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pdfManufactured Food
Regulatory Program Standards
U.S. Department of Health and Human Services
Food and Drug Administration
Human Foods Program
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TABLE OF CONTENTS
TABLE OF CONTENTS ............................................................................................................................ 3
INTRODUCTION ...................................................................................................................................... 5
BACKGROUND ........................................................................................................................................ 6
DEFINITIONS ............................................................................................................................................ 7
STANDARD 1 Regulatory Foundation .................................................................................................... 11
STANDARD 2 Training Program ............................................................................................................ 13
STANDARD 3 Inspection Program ......................................................................................................... 19
STANDARD 4 Inspection Audit Program ............................................................................................... 25
STANDARD 5 Food-related Illness, Outbreak and Hazards Response ................................................... 28
STANDARD 6 Compliance and Enforcement Program .......................................................................... 31
STANDARD 7 Industry and Community Relations ................................................................................ 33
STANDARD 8 Program Resources.......................................................................................................... 35
STANDARD 9 Program Assessment ....................................................................................................... 36
STANDARD 10 Laboratory Support ....................................................................................................... 38
Appendix 1.1: Self-Assessment Worksheet .............................................................................................. 41
Appendix 1.2: Regulatory Foundation Worksheet ................................................................................... 42
Appendix 2.1: Self-Assessment Worksheet .............................................................................................. 50
Appendix 2.2: Inspector Training Record Summary ................................................................................ 54
Appendix 2.3: Inspector Training Record ................................................................................................ 55
Appendix 3.1: Self-Assessment Worksheet .............................................................................................. 60
Appendix 4.1: Self-Assessment Worksheet .............................................................................................. 65
Appendix 4.2: Instructions for Performance Ratings of Audit Findings .................................................. 68
Appendix 4.3: Field Inspection Audit Form ............................................................................................. 69
Appendix 4.3a: Summary of Field Inspection Audit Findings ................................................................. 77
Appendix 4.4: Inspection Report Audit Form .......................................................................................... 79
Appendix 4.4a: Summary of Inspection Report Audit Findings .............................................................. 82
Appendix 4.5: Sample Report Audit Form ............................................................................................... 84
Appendix 4.5a: Summary of Sample Report Audit Findings ................................................................... 88
Appendix 5.1: Self-Assessment Worksheet .............................................................................................. 90
Appendix 6.1: Self-Assessment Worksheet .............................................................................................. 93
Appendix 6.2: Calculation of the Level of Conformance to Compliance Procedures.............................. 94
Appendix 6.2a: Instructions for Performance Review of Enforcement Actions ...................................... 96
Appendix 7.1: Self-Assessment Worksheet .............................................................................................. 97
Appendix 7.2: Outreach Activity Event and Self-Evaluation Worksheet ................................................ 98
Appendix 8.1: Self-Assessment Worksheet .............................................................................................. 99
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Appendix 8.2: Resource Summary Report ............................................................................................. 100
Appendix 8.2a: Resource Summary Report Instructions........................................................................ 101
Appendix 9.1: Self-Assessment Worksheet ............................................................................................ 102
Appendix 9.2: Self-Assessment Summary Report.................................................................................. 105
Appendix 10.1: Self-Assessment Worksheet.......................................................................................... 107
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INTRODUCTION
The Food Safety Modernization Act (FSMA) mandates that the Food and Drug Administration (FDA)
establish an Integrated Food Safety System (IFSS). An IFSS requires partnerships between federal, state,
local, and tribal agencies to collaborate and leverage resources to ensure the protection of public health.
The Manufactured Food Regulatory Program Standards (MFRPS) is a critical component in establishing
the FDA’s IFSS. The MFRPS (henceforth also referred to as “program standards”) establishes a uniform
foundation for regulatory agencies responsible for oversight of food manufacturing food firms. When
fully implemented, the program standards define a set of best practices of a regulatory system.
Conformance with the program standards requires a regulatory agency to continuously assess, evaluate,
and take necessary corrective actions to address gaps. MFRPS conformance will facilitate a system of
mutual reliance between the FDA and other regulatory agencies and support continued improvements in
regulatory manufactured food programs throughout the nation.
The program standards are comprised of ten standards that establish requirements for the critical
elements of a regulatory program designed to protect the public from foodborne illness and injury. These
elements include the program’s regulatory foundation, staff training, inspection, quality assurance, food
defense preparedness and response, foodborne illness and incident investigation, enforcement, education
and outreach, resource management, laboratory resources, and program assessment. Each standard
contains a purpose statement, requirement summary, description of program elements, projected
outcomes, and a list of required documentation. The program standards have corresponding selfassessment and supplemental worksheets designed to assist the regulatory program in achieving and
sustaining conformance.
The FDA will use the program standards as a tool to continuously improve manufactured food contracts
and promote the development of a high-quality state manufactured food regulatory program which
includes a process for continuous improvement based upon quality management systems. The program
standards will assist both the FDA and the states in fulfilling their regulatory obligations. States will be
expected to develop and implement improvement plans to demonstrate that they are moving toward full
implementation and to participate in the FDA audits to determine level of conformance. States are
encouraged to build sustainable systems including sustainability strategies and plans that will result in
the standards being maintained in conformance.
The goal of the MFRPS is to implement a nationally integrated, risk-based, food safety system focused
on protecting public health. The program standards establish a uniform basis for measuring and
improving the performance of prevention, intervention, and response activities of manufactured food
regulatory programs in the United States. The development and implementation of these program
standards will help federal and state programs better direct their regulatory activities toward reducing
foodborne illness hazards in manufactured food firms. Consequently, the safety and security of the
United States food supply will improve as greater focus is placed on prevention.
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BACKGROUND
The food safety regulatory system in the United States is a tiered system that involves federal, state, and
local governments. The FDA is responsible for ensuring that all foods moving in interstate commerce,
except those under the United States Department of Agriculture (USDA) jurisdiction, are safe,
wholesome, and labeled properly. State agencies conduct inspection and regulatory activities that help
ensure food produced, processed, or sold within their jurisdictions is safe. Many state agencies also
conduct manufactured food firm inspections under contract with the FDA. These inspections either are
performed under the states’ laws and authorities or the provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) or both. To maximize the use of resources among the FDA and the states,
particularly when their jurisdictions overlap, their inspection programs should be equivalent in effect.
In June 2000, the Department of Health and Human Services’ Office of the Inspector General (OIG)
released a report of FDA’s oversight of state contracts. In this report, the OIG recommended that (FDA)
take steps to promote “equivalency among Federal and State food safety standards, inspection programs,
and enforcement practices. 1 In response to their findings, the FDA established a committee to develop a
set of quality standards for manufactured food regulatory programs. The committee was comprised of
officials from the FDA and state agencies responsible for regulating manufactured food firms. 2 The
result of the committee was the first edition of the program standards published by the FDA in 2007.
In January 2011, FSMA gave the FDA authority to develop a framework to build the capacity of state
and local regulatory agencies to support the IFSS model. In 2012, the FDA created the Standards
Implementation Staff to give assistance, support and guidance to state programs enrolled in the MFRPS.
Additionally, FDA helped establish the Manufactured Food Regulatory Program Standards (MFRPS)
Alliance to create a network of state programs and assist with further development and revisions of the
program standards.
In December 2011, the OIG released “Vulnerabilities in FDA’s Oversight of State Food Facility
Inspections”. In response, the FDA stated, “Collaboration with our state partners is critical to an
integrated national food safety system and is also mandated under the FDA Food Safety Modernization
Act (FSMA). 3 Over the last decade, the FDA has worked to develop and implement the MFRPS which
will strengthen states’ food safety programs. These program standards reflect an effort in which the FDA
has been engaged in for many years of partnering, leveraging and empowering agencies to move the
vision of a nationally integrated food safety system.
1
Office of Inspector General, FDA Oversight of State Food Firm Inspections: OEI-01-98-00400 (Department of Health and
Human Services, 2000), p. 5.
2
A building or structure or facility or parts thereof, used for or in connection with the manufacturing, processing, packaging,
or holding of human food as defined by 21 CFR Part 117.3.
3
Office of Inspector General, Vulnerabilities in FDA’s Oversight of State Food Facility Inspections: OEI-02-09-00430
(Department of Health and Human Services, 2011), p. 34.
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DEFINITIONS
1.
Assessment: means a systematic, independent, and documented process for obtaining objective
evidence and evaluating it to determine the extent to which a requirement is met. The MFRPS
assessments are conducted by the FDA at approximately 18, 36, and 60 months after enrollment.
Assessments after 60 months will be conducted every two years. The FDA will determine
IMPLEMENTATION during each assessment. The FDA will determine CONFORMANCE at 60
months. The FDA may determine CONFORMANCE at 18 and 36 months when a standard is found
to be fully implemented.
2.
Conformance or Conformity: means the fulfillment of a requirement, specifically a state
program is using and can demonstrate the use of a particular element, system, or program listed
in the MFRPS.
3.
Consumer Complaints: are complaints made by the public regarding food products, facility,
practices, labeling, and any other related activities.
4.
Contact Hour: an inspector qualifies for one contact hour of continuing education for each
clock hour of participation. Contact hours for a specified presentation, course, or training activity
will be recognized only one time within a three-year continuing education period.
5.
Correction: action to eliminate a detected non-CONFORMITY.
6.
Corrective Action(s): action to eliminate the cause of a non-CONFORMITY and to prevent
recurrence.
7.
Critical Violations: are violations which are directly linked to public health risk, food
adulteration, and/or known contributors to foodborne illness unless otherwise defined by the
state.
8.
Current and Fit-for-Use: “current” indicates that documentation is signed and dated in
accordance with program policies and procedures that meet criteria in the most current standard.
“Fit-for-use” is a quality term used to indicate that a product or service fits the customer’s
defined purpose for that product or service. Documentation may be electronic or hard copy.
9.
Current Experienced Staff: defined by the state program in their training plan.
10.
Document Control: document control ensures that documents are reviewed for adequacy,
approved for release by authorized personnel and distributed to and used at the location where
the prescribed activity is performed.
11.
Environmental Assessment (Also called “Environmental Health Assessment”): means an
on-site food product investigation, conducted in conjunction with investigations (e.g.,
TRACEBACK) as needed to assess and rule out the potential that the contaminant of concern was
introduced at a particular point in the distribution or production system. This is achieved by
identifying contributing factors and environmental antecedents.
12.
Equivalent: means that the state law directly references the relevant provision or regulation of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) or Title 21 Code of Federal Regulations
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(CFR). The state program specifies the federal statute or regulation that is incorporated into the
state law, including the revision date of the state statutory provision or regulation, the date the
federal statutory provision or regulation was incorporated into the state law, and whether that
statutory or regulatory provision is included in whole, in part, or modified from the original.
13.
Equivalent in Effect: means that the state law has the same regulatory effect as the relevant
FD&C Act provision or CFR regulation. A state law may have the same regulatory effect as the
federal law or regulation if either a single state law or rule has the same regulatory effect as the
federal law or regulation, or when multiple laws of that state are combined and deemed
EQUIVALENT to a single federal law or regulation. In conducting a self-assessment, the state
program may need to consult with its legal counsel when a provision is determined to be
equivalent in effect.
14.
Evaluation: means an inspection in which the ability of an inspector is assessed to determine if
they are competent to complete independent inspections. Evaluations are required for basic and
each advanced (specialized) inspection type. The evaluation should assess an inspector’s ability
to:
x Prepare for an inspection
x Conduct an inspection
x Follow procedures identified by the state for the specific type of inspection
x Communicate during the inspection and on the inspection report; and
x Assess advanced (specialized) inspection types (as applicable).
Appendix 4.3 Field Inspection Audit Form, a modified version of the Conference for Food
Protection Audit form, or an original form created by the state which evaluates the elements
listed above may be used. It is recommended that new inspectors complete evaluations and
independent inspections before entering the audit cycle. However, if states use the Appendix 4.3
– Field Inspection Audit Form, the evaluations may be counted toward the total audits for that
year.
15.
Field Inspection Audit: means an inspection in which a state inspector is accompanied by a
(either the FDA or state) for the purpose of assessing the
quality and performance of inspections either contract or state. These inspections may be counted
under 2.3.2.3 and 2.3.3.2 Field Training as EVALUATIONS and also under 4.3.2 Field Inspection
Audit if Appendix 4.3 is used.
QUALIFIED FIELD INSPECTION AUDITOR
16.
Food-Related Incident: means an unintentional or deliberate contamination, threatened or
actual, of food that may occur at any point in the production system (e.g., pre-harvest production,
processing, distribution) and may cause food-related illness, injury, outbreaks and HAZARDS.
Examples of food-related incidents include but are not limited to foodborne illness outbreaks and
food tampering.
17.
Hazard: means any biological, chemical, or physical agent in food that is reasonably likely to
cause illness or injury in the absence of its control.
18.
Implementation: means a state program has a particular element, system, or program as
required in the Program Elements and documentation requirements for MFRPS.
19.
Industry Complaints: are complaints made by industry about inspections or inspectors.
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20.
Joint Field Training Inspection: means an inspection conducted jointly by the FDA and/or
state personnel for the purposes of training or enforcement. A joint inspection may be used to
provide training to a state inspector during an inspection of a manufactured food firm and may
either be trainer led or trainee led.
21.
Newly Hired Experienced Staff: staff with manufactured food regulatory experience received
outside the manufactured food safety program to which they are currently employed.
22.
No Authority: responsibility for enforcing a specific section of the federal statutes and/or
regulations lies with another program or agency and not the state program. There is such a state
law, but it does not apply to the state program.
23.
Not Equivalent: means 1) there is no state law EQUIVALENT to the relevant federal law or
regulation, or 2) the federal and state laws address the same matter but are inconsistent and do
not have the same regulatory effect.
24.
Outreach Activity Event: means an outreach activity which the state program hosts, co-hosts or
is an invited presenter such as seminars, workshops, conferences, trainings, or meetings that
relate to food protection topics and that support communication and information exchange
among regulators, industry, academia, and consumer representatives.
25.
Primary Servicing Laboratory: means any laboratory used by the state program for ongoing or
routine testing.
26.
Qualified Date: begins when an inspector has completed all basic course and field elements and
has been signed off to do independent inspections. This date is used to calculate the start of the
continuing education hours in 2.3.5.
27.
Qualified Field Inspection Auditor: means an individual who is recognized by the regulatory
jurisdiction’s food safety program manager as having field experience and communication skills
necessary to audit other inspectors/investigators and who has:
x Demonstrated the competency for basic food inspection auditing to the food safety
program manager;
x Successfully completed advanced food inspection training coursework and field training
in any areas where the auditor performs advanced auditing, such as low-acid canned
foods, acidified foods, seafood HACCP, or juice inspections;
x Been assigned this auditing responsibility; and
x Completed the required audit training per the state program requirements
28.
Qualified Field Inspection Trainer: means an individual who is recognized by the regulatory
jurisdiction’s food safety program manager as having field experience and communication skills
necessary to train or supervise other inspectors/investigators and who has:
x Demonstrated the competency for basic food inspection training to the food safety
program manager;
x Successfully completed advanced food inspection training coursework and field training
in any areas where the trainer performs advanced training, such as low-acid canned
foods, acidified foods, seafood HACCP, or juice inspections; and
x Been assigned this training responsibility.
x State program includes a definition of “qualified trainer” within their training plan.
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29.
Recall Audit Checks: are conducted by the state agency to verify that the manufactured food
firm’s recall was successful as defined by the state’s recall procedures.
30.
Regulatory Foundation: means laws, regulations, rules, ordinances, or other regulatory
requirements that govern the operation of a manufactured food firm.
31.
Sampling Program: means a program in which the state collects samples as part of their
manufactured food program in one or more of the sampling types as defined in the Partnership
for Food Protection’s (PFP) Food/Feed Testing Laboratories Best Practices Manual 4 . The
program can be based on state defined sampling frequency and does not have to be continuous or
routine.
32.
Start Date: date an employee is hired or assigned to the manufactured food program as the
beginning date for training timelines.
33.
Strategic Improvement Plan: means a type of improvement plan that includes the following
information: (1) the individual element or documentation requirement of the standard that was
not met, (2) improvements needed to meet the program element or documentation requirement of
the standard, (3) projected completion dates for each task, (4) personnel responsible, and (5) date
completed.
34.
Traceback: begins at the end of the supply chain at the point of purchase or point of service
(e.g., grocery stores and restaurants) and follows the food product back through the points of
distribution, processing, and production to determine the source of the product and its
ingredients.
35.
Traceforward: traceforward follows the movement of a food in the opposite direction, from the
source (e.g., a farm or manufacturer) forward to the retail shelf, to determine the scope of a
potential recall and the impact of the contaminated product on the public health.
36.
Verification Audit Inspection: means an inspection in which a qualified FDA or state
QUALIFIED FIELD INSPECTION AUDITOR observes a state QUALIFIED FIELD INSPECTION AUDITOR
performing an audit of a state inspector conducting an inspection
4
Reference: PFP Human and Animal Food Testing Laboratories Best Practices Manual: https://www.pfp-ifss.org/ifssresources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/
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Standard 1
STANDARD 1
Regulatory Foundation
Purpose
This standard describes the elements of the REGULATORY FOUNDATION used by a state program to
regulate manufactured food firms.
Requirement Summary
The state program evaluates the scope of its legal authority and regulatory provisions to ensure the
protection of manufactured food within its jurisdiction. The state program’s evaluation includes a
determination of how the state’s REGULATORY FOUNDATION corresponds to the U.S. FDA’s
REGULATORY FOUNDATION.
Program Elements
1.3.1
Written Procedure for Evaluation of Legal Authority
The state program has a written procedure to evaluate the legal authority and regulatory
provisions to inspect and investigate manufactured food firms, gather evidence, collect
and analyze samples, and take enforcement actions. The written procedure must:
1.3.1.1
Include timeframes for a regulatory foundation assessment.
1.3.1.2
Describe the regulatory foundation assessment process, to include whenever
significant changes are made to applicable federal and/or state laws and
regulations.
1.3.1.3
Address the statutes, regulations, rules, ordinances, and other prevailing
regulatory requirements that:
1.3.1.3.1
1.3.1.3.2
1.3.1.3.3
1.3.1.3.4
1.3.2
Apply to the regulation of manufactured food.
Delegate authority to the state program.
Describe the state program’s administrative procedures for
rulemaking to protect public health.
Identifies and lists other state or federal agencies that have
authority for any area of the REGULATORY FOUNDATION that the
state program lacks.
REGULATORY FOUNDATION
Assessment
The state program must complete Appendix 1.2 or equivalent form. The state program
conducts a baseline self-assessment to determine if they are EQUIVALENT, EQUIVALENT IN
EFFECT, NOT EQUIVALENT or have NO AUTHORITY to sections of the current Federal Food,
Drug, and Cosmetic Act (FD&C Act) and Code of Federal Regulations (CFR) Title 21
specified in Appendix 1.2.
Note: If the state program has laws and regulations pertinent to the regulation of
manufactured food, for which there are no federal provisions, these laws and regulations
can also be listed in Appendix 1.2 or equivalent form.
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Standard 1
Note: In conducting a self-assessment, the state program may need to consult with legal
counsel when determining whether a provision is EQUIVALENT IN EFFECT.
Outcome
The state program has the legal authority and regulatory provisions to protect the public health by
ensuring the safety and security of the manufactured food supply within its jurisdiction. For any part of
the REGULATORY FOUNDATION that the state program lacks, the state program identifies another state or
federal program with that regulatory authority to protect public health.
Documentation
The state program maintains the records listed here.
1.5.1
1.5.2
1.5.3
1.5.4
1.5.5
1.5.6
Written procedure for evaluation for legal authority.
State program’s written regulatory foundation assessment process.
The statutes, regulations, rules, ordinances, and other prevailing regulatory requirements
that: (1) apply to the regulation of manufactured food, (2) delegate authority to the state
agency, and (3) describe the state agency’s administrative procedures for rulemaking to
protect public health.
Appendix 1.1 Self-Assessment Worksheet (or equivalent form).
Appendix 1.2 Regulatory Foundation Worksheet (or equivalent form).
If applicable, review by legal counsel.
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Standard 2
STANDARD 2
Training Program
Purpose
This standard defines the essential elements of a training program for inspectors.
Requirement Summary
The state program uses a written training plan that promotes development and demonstrates that all
inspectors who will conduct manufactured food inspections complete course curriculums, field training,
and continuing education to adequately perform their work.
Program Elements
2.3.1
2.3.2
Training Plan and Training Records
2.3.1.1
The state program uses a written training plan that ensures all inspectors
receive training required to adequately perform their work assignments. The
training plan includes course curriculums which provides for basic and
advanced food inspection training as well as continuing education.
2.3.1.2
Appendix 2.2 or equivalent form must be used to document and summarize all
training provided to inspectors.
2.3.1.3
The state program maintains a training history for active inspectors. The
training history for all inactive inspectors must be kept for three years or per
the state’s record retention policy.
2.3.1.4
Appendix 2.3 or equivalent form must be used to document training for each
inspector.
2.3.1.5
The state training record summary and individual training records must include
the inspector’s start date. Equivalent forms including electronic records may be
used for required appendices.
Basic Food Inspection Training
The state program requires that each inspector complete a basic food inspection training
curriculum that consists of coursework and field training described here.
2.3.2.1
Timeframe
The basic food inspection training course curriculum shall be successfully
completed within 24 months of the inspector’s START DATE with the
manufactured food program.
2.3.2.2
Course Curriculum:
The basic food inspection training consists of coursework in the subject areas
listed in this section.
2.3.2.2.1
Prevailing statutes, regulations, and ordinances
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Standard 2
2.3.2.2.2
2.3.2.2.3
2.3.2.2.4
2.3.2.2.5
2.3.2.2.6
2.3.2.2.7
2.3.2.2.8
2.3.2.2.9
2.3.2.2.10
2.3.2.2.11
Public health principles
Emergency management
Communications skills
Microbiology
Epidemiology
Basics of HACCP
Allergen management
Basic food labeling
Food defense
Sampling technique and preparation
Note: States may further subdivide their basic training by identifying courses
required for inspectors who only inspect non-high risk warehouses. These
courses must be clearly defined in the state training plan.
2.3.2.3
Field Training
2.3.2.3.1
Each inspector who will inspect general manufactured food firms
must complete:
2.3.2.3.1.1
2.3.2.3.1.2
2.3.2.3.2
Each inspector who will only inspect non-high risk food
warehouses must complete:
2.3.2.3.2.1
2.3.2.3.2.2
2.3.2.3.3
Five joint field training inspections, field inspection
audits, or evaluations with a qualified field
inspection trainer, and
Of the five, two must be acceptable field inspection
audits or evaluations by a qualified field inspection
trainer or qualified field inspection auditor.
Inspectors who meet 2.3.2.3.2 and advance to conduct general
manufactured food firms must complete:
2.3.2.3.3.1
2.3.2.3.3.2
2.3.2.3.4
10 JOINT FIELD TRAINING INSPECTIONS, field
inspection audits, or evaluations with a qualified
field inspection trainer, and
Of the 10, two must be acceptable field inspection
audits or evaluations by a qualified field inspection
trainer or qualified field inspection auditor.
Five additional JOINT FIELD TRAINING INSPECTIONS,
FIELD INSPECTION AUDITS, or EVALUATIONS to fulfill
requirements identified in 2.3.2.3.1, and
Of the five, two must be acceptable field inspection
audits or evaluations by a qualified field inspection
trainer or qualified field inspection auditor.
JOINT FIELD TRAINING INSPECTIONS or FIELD INSPECTION
AUDITS/EVALUATIONS are conducted in manufactured food firms
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Standard 2
that are representative of the manufactured food firms to be
inspected by the inspector. Each inspector will complete the
minimum field training requirements prior to conducting
independent inspections.
2.3.3
Advanced Food Inspection Training
The state program requires each inspector who will conduct specialized food inspections
to complete an advanced inspection training curriculum which consists of relevant
coursework and field training as described here.
2.3.3.1
Coursework
The state program requires each inspector who will perform specialized food
inspections to successfully complete the coursework specific to the type of
specialized food inspections they will be performing. Specialized food
inspection courses include, but are not limited to:
2.3.3.1.1
2.3.3.1.2
2.3.3.1.3
2.3.3.1.4
2.3.3.1.5
2.3.3.1.6
2.3.3.1.7
2.3.3.2
Acidified foods
Low-acid canned foods
Juice HACCP
Seafood HACCP
Traceback Investigations 5
Foodborne Illness Investigations5
Preventive Controls for Human Food
Field Training
The state program requires that each inspector successfully complete each of
the following before performing independent specialized food inspections.
2.3.3.2.1
2.3.3.2.2
2.3.3.2.3
2.3.4
Participate in two joint field training inspections.
After successful completion of the course participate in one
EVALUATION or FIELD INSPECTION AUDIT that is found to be
acceptable by a QUALIFIED FIELD INSPECTION TRAINER or
QUALIFIED FIELD INSPECTION AUDITOR prior to conducting
independent inspections.
Within one year after being released to do specialized food
inspections complete a second EVALUATION or FIELD INSPECTION
AUDIT that is found to be acceptable by a QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD INSPECTION AUDITOR in
the area of specialty.
Experienced Inspectors
The criterion for conducting a minimum of 10 JOINT FIELD TRAINING INSPECTIONS and
required coursework is intended for new employees or employees new to the food safety
5
These advanced food inspection training courses are not subject to 2.3.3.2 Field Training requirements.
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Standard 2
program. For CURRENT EXPERIENCED STAFF or NEWLY HIRED EXPERIENCED STAFF, a state
program’s training plan shall include the following unless the state determines in their
training plan that all staff will be required to complete the program elements in 2.3.2 and
2.3.3:
2.3.4.1
Current Experienced Staff
Documentation in Employee Training
File
JOINT FIELD
Statement or affidavit explaining the
TRAINING
background or experience that justifies a
INSPECTIONS
waiver of the basic or specialized JOINT
FIELD TRAINING INSPECTIONS.
Basic food
Document training records available.
inspections
Create a statement or affidavit explaining
course work
the background or experience that
justifies a waiver of the missing basic
food inspection course work.
Specialized food Statement or affidavit explaining the date
inspection course and location that they have successfully
work certificates completed the specialized food inspection
training course work.
Missing Record
2.3.4.1.1
2.3.4.1.2
2.3.4.1.3
2.3.4.2
Newly Hired Experienced Staff
Missing Record
2.3.4.2.1
JOINT FIELD
TRAINING
INSPECTIONS
2.3.4.2.2 Basic food
inspection
training course
work
2.3.4.2.3 Specialized food
inspection course
work certificates
2.3.5
Documentation in Employee Training
File
Statement or affidavit explaining the
background or experience that justifies a
waiver of some or all of the basic or
specialized JOINT FIELD TRAINING
INSPECTIONS. Conduct two successful
EVALUATIONS or FIELD INSPECTION
AUDITS within 6 months of the
inspector’s QUALIFIED DATE.
Document training records available.
Statement or affidavit explaining the
background or experience that justifies a
waiver of the basic food inspection
course work.
Statement or affidavit explaining the date
and location that they have successfully
completed the specialized food inspection
training course work.
Continuing Education
Within the scope of this standard, the goal of continuing education and training is to
enhance the inspector’s knowledge, skills, and ability to perform manufactured food
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Standard 2
inspections. The objective is to build upon the inspector’s knowledge base.
2.3.5.1
Each inspector must accumulate 20 contact hours of continuing education in
food safety every 36 months.
2.3.5.2
The 36-month continuing education interval starts at the qualified date, when
the basic training cycle is completed.
2.3.5.3
The program may establish an alternate timeframe to track continuing
education as long as the alternate timeframe and how that timeframe still meets
or exceeds the intent of the standard (at least 20 contact hours every 36
months) are clearly identified in program procedures.
2.3.5.4
The inspector qualifies for contact hours for participation in any of the
following activities that are related specifically to manufactured food safety or
manufactured food inspectional work:
2.3.5.4.1
2.3.5.4.2
2.3.5.4.3
2.3.5.4.4
2.3.5.4.5
2.3.5.4.6
2.3.5.5
Attendance at national or 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.
Distance learning opportunities that pertain to food safety.
Training approved by a qualified field inspection trainer.
Of the accumulated 20 contact hours of continuing education, a maximum of
ten (10) contact hours may be accrued from the following activities:
2.3.5.5.1
2.3.5.5.2
2.3.5.5.3
Delivering presentations at professional conferences.
Providing classroom and/or field training to newly hired
inspectors, or being a course instructor in food safety.
Publishing an original article in a peer-reviewed professional or
trade association journal/periodical.
2.3.5.6
Of the accumulated 20 contact hours of continuing education, a maximum of
four (4) contact hours may be accrued for reading technical publications
related to manufactured food safety.
2.3.5.7
Documentation must accompany each activity submitted for continuing
education credit. Examples of acceptable documentation may include:
2.3.5.7.1
2.3.5.7.2
2.3.5.7.3
2.3.5.7.4
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
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Standard 2
2.3.5.7.5
2.3.5.7.6
2.3.6
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.
An agenda and attendance roster.
Documentation approved by the qualified field inspection trainer.
Coursework Sources
Basic, advanced, and continuing education coursework must be obtained from one of the
sources listed here:
2.3.6.1
Training provided by a government agency (including in-house training).
2.3.6.2
Distance learning, for example, satellite downlinks or web-based training.6
2.3.6.3
Colleges, schools, research centers, and institutes.
2.3.6.4
Food safety alliances recognized by FDA.
Outcome
The state program has trained inspectors with the knowledge, skills, and abilities to competently inspect,
conduct investigations, gather evidence, collect samples, and take enforcement actions with
manufactured food firms.
Documentation
The state program maintains the records listed here.
2.5.1
2.5.2
2.5.3
2.5.4
2.5.5
2.5.6
2.5.7
2.5.8
2.5.9
6
Appendix 2.1 Self-Assessment Worksheet (or equivalent form).
Appendix 2.2 State Training Record Summary (or equivalent form).
Appendix 2.3 Individual Training Record (or equivalent form).
Documents verifying successful completion of required courses.
Course description or agendas for non-FDA courses.
Signed statements for experienced inspectors.
Evaluations or field inspection audits.
Documentation for continuing education credit.
Written Training Plan.
FDA/ORA Office of Education Training and Development courses (classroom and online) are listed at:
https://www.fda.gov/training-and-continuing-education/office-training-education-and-development-oted.
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Standard 3
STANDARD 3
Inspection Program
Purpose
This standard describes the elements of an effective inspection program for manufactured food firms.
Requirement Summary
The state program has a manufactured food inspection system. This system provides the foundation for
inspecting manufactured food firms to determine compliance with the laws administered by federal,
state, and local governments. In addition, the state program has: (1) a risk-based inspection program, (2)
an inspection procedure, (3) an inspection report procedure, (4) a system to respond to CONSUMER
COMPLAINTS, (5) a system to resolve INDUSTRY COMPLAINTS about inspections, (6) a recall system, and
(7) a sampling procedure.
Program Elements
3.3.1
Risk-based Inspection Program
The state program has an inventory of manufactured food firms for which the state has
regulatory oversight. The inventory is categorized by the risk associated with the
likelihood that a FOOD-RELATED INCIDENT will occur.
3.3.1.1
Inspections are prioritized and frequencies assigned based on established risk
categories. The state program has a written procedure documenting their
classification criteria and inspection frequencies.
3.3.1.2
The state program must use the risk factors and classification criteria as
described in:
3.3.1.2.1
3.3.1.2.2
3.3.2
FD&C Act, section 421(a)(1), or
Develop its own risk factor and classification criteria. If the state
chooses to develop its own risk factor and classification criteria a
written rationale must be provided that demonstrates how public
health is protected.
Inspection Procedure
The state program has a written procedure for inspecting manufactured food firms that
requires the inspectors to:
3.3.2.1
Review the previous inspection report and consumer complaints.
3.3.2.2
Have appropriate equipment and forms (if necessary). Equipment must be
verified and maintained as defined by the state’s standard operating procedures
or manufacturer’s recommendations.
3.3.2.3
Make appropriate introductions and explain the purpose and scope of the
inspection.
3.3.2.4
Establish jurisdiction.
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Standard 3
3.3.2.5
Select an appropriate product for the inspection and, if necessary, make
appropriate adjustments based on what the manufactured food firm is
producing.
3.3.2.6
Assess employee practices critical to the safe and sanitary production and
storage of food.
3.3.2.7
Properly evaluate the likelihood that conditions, practices, components, and/or
labeling could cause the product to be adulterated, misbranded or otherwise in
violation of applicable law.
3.3.2.8
Recognize significant violative conditions or practices, if present, and record
findings consistent with state program procedures.
3.3.2.9
Distinguish between significant and insignificant observations and isolated
incidents versus trends.
3.3.2.10 Review and evaluate the appropriate records and procedures for the
manufactured food firm operation and effectively apply the information
obtained from this review (during the inspection).
3.3.2.11 Collect adequate evidence and documentation to support inspection
observations in accordance with state program procedures.
3.3.2.12 Verify correction of deficiencies identified during the previous inspection.
3.3.2.13 Behave professionally and demonstrate proper sanitary practices during the
inspection.
3.3.2.14 Properly evaluate good manufacturing practice requirements (21 CFR 117,
Subparts A, B, and F (for training records only) or equivalent state regulation).
3.3.2.15 When appropriate, verify the manufactured food firm has a written food safety
plan which includes a written hazard analysis that appropriately addresses
hazards, and when appropriate, addresses preventive controls (process controls,
allergen controls, sanitation controls, supply-chain controls, other controls) and
a recall plan.
3.3.2.16 When appropriate, review the manufactured food firm’s written procedures,
monitoring, verification, correction, and corrective action records for process,
allergen, sanitation, supply-chain controls, and other controls which are
identified in their food safety plan.
3.3.2.17 When appropriate, verify the manufactured food firm is in compliance with the
modified requirements that apply to a qualified facility (attestation).
3.3.2.18 When appropriate, verify the modified requirements and time/temperature
controls that apply to a facility solely engaged in the storage of unexposed
packaged foods that require refrigeration for safety.
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Standard 3
3.3.2.19 When appropriate, assess the sanitary transportation of human food
requirements that apply to transportation operations.
3.3.2.20 When appropriate, review the manufactured food firm’s food defense plan,
including mitigation strategies, monitoring, corrective action, and verification
activities.
3.3.2.21 Use current versions of applicable hazard guides or other guidance, to identify
and evaluate the hazards associated with product(s) and process(es) when
conducting inspections of specialized food and processes.
3.3.2.22 Assess the manufactured food firm’s implementation of sanitation monitoring
for the applicable eight key areas of sanitation when required by regulation.
3.3.2.23 When appropriate, review the manufactured food firm’s; scheduled process;
HACCP plan or necessary process controls in the absence of a HACCP plan;
food safety control plan and applicable monitoring, verification and deviation
or corrective action records, including those related to sanitation.
3.3.2.24 Recognize deficiencies in the manufactured food firm’s monitoring controls
and sanitation procedures through in manufactured food firm observations.
3.3.2.25 Use suitable interviewing techniques.
3.3.2.26 Explain findings clearly and adequately throughout the inspection.
3.3.2.27 Alert the manufactured food firm’s person in charge when an immediate
corrective action is necessary.
3.3.2.28 Answer questions and provide information in an appropriate manner.
3.3.2.29 Write findings accurately, clearly, and concisely on the state document and
provide a copy to the manufactured food firm’s person in charge.
3.3.3
Inspection Report
The state program has a written inspection report procedure that requires inspectors to:
3.3.4
3.3.3.1
Submit the inspection report within designated timeframes.
3.3.3.2
Complete the inspection report form completely and accurately.
3.3.3.3
Document violations and observations clearly, legibly, and concisely.
3.3.3.4
Follow-up with corrective action, compliance, and enforcement.
Food Recalls7
7
Reference: PFP Best Practices for Improving FDA and State Communication During Recalls (version 2) can be found:
https://www.pfp-ifss.org/ifss-resources/best-practices-for-improving-fda-and-state-communications-during-recalls-fall-2021/.
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Standard 3
The state program has a food recall system with written recall procedures for:
3.3.5
3.3.4.1
Sharing information about recalls with relevant agencies.
3.3.4.2
Ensuring recalled products are removed promptly from the market.
3.3.4.3
Performing recall audit checks.
Consumer complaints
The state program has a system for handling CONSUMER COMPLAINTS that contains written
procedures for:
3.3.6
3.3.5.1
Receiving.
3.3.5.2
Tracking.
3.3.5.3
Evaluating.
3.3.5.4
Responding.
3.3.5.5
Closing.
Complaints Resulting from State Program Inspection Activities
The state program has a system for handling INDUSTRY COMPLAINTS about inspections that
contains written procedures for:
3.3.7
3.3.6.1
Receiving.
3.3.6.2
Evaluating.
3.3.6.3
Responding.
Sampling Procedure4
The state program has a written sampling procedure to ensure its SAMPLING PROGRAM is
carried out in a manner that is consistent with state procedure. The sampling procedures
must be reflective of the types of food and samples that the state collects and must include:
3.3.7.1
Procedures that require sample collectors to:
3.3.7.1.1
3.3.7.1.2
3.3.7.1.3
3.3.7.1.4
3.3.7.2
Use the appropriate method and equipment to collect the sample.
Record sample chain of custody per state procedure.
Handle, package, and ship sample using procedures appropriate to
prevent compromising condition of the sample and ensuring
security of the sample.
Deliver or ship sample to the appropriate laboratory program
within prescribed timeframes.
Instructions for documenting the sample collection must include the following
elements, when applicable, to the state’s sampling program:
3.3.7.2.1
3.3.7.2.2
Date of Sample Collection.
Product Identification Including:
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Standard 3
3.3.7.2.2.1
3.3.7.2.2.2
3.3.7.2.3
3.3.7.2.4
Name of Product
Unique Manufacturing Identification references
Description of the product.
Collection information including:
3.3.7.2.4.1
3.3.7.2.4.2
3.3.7.2.4.3
Method of Collection
Lot Sampled
Lot Size
3.3.7.2.5
3.3.7.2.6
Location where sample was collected.
Name and address of responsible party, guarantor, possessor, or
distributor.
3.3.7.2.7 Sample type.
3.3.7.2.8 Analysis requested if applicable.
3.3.7.2.9 Product labels or specific labeling information that is collected or
reproduced per state policies.
3.3.7.2.10 Identification of the sample with the sample number assigned by
the sampler at the time of collection.
3.3.7.3
3.3.8
State programs are not required to have a written sampling procedure unless
they collect samples. However, these programs must have a statement in lieu
of sampling procedures that explains why a sampling program is not supported
and how the public health is protected in the absence of such a program. An
example may include: stating that public health is protected because another
state or federal agency collects samples and fulfills this need. The statement
should include the name of the agency and the type of samples that it collects.
Records Retention
The state program must maintain records as required under Section 9.3.5.2 for the
following:
3.3.8.1
Inspection reports which include follow-up activities.
3.3.8.2
Essential recall information.
3.3.8.3
Consumer complaints.
3.3.8.4
Industry complaints about inspections.8
3.3.8.5
Documentation associated with sample collection.
Outcome
The state program is based on an inspection program that reduces the occurrence of foodborne illness,
injury, or allergic reaction.
8
Records dealing with personnel actions are not subject to review during an ASSESSMENT.
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Standard 3
Documentation
The state program maintains the records listed here.
3.5.1
3.5.2
3.5.3
3.5.4
3.5.5
3.5.6
3.5.7
3.5.8
3.5.9
3.5.10
3.5.11
3.5.12
3.5.13
3.5.14
3.5.15
3.5.16
Appendix 3.1 Self-Assessment Worksheet (or equivalent form).
An inventory of manufactured food firms for which the state has regulatory oversight.
Written procedure documenting the classification criteria and inspection frequencies.
Written rationale of the risk factor and classification criteria if a state program develops
its own risk factor and classification criteria.
Written procedure for inspecting manufactured food firms.
Written inspection reports procedure.
Written inspection reports, which include follow-up activities.
Written procedure for food recalls.
Essential recall information.
Written procedure for consumer complaints.
Consumer complaints.
Written procedure for industry complaints about inspections.
Industry complaints about inspections.8
Written procedures for sampling or, in the absence of any sampling program, a statement
explaining how public health is protected.
Sample collection reports.
Documentation associated with sample collection.
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September 2022
Standard 4
STANDARD 4
Inspection Audit Program
Purpose
This standard describes the Quality Assurance Program (QAP) and auditing procedures necessary for a
state program to (1) evaluate the effectiveness and accuracy of the inspection program, inspection
records, and sampling records; and (2) identify best practices used to achieve quality inspections and
sample collections.
Requirement Summary
The state program has a QAP that conducts audits to assess the effectiveness and accuracy of its
inspections and sample collections. The QAP has two components: (1) a FIELD INSPECTION AUDIT
component, which is an on-site performance EVALUATION of inspections and (2) a desk audit
component, which is a performance review of the written reports of inspections and sample collections.
Program Elements
4.3.1
Quality Assurance Program
The state program has a written QAP that contains written procedures for:
4.3.2
4.3.1.1
Conducting field inspection audits as described in section 4.3.2.
4.3.1.2
Conducting inspection report audits as described in section 4.3.3.
4.3.1.3
Conducting sample report audits as described in section 4.3.4.
4.3.1.4
Initiating corrective action(s), which will be documented on the strategic
improvement plan as described in section 9.3.2.
Field inspection audit
QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED FIELD INSPECTION AUDITOR conducts
FIELD INSPECTION AUDITS or VERIFICATION AUDIT INSPECTIONS to verify that inspections
are consistently performed according to the state’s written procedures described in
Standard 3.
4.3.3
4.3.2.1
Frequency: The QAP requires a minimum of two field inspection audits of
each inspector be conducted every 36 months. Inspections selected for audits
should include the highest risk manufactured food firms that the inspector is
trained for including specialized food inspections.
4.3.2.2
Performance is documented on Appendix 4.3 or equivalent form and Appendix
4.3a or a state audit form that meets the program elements in Standard 3,
Program Element 3.3.2.
4.3.2.3
State programs may use the current Form FDA 3610 in lieu of Appendix 4.3.
Inspection Report Audit
The QAP requires periodic review of inspection reports to verify that inspectional findings
Manufactured Food Regulatory Program Standards
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Standard 4
are obtained and reported according to established written procedure. The quality of each
inspection report is audited using the performance factors listed in Appendix 4.4. An
overall inspection report rating is calculated using Appendix 4.4a or equivalent form.
4.3.3.1
The state program will review a random selection of inspection reports based
on the number of inspections completed in the last 12 months using the table
below:
Number of
Inspections in 12
Months
Less than 40
reports
40 – 800 reports
More than 800
reports
4.3.4
Minimum Number
of Reports
Required
Maximum
Number of
Reports Required
All
All
40
40
5% of reports
70
4.3.3.2
Seven percent (7%) of the inspection reports reviewed must be taken from
inspections that were audited.
4.3.3.3
Performance is documented on Appendices 4.4 and 4.4a or equivalent forms.
Sample Report Audit
If the samples are collected in conjunction with the manufactured food program, the QAP
requires periodic review of sample reports. This review is to verify that samples were
properly collected, identified, recorded, and submitted according to established written
procedure. The quality of each sample report is audited using the performance factors
listed in Appendix 4.5. An overall sample report rating is calculated using Appendix 4.5a
or equivalent form.
4.3.4.1
The state program will review a random selection of sample reports based on
the number of samples collected in the last 12 months using the table below:
Number of
samples in 12
Months
Less than 40
reports
40 – 800 reports
More than 800
reports
4.3.4.2
4.3.5
Minimum Number
of Reports
Required
Maximum Number
of Reports
Required
All
All
40
40
5% of reports
70
Performance is documented on Appendices 4.5 and 4.5a or equivalent forms.
Corrective action
The state program shall initiate CORRECTIVE ACTIONS as described in 9.3.2 when the FIELD
inspection report audit, or sample report audit meets one or more of the
conditions below:
INSPECTION AUDIT,
4.3.5.1
An individual receives an overall rating of “needs improvement”.
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Standard 4
4.3.5.2
A single performance factor for the program falls below 80%, or four or more
“needs improvement” ratings are identified in a single performance factor.
Note that if fewer than four audits are conducted, a performance deficiency
may be considered for a single performance factor that “needs improvement”.
4.3.5.3
An overall rating for the program falls below 80%.
Outcome
The state program systematically evaluates and improves its inspection and sample collection systems to
ensure that activities and information are accurate, complete, and comply with the jurisdiction’s
procedures and policies.
Documentation
The state program maintains the records listed here.
4.5.1
4.5.2
4.5.3
4.5.4
4.5.5
4.5.6
4.5.7
4.5.8
Written procedures that describe the Quality Assurance Program.
Appendix 4.1 Self-Assessment Worksheet (or equivalent form).
Appendix 4.3 Field Inspection Audit form (or equivalent form) or a state audit form that
meets the program elements in Standard 3, Program Element 3.3.2.
Appendix 4.3a Summary of Field Inspection Audit Findings (or equivalent form).
Appendix 4.4 Inspection Report Audit Form (or equivalent form).
Appendix 4.4a Summary of Inspection Report Audit Findings (or equivalent form).
Appendix 4.5 Sample Report Audit Form (or equivalent form).
Appendix 4.5a Summary of Sample Report Audit Findings (or equivalent form).
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Standard 5
STANDARD 5
Food-related Illness, Outbreak and Hazards Response
Purpose
This standard describes the food emergency response functions and related activities necessary to
investigate FOOD-RELATED INCIDENTS to stop, control and prevent HAZARDS that are likely to result in a
foodborne illness, injury, or outbreak.
Requirement Summary
The state program has a written food emergency response program. The program describes surveillance,
investigation, control measures and post response activities in collaboration with other agencies and
jurisdictions for responding to reports of food-related illness, injury, outbreaks and HAZARDS, whether
unintentional or deliberate, and for generating recommendations for foodborne illness prevention.
Program Elements
5.3.1
Coordination of Food-related Illness, Outbreak and Hazards Response Activities with
Other Authorities.
5.3.1.1
Memorandum of understanding with other state agencies: If the responsibility
for state food-related illness and outbreak investigations is assigned to another
state agency, a memorandum of understanding with this agency is required to
fulfill the requirements of this standard.
5.3.1.2
The state program has a written procedure that:
5.3.1.2.1
5.3.1.2.2
5.3.1.2.3
5.3.1.2.4
5.3.1.2.5
5.3.1.2.6
5.3.2
Identifies and describes the roles, duties, and responsibilities of
each program for the requirements in 5.3.2-5.3.5.
Describes agency collaboration as necessary with the FDA and
other appropriate local, state, and federal authorities in multijurisdictional FOOD-RELATED INCIDENTS.
Designates response coordinator(s) to guide program investigation
efforts in collaboration with all agencies involved.
Describes how all relevant agencies are notified in case of FOODRELATED INCIDENTS.
Provides guidance for notification of appropriate law enforcement
agencies when intentional food contamination is suspected or
threatened.
Describes the maintenance of a list(s) of relevant agencies and
emergency contacts that is updated at least yearly.
Surveillance
The state program:
5.3.2.1
Uses epidemiological information from local, state, or federal agencies to
detect incidents or outbreaks of foodborne illness or injury.
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Standard 5
5.3.2.2
5.3.3
Maintains notifications of food-related incidents that are reported to the
program, in a log(s) or database(s).
Investigation/Environmental assessment
The state program:
5.3.4
5.3.3.1
Uses established procedures with recommended timeframes to investigate
reports of food-related incidents.
5.3.3.2
Collects environmental assessment data using established procedures similar to
those found in the most current versions of “International Association for Food
Protection Procedures to Investigate Foodborne Illnesses" and the CIFOR
“Guidelines for Foodborne Disease Outbreak Response.”9
5.3.3.3
Coordinates the traceback and traceforward of food implicated in an illness,
injury, outbreak or found to contain a hazard in accordance with written
procedures.
5.3.3.4
Has access to laboratory support10 for investigation of reports of food-related
incidents.
5.3.3.5
Correlates and analyzes environmental assessment data to identify contributing
factors and antecedents that led to food contamination or adulteration causing
illness, injury, or outbreak.
Control Measures
The state program:
5.3.5
5.3.4.1
Mitigates and contains food-related illness, injury and hazards through
strategies that include industry education, enforcement, and public awareness
activities.
5.3.4.2
Maintains a written procedure with criteria for releasing prevention guidance
and information to the public (includes identifying a media person and
developing guidelines for coordinating media information with other
jurisdictions).
Post Response
The state program:
9
Council to Improve Foodborne Outbreak Response (CIFOR). Guidelines for Foodborne Disease Outbreak Response.
Atlanta: Council of State and Territorial Epidemiologists available http://cifor.us/ .
10
Specific requirements for laboratory support are contained in Standard 10.
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Standard 5
5.3.5.1
Maintains program investigation and environmental assessment findings and
reports.
5.3.5.2
Distributes final program investigation report(s), including an environmental
assessment if completed, to relevant agencies responsible for reporting
contributing factors and antecedents to CDC.
5.3.5.3
Distributes recommendations, when available, from investigation and
environmental assessment findings and reports to relevant agencies and
stakeholders responsible for prevention, education, and outreach.
Outcome
The state program uses a systematic approach for the detection, investigation, mitigation, documentation
and analysis of FOOD-RELATED INCIDENTS to stop, control and prevent HAZARDS that are likely to result
in a foodborne illness, injury, or outbreak.
Documentation
The program maintains the records listed here:
5.5.1
5.5.2
5.5.3
5.5.4
5.5.5
5.5.6
Appendix 5.1 Self-Assessment Worksheet (or equivalent form).
A Memorandum of Understanding, if applicable.
Written procedures for coordination, surveillance, environmental assessment, control
measures, and post response.
Records associated with coordination, surveillance, environmental assessment, control
measures, and post response.
A log(s) or database(s) that tracks notification of food-related incidents.
Investigation/environmental assessment, reports, and summaries.
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Standard 6
STANDARD 6
Compliance and Enforcement Program
Purpose
This standard describes the state agency’s strategies, procedures, and actions to enforce the laws and
regulations to achieve compliance and to evaluate the effectiveness of its compliance and enforcement
program.
Requirement Summary
The state program has a written compliance and enforcement program, which describes its compliance
strategy and procedures. The compliance and enforcement program conducts an annual review and
records those actions on appendix 6.2. The state calculates an overall rating which is used to determine
if compliance and enforcement procedures were followed. Results of the review are used to identify
improvements and modify procedures.
Program Elements
6.3.1
Compliance and Enforcement Program
The state program has a written compliance and enforcement program that:
6.3.1.1
Contains compliance and enforcement strategies.
6.3.1.2
Describes the procedure to monitor
6.3.1.2.1
6.3.1.2.2
6.3.1.2.3
6.3.2
critical violations.
chronic violations.
chronic violators.
6.3.1.3
Uses a risk-based process to determine when a directed investigation, followup, or re-inspection is needed.
6.3.1.4
Establishes a framework for compliance and enforcement progressive
actions.11
Performance Review
The state program conducts a performance review of compliance and enforcement actions
as defined by the state program. The state program will conduct a performance review:
11
Compliance and Enforcement Progressive Actions may include, but are not limited to:
x
x
x
x
x
Preventive actions such as promoting voluntary compliance through education program and consultation;
Field actions such as verbal warnings, documented warnings, re-inspections, and product embargos;
Supervisory/management actions such as warning letters or informal hearings;
Administrative actions such as complaints and evidentiary hearings to suspend or revoke a business license; and
Civil or criminal sanctions.
Manufactured Food Regulatory Program Standards
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September 2022
Standard 6
6.3.2.1
Annually.
6.3.2.2
Document on Appendix 6.2 or equivalent form to evaluate if internal
compliance and enforcement actions are followed.
6.3.2.3
Use results of the review to identify improvements and modify procedures.
6.3.2.4
Require a corrective action if performance ratings fall below 80%, which will
be documented on the strategic improvement plan as described in 9.3.2.
Outcome
The state program has a compliance and enforcement program that has written procedures to ensure that
compliance actions are supported by sound judgment, adequate evidence, and appropriate
documentation that is submitted in program-prescribed formats.
Documentation
The state program maintains the records listed here.
6.5.1
6.5.2
6.5.3
Appendix 6.1 Self-Assessment Worksheet (or equivalent form).
Written Compliance and Enforcement Program.
Appendix 6.2 Performance Review of Enforcement Actions (or equivalent form).
Manufactured Food Regulatory Program Standards
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September 2022
Standard 7
STANDARD 7
Industry and Community Relations
Purpose
This standard describes the elements of industry and community outreach activities or OUTREACH
ACTIVITY EVENTS developed and accomplished by the state program.
Requirement Summary
The state program participates in activities that support communication and information exchange
among regulators, industry, academia, and consumer representatives. It also coordinates or participates
in outreach activities or OUTREACH ACTIVITY EVENTS that provide educational information about food
protection topics
Program Elements
The state program has a written procedure of the methods that will be used for communication
with food industry stakeholders and consumers. The written procedure includes how the state
program will:
7.3.1
Identify the methods for communication with food industry stakeholders and consumers.
7.3.2
Interact with industry and consumers by sponsoring or actively participating in meetings
such as task forces, advisory boards, or advisory committees.
7.3.3
Tailor outreach efforts to a target population, which may include dissemination of
information using electronic sources and traditional methods such as mailings. Topics of
outreach efforts may include food defense, investigation strategies, regulatory
requirements, violation trends, and emerging issues regarding manufactured foods.
Representatives from affected food industries, consumers, academia, and other federal,
state, and local food protection agencies are invited to these meetings.
7.3.4
Document and evaluate outreach activity events using Appendix 7.2 or equivalent form.
Include documents such as agendas and meeting summaries and program evaluations.
Outcome
The state program uses outreach activities or OUTREACH ACTIVITY EVENTS to inform varied populations
about food protection-related issues.
Documentation
The state program maintains the records listed here.
7.5.1
7.5.2
7.5.3
Written procedure for methods used to communicate with food industry stakeholders and
consumers.
Appendix 7.1 Self-Assessment Worksheet (or equivalent form).
Appendix 7.2 or equivalent documentation for each outreach activity event (or equivalent
form).
Manufactured Food Regulatory Program Standards
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September 2022
Standard 7
7.5.4
Meeting summaries, agendas, or other records documenting interaction with food
industry stakeholders and consumers.
Manufactured Food Regulatory Program Standards
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September 2022
Standard 8
STANDARD 8
Program Resources
Purpose
This standard describes the elements for assessing the resources (staff, equipment, and funding) needed
to support a manufactured food regulatory program.
Requirement Summary
The state program conducts an assessment of resource needs for staffing, equipment, and funding for the
manufactured food regulatory program.
Program Elements
8.3.1
Program Assessment
The state program completes the Resource Summary Report to assess staffing, funding,
and equipment using Appendix 8.2 or equivalent form. The administrative functions
needed to support all program areas should be considered when determining program
resources.
8.3.2
Staffing
The state program conducts and documents the calculation for determining the required
number of inspectors to inspect manufactured food firms in its manufactured food firm
inventory at a frequency that is based on the manufactured food firm’s risk classification
and the necessary inspection and travel time.
8.3.3
Equipment
A list of the equipment required for inspections and sample collections must be
established and maintained by the state program.
Outcome
The state program assesses and allocates resources needed to support a manufactured food regulatory
program.
Documentation
The state program maintains the records listed here:
8.5.1
8.5.2
8.5.3
8.5.4
Appendix 8.1 Self-Assessment Worksheet (or equivalent form).
Appendix 8.2 Resource Summary Report (or equivalent form).
Documentation of the calculation of number of inspectors.
List of equipment used for inspections and sample collections.
Manufactured Food Regulatory Program Standards
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September 2022
Standard 9
STANDARD 9
Program Assessment
Purpose
This standard describes the process a state program uses to assess and demonstrate its CONFORMANCE
with each of the program standards.
Requirement Summary
Managers conduct periodic self-assessments of the manufactured food regulatory program against the
criteria established in each program standard. These self-assessments are designed to identify the
strengths and weaknesses of the state programs by using the program standards.
The results of the self-assessments are used to determine areas or functions of the state program that
need improvement. The results of the baseline self-assessment are used to develop a STRATEGIC
IMPROVEMENT PLAN and establish timeframes for making improvements. Subsequent self-assessments
and FDA ASSESSMENTS are used to track progress toward meeting and maintaining CONFORMANCE with
the program standards or identifying any non-CONFORMANCE when the program was previously in
CONFORMANCE with the standards.
Program Elements
9.3.1
In the first year, the state program conducts a baseline self-assessment to determine if the
program meets the elements of each standard. The state program uses the appendices and
worksheets contained herein or equivalent forms. The state program uses the results of its
self-assessments to complete the Self-Assessment Summary Report (also known as
Appendix 9.2) or equivalent form.
9.3.2
If the state program fails to meet any of the program elements and documentation
requirements of a standard, whether identified through self-assessment or FDA
assessments, the program shall develop or update a written strategic improvement plan
that includes the following information (as applicable):
9.3.2.1
The individual element or documentation requirement of the standard that was
not met.
9.3.2.2
Improvements or corrections needed to meet the program element or
documentation requirement of the standard.
9.3.2.3
The cause for any non-conformance requiring correction when the program
was previously in conformance with the individual element or documentation
requirement of a standard.
9.3.2.4
The corrective action taken to prevent future similar non-conformance when
the program was previously in conformance with the individual element or
documentation requirement of the standard that was corrected.
9.3.2.5
Projected completion dates for each task.
9.3.2.6
Personnel responsible.
Manufactured Food Regulatory Program Standards
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September 2022
Standard 9
9.3.2.7
Date completed for each task.
9.3.3
The state program shall review and update self-assessment appendices and its strategic
improvement plan at least annually.
9.3.4
The state program participates in FDA assessments to determine implementation and
conformance to the standards. The state program addresses FDA assessment observations
and incorporates corrective actions as needed into its strategic improvement plan.
9.3.5
The state program must:
9.3.5.1
Have a written document control procedure that ensures that all guidance,
procedures, documents, and forms required by the standards are current and fitfor-use.
9.3.5.1.1
All of the documents subject to this procedure can demonstrate
they are CURRENT AND FIT-FOR-USE through maintenance of a
master document list or other system that shows:
9.3.5.1.1.1
9.3.5.1.1.2
9.3.5.1.1.3
9.3.5.2
Documents are reviewed for accuracy.
Documents are approved for release by authorized
personnel and signed/dated with an approval or
revision date.
Documents are distributed to applicable staff, as
appropriate, and used at the location where the
prescribed activity is performed.
Retain records or procedures required under x.5 of each standard for the three
previous years, or per the state program’s record retention policy, whichever is
longer. Records or procedures can be maintained either electronically or in
hardcopy.
Outcome
The state program conforms to the program standards through well-defined and written evaluation
activities and a process for continuous improvement.
Documentation
The state program maintains records listed here.
9.5.1
9.5.2
9.5.3
9.5.4
9.5.5
9.5.6
Appendix 9.1 Self-Assessment Worksheet (or equivalent form).
Appendix 9.2 Self-Assessment Summary Report (or equivalent form).
Strategic improvement plan.
Document control procedure.
Record retention rules, policies, or procedures.
FDA Assessment reports.
Manufactured Food Regulatory Program Standards
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September 2022
Standard 10
STANDARD 10
Laboratory Support
Purpose
This standard describes the elements of laboratory support for a manufactured food regulatory program.
Requirement Summary
The state program has access to the laboratory services needed to support program functions and
documents its laboratory capabilities including agreements with external laboratories.
Program Elements
10.3.1
Laboratory Support
10.3.1.1 The state program has access to a laboratory that is capable of analyzing a
variety of samples including food, environmental, and clinical samples.
10.3.1.2 The state program maintains a list of services for routine and non-routine
analyses such as biological hazard determinations.
10.3.1.3 The state program has a contract or written agreement with each primary
servicing laboratory unless under the same administrative agency. The contract
or written agreement must be documented such as a memorandum of
understanding, e-mail, or any written format but must contain each the
components below:
10.3.1.3.1 Define the responsibilities of each party.
10.3.1.3.2 Describe the types of testing services to be performed.
10.3.1.3.3 Describe how exceptions to planned work will be communicated.
10.3.1.4 When a program uses a laboratory service from a non-primary servicing
laboratory, there shall be documentation of the service provided; the
documentation can be in a simplified format.
10.3.2
ISO Accredited Laboratories
The state program utilizes laboratories that have a current accreditation to the ISO/IEC
17025:2017 (or current version) standards to analyze food and environmental samples.
The accreditation body of the laboratory must be a full member of the International
Laboratory Accreditation Cooperation (ILAC) and a signatory to the ILAC Mutual
Recognition Arrangement (MRA).
10.3.3
Non-ISO Accredited Laboratories
If state programs do not use laboratories holding accreditation to ISO/IEC 17025:2017 (or
current version) for the analysis of food and environmental samples, then the program
must utilize laboratories that have in place a quality system which incorporates the
following management and technical requirements of ISO/IEC 17025:2017 (or current
version) at a minimum:
Manufactured Food Regulatory Program Standards
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September 2022
Standard 10
10.3.3.1 A documented quality system which incorporates management and technical
requirements of ISO/IEC 17025:2017 (or current version) and associated
procedures, that include but are not limited to:
10.3.3.1.1 Calibration and maintenance of equipment.
10.3.3.1.2 Analyses are performed using validated and verified test
procedures.
10.3.3.1.3 Documentation of sample traceability.
10.3.3.1.4 Documentation of analytical results and analysts performing work.
10.3.3.1.5 Analysts that are trained and authorized to perform technical
procedures.
10.3.3.1.6 Periodic audits.
10.3.3.2 A procedure that defines the activities necessary when non-conforming work
occurs. The documented process must describe how quality control data are
assessed to assure that test results from non-conforming work are not released.
The documented process must describe how cause analysis and problem
resolution are recorded.
10.3.3.3 A document control procedure that assures documents issued to personnel are
current, suitable, and reviewed and approved by authorized personnel prior to
release. The procedure must also assure that obsolete documents are removed
from use.
10.3.3.4 A documented record keeping process that assures that records of original
observations and data collection are maintained and sufficient to establish
traceability of test results to: sample handling and storage, sample analysis
including data collection, equipment calibration and maintenance, and the
review of test results prior to release.
10.3.3.5 A documented process to assure that reference materials and reference cultures
used are fit for purpose, are not outdated, and are traceable to a lot number or
other unique identifier.
10.3.3.6 A documented process to assure that the laboratory participates in relevant and
available proficiency testing activities.
Outcome
The state program has access to laboratory services described in this standard.
Documentation
The state program maintains records listed here.
10.5.1
10.5.2
10.5.3
Appendix 10.1 Self-Assessment Worksheet (or equivalent form).
Contracts or written agreements with primary servicing laboratories.
A list of laboratories used by the state that are non-primary servicing laboratories.
Manufactured Food Regulatory Program Standards
39
September 2022
Standard 10
10.5.4
10.5.5
10.5.6
Documentation of services provided by primary servicing laboratories and non-primary
servicing laboratories.
ISO Accredited Laboratory: ISO/IEC 17025:2017 (or current version) Certificate and
Scope of Accreditation.
Non-ISO Accredited Laboratory Documents:
10.5.6.1
10.5.6.2
10.5.6.3
10.5.6.4
10.5.6.5
Documented Quality System.
Corrective Action.
Document Control.
Record Keeping.
Process for Ensuring Validity of Results (including but not limited to
Reference Materials and or Proficiency Testing).
Manufactured Food Regulatory Program Standards
40
September 2022
Appendix 1.1
Appendix 1.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
Yes/No
If No, please explain why
element is not met. May use this
space for additional notes.
1.3.1 Written Procedure for Evaluation of Legal
Authority
Does the state program’s written procedure:
1. Describe the REGULATORY FOUNDATION
assessment process?
2. Include timeframes for conducting a REGULATORY
FOUNDATION assessment; including whenever
significant changes are made to applicable Federal
and/or state laws and regulations?
3. Address statutes, regulations, rules, ordinances,
and other prevailing regulatory requirements that:
a. Apply to the regulation of manufactured food?
b. Delegate authority to the state’s program?
c. Describe the state administrative procedures
for rulemaking to protect public health?
d. Identify and list other state and federal
agencies that have authority for any area of the
REGULATORY FOUNDATION the state program
lacks?
1.3.2 REGULATORY FOUNDATION Assessment
Does the state’s REGULATORY AUTHORITY assessment
include a baseline self-assessment using Appendix 1.2
or equivalent form to determine if the state is
EQUIVALENT, EQUIVALENT IN EFFECT, NOT
EQUIVALENT, or NO AUTHORITY to sections of the
FD&C Act and CFRs as specified in Appendix 1.2?
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
41
September 2022
Seizure
Definitions and standards
for food
Adulterated food
304/334**
401/341
402/342
Manufactured Food Regulatory Program Standards
Penalties
Definitions (f), (k), (m),
and (ff)
Prohibited acts (a), (b),
(c), (d), (e), (f), (k), and
(v)
Title
303/333*
301/331
201/321
FD&C
Act/US
Code
State Agency:
Equivalency
Status
42
State Citation
Date
Incorporated
into State Law
Federal Food, Drug & Cosmetic Act
Notes
September 2022
Note: the FD&C Act reference links direct you to the relevant U.S. Code section number. For a cross reference of FD&C Act and U.S. Code sections
please visit the FDA's website: https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
For those statutes and regulations for which the state program does have authority, record the state law or regulations and the date it was
incorporated. The Notes section shall be used in part to detail differences between state and federal laws and regulations, and to clarify when other
agencies may have regulatory jurisdiction. This self-assessment relates only to human food and public health. Any commodities within the statutes
and regulations outside this scope do not need to be included on the self-assessment.
Instructions: Determine if state laws and regulations are EQUIVALENT, EQUIVALENT IN EFFECT, or NOT EQUIVALENT to Federal statutes and regulations.
Select "NO AUTHORITY" if the program has no regulatory responsibility for a statue or regulation or the authority falls under the jurisdiction of
another agency.
Appendix 1.2: Regulatory Foundation Worksheet
Appendix 1.2
Misbranded food (a)-(s)
New dietary ingredients
Regulations and hearings
Records of interstate
shipments
Inspection
403/343
413/350b
701/371
703/373***
704/374
Equivalency
Status
State Citation
Date
Incorporated
into State Law
Notes
General Enforcement
Regulations
(§ 1.20-1.24); Foreign
Supplier Verification
Program (Subpart L §
1.500-1.514);
and Sanitary
Transportation (Subpart
O § 1.900-1.934)
Enforcement Policy
(ONLY § 7.1-7.13 and §
7.40-7.59)
Title
Manufactured Food Regulatory Program Standards
7
1
21 CFR
Part
Equivalency
Status
43
State Citation
Date
Incorporated
into State Law
Title 21 Code of Federal Regulations: Food and Drugs
Notes
September 2022
*Penalties may vary from Federal statute.
**Although the state program may not have authority for seizure, the state program could have legal authority to stop adulterated and misbranded products from moving in commerce, for example,
detention, stop-sale orders, withdrawal from distribution, and embargoes.
*** This section covers records in interstate commerce. State laws should include intrastate records.
Title
FD&C
Act/US
Code
Appendix 1.2
Color Additives
(ONLY § 70.20-§ 70.25)
Listing of Colors Exempt
From Certification
(ONLY § 73.1-§ 73.615)
Listing of Color
Additives Subject to
Certification (ONLY §
74.101-§ 706)
General Restrictions for
Provisional Color
Additives for Use in
Foods, Drugs, and
Cosmetics
Listing of Certified
Provisionally Listed
Colors and Specifications
(ONLY § 82.3-§ 82.706)
General (ONLY §
100.155)
Food Labeling (EXCEPT
§ 101.69 and § 101.108)
Common or Usual Name
for Nonstandardized
Foods (EXCEPT §
102.19)
Nutritional Quality
guidelines for foods
Foods for Special Dietary
Use
Title
Manufactured Food Regulatory Program Standards
105
104
102
101
100
82
81
74
73
70
21 CFR
Part
Appendix 1.2
Equivalency
Status
44
State Citation
Date
Incorporated
into State Law
Notes
September 2022
Acidified Foods
Infant Formula Quality
Control Procedures
(EXCEPT § 106.120)
Infant Formula (EXCEPT
§ 107.200-§ 107.280)
Emergency Permit
Control (ONLY § 108.25§ 108.35)
Unavoidable
Contaminants in Food for
Human Consumption and
Food-Packaging
Materials
Current Good
Manufacturing Practice in
Manufacturing, Packing,
or Holding Human Food
Current Good
Manufacturing Practice
for Dietary Supplements
Thermally Processed
Low-Acid Foods
Packaged in Hermetically
Sealed Containers
Title
Equivalency
Status
State Citation
Date
Incorporated
into State Law
Notes
Manufactured Food Regulatory Program Standards
45
September 2022
21 CFR Part 110 was modernized and codified in 21 CFR Part 117 by the current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for
Human Food Rule.
12
114
113
111
110 12
109
108
107
106
21 CFR
Part
Appendix 1.2
Cheeses and Related
Cheese Products
Frozen Desserts
Bakery Products
133
135
136
Manufactured Food Regulatory Program Standards
Milk and Cream
Processing and Bottling
of Bottled Drinking
Water
Food Standards: General
(EXCEPT § 130.5-6 and
§ 130.17)
Fish and Fishery Products
Current Good
Manufacturing Practice
and Hazard Analysis and
Risk-Based Preventive
Controls for Human Food
Production, Storage, And
Transportation of Shell
Eggs
Hazard Analysis and
Critical Control Point
(HACCP) systems
Mitigation Strategies to
Protect Food from
Intentional Adulteration
Shell Eggs
Title
131
130
129
123
121
120
118
117
115
21 CFR
Part
Appendix 1.2
Equivalency
Status
46
State Citation
Date
Incorporated
into State Law
Notes
September 2022
Canned Fruit Juices
Fruit Butters, Jellies,
Preserves, and Related
Products
Fruit Pies
Canned Vegetables
Vegetable Juices
Frozen Vegetables
Eggs and Egg Products
Fish and Shellfish
Cacao Products
Tree Nut and Peanut
Products
Beverages
Margarine
Sweeteners and Table
Syrups
146
150
152
155
156
158
160
161
163
164
165
166
168
Manufactured Food Regulatory Program Standards
Canned Fruits
Cereal Flours and Related
Products
Macaroni and Noodle
Products
Title
145
139
137
21 CFR
Part
Appendix 1.2
Equivalency
Status
47
State Citation
Date
Incorporated
into State Law
Notes
September 2022
Food Dressings and
Flavorings
Food Additives
EXCEPT § 170.6, §
170.15, and § 170.17)
Food Additives Permitted
for Direct Addition to
Food for Human
Consumption
Secondary Direct Food
Additives Permitted in
Food for Human
Consumption
Indirect Food Additives:
General
Indirect Food Additives:
Adhesives and
Components of Coatings
Indirect Food Additives:
Paper and Paperboard
Components
Indirect Food Additives:
Polymers
Indirect Food Additives:
Adjuvants, Production
Aids, And Sanitizers
Food Additives Permitted
In Food Or In Contact
With Food On An Interim
Basis Pending Additional
Study
Title
Manufactured Food Regulatory Program Standards
180
178
177
176
175
174
173
172
170
169
21 CFR
Part
Appendix 1.2
Equivalency
Status
48
State Citation
Date
Incorporated
into State Law
Notes
September 2022
Dietary Supplements
Prior-Sanctioned Food
Ingredients
Substances Generally
Recognized As Safe
Direct Food Substances
Affirmed As Generally
Recognized As Safe
Indirect Food Substances
Affirmed As Generally
Recognized As Safe
Substances Prohibited
From Use In Human
Food
Title
Equivalency
Status
State Citation
Date
Incorporated
into State Law
Notes
Manufactured Food Regulatory Program Standards
Name
Assessment Completed By:
49
Date:
State laws and regulations used by the program to address regulatory responsibilities outside of the FDA jurisdiction are listed below.
190
189
186
184
182
181
21 CFR
Part
Appendix 1.2
September 2022
Appendix 2.1
Appendix 2.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
If no, please explain why element is not
Yes/No met. May use this space for additional
notes.
2.3.1. Training Plan and Training Records
Does the state program:
1. Have a written training plan that ensures all
inspectors receive training required to
adequately perform their work assignments?
2. Maintain a training history for active
inspectors?
3. Maintain a history for all inactive inspectors
for three years or per the state’s record
retention policy?
4. Use Appendix 2.2 or equivalent form to
document and summarize all training
provided to inspectors?
5. Use Appendix 2.3 or equivalent form to
document training for each inspector?
6. Training record summary and individual
training records include the inspector’s
START DATE?
2.3.2. Basic Food Inspection Training
Does the state program require that each
inspector:
1. Complete all basic food inspection training
coursework within 24 months of their START
DATE with manufactured food program?
2. Complete the basic course curriculum in the
subject areas listed in 2.3.2.2.1 – 2.3.2.2.11?
3. Who will inspect general manufactured food
firms complete 10 JOINT FIELD TRAINING
INSPECTIONS FIELD INSPECTION AUDITS, or
EVALUATIONS with a QUALIFIED FIELD
INSPECTION TRAINER?
4. Who will inspect general food manufactured
food firms complete two acceptable FIELD
INSPECTION AUDITS or EVALUATIONS by a
QUALIFIED FIELD INSPECTION TRAINER or
QUALIFIED FIELD INSPECTION AUDITOR?
Manufactured Food Regulatory Program Standards
50
September 2022
Appendix 2.1
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
5. Who will inspect non-high risk food
warehouses complete five JOINT FIELD
TRAINING INSPECTIONS, FIELD INSPECTION
AUDITS, or EVALUATIONS with a QUALIFIED
FIELD INSPECTION TRAINER?
6. Who will inspect non-high risk food
warehouses complete two acceptable FIELD
INSPECTION AUDITS, or EVALUATIONS with a
QUALIFIED FIELD INSPECTION TRAINER?
7. Who advances to conduct general
manufactured food firms from non-high risk
food warehouses complete five additional
JOINT FIELD TRAINING INSPECTIONS, FIELD
INSPECTION AUDITS, or EVALUATIONS to
fulfill requirements identified in 2.3.2.3.1, of
which, two are representative of the general
manufactured food firms?
8. Who advances to conduct general
manufactured food firms from non-high risk
food warehouses complete two additional
acceptable FIELD INSPECTION AUDITS, or
EVALUATIONS with a QUALIFIED FIELD
INSPECTION TRAINER?
9. Complete the minimum field training
requirements prior to conducting independent
inspections?
2.3.3. Advanced Food Inspection Training
Does the state program require each inspector:
1. Who performs specialized food inspections
to complete the coursework specific to the
type of specialized food inspection they will
be performing?
2. Who performs specialized food inspections
to participate in two JOINT FIELD TRAINING
INSPECTIONS?
3. After successful completion of the course,
participate in one EVALUATION or FIELD
INSPECTION AUDIT with a QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD
INSPECTION AUDITOR prior to conducting
independent inspections?
Manufactured Food Regulatory Program Standards
51
September 2022
Appendix 2.1
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
4. Within one year after being released to do
specialized food inspections complete a
second EVALUATION or FIELD INSPECTION
AUDIT with a QUALIFIED FIELD INSPECTION
TRAINER or QUALIFIED FIELD INSPECTION
AUDITOR in the area of specialty?
2.3.4 Experienced Inspectors
For CURRENT EXPERIENCED STAFF or NEWLY
HIRED EXPERIENCED STAFF a state program’s
training plan shall include the following unless
the state determines in their training plan that all
staff will be required to complete the program
elements in 2.3.2 and 2.3.3:
1. Missing basic course work, does the state
program have a statement or affidavit that
explains the background or experience that
justifies the waiver?
2. Missing JOINT FIELD TRAINING INSPECTIONS,
does the state program have a statement or
affidavit explaining the background or
experience that justifies a waiver of the basic
or specialized JOINT FIELD TRAINING
INSPECTIONS?
3. Who is newly hired who had JOINT FIELD
TRAINING INSPECTIONS waived, were two
successful EVALUATIONS or FIELD INSPECTION
AUDITS completed within 6 months of the
inspector’s QUALIFIED DATE?
4. Missing specialized coursework, does the
state program have a statement or affidavit
explaining the date and location that the
specialized training was completed?
2.3.5 Continuing Education and Training
1. Does each inspector conducting
manufactured food inspections accumulate
20 CONTACT HOURS of continuing education
every 36 months from the start of the
QUALIFIED DATE?
2. Does the state program maintain
documentation for continuing education
credit as outlined in 2.3.5.7?
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Appendix 2.1
2.3.6 Coursework Sources
Is all basic, advanced, and continuing education
coursework obtained from sources listed in
2.3.6.1 – 2.3.6.4?
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
53
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Manufactured Food Regulatory Program Standards
Name
Assessment Completed By:
Employee Name
START
DATE
Basic Food
Inspection
Curriculum
Course
Field
Work
Work
54
Area of Specialty
Course
Work
Date:
Field
Work
Advanced Food Inspection Curriculum
QUALIFIED
DATE
September 2022
CONTACT
HOURS
Continuing Education
Instructions: This Appendix is used to document and track inspectors’ training status. Enter the name of all active inspectors. Include the START DATE
of employment and record the date the inspector completed the coursework and field training for the basic and advanced curriculums. For
continuing education, indicate the QUALIFIED DATE and number of CONTACT HOURS completed.
Appendix 2.2: Inspector Training Record Summary
Appendix 2.2
Appendix 2.3
Appendix 2.3: Inspector Training Record
State Agency:
Name of Inspector:
Start Date:
Basic Food Inspection Curriculum
Coursework
Course
Please provide the course name and location for
each subject area
Date Completed
Course Documentation
Available for Review
(Yes/No)
Prevailing statutes, regulations, and ordinances
Public health principles
Emergency management
Communication skills
Microbiology
Epidemiology
Basics of HACCP
Allergen management
Basic food labeling
Food defense
Sampling techniques and preparation
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Appendix 2.3
Name of Inspector:
Start Date:
Basic Food Inspection Curriculum
Fieldwork
JOINT FIELD TRAINING INSPECTION or
FIELD INSPECTION AUDITS
Date
Completed
EVALUATION/AUDIT
Acceptable
(Yes/No)
Documentation
Available for
Review
(Yes/No)
Please provide the name of the
manufactured food firm and
identification number.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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Appendix 2.3
Name of Inspector:
Start Date:
Advanced Food Inspection Curriculum Fieldwork
Course
Please provide the name and location of the course.
Completion
Date
Course
Documentation
Available For
Review
(Yes/No)
Acidified foods
Low-acid canned food
Juice HACCP
Seafood HACCP
Traceback investigations
Foodborne illness investigations
Preventive controls for human foods
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Appendix 2.3
Name of Inspector:
Start Date:
Instructions: Identify and record the type of specialized food inspection conducted for the JOINT FIELD
or FIELD INSPECTION AUDITS, such as acidified foods, low-acid canned foods, juice
HACCP, seafood HACCP, or preventive controls for human foods.
TRAINING INSPECTION
Advanced Food Inspection Curriculum Fieldwork
Specialized food inspection
JOINT FIELD TRAINING INSPECTION or
FIELD INSPECTION AUDITS
Completion
Date
EVALUATION/AUDIT
Acceptable
(Yes/No)
Documentation
Available for
Review
(Yes/No)
Completion
Date
EVALUATION/AUDIT
Acceptable
(Yes/No)
Documentation
Available for
Review (Yes/No)
Please provide the name of the
manufactured food firm and
identification number.
1.
2.
3.
4.
Specialized food inspection
JOINT FIELD TRAINING INSPECTION or
FIELD INSPECTION AUDITS
Please provide the name of the
manufactured food firm and
identification number.
1.
2.
3.
4.
Manufactured Food Regulatory Program Standards
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Appendix 2.3
Name of Inspector:
Start Date:
CONTINUING EDUCATION COURSEWORK
A total of 20 CONTACT HOURS required every 36 months
Activities in Program Element 2.3.4.4
Maximum of 20 CONTACT HOURS
Documentation
Type of Activity
Date
Available for Review
Provide Title and Brief Description
Completed
(Yes/No)
CONTACT
HOURS
Earned
Subtotal
Presenting, Training, or Publishing (Program Element 2.3.4.5)
Maximum of 10 CONTACT HOURS
Documentation
Type of Activity
Date
Available for Review
Provide Title and Brief Description
Completed
(Yes/No)
CONTACT
HOURS
Earned
Subtotal
Reading Technical Publications (Program Element 2.3.4.6)
Maximum of 4 CONTACT HOURS
Documentation
Type of Activity
Date
Available for Review
Provide Title and Brief Description
Completed
(Yes/No)
CONTACT
HOURS
Earned
Subtotal
Total CONTACT HOURS Earned
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Appendix 3.1
Appendix 3.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
3.3.1 Risk-based Inspection Program
1. Does the state program maintain an
inventory of manufactured food firms for
which the state has regulatory oversight?
2. Does the state program have a written
procedure documenting the classification
criteria and inspection frequencies?
3. Is the inventory categorized by the degree
of risk associated with the likelihood that a
FOOD-RELATED INCIDENT will occur?
4. Does the state program use the risk factors
and classification criteria as described in
3.3.1.2?
3.3.2 Inspection Procedure
Does the state program’s inspection procedure
require inspectors to:
1. Review the previous inspection report and
CONSUMER COMPLAINTS?
2. Have appropriate forms (if necessary) and
equipment that has been verified and
maintained as defined by the state’s
standard operating procedures or
manufacturer’s recommendations?
3. Make appropriate introductions and explain
the purpose and scope of the inspection?
4. Establish jurisdiction?
5. Select an appropriate product for the
inspection and, if necessary, make
appropriate adjustments based on what the
manufactured food firm is producing?
6. Assess employee practices critical to the
safe and sanitary production and storage of
food?
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Appendix 3.1
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
7. Properly evaluate the likelihood that
8.
9.
10.
11.
12.
13.
14.
15.
16.
conditions, practices, components, and/or
labeling could cause the product to be
adulterated or misbranded?
Recognize significant violative conditions
or practices, and record findings consistent
with program procedures?
Distinguish between significant and
insignificant observations, and isolated
incidents versus trends?
Review and evaluate the appropriate
operational records and procedures and
apply the information obtained from this
review?
Collect adequate evidence and
documentation in accordance with program
procedures to support the inspectional
observations?
Verify correction of deficiencies identified
during the previous inspection?
Behave professionally and demonstrate
proper sanitary practices during the
inspection?
Properly evaluate good manufacturing
practice requirements (21 CFR 117,
Subparts A, B, and F (for training records
only) or equivalent state regulation)?
Verify manufactured food firm has a written
food safety plan which includes a written
HAZARD analysis that appropriately
addresses HAZARDS, and when appropriate,
addresses preventive controls (process
controls, allergen controls, sanitation
controls, supply-chain controls and other
controls) and a recall plan?
When appropriate, review the manufactured
food firm’s written procedures, monitoring,
verification, correction, and corrective
action records for process, allergen,
sanitation controls, supply-chain controls,
and other controls which are identified in
their food safety plan?
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Appendix 3.1
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
17. When appropriate, verify the manufactured
18.
19.
20.
21.
22.
23.
24.
25.
food firm is in compliance with the
modified requirements that apply to a
qualified facility (attestation)?
When appropriate, verify the modified
requirements and time/temperature controls
that apply to a facility solely engaged in the
storage of unexposed packaged foods that
require refrigeration for safety?
When appropriate, assess the sanitary
transportation of human food requirements
that apply to transportation operations?
When appropriate, review the manufactured
food firm’s food defense plan, including the
mitigation strategies, monitoring, corrective
action, and verification activities?
Use current versions of applicable HAZARD
guides or other guidance, to identify and
evaluate the HAZARDS associated with
product(s) and process(es) when conducting
inspections of specialized food and
processes?
Assess the manufactured food firm’s
implementation of sanitation monitoring for
the applicable eight key areas of sanitation
when required by regulation?
When appropriate, review the manufactured
food firm’s; scheduled process; HACCP
plan or necessary process controls in the
absence of a HACCP plan; food safety
control plan and applicable monitoring,
verification and deviation or corrective
action records, including those related to
sanitation?
Recognize deficiencies in the manufactured
food firm’s monitoring controls and
sanitation procedures through in
manufactured food firm observations?
Use suitable interviewing techniques?
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Appendix 3.1
26. Explain findings clearly and adequately
throughout the inspection?
27. Alert the manufactured food firm’s person
in charge when an immediate corrective
action is necessary?
28. Answer questions and provide information
in an appropriate manner?
29. Write findings accurately, clearly, and
concisely on the state document and provide
a copy to the manufactured food firm’s
person in charge?
3.3.3 Inspection Reports
Does the state program have written inspection
report procedures that require inspectors to:
1. Submit inspection report within designated
timeframes?
2. Complete the inspection report form
completely and accurately?
3. Document violations and observations
clearly, legibly, and concisely?
4. Follow-up with corrective action,
compliance, and enforcement?
3.3.4 Food Recalls
Does the state program have a food recall
system with written procedures for:
1. Sharing information about recalls with
relevant agencies?
2. Ensuring recalled products are removed
promptly from the market?
3. Performing RECALL AUDIT CHECKS?
3.3.5 CONSUMER COMPLAINTS
Does the program have procedures for
receiving, tracking, evaluating, responding to,
and closing CONSUMER COMPLAINTS?
3.3.6 Complaints Resulting from State Program Inspection Activities
Does the program have procedures for
receiving, evaluating, and responding to food
INDUSTRY COMPLAINTS about inspections?
3.3.7 Sampling Procedure
Does the state program’s sampling procedure
include:
1. Procedures that require sample collectors
to:
a. Use the appropriate method and
equipment to collect the sample?
b. Record sample chain of custody per
state procedures?
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Appendix 3.1
c. Handle, package, and ship sample
using procedures appropriate to prevent
compromising condition of the sample
and ensuring security of the sample?
d. Deliver or ship sample to the
appropriate laboratory within
prescribed timeframes?
2. Instructions for documenting the applicable
sample collection information?
a. Date of sample collection?
b. Product identification which includes
name of product and unique
manufacturing identification reference?
c. Description of product?
d. Collection information which includes
method of collection, lot sampled, and
lot size?
e. Location where sample was collected?
f. Name and address of responsible party,
guarantor, processor or distributor?
g. Sample type?
h. Analysis requested (if applicable)?
i. Product labeling or labeling
information?
j. Identification of the sample with a
sample number assigned at the time of
collection?
3. For states that do not have a SAMPLING
PROGRAM, is there a statement that explains
why a SAMPLING PROGRAM is not supported
and how public health is protected in the
absence of such a program?
3.3.8 Records Retention
Does the state program maintain records as
required under 9.3.5.2 for the following:
1. Inspection reports which include follow-up
activities?
2. Essential recall information?
3. CONSUMER COMPLAINTS?
4. INDUSTRY COMPLAINTS about inspections8
5. Documentation associated with sample
collection?
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
64
September 2022
Appendix 4.1
Appendix 4.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
4.3.1 Quality Assurance
The state program has a written Quality
Assurance Program (QAP) that contains
written procedures for:
1. Conducting FIELD INSPECTION AUDITS as
described in section 4.3.2?
2. Conducting inspection report audits as
described in section 4.3.3?
3. Conducting sample report audits as
described in section 4.3.4?
4. Initiating CORRECTIVE ACTION, which will
be documented on the STRATEGIC
IMPROVEMENT PLAN as described in
section 9.3.2?
4.3.2 FIELD INSPECTION AUDIT
Does the state program:
1. Use a QUALIFIED TRAINER or QUALIFIED
AUDITOR conduct FIELD INSPECTION
AUDITS or VERIFICATION AUDIT
INSPECTIONS to verify that inspections are
consistently performed according state
program’s written inspection procedures
described in Standard 3?
2. Conduct a minimum of two FIELD
INSPECTION AUDITS per inspector
conducted every 36 months?
3. Select inspections for FIELD INSPECTION
AUDITS that include the highest risk
manufactured food firms that the inspector
is trained for including specialized food
inspections?
4. Complete Appendix 4.3 or equivalent
form be used to document FIELD
INSPECTION AUDITS?
5. Complete Appendix 4.3a or equivalent
form document overall rating calculations
of FIELD INSPECTION AUDITS?
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Appendix 4.1
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
4.3.3 Inspection Report Audit
Does the state program:
1. Conduct a periodic review of inspection
reports to verify that inspectional findings
are obtained and reported according to
established written procedure?
2. Use a random selection of inspection
reports based on the number of inspections
completed in the last 12 months using the
table in 4.3.3.1?
3. Take seven percent (7%) of inspection
reports reviewed from inspections that
were FIELD INSPECTION AUDITS?
4. Complete Appendix 4.4 or equivalent
form to document inspection report
audits?
5. Complete Appendix 4.4a or equivalent
form to document overall rating
calculations of inspection report audits?
4.3.4 Sample Report Audit
Does the state program:
1. Conduct a periodic review of sample
reports to verify that samples were
collected, identified, recorded, and
submitted according to established written
procedure?
2. Use a random selection of sample reports
based on the number of samples collected
in the last 12 months using the table in
4.3.4.1?
3. Complete Appendix 4.5 or equivalent
form to document sample report audits?
4. Complete Appendix 4.5a or equivalent
form to document overall rating
calculations of sample report audits?
4.3.5 CORRECTIVE ACTION
Does the state program initiate CORRECTIVE
ACTIONS as described in 9.3.2 when the FIELD
INSPECTION AUDIT, inspection report audit, or
sample report audit meets one or more of the
conditions below:
1. An individual receives a rating of “needs
improvement”?
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Appendix 4.1
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
2. A single performance factor for the
program falls below 80%, or four or more
“needs improvement” ratings are
identified in a single performance factor.
Note that if fewer than four audits are
conducted, a performance deficiency may
be considered for a single performance
factor that “needs improvement”?
3. An overall rating for the program falls
below 80%?
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
67
September 2022
Appendix 4.2
Appendix 4.2: Instructions for Performance Ratings of Audit Findings
The three performance rating of audit findings summary appendices (4.3a, 4.4a and 4.5a) allow the state
program to recognize trends and identify specific areas in their audit program that may need
improvement.
These summary appendices are used to calculate an overall rating during the performance period and
identify areas for improvement. The state program shall initiate CORRECTIVE ACTIONS as described in
9.3.2 when one or more of the conditions below are met: (a) an individual receives an overall rating of
“needs improvement”; (b) a single performance factor for the program falls below 80%; or (c) an overall
rating for the program falls below 80%.
INSTRUCTIONS:
(1) For each audit, record the manufactured food firm identification number,
inspection date, auditor’s initials, and date of audit.
(2) For each audit (vertical column), record the rating for each performance
factor (A = acceptable; NI = needs improvement). Record the individual audit
score on the row indicated.
(3) Count the number of “A” and “NI” for each performance factor
(horizontal) and record the total number of “A” and “NI” ratings. Calculate the
performance factor score using the formula below:
At = horizontal total of acceptable ratings.
NIt = horizontal total of needs improvement ratings.
Performance Factor Score = [At/(At + Nit)] x 100
(4)
Sum the Total Number of “A” and “NI” ratings for all audits.
$t = vertical sum of acceptable ratings.
1,t = vertical sum of needs improvement ratings.
127( LVWKHVWDWLVWLFDOV\PEROIRUWKHVXPRIDOOQXPEHUV
(5) Calculate the cumulative score for all audits. Record the cumulative score
in the space provided at the top of the worksheet.
&XPXODWLYH6FRUH >$t $t 1,t )] x 100
(6) Identify and make notes about trends and single performance factors rated
as “NI” in multiple audits.
Manufactured Food Regulatory Program Standards
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September 2022
Appendix 4.3
Appendix 4.3: Field Inspection Audit Form
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
FIELD INSPECTION AUDIT
AUDITOR
STATE INSPECTOR
FIRM Name
FEI NUMBER
FIRM ADDRESS
PRODUCT(S) COVERED
AUDIT DATE
TIME IN/OUT
OVERALL RATING
Acceptable
Needs Improvement
NOTE: Every item marked “needs improvement” must be accompanied by an explanation of
why the item was judged as needing improvement.
Overall Rating: If three or less items are marked "needs improvement," the overall rating is
"acceptable." If four or more items are marked "needs improvement," the overall rating is "needs
improvement." The overall rating must be marked in the space provided in the header on the first
page.
All questions must be answered "acceptable" or "needs improvement," except for section II.A.
Inspection Observations and Performance for ’HACCP-Regulated’ Facilities, section IV. Inspectional
Observations and Performance for Limited Scope PC and Modified Audits, section V. Inspection
Observations and Performance for Transportation Operations Subject to the Sanitary Transportation
of Human and Animal Food Rule, and section VI. Inspection Observations and Performance for Food
Defense Plan Reviews. If the manufactured food firm is not subject to Seafood or Juice HACCP
regulations or preventive controls regulations (including modified scope requirements), sanitary
transportation regulations, and intentional adulteration regulations, leave the scoring for these
questions blank and check “not applicable.”
If four or more evaluated items are marked as "needs improvement," the state program manager must
be notified by the QUALIFIED FIELD INSPECTION AUDITOR that additional training or other performance
improvement measures for the inspector being audited should be initiated. All contract inspectors who
receive an overall audit score of "needs improvement" shall receive remedial training in deficient
areas or as agreed upon by the state and FDA Division prior to resuming contract inspection duties.
Manufactured Food Regulatory Program Standards
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September 2022
Appendix 4.3
I. PRE-INSPECTION ASSESSMENT
1. Did the inspector review the state’s establishment file for the previous inspection report and
possible complaints, or access other available resources in preparation for the inspection?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
2. Did the inspector have the appropriate equipment and forms to properly conduct the inspection?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
II. INSPECTION OBSERVATIONS AND PERFORMANCE
1. Was the FDA/state jurisdiction established?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
2. Did the inspector select an appropriate product for the inspection and, if necessary, make
appropriate adjustments based on what the firm was producing?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
3. Did the inspector assess the employee practices critical to the safe production and storage of food?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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Appendix 4.3
4. Did the inspector properly evaluate the likelihood that conditions, practices, components, and/or
labeling could cause the product to be adulterated or misbranded?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
5. Did the inspector recognize significant violative conditions or practices, if present, and record
findings consistent with state and/or the FDA procedures?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
6. Did the inspector demonstrate the ability to distinguish between significant versus insignificant
observations and isolated incidents versus trends?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
7. Did the inspector review and evaluate the appropriate records and procedures for this
establishment’s operation and effectively apply the information obtained from this review?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
8. Did the inspector collect adequate evidence and documentation in accordance with state and/or
FDA procedures given the nature of the inspectional findings?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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Appendix 4.3
9. Did the inspector verify correction of deficiencies identified during the previous inspection?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
10. Did the inspector act in a professional manner and demonstrate proper sanitary practices during the
inspection?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
II. A. INSPECTION OBSERVATIONS AND PERFORMANCE FOR ‘HACCPREGULATED’ FACILITIES
Note to Auditor: These four questions apply to only firms subject to HACCP regulations. These four
questions should be left blank for manufactured food firms not subject to HACCP regulations.
1. Did the inspector use the “Fish and Fishery Products Hazards and Controls Guide” or the “Juice
Hazard Analysis Critical Control Point Hazards and Controls Guidance”, as appropriate, to
identify and evaluate the HAZARDS associated with the product and process?
Acceptable
Needs Improvement
Not Applicable
Comments (required for Needs Improvement)
2. Did the inspector assess the manufactured food firm’s implementation of sanitation monitoring for
the applicable eight key areas of sanitation?
Acceptable
Needs Improvement
Not Applicable
Comments (required for Needs Improvement)
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Appendix 4.3
3. Did the inspector review the firm’s HACCP plan (or necessary process controls in the absence of a
HACCP plan) and applicable monitoring, verification, and corrective action records, including
those related to sanitation?
Acceptable
Needs Improvement
Not Applicable
Comments (required for Needs Improvement)
4. Did the inspector recognize deficiencies in the firm’s monitoring and sanitation procedures
through in-plant observations?
Acceptable
Needs Improvement
Not Applicable
Comments (required for Needs Improvement)
III. ORAL AND WRITTEN COMMUNICATION
1. Did the inspector identify himself/herself and make appropriate introductions, which include
explaining the purpose and scope of the inspection?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
2. Did the inspector use suitable interviewing techniques?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
3. Did the inspector explain findings clearly and adequately throughout the inspection?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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Appendix 4.3
4. Did the inspector alert the firm’s appropriate management when immediate corrective action was
necessary?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
5. Did the inspector answer questions and provide information in an appropriate manner?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
6. Did the inspector write their findings accurately, clearly, and concisely on the state
form/document or Form FDA 483 left with the firm?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
IV. INSPECTION OBSERVATIONS AND PERFORMANCE FOR LIMITED SCOPE PC
AND MODIFIED AUDITS
Note to Auditor: Question 2 only applies to limited scope PC inspections. Question 3 only applies to
manufactured food firms that have submitted a qualified facility attestation. Question 4 only applies to
facilities solely engaged in the storage of unexposed packaged food. If these questions do not apply,
select Not Applicable.
1. Did the inspector properly evaluate the current good manufacturing practice requirements (21CFR
117 Subparts A, B, and F, or equivalent state regulation)? This question applies to all audits
performed including food, seafood, and juice. It cannot be left blank.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
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Appendix 4.3
2. Did the inspector conduct a broad-based assessment of the preventive controls program where
necessary? Applies only to limited scope PC. If this question does not apply, select Not
Applicable.
Acceptable
Needs Improvement
Not Applicable
Comments (required for Needs Improvement)
3. Did the inspector verify whether the facility has attested and if so confirm whether the provisions
in the attestation were understood? Applies only to qualified facilities. If this question does not
apply, select Not Applicable.
Acceptable
Needs Improvement
Not Applicable
Comments (required for Needs Improvement)
4. Did the inspector properly evaluate the implementation of time/temperature controls? Only answer
if the facility is a warehouse solely engaged in the storage of unexposed packaged food that
requires refrigeration for safety. If this question does not apply, select Not Applicable.
Acceptable
Needs Improvement
Not Applicable
Comments (required for Needs Improvement)
V. INSPECTION OBSERVATIONS AND PERFORMANCE FOR TRANSPORTATION
OPERATIONS SUBJECT TO THE SANITARY TRANSPORTATION OF HUMAN AND
ANIMAL FOOD RULE
1. Did the inspector conduct an assessment of the sanitary transportation practices applicable to
transportation operations?
Acceptable
Needs Improvement
Not Applicable
Comments (required for Needs Improvement)
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Appendix 4.3
VI. INSPECTION OBSERVATIONS AND PERFORMANCE FOR FOOD DEFENSE
PLAN REVIEWS
1. Did the inspector conduct an assessment of the food defense plan, including review of mitigation
strategies, monitoring, corrective actions, and verification activities?
Acceptable
Needs Improvement
Not Applicable
Comments (required for Needs Improvement)
ADDITIONAL COMMENTS
SIGNATURE OF AUDITOR
Manufactured Food Regulatory Program Standards
DATE
76
September 2022
Enter the sum of the totals from all continuation sheets.
Enter the final sums (subtotal + sums of (3) on this form).
Auditor’s initials and date of audit (1)
Performance ratings (2)
Date:
Performance Rating:
Performance Period:
Manufactured Food Regulatory Program Standards
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At
(3)
NIt
(3)
September 2022
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
IIA.1
IIA.2
IIA.3
IIA.4
III.1
III.2
III.3
III.4
III.5
III.6
IV. 1
IV.2
IV.3
IV.4
V.1
VI.1
Subtotal
Total
Performance
factors (5)
Reviewed By:
State Agency:
Appendix 4.3a: Summary of Field Inspection Audit Findings
Appendix 4.3a
Enter the sums of (3).
Performance ratings (2)
Auditor’s initials and date of audit (1)
Performance Period:
Manufactured Food Regulatory Program Standards
78
At
(3)
NIt
(3)
September 2022
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
IIA.1
IIA.2
IIA.3
IIA.4
III.1
III.2
III.3
III.4
III.5
III.6
IV.1
IV.2
IV.3
IV.4
V.1
VI.1
Total
Performance
factors (5)
State Agency:
Appendix 4.3a
Appendix 4.4
Appendix 4.4: Inspection Report Audit Form
MANUFACTURED FOOD REGULATORY PROGRAM STANDARDS
INSPECTION REPORT AUDIT FORM
AUDITOR:
DATE OF AUDIT:
DATE OF INSPECTION:
FIRM NAME:
Type of Inspection:
FIRM ADDRESS:
General Food
Seafood HACCP
Juice HACCP
LACF
Acidified
Preventive Controls
Other:
TOTAL NUMBER:
AUDIT RATING:
Acceptable
Acceptable
Needs Improvement
Needs Improvement
Audit Score:
INSTRUCTIONS TO THE AUDITOR
All performance factors must be rated “Acceptable” or “Needs Improvement.” The total number of
“Acceptable” and “Needs Improvement,” as well as the audit score and audit rating, must be
recorded in the space above.
To calculate the audit score: Audit Score = [# Acceptable/ (# Acceptable + # Needs Improvement)] x
100.
If the audit score is below 80%, the audit rating must be marked as “Needs Improvement.”
I. ORGANIZATION AND RECORDS OF FINDINGS
1. The inspector submitted the report within designated timeframes.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
Manufactured Food Regulatory Program Standards
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September 2022
Appendix 4.4
2. All required fields on inspection report or related forms were completed.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)
3. Written observations were clear and concise.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
4. The inspector followed all current and applicable report writing and documentation procedures.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
5. The inspector identified violations based on state and/or federal regulations.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
6. The inspector reviewed past inspection findings and acted on repeated or unresolved violations.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
7. The inspector recorded significant findings.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
Manufactured Food Regulatory Program Standards
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September 2022
Appendix 4.4
8. The inspector recorded the collection of all samples, exhibits, photographs, or photocopies to
support findings.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
9. The inspector obtained and documented on-site corrective action at the time of inspection as
appropriate to the type of violation.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
10. The inspector followed through and documented compliance activities per state policy.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
GENERAL COMMENTS
Enter any general comments or recommendations as a result of this audit.
Manufactured Food Regulatory Program Standards
81
September 2022
Date:
Enter the final sums (subtotal + sums of (3) on this form).
Total
Performance Rating:
Performance Period:
Manufactured Food Regulatory Program Standards
82
NIt
(3)
At
(3)
September 2022
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
Enter the sum of the totals from all continuation sheets.
Performance ratings (2)
Firm identification number and date of inspection (1)
Subtotal
I.10
I.9
I.8
I.7
I.6
I.5
I.4
I.3
I.2
I.1
Performance
factors (5)
Reviewed By:
State Agency:
Appendix 4.4a: Summary of Inspection Report Audit Findings
Appendix 4.4a
Enter the final sums (subtotal + sums of (3) on this form).
Total
Performance Period:
Manufactured Food Regulatory Program Standards
83
At
(3)
NIt
(3)
September 2022
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
Enter the sum of the totals from all continuation sheets.
Performance ratings (2)
Firm identification number and date of inspection (1)
Subtotal
I.10
I.9
I.8
I.7
I.6
I.5
I.4
I.3
I.2
I.1
Performance
factors (5)
State Agency:
Appendix 4.4a
Appendix 4.5
Appendix 4.5: Sample Report Audit Form
MANUFACTURED FOOD REGULATORY PROGRAM STANDARDS
SAMPLE REPORT AUDIT FORM
AUDITOR:
DATE OF AUDIT:
DATE OF INSPECTION:
FIRM NAME:
DATE OF COLLECTION:
FIRM ADDRESS:
SAMPLE ID #:
TOTAL NUMBER:
AUDIT RATING:
Acceptable
Acceptable
Needs Improvement
Needs Improvement
Audit Score:
INSTRUCTIONS TO THE AUDITOR
All performance factors must be rated “Acceptable” or “Needs Improvement.” The total number of
“Acceptable” and “Needs Improvement,” as well as the audit score and audit rating, must be recorded
in the space above.
To calculate the audit score: Audit Score = [# Acceptable/ (# Acceptable + # Needs Improvement)] x
100.
If the audit score is below 80%, the audit rating must be marked as “Needs Improvement.”
I. SAMPLE OBSERVATIONS AND PERFORMANCE
1. Method of collection and equipment was appropriate.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
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September 2022
Appendix 4.5
2. Record sample chain of custody per state procedure.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
3. Sample was handled, packaged, and shipped to prevent compromising the condition or integrity of
the sample, as evidenced by acceptance and testing by the receiving laboratory.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
4. Sample was submitted within prescribed timeframes.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
II. SAMPLE COLLECTION
1. Date of sample collection was recorded.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
2. Product identification including name and manufacturing reference information was recorded. For
environmental samples a description of the collection point is acceptable.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
Manufactured Food Regulatory Program Standards
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September 2022
Appendix 4.5
3. Description of product including sample size was recorded.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
4. Collection information, including method of collection, lot sampled, lot size, and any special
techniques used to collect the sample was recorded.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
5. Location where sample was collected was recorded.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
6. Name and address of manufacturer, responsible party, guarantor, processor, or distributor were
recorded. For environmental samples the physical location of the collection site and responsible
party is acceptable.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
7. Sample type (surveillance, compliance, investigational, or regulatory) was recorded.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
Manufactured Food Regulatory Program Standards
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September 2022
Appendix 4.5
8. The type of analysis requested was recorded if applicable. If the type of analysis is not required on
sample report per state procedures this item is acceptable.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
9. Product labels or labeling information is collected or reproduced if required by state procedures.
For environmental samples the description of the location of the sample collection point is
acceptable.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
10. The sample identification assigned by the sampler at the time of collection was reported.
Acceptable
Needs improvement
Comments (required for Needs Improvement)
GENERAL COMMENTS
Enter any general comments or recommendations as a result of this audit.
Manufactured Food Regulatory Program Standards
87
September 2022
Date:
Enter the final sums (subtotal + sums of (3) on this form).
Total
Manufactured Food Regulatory Program Standards
88
At
(3)
NIt
(3)
September 2022
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
Enter the sum of the totals from all continuation sheets.
Performance ratings (2)
Performance Rating:
Performance Period:
Sample report identification number and date of sample collection (1)
Subtotal
II.10
II.9
II.8
II.7
II.6
II.5
II.4
II.3
II.2
II.1
I.4
I.3
I.2
I.1
Performance
factors (5)
Reviewed By:
State Agency:
Appendix 4.5a: Summary of Sample Report Audit Findings
Appendix 4.5a
Enter the sums of (3).
Performance ratings (2)
Sample report identification number and date of sample collection (1)
Performance Period:
Manufactured Food Regulatory Program Standards
89
At
(3)
NIt
(3)
September 2022
(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.
Total
II.10
II.9
II.8
II.7
II.6
II.5
II.4
II.3
II.2
II.1
I.4
I.3
I.2
I.1
Performance
factors (5)
State Agency:
Appendix 4.5a
Appendix 5.1
Appendix 5.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
5.3.1 Coordination with Other Authorities
Does the state program:
1. Have a Memorandum of Understanding
for foodborne illness outbreak
investigations, if required?
2. Have a written procedure that identifies
and describes the roles, responsibilities,
and duties of each program responsible
for supporting foodborne illness outbreak
response in requirements 5.3.2 – 5.3.5?
3. Have a written procedure that describes
agency collaboration as necessary with
the FDA and other appropriate local,
state, and federal authorities in multijurisdictional FOOD-RELATED INCIDENTS?
4. Have a written procedure that designates
a response coordinator(s) to guide
program investigation efforts in
collaboration with all agencies involved?
5. Have a written procedure that describes
how all relevant agencies are notified in
case of FOOD-RELATED INCIDENTS?
6. Have a written procedure that provides
guidance for notification of appropriate
law enforcement agencies when
intentional food contamination is
suspected or threatened?
7. Have a written procedure that describes
the maintenance of a list(s) of relevant
agencies and emergency contacts that is
updated at least yearly?
Manufactured Food Regulatory Program Standards
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September 2022
Appendix 5.1
5.3.2 Surveillance
Does the state program:
1. Use epidemiological information from
local, state, or federal agencies to detect
incidents or outbreaks of foodborne
illness or injury?
2. Maintain notifications of FOOD-RELATED
INCIDENTS that are reported to the
program, in a log(s) or database(s)?
5.3.3 Investigation/ENVIRONMENTAL ASSESSMENT
Does the state program:
1. Use established procedures with
recommended timeframes to investigate
reports of FOOD-RELATED INCIDENTS?
2. Collect ENVIRONMENTAL ASSESSMENT
data using established procedures similar
to those found in IAFP and CIFOR?
3. Coordinate the TRACEBACK and
TRACEFORWARD of food implicated in an
illness, injury, outbreak or found to
contain a HAZARD in accordance with
written procedures?
4. Have access to laboratory support for
investigation of reports of FOOD-RELATED
INCIDENTS?
5. Correlate and analyze ENVIRONMENTAL
ASSESSMENT data to identify contributing
factors and antecedents that led to food
contamination or adulteration causing
illness, injury, or outbreak?
5.3.4 Control Measures
Does the state program:
1. Mitigate and contain food-related illness,
injury and HAZARDS through strategies
that include industry education,
enforcement, and public awareness
activities?
2. Maintain a written procedure with criteria
for releasing prevention guidance and
information to the public?
Manufactured Food Regulatory Program Standards
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September 2022
Appendix 5.1
5.3.5 Post Response
Does the state program:
1. Maintain program investigation and
ENVIRONMENTAL ASSESSMENT findings
and reports?
2. Distribute final program investigation
report(s), including an ENVIRONMENTAL
ASSESSMENT if completed to relevant
agencies responsible for reporting
contributing factors and antecedents to
CDC?
3. Distribute recommendations, when
available, from investigation and
ENVIRONMENTAL ASSESSMENT findings
and reports to relevant agencies and
stakeholders responsible for prevention,
education, and outreach?
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
92
September 2022
Appendix 6.1
Appendix 6.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
6.3.1 Compliance and Enforcement Program
Does the state have a written compliance
and enforcement program that:
1. Contains written compliance and
enforcement strategies?
2. Describes the procedure to monitor:
CRITICAL VIOLATIONS, chronic
violations, and chronic violators?
3. Uses a risk-based process to determine
when a directed investigation, follow-up,
or re-inspection is needed?
4. Establishes a framework for compliance
and enforcement progressive actions?
6.3.2 Performance Review
Does the state program conduct a
performance review:
1. Annually?
2. Document on Appendix 6.2, or
equivalent form to evaluate if internal
compliance and enforcement actions are
followed?
3. Use results of the review to identify
improvements and modify procedures?
4. Require a CORRECTIVE ACTION, which
will be documented on the STRATEGIC
IMPROVEMENT PLAN, if performance
ratings fall below 80%?
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
93
September 2022
Appendix 6.2
Appendix 6.2: Calculation of the Level of Conformance to Compliance Procedures
State Agency:
Rating for conformance to compliance procedures (4):
Food firm
identification
number (1)
Subtotal
Total
Enforcement action
recommended (1)
Compliance
procedures
followed? (2)
Enter the sum of the
totals from all
At =
continuation sheets.
Enter the final sums
--subtotal + sums of At =
(2) -- on this form.
Use this space for comments or to
explain improvements needed to follow
compliance procedures
NIt =
NIt =
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
94
September 2022
Appendix 6.2
Food firm
identification
number (1)
Enforcement action
recommended (1)
Total
Enter the sums of
(2).
Compliance
procedures
followed? (2)
At =
Manufactured Food Regulatory Program Standards
Use this space for comments or to
explain improvements needed to follow
compliance procedures
NIt =
95
September 2022
Appendix 6.2a
Appendix 6.2a: Instructions for Performance Review of Enforcement Actions
Appendix 6.2 is used to record the enforcement actions recommended in the past 12 months and to
calculate the state agency’s rating for conformance to compliance procedures. Supporting documents
should be referenced and maintained by the state agency. Please indicate if an action was taken because
voluntary compliance was not achieved.
It is recommended that all cases be reviewed; otherwise, a statistical approach should be used to
determine a representative number of cases. Use continuation sheets as necessary.
INSTRUCTIONS:
(1) Record the manufactured food firm identification number and the
recommended enforcement action.
(2) For each type of enforcement action, record the level of conformance to
compliance procedures.
A = acceptable; NI = needs improvement
(3)
Record the At and NIt .
At = vertical sum of acceptable ratings.
NIt = vertical sum of needs improvement ratings.
(4) Calculate the overall rating for the state agency’s conformance to
compliance procedures. Record the rating in the box located at the top of
Appendix 6.2.
FORMULA: Performance factor rating = [ At / ( At + NIt )] x 100
Manufactured Food Regulatory Program Standards
96
September 2022
Appendix 7.1
Appendix 7.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
Yes/No
If no, please explain why element is not met.
May use this space for additional notes.
7.3 Outreach Methods
Does the state program have a written
procedure that includes how the program
will:
1. Identify the methods that will be used
for communication with the food
industry stakeholders and consumers?
2. Interact with industry and consumers by
sponsoring or actively participating in
meetings such as task forces, advisory
boards, or advisory committees?
3. Tailor outreach efforts to a target
population which may include
dissemination of information using
electronic sources and traditional
methods such as mailings?
4. Document and evaluate OUTREACH
ACTIVITY EVENTS using Appendix 7.2 or
equivalent form? Include documents
such as agendas and meeting summaries
and program evaluations.
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
97
September 2022
Appendix 7.2
Appendix 7.2: Outreach Activity Event and Self-Evaluation Worksheet
State Agency:
This worksheet is completed by the state program to document OUTREACH ACTIVITY EVENTS. Attach
verifying documents such as agendas and meeting summaries and program evaluations to this form.
Section I. Overview of Outreach Activity
a. Type of OUTREACH ACTIVITY EVENT (check one):
Seminar
Workshop
Training course
Other
b. Subject or name of OUTREACH ACTIVITY EVENT:
c. Date of OUTREACH ACTIVITY EVENT:
d. Host organization:
Section II. Self-Evaluation of OUTREACH ACTIVITY EVENTS
Program Elements
a. The purpose and objectives were clearly
defined.
Yes/No
If no, please explain.
b. The content of the OUTREACH ACTIVITY EVENT
was consistent with the objectives
c. The activity was tailored to a target population.
Identify target population:
d. An evaluation was completed by attendees.
e. State program addressed comments from
attendees in Section III of this form.
Section III. Critique of OUTREACH ACTIVITY EVENT
Discuss what went well, what could be done better, and what more could be done to improve the
OUTREACH ACTIVITY EVENT. Address comments from attendees, if available.
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
98
September 2022
Appendix 8.1
Appendix 8.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
8.3.1 Program Assessment
Does the state program complete the Resource
Summary Report to assess staffing, funding,
and equipment using Appendix 8.2 or
equivalent form?
8.3.2 Staffing
Does the state program:
1. Conduct a calculation for determining the
required number of inspectors to inspect
manufactured food firms in its
manufactured food firm inventory at a
frequency that is based on the manufactured
food firm’s risk classification and the
necessary inspection and travel time?
2. Document the calculation for determining
the required number of inspectors to inspect
manufactured food firms in its
manufactured food firm inventory?
8.3.3 Equipment
Does the state program establish and maintain a
list of equipment required for inspections and
sampling?
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
99
September 2022
Appendix 8.2
Appendix 8.2: Resource Summary Report
State Agency:
Does the state program have sufficient funds, staff, equipment, and resources necessary to meet the
program standards? Answer “Yes” or “No” in each block. If “No”, please explain. Use additional
pages as needed.
Standard
Regulatory
1
Foundation
2 Training Program
Inspection
3
Program
Inspection Audit
4
Program
Food-related
Illness,
5
Outbreaks, and
Hazard Response
Compliance and
6
Enforcement
Industry and
7 Community
Relations
Program
8
Resources
Program
9
Assessment
Laboratory
10
Support
Funding
Staffing
Equipment
Other resources needed
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
100
September 2022
Appendix 8.2a
Appendix 8.2a: Resource Summary Report Instructions
The Appendix 8.2 Resource Summary Report summarizes the state program’s assessment of their resources
for all ten Standards.
Instructions: For each Standard, the state program conducts an assessment of resource needs for staffing,
equipment, and funding for the manufactured food regulatory program. Answer “Yes” or ”No” in each
block. If the response is “No”, please explain the additional resources needed. Use additional pages as
needed.
When completing Appendix 8.2 the state program should consider the following items:
x
Regulatory Foundation (Standard 1). The state program has resources to evaluate the scope of its
legal authority and regulatory provisions to ensure the protection of manufactured food within its
jurisdiction.
x
Training Program (Standard 2). The state program has resources to implement a training plan that
ensures all inspectors conducting manufactured food inspections complete course curriculums, field
training, and continuing education to adequately perform their work.
x
Inspection Program (Standard 3). The state program has resources to implement a risk-based
inspection program that reduces the occurrence of foodborne illness, injury, or allergic reactions.
x
Inspection Audit Program (Standard 4). The state program has resources to administer and monitor
the quality of its inspections and sample collections.
x
Food-related Illness, Outbreaks, and Hazards Response (Standard 5). The state program has the
resources necessary to detect, investigate, mitigate, document, and analyze the food-related incidents
to stop, control and prevent hazards that are likely to result in a foodborne illness, injury, or outbreak.
x
Compliance and Enforcement Program (Standard 6). The state program has resources to administer
and monitor a compliance and enforcement program.
x
Industry and Community Relations (Standard 7). The state program has resources that allow
participation and assessment of outreach activities and OUTREACH ACTIVITY EVENTS.
x
Program Resources (Standard 8). The state program has resources to conduct an assessment of
resource needs for staffing, equipment, and funding to support a manufactured food regulatory
program.
x
Program Assessment (Standard 9). The state program has the resources to conduct self-assessments
and develop and manage a STRATEGIC IMPROVEMENT PLAN resulting in CONFORMANCE with the
Manufactured Food Regulatory Program Standards and a process for continuous improvement. The
state program has resources to ensures that all guidance, procedures, documents, and forms required
by the standards are CURRENT AND FIT-FOR-USE.
x
Laboratory Support (Standard 10). The state program has resources to access laboratory services
needed to support program functions.
Manufactured Food Regulatory Program Standards
101
September 2022
Appendix 9.1
Appendix 9.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
9.3.1
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
Does the state program conduct a
baseline self-assessment:
1. Within the first year?
2. Using the self-assessment worksheets
associated with each standard?
3. Using the results of its self-assessments
to complete Appendix 9.2 (or
equivalent form)?
9.3.2 If the state program fails to meet
any of the program elements or
documentation requirements,
whether identified through a selfassessment or FDA ASSESSMENTS,
did the state program develop a
STRATEGIC IMPROVEMENT PLAN?
Does the STRATEGIC IMPROVEMENT PLAN
include:
1. The individual element or
documentation requirement that was not
met?
2. Improvements or CORRECTIONS needed
to meet the program element or
documentation requirement of the
standard?
3. The cause for any non-CONFORMANCE
requiring CORRECTION when the
program was previously in
CONFORMANCE with the individual
element or documentation requirement
of a standard?
Manufactured Food Regulatory Program Standards
102
September 2022
Appendix 9.1
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
4. The CORRECTIVE ACTION taken to
prevent future similar nonCONFORMANCE when the program was
previously in CONFORMANCE with the
individual element or documentation
requirement of the standard that was
corrected?
5. Projected completion dates for each
task?
6. Personnel responsible?
7. Date completed for each task?
9.3.3
Does the state program review
and update the self-assessment
appendices and STRATEGIC
IMPROVEMENT PLAN at least
annually?
9.3.4 Does the state program:
1. Participate in FDA ASSESSMENTS to
determine IMPLEMENTATION and
CONFORMANCE to the standards?
2. Address FDA ASSESSMENT
observations and establish CORRECTIVE
ACTION?
9.3.5
Does the state program:
1. Have a written DOCUMENT CONTROL
procedure?
a. Is the state program able to
demonstrate that all documents are
CURRENT AND FIT-FOR-USE through
maintenance of a master document
list or other system?
b.
Does the master document list or
other system show:
i.
ii.
Documents are reviewed for
accuracy?
Documents are approved for
release by authorized
personnel and signed/dated
with an approval or revision
date?
Manufactured Food Regulatory Program Standards
103
September 2022
Appendix 9.1
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
iii.
Documents are distributed to
applicable staff, as
appropriate, and used at the
location where the prescribed
activity is performed?
2. Retain records or procedures required
under each standard for the three
previous years, or per the state
program’s record retention policy,
whichever is longer?
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
104
September 2022
Appendix 9.2
Appendix 9.2: Self-Assessment Summary Report
State Agency:
Standard
Regulatory
Foundation
Self-Assessment
Complete
Incomplete
Hours used
Training Program
Inspection Program
Compliance and
Enforcement
Program Resources
Partial
Full
____
Partial
Full
____
Partial
Full
____
Complete
Incomplete
Hours used
Outreach Activities
____
Complete
Incomplete
Hours used
Partial
Full
Complete
Incomplete
Hours used
Food-related Illness,
Outbreak, and
Hazard Response
____
Complete
Incomplete
Hours used
Inspection Audit
Program
Full
Complete
Incomplete
Hours used
IMPLEMENTATION
Explain improvements needed to
fully IMPLEMENT standards
(required for incomplete selfassessment and partial
IMPLEMENTATION)
Partial
Full
____
Complete
Incomplete
Partial
Full
Hours used
Complete
Incomplete
____
Hours used
____
Partial
Full
Manufactured Food Regulatory Program Standards
Partial
105
September 2022
Appendix 9.2
Standard
Program Assessment
Self-Assessment
Complete
Incomplete
Hours used
Laboratory Support
Full
____
Complete
Incomplete
Hours used
IMPLEMENTATION
Explain improvements needed to
fully IMPLEMENT standards
(required for incomplete selfassessment and partial
IMPLEMENTATION)
Partial
Full
____
Partial
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
106
September 2022
Appendix 10.1
Appendix 10.1: Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluates if it includes
the associated components. If the state program has the main component and associated components
indicate “Yes”. If not, indicate “No”.
State Agency:
Program Elements
Yes/No
If no, please explain why element is not
met. May use this space for additional
notes.
10.3.1 Laboratory Support
Does the state program:
1. Have access to a laboratory that is
capable of analyzing a variety of samples
including food, environmental, and
clinical samples?
2. Maintains a list of services for routine and
non-routine analyses such as biological
HAZARD determinations?
3. Have a contract or written agreement with
each PRIMARY SERVICING LABORATORY
unless under the same administrative
agency? The contract or written
agreement can be a memorandum of
understanding, e-mail, or any written
format but must contain the components
below:
a. Define the responsibilities of each
party;
b. Describe the types of testing services
to be performed; and
c. Describe how exceptions to planned
work will be communicated.
4. Have documentation of the services
provided, if services are provided from a
non-PRIMARY SERVICING LABORATORY?
10.3.2 ISO Accredited Laboratories
Does the state program use laboratories that
have a current accreditation to the ISO/IEC
17025:2017 (or current version) standards to
analyze food and environmental samples?
Manufactured Food Regulatory Program Standards
107
September 2022
Appendix 10.1
10.3.3 Non-ISO Accredited Laboratories
If not using laboratories holding accreditation to
ISO/IEC 17025:2017 (or current version) for the
analysis of food and environmental samples, is
the program using laboratories that have in
place a quality system which incorporates the
following management and technical
requirements at a minimum:
1. A quality system that is documented and
includes items 10.3.3.1.1 through
10.3.3.1.6?
2. A procedure that defines the activities
necessary to take corrective action when
non-conforming work occurs?
3. A document control procedure that assures
documents issued to personnel are current,
suitable, and reviewed and approved by
authorized personnel prior to release?
4. A documented record keeping process that
assures that records of original observations
and data collection are maintained and
sufficient to establish traceability of test
results to sample handling and storage, to
sample analysis including data collection, to
equipment calibration and maintenance, and
to the review of test results prior to release?
5. A documented process to assure that
reference materials and reference cultures
used are fit for purpose, are not outdated,
and are traceable to a lot number or other
unique identifier?
6. A documented process to assure that the
laboratory participates in relevant and
available proficiency testing activities?
Assessment Completed By:
Name
Manufactured Food Regulatory Program Standards
Date:
108
September 2022
| File Type | application/pdf |
| File Title | MFRPS 2022 EXTENDED standards 508.pdf |
| Author | Weigner, Timothy |
| File Modified | 2025-09-15 |
| File Created | 2025-09-15 |