factors observed to be out of compliance.
NO
3-8
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
4. Written and Implemented Corrective Action Policy
a) The jurisdiction’s inspection frequency is based on
the assigned risk categories.
3. Inspection Frequency
a) A risk assessment is used to group food
establishments into at least 3 categories based on their
potential and inherent food safety risks.
2. Risk Assessment Categories
a) The jurisdiction’s inspection form identifies
foodborne illness risk factors and Food Code
interventions.
b) The jurisdiction’s inspection form documents actual
observations using the convention IN, OUT, NA, and
NO.
c) The jurisdiction’s inspection form documents
compliance and enforcement activities.
1. Inspection Form Design
Criteria
Jurisdiction Name:
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
Standard 3: Inspection Program Based On HACCP Principles
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
a) The jurisdiction has a written and implemented policy
for the verification and validation of HACCP plans,
when a HACCP plan is required by the Code.
6. Verification and Validation of HACCP Plans
a) The jurisdiction has a written and implemented
policy on variance requests related to foodborne illness
risk factors and Food Code interventions.
5. Variance Requests
c) The jurisdiction has a written and implemented policy
that requires follow-up activities on foodborne illness
risk factor violations.
Criteria
NO
3-9
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
3-10
GENERAL NOTES PERTAINING TO THE PROGRAM SELF-ASSESSMENT OR THE VERIFICATION AUDIT
Standard 3: Inspection Program Based On HACCP Principles
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 4
UNIFORM INSPECTION PROGRAM
Table of Contents
REQUIREMENT SUMMARY ......................................................................................................................................... 2
DESCRIPTION OF REQUIREMENT................................................................................................................................ 2
OUTCOME.................................................................................................................................................................. 4
DOCUMENTATION ..................................................................................................................................................... 4
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Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 4
UNIFORM INSPECTION PROGRAM
This standard applies to the jurisdiction’s internal policies and procedures established to ensure
uniformity among regulatory staff in the interpretation of regulatory requirements, program policies and
compliance / enforcement procedures.
Requirement Summary
Program management has established a quality assurance program to ensure uniformity among
regulatory staff in the interpretation and application of laws, regulations, policies, and procedures.
Description of Requirement
1) Program Management implements an on-going quality assurance program that evaluates inspection
uniformity to ensure inspection quality, inspection frequency and uniformity among the regulatory
staff. The quality assurance program shall:
A. The quality assurance program shall assure that each inspector:
1. Has required equipment and forms to conduct the inspection.
2. Reviews the contents of the establishment file, including the previous inspection report,
reported complaints on file, and, if applicable, required HACCP Plans or documents
supporting the issuance of a variance.
3. Verifies that the establishment is in the proper risk category and that the required inspection
frequency is being met. Informs the supervisor when the establishment is not in the proper
risk category or when the required frequency is not met.
4. Provides identification as a regulatory official to the person in charge and states the purpose
of the visit.
5. Interprets and applies the jurisdiction’s laws, rules, policies, procedures, and regulations
required for conducting retail food establishment inspections.
6. Uses a risk-based inspection methodology to conduct the inspection.
7. Accurately determines the compliance status of each risk factor and Food Code intervention
(i.e., IN compliance, OUT of compliance, Not Observed, or Not Applicable).
8. Obtains corrective action for out-of-compliance risk factors and Food Code interventions in
accordance with the jurisdiction’s policies.
9. Discuss options for the long-term control of risk factors with establishment mangers, when
the same out-of-control risk factor occurs on consecutive inspections, in accordance with the
jurisdiction’s policies. Options may include, but are not limited to; risk control plans,
standard operating procedures, equipment and/or facility modification, menu modification,
buyer specifications, remedial training, or HACCP plans.
10. Verifies correction of out-of-compliance observations identified during the previous
inspection. In addition, follows through with compliance and enforcement in accordance with
the jurisdiction’s policies.
11. Conducts an exit interview that explains the out-of-compliance observations, corrective
actions, and timeframes for correction, in accordance with the jurisdiction’s policies.
4-2
Voluntary National Retail Food Regulatory Program Standards – January 2017
12. Provides the inspection report and, when necessary, cross-referenced documents, to the
person in charge or permit holder, in accordance with the jurisdiction’s policies.
13. Demonstrates proper sanitary practices as expected from a food service employee.
14. Completes the inspection form per the jurisdiction’s policies (i.e. observations, public health
reasons, applicable code reference, compliance dates).
15. Documents the compliance status of each risk factor and intervention (IN, OUT, NA, NO).
16. Cites the proper code provisions for risk factors and Food code interventions, in accordance
with the jurisdiction’s policies.
17. Documents corrective action for out-of-compliance risk factors and Food code interventions
in accordance with the jurisdiction’s policies.
18. Documents that options for the long-term control of risk factors were discussed with
establishment managers when the same out-of-control risk factor occurs on consecutive
inspections. Options may include, but are not limited to, risk control plans, standard
operating procedures, equipment and/or facility modification, menu modification, buyer
specifications, remedial training, or HACCP Plans.
19. Compliance or regulatory documents (i.e. exhibits, attachments, sample forms) are accurately
completed, appropriately cross-referenced within the inspection report, and included with the
inspection report, in accordance with the jurisdiction’s policies.
20. Files reports and other documentation in a timely manner, in accordance with the
jurisdiction’s policies.
B. The quality assurance program shall describe the actions that will be implemented when the
program analysis identifies deficiencies in quality or consistency in any program element listed
above in 1) (A).
2) The quality assurance program must achieve an overall inspection program performance rating for
each of the twenty measured elements [Items1-20] of at least 75% using the self-assessment
procedure and the appropriate table provided in the Standard 4: Self-Assessment Instructions and
Worksheet.
An assessment review of each inspector’s work shall be made during at least three joint on-site
inspections, with a corresponding file review of at least the three most recent inspection reports of
the same inspected establishments, during every self-assessment period.
[*NOTE: Staff members who are within their initial 18 months of training and have not completed all
prerequisite courses, 25 joint inspections and 25 independent inspections as required in Standard 2, are
exempt from the joint on-site inspections and file reviews used in the performance measurement rating
calculation in the Standard 4 Self-Assessment Worksheet.]
4-3
Voluntary National Retail Food Regulatory Program Standards – January 2017
Outcome
A quality assurance program exists that ensures uniform, high quality inspections.
Documentation
The quality records needed for this standard include:
1. A written procedure that describes the jurisdiction’s quality assurance program that meets the
criteria under the Description of Requirement section 1) (A), including corrective actions for
deficiencies, and
2. Documentation that the program achieves a 75 percent performance rating on each element using
the self-assessment procedures described above.
4-4
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS FOR COMPLETING
THE PROGRAM SELF-ASSESSMENT AND VERIFICATION AUDIT FORM
STANDARD 4 – UNIFORM INSPECTION PROGRAM
Program Self-Assessment & Verification Audit Form
The Standard 4: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process. The form is included at the end of
these instructions. Whether one is performing a program self-assessment or conducting a verification
audit, it is recommended that the form be available as a reference to the Standards 4 criteria.
Using the Program Self-Assessment and Verification Audit Form
Documenting the Findings from the Self-Assessment
Jurisdictions conducting a self-assessment of Standard 4 must indicate on the form if each of the listed
criteria is met. These responses are recorded under the column “Jurisdiction’s Self Assessment.”
Jurisdictions are not obligated to use this form. An equivalent form or process is acceptable provided
that the results of the jurisdiction’s self-assessment for the specific Standard 4 criteria listed on this
form are available for review.
The Standard 4: Self-Assessment and Verification Audit Form is divided into three steps:
1. A quality assurance program that:
a. Is described in a written document and covers all inspection personnel performing food service or
retail food inspections,
b. Is monitored regularly and consistently as described in the written document, and
c. Has determined corrective actions that will be taken whenever quality and consistency problems
are identified,
2. Demonstration of review and monitoring methods for the concepts in the twenty quality elements,
and
3. Demonstration of program effectiveness using the provided statistical method1.
The self-assessor must review each Standard 4 criterion and determine if the jurisdiction's source
documents confirm that the Standard criteria are met. If the criteria are met, the self-assessor must
place an “X” in the “YES” box under the “Jurisdiction's Self-Assessment” column of the Standard 4:
Program Self-Assessment and Verification Audit Form.
If a review of the jurisdiction's source documents does not confirm that the Standard 4 criteria are met,
the self-assessor must place an “X” in the “NO” box under the “Jurisdiction's Self-Assessment” column
of the Standard 4 Program Self-Assessment and Verification Audit Form. The self-assessor may
specify why the criteria are not met in the box provided.
1
- This Standard criterion requires a statistical measure of the program’s effectiveness. Instructions for conducting the
statistical measure of program effectiveness are provided beginning on the Standard 4: Self-Assessment Worksheet
1
Voluntary National Retail Food Regulatory Program Standards – January 2017
The self-assessor should review the findings on the Standard 4: Program Self-Assessment and
Verification Form to ensure accuracy. The jurisdiction must provide the auditor with their completed
Standard 4: Program Self-Assessment and Verification Audit Form and any documents used to support
and demonstrate that the Standard 4 criteria have been met.
Once all the criteria have been reviewed and documented on the form, the self-assessor must complete
the Program Self-Assessment Summary section on page one of the Standard 4: Program SelfAssessment and Verification Audit Form. The self-assessor must:
• Enter their contact information;
• Documents if the jurisdiction met the Standard 4 criteria in the appropriate boxes; and
• Sign the form where indicated.
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 4 criteria.
Documenting the Findings from the Verification Audit
The jurisdiction requesting the verification audit must provide their completed Standard 4: Program
Self-Assessment and Verification Audit Form to the auditor for review. The auditor must indicate on
the Standard 4: Program Self-Assessment and Verification Audit Form if the criteria were met.
If a review of the jurisdiction’s source documents confirms the self-assessment conclusion that the
Standard criteria are met, the verification auditor places an “X” in the “YES” box under the “Auditor’s
Verification” column of the form.
If a review of the jurisdiction’s source documents does not confirm the self-assessment conclusion that
the Standard criteria are met, the verification auditor places and “X” in the “NO” box under the
“Auditor’s Verification” column of the form. The verification auditor must specify why the criterion is
not met in the box provided. Supplemental pages may be used to explain findings.
The verification auditor must discuss their findings with the program manager or their appointed
representative and provide constructive feedback at the conclusion of the on-site visit. In particular, any
Standard 4 criteria for which the auditor cannot confirm through a review of the self-assessment should
be thoroughly discussed. Ample time should be allotted to ensure that there is a clear understanding of
the reasons for the “non-conforming” finding. The auditor should be prepared to identify the elements
required for the jurisdiction to meet the Standard.
Once the close out interview has been conducted, the auditor must complete the Verification Audit
Summary section located on the first page of the Standard 4: Program Self-Assessment and Verification
Audit Form. The auditor must:
• Enter their contact information;
• Document if the jurisdiction met the Standard 4 criteria in the appropriate box;
• Sign the form where indicated.
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 4 criteria if the auditor does not confirm the self-assessment
findings.
2
Fax:
YES
YES
Signature of the Verification Auditor:
1
I affirm that the information represented in the Verification Audit of Standard 4 is true and correct
Verification Audit indicates that the Jurisdiction MEETS the Standard 4 criteria:
Date the Verification Audit of Standard 4 was Completed:
Phone:
Auditor’s Jurisdiction Address:
Auditor’s Jurisdiction Name:
Verification Auditor’s Title:
Fax:
VERIFICATION AUDIT SUMMARY
Printed Name of the Person who conducted the Verification Audit:
Signature of the Self-Assessor:
I affirm that the information represented in the Self-Assessment of Standard4 is true and correct
Self-Assessment indicates that the Jurisdiction MEETS the Standard 4 criteria:
Date the Standard 4 Self-Assessment was Completed:
Phone:
Jurisdiction Address:
Jurisdiction Name:
Self-Assessor’s Title:
Printed Name of the Person who conducted the Self-Assessment:
E-mail
E-mail
PROGRAM SELF-ASSESSMENT SUMMARY
Standard 4: Uniform Inspection Program
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
NO
NO
YES
II. The jurisdiction’s quality assurance program assures that
each inspector reviews the contents of the establishment
file, including the previous inspection report, reported
complaints on file, and, if applicable, required HACCP
Plans or documents supporting the issuance of a variance.
I. The jurisdiction’s quality assurance program assures that
each inspector has the required equipment and forms to
conduct the inspection.
The jurisdictions quality assurance program provides a
method to review or monitor, either individually or
programmatically, the concepts in the twenty quality
elements. The twenty elements follow in I. through XX.
2. Twenty Quality Assurance Program Elements
c. The jurisdiction’s written quality assurance program
describes corrective actions to address an individual retail
food program inspector’s performance quality or
consistency issues when they are identified.
b. The jurisdiction periodically conducts an analysis of the
results of the quality assurance program to identify quality
or consistency problems among the staff in the twenty
quality elements.
a. The jurisdiction has a written quality assurance program
that covers all regulatory staff that conducts retail food and/
or foodservice inspections.
1. Written Quality Assurance Program Document
Criteria
2
Jurisdiction’s
Self-Assessment
Self-Assessor’s
NO
General Comments
YES
Standard 4: Uniform Inspection Program
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Auditor’s
Verification
If NO, Auditor is to specify
NO
why criterion is not met
YES
VIII. The jurisdiction’s quality assurance program assures
that each inspector obtains corrective action for out-ofcompliance risk factors and Food Code interventions in
accordance with the jurisdictions policies.
VII. The jurisdiction’s quality assurance program assures
that each inspector accurately determines the compliance
status of each risk factor and Food Code intervention (i.e.,
IN compliance, OUT of compliance, Not Observed, or Not
Applicable).
VI. The jurisdiction’s quality assurance program assures
that each inspector uses a risk-based inspection
methodology to conduct the inspection.
V. The jurisdiction’s quality assurance program assures that
each inspector interprets and applies the jurisdiction’s laws,
rules, policies, procedures, and regulations required for
conducting retail food inspections.
IV. The jurisdiction’s quality assurance program assures
that each inspector provides identification as a regulatory
official to the person in charge and states the purpose of the
visit.
III. The jurisdiction’s quality assurance program assures
that each inspector verifies that the establishment is in the
proper risk category and that the required inspection
frequency is being met, Informs the supervisor when the
establishment is not in the proper risk category or when
frequency is not met.
2. Twenty Quality Assurance Program Elements (contd.)
Criteria
3
Jurisdiction’s
Self-Assessment
Self-Assessor’s
NO
General Comments
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
Auditor’s
Verification
If NO, Auditor is to specify
NO
why criterion is not met
YES
XIII. The jurisdiction’s quality assurance program assures
that each inspector demonstrates proper sanitary practices as
expected from a food service employee.
XII. The jurisdiction’s quality assurance program assures
that each inspector provides the inspection report and, when
necessary, cross-referenced documents, to the person in
charge or permit holder, in accordance with the
jurisdiction’s policies.
XI. The jurisdiction’s quality assurance program assures
that each inspector conducts an exit interview that explains
the out-of-compliance observations, corrective actions, and
timeframes for correction, in accordance with the
jurisdiction’s policies.
X. The jurisdiction’s quality assurance program assures that
each inspector verifies correction of out-of-compliance
observations identified during the previous inspection. In
addition, follows through with compliance and enforcement
in accordance with jurisdiction’s policies.
IX. The jurisdiction’s quality assurance program assures
that each inspector discusses options for the long-term
control of risk factors with establishment managers when
the same out-of-control risk factor occurs on consecutive
inspections, in accordance with the jurisdiction’s policies.
Options may include, but are not limited to, risk control
plans, standard operating procedures, equipment and/or
facility modification, menu modification, buyer
specifications, remedial training, or HACCP Plans.
2. Twenty Quality Assurance Program Elements (contd.)
Criteria
4
Jurisdiction’s
Self-Assessment
Self-Assessor’s
NO
General Comments
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
Auditor’s
Verification
If NO, Auditor is to specify
NO
why criterion is not met
YES
XVIII. The jurisdiction’s quality assurance program
assures that each inspector documents that options for the
long-term control of risk factors were discussed with
establishment managers when the same out-of-control risk
factor occurs on consecutive inspections. Options may
include, but are not limited to, risk control plans, standard
operating procedures, equipment and/or facility
modification, menu modification, buyer specifications,
remedial training, or HACCP Plans.
XVII. The jurisdiction’s quality assurance program assures
that each inspector documents corrective action for out-ofcompliance risk factors and Food Code interventions in
accordance with the jurisdiction’s policies.
XVI. The jurisdiction’s quality assurance program assures
that each inspector cites the proper code provisions for risk
factors and Food Code interventions, in accordance with the
jurisdiction’s policies.
XV. The jurisdiction’s quality assurance program assures
that each inspector document the status of each risk factor
and intervention (IN, OUT, NA, NO).
XIV. The jurisdiction’s quality assurance program assures
that each inspector completed the inspection form per the
jurisdiction’s policies (i.e., observations, public health
reasons, applicable code reference, compliance dates).
2. Twenty Quality Assurance Program Elements (contd.)
Criteria
5
Jurisdiction’s
Self-Assessment
Self-Assessor’s
NO
General Comments
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
Auditor’s
Verification
If NO, Auditor is to specify
NO
why criterion is not met
YES
YES
Auditor’s
Verification
If NO, Auditor is to specify
NO
why criterion is not met
b. Based on the self-assessment field reviews using the
statistical method described in Standard 4: Self-Assessment
Worksheet, the jurisdiction’s regulatory staff achieves a rate
of 75% on each quality element for jurisdictions with 10 or
more inspectors. For jurisdictions with less than 10
inspectors, the achievement rate meets or exceeds the Table
4-1 calculation.
a. The program effectiveness measure documents that 2
self-assessment field reviews were conducted for each
employee performing retail food and or foodservice
inspection work during the five-year self-assessment period.
[New staff who have not completed Steps 1 through 3 of
Standard 2 are exempt from this field measurement.]
6
3. Demonstration of Program Effectiveness Using the Statistical Method in Standard 4: Self-Assessment Worksheet
XX. The jurisdiction’s quality assurance program assures
that each inspector files reports and other documentation in
a timely manner, in accordance with the jurisdiction’s
policies.
XIX. The jurisdiction’s quality assurance program assures
that each inspector accurately completes compliance or
regulatory documents (i.e., exhibits, attachments, sample
forms), appropriately cross-references them within the
inspection report, and includes them with the inspection
report, in accordance with the jurisdiction’s policies.
2. Twenty Quality Assurance Program Elements (contd.)
Criteria
Jurisdiction’s
Self-Assessment
Self-Assessor’s
NO
General Comments
Voluntary National Retail Food Regulatory Program Standards – January 2017
7
GENERAL NOTES PERTAINING TO THE PROGRAM SELF-ASSESSMENT OR THE VERIFICATION AUDIT
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A SELF-ASSESSMENT
STANDARD 4 – UNIFORM INSPECTION PROGRAM
Using the Standard 4 Self-Assessment Worksheet
Criterion three on the Standard 4: Self-Assessment and Verification Audit Form requires a
statistical measure of the program’s effectiveness. Tables 4-1 and 4-2 on the Standard 4: SelfAssessment Worksheet, included at the end of these instructions, is designed to assist the
jurisdiction in determining by statistical method the effectiveness of its Uniform Inspection
Program and in documenting its findings. The jurisdictions are not obligated to use the
worksheet. Equivalent forms or processes are acceptable provided that the statistical process
and result is available for review.
Step 1 – Conduct three field reviews for each employee performing food service or retail food
inspection work during the five-year self-assessment period.
The jurisdiction must conduct three field reviews with each employee performing food service
or retail food inspection work during the five-year self-assessment period. Staff members who
are within their initial 18 months of training and have not completed all prerequisite courses,
25 joint inspections and 25 independent inspections as required in Standard 2, are exempt from
the field reviews and file reviews used in the performance measurement rating calculation in
the Standard 4 Self-Assessment Worksheet.
Field reviews must be conducted by someone who has competed Steps 1-3 in Standard 2, and is
recognized by the program manager as having the field experience and communication skills
necessary to train new employees.
Some of the performance elements can only be assessed after thorough a review of the
establishment files. Therefore, each field review must be accompanied by a review of the
establishment file. Information from the file review will help the field assessor determine if the
FSIO:
• Obtained corrective action for out-of-compliance risk factors and Food Code
interventions in accordance with the jurisdiction’s policies;
• Discussed options for the long-term control of risk factors with establishment managers,
when the same out-of-control risk factor occurs on consecutive inspections, in
accordance with the jurisdiction’s policies; and
• Verified correction of out-of-compliance observations identified during the previous
inspection. In addition, follows through with compliance and enforcement in
accordance with the jurisdiction’s administrative procedures.
The field reviews must be conducted at establishment types representative of the employee’s
case load. The jurisdiction should determine a method for selecting appropriate facilities for
the field review process, and use that method consistently for all employees.
Page 1 of 6
Voluntary National Retail Food Regulatory Program Standards – January 2017 - DRAFT
The field review process (and the accompanying file review) is intended to evaluate the quality
and consistency of the program for each performance element. The following should be taken
into consideration when implementing the field review process:
• This Standard is intended to ensure that inspections are of a satisfactory quality and
uniformity across the entire program.
• When assessing a staff member’s performance during the field review process,
perfection is not required to demonstrate successful achievement of a performance
element.
• Table 4-2 is intended to document the results of the field review process for the
purpose of determining if a jurisdiction has achieved conformance with Standard 4.
Table 4-2 is not intended as a mechanism for providing feedback to staff on their
performance during the field review process. Therefore, jurisdictions are encouraged
to incorporate the performance elements from Standard 4 into a field review tool so
that staff can be provided with meaningful feedback that improves the quality and
uniformity of their inspections.
• Jurisdictions may assess additional jurisdiction-specific performance elements during
the field review process. However, for the purposes of determining conformance with
Standard 4, additional jurisdiction-specific performance elements may not be included
in the calculation used for Table 4-1 or 4-2.
Step 2 – Confirm that three field reviews have been conducted for each employee performing
foodservice or retail food inspection work during the five-year self-assessment period.
Table 4-2 of the Standard 4: Self-Assessment Worksheet is used to document the field
inspections and to analyze statistically the program’s overall effectiveness. The jurisdiction
conducts at least three field inspections with each inspector who conducts food service or retail
food inspections during each five-year self-assessment period.
Table 4-2 must be completed with at least twelve field inspections. Jurisdictions with less than
four inspectors must complete additional field inspections with each inspector in order to reach
a total of twelve inspections. For example, a jurisdiction with three inspectors would need to:
Complete four inspections each inspector.
Step 3 – Use Table 4-2 to enter the results from the two field reviews for each Food Safety
Inspection Officer (FSIO)
¾ In the first column of Table 4-2, identify each FSIO by name or by a code.
¾ In the Establishment ID column, identify the two establishments included in the field
reviews for each FSIO.
¾ In the “DATE” column, record the dates of the field visit and file review.
¾ Items 1 through 20 are the Standard 4 criteria related to the FSIOs competencies.
The self-assessor must place a check mark in the corresponding column of Table 4-2
when the activity or competency is verified.
Step 4 – Conduct calculations to Determine Program Effectiveness
Page 2 of 6
Voluntary National Retail Food Regulatory Program Standards – January 2017
JURISDICTIONS WITH TEN OR MORE INSPECTORS
For jurisdictions with ten or more inspectors conducting foodservice or retail food inspections,
the self-assessor must:
1. Add the number of check marks in the column titled “Item 1”;
2. Divide the total number of checks marks from Step 1 by the total number of field
inspections documented in Table 4-2;
3. Multiply the number in Step 2 by 100; and
4. Repeat this process for Item 1 through Item 20.
This results in a percent achievement for each of the twenty quality elements. Each of the
twenty columns must show at least a 75% achievement rate in order for the program to meet
the effectiveness measure. Perform and review the calculations for each of the twenty
columns.
JURISDICTIONS WITH LESS THAN TEN INSPECTORS
For jurisdictions with less than ten inspectors conducting foodservice or retail food inspections,
an adjustment must be made in the statistical method to compensate for the small sample size.
The self-assessor must:
1. Add the total number of check marks for Item 1 through Item 20;
2. Refer to Chart 4-1. Column three of Chart 4-1 shows the minimum number of items that
must be marked “IN Compliance” to meet the effectiveness measure for Standard 4.
3. Complete Table 4-1 to determine if the jurisdiction achieves conformance with the
effectiveness measure in Standard 4.
Step 5 – Document Results of the Uniform Program Assessment
Use the worksheet results to mark “YES” or “NO” for criteria list under “ 3 – Demonstration of
Program Effectiveness Using the Statistical Method in Standard 4 Self-Assessment Worksheet ”
on the Standard 4: Self-Assessment and Verification Audit Form.
Page 3 of 6
Voluntary National Retail Food Regulatory Program Standards – January 2017
Standard 4: Uniform Inspection Program
Self-Assessment Worksheet
Chart 4-1
Method of Calculation for Jurisdictions with Less Than Ten Inspectors
# of inspectors
# inspections needed
# of items needed to be marked IN compliance
in order to meet Standard 4 criteria
<4
12 minimum
200
(out of 240 possible Items)
4-9
3 per inspector
4 inspectors
5 inspectors
6 inspectors
7 inspectors
8 inspectors
9 inspectors
=
=
=
=
=
=
200 (out of 240 possible Items)
252 (out of 300 possible Items)
303 (out of 360 possible Items)
355 (out of 420 possible Items)
407 (out of 480 possible Items)
459 (out of 540 possible Items)
NOTE:
1.
These minimum inspection program assessment criteria are comparable to the 75% IN Compliance rate
for each of the ten inspection program areas for jurisdictions with 10 or more inspectors.
Example: For 6 inspectors, there will be 3 field visits per inspector = 18 visits
18 visits X 20 Items per visit = 360 Total Possible Items
Table 4-1
Calculation of Uniformity for Jurisdictions with Less Than Ten Inspectors
Period from
to
1. Number of inspectors in the jurisdiction
2. Number of inspections used in the calculation (minimum of 12)
3. Total number of items marked as correct during joint field visits and
corresponding file reviews and recorded on Table 4-2.
4. Total number of possible items based on the number of inspections
(20 items times the # of inspections – see Chart 4-1, column 3)
Determine conformance (YES or NO) using Chart 4-1, column 3
Page 4 of 6
Inspector ID
Establishment ID
Date
NOTE: 1. A check mark indicates the inspector complies with the item.
20
19
18
17
16
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
No.
5
Item Item Item Item Item Item Item Item Item Item Item Item Item Item Item Item Item Item Item Item
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9) (10) (11) (12) (13) (14) (15) (16) (17) (18) (19) (20)
Table 4-2: Calculation of Uniformity for Jurisdictions with Ten or More Inspectors
Standard 4: Uniform Inspection Program
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
3. % IN Compliance (Row 1
÷ Row 2)
2. Number of Inspections
Reviewed in Table 4-2
1. Number of Check Marks
From Table 4-2
Item
(1)
Item
(2)
Item
(3)
Item
(4)
Item
(5)
Item
(6)
Item
(7)
6
Item
(8)
Item
(9)
Item
(10)
Item
(11)
Item
(12)
Item
(13)
Item
(14)
Item
(15)
Item
(16)
Table 4-3: Calculation of Uniformity for Jurisdictions with Ten or More Inspectors
Standard 4: Uniform Inspection Program
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Item
(17)
Item
(18)
Item
(19)
Item
(20)
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 5
FOODBORNE ILLNESS AND FOOD DEFENSE
PREPAREDNESS AND RESPONSE
Table of Contents
REQUIREMENT SUMMARY ........................................................................................................................... 2
DESCRIPTION OF REQUIREMENT.................................................................................................................. 2
1. Investigative Procedures ................................................................................................................... 2
2. Reporting Procedures ....................................................................................................................... 3
3. Laboratory Support Documentation.................................................................................................. 3
4. Trace-back Procedures ..................................................................................................................... 3
5. Recalls ............................................................................................................................................... 3
6. Media Management........................................................................................................................... 4
7. Data Review and Analysis ................................................................................................................. 4
OUTCOME.................................................................................................................................................... 5
DOCUMENTATION ....................................................................................................................................... 5
5-1
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 5
FOODBORNE ILLNESS AND FOOD DEFENSE PREPAREDNESS AND
RESPONSE
This standard applies to the surveillance, investigation, response, and subsequent review of alleged foodrelated incidents and emergencies, either unintentional or deliberate, which results in illness, injury and
outbreaks.
Requirement Summary
The program has an established system to detect, collect, investigate and respond to complaints and
emergencies that involve foodborne illness, injury, and intentional and unintentional food
contamination.
Description of Requirement
1. Investigative Procedures
a. The program has written operating procedures for responding to and /or conducting
investigations of foodborne illness and food-related injury*. The procedures clearly identify the
roles, duties and responsibilities of program staff and how the program interacts with other
relevant departments and agencies. The procedures may be contained in a single source
document or in multiple documents.
b. The program maintains contact lists for individuals, departments, and agencies that may be
involved in the investigation of foodborne illness, food-related injury* or contamination of food.
c. The program maintains a written operating procedure or a Memorandum of Understanding
(MOU) with the appropriate epidemiological investigation program/department to conduct
foodborne illness investigations and to report findings. The operating procedure or MOU clearly
identifies the roles, duties and responsibilities of each party.
d. The program maintains logs or databases for all complaints or referral reports from other sources
alleging food-related illness, food-related injury* or intentional food contamination. The final
disposition for each complaint is recorded in the log or database and is filed in or linked to the
establishment record for retrieval purposes.
e. Program procedures describe the disposition, action or follow-up and reporting required for each
type of complaint or referral report.
f. Program procedures require disposition, action or follow-up on each complaint or referral report
alleging food-related illness or injury within 24 hours.
g. The program has established procedures and guidance for collecting information on the suspect
food’s preparation, storage or handling during on-site investigations of food-related illness, foodrelated injury*, or outbreak investigations.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
h. Program procedures provide guidance for immediate notification of appropriate law enforcement
agencies if at any time intentional food contamination is suspected.
i. Program procedures provide guidance for the notification of appropriate state and/or federal
agencies when a complaint involves a product that originated outside the agency’s jurisdiction or
has been shipped interstate.
2. Reporting Procedures
a. Possible contributing factors to the food-related illness, food-related injury* or intentional food
contamination are identified in each on-site investigation report.
b. The program shares final reports of investigations with the state epidemiologist and reports of
confirmed foodborne disease outbreaks* with CDC.
3. Laboratory Support Documentation
a. The program has a letter of understanding, written procedures, contract or MOU acknowledging,
that a laboratory(s) is willing and able to provide analytical support to the jurisdiction’s food
program. The documentation describes the type of biological, chemical, radiological
contaminants or other food adulterants that can be identified by the laboratory. The laboratory
support available includes the ability to conduct environmental sample analysis, food sample
analysis and clinical sample analysis.
b. The program maintains a list of alternative laboratory contacts from which assistance could be
sought in the event that a food-related emergency exceeds the capability of the primary support
lab(s) listed in paragraph 3.a. This list should also identify potential sources of laboratory
support such as FDA, USDA, CDC, or environmental laboratories for specific analysis that
cannot be performed by the jurisdiction’s primary laboratory(s).
4. Trace-back Procedures
a. Program management has an established procedure to address the trace-back of foods implicated
in an illness, outbreak or intentional food contamination. The trace-back procedure provides for
the coordinated involvement of all appropriate agencies and identifies a coordinator to guide the
investigation. Trace-back reports are shared with all agencies involved and with CDC.
5. Recalls
a. Program management has an established procedure to address the recall of foods implicated in an
illness, outbreak or intentional food contamination.
b. When the jurisdiction has the responsibility to request or monitor a product recall, written
procedures equivalent to 21 CFR, Part 7 are followed.
5-3
Voluntary National Retail Food Regulatory Program Standards – January 2017
c. Written policies and procedures exist for verifying the effectiveness of recall actions by firms
(effectiveness checks) when requested by another agency.
6. Media Management
a. The program has a written policy or procedure that defines a protocol for providing information
to the public regarding a foodborne illness outbreak or food safety emergency. The
policy/procedure should address coordination and cooperation with other agencies involved in the
investigation. A media person is designated in the protocol.
7. Data Review and Analysis
a. At least once per year, the program conducts a review of the data in the complaint log or
database and the foodborne illness and food-related injury* investigations to identify trends and
possible contributing factors that are most likely to cause foodborne illness or food-related
injury*. These periodic reviews of foodborne illnesses may suggest a need for further
investigations and may suggest steps for illness prevention.
b. The review is conducted with prevention in mind and focuses on, but is not limited to, the
following:
1) Foodborne Disease Outbreaks*, Suspect Foodborne Outbreaks* and Confirmed Foodborne
Disease Outbreaks* in a single establishment;
2) Foodborne Disease Outbreaks*, Suspect Foodborne Outbreaks* and Confirmed Disease
Outbreaks* in the same establishment type;
3) Foodborne Disease Outbreaks*, Suspect Foodborne Outbreaks* and Confirmed Foodborne
Disease Outbreaks* implicating the same food;
4) Foodborne Disease outbreaks*, Suspect Foodborne Outbreaks* and Confirmed Foodborne
Disease Outbreaks* associated with similar food preparation processes;
5) Number of confirmed foodborne disease outbreaks*;
6) Number of foodborne disease outbreaks* and suspect foodborne disease outbreaks*;
7) Contributing factors most often identified;
8) Number of complaints involving real and alleged threats of intentional food contamination;
and
9) Number of complaints involving the same agent and any complaints involving unusual
agents when agents are identified.
c. In the event that there have been no food-related illness or food-related injury* outbreak
investigations conducted during the twelve months prior to the data review and analysis,
program management will plan and conduct a mock foodborne illness investigation to test
program readiness. The mock investigation should simulate response to an actual confirmed
foodborne disease outbreak* and include on-site inspection, sample collection and analysis. A
mock investigation must be completed at least once per year when no foodborne disease
outbreak* investigations occur.
Note: Regulatory Programs are encouraged to also participate in the CDC National
Environmental Assessment Reporting System (NEARS). NEARS is designed to provide a more
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Voluntary National Retail Food Regulatory Program Standards – January 2017
comprehensive approach to foodborne disease outbreak investigation and response and will
provide a data source to measure the impact of food safety programs to further research and
understand foodborne illness causes and prevention. (The following link provides additional
information regarding NEARS: http://www.cdc.gov/nceh/ehs/nears/index.htm )
Outcome
A food regulatory program has a systematic approach for the detection, investigation, response,
documentation and analysis of alleged food-related incidents that involve illness, injury, unintentional or
deliberate food contamination.
Documentation
The quality records required to meet this standard include:
1. Logs or databases of alleged food-related illness and food-related injury* complaints maintained
and current.
2. Collection forms specified in the operating procedures.
3. Investigation reports of alleged food-related illness, food-related injury*, or incidents. Reports
are retrievable by implicated establishment name.
4. The written procedures, contracts or MOU’s with the supporting laboratories.
5. The procedure addressing the trace-back of food products implicated in an illness, outbreak, or
contamination event.
6. 21 CFR, Part 7, or written procedures equivalent to 21 CFR, Part 7 for recalls.
7. Completed copies of the annual review and analysis (after 12 months of data).
8. Current written media policy/procedure and contact person.
9. The contact list for communicating with all relevant agencies.
10. Portions of any emergency response relevant to food safety and security.
[*Note: See the Standards Definitions for the meaning of these defined terms.]
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Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS FOR COMPLETING
THE PROGRAM SELF-ASSESSMENT AND VERIFICATION AUDIT FORM
STANDARD 5 – FOODBORNE ILLNESS AND FOOD DEFENSE
PREPAREDNESS AND RESPONSE
Program Self-Assessment & Verification Audit Form
The Standard 5: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process for Standard 5. The form is included at
the end of these instructions. Whether one is performing a program self-assessment or conducting a
verification audit, it is recommended that the form be available as a reference to the Standard 5 criteria.
Using the Program Self-Assessment and Verification Audit Form
Documenting the Findings from the Self-Assessment
Jurisdictions conducting a self-assessment of Standard 5 must indicate on the form if each of the listed
criteria is met. These responses are recorded under the column “Jurisdiction’s Self Assessment.”
Jurisdictions are not obligated to use this form. An equivalent form or process is acceptable provided that
the results of the jurisdiction’s self-assessment for the specific Standard 5 criteria listed on this form are
available for review.
The Standard 5: Program Self-Assessment and Verification Audit Form is the only form a jurisdiction needs
to use to record the results of their self-assessment. The Standard 5: Program Self-Assessment and
Verification Audit Form divides the Standard 5 criteria into seven categories:
1. Investigation Procedures;
Written Operating Procedure; Contact Lists; Cooperative Agreements;
Documenting and Responding to Reported Complaints/Incidences;
Complaint/Incident Investigation Procedures;
2. Reporting Procedures;
3. Laboratory Support Documentation;
4. Trace-back Procedures;
5. Recalls;
6. Media Management; and
7. Data Review and Analysis.
The self-assessor must review each Standard 5 criterion and determine if the jurisdiction’s source
documents confirm that the Standard criteria are met. If the criteria are met, the self-assessor must place an
“X” in the “YES” box under the “Jurisdiction’s Self-Assessment” column of the Standard 5: Program SelfAssessment and Verification Audit Form.
If a review of the jurisdiction’s source documents does not confirm that the Standard 5 criteria are met, the
self-assessor must place an “X” in the “NO” box under the “Jurisdiction’s Self-Assessment” column of the
Standard 5: Program Self-Assessment and Verification Audit Form. The self-assessor may specify why the
criteria are not met in the box provided.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
The self-assessor should review the findings on the Standard 5: Program Self-Assessment and Verification
Form to ensure accuracy. The jurisdiction will be required to provide the auditor with their completed
Standard 5: Program Self-Assessment and Verification Audit Form and any documents used to support and
demonstrate that the Standard 5 criteria have been met.
Once all the criteria have been reviewed and documented on the form, the self-assessor must complete the
Program Self-Assessment Summary section on page one of the Standard 5: Program Self-Assessment and
Verification Audit Form. The self-assessor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 5 criteria in the appropriate boxes; and
•
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 5 criteria.
Documenting the Findings from the Verification Audit
The jurisdiction requesting the verification audit must provide their completed Standard 5: Program SelfAssessment and Verification Audit Form to the auditor for review. The auditor must indicate on the
Standard 5: Program Self-Assessment and Verification Audit Form if the criteria were met.
If a review of the jurisdiction’s source documents confirms the self-assessment conclusion that the Standard
criteria are met, the verification auditor places an “X” in the “YES” box under the “Auditor’s Verification”
column of the form.
If a review of the jurisdiction’s source documents does not confirm the self-assessment conclusion that the
Standard criteria are met, the verification auditor places and “X” in the “NO” box under the “Auditor’s
Verification” column of the form. The verification auditor must specify why the criterion is not met in the
box provided. Supplemental pages may be used to explain findings. The jurisdiction must meet all seven
program performance criteria outlined in Standard 5.
The verification auditor must discuss their findings with the program manager or their appointed
representative and provide constructive feedback at the conclusion of the on-site visit. In particular, any
Standard 5 criteria for which the auditor cannot confirm through a review of the self-assessment should be
thoroughly discussed. Ample time should be allotted to ensure that there is a clear understanding of the
reasons for the “non-conforming” finding. The auditor should be prepared to identify the elements required
for the jurisdiction to meet the Standard.
Once the close out interview has been conducted, the auditor must complete the Verification Audit
Summary section located on the first page of the Standard 5: Program Self-Assessment and Verification
Audit Form. The auditor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 5 criteria in the appropriate boxes; and
•
•
Sign the form where indicated.
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 5 criteria if the auditor does not confirm the self-assessment
findings.
5-7
FAX:
FAX:
Signature of the Verification Auditor:
5-8
I affirm that the information represented in the Verification Audit of Standard 5 is true and correct
Verification Audit indicates that the Jurisdiction MEETS the Standard 5 criteria: YES
Date the Verification Audit of Standard 5 was Completed:
Phone:
Auditor’s Jurisdiction Address:
Auditor’s Jurisdiction Name:
Verification Auditor’s Title:
NO
NO
VERIFICATION AUDIT SUMMARY
Printed Name of the Person who conducted the Verification Audit:
Signature of the Self-Assessor:
I affirm that the information represented in the Self-Assessment of Standard 5 is true and correct:
Self-Assessment indicates that the Jurisdiction MEETS the Standard 5 criteria: YES
Date the Standard 5 Self-Assessment was Completed:
Phone:
Jurisdiction Address:
Jurisdiction Name:
Self-Assessor's Title
Printed Name of the Person who conducted the Self-Assessment:
E-mail:
E-mail:
PROGRAM SELF-ASSESSMENT SUMMARY
Standard 5: Foodborne Illness and Food Defense Preparedness and Response
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Criteria
a) The program has written operating procedures for
responding to and/or conducting investigations of
foodborne illness and food-related injury that clearly
identify the roles, duties, and responsibilities of program
staff and how the program interacts with other relevant
departments and agencies. (The procedures may be
contained in a single source document or in multiple
documents.)
b) The program maintains contact lists for individuals,
departments, and agencies that may be involved in the
investigation of foodborne illnesses, food-related injuries,
or contamination of food.
c) The program maintains a written operating procedure
or a Memorandum of Understand (MOU) with the
appropriate epidemiological investigation program /
department to conduct foodborne illness investigations
and to report findings. The operating procedure or MOU
clearly identifies the roles, duties, and responsibilities
of each party.
1. Investigation Procedures
Jurisdiction Name:
YES
NO
5-9
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
Standard 5: Foodborne Illness and Food Defense Preparedness and Response
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
a) Possible contributing factors to the illness, food-related
injury, or intentional food contamination are identified in
each on-site investigation report.
2. Reporting Procedures
i) Program procedures provide guidance for the notification
of appropriate state and/or federal agencies when a
complaint involves a product that originated outside the
agency's jurisdiction or has been shipped interstate.
h) Program procedures provide guidance for immediate
notification of appropriate law enforcement agencies if at
any time intentional food contamination is suspected.
g) The program has established procedures and guidance
for collecting information on the suspect foods'
preparation, storage or handling during on-site illness,
food-injury, or outbreak investigations.
f) Program procedures require disposition, action or
follow-up on each complaint or referral report alleging
food-related illness or injury within 24 hours.
e) Program procedures describe the disposition, action,
or follow-up and reporting required for each type of
complaint or referral report.
d) The program maintains logs or databases for all
complaint or referral reports from other sources alleging
food-related illness, food-related injury, or unintentional
food contamination. The final disposition for each
complaint is recorded in the database or log and is filed in,
or linked to, the establishment record for retrieval purposes.
Criteria
YES
NO
5-10
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
a) Program management has an established procedure to
address the trace-back of foods implicated in an illness,
outbreak or intentional food contamination. The trace-back provides for the coordinated involvement of all
appropriate agencies and identifies a coordinator to guide
the investigation. Trace-back reports are shared with all
agencies involved and with CDC.
4. Trace-Back Procedures
b) The program maintains a list of alternative laboratory
contacts from which assistance could be sought in the
event that a food-related emergency exceeds the capability
of the primary support lab(s) identified in paragraph 3.a.
This list should also identify potential sources of
laboratory support such as FDA, USDA, CDC, or
environmental laboratories for specific analysis that
cannot be performed by the jurisdiction's primary
laboratory(s).
a) The program has a letter of understanding, written
procedures, contract, or MOU acknowledging that a
laboratory(s) is willing and able to provide analytical
support to the jurisdiction's food program. The
documentation describes the type of biological, chemical,
radiological, contaminants or other food adulterants that
can be identified by the laboratory. The laboratory
support available includes the ability to conduct
environmental, food, and/or clinical sample analyses.
3. Laboratory Support Documentation
b) The program shares final reports of investigations with
the state epidemiologist and reports of confirmed disease
outbreaks with CDC.
Criteria
YES
NO
5-11
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
a) At least once per year, the program conducts a review
of the data in the complaint log or database and the illness
and food-related injury investigations to identify trends
and possible contributing factors that are most likely to
cause illness or injury. These periodic reviews of
multiple complaints and contributing factors may suggest
a need for further investigations may suggest steps for
illness prevention.
7. Data Review and Analysis
a) The program has a written policy and procedure that
defines a protocol for providing information to the public
regarding a foodborne illness outbreak or food safety
emergency. The protocol should address coordination
and cooperation with other agencies involved in the
investigation. A media person is designated in the protocol.
6. Media Management
c) Written policies and procedures exist for verifying the
effectiveness of recall actions by firms (effectiveness
checks) when requested by another agency.
b) When the jurisdiction has the responsibility to request
or monitor a product recall, written procedures equivalent
to 21 CFR Part 7 are followed.
a) Program management has an established procedure to
address the recall of foods implicated in an illness,
outbreak, or intentional food contamination.
5. Recalls
Criteria
YES
NO
5-12
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
9) Number of complaints involving the same agent
and any complaints involving unusual agents
when agents are identified.
c) In the event that there have been no illness or food-related injury outbreak investigations conducted during
the twelve months prior to the trend analysis, program
management will plan and conduct a mock foodborne
illness or food defense investigation to test program
readiness. The mock investigation should simulate
response to an actual illness outbreak and include on-site
inspection, sample collection, and analysis. A mock
investigation must be completed at least once per year
when no illness outbreak investigations occur.
8) Number of complaints involving real and alleged
threats of intentional food contamination.
4) Multiple complaints associated with similar food
preparation processes;
5) Number of confirmed foodborne disease
outbreaks;
6) Number of foodborne disease outbreaks and
suspect foodborne disease outbreaks;
7) Contributing factors most often identified;
2) Multiple complaints on the same establishment
type;
3) Multiple complaints implicating the same food;
b) The review is conducted with prevention in mind and
focuses on, but is not limited to, the following:
1) Multiple complaints on the same establishment;
Criteria
YES
NO
5-13
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
5-14
(NOTE: Item 7c can be marked “not applicable” (NA) if the jurisdiction DID conduct a foodborne illness or food defense
investigation within the twelve month period since the last trend analysis. If the jurisdiction DID conduct a foodborne illness or food
defense investigation within this twelve month period, then they are not required to conduct a mock foodborne illness/food defense
training exercise.)
A “yes” affirmation to each statement is required to meet Standard 5. If an item contains multiple questions, then all questions must
be answered in the affirmative in order to meet that element of the Standard. The source documents, such as the various policies and
procedures, that support this summary record must be maintained in good order by the regulatory authority and must be made
available upon request for purposes of a verification audit.
GENERAL NOTES PERTAINING TO THE PROGRAM SELF-ASSESSMENT OR THE VERIFICATION AUDIT
Standard 5: Foodborne Illness and Food Defense Preparedness and Response
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 6
COMPLIANCE AND ENFORCEMENT
Table of Contents
REQUIREMENT SUMMARY ......................................................................................................................................... 2
DESCRIPTION OF REQUIREMENT................................................................................................................................ 2
OUTCOME.................................................................................................................................................................. 2
DOCUMENTATION ..................................................................................................................................................... 3
6-1
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 6
COMPLIANCE AND ENFORCEMENT
This standard applies to all compliance and enforcement activities used by a jurisdiction to achieve
compliance with regulations.
Requirement Summary
Compliance and enforcement activities result in follow-up actions for out-of-control risk factors and
timely correction of code violations.
Description of Requirement
Compliance and enforcement encompasses all voluntary and regulatory actions taken to achieve
compliance with regulations. Voluntary corrective action includes, but is not limited to, such activities
as on-site corrections at time of inspection, voluntary destruction of product, risk control plans and
remedial training. Enforcement action includes, but is not limited to, such activities as warning letters,
re-inspection, citations, administrative fines, permit suspension and hearings. Compliance and
enforcement options may vary depending on state and local law.
The program must demonstrate credible follow-up for each violation noted during an inspection, with
particular emphasis being placed on risk factors that most often contribute to foodborne illness and Food
Code interventions intended to prevent foodborne illness. The resolution of out-of-compliance risk
factors and/or Food Code interventions must be documented in each establishment record. The essential
program elements required to meet this standard are:
1. A written step-by-step procedure that describes how compliance and enforcement tools are to be
used to achieve compliance.
2. Inspection report form(s) that records and quantifies the compliance status of risk factors and
interventions (i.e., IN compliance, OUT of compliance, Not Observed, or Not Applicable).
3. Documentation on the establishment inspection report form or in the establishment file using the
statistical method for file selection in the Supplement to Standard 6, Appendix F, where at least
80 percent of sampled establishments meet the following conditions:
a) The inspection and enforcement staff takes compliance and enforcement action according to
the procedure (i.e. the staff follow the step-by-step compliance and enforcement procedures
when violations occur), and
b) Resolution was successfully achieved for all out-of-control risk factors or interventions that
were recorded on the selected routine inspection.
Outcome
The desired outcome of this standard is an effective compliance and enforcement program that is
implemented consistently to achieve compliance with regulatory requirements.
6-2
Voluntary National Retail Food Regulatory Program Standards – January 2017
Documentation
The quality records needed for this standard include:
1. A copy of the written step-by-step enforcement procedures.
2. Inspection form that meets the criteria.
3. Documentation that compliance and enforcement action was taken correctly for at least 80
percent of the sampled establishments using the Standard 6: Establishment File Worksheet and
the Standard 6: Self-Assessment Summary Worksheet when out-of-control risk factors or code
interventions are recorded on routine inspections.
4. A reference “Key” which identifies the major risk factors and Food Code interventions on the
jurisdiction's inspection report form. [Note: A jurisdiction will not be penalized under Standard
6 for sections of the Food Code which have not yet been adopted.
6-3
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS FOR COMPLETING
THE PROGRAM SELF-ASSESSMENT AND VERIFICATION AUDIT FORM
STANDARD 6 – COMPLIANCE AND ENFORCEMENT
Program Self-Assessment and Verification Audit Form
The Standard 6: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process for Standard 6. The form is
included at the end of these instructions. Whether one is performing a program self-assessment or
conducting a verification audit, it is recommended that the form be available as a reference to the
Standards 6 criteria.
Using the Program Self-Assessment and Verification Audit Form
Documenting the Findings from the Self Assessment
Jurisdictions conducting a self-assessment of Standard 6 must indicate on the form if each of the criteria
is met. These responses are recorded under the column “Jurisdiction’s Self-Assessment.”
The self-assessor must review each Standard 6 criterion and determine if the jurisdiction’s source
documents confirm that the Standard criteria are met. If the criteria are met, the self-assessor must place
an “X” in the “YES” box under the “Jurisdiction’s Self-Assessment” column of the Standard 6:
Program Self-Assessment and Verification Audit Form.
If a review of the jurisdiction’s source documents does not confirm that the Standard 6 criteria are met,
the self-assessor must place an “X” in the “NO” box under the “Jurisdiction’s Self-Assessment” column
of the Standard 6: Program Self-Assessment and Verification Audit Form. The self-assessor may
specify why the criteria are not met in the box provided.
The self-assessor should review the findings on the Standard 6: Program Self-Assessment and
Verification Form to ensure accuracy. The jurisdiction will be required to provide the auditor with their
completed Standard 6: Program Self-Assessment and Verification Audit Form and any documents
used to support and demonstrate that the Standard 6 criteria have been met.
Once all the Standard 6 criteria have been reviewed and the findings from the Standard 6: Establishment
File Worksheet and the Standard 6: Self-Assessment Summary Worksheet documented on the form, the
self-assessor must complete the Program Self-Assessment Summary section on page one of the
Standard 6: Program Self-Assessment and Verification Audit Form. The self-assessor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 6 criteria in the appropriate boxes; and
•
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 6 criteria.
6-4
Voluntary National Retail Food Regulatory Program Standards – January 2017
Documenting the Findings from the Verification Audit
The jurisdiction requesting the verification audit must provide their completed Standard 6: Program
Self-Assessment and Verification Audit Form to the auditor for review. The auditor must indicate on the
Standard 6: Program Self-Assessment and Verification Audit Form if the criteria were met.
If a review of the jurisdiction’s source documents confirms the self-assessment conclusion that the
Standard criteria are met, the verification auditor places an “X” in the “YES” box under the “Auditor’s
Verification” column of the form.
If a review of the jurisdiction’s source documents does not confirm the self-assessment conclusion that
the Standard criteria are met, the verification auditor places and “X” in the “NO” box under the
“Auditor’s Verification” column of the form. The verification auditor must specify why the criterion is
not met in the box provided. Supplemental pages may be used to explain findings.
The verification auditor must discuss their findings with the program manager or their appointed
representative and provide constructive feedback at the conclusion of the on-site visit. In particular, any
Standard 6 criteria for which the auditor cannot confirm through a review of the self-assessment should
be thoroughly discussed. Ample time should be allotted to ensure that there is a clear understanding of
the reasons for the “non-conforming” finding. The auditor should be prepared to identify the elements
required for the jurisdiction to meet the Standard.
Once the close out interview has been conducted, audit must complete the Verification Audit Summary
section located on the first page of the Standard 6: Program Self-Assessment and Verification Audit
Form. The auditor must:
•
Enter their contact information;
•
Document if the jurisdiction met the Standard 6 criteria in the appropriate boxes; and
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 6 criteria if the auditor does not confirm the self-assessment
findings.
6-5
FAX:
Signature of the Verification Auditor:
6-6
I affirm that the information represented in the Verification Audit of Standard 6 is true and correct
Verification Audit indicates that the Jurisdiction MEETS the Standard 6 criteria: YES
Date the Verification Audit of Standard 6 was Completed:
Phone:
Auditor’s Jurisdiction Address:
Auditor’s Jurisdiction Name:
FAX:
Printed Name of the Person who conducted the Verification Audit:
Verification Auditor’s Title:
NO
NO
VERIFICATION AUDIT SUMMARY
I affirm that the information represented in the Self-Assessment of Standard 6 is true and correct
Signature of the Self-Assessor:
Self-Assessment indicates that the Jurisdiction MEETS the Standard 6 criteria: YES
Date the Standard 6 Self-Assessment was Completed:
Phone:
Jurisdiction Address:
Jurisdiction Name:
Self-Assessor's Title:
Printed Name of the Person who conducted the Self-Assessment:
E-mail:
E-mail:
PROGRAM SELF-ASSESSMENT SUMMARY
Standard 6: Compliance and Enforcement
Program-Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
b) The jurisdiction has written documentation verifying
that at least 80% of the sampled files follow the
agency's step-by-step compliance and enforcement
procedures and actions were taken to resolve
out-of-compliance risk factors recorded on the selected
routine inspection in accordance with the Standard
criteria.
a) The jurisdiction has written documentation that
verifies the review of the effectiveness of the staff's
implementation of the program's compliance and
enforcement procedure that includes a selection of
establishment files for review in accordance with the
Standard criteria.
2. Assessment of Effectiveness
b) The jurisdiction's inspection form(s) record and
quantify the compliance status of foodborne illness
risk factors, Food Code interventions and other serious
serious code violations.
a) The jurisdiction has a written step-by-step compliance
and enforcement procedure that describes what actions
and tools (i.e. forms, documents, interventions)
are to be used to achieve compliance.
1. Compliance and Enforcement Procedure
Criteria
Jurisdiction Name:
YES
NO
6-7
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
YES
If NO, Auditor is to specify
why criterion is not met
Verification Audit
NO
Standard 6: Compliance and Enforcement
Program-Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
6-8
GENERAL NOTES PERTAINING TO THE PROGRAM SELF-ASSESSMENT OR THE VERIFICATION AUDIT
Standard 6: Compliance and Enforcement
Program-Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A SELF-ASSESSMENT
STANDARD 6 – COMPLIANCE AND ENFORCEMENT
Using the Standard 6 Establishment File Worksheet
The self-assessor should have the Standard 6 self-assessment worksheets available as a reference
when reading through this guidance. The following worksheets are provided at the end of these
instructions:
• Standard 6: Self-Assessment Summary Worksheet
• Standard 6: Establishment File Worksheet
The Standard 6: Self-Assessment Summary Worksheet is designed to provide a listing of the
establishments randomly selected from the jurisdiction’s inventory that were reviewed as part of the
self-assessment process. This worksheet provides a summary as to whether or not the inspection file/
records for each of the randomly selected establishments meet the Standard 6 criteria.
The Standard 6: Establishment File Worksheet provides a systematic way of collecting the compliance
and enforcement history for each of the randomly selected establishments. Jurisdictions
do not have to use this form. However, a jurisdiction must provide documentation of the review
process. The documentation must indicate if appropriate compliance and enforcement actions were
taken for out-of-control risk factors and Food Code interventions at each establishment randomly
selected for the self-assessment.
STEP 1 – Assess the Elements in the Written Compliance & Enforcement Program
To meet the criteria of Standard 6, the jurisdiction must have written step-by-step procedures
outlining its compliance and enforcement process. The jurisdiction should review its compliance
and enforcement policies and procedures to ensure that there is clear guidance for staff. The policies
and procedures should provide steps and actions to be taken when various categories of violations
occur. The policies and procedures should also provide a progression of steps to be taken when
violations are not corrected within regulatory or administratively established time frames.
In addition, the jurisdiction’s inspection form must use the IN compliance, OUT of compliance, Not
Applicable, and Not Observed conventions to record the compliance status of the foodborne illness
risk factors and the public health interventions identified in the Food Code to meet the requirements
of Standard 6.
STEP 2 – Assess the Effectiveness of the Compliance & Enforcement Program
Randomly selected establishment files will be reviewed to determine if documented violations were
resolved satisfactorily in the establishment. The results of the review will be used to assess the success
of the compliance and enforcement program. This section of the self-assessment process has been
broken down into the following four parts:
Part I Determine the number of establishment files to review
Part II Randomly select establishment files from the jurisdiction’s inventory
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Part III Conduct a review of each randomly selected establishment file
Part IV Determine the need to review additional randomly selected establishment files
Part I - Determine the number of establishment files to review
Jurisdictions with less than 800 total establishments must select at least 40 files for review. If a
jurisdiction has less than 40 establishments in the inventory, then all files will be reviewed.
Jurisdictions with 800 or more establishments must select a sample equal to 5% of the total
establishments (up to a maximum of 70 files). This initial selection of sample files must be the
first files reviewed.
Establishment Inventory
Number of Files to Review
Less than 800
40 establishment files
800 or more
5% of the total number of establishments
(Up to a maximum of 70 files)
Part II - Randomly select establishment files from the jurisdiction’s inventory
Sample selection using a table of random numbers or a random number generator is preferred. This
can be performed with a card file, ledger, list, or automated data system. The card file, ledger, list or
automated database must be numbered or ordered in some fixed fashion so that the establishment
files can be associated with the numbers selected by the random number generator.
There are many ways a jurisdiction can produce a listing of all the establishments in its inventory.
The listing can be produced alphabetically; by permit number; permit date, etc. The establishment
listing can be computer generated or it can be produced manually. Any method can be used as long
as all the establishments are included once and only once.
When randomly selecting establishments, the self-assessor must perform the following steps:
1. Record the random numbers in the order they were selected under the column “Randomly
Selected Numbers” on the Standard 6: Self-Assessment Summary Worksheet;
2. Identify the establishment file that corresponds to the randomly selected number recorded
on the Standard 6: Self-Assessment Summary Worksheet; and
3. Record the establishment name or identification number for each of the randomly
selected numbers on the Standard 6: Self-Assessment Summary Worksheet.
Part III - Conduct a review of each randomly selected establishment file
When reviewing the compliance and enforcement history for each of the randomly selected files, the
self-assessor should use a form similar to the Standard 6: Establishment File Worksheet to document
their findings. This worksheet is included at the end of these instructions.
For each randomly selected establishment listed on the Standard 6: Self Assessment Summary
Worksheet, the self-assessor must complete a separate Standard 6: Establishment File Worksheet.
The worksheet must document the following information:
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Voluntary National Retail Food Regulatory Program Standards – January 2017
The name of the establishment and the permit number in the upper left hand corner of the
“Establishment File Worksheet;”
The “Start Point Inspection Date” under the heading provided. The “start-point” inspection
willbe the third oldest routine inspection in the establishment’s file at the time of the review
if it shows a violation of one of the risk factors or public health interventions. If no risk
factor or public health intervention violation is shown on that inspection, then the fourth
oldest routine inspection may be used if it shows a risk factor or public health intervention
violation. If no violation of a risk factor or public health intervention is documented on the
third or fourth oldest routine inspection, then no “start-point” inspection exists for that
establishment. Therefore, that establishment’s file “does not qualify” for the self-assessment
review process. If the establishment “does not qualify,” the self-assessor must check the
D.N.Q (did not qualify) box under the “Status of Reviewed File” and remove it from the
review process. A substitute establishment file must be chosen using the second set of
randomly selected numbers to replace this file.
The Establishment File Worksheet lists ten foodborne illness risk factor and public health
interventions along the top line. The self-assessor will record item numbers or other
identifiers from its inspection form that correspond with each of the ten listed risk factors and
public health intervention in the spaces provided adjacent the heading Reference to local
inspection items.
Note: The self-assessor should use the Standard 1: Self-Assessment Worksheet for Part I Interventions and Risk Factor Controls to identify the jurisdiction's code requirements that
correspond to the Food Code provisions included under each of the ten foodborne illness risk
factor and intervention categories. If there is no corresponding local requirement for a
particular foodborne illness risk factor or Food Code intervention, that item can be marked as
"Not Applicable" in the Reference Key. Jurisdictions are not penalized under Standard 6 for
items in the Food Code that have not been adopted.
Using the Start Point Inspection Violations row of the worksheet, the self-assessor places an
"X" under the appropriate foodborne illness risk factor or public health intervention headings
if a violation was noted on the “start-point” inspection. The “X” must be entered under the
appropriate heading even if the violations were corrected on site.
For the purposes of the self-assessment, follow-up actions have been divided into three types:
•
•
•
Was on-site corrective action taken? – On-site corrective action that occurs at the time of
a routinely scheduled inspection;
Was follow-up corrective action taken? – Follow-up action that occurs after the routine
inspection such as re-inspection, training, risk control plans, and informal conferences;
Was enforcement action taken? – Enforcement activities such as fines permit suspension,
hearings, mandated training, restriction of operations, embargo, etc.
Completion of these three items requires a complete review of the selected establishment file.
To facilitate the documentation of the file review, the self-assessor may complete the table
provided at the bottom of the Establishment File Worksheet. The summary table provides a
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Voluntary National Retail Food Regulatory Program Standards – January 2017
method for defining the acronyms and notations used on the worksheet to describe the type of
compliance and enforcement action taken. The self-assessor must review all the
documentation in the establishment file from the “start-point” inspection forward to the
current date to determine if follow-up action was taken and documented for each risk factor
and public health intervention that was out of compliance on the “start-point” inspection.
The self-assessor must review the follow-up actions for each risk factor and public health
intervention violation documented on the “start-point” inspection. The self-assessor must
determine if the follow-up actions complied with the jurisdiction’s written procedures.
• The self-assessor must place an “X” in the “File Meets the Standard 6 Criteria” box if:
o The completed Worksheet shows at least one follow-up action in each column
where a foodborne illness risk factor or public health intervention violation was
marked on the “start-point” inspection; and
o The jurisdiction’s written procedure was followed.
• The self-assessor must place an “X” in the “File Does NOT Meet the Standard 6 Criteria
box.” if:
o The completed Worksheet shows that one or more of the “start-point” violations
do not have at least one follow-up activity; or
o The jurisdiction’s written procedure was not followed for one or more follow-up
activities.
When the review for each randomly selected establishment file is completed, the selfassessor must indicate his or her findings on the Self-Assessment Summary Worksheet.
Under the “Status of Reviewed File” column, the self-assessor must check one of the
following boxes:
• “YES” – indicating that the reviewed file meets the Standard 6 criteria.
• “NO” – indicating that the reviewed file does not meet the Standard 6 criteria.
• “D.N.Q.” – indicating that the establishment file did not qualify for the assessment and a
substitute file will need to be randomly selected and reviewed.
Part IV - Determine the need to review additional randomly selected establishment files
Randomly selected establishment files should be removed from the sample only if:
• The establishment has not been in business long enough to have at least three routine
inspections; or
• Files in which no risk factor or public health intervention violation was documented on
the “start-point” inspection.
When an establishment file is eliminated from the initial random draw, a new establishment file must
be selected using the random selection methodology used for the original sample. The Establishment
File Worksheet contains a specific page for listing the results from the randomly selected substitute
establishment files. If there is a need to identify other substitute establishment files, continue to use the
randomly generated numbers in the order they appear to identify the corresponding establishments from
the jurisdiction's inventory. The file number and the name of the originally selected
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Voluntary National Retail Food Regulatory Program Standards – January 2017
establishment that did not qualify for the self-assessment review process must be recorded under the
first column of the “Substitute Establishment” summary worksheet. This provides a direct
association between the newly selected establishment file and the one it is replacing.
STEP 3 – Determine if the Standard 6 criteria are met
Standard 6 requires that 80 percent of the reviewed files adhere to the jurisdiction’s written compliance
and enforcement procedures. Files that “did not qualify” (D.N.Q.) for the self-assessment review are not
included in the calculation for this percentage. The self-assessor must determine if 80% of the
establishment files reviewed met the Standard 6 criteria.
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10
9
8
7
6
5
4
3
2
1
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-14
Yes
No
Does Not
Qualify
Standard 6: Compliance and Enforcement
Self-Assessment Summary Worksheet
Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Self-Assessor's General Comments
20
19
18
17
16
15
14
13
12
11
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-15
Yes
No
Does Not
Qualify
Standard 6: Compliance and Enforcement
Self-Assessment Summary Worksheet
Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Self-Assessor's General Comments
30
29
28
27
26
25
24
23
22
21
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-16
Yes
No
Does Not
Qualify
Standard 6: Compliance and Enforcement
Self-Assessment Summary Worksheet
Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Self-Assessor's General Comments
40
39
38
37
36
35
34
33
32
31
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-17
Yes
No
Does Not
Qualify
Standard 6: Compliance and Enforcement
Self-Assessment Summary Worksheet
Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Self-Assessor's General Comments
50
49
48
47
46
45
44
43
42
41
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-18
Yes
No
Does Not
Qualify
Standard 6: Compliance and Enforcement
Self-Assessment Summary Worksheet
Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Self-Assessor's General Comments
60
59
58
57
56
55
54
53
52
51
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-19
Yes
No
Does Not
Qualify
Standard 6: Compliance and Enforcement
Self-Assessment Summary Worksheet
Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Self-Assessor's General Comments
70
69
68
67
66
65
64
63
62
61
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-20
Yes
No
Does Not
Qualify
Standard 6: Compliance and Enforcement
Self-Assessment Summary Worksheet
Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Self-Assessor's General Comments
10
9
8
7
6
5
4
3
2
1
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-21
Yes
No
Does Not
Qualify
Standard 6: Compliance and Enforcement
Self-Assessment Summary Worksheet
Substitute Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Self-Assessor's General Comments
20
19
18
17
16
15
14
13
12
11
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-22
Yes
No
Does Not
Qualify
Standard 6: Compliance and Enforcement
Self-Assessment Summary Worksheet
Substitute Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Self-Assessor's General Comments
Unsafe
Source
Inadequate
Cooking
Improper
Holding
Temperatures
Hot & Cold
Establishment Name:
Bare Hand
Time/ Temperature
Poor
Parameters not Met (Time Contact with Personal
as a Control, date marking, Ready-to-Eat Hygiene
Food
rapid cooling)
Risk Factor and Food Code Interventions
Permit Number:
Contaminated
Food Contact
Surface &
Equipment
Consumer
Advisory
(when
required)
Employee
Demonstration Health Control
of
system or
Knowledge by
policy
PIC
implemented
Inspection Date (Start Point):
Acronym /
Notation
Acronym /
Notation
File Meets the Standard 6 Criteria:
Select One
Definitions
YES
NO
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Definitions
Definitions
File Does NOT Meet the Standard 6 Criteria:
Acronym /
Notation
Jurisdictions definitions of acronyms and notations used to reflect follow-up action
Was the Written Procedure Followed?
Note:
1. Each column in which a violation is noted must receive a yes response to one of the three questions in order for the file to pass. Additionally, written
procedures must have been followed.
Reference to local
inspection items
Start Point Inspection
Violations
Was on-site corrective
action taken?
Was follow-up corrective
action taken?
Was enforcement action
taken?
File Number:
Standard 6: Compliance and Enforcement
Establishment File Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A VERIFICATION AUDIT
STANDARD 6 – COMPLIANCE AND ENFORCEMENT
Using the Standard 6: Verification Audit Worksheet
The auditor should have the Standard 6: Verification Audit Worksheets available as a reference
when reading through this guidance. The following worksheet is provided at the end of these
instructions:
• Standard 6: Verification Audit Worksheet
The Standard 6: Verification Audit Worksheet is designed to provide a listing of the establishments
randomly selected from the jurisdiction’s inventory that were reviewed as part of the self-assessment
process. This worksheet provides a summary as to whether or not the inspection file/records for each of
the randomly selected establishments meet the Standard 6 criteria.
The Standard 6: Establishment File Worksheet provides a systematic way of collecting the compliance
and enforcement history for each of the randomly selected establishments. Jurisdictions do not have to
use this form. However, a jurisdiction must provide documentation of the review process. The
documentation must indicate if appropriate compliance and enforcement actions were taken for out-of
control risk factors and Food Code interventions at each establishment randomly selected for the
self-assessment.
STEP 1 – Verify the Elements in the Written Compliance & Enforcement Program
To meet the criteria of Standard 6, the jurisdiction must have written step-by-step procedures
outlining its compliance and enforcement process. The verification auditor should review its
compliance and enforcement policies and procedures to ensure that there is clear guidance for staff. The
policies and procedures should provide steps and actions to be taken when various categories of
violations occur. The policies and procedures should also provide a progression of steps to be taken
when violations are not corrected within regulatory or administratively established time frames.
Standard 6 does not dictate a required compliance process. The jurisdiction is free to determine any
actions to be taken for violations of its regulations and the progression of consequences for repeated
violations. The time frames and triggers for additional actions are also left to the discretion of the
jurisdiction.
In addition, to meet the requirements of Standard 6, the jurisdiction’s inspection form must use the IN
compliance, OUT of compliance, Not Applicable, and Not Observed conventions to record the
compliance status of the foodborne illness risk factors and the public health interventions identified in
the Food Code.
Jurisdictions that have not adopted all the recommended foodborne illness risk factors and Food Code
interventions are not penalized under Standard 6 for these omissions.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
STEP 2 – Verify the Effectiveness of the Compliance & Enforcement Program
Randomly selected establishment files must be reviewed to determine if documented violations were
resolved satisfactorily. The results of the review will be used to assess the success of the compliance
and enforcement program. This section of the self-assessment process has been broken down into the
following four parts:
Part I Verify that the jurisdiction reviewed the appropriate number of files
Part II Randomly select establishment files from the jurisdiction’s Standard 6:
Self-Assessment Summary Worksheet
Part III Verify Self-Assessment findings for each selected establishment file
Part IV Verify that 80% of selected establishment files adhere to the
jurisdiction's written compliance and enforcement procedures
Part I - Verify that the jurisdiction reviewed the appropriate number of files
The number of establishment files a jurisdiction must review as part of the Standard 6 self-assessment
process is based on the size of their establishment inventory. Jurisdictions with less than 800 total
establishments must select at least 40 files for review. If a jurisdiction has less than 40 establishments in
the inventory, then all files will be reviewed. Jurisdictions with 800 or more establishments must select
a sample size equal to 5% of the total establishments up to a maximum of 70 files.
Establishment Inventory
Number of Files to Review for the
Self-Assessment
Less than 800
800 or more
40 establishment files
5% of the total number of establishments
(Up to a maximum of 70 files)
Some of the randomly selected establishment files listed on the Standard 6: Self-Assessment Summary
Worksheet may not qualify for the self-assessment process. Deletion of an establishment from the
sample of files to be reviewed as part of the self-assessment process is limited to those establishments
where:
1. The selected establishment has not been in business long enough to have at least three
regularly scheduled routine inspections; or
2. A review of inspection reports in the selected establishment file reveals that there were no risk
factor or Food Code intervention violations documented on the "start-point" inspection
The jurisdiction's self-assessment process must include a listing of the substitute establishment files that
were reviewed as replacements for those that did not qualify. When an establishment does not qualify
for the self-assessment process, the substitute establishment must not be recorded on the Standard 6:
Self-Assessment Summary Worksheet, but instead on the Standard 6: Self-Assessment Summary
Worksheet Substitute Establishment Files Worksheet. The auditor should verify this.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Part II - Randomly select establishment files from the jurisdiction’s Standard 6: Self-Assessment
Summary Worksheet
Using a table of random numbers or a random number generator is the preferred method of sample
selection. The random selection will be made from the establishment files listed on the jurisdiction's
Standard 6: Self-Assessment Summary Worksheet. The number of establishment files that must be
selected for review as part of the verification audit process is indicated in the chart below.
Establishment Inventory
Less than 800
800 or more
Number of Files to Review for the
Self-Assessment
40 establishment files
5% of the total number of establishments
(Up to a maximum of 70 files)
Number of Files to Select
for the Verification Audit
5
10
Using the jurisdiction's Standard 6: Self-Assessment Summary Worksheet, the verification auditor will
identify the establishment files that correspond to the randomly selected number recorded on the
Standard 6: Verification Audit Worksheet. The verification auditor must record the establishment name
or identification number for each of the randomly selected numbers on the Standard 6: Verification
Audit Worksheet.
The verification auditor must only review establishment files that the jurisdiction has indicated as
meeting all the elements of their compliance and enforcement procedures. This will require the
verification auditor to eliminate establishment files that are marked “NO” on the jurisdiction's SelfAssessment Summary Worksheet. (An “X” placed in the “NO” box indicates that the self-assessment
review process determined that the inspection history documented in the establishment file did not meet,
or only partially met, the Standard 6 criteria and all the elements in the jurisdiction's written compliance
and enforcement procedures.)
In instances where the verification auditor has randomly selected an establishment file from the
jurisdiction's Standard 6: Self-Assessment Summary Worksheet that did not qualify (D.N.Q.) for the selfassessment review process, the substitute establishment that the jurisdiction selected for that disqualified
establishment should be used.
Note: There are two types of substitutes for the audit process, which are treated differently:
1. If the auditor selects an establishment that was previously failed by the self-assessor, then use
the auditor-generated substitute list of random numbers to select a substitute establishment.
2. If the auditor selects an establishment that “did not qualify” for the original self-assessment,
then use the substituted establishment that was already assigned in the original selfassessment review.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Part III - Verify Self-Assessment findings for each selected establishment file
Using the jurisdiction's written compliance and enforcement procedures, the verification auditor will
review the Establishment File Worksheet for each of the establishments randomly selected for the
verification audit.
The Standard 6: Establishment File Worksheet provides a systematic way of documenting the
compliance and enforcement history for each of the randomly selected establishments. Jurisdictions do
not have to use this form but must provide documentation of the review process conducted to determine
whether the appropriate compliance and enforcement actions for out-of-control risk factors and Food
Code interventions were taken for each selected establishment.
Review the inspection history in each selected file beginning with the identified “start-point” inspection
and moving forward through two additional inspections. Verify that either on-site corrective action,
follow-up corrective action or enforcement action occurred by the end of the third inspection for each
out-of-compliance risk factor or intervention marked on the start point inspections. In addition, verify
that the actions taken on each violation documented on the “start-point” inspection followed the
jurisdiction's written compliance policy and procedures.
In order for an establishment file to meet the Standard 6 criteria, each column marked with a violation
at the “start-point” inspection must have a subsequent indication that at least one type of follow-up
action was taken and the jurisdiction's written procedures must have been followed. A single violation
on the “start-point” inspection without a final resolution, either correction or compliance/enforcement
activity, will result in a determination that the establishment file does not meet the Standard 6 criteria.
In any instances where the auditor disagrees with the jurisdiction's self-assessment of a file, the auditor
must meet with the jurisdiction's program manager or representative to gain a full understanding of the
rationale used for the self-assessment determination.
The verification auditor will record his or her findings for each of the establishment files reviewed on
the Standard 6: Verification Audit Worksheet. If the verification audit of the establishment file review
indicates that the full intent of the Standard 6 criteria is met, place an “X” in the “YES” box. If full
intent of the Standard 6 criteria is not met, place an “X” in the “NO” box. If the verification auditor
disagrees with the jurisdiction's self-assessment decision, an explanation must be provided in the last
column of the Standard 6: Verification Audit Worksheet. Additional sheets can be used to document
the need for expanded explanations.
Part IV - Verify that 80% of selected establishment files adhere to the jurisdiction's written compliance
and enforcement procedures
The criteria for Standard 6 requires that 80 percent of the files with an identified violation of a
foodborne illness risk factor or a Food Code intervention on the “start-point” inspection adhere to the
jurisdiction's written compliance and enforcement procedures. Files that “did not qualify” (D.N.Q.) for
the self-assessment review are not used in the calculation of the percentage.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Legitimate differences of opinion regarding stringency of language may occur during the verification
audit process. An approximate ten percent (10%) discrepancy allowance is made to accommodate
potential differences in interpretations.
Jurisdictions with less than 800 Establishments - If two or more of the five audited establishment
files rated as passing by the jurisdiction are not verified by the auditor as having met the Standard 6
criteria, the Part III element fails to meet the criteria, and no further sampling is necessary. Even if no
additional disagreements are found by sampling an additional set of randomly drawn establishment files,
the dilution of agreements to disagreements will be insufficient to meet the approximate ten percent
(10%) disagreement allowance.
Determine the need for supplemental sampling. If only one establishment file from the initial sample is
determined by auditor to have not met the Standard 6 criteria, then randomly select an additional 5
establishment files. Follow the same audit process used to review the first set of establishment files.
The Standard 6: Verification Audit Worksheet for substitute establishment files, provided on a following
page, can be used to record all the information related to the supplemental sampling of establishment
files.
If no additional disagreements in the review of establishment files are noted, then the jurisdiction meets
the Standard 6 criteria. If one or more additional establishment files fails the audit review, then the
Standard 6 criteria is not met, since the dilution of agreements to disagreements will be insufficient to
meet the approximate ten percent (10%) disagreement allowance.
Jurisdictions with more than 800 Establishments - If three or more of the ten audited establishment
files rated as passing by the jurisdiction are not verified by the auditor as having met the Standard 6
criteria, then the jurisdiction fails to meet Standard 6. Even if no additional disagreements are found by
sampling an additional set of randomly drawn establishment files, the dilution of agreements to
disagreements will be insufficient to meet the approximate ten percent (10%) disagreement allowance.
Determine the need for supplemental sampling. If one or two establishment files from the initial sample
are determined by auditor to have not met the Standard 6 criteria, then randomly select an additional 10
establishment files. Follow the same audit process used to review the first set of establishment files.
The Standard 6: Verification Audit Worksheet for substitute establishment files, provided on a following
page, can be used to record all the information related to the supplemental sampling of establishment
files.
No more than a total of two of 20 establishment files drawn can be determined by the auditor as not
meeting the Standard 6 criteria. If more than two establishment files fail the audit review, then the
Standard 6 criteria is not met, since the dilution of agreements to disagreements will be insufficient to
meet the approximate ten percent (10%) disagreement allowance.
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10
9
8
7
6
5
4
3
2
1
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-29
Yes
No
Does Not
Qualify
If NO, Auditor is to specify why the establishment file does
not meet all the elements contained in the jurisdiction's
written compliance and enforcement procedures
Standard 6: Compliance and Enforcement
Verification Audit Worksheet
Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
20
19
18
17
16
15
14
13
12
11
Number
of Files
Selected
Randomly
Selected
Number
Jurisdiction Name:
Name or ID of Establishment
6-30
Yes
No
Does Not
Qualify
If NO, Auditor is to specify why the establishment file does
not meet all the elements contained in the jurisdiction's
written compliance and enforcement procedures
Standard 6: Compliance and Enforcement
Verification Audit Worksheet
Substitute Establishment Files
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
EXPLANATION OF THE STATISTICAL MODEL FOR STANDARD 6
In this part of the self-assessment, the self-assessor or auditor will review a randomly selected sample of
establishment files. The review will determine if the establishments were given adequate follow-up for
documented violations. Each file will be scored as passing or failing each of four aspects. In order for the
program to pass, each aspect must be found passing for at least 80 percent of the establishment files reviewed.
If the inventory of establishment files is less than 800, the self-assessor or auditor must randomly select 40 files at
a minimum. If the inventory of establishment files is 800 or more, the self-assessor or auditor must randomly
select 5 percent of the inventory (up to a maximum of 70).
At the smallest sample, a 90 percent performing jurisdiction would pass the standard 95.4 percent of the time
using 40 files. Using 45 files, the passing rate would increase to 96.4 percent, and using 50 files it raises to 97.2
percent. Raising the minimum number of files from 20 to 40 would increase the workload by 50 percent. It
would reduce the risk of failure, however, for a 90 percent performer from 12.4 percent to 7.6 percent, a 41percent
reduction. Considering the consequences of failing, it is possible that some programs with inventories much less
than 800 might still wish to expand their sampling to 40 files. For purposes of the self-assessment requirements,
40 is the minimum number of files to be reviewed but a larger minimum is permitted.
The statistical task here was to determine an upper bound on the sample size in order to avoid wasted effort. The
proposition that was used to decide the upper bound was to have a high rate of passage for any program that does
each aspect correctly 90 percent of the time. A further proposition was that we have a low rate of passage for any
program that does each aspect correctly only 70 percent of the time.
Even at the smallest sample of 40 files, a 70 percent performing program would pass the standard only 1.3 percent
of the time; at 30 files the passing percent drops to 0.4 percent. Therefore, the low passing rate for 70 percent
performers will be met easily by any upper bound.
For inventories of 800 or more, the standard calls for sampling 5 percent of the inventory, up to some limit. The
following are the probabilities of passing the Standard for a series of sample sizes, given that the program is a 90
percent performer for each aspect in any particular file review.
Sample
20
25
30
35
40
45
50
55
Probability of passing if
overall performance is 90%
0.876
0.903
0.924
0.941
0.954
0.964
0.972
0.978
Sample
60
65
70
75
80
85
90
Probability of passing if
overall performance is 90%
0.983
0.987
0.990
0.992
0.994
0.995
0.996
At 70 files, a 90 percent performing program has a 99 percent chance of passing this Standard. Going further
buys only tiny increments of improvement. At much higher sample sizes of around 140 files, lower performing
programs significantly increase their chances of passing, a change of fortune that favors the very biggest
programs. Therefore the upper limit boundary has been set at 70 files for all programs of all sizes.
6-31
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 6: COMPLIANCE AND ENFORCEMENT
ESTABLISHMENT FILE WORKSHEET
Establishment Name:
File Number:
Permit Number:
Inspection Date (Start Point):
Risk Factor and Food Code Interventions
Unsafe
Source
Inadequate
Cooking
Improper
Holding
Temperatures
Hot & Cold
Bare Hand
Time/ Temperature
Poor
Parameters not Met (Time Contact with Personal
as a Control, date marking, Ready-to-Eat Hygiene
Food
rapid cooling)
Contaminated
Food Contact
Surface &
Equipment
Consumer
Advisory
(when
required)
Employee
Demonstration Health Control
of
system or
Knowledge by
policy
PIC
implemented
Reference to local
inspection items
Start Point Inspection
Violations
Was on-site corrective
action taken?
Was follow-up corrective
action taken?
Was enforcement action
taken?
Note:
1. Each column in which a violation is noted must receive a yes response to one of the three questions in order for the file to pass. Additionally, written
procedures must have been followed.
Was the Written Procedure Followed?
YES
NO
Jurisdictions definitions of acronyms and notations used to reflect follow-up action
Acronym /
Notation
Definitions
Acronym /
Notation
Definitions
Acronym /
Notation
Definitions
Select One
File Meets the Standard 6 Criteria:
File Does NOT Meet the Standard 6 Criteria:
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 7
INDUSTRY AND COMMUNITY RELATIONS
Table of Contents
REQUIREMENT SUMMARY ......................................................................................................................................... 2
DESCRIPTION OF REQUIREMENT................................................................................................................................ 2
1.
Industry and Consumer Interaction ........................................................................................................... 2
2.
Educational Outreach................................................................................................................................ 2
OUTCOME.................................................................................................................................................................. 2
DOCUMENTATION ..................................................................................................................................................... 3
7-1
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 7
INDUSTRY AND COMMUNITY RELATIONS
This standard applies to industry and community outreach activities used by a retail food regulatory
program to solicit a broad spectrum of input about a retail food regulatory program’s previous, current,
and future activities, communicate sound public health food safety principles, and foster and recognize
community initiatives focused on the reduction of foodborne illness risk factors.
Requirement Summary
The jurisdiction documents participation in forums that foster communication and information exchange
among the regulators, industry and consumer representatives.
The jurisdiction documents outreach activities that provide educational information on food safety.
Description of Requirement
1. Industry and Consumer Interaction
The jurisdiction sponsors or actively participates in forums with two-way communication such as
food safety task force meetings, advisory boards, advisory committees, customer surveys, webbased meetings or forums, or other mechanisms. These forums shall present information on food
safety, food safety strategies and interventions to control risk factors. Offers of participation
must be extended to industry and consumer representatives.
2. Educational Outreach
Outreach encompasses industry and consumer groups as well as media and elected officials.
Outreach efforts may include industry recognition programs, web sites, newsletters, FightBAC«®
campaigns, food safety month activities, food worker training, school-based activities, use of oral
culture learner materials, or other activities that increase awareness of the foodborne illness risk
factors and control methods to prevent foodborne illness. Outreach activities may also include
posting inspection information on a web site or in the press.
Agency participation in at least one activity in each of the above categories annually is sufficient to meet
this standard.
Outcome
The desired outcome of this standard is enhanced communication with industry and consumers through
forums designed to solicit input to improve the retail food regulatory program. A further outcome is the
reduction of foodborne illness risk factors through educational outreach and cooperative efforts with
stakeholders.
7-2
Voluntary National Retail Food Regulatory Program Standards – January 2017
Documentation
The quality records needed for this standard include:
1. Minutes, agendas or other records documenting that forums were conducted,
2. For formal, recurring meetings, documents such as by-laws, charters, membership criteria and
lists, frequency of meetings, roles, etc.,
3. Surveys, web feedback links with associated follow-up materials and review documents,
4. Documentation of activities designed with input from industry and consumers to improve the
control of foodborne illness risk factors, or
5. Documentation of food safety educational efforts.
Statements of policies and procedures may suffice if activities are continuous, and documenting multiple
incidents would be cumbersome, (e.g, recognition provided to establishments with exemplary records or
an on-going web site).
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Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS FOR COMPLETING
THE PROGRAM SELF-ASSESSMENT AND VERIFICATION AUDIT FORM
STANDARD 7 – INDUSTRY AND COMMUNITY RELATIONS
Program Self-Assessment & Verification Audit Form
The Standard 7: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process. The form is included at the end of
these instructions. Whether one is performing a program self-assessment or conducting a verification
audit, it is recommended that the form be available as a reference to the Standards 7 criteria.
Using the Program Self-Assessment and Verification Audit Form
Documenting the Findings from the Self Assessment
Jurisdictions conducting a self-assessment of Standard 7 must indicate on the form if each of the criteria
is met. The self-assessor must record their findings under the column “Jurisdiction’s Self Assessment.”
Jurisdictions are not obligated to use the form. An equivalent form or process is acceptable provided
that the results of the jurisdiction’s self-assessment for the specific Standard 7 criteria listed on the form
are available for review.
The self-assessor must review each Standard 7 criterion and determine if the jurisdiction’s source
documents confirm that the Standard criteria are met. If the criteria are met, the self-assessor must place
an “X” in the “YES” box under the “Jurisdiction’s Self-Assessment” column of the Standard 7 Program
Self-Assessment and Verification Audit Form.
If a review of the jurisdiction’s source documents does not confirm that the Standard 7 criteria are met,
the self-assessor must place an “X” in the “NO” box under the “Jurisdiction’s Self-Assessment” column
of the Standard 7: Program Self-Assessment and Verification Audit Form. The self-assessor may specify
why the criteria are not met in the box provided.
The self-assessor should review the findings on the Standard 7: Program Self-Assessment and
Verification Form to ensure accuracy. The jurisdiction will be required to provide the auditor with their
completed Standard 7: Program Self-Assessment and Verification Audit Form and any documents used
to support and demonstrate that the Standard 7 criteria have been met.
Once all the criteria have been reviewed and documented on the form, the self-assessor must complete
the Program Self-Assessment Summary section on page one of the Standard 7: Program Self-Assessment
and Verification Audit Form. The self-assessor must:
•
Enter their contact information;
•
Document if the jurisdiction met the Standard 7 criteria in the appropriate boxes; and
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 7 criteria.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Documenting the Findings from the Verification Audit
The jurisdiction requesting the verification audit must provide their completed Standard 7: Program
Self-Assessment and Verification Audit Form to the auditor for review. The auditor must indicate on the
Standard 7: Program Self-Assessment and Verification Audit Form if the criteria were met.
If a review of the jurisdiction’s source documents confirms the self-assessment conclusion that the
Standard criteria are met, the verification auditor must place an “X” in the “YES” box under the
“Auditor’s Verification” column of the form.
If a review of the jurisdiction’s source documents does not confirm the self-assessment conclusion that
the Standard criteria are met, the verification auditor must place and “X” in the “NO” box under the
“Auditor’s Verification” column of the form. The verification auditor must specify why the criterion is
not met in the box provided. Supplemental pages may be used to explain findings.
The verification auditor must discuss their findings with the program manager or their appointed
representative and provide constructive feedback at the conclusion of the on-site visit. In particular, any
Standard 7 criteria for which the auditor cannot confirm through a review of the self-assessment should
be thoroughly discussed. Ample time should be allotted to ensure that there is a clear understanding of
the reasons for the “non-conforming” finding. The auditor should be prepared to identify the elements
required for the jurisdiction to meet the Standard.
Once the close out interview has been conducted, the auditor must complete the Verification Audit
Summary section located on the first page of the Standard 7: Program Self-Assessment and Verification
Audit Form. The auditor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 7 criteria in the appropriate boxes; and
•
•
Sign the form where indicated.
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 7 criteria if the auditor does not confirm the self-assessment
findings.
7-5
FAX:
FAX:
Signature of the Verification Auditor:
7-6
I affirm that the information represented in the Verification Audit of Standard 7 is true and correct
Verification Audit indicates that the Jurisdiction MEETS the Standard 7 criteria: YES
Date the Verification Audit of Standard 7 was Completed:
Phone:
Auditor’s Jurisdiction Address:
Auditor’s Jurisdiction Name:
Verification Auditor’s Title:
NO
NO
VERIFICATION AUDIT SUMMARY
Printed Name of the Person who conducted the Verification Audit:
Signature of the Self-Assessor:
I affirm that the information represented in the Self-Assessment of Standard 7 is true and correct
Self-Assessment indicates that the Jurisdiction MEETS the Standard 7 criteria: YES
Date the Standard 7 Self-Assessment was Completed:
Jurisdiction Address:
Phone:
Jurisdiction Name:
Self-Assessor's Title:
Printed Name of the Person who conducted the Self-Assessment:
E-mail:
E-mail:
PROGRAM SELF-ASSESSMENT SUMMARY
Standard 7: Industry and Community Relations
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
confirming that the agency has sponsored or
coordinated at least one educational outreach activity
annually directed at industry, consumer groups, the
media, and/or elected officials. Educational outreach
activities focus on increasing awareness of foodborne
illness risk factors and control methods to prevent
foodborne illness and may include industry
recognition programs, web sites, newsletters, Fight
BAC campaigns, food safety month activities, food
worker training, and use of oral culture learner materials.
a) The jurisdiction maintains written documentation
2. Educational Outreach
confirming that the agency has sponsored or actively
participated in at least one meeting/forum annually,
such as food safety task forces, advisory boards /
committees, customer surveys, web-based meetings or
forums. Documentation confirms that
offers of participation have been extended to industry
and consumer representatives.
a) The jurisdiction maintains written documentation
1. Industry and Consumer Interaction
Criteria
Jurisdiction Name:
YES
NO
7-7
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
YES
If NO, Auditor is to specify
why criterion is not met
Verification Audit
NO
Standard 7: Industry and Community Relations
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
7-8
GENERAL NOTES PERTAINING TO THE PROGRAM SELF-ASSESSMENT OR THE VERIFICATION AUDIT
Standard 7: Industry and Community Relations
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A SELF-ASSESSMENT
STANDARD 7 – INDUSTRY AND COMMUNITY RELATIONS
Using the Standard 7 Self-Assessment Worksheet
The Standard 7: Self-Assessment Worksheet is designed to assist jurisdictions with maintaining
documentation and information required in the Standard 7 criteria. The Standard 7: Self-Assessment
Worksheet is divided in two sections:
1. Industry and Consumer Interaction; and
2. Educational Outreach.
STEP 1 – Confirm Documentation of Industry and Consumer Interaction Forums
The jurisdiction must maintain written documentation confirming that the agency has sponsored or
actively participated in at least one meeting/forum annually. Meetings and forums include, but are not
limited to food safety task forces, advisory boards or advisory committees, customer surveys, and web
based meetings or forums. Documentation also confirms that offers of participation have been extended
to industry and consumers. The jurisdiction must sponsor or participate in activities within its regulated
community. These activities must be documented in Part I on the Standard 7: Self-Assessment
Worksheet. The jurisdiction can use a different form if that document captures the same information.
The worksheet is included at the end of these instructions.
In order to properly document these activities, the self-assessor must:
• Enter the name of the forum/meeting under the “Forum Title” column;
• Document the names of meeting/forum participants. (The appropriate column should be used to
document participants from regulatory agencies, industry, and the public). If industry or
consumers were not present at a meeting, a statement should be entered that conveys that an
offer to participate was extended to these groups. The jurisdiction must maintain records to
show that an effort was made to gain input from the regulated community and the public. Copies
of letters of invitation or email print-outs soliciting participation may be retained to substantiate
the offer;
• Confirm that the dates of meetings have been recorded because it establishes that the activity
took place at least once annually in the most recent five-year period of the self-assessment. If
meetings are recurring such as held monthly, the jurisdiction may record “monthly” under the
date column and include the inception date of the meeting/forum; and
• Document action items and program items that resulted from the meeting. These should be
documented in the final column titled “Summary of Activities Related to Control of Risk
Factors.”
Examples of documents that may be reviewed as part of the self-assessment process
Minutes or agendas from the forum/meeting that describe the topics covered and the participants
present.
For formal, recurring meetings, documents such as by-laws, charters, membership criteria and
lists that detail the purpose of the meetings, the committee make-up, frequency of meetings, and
7-9
Voluntary National Retail Food Regulatory Program Standards – January 2017
roles of participants.
Brochures that detail the purpose of the meeting and topics that were presented, or illustrate
collaborative food safety efforts by regulatory, industry and/or consumers.
Letters or printed email messages that document invitations to consumers and/or industry
representatives to participate in forums/meetings.
STEP 2 – Review Documentation of Educational Outreach
To meet the standard criteria, the jurisdiction must have performed at least one educational outreach
activity per year during the most recent five-year period of the self-assessment. The educational
outreach activity can be focused on industry, the media, consumers and/or elected officials The methods
of outreach and a summary of the activities should be recorded in Part II of Standard 7: Self-Assessment
Worksheet.
In order to properly document the education outreach activities, the self-assessor must:
• Record the date of the educational outreach activity under the “Date” column of the worksheet.
For outreach activities that are on-going such as the quarterly issuance of a food safety bulletin
or a website that posts inspection scores or other food safety information, the jurisdiction need
not record each date. For documentation of this component on the worksheet the information
may be listed as ongoing using a date range such as “January 1 – December 31, 2013” or
“Ongoing since 2008.” The jurisdiction would need to include the date the activity began so it
can be shown that the activities occurred over the most recent five-year period.
• Briefly describe the educational outreach initiative that was conducted on the recorded date or
within the specified time frame. This should be done under the “Summary of Activities”
column.
Examples of documents that may be reviewed as part of the self-assessment process:
Food Safety Brochures or Flyers
Completed Customer Survey Cards
Dated pictures of Food Safety Activities such as Fight BAC events held in the community,
display booths at fairs
Jurisdiction Websites
Food Safety Newsletters
Acknowledgement letters thanking members from the regulatory agency for providing food
safety training in forums such as schools, churches, and civic groups
A listing of scheduled Manager Certification courses
Sign-in Sheets from Training or Courses offered to consumers and the regulated industry
Minutes from meetings on food safety with elected officials
Newspapers with printed food service facility scores
Agendas from food safety expos
7-10
Forum Title
Regulatory
Participants by
Organization
Industry
Participants by
Organization
7-11
Consumer
Participants by
Organization
PART I – Industry and Consumer Interaction Forums
Meeting
Dates
Summary of Activities Related to Control of Risk
Factors
It is necessary to maintain records of the Industry and Consumer Interaction forums and of the Educational Outreach activities
over the most recent five-year period. The following chart is used to document the occurrence of those forums and activities.
Meeting minutes, agendas, by-laws, charters, membership criteria and lists, frequency of meetings, roles, performed actions and
documentation of food safety educational efforts must be maintained by the regulatory authority.
Standard 7: Industry and Community Relations
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Dates
PART II – Educational Outreach
7-12
Summary of Activities
Standard 7: Industry and Community Relations
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 8
PROGRAM SUPPORT AND RESOURCES
Table of Contents
REQUIREMENT SUMMARY..........................................................................................................................................2
DESCRIPTION OF REQUIREMENT ................................................................................................................................2
1.
Staffing Level ..............................................................................................................................................2
2.
Inspection Equipment .................................................................................................................................2
3.
Administrative Program Support................................................................................................................3
4.
Regulatory Foundation...............................................................................................................................3
5.
Trained Regulatory Staff.............................................................................................................................3
6.
Inspection Program Based on HACCP Principles .....................................................................................3
7.
Uniform Inspection Program......................................................................................................................3
8.
Foodborne Illness & Food Defense Preparedness & Response .................................................................3
9.
Compliance & Enforcement .......................................................................................................................3
10. Industry & Community Relations ...............................................................................................................3
11. Program Assessment...................................................................................................................................3
12. Accredited Laboratory................................................................................................................................4
OUTCOME ..................................................................................................................................................................4
DOCUMENTATION ......................................................................................................................................................4
8-1
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 8
PROGRAM SUPPORT AND RESOURCES
This standard applies to the program resources (budget, staff, equipment, etc.) necessary to support an
inspection and surveillance system that is designed to reduce risk factors and other factors known to
contribute to foodborne illness.
Requirement Summary
The program provides funding, staff and equipment necessary to accomplish compliance with the
Voluntary National Retail Food Regulatory Program Standards.
Description of Requirement
The program budget provides the necessary resources to develop and maintain a retail food safety
program that meets the following criteria:
1.
Staffing Level
A staffing level of one full-time equivalent (FTE) devoted to food for every 280 – 320 inspections
performed. Inspections for purposes of this calculation include routine inspections, reinspections, complaint investigations, outbreak investigations, compliance follow-up inspections,
risk assessment reviews, process reviews, variance process reviews and other direct establishment
contact time such as on-site training.
A process should exist for the regulated food establishments to be grouped into at least three
categories based on food safety risk (See Standard 3). The number of inspections assigned per
FTE should be adjusted within the 280 – 320 range depending upon the composition of low- to
high –risk establishments in the assigned inventory. When an FTE is divided between program
areas, the total number of food inspections planned for that FTE should be adjusted to
compensate for the additional training time required to maintain competency in multiple program
areas. An adjustment of planned inspections per FTE should also occur when food
establishments are geographically dispersed due to increased travel time. Through their
committee process, the Conference for Food Protection has developed an assessment tool and
instruction guide as resources that can be used by a jurisdiction to calculate the FTE to inspection
ration The Standard 8 – Assessment Too and Standard 8 – Assessment Workbook Instruction
Guide are available for downloading from the CFP web site: www.foodprotect.org and are
located under the icon titled, “Conference Developed Guides and Documents.”
2.
Inspection Equipment
Inspection equipment of each inspector to include head covers, thermocouples, flashlights,
sanitization test kits, heat sensitive tapes or maximum registering thermometers, necessary forms
and administrative materials. The following equipment must be available for use by inspectors
when needed: computers, cameras, black lights, light meters, pH meters, foodborne illness
investigation kits, sample collection kits, data loggers and cell phones.
8-2
Voluntary National Retail Food Regulatory Program Standards – January 2017
3.
Administrative Program Support
Equipment for administrative staff to include computers, software and/or items necessary to
support the record keeping system utilized by the program. A system is in place to collect,
analyze, retain and report pertinent information.
4.
Regulatory Foundation
Staff and resources to adopt a sound, science-based regulatory foundation for the public
health program and the uniform regulation of industry required in Standard No. 1.
5.
Trained Regulatory Staff
Training and training documentation for all regulatory staff to meet the level specified in
Standard No. 2.
6.
Inspection Program Based on HACCP Principles
Staff to meet all of the requirements in Standard No. 3, inspection based on HACCP principles.
7.
Uniform Inspection Program
Administrative and supervisory staff to administer and monitor a uniform inspection program
based on HACCP principles that meet Standards No. 3 and 4.
8.
Foodborne Illness & Food Defense Preparedness & Response
Staff and resources to maintain a foodborne illness investigation and response system that meets
Standard No. 5.
9.
Compliance & Enforcement
A program that demonstrates follow-though on all compliance and enforcement actions initiated
according to the written step-by-step procedures required in Standard No. 6.
10. Industry & Community Relations
An industry and consumer relations program as specified in Standard No. 7.
11. Program Assessment
Sufficient staff and resources to conduct regular program self-assessment and risk factor surveys
as specified in Standard No. 9.
8-3
Voluntary National Retail Food Regulatory Program Standards – January 2017
12. Accredited Laboratory
Funds to provide access to accredited laboratory resources in support of the program as specified
under these nine Standards.
The essential program elements required to demonstrate compliance with this standard are:
A.
B.
C.
D.
Full-time equivalent (FTE) personnel to inspections accomplished ratio as described in section 1.
Inspection equipment assigned or available as described in section 2.
Equipment and/or supplies required for administering the program as described in Section 3.
A full and accurate completion of the Standard 8: Self-Assessment Worksheet or equivalent
whether or not those standards are met.
Outcome
The desired outcome of this standard is that resources are available to support a risk-based retail food
safety program designed to reduce the risk factors known to contribute to foodborne illness.
Documentation
The quality records needed for this standard include:
1. Documentation of FTE to inspections ratio,
2. Inventory of assigned and available inspection equipment,
3. Documentation and demonstration of records system and adequacy of support,
4. The completed Standard 8 Self-Assessment Worksheet
[*NOTE: An average workload figure of 150 establishments per FTE with two inspections per year was
originally recommended in the 1976 Food Service Sanitation Manual, the standard originating from a
book entitled, “Administration of Community Health Services.” Annex 4 of the Code since 1993 has
included a recommendation that 8 to 10 hours be allocated for each establishment per year to include all
the activities reflected here in the definition of an inspection. The range of 280 – 320 broadly defined
inspections per FTE is consistent with these previous recommendations. A measure of resources defined
as inspections per FTE rather than establishments per FTE allows for the same unit of measure to be
used for any jurisdiction regardless of the frequency of routine inspections conducted among the various
priority categories.]
8-4
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS FOR COMPLETING
THE PROGRAM SELF-ASSESSMENT AND VERIFICATION AUDIT FORM
STANDARD 8 – PROGRAM SUPPORT AND RESOURCES
Program Self-Assessment & Verification Audit Form
The Standard 8: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process. The form is included at the end of
these instructions. Whether one is performing a program self-assessment or conducting a verification
audit, it is recommended that the form be available as a reference to the Standards 8 criteria.
Using the Program Self-Assessment and Verification Audit Form
Documenting the Findings from the Self Assessment
Jurisdictions conducting a self-assessment of Standard 8 must indicate on the form if each of the criteria
is met. The self-assessor must record their findings under the column “Jurisdiction’s Self Assessment.”
Jurisdictions are not obligated to use the form. An equivalent form or process is acceptable provided
that the results of the jurisdiction’s self-assessment for the specific Standard 8 criteria listed on the form
are available for review.
The self-assessor must review each Standard 8 criterion and determine if the jurisdiction’s source
documents confirm that the Standard criteria are met. If the criteria are met, the self-assessor must place
an “X” in the “YES” box under the “Jurisdiction’s Self-Assessment” column of the Standard 8 Program
Self-Assessment and Verification Audit Form.
If a review of the jurisdiction’s source documents does not confirm that the Standard 8 criteria are met,
the self-assessor must place an “X” in the “NO” box under the “Jurisdiction’s Self-Assessment” column
of the Standard 8: Program Self-Assessment and Verification Audit Form. The self-assessor may specify
why the criteria are not met in the box provided.
The self-assessor should review the findings on the Standard 8: Program Self-Assessment and
Verification Form to ensure accuracy. The jurisdiction will be required to provide the auditor with their
completed Standard 8: Program Self-Assessment and Verification Audit Form and any documents used
to support and demonstrate that the Standard 8 criteria have been met.
Once all the criteria have been reviewed and documented on the form, the self-assessor must complete
the Program Self-Assessment Summary section on page one of the Standard 8: Program Self-Assessment
and Verification Audit Form. The self-assessor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 8 criteria in the appropriate boxes; and
•
•
Sign the form where indicated.
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 8 criteria.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Documenting the Findings from the Verification Audit
The jurisdiction requesting the verification audit must provide their completed Standard 8: Program
Self-Assessment and Verification Audit Form to the auditor for review. The auditor must indicate on the
Program Self-Assessment and Verification Audit Form if the criteria were met.
If a review of the jurisdiction’s source documents confirms the self-assessment conclusion that the
Standard criteria are met, the verification auditor places an “X” in the “YES” box under the “Auditor’s
Verification” column of the form.
If a review of the jurisdiction’s source documents does not confirm the self-assessment conclusion that
the Standard criteria are met, the verification auditor places and “X” in the “NO” box under the
“Auditor’s Verification” column of the form. The verification auditor must specify why the criterion is
not met in the box provided. Supplemental pages may be used to explain findings.
The verification auditor must discuss their findings with the program manager or their appointed
representative and provide constructive feedback at the conclusion of the on-site visit. Ample time
should be allotted to ensure that there is a clear understanding of the reasons for the “non-conforming”
finding. The auditor should be prepared to identify the elements required for the jurisdiction to meet the
Standard.
Once the close out interview has been conducted, the auditor must complete the Verification Audit
Summary section located on the first page of the Standard 8: Program Self-Assessment and Verification
Audit Form. The auditor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 8 criteria in the appropriate boxes; and
•
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 8 criteria if the auditor does not confirm the self-assessment
findings.
8-6
FAX:
YES
FAX:
Signature of the Verification Auditor:
8-7
I affirm that the information represented in the Verification Audit of Standard 8 is true and correct
Verification Audit indicates that the Jurisdiction MEETS the Standard 8 criteria: YES
Date the Verification Audit of Standard 8 was Completed:
Auditor’s Jurisdiction Address:
Phone:
Auditor’s Jurisdiction Name:
Verification Auditor’s Title:
NO
NO
VERIFICATION AUDIT SUMMARY
Printed Name of the Person who conducted the Verification Audit:
Signature of the Self-Assessor:
I affirm that the information represented in the Self-Assessment of Standard 8 is true and correct
Self-Assessment indicates that the Jurisdiction MEETS the Standard 8 criteria:
Date the Standard 8 Self-Assessment was Completed:
Jurisdiction Address:
Phone:
Jurisdiction Name:
Self-Assessor's Title:
Printed Name of the Person who conducted the Self-Assessment:
E-mail:
E-mail:
PROGRAM SELF-ASSESSMENT SUMMARY
Standard 8: Program Support and Resources
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
a) The jurisdiction has written documentation,
calculations, or a program resource assessment that
demonstrates sufficient equipment is available to
support the record keeping system utilized by the
program.
3. Administrative Program Support
b) The jurisdiction has written procedures for obtaining
the use of computers, cameras, black lights, pH
meters, foodborne illness kits, sample collection kits,
data loggers, and cell phones should this equipment
not be part of the agency's general inventory.
a) The jurisdiction can show through written records,
equipment inventories, or actual observations that
each retail food program inspector has a head cover,
thermocouple, flashlight, sanitization test kit, heat
sensitive tapes or maximum registering thermometer,
and necessary forms and administrative materials.
2. Inspection Equipment
a) The jurisdiction has written documentation,
calculations, or a program resource assessment that
demonstrates a staffing level of one FTE for every
280-320 retail food program inspections performed.
NO
8-8
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
1. Staffing Level - FTE's per Inspections Performed
Criteria
Jurisdiction Name:
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
Standard 8: Program Support and Resources
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
a) The jurisdiction has conducted an assessment to
determine if the agency has the budget, staffing, and
equipment necessary to meet Standard #1 - Regulatory
Foundation.
b) The jurisdiction has conducted an assessment to
determine if the agency has the budget, staffing, and
equipment necessary to meet Standard #2 - Trained
Regulatory Staff.
c) The jurisdiction has conducted an assessment to
determine if the agency has the budget, staffing, and
equipment necessary to meet Standard #3 - Inspection
Program Based on HACCP Principles.
d) The jurisdiction has conducted an assessment to
determine if the agency has the budget, staffing, and
equipment necessary to meet Standard #4 - Uniform
Inspection Program.
e) The jurisdiction has conducted an assessment to
determine if the agency has the budget, staffing, and
equipment necessary to meet Standard #5 Foodborne Illness and Food Security Preparedness
and Response.
f) The jurisdiction has conducted an assessment to
determine if the agency has the budget, staffing, and
equipment necessary to meet Standard #6 Compliance and Enforcement.
g) The jurisdiction has conducted an assessment to
determine if the agency has the budget, staffing, and
equipment necessary to meet Standard #7 - Industry
and Community Relations.
4. Program Resource Assessment
b) The jurisdiction has a system in place to collect,
analyze, retain, and report pertinent information
required to manage and implement the program.
Criteria
YES
NO
8-9
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
h. The jurisdiction has conducted an assessment to
determine if the agency has the budget, staffing, and
equipment necessary to meet Standard #9 Program Assessment.
Criteria
YES
NO
8-10
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
8-11
A “yes” affirmation to criteria 1-3 and 4 (h) is required to meet Standard 8. Disclosure and analysis only is required for criteria 4 (a/i
except h). If an item contains multiple questions, then all questions must be answered in the affirmative in order to meet that element of
the Standard. The source documents, such as the various policies and procedures, that support this summary record must be maintained
in good order by the regulatory authority and must be made available upon request for purposes of a verification audit.
GENERAL NOTES PERTAINING TO THE PROGRAM SELF-ASSESSMENT OR THE VERIFICATION AUDIT
Standard 8: Program Support and Resources
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS AND WORKSHEET
FOR CONDUCTING A SELF-ASSESSMENT
STANDARD 8 – Program Support and Resources
STEP 1 – Review Staffing Level – FTE’s per Inspections Performed
The jurisdiction must have written documentation, calculations, or a program resource assessment that is
used to determine staffing levels for retail food inspections. The “FTE (Full-Time Equivalent) per
Inspections Performed” is the measure of a program’s capacity to fulfill its inspection obligations.
Full-Time Equivalent (FTE) is defined as the number of productive hours (conducting retail food
inspections) contributed by one person working full-time for one year.
Determine Number of Inspections: For the purposes of this standard, “inspections” are defined as
routine inspections, re-inspections, complaint investigations, outbreak investigations, compliance
follow-up inspections, risk assessment reviews, process reviews, variance process reviews, foodborne
illness complaint response, final construction inspections and other direct establishment contact time
such as on-site training that is performed by the field inspection staff. If the same personnel who
conduct inspections of the fixed-site establishments also conduct the inspections of temporary events
and mobile units, then these inspection events should also be counted as “inspections” for purposes of
calculating the workload ratio.
The jurisdiction must estimate the number of on-site contacts made in a year. The Inspection-to-FTE
Ratio is then calculated as the total number of inspections (or on-site visits) divided by the number of
FTE's. To meet the Standard 8 criteria, the ratio must fall between 280 and 320 inspections per FTE.
The Conference for Food Protection’s Program Standard Committee has designed resource tools for
assisting jurisdictions with calculating the Inspection-to-FTE ratio:
Standard 8 – Staffing Level Assessment Workbook
Standard 8 – Staffing Level Assessment Workbook; Instruction Guide
The above resources are available on the Conference for Food Protection web site: www.foodprotect.org
STEP 2 – Review Inspectional Equipment Documentation
Documentation for inspection equipment: The self-assessor must confirm that the jurisdiction has
documentation to verify that necessary inspection equipment is provided and assigned to each
inspector, including head covers, thermocouples, flashlights, sanitization test kits, heat sensitive
tapes or maximum registering thermometers, necessary forms and administrative materials.
Documentation for accessing use of additional equipment: The self-assessor must confirm that the
jurisdiction has documentation for obtaining use of equipment that may not be part of standard
equipment issued for inspection purposes, such as computers, cameras, black lights, light meters, pH
meters, foodborne illness investigation kits, sample collection kits, data loggers and cell phones.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
STEP 3 – Review Administrative Program Support Documentation
Documentation of equipment/supplies for maintaining program records: The self-assessor must
confirm that the jurisdiction has documentation that equipment and/or supplies required for
administering the program, including computers, software and other items necessary to support the
record keeping system utilized by the program, are available.
System to analyze data: The self-assessor must verify that a system is in place to collect, analyze,
retain and report pertinent information about the program.
STEP 4 – Program Resource Assessment
The Standard 8 self-assessment worksheet is designed to assist jurisdictions with maintaining
documentation and information required for assessing funding, staffing, and equipment needs associated
with Standards 1 through 7 and Standard 9. The worksheet is included with these instructions.
There is no penalty for a jurisdiction’s failure to meet Standards 1 through 7 or Standard 9. Moreover,
there is no penalty for failing to have the necessary funding and support under the criteria required in the
Program Resource Assessment portion of the Standard 8: Program Self-Assessment and Verification
Audit Form. The intent is for the jurisdiction to perform the assessment to determine if program
resources are sufficient for each standard.
The self-assessor must document on the Standard 8: Self-Assessment Worksheet if the jurisdiction has
sufficient funding, staff, and equipment to achieve each of the Standards listed on the worksheet. Each
of the three resource areas (funding / staff / equipment) is assessed separately for each of the Standards.
A check mark in the “YES” column indicates that the jurisdiction has sufficient resources. A check
mark in the “NO” column indicates that the jurisdiction does not have sufficient resources. A “NO”
response require an explanation as to what additional resources may be needed to assist the jurisdiction
with meeting the Standard.
At the bottom of the worksheet, the self-assessor will indicate if the jurisdiction meets the Standard 8
requirements by checking either “YES” or “NO”. Upon completing the worksheet, the self-assessor
must sign and date it. The self-assessor must retain the worksheet with the other Standard 8 selfassessment documentation
8-13
NO
NO
NO
NO
YES
YES
YES
YES
NO
NO
YES
YES
NO
YES
NO
YES
NO
NO
YES
YES
YES NO
*
YES
NO
YES
YES
**
YES
YES
YES
YES
YES
YES
NO
NO
NO
NO
NO
NO
NO
NO
Equipment
YES NO
NO
NO
YES
NO
YES
YES
Staffing
Funding
***
EXPLANATION - OTHER RESOURCES NEEDED
8-14
Title: ________________________________
Signature: ____________________________
NO
YES
The requirements of Standard 8 are met:
Date: ____________________
*
Do you meet the full-time equivalent (FTE) staff to inspection ration as required in Standard 8?
** Do your inspectors have the equipment provided and available as required in Standard 8?
*** Does your department have the equipment and supplies neccessary to maintain the records and reports system that supports the program as
required in Standard 8?
**** Other shared
resources
9
8
7
6
5
4
3
2
1
Standard #
Instructions: Do you have sufficient funds, staff, equipment, and resources to meet the following Standards? Answer "YES" or "NO" in each block. A "NO"
answer requires explanation. Use additional pages as needed. Disclosure and analysis only is required for Standard 1 through Standard 7, and Standard 9. Standard 8
requires a positive response to the three identified items.
**** The row at the bottom for "other shared resources" provides a place for you to identify needs that may not be easily attached to a specific Standard (i.e. copy
machines, data lines).
Standard 8: Program Support and Resources
Self-Assessment Worksheet
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 9
PROGRAM ASSESSMENT
Table of Contents
REQUIREMENT SUMMARY ......................................................................................................................................... 2
DESCRIPTION OF REQUIREMENT................................................................................................................................ 2
OUTCOME.................................................................................................................................................................. 3
DOCUMENTATION ..................................................................................................................................................... 3
9-1
Voluntary National Retail Food Regulatory Program Standards – January 2017
STANDARD 9
PROGRAM ASSESSMENT
This Standard applies to the process used to measure the success of a jurisdiction’s program in reducing
the occurrence of foodborne illness risk factors to enhance food safety and public health in the
community.
Requirement Summary
Program management must ensure that:
1. A RISK FACTOR STUDY on the occurrence of the five foodborne illness risk factors is conducted
and repeated at least once every 60 months to measure trends in the occurrence of the risk
factors;
2. An analysis is made of the data collected and a report on the outcomes and conclusions of the
RISK FACTOR STUDY is written; and
3. A targeted intervention strategy designed to address the occurrence of the risk factors(s)
identified in their RISK FACTOR STUDY is implemented and the effectiveness of such strategy is
evaluated by subsequent RISK FACTOR STUDIES or other similar tools.
Description of Requirement
To achieve the criteria of Standard 9, a jurisdiction must ensure that:
A. A RISK FACTOR STUDY and report on the occurrence of the five (5) foodborne illness risk factors
must be completed. A RISK FACTOR STUDY serves two purposes:
1. To identify risk factors most in need of priority attention in order to develop strategies to
reduce their occurrence.
2. To evaluate trends over time to determine whether progress is being made toward reducing
the occurrence of foodborne illness risk factors. Studies designed to measure trends require
analysis of data over a period of time, and no single point in time can be used to derive trend
conclusions.
B. The RISK FACTOR STUDY includes all facility categories under regulation by the jurisdiction.
It is recommended that a jurisdiction’s first RISK FACTOR STUDY be conducted as soon as possible
following its first SELF-ASSESSMENT, before programmatic changes are made. There is value in
using the first study to establish a “baseline” against which future performance can be measured.
Program improvements and changes may then be reflected in subsequent studies.
C. The RISK FACTOR STUDY information is to be updated at least once every 60 months to measure
trends specific to the occurrence of the five (5) foodborne illness risk factors.
9-2
Voluntary National Retail Food Regulatory Program Standards – January 2017
The data collection and analysis may occur at various times over the 60-month period, as long as
all facility categories under regulation are included in the 60-month cycle. The 60-month study
update is required to maintain achievement of Standard 9. The subsequent studies and reports
indicate if there has been a net change in the occurrence of the risk factors.
The four (4) facility categories are:
1.
2.
3.
4.
Health Care;
Schools (K-12);
Restaurants;
Retail Food Stores.
D. A jurisdiction may use routine inspection data or may conduct a separate data collection in
completing a RISK FACTOR STUDY. A data collection instrument similar to the FDA Model Data
Collection Form using the IN, OUT, NA, and NO convention, is required.
E. Failure to use this convention skews the data toward either IN compliance or OUT of
compliance. The FDA data collection instrument is not intended as an inspection form.
However, jurisdictions that have developed an inspection form using the IN, OUT, NA and NO
convention may use that inspection form as a survey instrument.
If the jurisdiction uses a different form, the data may be difficult to compare with the data from
the FDA National Foodborne Illness Risk Factor Studies or with data from other jurisdictions.
F. A jurisdiction must ensure that a targeted intervention strategy designed to address the
occurrence of the risk factor(s) identified in their Risk Factor Study is implemented and the
effectiveness is evaluated by subsequent Risk Factor Studies or other similar tools. Jurisdictions
are encouraged to incorporate various types of interventions such as code changes, educational
and training activities, enforcement and compliance strategies, etc. The purpose of the
intervention strategy is to attempt to affect improvement in reducing priority risk factor(s)
occurrence rates between measurement intervals and assess their effectiveness.
Outcome
The desired outcome of this Standard is to enable managers to measure their program against national
criteria and to demonstrate improvement in food safety. The process identifies program elements that
may require improvement or be deserving of recognition.
Documentation
The quality records required for this standard include:
1. Survey reports on the occurrence of risk factors and FDA Food Code interventions identified in
their RISK FACTOR STUDY,
2. Survey collection tools or inspection sheets used for the data collection,
9-3
Voluntary National Retail Food Regulatory Program Standards – January 2017
3. Documentation that each facility category regulation is surveyed during the 60-month survey
cycle,
4. Documentation of performed interventions, actions or activities designed to improve the control
of risk factors,
5. Documentation that the effectiveness of performed interventions is evaluated.
9-4
Voluntary National Retail Food Regulatory Program Standards – January 2017
INSTRUCTIONS FOR COMPLETING
THE PROGRAM SELF-ASSESSMENT AND VERIFICATION AUDIT FORM
STANDARD 9 – PROGRAM ASSESSMENT
Program Self-Assessment & Verification Audit Form
The Standard 9: Program Self-Assessment and Verification Audit Form is designed to document the
findings from the self-assessment and the verification audit process. The form is included at the end of
these instructions. Whether one is performing a program self-assessment or conducting a verification
audit, it is recommended that the form be available as a reference to the Standards 9 criteria.
Using the Program Self-Assessment and Verification Audit Form
Documenting the Findings from the Self Assessment
Jurisdictions conducting a self-assessment of the Standard 9 Program Assessment component must
indicate on the form if each of the criteria is met. The self-assessor must record their findings under the
column “Jurisdiction’s Self Assessment.”
Jurisdictions are not obligated to use the form. An equivalent form or process is acceptable provided
that the results of the jurisdiction’s self-assessment for the specific Standard 9 criteria listed on the form
are available for review.
The self-assessor must review each Standard 9 criterion and determine if the jurisdiction’s source
documents confirm that the Standard criteria are met. If the criteria are met, the self-assessor must
place an “X” in the “YES” box under the “Jurisdiction’s Self-Assessment” column of the Standard 9:
ProgramSelf-Assessment and Verification Audit Form.
If a review of the jurisdiction’s source documents does not confirm that the Standard 9 criteria are met,
the self-assessor must place an “X” in the “NO” box under the “Jurisdiction’s Self-Assessment” column
of the Standard 9: Program Self-Assessment and Verification Audit Form. The self-assessor may
specify why the criteria are not met in the box provided.
The self-assessor should review the findings on the Standard 9: Program Self-Assessment and
Verification Form to ensure accuracy. The jurisdiction will be required to provide the auditor with
their completed Standard 9: Program Self-Assessment and Verification Audit Form and any
documents used to support and demonstrate that the Standard 9 criteria have been met.
Once all the criteria have been reviewed and documented on the form, the self-assessor must complete
the Program Self-Assessment Summary section on page one of the Standard 9: Program SelfAssessment and Verification Audit Form. The self-assessor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 9 criteria in the appropriate boxes; and
•
Sign the form where indicated.
•
9-5
Voluntary National Retail Food Regulatory Program Standards – January 2017
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 9 criteria.
Documenting the Findings from the Verification Audit
The jurisdiction requesting the verification audit must provide their completed Standard 9: Program
Self-Assessment and Verification Audit Form to the auditor for review. The auditor must indicate on
the Standard 9: Program Self-Assessment and Verification Audit Form if the criteria were met.
If a review of the jurisdiction’s source documents confirms the self-assessment conclusion that the
Standard criteria are met, the verification auditor places an “X” in the “YES” box under the “Auditor’s
Verification” column of the form.
If a review of the jurisdiction’s source documents does not confirm the self-assessment conclusion
that the Standard criteria are met, the verification auditor places and “X” in the “NO” box under the
“Auditor’s Verification” column of the form. The verification auditor must specify why the criterion
is not met in the box provided. Supplemental pages may be used to explain findings.
The verification auditor must discuss their findings with the program manager or their appointed
representative and provide constructive feedback at the conclusion of the on-site visit. In particular,
any Standard 9 criteria for which the auditor cannot confirm through a review of the self-assessment
should be thoroughly discussed. Ample time should be allotted to ensure that there is a clear
understanding of the reasons for the “non-conforming” finding. The auditor should be prepared to
identify the elements required for the jurisdiction to meet the Standard.
Once the close out interview has been conducted, the auditor must complete the Verification Audit
Summary section located on the first page of the Standard 9: Program Self-Assessment and
Verification Audit Form. The auditor must:
•
Enter their contact information;
Document if the jurisdiction met the Standard 9 criteria in the appropriate boxes; and
•
Sign the form where indicated.
•
It then will be up to the jurisdiction to determine its action plan and time frame for correcting any
deficiencies in order to meet the Standard 9 criteria if the auditor does not confirm the self-assessment
findings.
9-6
FAX:
FAX:
Signature of the Verification Auditor:
9-7
I affirm that the information represented in the Verification Audit of Standard 9 is true and correct.
Verification Audit indicates that the Jurisdiction MEETS the Standard 9 criteria: YES
Date the Verification Audit of Standard 9 was Completed:
Auditor’s Jurisdiction Address:
Phone:
Auditor’s Jurisdiction Name:
Verification Auditor’s Title:
NO
NO
VERIFICATION AUDIT SUMMARY
Printed Name of the Person who conducted the Verification Audit:
Signature of the Self-Assessor:
I affirm that the information represented in the Self-Assessment of Standard 9 is true and correct.
Self-Assessment indicates that the Jurisdiction MEETS the Standard 9 criteria: YES
Date the Standard 9 Self-Assessment was Completed:
Jurisdiction Address:
Phone:
Self-Assessor's Title:
Jurisdiction Name:
Printed Name of the Person who conducted the Self-Assessment:
E-mail:
E-mail:
PROGRAM SELF-ASSESSMENT SUMMARY
Standard 9: Program Assessment
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
c) The data collection form provides for marking
actual observations of food practices within an
establishment (IN, OUT, NO, and NA).
b) The data collection form includes items pertaining
to the following Center for Disease Control and
Prevention (CDC) identified contributing factors to
foodborne illness.
1. Food from Unsafe Sources;
2. Improper Holding/Time and Temperature;
3. Inadequate Cooking;
4. Poor Personal Hygiene; and
5. Contaminated equipment / Protection
from contamination.
a) A study on the occurrence of foodborne illness
risk factors has been completed and includes data
for each facility type regulated by the jurisdiction
collected over the study cycle.
1. Risk Factor Study
Criteria
Jurisdiction Name:
YES
NO
9-8
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
Standard 9: Program Assessment
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
b) The report provides quantitate measurements upon
which to assess the trends in the occurrence of
foodborne illness risk factors over time.
a) A report is available that shows the results of the
data collection from the jurisdiction's foodborne
illness risk factor study.
2. Report of Analysis and Outcome
Criteria
YES
NO
9-9
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
Voluntary National Retail Food Regulatory Program Standards – January 2017
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
b) Documentation is provided of performed
interventions, action, or activities designed to improve
control of foodborne illness risk factors.
a) A targeted intervention strategy designed to
address the occurrence of the risk factor(s) identified
in their risk factor study is implemented and the
effectiveness of such strategy is evaluated by
subsequent risk factor studies.
3. Intervention Strategy
Criteria
YES
NO
9-10
Self-Assessor's
General Comments
Jurisdiction’s Self-Assessment
YES
NO
If NO, Auditor is to specify
why criterion is not met
Auditor’s Verification
Standard 9: Program Assessment
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
9-11
GENERAL NOTES PERTAINING TO THE PROGRAM SELF-ASSESSMENT OR THE VERIFICATION AUDIT
Standard 9: Program Assessment
Program Self-Assessment and Verification Audit Form
Voluntary National Retail Food Regulatory Program Standards – January 2017
Voluntary National Retail Food Regulatory Program Standards – January 2017
APPENDIX 1: SUMMARY OF CHANGES
This summary provides a synopsis of the changes made to the 2017 edition of the Voluntary National
Retail Food Regulatory Program Standards (Retail Program Standards). The primary intent of this
record is to capture the nature of the changes found in the 2017 edition of the Voluntary National Retail
Food Regulatory Program Standards rather than to identify every word or editing change. This record
should not be relied upon as an absolute comparison that identifies each and every change.
Changes Recommended by the Conference for Food Protection (CFP)
FDA works closely with stakeholders through the biennial Conference for Food Protection (CFP) to
review proposed changes to the Voluntary National Retail Food Regulatory Program Standards.
Changes may be proposed by FDA, or by stakeholder groups such as academia, industry, consumer
groups, and regulatory officials. CFP provides an opportunity for stakeholders to provide comments
about proposed changes.
The following changes reflect the recommendations from the Conference for Food Protection, 2016
biennial meeting.
Updates to Program Standards Definitions
What changed in the Definitions?
The definition for “Training Standard” was updated to include two additional elements related to
training and standardization. The training standard definition now includes two new elements
addressing completion of 20 contact hours of continuing education in food safety every 36 months
after the initial training is completed as outlined in Standard 2, and maintenance of standardization
every three years as outlined in Standard 2
How do these changes affect your jurisdiction?
Jurisdictions will now have to meet two additional as defined in the definition of “training
standard”.
How will I be able to access these forms?
These forms are available on FDA’s website.
Updates to Standard 2- Trained Regulatory Staff
What changed in Standard 2?
Standard 2 applies to the essential elements of a training program for regulatory staff. Under Step
4: Food Safety Inspection Officer –Field Standardization, a re-emphasis was made regarding field
standardization and re-standardization criteria allowing the flexibility to adhere to the regulations
and ordinances germane to the jurisdiction along with a reference to using standardization
procedures similar to the FDA procedures for Standardization of Retail Food Inspection Training
Officers.
1
Voluntary National Retail Food Regulatory Program Standards – January 2017
How do these changes affect your jurisdiction?
Jurisdictions are encouraged to reference standardization procedures similar to those contained in
the FDA Procedures for Standardization of a Retail Food Inspection Training Officer. This is
intended to allow jurisdictions the flexibility to develop its own written protocol to ensure that
personnel are trained and prepared to competently conduct inspections.
How will I be able to access and complete these forms?
These forms are available on FDA’s website. Enrollees can print out the forms and complete
them by hand. Alternatively, these forms can be completed electronically and saved.
Updates to Standard 4 – Uniform Inspection Program
What changed in Standard 4?
Standard 4 applies to the jurisdiction’s internal policies and procedures established to ensure
uniformity among regulatory staff in the interpretation of regulatory requirements, program
policies and compliance/enforcement activities. The following changes reflect recommendations
provided in the Uniform Inspection Program – Audit Pilot Project Report while also providing
greater flexibility, improved program quality assessment and greater consistency between
Program Standards 2 and 4. The changes include:
•
•
•
More closely aligned Program Elements described in Program Standard No. 4 with the
Performance Elements and Competencies contained in the Standard No. 2 - CFP Field
Training Plan for new hires or staff newly assigned to the retail food protection program.
This alignment process has resulted in 20 Program Elements.
A re-ordered listing of the Program Elements in Program Standard No. 4 to reflect the
organized flow of the inspection process.
An increase the minimum number of required field assessments (joint inspections) to
maintain consistency with the current statistical model upon which Standard 4 is based.
The Instructions and Worksheet for Conducting a Self-Assessment – Trained Regulatory Staff
was updated to:
•
•
•
•
•
•
Clarify that jurisdictions may assess additional performance elements as part of their field
assessment process. However, for the purposes of achieving conformance with the Standard,
only the performance elements specified in the Standard will be used to assess conformance
with the Standard.
Clarify that the assessment of the performance elements is not an all-or-nothing approach.
(For instance, someone that misses one risk factor out of 10 risk factors during a field
assessment may still achieve an acceptable level of performance/uniformity on a particular
performance element)
Clarify that enrolled jurisdictions may wish to create a field assessment tool that enables
more specific comments and feedback for the individual food safety inspection officer.
Clarify how establishments should be selected for the field assessment process.
Provide more specific guidance about the file review process.
Clarify who should conduct the field assessment and associated file review.
2
Voluntary National Retail Food Regulatory Program Standards – January 2017
How do these changes affect your jurisdiction?
With the change in number of Performance Elements to 20, the statistical model for Standard 4 has
been updated. Previously in large jurisdictions (jurisdictions with 10 or more inspectors) the
evaluation was based on direct oversight of two inspections per inspector, with respect to 10
Performance Elements. By updating the statistical model the evaluation must now be based on direct
oversight of three inspections per inspector. In the same regard, the statistical model for jurisdictions
with less than 10 inspectors has also been updated. A new calculation model has been included.
Jurisdictions that have between four to nine inspectors will conduct three joint inspections for each
inspector and for jurisdictions that have three or less inspectors it is recommended that extra
oversight inspections be performed to produce a total of 12 inspections. The Program SelfAssessment and Verification Audit Form and Worksheets have been updated to reflect these
changes.
How will I be able to access and complete these forms?
These forms are available on FDA’s website. Enrollees can print out the forms and complete them
by hand. Alternatively, these forms can be completed electronically and saved.
Updates to Standard 7: Industry and Community Relations
What changed in Standard 7?
Standard 7 applies to the Industry and Community Relations outreach activities used by a retail food
regulatory program to solicit a broad spectrum of input about a retail food regulatory program’s
previous, current and future activities. In order to assess conformance with industry and consumer
interaction for Standard 7, enrolled jurisdictions may now include additional forms of two way
communications such as food safety task force meetings, advisory boards, advisory committees,
customer surveys, web based meetings or forums or other mechanisms. The educational outreach
component of Standard 7 now allows the usage of oral culture learner materials that increase the
awareness of the foodborne illness risk factors and control methods to prevent foodborne illness.
How do these changes affect your jurisdiction?
When conducting a self-assessment of Standard 7, enrolled jurisdictions now have additional options
available.
How will I be able to access and complete these forms?
These forms are available on FDA’s website. Enrollees can print out the forms and complete them
by hand. Alternatively, these forms can be completed electronically and saved.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Updates to the Standard 9: Program Assessment
What changed in Standard 9?
The Standard 9 criteria for an enrolled jurisdiction’s risk factor study now include facility categories
rather than facility types as stated in previous editions. The four categories have replaced the nine
facility types. The four facility categories are:
1. Health Care,
2. Schools (K-12)
3. Restaurants
4. Retail Food Stores.
How do these changes affect your jurisdiction?
The changes to the content of the Standard 9 allow enrolled jurisdictions to select categories of
facility types for their risk factor study. The data collection and analysis may occur at various times
over the 60- month period, as long as all facility categories under regulation are included in the 60month cycle. Subsequent studies and reports will indicate if there has been a net change in the
occurrence of the risk factors.
How will I be able to access and complete these forms?
These forms are available on FDA’s website. Enrollees can print out the forms and complete them
by hand. Alternatively, these forms can be completed electronically and saved.
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Voluntary National Retail Food Regulatory Program Standards – January 2017
Other Changes made by FDA
FDA made a number of changes to the Voluntary National Retail Food Regulatory Program
Standards. These changes are described below.
Standard 1: Regulatory Foundation
What changed in Standard 1?
Standard 1 applies to the regulatory foundation of a retail food regulatory program. In order to
assess conformance with Standard 1, enrolled jurisdictions must compare their regulatory foundation
with the provisions in the FDA Food Code. In order to facilitate this process, worksheets are
provided to guide the self-assessment process and the verification audit process. These worksheets
facilitate the comparison of the jurisdiction’s regulatory foundation with risk factor and public
health intervention provisions, good retail practice provisions, and compliance and enforcement
provisions contained within the FDA Food Code.
Standard 1: Self-Assessment Worksheet for Part I was updated to reflect a recent change in the
Food code. The change is as follows:
• Added Section 2-401.13 Bandages, Finger Cots, or Stall products on Wrists, Hands or
Fingers
This provision was incorporated into the Food Code through a recommendation from the
Conference for Food Protection, 2016 biennial meeting.
In addition, the Standard 1 Program Self-Assessment and Verification Audit Form contained a
typographical error that referenced completion dates for both the Self-assessment and audit as it
relates to Standard 2. The error has been fixed to reflect completion dates of the Self-Assessment
and Audit for Standard 1.
How do these changes affect your jurisdiction?
When conducting a self-assessment of Standard 1, jurisdictions must compare their regulatory
foundation to the current edition of the Food Code, or the two most recent previous editions.
These changes impact the provisions assessed during the self-assessment process when using the
current edition of the Food Code.
How will I be able to access and complete these forms?
These forms are available on FDA’s website. Enrollees can print out the forms and complete
them by hand. Alternatively, these forms can be completed electronically and saved.
Standard 3: Inspection Program Based on HACCP Principles Program Self-Assessment and
Verification Audit Form
What changed in Standard 3?
Section 4 of the Standard 3 Program Self-Assessment and Verification Audit Form contained a
typographical error that should have read “Written and Implemented Corrective Action Plan” as
opposed to “Written and Implement Corrective Action Plan”
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Voluntary National Retail Food Regulatory Program Standards – January 2017
How do these changes affect your jurisdiction?
The changes to the program Self-Assessment and Verification Audit Form will not affect a
jurisdiction’s ability to accurately report program Self-Assessment and Verification Audit
information.
How will I be able to access and complete these forms?
These forms are available on FDA’s website. Enrollees can print out the forms and complete
them by hand. Alternatively, these forms can be completed electronically and saved.
Standard 5: Foodborne Illness and Food Defense Preparedness and Response
What changed in Standard 5?
Within the data Review and Analysis section of Standard 5, Regulatory Programs are encouraged
to participate in the CDC National Voluntary Information System, previously known as
(NEAVIS). The name of the system has now changed to the National Environmental Assessment
Reporting System (NEARS). The web link has been updated to reflect the name change and
accompanying pathway accessing the page.
How do these changes affect your jurisdiction?
The change incorporated into the Standard was to include a note regarding the NEARS program.
Including this note does not change the process of conducting a self-assessment or verification
audit for this Standard.
How will I be able to access and complete these forms?
These forms are available on FDA’s website. Enrollees can print out the forms and complete
them by hand. Alternatively, these forms can be completed electronically and saved.
“The 2017 Voluntary Retail National Program Standards workbook primarily reflects an incorporation
of the recently approved changes that resulted from the 2016 Conference for Food Protection held in
Boise, ID and changes forwarded by the Food and Drug Administration’s CFSAN, Retail Food Policy
Team. In addition to these recommendations and changes from FDA, the workbook also contains
editorial corrections throughout to correct for spelling, grammar and date errors from previous
editions.”
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| File Type | application/pdf |
| Author | agelfius |
| File Modified | 2017-06-28 |
| File Created | 2017-06-14 |