HACCP participant application - new respondents

PART 3 – Policies, Procedures and
Requirements for the approval of
Facilities and Systems

Chapter 1 - Authority .................................................................................................................................... 2
Chapter 2 - Introduction ............................................................................................................................... 2
Chapter 3 – Scope ......................................................................................................................................... 3
Chapter 4 - Definitions .................................................................................................................................. 3
Chapter 5 – Application for Services ............................................................................................................. 6
Chapter 6 – Prior to USDC Validation of the System .................................................................................... 6
Chapter 7 – Additional Requirements for IQA and HACCP Quality Management Program Plan Review and
Desk Audit ..................................................................................................................................................... 7
Chapter 8 – Initial Assessment and Validation ............................................................................................. 7
Chapter 9 – Label Review Procedures .......................................................................................................... 8
Chapter 10 – Changes to the Approved System ........................................................................................... 8
Chapter 11 – System Audits - Surveillance ................................................................................................... 9
Chapter 12 – Tightened Audit Procedures.................................................................................................. 10
Chapter 13 – Corrective Action Plans ......................................................................................................... 10
Chapter 14 – Appeal Procedures ................................................................................................................ 11
Chapter 15 – Analytical Testing and Product Verificaiton .......................................................................... 11
Chapter 16 – Use of Marks ......................................................................................................................... 11
Chapter 17 – Advertising Participants ........................................................................................................ 11
Chapter 18 – System Compliance Rating Criteria ....................................................................................... 12

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Chapter 1 - Authority
Authority for the Seafood Inspection Program to provide these services can be found within the
Agricultural Marketing Act of 1946, the Fish and Wildlife Act of 1956, and the regulations promulgated
under these authorities (i.e., 50 CFR Part 260).

Chapter 2 - Introduction
Participants that process products under the USDC Seafood Inspection Program on a contract basis must
receive approval of buildings, facilities, and the applicable processes prior to the inauguration of such
service.
These establishments or vessels must be certified to meet U.S. Department of Commerce regulations
governing the construction and maintenance of facilities and equipment, processing techniques, and
employee practices in the production of fishery products for human consumption. Approved
establishments are eligible to produce fishery products bearing an official inspection mark. (Facilities
outside the United States currently are not eligible to have their products bear inspection marks,
although the master cases may bear statements applicable to their status per Program
policy.) Approved facilities are included on a list published on the Program’s official website and
periodically in hard copy. Inclusion on this list is contingent upon the firm’s continued ability to
maintain USDC requirements.
Approved establishments are verified by on-site audits to meet U.S. Food and Drug Administration and
U.S. Department of Commerce regulations governing the construction and maintenance of facilities and
equipment, processing techniques, and employer practices in the production of fishery products for
human consumption. USDC approved establishments shall notify USDC of regulatory visits and
findings. Participation in the USDC Seafood Inspection Program does not eliminate the responsibility
and obligation of the industry participant to meet all federal and applicable state regulations and
requirements.
There are three systems of participation as an approved facility, each of which offers differing methods
of product inspection service by USDC personnel. One system requires the system to be audited on a
regular basis and, while product bearing a USDC Inspection Mark is being produced, a USDC inspector is
present ascertaining the quality level of the product per applicable regulations and Program
requirements. This method is referred to as Resident Inspection.
The second system which reduces the product inspection effort is called the Integrated Quality
Assurance (IQA) Program and was established in the Federal Register, Volume 37, Number 161 on
August 18, 1972. Audits of the system are also performed regularly. However the firm’s quality
assurance personnel provide assistance to the USDC inspector by inspecting all lots to the applicable US
Grade or specification requirements. The USDC inspector then evaluates the system through a product
verification system. This system does not necessarily require the USDC inspector to be present for all
product inspection activity. However, it does require a USDC approved quality assurance system. All
products inspected or verified through this system are eligible to bear a mark.
In July 1992, the USDC published a Federal Register notice announcing the availability of a new seafood
inspection program based on Hazard Analysis Critical Control Point (HACCP) principles. In January 2000
this program was further enhanced to include the ISO 9001 Quality Management Standard. This
program further reduces the inspection effort of the USDC personnel by partnering with industry
participants and their responsibility for all food safety, wholesomeness, economic integrity, and quality
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concerns for the system and products produced at the firm. The firm is audited on varying levels based
upon its compliance to the Program requirements.
This chapter has been developed to provide interested parties with the various policies, procedures, and
requirements which must be met in order for facilities and systems to be approved by
USDC. Participants may elect to contract in any these of three programs. Under the IQA and the HACCP
QMP, the company takes on the responsibility of documenting and implementing a quality
system. USDC will then ensure that the quality system in place is adequate to control the critical
functions by regular inspections of the system, known as audits. These audits will evaluate the quality
system by examining product, processes, and records.
This chapter includes sections which explain the requirements of the Resident Inspection, IQA and
HACCP QMP programs for documenting a system that will meet USDC requirements. The document is
also a guide manual for use by interested parties in developing their own food safety and/or quality
manual. The IQA and HACCP QMP will allow participants an opportunity to apply their existing quality
systems more efficiently, receive the management benefits of producing safe, wholesome, and properly
labeled products more consistently and obtain the marketing benefits of using marks associated with
the Program.
In summary, these services are consistent with global activities to harmonize inspection protocols. In
addition, USDC believes that the services will enhance the safety, wholesomeness, economic integrity,
and quality of seafood available to consumers, as well as improve seafood industry quality assurance
and regulatory oversight.
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Chapter 3 – Scope
Program policy is to encourage and assist interested parties in the development and implementation of
management systems. The purpose of this policy is to facilitate the production and distribution of
fishery products that are safe, wholesome, properly labeled, and of desired uniform quality. Any facility,
whether processing plant, retail operation, or vessel, foreign or domestic, may become part of this
program.
The development and implementation of Integrated Quality Assurance or HACCP Quality Management
systems is optional. However, their use should result in more efficient use of industry and USDC
resources to inspect, grade, and certify fishery products. This document also provides guidance for the
development, implementation, and operation of these systems, which will meet USDC approval.

Chapter 4 - Definitions
1. Applicant: Any interested party who requests inspection service under the regulations in this
part.
2. Audit: A systematic and independent examination to determine whether activities and related
results comply with planned arrangements and whether these arrangements are implemented
effectively and are suitable to achieve objectives.
3. Auditor: A person qualified to perform audits.
4. Contamination: The presence of microbial pathogens, chemicals, foreign material, spoilage,
objectionable taints, unwanted or diseased matter in food or water which may compromise the
quality or suitability for consumption.
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5. Control Point: Any step in a process whereby biological, chemical, or physical factors may be
controlled.
6. Corrective Action: An action taken to eliminate the cause(s) of an existing nonconformity,
defect, or other undesirable situation in order to prevent recurrence.
7. Critical Control Point (CCP): A point, step, or procedure in a food process at which control can
be applied, and a food hazard can, as a result, be prevented, eliminated, or reduced to
acceptable levels.
8. Critical Deficiency: A hazardous deviation from plan requirements such that maintenance of the
safety, wholesomeness, and economic integrity is absent and will result in unsafe,
unwholesome, or misbranded product.
9. Critical Limit: The maximum or minimum value to which a physical, biological, or chemical
parameter must be controlled at a critical control point, or defect action point, to prevent,
eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.
10. Decision Tree: A sequence of questions applied to each process step with an identified hazard to
identify which process steps are CCPs. For the purpose of this Program, this also applies to a
DAP (Defect Action Point.)
11. Decomposition: A persistent and distinct objectionable odor and/or flavor including texture
breakdown caused by the deterioration of the product.
12. Defect: A condition found in a product which fails to meet essential quality, composition and/or
labeling provisions of the appropriate product standards or specifications.
13. Defect Action Point (DAP): A point, step or procedure at which control can be applied and a
defect can be prevented, eliminated or reduced to acceptable level, or a fraud risk eliminated.
14. Deviation: Any specifically defined variation from a particular requirement.
15. Establishment: Any premises, buildings, structures, facilities, and equipment (including vehicles)
used in the processing, handling, transporting, and storage of fish and fishery products.
16. Food Safety Hazard: Any biological, chemical, or physical property that may cause a food to be
unsafe for human consumption.
17. HACCP Plan: A document prepared in accordance with the principles of HACCP to ensure control
of hazards which are significant for food safety and control of defects which are significant for
essential quality, composition, and/or labeling provisions in the segment of the food chain under
consideration.
18. Hazard: A chance for, or the risk of, a biological, chemical, physical, or economic property in a
food product that could violate established program criteria or cause the consumer distress or
illness.
19. Hazard analysis: The process of collecting and evaluating information on hazards and conditions
leading to their presence to decide which are significant for food safety and therefore should be
addressed in the HACCP plan.
20. High risk products: Seafood that may pose a significant danger to the health of the public when
prepared for consumption by conventional or traditional means. For example, ready-to-eat;
heat and/or brown and serve products; products which may contain a microbial pathogen,
biotoxin, or physical or chemical contaminant which may pose an unacceptable health risk at
the time of consumption.
21. Interested party: Any person who has a financial interest in the applicable commodity, facility,
or firm. This includes, but is not limited to, the United States and any instrument or agency
thereof, any State, county, municipality, or common carrier, and any authorized agent on behalf
of the foregoing.
22. Lot: A production unit as defined by mutual agreement between the processor and the USDC
Seafood Inspection Program consisting of processed product of the same type, style, and size
which has been produced under conditions as nearly uniform as possible. The quantity of
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23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.

34.
35.

36.
37.
38.
39.
40.
41.
42.
43.

product in a “lot” may not exceed that quantity which is produced during a specific production
shift.
Low risk products: Seafood that poses no significant risk to the health of the public when
prepared for consumption by conventional or traditional means.
Major Deficiency: A significant deviation from plan requirements, such that maintenance of
safety, wholesomeness, or economic integrity is inhibited.
Minor Deficiency: A failure of the part of the HACCP-based system relative to facility sanitation
which is not likely to reduce materially the facility’s ability to meet acceptable sanitation
requirements.
Monitoring Procedures: Scheduled testing and/or observations recorded by the firm to report
the findings at each CCP or DAP.
Objective Evidence: Information, which can be proved true, based on facts, obtained through
observation, measurement, test, or other means.
Official Establishment: Any establishment which has been approved by the Program and utilizes
inspection service on a contract basis.
Plant: The premises, buildings, structures, and equipment (including, but not limited to,
machines, utensils, and fixtures) employed or used with respect to the manufacture or
production of processed products.
Prerequisite Program: Procedures, including Good Manufacturing Practices that address
operational conditions providing the foundation for the HACCP system.
Preventive Measure(s) (control measure(s)): Physical, chemical, or other factors that can be
used to control an identified food safety hazard. For the purposes of this program, this also
applies to a DAP.
Process: One or more actions or operations to harvest, produce, store, handle, distribute, or sell
a product or group of similar products.
Processed Product: Any fishery product or other food product covered under the regulations in
this part which has been preserved by any recognized commercial process, including, but not
limited to, canning, freezing, dehydrating, drying, the addition of chemical substances, or by
fermentation.
Product Form: Products which are similar in appearance, species, and/or processing
method. For example, raw shrimp, cooked shrimp, breaded shrimp, etc.
Quality: Totality of characteristics of an entity that bear on its ability to satisfy stated and
implied needs. The inherent properties of any processed product which determine the relative
degree of excellence of such product, and includes the effects of preparation and processing,
and may or may not include the effects of packing media, or added ingredients.
Record: A document that furnishes objective evidence of activities performed or results
achieved.
Risk: The probability that exposure to a hazard will lead to negative consequences.
Serious Deficiency: A severe deviation from plan requirements such that maintenance of safety,
wholesomeness, and economic integrity is prevented; and, if the situation is allowed to
continue, may result in unsafe, unwholesome, or misbranded product.
Severity: The seriousness of the effect(s) of a hazard or defect.
Specification: A document stating requirements. A detailed document describing the materials,
dimensions, and workmanship requirements of a product.
Systems Audit: On-site USDC SIP evaluation of the firm’s effectiveness in following the plan
after validation.
Validation: The collection and evaluation of scientific and technical information to determine if
the system, when properly implemented, will effectively control the hazards and defects.
Verification: Those activities performed by the firm, other than monitoring that determine the
system continues to be valid and is operating according to the plan.
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44. Wholesome: The minimum basis of acceptability for human food purposes, of any fish or fishery
product as defined in section 402 of the Federal Food, Drug, and Cosmetic Act, as amended.
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Chapter 5 – Application for Services
Firms wishing to receive facility inspection and certification services may apply orally or in writing to any
inspector or officer of the Program at or nearest the place where service is desired or the appropriate
Regional Inspection Branch. If application is made orally, it must be confirmed promptly in writing in the
English language. As part of the application, the requesting party must provide the necessary
information to perform the service, including, but not limited to: the name and address of the facility,
the interest of the applicant, the purpose for which the service is desired, and whether the facility was
inspected or certified by any other official party.
Failure to comply with these procedures may cause the application to be rejected. In addition, the
Program may reject an application due to nonpayment for previous services rendered or if it appears
that to perform the service would not be in the best interest of the U.S. Government. If the application
is rejected, the applicant will be notified promptly of the reasons in writing. An application for such
services may be withdrawn by the applicant at any time before the service is performed, provided that
the applicant shall pay for any reimbursable time spent on the servicing of the application, as well as for
any expenses incurred.
The Regional Inspection Branch will provide the applicant with all necessary materials to inform them of
the program, its requirements, and policies.
NOTE: Firms wishing to have a more in-depth presentation of the Program and its
requirements may request a meeting of all interested parties. This may incur a cost and
should be discussed with the Regional Inspection Branch.

Chapter 6 – Prior to USDC Validation of the System
The firm should begin following their plan as soon as possible. The firm must adhere to the plan’s
provisions and keep all records associated with the tentatively-approved plan for at least five (5), and
not more than thirty (30), consecutive production days. The firm will contact the Regional Inspection
Branch as soon as they believe the plan is functioning successfully and when they have records covering
the minimum number of production days. The Regional Inspection Branch will schedule a site visit with
the firm. The firm must verify through end-product examination that the process controls result in
product which complies with all regulations and applicable quality standards or specifications. If
documentation has not been previously provided, the firm must collect data prior to the site visit which
will be sufficient to demonstrate this relationship. Firms attempting to document this relationship must
collect data on not less than 20 percent of their lots using sampling plans comparable in statistical
confidence to those in 50 CFR Part 260, with at least one lot representing each product form. The
inspection records must be available to USDC personnel upon request. Although not required, USDC
recommends that the firm submit end-item verification records with their QMP Plan. This will allow the
firm to test their controls, provide plan reviewers more information, and possibly reduce the time and
cost of the site visit.
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NOTE: Firms may request the USDC to perform the end item evaluation described above,
which can be done immediately prior to or during the validation of the system.

Chapter 7 – Additional Requirements for IQA and HACCP Quality
Management Program Plan Review and Desk Audit
In addition to the requirements and procedures described thus far, each applicant entering the IQA or
HACCP QMP programs must submit a quality management plan which describes the policies and
procedures the firm will use to ensure product and process quality. Model system templates are
available through the USDC Seafood Inspection Program. At the request of the firm, USDC will provide
consultation toward the development of the IQA or HACCP Quality Management Program plan on a fee
basis.
Plans are submitted to the servicing Regional Inspection Branch for desk review. Reviews of the plan
may require requests for changes, clarifications, deletions, etc., from the firm. The servicing region will
work with the firm to finalize the development of the QMP Plan. A written review is sent to the firm
indicating what changes, if any, are necessary prior to scheduling the site visit. After any identified
changes have been made by the firm the Regional Inspection Branch will issue tentative approval of the
plan and work with the firm to schedule a date to conduct the validation audit. All work of the assigned
CSO and the Regional Inspection Branch is performed on a fee basis at established rates.

Chapter 8 – Initial Assessment and Validation
Once an application has been filed for this service, the Regional Inspection Branch will schedule a site
visit with the firm. Program personnel will evaluate the buildings, premises, facilities, and food safety
management system according to the requirements of the USDC Seafood Inspection Program and shall
determine compliance to these requirements and any corrections that may be required. A full report
will be provided detailing these findings.
The firm must verify through end-product examination that the process controls result in product which
complies with all federal regulations and applicable Program requirements. If documentation has not
been previously provided, the firm must collect data prior to the site visit which will be sufficient to
demonstrate this relationship. This verification may be accomplished utilizing the product inspection
services of the USDC Seafood Inspection Program.
The audit performed on site will determine whether all of the hazards and CCPs (and defects/DAPs for
the IQA and HACCP QMP Program) have been identified, the food safety management and/or quality
management plan is being followed and monitored by the firm, and the identified product hazards
and/or defects and processes are being effectively controlled. The site visit will be conducted on a fee
basis by personnel assigned based upon the demands of the audit. Firms applying for inclusion in either
the IQA or HACCP QMP Programs must have records available covering not less than 5 production days
for all processes and products requested for inclusion. The number and structure of the team will be
determined by the size and complexity of the firm’s process and nature of the hazards associated with
the product and processes to be evaluated. All audits (initial and surveillance) will include conducting
document and record reviews, evaluating sanitation and in-process observations, photographic
evidence, and end-product verification. All reviews will be performed using accepted auditing practices
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based on international recognized audit standards. Conducting a combination of statistical reviews of
records and finished product sample inspections will complete product verifications.
At least one lot for each product form under requested contract will be evaluated by USDC by inspecting
samples of finished product. USDC inspection personnel may sample and audit product in excess of this
guideline if necessary. Firms will be evaluated using the System Compliance Rating Criteria and other
requirements as applicable. Firms deemed acceptable may finalize a contract with the Program. If
during this audit deficiencies are noted that prevent an acceptable rating, the firm may correct these
deficiencies and request the audit team review these corrections prior to departing to determine system
acceptability. For those participating in the IQA or HACCP QMP Programs, a favorable audit will make all
products under review during the audit, including the previous five (5) to thirty (30) days of production
evaluated during the audit, eligible to bear the appropriate official marks or advertising
claim. Otherwise, a successful audit, either with significant deficiencies corrected or on a corrective
action plan, will be necessary prior to completing a contract with the Program.
Note for Vessels: The CSO will accompany the vessel, if determined necessary, for an
appropriate time period, performing the background checks of critical control points and
auditing the plan at the same time. The officer may assist the quality
assurance/management group on board the vessel in any alterations to bring the system
toward approval and a successful audit. Once the work is performed, the officer is taken
off the vessel as soon as is practicable. These procedural accommodations are made in
recognition of possible space restrictions and to reduce the numbers of transfers at
sea. Further, it is expected that such a visit will only be necessary for high risk products,
such as cooked crab product.

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Chapter 9 – Label Review Procedures
All labels bearing an inspection mark or statement must be approved prior to use, in accordance with
requirements and procedures of the USDC Seafood Inspection Program.

Chapter 10 – Changes to the Approved System
After the system has been approved, modifications may be made. The firm must notify the servicing
Regional Inspection Branch, in writing (including faxes or e-mail), of any modifications in their food
safety and/or quality system before implementing the changes. However, any changes to address a
health or safety issue may be made without prior approval, but must be documented in a corrective
action plan. The Regional Inspection Branch must be notified of these immediate changes within one
working day.
As the food safety or quality system outlines the basic foundation and policies of the firm’s program,
changes to the plan must be approved in advance with Program management. However, the specific
work procedures may change as necessary without prior approval, as long as they meet the Program’s
criteria. Prior to signing the contract, it will be determined which of the firm’s documentation requires
pre-approval.
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Chapter 11 – System Audits - Surveillance
Only with a valid contract and continued demonstrated compliance with all applicable laws, regulations,
and policies may 1) the firm be eligible to use official marks or other related statements and 2) firmcollected data be used by USDC personnel towards issuing applicable official certification of the firm’s
products or facility compliance. After the firm’s system is approved, USDC will conduct audits at a
minimum frequency—illustrated in the table below—to determine the firm’s continued adherence to
federal regulations and Program requirements. More frequent audits may be necessary for cause as
determined by the Regional Inspection Branch.
Resident and IQA Systems Audit Target Frequencies
Processors
Retail
Vessels
Once every calendar Once every six
Once every
quarter
months
calendar quarter
IQA firms will have their systems audited at the above frequency as well, but will have their product
quality audited at least once per week, as the workload demands. Firms in the HACCP QMP Program
will be audited at the frequencies illustrated in the tables found in Appendix 1.
Note: Audit frequency for firms operating on a seasonal basis will be determined on a
case-by-case basis using the guidance of the frequency listed in the chart above and the
tables in Appendix 1. With regard to seasonal contracts, the firm must request in writing,
to the servicing Regional Inspection Branch, to both suspend and reactivate the contract.
Firms that receive five (5) serious deficiencies or one (1) critical deficiency at the conclusion of an audit
are deemed unreliable and will be addressed using the tightened audit procedures described below.
In addition, the policies and procedures for each class of operation described below will be followed.
a. Vessels
Firms must provide the appropriate Regional Inspection Branch with their tentative season
schedules and off-loading schedules and sites as soon as they are known. Firms must give the
Regional Inspection Branch Office or the designated USDC Consumer Safety Officer notice prior
to each port arrival, providing sufficient time for the Officer to audit the vessel when required.
Failure to do so could result in the removal of the vessel from the Program.
A site visit of the vessel will be conducted at least once per year. The visit may not require the auditor
to be on board during fishing, but may require the auditor to be present during off-loading. The other
audits may be performed either by desk audit or during evaluation of stored product in the off season as
applicable. If the vessel receives an unreliable rating, it will be audited on a tightened level (as
necessary) until the firm is back under compliance.
b. Processing Establishments
USDC personnel will conduct unannounced Systems Audits to determine the firm’s continued
adherence to their plan. International facilities will be scheduled for site visits at a minimum of
twice during the year. The remaining audits may be performed by desk audit review of
documentation and records.

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Processors which desire product certification for lots produced under their operation must either have
an approved IQA or HACCP QMP system, have the lots inspected by USDC for conformance during
production, or USDC will inspect the product after it is produced using lot inspection services.
c. Retail and Food Service Establishments
USDC personnel will conduct unannounced Systems Audits to determine the firm’s continued
adherence to their plan.

Chapter 12 – Tightened Audit Procedures
A firm at the tightened audit frequency has demonstrated difficulties in administering their food safety
and/or quality management plan and was therefore rated by the USDC Seafood Inspection Program as
unreliable. If a Consumer Safety Officer rates a facility unreliable, he/she will rate the facility and
immediately contact his/her Supervisor. The decision to rate a facility unreliable will be made prior to
the Consumer Safety Officer performing the exit interview. Facilities which are rated unreliable have a
period of thirty days to take the necessary corrective actions to have the unreliable status
removed. Failure to do so will result in the facility’s removal from the approved list or the IQA or HACCP
QMP Program. A firm in the IQA or HACCP QMP Program which is deemed unreliable may continue to
use the mark or other applicable advertising privileges if consent is given by USDC for daily auditing of
the firm. Consent will be on a case by case basis and granted only if USDC believes the nature of the
condition which caused the firm to become unreliable can be adequately addressed through daily
auditing. Daily auditing will be acceptable to the Program under the following conditions:
a. The firm must submit a corrective action plan to the Consumer Safety Officer (auditor) detailing
how they will correct the problem.
b. The Consumer Safety Officer will review the corrective actions identified by the firm and will
approve or disapprove them and notify his/her Supervisor. Daily auditing will continue until the
issue is corrected, or up to a maximum of thirty calendar days.
c. Products may be certified during daily auditing. However, if any condition(s) exist(s) that is
considered critical, no product certification will occur until the condition is corrected to the
satisfaction of the USDC.
d. At the auditor’s discretion, product compliance will be verified by end-item evaluation. No
products covered by the contract will leave the firm without USDC approval.
e. Firms participating in the IQA or HACCP QMP programs deemed unreliable twice in a twelve
month period will be removed from the respective program. Firms who have been removed
may submit a request for reapplication after a period of three calendar months. Application will
be accepted by USDC only if evidence of a change in management philosophy can be
provided. Firms which have been removed from such programs may still be eligible to enter
into full-time auditing of the facility, system, and product.
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Chapter 13 – Corrective Action Plans
When applicable, the firm must submit a corrective action plan to the Consumer Safety Officer detailing
how they will correct the problem. The corrective action plan must include, at a minimum, detailed
descriptions of the following:
1. A statement of the problem;
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2.
3.
4.
5.

Identification of the person or persons responsible for addressing the situation;
The methods to be used to correct the problem;
A schedule which details the time frame to correct the problem; and
A statement with signatures of top management attesting to their commitment to correct the
deficiency, the corrective action plan must be written in sufficient detail to provide USDC with
all necessary information for its approval or disapproval.

Chapter 14 – Appeal Procedures
If a firm wishes to appeal an unreliable rating, they are to contact, in writing, the servicing Region
Inspection Branch Chief. The facility must provide, in writing, 1) all pertinent information as to why it is
believed the rating was determined in error and 2) the actions the firm has taken at that facility to
address the perceived deficiency(ies) and ensure that the facility, processes, and products will meet
applicable requirements. Once the Region Chief receives all information, he/she will investigate the
matter and consult with, and gain approval of, the Chief Quality Officer at headquarters. The final
determination will be communicated to the facility as soon as possible, followed by a written report.

Chapter 15 – Analytical Testing and Product Verificaiton
The firm must perform periodic end-item verification of product compliance to program
requirements. Both the firm and USDC must agree upon the firm’s frequencies and end-item
requirements; however samples for analytical testing must be collected and tested at least once per
year as part of their verification procedures. The level of analytical sampling per lot must be statistically
sufficient to draw a proper conclusion and agreed upon by the USDC Seafood Inspection
Program. Records of all analytical findings will be made available to USDC personnel during Systems
Audits and at other times as necessary. As part of the system evaluation, USDC will have product tested
analytically throughout the year as described in the Surveillance Sampling Program.
To determine whether the product produced at the firm meets specification and/or requirements, USDC
will routinely perform a product audit on up to three (3) lots produced by the firm since the last Systems
Audit. This information will be used to guide the auditor in his/her audit of the system. Product audits
will be completed by conducting records reviews and finished product sample inspections. Additional
lots may be sampled if the situation warrants. Lots must be defined by the firm and the definition
agreed upon by the USDC Seafood Inspection Program.

Chapter 16 – Use of Marks
Participating firms are responsible for using the marks in accordance with the regulations set forth in 50
CFR Part 260 and the Policy and Guidelines for Advertising and Marking Products Inspected by the U.S.
Department of Commerce. Firms may be issued official stamping devices to aid in affixing marks on
cases or product if they meet program requirements. Facilities who have received official stamping
devices must have written procedures in place to ensure security of the devices and protection from
misuse.

Chapter 17 – Advertising Participants
Firms who are successfully participating in the Approved Facility Program will be listed in the USDC
Participants List for Firms, Facilities, and Products as an approved facility. The list will include the firm’s
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name, all pertinent locations, and approved processes. This list is updated regularly on the Program’s
website and printed in hard copy twice per year. These firms may advertise their participation in the
Program as long as all advertisement claims are truthful and not misleading as to product
certification. Advertisement forms may include flyers, banners, print media, other media, and
statements on product. To make certain advertisements meet all regulations and Program
requirements, it is strongly advised that participant claims be approved by the USDC Seafood Inspection
Program prior to use.

Chapter 18 – System Compliance Rating Criteria
a. 1.0 Management Controls and Responsibilities
The elements of this section apply to all participants in the USDC Seafood Inspection Program in the
evaluation of facilities, processes and systems.
1.1.0 Management Responsibilities
1.1.1 Management commitment not properly implemented or communicated.
Top management shall provide evidence of its commitment to the development and implementation of
the food safety management system and to continually improving its effectiveness by: a) showing food
safety is supported by the business objectives of the organization, b) communicating to the organization
the importance of meeting food safety standards, statutory and regulatory requirements, as well as
customer requirements relating to food safety, c) establishing a food safety policy, d) conducting
management reviews, and e) ensuring the availability of resources.
Deficiency: Critical
1.1.2 Food safety policy not prepared or properly implemented.
Top management shall define, document and communicate its food safety policy. Top management
shall ensure that the food safety policy a) is appropriate to the role of the organization in the food chain,
b) conforms with both statutory and regulatory requirements and with mutually agreed food safety
requirements of customers, c) is communicated, implemented, and maintained at all levels of the
organization, d) is reviewed for continued suitability, e) adequately addresses communication, and f) is
supported by measurable objectives.
Deficiency: Serious
1.1.3 Food safety management system planning not properly performed.
Top management shall ensure that a) planning of the food safety management system is properly
carried out to meet all applicable requirements, and b) the integrity of the food safety management
system is maintained when changes to the food safety management system are planned and
implemented.
Deficiency: Serious
1.1.4 Responsibility and authority not properly defined or communicated.
Top management shall ensure that responsibilities and authorities are defined and communicated
within the organization to ensure the effective operation and maintenance of the food safety
management system. All personnel shall have responsibility to report problems with the food safety
management system to identified person(s). Designated personnel shall have defined responsibility and
authority to initiate and record actions
Deficiency: Serious
1.2.0 Food Safety Team
1.2.1 Food safety team leader not appointed.
Top management shall appoint a food safety team leader who, irrespective of other duties, shall have
12

the responsibility and authority to: a) manage a food safety team and organize its work, b) ensure
relative training and education of the team members, and c) ensure that the food safety management
system is established, implemented, maintained and updated.
Deficiency: Serious
1.2.2 Food safety team leader does not report to top management.
The food safety team leader must report to the organization’s top management and will inform them on
the effectiveness and suitability of the food safety management system.
Deficiency: Major
1.2.3 Food safety team is not interdisciplinary as applicable.
The food safety team shall have a combination of multi-disciplinary knowledge and experience in
developing and implementing the food safety management system. This includes, but need not be
limited to, the organization’s products, processes, equipment and food safety hazards within the scope
of the food safety management system. Records shall be maintained that demonstrate that the food
safety team has the required knowledge and experience.
Deficiency: Major
1.3.0 Communication
1.3.1 Effective external communication not established, implemented, or maintained.
To ensure that sufficient information on issues concerning food safety is available throughout the food
chain, the organization shall establish, implement, and maintain effective arrangements for
communicating with: a) suppliers and contractors, b) customers or consumers, in particular in relation to
product information (including instructions regarding intended use, specific storage requirements, and
as appropriate, shelf life), enquiries, contracts or order handling including amendments, and customer
feedback including customer complaints, c) statutory and regulatory authorities, and d) other
organizations that have an impact on or will be affected by the effectiveness or updating of the food
safety system.
The communication shall provide information on food safety aspects of the organization’s products that
may be relevant to other organizations in the food chain. This applies especially to known food safety
hazards that need to be controlled by other organizations in the food chain. Records of communications
shall be maintained. Food safety requirements from statutory and regulatory authorities and customers
shall be available. Designated personnel shall have defined responsibility and authority to communicate
information concerning food safety externally. Information obtained through external communication
shall be included as input to all system updating and management reviews.
Deficiency: Serious
1.3.2 Effective internal communication not established, implemented, or maintained.
The organization shall establish, implement, and maintain effective arrangements for communicating
with personnel on issues having an impact on food safety. In order to maintain the effectiveness of the
food safety management system, the organization shall ensure that the food safety team is informed in
a timely manner of changes, including but not limited to the following: a) products or new products, b)
raw materials, ingredients and services, c) production systems and equipment, d) production premises,
location of equipment, surrounding environment, e) cleaning and sanitation programs, f) packaging,
storage, and distribution systems, g) personnel qualification level and/or allocation of responsibilities
and authorizations, h) statutory and regulatory requirements, i) knowledge regarding food safety
hazards and control measures, j) customer, sector, and other requirements which the organization
observes, k) relevant enquiries from external interested parties, l) complaints indicating food safety
hazards associated with the product, and m) other conditions which have an impact on food safety.

13

The food safety team shall ensure that this information is included in the updating of the food safety
management system. Top management shall ensure that relevant information is included as input to
management review.
Deficiency: Serious
1.4.0 Emergency Preparedness and Response
1.4.1 Emergency response procedures not established, implemented or maintained.
Top management shall establish, implement and maintain procedures to manage potential emergency
situations and accidents that can impact food safety relevant to the role of the organization in the food
chain.
Deficiency: Critical
1.5.0 Management Review
1.5.1 Management review not properly performed or documented.
Top management shall review the organization’s food safety management system at planned intervals
to ensure its continuing suitability, adequacy, and effectiveness. This review shall include assessing
opportunities for improvement and the need for change to the system, including the food safety and
quality policy. Records from management reviews shall be maintained.
The input to management review shall include, but is not limited to information on: a) follow-up actions
from previous management reviews, b) analysis of results of verification activities, c) changing
circumstances that can affect food safety or quality, d) emergency situations, accidents, and
withdrawals, e) reviewing results of system updating activities, f) review of communication activities
including customer feed-back, and g) external audits or inspections. The data shall be presented in a
manner that enables top management to relate the information to stated objectives of the food safety
and quality management system.
The output from the management review shall include decisions and actions related to: a) assurance of
food safety, b) improvement of the effectiveness of the food safety management system, c) resource
needs, and d) revisions of the organization’s food safety policy and objectives.
Deficiency: Serious
1.6.0 Resource Management
The organization shall provide adequate resources for the establishment, implementation, maintenance
and updating of the food safety management system.
1.6.1 Necessary human resource competencies not identified.
The food safety team and the other personnel carrying out activities having an impact on food safety
shall be competent and shall have appropriate education, training skills and experience. Where the
assistance of external experts is required for the development, implementation, operation, or
assessment of the food safety management system, records of agreement or contracts defining the
responsibility and authority of external experts shall be available.
Deficiency: Serious
1.6.2 Personnel have not received documented training necessary for the proper function of the food
system.
The organization shall: a) identify the necessary competencies for personnel whose activities have an
impact on food safety, b) provide training or take other action to ensure personnel have the necessary
competencies, c) ensure that personnel responsible for monitoring, corrections, and corrective actions
of the management system are trained, d) evaluate the implementation and the effectiveness of a), b),
and c), e) ensure that the personnel are aware of the relevance and importance of their individual
activities in contributing to food safety, f) ensure that the requirement for effective communication is
14

understood by all personnel whose activities have an impact on food safety, and g) maintain appropriate
records of training and action s described above.
Training must include the areas of HACCP, good manufacturing practices, and allergens to appropriate
personnel. Each firm must have available a person who has met the training requirement by NOAA for
this program. The training requirement 1) fulfills the 21 CFR part 123.10 training requirement and, 2)
personnel must pass the NOAA HACCP Exam with an 80% or better. In addition, copies of all trained
personnel’s certificates must on file with the firm. Per 21 CFR part 123, these duties are assigned only to
properly trained personnel. However, failure of this element will not likely cause an immediate hazard
or defect. Therefore it is rated as a Serious deficiency. Per 21 CFR part 123, these duties are assigned to
only properly trained personnel. Failure of this element could lead to an immediate hazard or defect.
At a minimum, the following functions shall be performed by an individual who has successfully
completed training in the application of HACCP principles to fish and fishery product processing at least
equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food and
Drug Administration or who is otherwise qualified through job experience to perform these
functions. Job experience will qualify an individual to perform these functions if it has provided
knowledge at least equivalent to that provided through the standardized curriculum.
•

•

•

Developing a HACCP plan, which could include adapting a model or generic-type HACCP
plan, that is appropriate for a specific processor, in order to meet the requirements of
Sec. 123.6(b);
Reassessing and modifying the HACCP plan in accordance with the corrective action
procedures specified in Sec. 123.7(c)(5), the HACCP plan in accordance with the
verification activities specified in Sec. 123.8(a)(1), and the hazard analysis in accordance
with the verification activities specified in Sec. 123.8(c); and
Performing the record review required by Sec. 123.8(a) (3). The trained individual need
not be an employee of the processor.

Deficiency: Serious/Critical
1.6.3 Insufficient infrastructure to implement and maintain the food safety system.
The organization shall provide the resources for the establishment and maintenance of the
infrastructure needed to implement a proper food safety system.
Deficiency: Serious
1.6.4 Work environment is not properly established, managed, or maintained relative to food safety.
The organization shall provide the resources for the establishment, management, and maintenance of
the work environment needed to implement a proper food safety management system.
Deficiency: Serious
1.7.0 Continual Improvement
1.7.1 Continuous improvement activities not performed.
Top management shall ensure that the organization continually improves the effectiveness of the food
safety management system through the use of communication, management review, internal audit,
evaluation of individual verification results, analysis of results of verification activities, validation of
control measure combinations, and corrective actions.
Deficiency: Serious
b. 2.0 Food Safety
The elements of this section apply to all participants in the USDC Seafood Inspection Program in the
evaluation of facilities, processes and systems.
15

The organization shall plan and develop the processes needed for the realization of safe products. The
organization shall implement, operate, and ensure the effectiveness of the planned activities and any
changes to those activities. This includes pre-requisite programs as well as the HACCP plan.
2.1.0 Operational Prerequisite Programs
2.1.1 Operational prerequisite programs not present or not effective.
Each processor shall have and implement a written operational prerequisite procedures or similar
document that is specific to each location where fish and fishery products are produced. The
operational prerequisite programs shall be documented and shall include the following information for
each program: a) food safety hazard(s) to be controlled by the program, b) control measure(s), c)
monitoring procedures that demonstrate that the prerequisite programs are implemented; d)
corrections and corrective actions to be taken if monitoring shows that the operational prerequisite
programs are not in control; e) responsibilities and authorities; f) record(s) of monitoring.
Deficiency: Serious
2.1.2 Operational prerequisite procedures not followed.
This deficiency will be assessed if it is determined that the firm did not follow their written procedures,
whether or not specific s deficiencies were observed.
Deficiency: Serious
2.2.0 Hazard Analysis
2.2.1 Description of products, processes or control measures not properly performed.
All relevant information needed to conduct the hazard analysis shall be collected, maintained, updated
and documented. Records shall be maintained.
All raw materials, ingredients and product-contact materials shall be described in documents to the
extent needed to conduct the hazard analysis, including the following, as appropriate: a) biological,
chemical, and physical characteristics; b) composition of formulated ingredients, including additives and
processing aids; c) origin; d) method of production; e) packaging and delivery methods; f) storage
conditions and shelf life; g) preparation and/or handling before use or processing; h) food safety-related
acceptance criteria or specifications of purchased materials and ingredients appropriate to their
intended uses. The organization shall identify statutory and regulatory food safety requirements related
to the above.
The characteristics of end products shall be described in documents to the extent needed to conduct the
hazard analysis, including information on the following, as appropriate: a) product name or similar
identification; b) composition; c) biological, chemical and physical characteristics relevant for food
safety; d) intended shelf life and storage conditions; e) packaging; f) labeling relating to food safety
and/or instructions for handling, preparation and usage; g) method(s) of distribution. The organization
shall identify statutory and regulatory food safety requirements related to the above.
The intended use, the reasonably expected handling of the end product, and any unintended but
reasonably expected mishandling and misuse of the end product shall be considered and shall be
described in documents to the extent needed to conduct the hazard analysis. Groups of users and,
where appropriate, groups of consumers shall be identified for each product, and consumer groups
known to be especially vulnerable to specific food safety hazards shall be considered.
Flow diagrams shall be prepared for the products or process categories covered by the food safety
management system. Flow diagrams shall provide a basis for evaluating the possible occurrence,
increase or introduction of food safety hazards. Flow diagrams shall be clear, accurate and sufficiently
detailed. Flow diagrams shall, as appropriate, include the following: a) the sequence and interaction of
all steps in the operation; b) any outsourced processes and subcontracted work; c) where raw materials,
ingredients and intermediate products enter the flow; d) where reworking and recycling take place; e)
16

where end products, intermediate products, by-products and waste are released or removed. The food
safety team shall verify the accuracy of the flow diagrams by on-site checking. Verified flow diagrams
shall be maintained as records.
All information described above shall be updated as necessary.
Deficiency: Major
2.2.2 Hazard analysis not properly performed.
The food safety team shall conduct a hazard analysis to determine which hazards need to be controlled,
the degree of control required to ensure food safety, and which combination of control measures is
required. A food safety hazard that is reasonably likely to occur is one for which a prudent processor
would establish controls because experience, illness data, scientific reports, or other information
provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type
of fish or fishery product being processed in the absence of those controls.
All food safety hazards that are reasonably expected to occur in relation to the type of product, type of
process and actual processing facilities shall be identified and recorded. Such hazard analysis must also
consider any products, including ingredients or additives, that may contain allergens as a significant
hazard. Allergen assessment must also consider unintentional inclusion of an allergenic ingredient or
additive. (21CFR123.6a)
The identification shall be based on a) the preliminary information and data collected according to the
previous section, b) experience, c) external information including, to the extent possible,
epidemiological and other historical data, and d) information from the food chain on food safety hazards
that may be of relevance for the safety of the end products, intermediate products and the food at
consumption. The step(s) (from raw materials, processing and distribution) at which each food safety
hazard may be introduced shall be indicated.
When identifying the hazards, consideration shall be given to a) the steps preceding and following the
specified operation, b) the process equipment, utilities/services and surroundings, and c) the preceding
and following links in the food chain.
For each of the food safety hazards identified, the acceptable level of the food safety hazard in the end
product shall be determined whenever possible. The determined level shall take into account
established statutory and regulatory requirements, customer food safety requirements, the intended
use by the customer and other relevant data. The justification for, and the result of, the determination
shall be recorded.
A hazard assessment shall be conducted to determine, for each food safety hazard identified, whether
its elimination or reduction to acceptable levels is essential to the production of a safe food, and
whether its control is needed to enable the defined acceptable levels to be met. Each food safety
hazard shall be evaluated according to the possible severity of adverse health effects and the likelihood
of their occurrence. The methodology used shall be described, and the results of the food safety hazard
assessment shall be recorded.
Based on the hazard assessment, an appropriate combination of control measures shall be selected
which is capable of preventing, eliminating or reducing these food safety hazards to defined acceptable
levels. In this selection, each of the control measures as determined shall be reviewed with respect to
its effectiveness against the identified food safety hazards. The control measures selected shall be
categorized as to whether they need to be managed through operational prerequisite programs or by
the HACCP plan.

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The existing control measures, process parameters and/or the rigorousness with which they are applied,
or procedures that may influence food safety, shall be described to the extent needed to conduct the
hazard analysis. External requirements (e.g., from regulatory authorities or customers) that may impact
the choice and the rigorousness of the control measures shall also be described.
The selection and categorization shall be carried out using a logical approach that includes assessments
with regard to the following: a) its effect on identified food safety hazards relative to the strictness
applied; b) its feasibility for monitoring (e.g., ability to be monitored in a timely manner to enable
immediate corrections); c) its place within the system relative to other control measures; d) the
likelihood of failure in the functioning of a control measure or significant processing variability; e) the
severity of the consequence(s) in the case of failure in its functioning; f) whether the control measure is
specifically established and applied to eliminate or significantly reduce the level of hazard(s); g)
synergistic effects (i.e., interaction that occurs between two or more measures resulting in their
combined effect being higher than the sum of their individual effects).
Control measure categorized as belonging to the HACCP plan shall be implemented as such. The
methodology and parameters used for this categorization shall be described in documents, and the
results of the assessment shall be recorded.
Deficiency: Serious/Critical
2.2.3 Hazard analysis not available.
The hazard and defect analysis is the foundation of the HACCP plan. If the analysis is not performed, the
entire plan and its efficacy is suspect. Firms must provide this analysis to the requesting Consumer
Safety Officer in writing. If it is not provided and evidence suggests that it was performed but a written
document is not available, a Serious deficiency will be assessed. Otherwise, a Critical deficiency will be
assessed.
Deficiency: Serious/Critical
2.3.0 HACCP Plan
2.3.1 No written HACCP plan when one is required.
Every processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one
or more food safety hazards that are reasonably likely to occur. (21CFR123.6b)Firms must provide this
plan to the requesting Consumer Safety Officer.
Deficiency: Serious
2.3.2 Plan is not location and/or fish species specific.
A HACCP plan shall be specific to:
1. Each location where fish and fishery products are processed by that processor; and
2. Each kind of fish and fishery product processed by the processor. The plan may group
kinds of fish and fishery products together, or group kinds of production methods
together, if the food safety hazards, critical control points, critical limits, and procedures
required to be identified and performed are identical for all fish and fishery products so
grouped or for all production methods so grouped.
Deficiency: Major
2.3.3 Hazard(s) is not listed in the plan.
The HACCP plan shall, at a minimum list the food safety hazards that are reasonably likely to occur and
that thus must be controlled for each fish and fishery product. Consideration should be given to
whether any food safety hazards are reasonably likely to occur as a result of the following:
18

1.
2.
3.
4.
5.
6.

Natural toxins;
Microbiological contamination;
Chemical contamination;
Pesticides;
Drug residues;
Decomposition in scombroid toxin-forming species or in any other species where a food
safety hazard has been associated with decomposition;
7. Parasites, where the processor has knowledge or has reason to know that the parasitecontaining fish or fishery product will be consumed without a process sufficient to kill
the parasites, or where the processor represents, labels, or intends for the product to be
so consumed;
8. Unapproved use of direct or indirect food or color additives or allergens; and
9. Physical hazards
In the event that one or more hazards are not identified, a deficiency will be assessed.
Deficiency: Serious
2.3.4 Hazard(s) is not controlled.
Firms may not have met the requirements of performing the hazard analysis or writing a required
HACCP plan. However, controls may still be in place for the hazards identified by the Consumer Safety
Officer. If it is determined that the controls are not in place, a Critical deficiency will be assessed.
Deficiency: Critical
2.3.5 CCPs are not properly identified in the plan.
The HACCP plan shall, at a minimum list the critical control points for each of the identified food safety
hazards, including as appropriate:
1. Critical control points designed to control food safety hazards that could be introduced
in the processing plant environment; and
2. Critical control points designed to control food safety hazards introduced outside the
processing plant environment, including food safety hazards that occur before, during,
and after harvest. (21CFR123.6c.2)
Deficiency: Serious
2.3.6 Appropriate critical limit(s) is not listed in the plan.
Critical limits shall be determined for the monitoring established for each critical control point. Critical
limits shall be established to ensure that the identified acceptable level of the food safety hazard in the
end product is not exceeded. Critical limits shall be measurable. The rationale for the chosen critical
limits shall be documented. Critical limits that are evaluated by observation (e.g., visually or by sensory
evaluation) shall be supported by instructions or specifications and/or education and training. If
evidence is present that the critical limits were improperly identified but those identified were followed,
the deficiency will be assessed here. (21CFR123.6c.3)
Deficiency: Serious
2.3.7 Critical limits not followed.
Self-explanatory.
Deficiency: Critical
2.3.8 Monitoring procedure stated in the plan is inadequate.
Monitoring procedures shall be established for each critical limit. (21CFR123.6c.4) The results of
monitoring will indicate whether the CCP is in or out of control. The system shall include all scheduled
19

measurements or observations relative to the critical limit(s). The monitoring system shall consist of
relevant procedures, instructions and records that cover the following: a) measurements or
observations that provide results within an adequate time frame; b) monitoring devices used; c)
applicable calibration methods; d) monitoring frequency; e) responsibility and authority related to
monitoring and evaluation of monitoring results; f) record requirements and methods. The monitoring
methods and frequency shall be capable of determining when the critical limits have been exceeded in
time for the product to be isolated before it is used or consumed. Where allergen controls are not
sufficient or proper or identified allergens are not declared on product labels where appropriate, a
critical deficiency will be assessed.
Deficiency:
Serious/Critical
2.3.9 Monitoring procedures not followed:
Monitoring procedures must be followed to maintain control of the process. If any monitoring
procedure has not been followed the firm is not in compliance with this item
Deficiency:
Serious
2.3.10 Corrective action listed in plan is not appropriate or adequate.
Planned corrections and corrective actions to be taken when critical limits are exceeded shall be
specified in the HACCP plan. The actions shall ensure that the cause of nonconformity is identified, that
the parameter(s) controlled at the CCP is (are) brought back under control, and that recurrence is
prevented. Documented procedures shall be established and maintained for the appropriate handling
of potentially unsafe products to ensure that they are not released until they have been evaluated and
the cause of the deviation is corrected (e.g., not injurious to health or adulterated).
A corrective action plan that is appropriate for a particular deviation is one that describes the steps to
be taken and assigns responsibility for taking those steps, to ensure that:
1. No product enters commerce that is either injurious to health, is otherwise adulterated
as a result of the deviation, or does not meet Program requirements; and
2. The cause of the deviation is corrected. (21CFR123.7)
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Deficiency: Serious
2.3.11 Corrective action not taken
Whenever a deviation from a critical limit, sanitation, monitoring or verification procedures occurs, a
processor shall take corrective action. Processors shall develop written corrective action plans, which
become part of their plans by which they predetermine the corrective actions that they will take
whenever there is a deviation from a critical limit.
A firm is provided room for error in their plan through a system of corrective actions. If an error or
problem arises in the conduct of the food safety management plan, the firm must file a corrective action
report. All other deficiencies may possibly be averted in this checklist if corrective action reports are
filed for each problem or situation. Failure to file a corrective action report will be considered a failure
to take a corrective action and the firm will then not be in compliance with this item.
When a deviation from the plan occurs and the processor does not have a corrective action plan that is
appropriate for that deviation, the processor shall:
1. Segregate and hold the affected product.
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2. Perform or obtain a review to determine the acceptability of the affected product for
distribution. The review shall be performed by an individual or individuals who have
adequate training or experience to perform such a review.
3. Take corrective action, when necessary, with respect to the affected product to ensure
that no product enters commerce that is either injurious to health or is otherwise
adulterated as a result of the deviation or does not meet other program requirements;
4. Take corrective action, when necessary, to correct the cause of the deviation;
5. Perform or obtain timely reassessment of the system by an individual or individuals who
have been properly trained to do so, to determine whether the plan needs to be
modified to reduce the risk of recurrence of the deviation, and modify the plan as
necessary.
In addition, the organization shall assess the validity of the previous measurement results when the
equipment or process is found not to conform to requirements. If the measuring equipment is
nonconforming, the organization shall take action appropriate for the equipment and any product
affected. Records of such assessment and resulting action shall be maintained.
Deficiency: Critical
2.3.12 Verification procedure stated in plan is inadequate.
The HACCP plan shall list the verification procedures, and frequency thereof, that the processor will
use. Every processor shall verify that the HACCP plan is adequate to control food safety hazards that are
reasonably likely to occur, and that the plan is being effectively implemented.
Verification shall include, at a minimum:
1. Reassessment of the food safety management system. A reassessment of the adequacy
of the plan whenever any changes occur that could affect the hazard analysis or alter
the plan in any way or at least annually. (21CFR123.8a.1) Such changes may include
changes in the following: Raw materials or source of raw materials, product formulation,
processing methods or systems, finished product distribution systems, or the intended
use or consumers of the finished product. The reassessment shall be performed by an
individual or individuals who have been trained in accordance with Sec. 123.10 of 21
CFR Part 123.
The system shall be modified immediately whenever a reassessment reveals that the plan is no longer
adequate to fully meet the requirements.
2. Ongoing verification activities. Ongoing verification activities including:
• A review of any consumer complaints that have been received by the processor
to determine whether they relate to the performance of critical control points
or reveal the existence of unidentified critical control points;
• The calibration of process-monitoring instruments; and,
• At the option of the processor, the performing of periodic end-product or inprocess testing. (Note: Some end item testing is required as part of the HACCP
QMP system. See Program requirements.) (21CFR123.8a.2)
3. Records review. (21CFR123.8a.3) A review, including signing and dating, by an individual
who has been trained in accordance with Sec. 123.10, of the records that document:
• The monitoring of critical control points. The purpose of this review shall be, at
a minimum, to ensure that the records are complete and to verify that they
21

document values that are within the critical limits. This review shall occur
within 1 week of the day that the records are made;
• The taking of corrective actions. The purpose of this review shall be, at a
minimum, to ensure that the records are complete and to verify that
appropriate corrective actions were taken in accordance with Sec. 123.7. This
review shall occur within 1 week of the day that the records are made; and
• The calibrating of any process control instruments used at critical control points
and the performing of any periodic end-product or in-process testing that is part
of the processor's verification activities. The purpose of these reviews shall be,
at a minimum, to ensure that the records are complete, and that these activities
occurred in accordance with the processor's written procedures. These reviews
shall occur within 1 week of the day that the records are made.
4. Processors shall immediately follow corrective action procedures whenever any
verification procedure, including the review of a consumer complaint, reveals the need
to take a corrective action. (21CFR123.8b)(See Corrective Action sections listed above.)
5. Reassessment of the hazard analysis. (21CFR123.8c) Whenever a processor does not
have a HACCP plan because a hazard analysis has revealed no food safety hazards that
are reasonably likely to occur, the processor shall reassess the adequacy of that hazard
analysis whenever there are any changes that could reasonably affect whether a food
safety hazard now exists. Such changes may include, but are not limited to changes in:
Raw materials or source of raw materials, product formulation, processing methods or
systems, finished product distribution systems, or the intended use or consumers of the
finished product. The reassessment shall be performed by an individual or individuals
who have been properly trained in accordance with 21 CFR 123.10. (See 1.6.2)
6. Recordkeeping. (21CFR123.8d) All verification activities, including the calibration of
process-monitoring instruments and the performing of any periodic end-product and inprocess testing, shall be documented and recorded and is subject to the recordkeeping
requirements listed below. The organization shall provide evidence that the specified
monitoring and measuring methods and equipment are adequate to ensure the
performance of the monitoring and measuring procedures. Where necessary to ensure
valid results, the measuring equipment and methods used a) shall be calibrated or
verified at specified intervals, or prior to use, against measurement standards traceable
to international or national measurement standards, where no such standards exist, the
basis used for calibration or verification shall be recorded, b) shall be adjusted or readjusted as necessary, c) shall be identified to enable the calibration status to be
determined, d) shall be safeguarded from adjustments that would invalidate the
measurements results, and e) shall be protected from damage and deterioration. When
used in the monitoring and measurement of specified requirements, the ability of
computer software to satisfy the intended application shall be confirmed. This shall be
undertaken prior to initial use and shall be reconfirmed as necessary.
The output of this activity shall be in a form suitable for the organization’s method of
operations. Verification results shall be recorded and shall be communicated to the food safety
team. Verification results shall be provided to enable the analysis of the results of the verification
activities. If system verification is based on testing of end product samples, and where such test
samples show nonconformity with the acceptable level of the food safety hazard, the affected lots of
product shall be handled as potentially unsafe.
The organization shall conduct internal audits at planned intervals to determine whether the food safety
management system a) conforms to the planned arrangements, to the food safety management system
22

requirements established by the organization, and b) is effectively implemented and updated. An audit
program shall be planned, taking into consideration the importance of the processes and areas to be
audited, as well as any actions resulting from previous audits. The audit criteria, scope, frequency and
methods shall be defined and documented. Selection of auditors and the conduct of audits shall ensure
the objectivity and impartiality of the audit process. Auditors shall not audit their own work. The
management responsible for the area being audited shall ensure that actions are taken without undue
delay to eliminate nonconformities and their causes.
The food safety team shall systematically evaluate the individual results of planned verification. If
verification does not demonstrate conformity with the planned arrangements, the organization shall
take action to achieve the required conformity. The food safety team shall analyze the results of
verification activities, including the results of the internal and external audits. The results of the
analyses and the resulting activities shall be recorded and shall be reported, in an appropriate manner,
to top management as input to the management review.
The monitoring system shall consist of relevant procedures, instructions and records that cover the
following: a) measurements or observations that provide results within an adequate time frame; b)
monitoring devices used; c) applicable calibration methods; d) monitoring frequency; e) responsibility
and authority related to monitoring and evaluation of monitoring results; f) record requirements and
methods.
Deficiency: Serious
2.3.13 Verification procedures not followed.
Verification procedures are those that provide for management to determine the overall effectiveness
of the plan. Not following these procedures could ultimately cause the plan to fail or misidentify a
hazard, defect, or control procedure. Since failure of these procedures will likely not immediately cause
the plan to fail, it is rated at a Serious level. This item should be checked on a trend basis, not based on
isolated incidences unless they are of such severity to warrant action. Firms must reassess their hazard
analyses when information or other evidence indicates the need and at least yearly. The plan must be
signed and dated by a management official responsible for the operation of the facility. The plan must
be signed upon implementation and at least once each year.
Deficiency: Serious
2.4.0 Control of Nonconformity
2.4.1 Traceability system inadequate.
The organization shall establish and apply a traceability system that enables the identification of product
lots and their relation to batches of raw materials, processing and delivery records. The traceability
system shall be able to identify incoming material from the immediate suppliers and the initial
distribution route of the end product. Traceability records shall be maintained for a defined period for
system assessment to enable the handling of potentially unsafe products and in the event of product
withdrawal. Records shall be in accordance with statutory and regulatory requirements (including those
for firm registration and traceability relative to the Bioterrorism Act) and customer requirements and
may, for example, be based on the end product lot identification.
Deficiency: Serious
2.4.2 Improper handling of potentially unsafe products
The organization shall handle nonconforming products by taking action(s) to prevent the nonconforming
product from entering the food chain unless it is possible to ensure that a) the food safety hazard(s) of
concern has(ve) been reduced to the defined acceptable levels, b) the food safety hazard(s) of concern
will be reduced to identified acceptable levels prior to entering the food chain, or c) the product still
meets the defined acceptable level(s) of the food safety hazard(s) of concern despite the nonconformity.
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All lots of product that may have been affected by a nonconforming situation shall be held under control
of the organization until they have been evaluated. If products that have left the control of the
organization are subsequently determined to be unsafe, the organization shall notify relevant interested
parties and initiate a withdrawal or recall. The controls and related responses and authorization for
dealing with potentially unsafe products shall be documented.
Each lot of product affected by the nonconformity shall only be released as safe when any of the
following conditions apply: a) evidence other than the monitoring system demonstrates that the control
measure have been effective; b) evidence shows that the combined effect of the control measures for
that particular product complies with the performance intended; c) the results of sampling, analysis
and/or other verification activities demonstrate that the affected lot of product complies with the
identified acceptable levels for the food safety hazard(s) concerned.
Following evaluation, if the lot of product is not acceptable for release it shall be handled by one of the
following activities: a) reprocessing or further processing within or outside the organization to ensure
that the food safety hazard is eliminated or reduced to acceptable levels; b) destruction and/or disposal
as waste.
Back to top
Deficiency: Serious
2.4.3 Withdrawals and recalls not designed or implemented properly.
To enable and facilitate the complete and timely withdrawal of lots of end products which have been
identified as unsafe a) top management shall appoint personnel having the authority to initiate a
withdrawal and personnel responsible for executing the withdrawal, and b) the organization shall
establish and maintain a documented procedure for
1. notification to relevant interested parties (e.g. statutory and regulatory authorities,
customers and/or consumers),
2. handling of withdrawn products as well as affected lots of the products still in stock, and
3. the sequence of actions to be taken.
Withdrawn products shall be secured or held under supervision until they are destroyed, used for
purposes other than originally intended, determined to be safe for the same (or other) intended use, or
reprocessed in a manner to ensure they become safe. The cause, extent and result of a withdrawal shall
be recorded and reported to top management as input to the management review. The organization
shall verify and record the effectiveness of the withdrawal program through the use of appropriate
techniques (e.g. mock or practice withdrawal).
Deficiency: Serious
2.5.0 Validation
2.5.1 Validation activities improperly performed
The food safety team shall plan and implement the processes needed to validate control measures
and/or control measure combinations. Prior to implementation of control measures to be included in
operational prerequisite programs and the HACCP plan and after any change therein, the organization
shall validate that a) the selected control measures are capable of achieving the intended control of the
food safety hazard(s) for which they are designated, and b) the control measures are effective and
capable of, in combination, ensuring control of the identified food safety hazard(s) to obtain end
products that meet the defined acceptable levels.
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If the result of the validation shows that one or both of the above elements cannot be confirmed, the
control measure and/or combinations thereof shall be modified and re-assessed. Modifications may
include changes in control measures (i.e. process parameters, rigorousness and/or their combination)
and/or change(s) in the raw materials, manufacturing technologies, end-product characteristics,
methods of distribution and/or intended use of the end product.
Deficiency: Serious
2.6.0 Records
2.6.1 Inadequate information on records (Facility name and location, etc.)
Based on the required information stated in 21 CFR Part 123.9a.
All records required by this part shall include:
1.
2.
3.
4.

The name and location of the processor or importer;
The date and time of the activity that the record reflects;
The signature or initials of the person performing the operation; and
Where appropriate, the identity of the product and the production code, if any.

Deficiency: Major
2.6.2 Record data is missing.
All records must be kept up-to-date. Entries must be made as they are measured. The records shall
contain the actual values and observations obtained during monitoring or measurement. All time
schedules outlined in the QMP plan must be maintained. Examples of non-compliance include:
measurement observed to be taken but not entered on record; partial entry of information from
monitoring procedures; initials for QA verification not recorded in a timely manner; etc. If record data is
missing, a Major deficiency will be assessed.
All labels must be up-to-date. All labels must be kept on file by the firm. If labels are not up-to-date, a
Serious deficiency will be assessed.
The maintenance of records on computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and signatures.
Deficiency: Major (Serious for Labels)
2.6.3 Records are inaccurate.
All entries must be accurate or the record is meaningless. If calculations, time test measured, etc., are
not correct, the box for this deficiency should be checked. Further, as the use of correction fluid and
obliterating a record entry are not proper in the keeping of records, their routine use should be
considered an inaccurate reading and the serious deficiency assigned. This deficiency will also be used
for the compliance of product leaving the firm.
Deficiency: Serious/Critical
2.6.4 Records are not available for inspection.
If the firm is unable to supply the requested record(s) in a reasonable amount of time for inspector
review, they are not in compliance with this item. If portions of a record are not available, the firm is not
in compliance with this item. All required records shall be retained at the processing facility or
importer's place of business in the United States for at least 1 year after the date they were prepared in
the case of refrigerated products and for at least 2 years after the date they were prepared in the case
of frozen, preserved, or shelf-stable products.
Records that relate to the general adequacy of equipment or processes being used by a processor,
including the results of scientific studies and evaluations, shall be retained at the processing facility or
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the importer's place of business in the United States for at least 2 years after their applicability to the
product being produced at the facility.
If the processing facility is closed for a prolonged period between seasonal packs, or if record storage
capacity is limited on a processing vessel or at a remote processing site, the records may be transferred
to some other reasonably accessible location at the end of the seasonal pack but shall be immediately
returned for official review upon demand.
Deficiency: Critical
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2.6.5 Documents or records are falsified.
This item is self-explanatory. However, intent on the part of the firm or its representatives must be
shown. For example, if an item on a record was shown to be corrected with correction fluid or other
means of obliteration, the inspector must show that someone with, full knowledge, changed the entry
to reflect a value that was not the value measured or observed. Otherwise, this will be considered an
inaccurate entry.
Deficiency: Critical
c. 3.0 Sanitation and Prerequisite Programs
The elements of this section apply to all participants in the USDC Seafood Inspection Program in the
evaluation of facilities, processes and systems.
References:

21 CFR Part 110; 21 CFR Part 123.11(b); 50 CFR Parts 260.96-260.104

3.1.0 Sanitation Standard Operating Procedures and Prerequisite Programs
3.1.1 Sanitation standard operating procedures or prerequisite programs not present or not effective.
Each processor shall have and implement a written sanitation standard operating procedure (SSOP) or
similar document that is specific to each location where fish and fishery products are produced. The
SSOP shall specify how the processor would meet those sanitation conditions and practices that are to
be monitored.
Deficiency: Serious
3.1.2 Sanitation standard operating procedures not followed.
This deficiency will be assessed if it is determined that the firm did not follow their written SSOPs,
whether or not specific sanitation deficiencies were observed.
Deficiency: Serious
3.1.3 Sanitation not monitored.
Each processor shall monitor the conditions and practices during processing with sufficient frequency to
ensure, at a minimum, conformance with those conditions and practices specified in 21 CFR Part 110
and 123 that are both appropriate to the plant and the food being processed and relate to the following:
1. Safety of the water that comes into contact with food or food contact surfaces, or is
used in the manufacture of ice;
2. Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer
garments;
3. Prevention of cross-contamination from unsanitary objects to food, food packaging
material, and other food contact surfaces, including utensils, gloves, and outer
garments, and from raw product to cooked product;
4. Maintenance of hand washing, hand sanitizing, and toilet facilities;
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5. Protection of food, food packaging material, and food contact surfaces from
adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents,
condensate, and other chemical, physical, and biological contaminants;
6. Proper labeling, storage, and use of toxic compounds;
7. Control of employee health conditions that could result in the microbiological
contamination of food, food packaging materials, and food contact surfaces; and
8. Exclusion of pests from the food plant.
The firm shall define the applicable frequencies of monitoring in their sanitation standard operating
procedures and must adhere to these frequencies.
Deficiency: Serious
3.2.0 Safety of Process Water
Process water must be of suitable quality as it directly interfaces or becomes part of the product being
manufactured. Therefore, no filth, deleterious chemicals, bacteria, or other contaminants may be
present in solution as it will directly affect the safety or wholesomeness of the product. Available water
must pass potability standards established by federal, state, and local authorities. Water that is supplied
to the plant must meet certain minimum standards. However, processing water must also be reasonably
protected in the facility. Conditions that allow contamination to occur cannot be allowed. These may
include cross-connection of plumbing, back-siphonage, or back flow from a contaminated source to the
supply system or open vessels of water.
3.2.1 Unsafe or unsanitary water supply.
The water supply, including seawater, will be in compliance when by certification or direct testing the
supply is found to meet the federal standards set forth by the Environmental Protection Agency or the
World Health Organization as applicable. Water used for washing, rinsing, or conveying food shall be
safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it
does not increase the level of contamination of the food.
Deficiency: Serious/Critical
3.2.2 Water potability certificate not current
Private supplies shall have testing performed at a minimum of every six (6) months. Certification of
municipal or community systems should be secured at a minimum of once per year. Where used,
seawater must meet processing use requirements and potability must be tested at a frequency
sufficient to ensure the acceptability of the water source from that geographic area.
Deficiency: Serious
3.2.3 Self water treatment performed improperly.
Where water supply is treated (such as chlorinated, ozone, UV) on premises, equipment must be
properly maintained and/or residual must be within acceptable limits based upon statutory, regulatory,
and requirements of the end-user.
Deficiency: Serious
3.2.4 No protection against backflow, back-siphonage, or other sources of contamination.
A facility will be in compliance when all cross-connections are eliminated, backflow prevention devices
are installed wherever backflow or siphonage may occur, or where other possible forms of
contamination may be present. A diagram or chart of all such devices will be on file for review.
Deficiency: Serious
3.2.5 Inadequate supply of water and hot water.
The water supply shall be sufficient for the operation intended. Plumbing shall be of adequate size and
design and adequately installed and maintained to carry sufficient quantities of water to required
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locations throughout the plant. Water shall be sufficient to properly convey sewage and liquid
disposable waste from the plant. Running water at a suitable temperature and under pressure as
needed, shall be provided in all areas where required for processing of food, for the cleaning of
equipment, utensils and food packaging, or for employee sanitary facilities.
Hot water is necessary for many cleaning techniques. In addition, a hot water supply is necessary to
provide a comfortable means for employees to wash their hands. If the tap is on and a luke-warm supply
of water is present in sufficient quantities for the tasks it will perform in the facility, the plant is in
compliance. The supply must also be easily accessible for its proper use.
Deficiency: Minor (Lack of hot water)/Major (Lack of sufficient water supply)
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3.2.6 Ice not manufactured, handled, or used in a sanitary manner.
A facility will be in compliance when potable water is used for manufacturing ice, when the
manufacturing equipment is clean, and the ice only contacts impervious surfaces; the ice holding
containers are clean and made of appropriate impervious material; handling equipment is clean and
appropriate for food contact; and ice is properly used. For facilities receiving ice from an outside supply,
a certificate of conformance will be necessary to ensure that the ice being received meets the standards
set forth in this document. In addition, potability checks must be made at a minimum of every six (6)
months on ice received.
Deficiency: Major/Critical
3.2.7 Other areas covered by the CGMPs.
Deficiency: Minor
3.3.0 Food Contact Surfaces
3.3.1 Equipment and utensils' design, construction, location, or materials cannot be readily cleaned or
sanitized; does not preclude product adulteration or contamination.
Any equipment used in the manufacturing or handling of the food product must be designed or
constructed so that it can be properly cleaned and inspected. Failure to do so will cause the facility to be
out of compliance. In addition, if the materials used are not of a material suitable for its intended
purpose or there is reuse of single-service items, then the facility is also out of compliance.
Seams on product-contact surfaces shall be smoothly bonded or maintained so as to minimize
accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of
microorganisms.
All plant equipment and utensils shall be so designed and of such material and workmanship as to be
adequately cleanable, and shall be properly maintained. All equipment should be so installed and
maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Product-contact
surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic
materials and designed to withstand the environment of their intended use and the action of food and,
if applicable, cleaning compounds and sanitizing agents. Food containers and food-packaging materials
that are safe and suitable are to be used. Product-contact surfaces shall be maintained to protect food
from being contaminated by any source, including unlawful indirect food additives.
Deficiency: Serious/Critical
3.3.2 Equipment and utensils not maintained in proper repair or removed when necessary. (Food
contact surfaces)
All food contact surfaces must be kept in good repair. If the contact surface cannot be repaired, then the
piece of equipment or utensil should be removed so as not to allow for its use. Failure to provide these
conditions will result in non-compliance. Assessment of this deficiency will be made relative to the risk
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of the product at that stage of production. For example, if the equipment under consideration is being
used for handling product after a kill step in the process, this product is higher risk and therefore the
deviation is more significant.
Deficiency: Major (Serious for products at a high risk stage of processing)
3.3.3 Food contact surfaces not cleaned or sanitized before use, after interruptions, or as necessary.
Food contact surfaces and food containers must be adequately cleaned using proper techniques to
remove dirt and debris and must be adequately sanitized. Sanitizers must be used before product
contacts the surface. Sanitizing without cleaning is insufficient. Any violation will be considered noncompliance. Risk should be considered when assessing this deficiency. Product leaving a cooker to be
packaged and frozen will have a higher level of risk than a raw fish at receiving.
Deficiency: Serious/Critical
3.3.4 Concentrations of cleaners and sanitizers are not effective, safe, or routinely checked.
All sanitizing agents (e.g., hand sanitizers, equipment sanitizers, etc) must be used in the proper
concentration and in the manner prescribed in the usage instructions to be effective.
Deficiency: Major
3.3.5 Other areas covered by the CGMPs.
Deficiency: Minor
3.4.0 Prevention of Cross Contamination
3.4.1 Grounds condition can permit contaminants to enter the facility.
There shall be no conditions on the grounds such as dusty roads or parking lots, standing or ponding
water, chemical spills, etc., that can cause contamination to be carried into the plant through such
means as wind drafts, personnel foot traffic, adherence to personnel clothing, flooding, etc.
Deficiency: Minor/Major
3.4.2 Facility
3.4.2.1 Design, layout of materials used cannot be readily cleaned and sanitized; does not preclude
product contamination. Insufficient lighting for the applicable operation.
Design of the facility structure should be such that access is easily obtained to all areas. This is necessary
for proper cleaning and sanitizing of floors, walls and ceilings, as well as for visual inspections. If the
rooms (including restrooms and employee break rooms) in the facility are laid out or designed in such a
way that they cannot be readily cleaned or sanitized, then the facility is not in compliance. This would
include insufficient lighting, improper materials for walls, ceilings, etc., as well as hard-to-reach rooms or
corners even when the equipment is removed from the room.
Deficiency: Major
3.4.2.2 Insufficient separation by space or other means allows product to be adulterated or
contaminated.
There must be sufficient separation between different activities in the processing, packaging and
handling of food products such as 1) separation between activities, 2) layout of facility (employee traffic)
3) product sequencing and 4) product display. This includes the complete separation of living/sleeping
quarters or heavy maintenance areas from food-handling areas. The food product should flow easily
from one stage to another and not be allowed to come into contact with non-food contact surfaces if
exposed. In addition, the layout of the facility should not be such that product
contamination/adulteration is likely due to issues such as heavy employee traffic through work
areas. Production is not organized and scheduled in a manner which precludes cross-contamination or
cross-contact of product by allergens. Adequate separation can be by physical barrier, time, space,
etc. Sanitary handling procedures and processing methods during operations are to be in place to
protect food against contamination to include physical protection from airborne contamination.
29

Retail product displays should be arranged so that there is sufficient separation to assure that no crosscontamination can occur between raw, cooked, and live product.
Food manufacturing areas and equipment used for manufacturing human food should not be used to
manufacture nonhuman food grade animal feed or inedible products unless there is no reasonable
possibility for the contamination of human food.
Deficiency: Serious/Critical
3.4.3 Condition of roof, ceilings, walls, floors, or lighting not maintained; lights not protected.
3.4.3.1 Areas directly affecting product or packaging material.
For those areas that will directly affect product or primary packaging materials, (packaging immediately
surrounding product), the roof, ceiling, walls, floors, the storage of ingredients or materials that permits
cross-contamination or cross-contact by allergens or ingredients, and lighting fixtures must be
maintained as designed and lights must be protected. Failure to do so causes the facility to be out of
compliance.
Deficiency: Serious
3.4.3.2 Other.
For areas in the facility other than in 3.4.3.1 above, the roof, ceilings, walls, floors, or lighting fixtures
must also be maintained as designed. This does not include those areas designated as offices and in
which food products or primary packaging materials in any stage of production will not be handled or
stored.
Deficiency: Major
3.4.4 Cleaning methods permit adulteration or contamination.
Employees must take care to use methods that will not adulterate or contaminate the product. Any
cleaning or sanitizing procedures or techniques that may cause the product to become adulterated or
contaminated will cause the facility to be in non-compliance. Examples of non-compliance include but
are not limited to inadvertent touching of product or product surfaces with wash water, detergent,
sanitizers, etc., during production.
Deficiency: Serious (Critical for products at a high risk stage of production)
3.4.5 Finished product/primary packaging material not properly covered or protected.
Finished product must be packaged, covered or protected so as to not permit contamination or
adulteration prior to shipment and during transportation. Primary packaging materials should be
adequately covered when stored or not in use. Failure to provide these conditions will result in noncompliance.
Deficiency: Major/Serious
3.4.6 Equipment and utensils not maintained in proper repair or removed when necessary. (Non-food
contact surfaces)
All non-food contact surfaces should also be maintained in good repair. The facility is in non-compliance
when the maintenance of all additional equipment or areas of equipment and utensils not referred to in
item 3.4.3.1 above is insufficient and may allow indirect product contamination.
Deficiency: Minor (Major for products at a high risk stage of production)
3.4.7 Non-food contact surfaces, equipment, or areas not cleaned before use.
Non-food contact areas must also be cleaned prior to use. Areas such as walls, ceilings, floors, as well as
equipment must also be cleaned prior to use. However, sanitizing is not required.
Deficiency: Major
3.4.8 Processing or food handling personnel do not maintain a high degree of personal cleanliness.
All persons, while in food preparation or handling areas, shall wear clean outer garments and conform
30

to hygienic practices while on duty to the extent necessary to prevent contamination or adulteration of
food. This includes occasional workers or visitors to the area.
Deficiency: Major/Serious
3.4.9 Processing or food handling personnel do not take necessary precautions to prevent adulteration
or contamination of food.
All persons, while in a food preparation or handling area, shall:
1. Wash their hands thoroughly to prevent contamination by undesirable microorganisms
before starting work, after each absence from the work station, and at any other time
when the hands may have become soiled or contaminated. After washing, the hands
must be sanitized
2. Remove all insecure jewelry, and when food is being manipulated by hand, remove from
hands any jewelry that cannot be adequately sanitized or properly covered.
3. If gloves are used in food handling, maintain them in an intact, clean, and sanitary
condition. Such gloves shall be of an impermeable material except where their usage
would be inappropriate or incompatible with the work involved. If gloves are used they
will be washed and sanitized at the same frequency as employees’ hands as described in
number one of this list.
4. Wear hair nets, caps, masks, or other effective hair restraint. Other persons that may
incidentally enter the processing areas shall comply with this requirement.
5. Not expectorate; nor store clothing or other personal belongings; not eat food or drink
beverages; nor use tobacco in any form in areas where food or food ingredients are
exposed, or in areas used for food processing, storage of food ingredients and/or
packaging materials, washing of equipment and utensils, or in production areas.
6. Take other necessary precautions to prevent contamination of foods with
microorganisms or foreign substances including, but not limited to perspiration, hair,
cosmetics, tobacco, chemicals, and medicants.
7. Using sanitary handling procedures during operations to protect food against
contamination, e.g., picking up dropped food from the floor.
Deficiency: Serious/Critical
3.4.10 Other areas covered by the CGMPs.
Deficiency: Minor
3.5.0 Handwashing, Hand Sanitizing, and Toilet Facilities
3.5.1 Hand washing and hand sanitizing stations not present or conveniently located.
Hand washing and hand sanitizing stations must be present and located properly and in sufficient
numbers to provide employees ease of their use. Devices or fixtures, such as water control valves, shall
be so designed and constructed to protect against recontamination of clean, sanitized hands.
Deficiency: Serious (Critical for products at a high risk stage of production)
3.5.2 Improper disposal of toilet waste or sewage.
A facility is in compliance when sewage systems drain properly, are vented to the outside, and are
connected to an approved private septic system or a public septic and/or sewage system.
Deficiency: Critical
3.5.3 Inadequate supplies/signs for employees.
The restrooms and hand-washing stations must provide supplies such as toilet paper, soap, waste
containers, running water (see 3.2.5), sanitary towel service or suitable drying devices, etc., sufficient to
meet employees’ needs. Readily understandable signs directing employees handling unprotected food,
31

food packaging materials, or food contact surfaces to wash and sanitize their hands at the proper
frequency. Refuse receptacles shall be constructed and maintained in a manner that protects against
contamination of food.
Deficiency: Major/Serious
3.5.4 Insufficient number of functional toilets.
The facility must have one operable, clean, in good repair, conveniently accessible toilet per fifteen (15)
employees, per gender. For men, urinals may be substituted for toilet bowls, but only to the extent of
one-third (1/3) of the total number of bowls required. Facilities shall be maintained in a sanitary
condition with self-closing doors that do not open directly into areas where food is exposed to airborne
contamination, except where alternate means of protection have been implemented.
Deficiency: Major/Serious
3.5.5 Other areas covered by the CGMPs.
Deficiency: Minor
3.6.0 Protection From Adulteration
3.6.1 Condensation or other deleterious sources present.
Adequate physical protection of food from adulterants that may drip, drain, or be drawn into the food
must be in place. Provide adequate physical protection or separation of food during processing (filling,
packaging, assembling, etc.) to protect from contamination. If any condensation, overhead leaks, water
splash or other conditions occur that may result in the adulteration of product or primary packaging
material, the facility is in non-compliance for this item.
Deficiency: Critical
3.6.2 Adequate air exchange does not exist.
A facility is in compliance when adequate air exchange exists to preclude the development of foul odors
or contamination of product.
Deficiency: Minor (Only for products at a high risk stage of production)
3.6.3 Other areas covered by the CGMPs.
Deficiency: Minor
3.7.0 Proper Labeling, Use, and Storage of Toxic Compounds
Plant chemicals are cleaners, sanitizers, rodenticides, insecticides, food grade machine lubricants, etc.
They must be used according to manufacturer's instructions, have proper labeling, and be stored in a
safe manner or they may pose a risk of contaminating the food product that the establishment is
handling or manufacturing.
A facility will be in compliance when the chemicals are used according to manufacturer's instructions
and recommendations and stored in an area of limited access away from food handling or
manufacturing. All chemicals must be labeled to show the name of the manufacturer, instructions for
use, and the appropriate EPA approval.
Only the following toxic materials may be used or stored in a plant where food is processed or exposed:
a) those required to maintain clean and sanitary equipment and surfaces, b) those necessary for use in
laboratory testing procedures, c) those necessary for plant and equipment maintenance and operation,
and d) those necessary for use in the plant’s operations.
3.7.1 Chemical(s) improperly used or handled.
Deficiency: Critical
3.7.2 Chemical(s) improperly stored.
Deficiency: Serious
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3.7.3 Chemical(s) improperly labeled.
Deficiency: Major
3.7.4 Material Safety Data Sheets (MSDS) not available for all chemicals in use at the facility.
Deficiency: Serious
3.7.5 Other areas covered by the CGMPs.
Deficiency: Minor
3.8.0 Control of Employee Health Conditions
3.8.1 Facility management does not have in effect measures to restrict people with known disease
from contaminating the product.
No person affected by disease in a communicable form, or while a carrier of such disease, or while
affected with boils, sores, infected wounds, or other abnormal sources of microbiological
contamination, shall work in a food plant in any capacity in which there is a reasonable possibility of
food or food ingredients becoming contaminated by such person. Plant management shall require
employees to report illness or injury to supervisors.
Deficiency: Serious
3.8.2 Other areas covered by the CGMPs.
Deficiency: Minor
3.9.0 Exclusion of Pests
The presence of rodents, insects, and other animals in the facility must not be allowed because they are
sources for the contamination of food with foreign material, filth, and bacteria, etc.
3.9.1 Harborage and attractant areas present.
The facility and grounds are free of harborage areas. These include but are not limited to: uncut weeds,
brush or tall grass; improper storage of unused equipment or materials; presence of litter, waste and
refuse; or standing or stagnant water. All garbage and refuse containers are rodent/insect-resistant and
outside storage areas are to be properly constructed. If the plant grounds are bordered by grounds not
under the operator’s control and these grounds are not maintained in a proper manner with regard to
this element, care shall be exercised in the facility to exclude pests that may be a source of
contamination by the means outlined in the other areas of this element.
Deficiency: Major
3.9.2 Pest control measures not effective.
3.9.2.1 Exclusion
Openings to the outside of or within the facility may allow vermin or other pests to enter. Openings and
cracks should be screened or otherwise sealed. Screens must be of a mesh not larger than 1/16th of an
inch in order to exclude insects. Cracks or holes should be sealed and doors and windows should close
tightly (no opening larger than 1/4 ") to exclude rodents or other animals. Air curtains and strip curtains
must be effective. Air curtains shall comply with National Sanitation Standard Number 37 for Air
Curtains for entranceways in food establishments. Strip curtains must run the entire opening with
sufficient overlap between flaps (1/2 inch). In addition, every effort should be made to keep birds from
areas of the plant where food is transferred or processed.
Deficiency: Major
3.9.2.2 Extermination
Birds--Nesting areas must be eliminated.
Insects--There should not be a significant number of insects present in the facility. Insect electrocution
devices, when used, must be located near the entranceway. Approved insecticides should be used
whenever insect populations become noticeable.
Rodents--There should not be evidence of rodent activity. Evidence of rodents includes, but is not
33

limited to: fecal droppings present; urine stains on bags or walls; slide marks along rodent runways; or
feeding areas around stored dry goods bags that may be excessive. The facility should have appropriate
rodent control measures in place. If not, the facility is not in compliance.
Deficiency: Major/Serious
3.9.3 Improper disposal of processing waste.
A facility is in compliance with regard to processing wastes when they are placed in proper containers,
placed at appropriate locations throughout the plant, and removed frequently.
Deficiency: Serious
3.9.4 Inadequate housekeeping.
Any excess clutter in production areas, employee areas, or other areas of the facility will cause the
facility to be in non-compliance. This does not include those areas designated as office areas.
Deficiency: Minor
3.9.5 No written pest control program.
Self-explanatory. Diagrams of bait station locations at the facility shall be maintained and kept available
for review.
Deficiency: Serious
3.9.6 Pesticides not applied by a licensed individual.
Self-explanatory. However, in some locations, particularly outside the United States, licensing is not
performed. In such instances the application shall be performed by a trained individual.
Deficiency: Serious
3.9.7 Other areas covered by the CGMPs.
Deficiency: Minor
d. 4.0 Quality System
The elements of this section apply to participants in the Integrated Quality Assurance Program and the
HACCP Quality Management Program in the evaluation of facilities, processes and systems. This section
may also apply if requested specifically.
4.1.0 Management Responsibilities
4.1.1 Management commitment not properly implemented or communicated.
Top management shall provide evidence of its commitment to the development and implementation of
the quality management system and to continually improving its effectiveness by: a) communicating to
the organization the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing a quality policy, c) ensuring that quality objectives are established, d) conducting
management reviews, and e) ensuring the availability of resources.
Deficiency: Critical
4.1.2 Food quality policy not prepared or properly implemented.
Top management shall ensure that customer requirements are determined and are met with the aim of
enhancing customer satisfaction. Top management shall ensure that the quality policy a) is appropriate
to the role of the organization, b) includes a commitment to comply with requirements and continually
improve the effectiveness of the quality management system, c) provides a framework for establishing
and reviewing quality objectives, d) is communicated and understood within the organization, and e) is
reviewed for continuing suitability.
Deficiency: Serious
4.1.3 Quality system planning not properly performed.
Top management shall ensure that quality objectives, including those needed to meet requirements for
34

product, are established at relevant functions and levels within the organization. The quality objectives
shall be measurable and consistent with the quality policy. Top management shall ensure that a) the
planning of the quality management system is carried out as well as the quality objectives, and b) the
integrity of the quality management system is maintained when changes to the quality management
system are planned and implemented.
Deficiency: Serious
4.1.4 Responsibility and authority not properly defined or communicated.
Top management shall ensure that responsibilities and authorities are defined and communicated
within the organization.
Deficiency: Serious
4.2.0 Quality Team
4.2.1 Quality team leader not appointed.
Top management shall appoint a quality team leader who, irrespective of other responsibilities, shall
have the responsibility and authority to: a) ensure that processes needed for the quality management
system are established, implemented and maintained, b) report to top management on the
performance of the quality management system and any need for improvement, and c) ensure the
promotion of awareness of customer requirements throughout the organization.
Deficiency: Serious
4.3.0 Internal Communication
4.3.1 Effective internal communication not established, implemented, or maintained.
Top management shall ensure that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of the quality
management system.
Deficiency: Serious
4.4.0 Management Review
4.4.1 Management review not properly performed or documented.
Top management shall review the organization’s quality management system at planned intervals to
ensure its continuing suitability, adequacy, and effectiveness. This review shall include assessing
opportunities for improvement and the need for change to the system, including the quality policy and
objectives. Records from management reviews shall be maintained.
The input to management review shall include information on: a) results of audits, b) customer
feedback, c) process performance and product conformity, d) status of preventive and corrective
actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality
management system, and g) recommendations for improvement.
The output from the management review shall include decisions and actions related to: a) improvement
of the effectiveness of the quality management system and its processes, b) improvement of product
related to customer requirements, and c) resource needs.
Deficiency: Serious
Back to top
4.5.0 Resource Management
The organization shall determine and provide the resources needed a) to implement and maintain the
quality management system and continually improve its effectiveness, and b) to enhance customer
satisfaction by meeting customer requirements.

35

4.5.1 Necessary human resource competencies not identified.
Personnel performing work affecting product quality shall be competent on the basis of appropriate
education, training, skills and experience.
Deficiency: Serious
4.5.2 Personnel have not received documented training necessary for the proper function of the quality
system.
The organization shall: a) identify the necessary competencies for personnel performing work affecting
product quality, b) provide training or take other action to satisfy these needs, c) evaluate the
effectiveness of the actions taken, d) ensure that the personnel are aware of the relevance and
importance of their individual activities in contributing to the quality objectives, f) maintain appropriate
records of training and action s described above.
Deficiency: Critical
4.5.3 Insufficient infrastructure to implement and maintain the food quality system.
The organization shall provide the resources for the establishment and maintenance of the
infrastructure needed to implement a proper quality management system.
Deficiency: Serious
4.5.4 Work environment is not properly established, managed, or maintained relative to food quality.
The organization shall provide the resources for the establishment, management, and maintenance of
the work environment needed to achieve conformity to product requirements.
Deficiency: Serious
4.6.0 Quality Manual
4.6.1 Quality manual is inadequate.
Every IQA or HACCP QMP processor, as applicable, shall have and implement a written quality manual
which covers each of the elements delineated in the Quality System Requirements. Firms must provide
this plan to the requesting Consumer Safety Officer.
The organization shall establish and maintain a quality manual that includes a) the scope of the quality
management system, b) the documented procedures established for the quality management system,
or reference to them, and c) a description of the interaction between the processes of the quality
management system.
Deficiency: Serious
4.6.2 Defect action plan is not adequate to control product quality characteristics.
Every processor, as applicable, shall have and implement a written Defect Action Plan and a quality
defect analysis for products that will either bear an inspection mark or will be advertised as under the
NOAA Seafood Inspection Program. Firms must provide this plan to the requesting Consumer Safety
Officer.
Deficiency: Serious
4.6.3 Defect action plan/quality manual not followed.
This deficiency will be assessed if the firm did not follow the policies outlined in their Quality manual or
did not follow the procedures listed in their defect action plan. This deficiency will be assessed whether
or not it was determined that product was affected.
Deficiency: Critical
4.7.0 Product requirements and specifications.
4.7.1 Product characteristics not properly described including raw materials, ingredients, and end
product.
All raw materials, ingredients and food contact materials shall be described in documents to the extent
36

needed to conduct the hazard and defect analysis, including the following: a)biological, chemical, and
physical characteristics, b)composition of formulated ingredients including additives and processing
aids, c)origin, d)method of production, e)packaging and delivery methods, f)storage conditions and shelf
life, g)preparation and/or handling before use or processing, and h)food safety and quality related
acceptance criteria or specifications of purchased materials and ingredients appropriate to their
intended uses.
The characteristics of end products shall be described in documents to the extent needed to conduct the
hazard and defect analysis, including information as appropriate on the following: a)product name or
similar identification, b)composition, c)biological, chemical, and physical characteristics relevant to food
safety and quality, d)intended shelf life and storage conditions, e)packaging, f)labeling relating to food
safety and quality, and/or instructions for handling, preparation, and usage, and g)methods of
distribution.
The customer requirements, including any requested changes, are to be reviewed before a commitment
to supply a product is provided to the customer (e.g. submission of a tender, acceptance of a contract or
order) to ensure that: a)identified customer requirements are clearly defined for the product, b)where
the customer provides no written statement of requirement, the order requirements are confirmed
before acceptance, c)contract or order requirements differing from those previously expressed are
resolved, and d)the organization has the ability to meet the customer requirements for the
product. The results of reviews and subsequent follow-up are to be recorded.
The organization shall identify statutory and regulatory quality requirements to the above and these
descriptions are to be kept properly updated.
Deficiency: Serious
4.7.2 Intended use and reasonably expected handling of the product not properly considered.
The intended use, the reasonably expected handling of the end product, and unintended but reasonably
expected mishandling and misuse of the end product shall be considered and be described in
documents to the extent needed to conduct the hazard and defect analysis. Groups of users and where
appropriate, groups of consumers shall be identified for each product, and consumer groups known to
be especially vulnerable to specific food safety hazards, or product defects, shall be considered. The
descriptions shall be kept updated.
Deficiency: Major
4.7.3 Product requirements not discussed and agreed with the customer.
The organization shall implement effective liaison with its customers, with the aim of meeting customer
requirements. The organization shall define communication requirements relating to product
information and order handling, including amendments. Such communication shall be recorded and
must include customer agreement to the terms.
Deficiency: Serious
4.7.4 Labels and/or specifications are inadequate.
Title 50 of the Code of Federal Regulations (CFR) requires that establishments contracting for fishery
product inspection service obtain NOAA approval of labels prior to use on products packed under
Federal inspection, regardless of whether or not they bear official inspection or grade
marks. Additionally, the "Policy for Advertising Services and Marks" identifies additional labeling and
advertising of marks and services that must be approved prior to use. The Regulations Governing
Processed Fishery Products require that specifications for all products for which U.S. Standards for
Grades are not available be approved by the Secretary of Commerce and that end-product samples,
when requested, be evaluated to determine their compliance with approved specifications prior to
37

NOAA inspection and certification of such products.
Deficiency: Serious
4.7.5 Nonconforming product is improperly controlled.
The manufacturer shall establish and maintain procedures that define the responsibility for review and
the authority for the disposition of nonconforming product. The procedures shall set forth the review
and disposition process. Disposition of nonconforming product shall be documented. Documentation
shall include the justification for use of nonconforming product and the signature of the individual(s)
authorizing the use.
The manufacturer shall establish and maintain procedures for rework, to include retesting and
reevaluation of the nonconforming product after rework, to ensure that the product meets its current
approved specifications. Rework and reevaluation activities, including a determination of any adverse
effect from the rework upon the product, shall be documented.
The manufacturer shall establish and maintain procedures to control product that does not conform to
specified requirements. The procedures shall address the identification, documentation, evaluation,
segregation, and disposition of nonconforming product. The evaluation of nonconformance shall
include a determination of the need for an investigation and notification of the persons or organizations
responsible for the nonconformance. The evaluation and any investigation shall be documented.
Deficiency: Critical
4.8.0 Purchasing
4.8.1 Evaluation, re-evaluation, and selection criteria for suppliers are not established.
The manufacturer shall establish and maintain the requirements (including safety, wholesomeness,
proper labeling, and quality requirements) that must be met by suppliers, contractors, and
consultants. The manufacturer shall:
a. Evaluate and select potential suppliers, contractors, and consultants on the basis of
their ability to meet specified requirements, including quality requirements. The
evaluation shall be documented.
b. Define the type and extent of control to be exercised over the product, services,
suppliers, contractors, and consultants, based on the evaluation results. This shall be
dependent upon the type of product, the impact of subcontracted product on the
quality of final product, and, where applicable, on the quality audit reports and/or
quality records of the previously demonstrated capability and performance of
subcontractors.
c. Establish and maintain quality records of acceptable suppliers, contractors, and
consultants.

Back to top
Deficiency: Major
4.8.2 Purchasing documents are not clear, reviewed, approved, or adequate.
The manufacturer shall establish and maintain data that clearly describe or reference the specified
requirements, including food safety and quality requirements, for purchased or otherwise received
product and services. Purchasing documents shall include, an agreement that the suppliers, contractors,
and consultants agree to notify the manufacturer of changes in the product or service so that
manufacturers may determine whether the changes may affect the safety or quality of a finished
product. The manufacturer shall review and approve purchasing documents for adequacy of the
38

specified requirements prior to release.
Deficiency: Serious
4.8.3 Verification of purchased product not properly performed or documented.
The manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise
received product and services conform to specified requirements including any arrangements by the
customer. Verification by the customer shall not absolve the supplier of the responsibility to provide
acceptable product, nor shall it preclude subsequent rejection by the customer.
Deficiency: Serious
4.8.4 Customer property not properly maintained or controlled.
The manufacturer shall establish and maintain documented procedures for the control of verification,
storage, and maintenance of customer-supplied product provided for incorporation into the supplies or
for related activities. Any such product that is lost, damaged, or is otherwise unsuitable for use shall be
recorded and reported to the customer.
Verification by the manufacturer does not absolve the customer of the responsibility to provide
acceptable product.
Deficiency: Serious
4.9.0 Measurement, Analysis, and Improvement
4.9.1 Customer satisfaction/dissatisfaction data not maintained or monitored.
The organization shall monitor information and data on customer satisfaction or dissatisfaction. The
methods and measures for obtaining this information and data including the nature and frequency of
reviews shall be defined and documented.
Deficiency: Serious
4.9.2 Internal audits not established or properly performed.
The organization shall conduct internal audits at planned intervals to determine whether the food safety
and quality management system a) conforms to the planned arrangements, to the management system
requirements established by the organization, and to the applicable regulatory requirements, and b) is
effectively implemented and updated.
An audit program shall be planned, taking into consideration the importance of the processes and areas
to be audited, as well as any updating actions resulting from previous audits. The audit criteria, scope,
frequency, and methods shall be defined. Selection of auditors and conduct of audits shall ensure
objectivity and impartiality of the audit process. Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits, and for reporting results and
maintaining records shall be defined in a documented procedure. The management responsible for the
area being audited shall ensure that actions are taken without undue delay to eliminate detected
nonconformities and their causes. Follow-up activities shall include the verification of the actions taken
and the reporting of the verification audits.
Deficiency: Serious
4.9.4 Analysis of data and continuous improvement not properly performed with regard to the system.
The organization shall collect data generated by measuring and monitoring activities and other relevant
sources as a means of determining the effectiveness of the management system and for identifying
where improvements can be made. The organization shall analyze applicable data to provide
information on: a)the suitability, effectiveness and adequacy of the system, b)process operation trends,
c)customer satisfaction and dissatisfaction, d)conformance to customer requirements, e)characteristics
of processes and products and their trends, and f)suppliers.
Deficiency: Serious
39

e. 5.0 Food Security
This section outlines the elements found in federal guidance on food security systems and as such only
applies if requested.
5.1.0 Management
5.1.1 A comprehensive food security plan has not been written, implemented, and periodically
reviewed by the processor.
A comprehensive food security plan must be written, implemented and periodically reviewed. Such a
plan should consider:
1. Preparing for the possibility of tampering or other malicious, criminal, or terrorist actions
• assigning responsibility for security to knowledgeable individual(s)
• conducting an initial assessment of food security procedures and operations, which we
recommend be kept confidential
• having a security management strategy to prepare for and respond to tampering and
other malicious, criminal, or terrorist actions, both threats and actual events, including
identifying, segregating and securing affected product
• planning for emergency evacuation, including preventing security breaches during
evacuation
• maintaining any floor or flow plan in a secure, off-site location
• becoming familiar with the emergency response system in the community
• making management aware of 24-hour contact information for local, state, and federal
police/fire/rescue/health/homeland security agencies
• making staff aware of who in management they should alert about potential security
problems (24-hour contacts)
• promoting food security awareness to encourage all staff to be alert to any signs of
tampering or other malicious, criminal, or terrorist actions or areas that may be
vulnerable to such actions, and reporting any findings to identified management (for
example, providing training, instituting a system of rewards, building security into job
performance standards)
• having an internal communication system to inform and update staff about relevant
security issues
• having a strategy for communicating with the public (for example, identifying a media
spokesperson, preparing generic press statements and background information, and
coordinating press statements with appropriate authorities)
2. Supervision
• providing an appropriate level of supervision to all staff, including cleaning and
maintenance staff, contract workers, data entry and computer support staff, and
especially, new staff
• conducting routine security checks of the premises, including automated manufacturing
lines, utilities and critical computer data systems (at a frequency appropriate to the
operation) for signs of tampering or malicious, criminal, or terrorist actions or areas that
may be vulnerable to such actions
3. Recall strategy
• identifying the person responsible, and a backup person
• providing for proper handling and disposition of recalled product
• identifying customer contacts, addresses and phone numbers
4. Investigation of suspicious activity
40

investigating threats or information about signs of tampering or other malicious,
criminal, or terrorist actions
• alerting appropriate law enforcement and public health authorities about any threats of
or suspected tampering or other malicious, criminal, or terrorist actions
5. Evaluation program
• evaluating the lessons learned from past tampering or other malicious, criminal, or
terrorist actions and threats
• reviewing and verifying, at least annually, the effectiveness of the security management
program (for example, using knowledgeable in-house or third party staff to conduct
tampering or other malicious, criminal, or terrorist action exercises and mock recalls and
to challenge computer security systems), revising the program accordingly, and keeping
this information confidential
• performing random food security inspections of all appropriate areas of the facility
(including receiving and warehousing, where applicable) using knowledgeable in-house
or third party staff, and keeping this information confidential
• verifying that security contractors are doing an appropriate job, when applicable
•

Deficiency: Critical
5.2.0 Human Element
5.2.1 Access to plant or sensitive areas of the facility (by employees or visitors) is not sufficiently
restricted to authorized personnel. Deficiency: Serious
5.2.2 Appropriate controls are not required of employees for gaining access to the facility.Deficiency:
Serious
5.2.3 Hiring practices do not include a screening process.
Self-explanatory. Deficiency: Serious
5.3.0 Facility
5.3.1 Facility, including outside premises, grounds, and perimeter, are not properly secure.
Self-explanatory. Deficiency: Critical
5.4.0 Operations
5.4.1 Raw material suppliers are not subject to a documented approval/screening process.Deficiency:
Critical
5.4.2 Supplier COCs or invoices do not address the subject of product origin and food
security. Deficiency: Serious
5.4.3 Product integrity is not assured from time of shipping raw materials to processor through
delivery of finished product to end-user.
Self-explanatory. Deficiency: Serious/Critical
Back to top
Appendix 1
a. HACCP Quality Management Program Audit Frequency
Systems Audit Target Frequencies

Deficiencies

41

Facility Rating

Processors

Retail

Reduced

Once every
calendar
quarter

Once every
six months

Normal

Tightened

Vessels Minor Major Serious Critical

0-6

0-5

1

0

Once every
month

Once
Once every
every
calendar
calendar
quarter
quarter

>7

6-10

2-4

0

Daily until
corrected

As
Daily until necessary
corrected
until
corrected

NA

>11

>5

>1

Three
Requirements
Three
consecutive
to be Audited consecutive
audits at
at a Reduced
audits at
Reduced
Frequency Reduced Rating
Rating

N/A

N/A

Audit frequency for firms operating on a seasonal basis will be determined on a case-by-case basis using
the guidance of the frequency listed in the chart above. With regard to seasonal contracts, the firm
must request in writing, to the servicing Regional Inspection Branch, to both suspend and reactivate the
contract.
b. Chain Retail Store Audit Frequency
Firms which operate a chain of stores may have the stores under the program sampled as outlined in
the chart below, provided they have an established approved Quality Assurance System.
Table 3

Stores to Sample Per Calendar
Quarter

Number of
Reduced Normal Tightened
Facilities
2-4

1

2

ALL

5-8

3

4

5

9 - 12

4

6

8

13 - 16

6

8

10

17 - 20

8

10

13

21-30

9

13

18

31-40

10

15

21

41-70

10

18

25

71-100

10

19

30
42

101 or
more

10

20

35

In addition, the following criteria apply:
1. All firms will begin at Tightened Sampling. After two successive calendar quarters the firm will
move to Normal sampling. After two successive calendar quarters at Normal sampling, the firm
will move to reduced sampling.
2. No stores in the sample may be considered unreliable. If a store in the sample is deemed
unreliable (Five Serious deficiencies or One Critical deficiency), the Firm’s Quality Assurance
System is suspect. USDC will perform an audit on the total Quality Assurance System for the
next thirty days. This audit will include the sampling of additional stores.
3. If, after the audit, the Quality Assurance System is deemed under control, the firm will be
sampled at the Tightened level and the system begins again.
4. If the Quality Assurance System is deemed to not be performing as designed, Regional
Management will evaluate the company’s entire program and suggest the necessary changes to
continue in the Program. This evaluation may result in a permanent or temporary removal from
the program.
5. During this thirty day period, the stores may continue to use all advertisement claims.
6. If the sample of stores does not meet the above requirements, then each store in the chain
must be audited on its own until such time as the Quality Assurance System has been reapproved
Appendix 2
a. Product Verification for IQA Facilities
To assess the plant QA’s ability to evaluate accurately a product’s degree of compliance with its
applicable standard, specification, or other approved document, the USDC inspector must sample and
inspect the product(s) produced for USDC certification. The inspector’s results are then compared to
the results obtained and reported by the plant’s QA department to determine whether any significant
differences exist. The plant is required to sample, inspect, and record the findings of each lot
produced. The USDC inspector is required to sample and inspect (verify) a certain percentage of the lots
produced. It is extremely important that the verification samples and inspections be conducted on an
unscheduled, random basis, and independently from the plant’s own sampling and inspection. This
independence of sampling and inspection, and recording of inspection findings, is necessary to satisfy
the verification objectives under the IQA system.
Note: The independent sampling and inspection for product verification does not
mean that the USDC inspector takes no action if his/her inspection results indicate a
potential or actual rejection of a production lot currently being processed.
There are three instances where the inspector will notify the plant QA department of potential or actual
product rejections when verifying a product being processed.
Absolute Factors: For factors such as flavor and odor, health hazard situations, scores below 81 in the
case of a US Grade A product, or for any reason that the product cannot pass inspection, the plant QA
will be notified immediately. If the plant QA has found similar results and is taking appropriate action,
43

no penalty, i.e., a major or minor deviation, will be assessed. However, if the plant QA is unaware of the
problem, a major deviation will be assessed and the lot placed on “hold” for proper disposition, i.e.,
reworking, destruction, appeal, etc.
Acceptance/Rejection Levels for Scores: When the acceptance number for scores has been reached, for
example, 1 for a sample size of 6, 2 for a sample size of 13, etc., the plant QA will be notified of a
potential rejection. The inspector will review the plant QA records to determine whether similar results
have been found and corrective action taken. If so, the inspector will take no action. If the plant QA
does not have similar findings, it will be advised of a potential rejection and a minor deviation will be
assessed. It should be noted that if a sample size of 3 is used, there is no mechanism for alerting the
plant QA since the acceptance number is 0. Some plants may wish to increase the sample size to 6 in
this instance, prior to the start of production.
Averages: For factors in which acceptance is based on an overall average, a running computation will be
kept. When the “W” number is exceeded, the inspector will notify the QA department of a potential
rejection. The inspector will review the plant QA records to determine whether similar results have
been found and corrective action taken. If so, the inspector will take no action. If the plant QA does not
have similar findings, it will be advised of a potential rejection and a minor deviation will be assessed.
In the above situations the inspector must keep in mind that this does not mean that he/she is to work
so closely with QA as to diminish the independent nature of USDC and plant QA activities. The inspector
must remember that USDC is verifying what the plant QA is doing – not working so closely with it as to
influence QA results to agree with those found by USDC.
i. Product Group:
For verification purposes, products which are similar in appearance and scoring factors (or other
inspection criteria) may be combined to represent one product group. Products grouped in this manner
will be identified in the QA plan on a plant-by-plant basis as approved by USDC. A product group is
considered to be but one product when determining the product verification rate.
ii. Product Verification Rate:
The minimum number of products to be verified by the inspector will depend upon the total number of
products produced since the last Group 1 verification. (The time period between successive product
verifications will not exceed one production week.) The following product rate table is used to
determine the minimum number of products that require verification.
Total Number of Products
Processed since the Last
Group 1 Verification

Minimum
Number of
Products to
Verify

1

1

2-4

2

5-8

3

9-13

4

14-19

5

20 or more

6

Based on the product rate table, the particular products to be verified will be randomly selected from
the total number of products produced since the last product verification; except in those cases where
all products must be verified or as noted below.
44

Back to top
After a particular product has been verified and found to be acceptable, it may be excluded from further
applications of product verification until all other products produced have been verified; except when an
audit indicates potential noncompliance.
When there is reason to suspect that a particular product is not in compliance and QA has not taken
appropriate action, that product will be verified.
iii. Selection of Lots from each Product: Following the random selection of products to be verified, the
number of lots of each product must be selected. This may be accomplished in either of two ways.
1. Random Selection from All Lots: For each product to be verified, randomly select 25
percent of all lots produced since the last Group 1 verification. More than 25 percent of
the lots may be selected and verified if results indicate the need. If less than 4 lots are
available, select 1 lot at random to verify. Otherwise, use the following rule: When the
percentage calculation yields a decimal part of 0.25, round down; if the decimal part is
0.50 or 0.75, then round up. For example, if 9 lots are available, then 2 lots would be
verified; whereas, if 10 or 11 lots are available, then 3 lots would be verified.
2. Random Selection of Lots from each of Five Possible Lot Size Classes: To use this
method, all lots of a product produced since the last Group 1 verification are assigned to
a lot size class depending on the sample size each lot would require using the single
sampling plans contained in 50 CFR 260.61 as follows:
Lot Size Sample Size Required
Class
for Inspection
1

3

2

6

3

13

4

21

5

29

Note: Lot size class 5 includes all lot sizes requiring (per 50
CFR 260.61) sample sizes of 29 or more. For lots in this class a
sample size of 29 will be drawn.
For example, those lots of a product to be verified that would require a sample of 3 units make up lot
size class 1. Then from each lot size class, randomly select 25 percent of the applicable lots. More than
25 percent of the lots may be selected and verified if results indicate the need. If less than 4 lots are
available, select 1 lot at random to verify. Otherwise, use the following rule: When the percentage
calculation yields a decimal part of 0.25, round down; if the decimal part is 0.50 or 0.75, then round
up. For example, if 9 lots are available, then 2 lots would be verified; whereas, if 10 or 11 lots are
available, then 3 lots would be verified.
The inspector has the option of using either of the above two methods. In some cases the lot size class
method may reduce the total number of sample units needed to perform product verification. The
product(s)/lot(s) rates specified above serve only as minimum requirements. The inspector may
increase these rates provided that the total number of products, lot, and sample units are within the
inspector’s capability to verify.
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iv. Selection of Sample Units:
Only single sampling plans as specified by lot size in 50 CFR 260.61 will be used by the inspector when
verifying each selected lot. A maximum of 29 sample units per lot will be used.
v. Product Examination and Quality Assurance Records Review:
Product verification consists of examining the product sample units and reviewing and evaluating all
plant QA records covering the particular product(s)/lot(s) selected for verification.
Verification Factors: For each product, the verification factors (as applicable) are:
1.
2.
3.
4.
5.
6.
7.
8.
9.

Net Weight
Pressed Weight
Count
Scored Grade Factors (Items rated by score points will be evaluated
individually. However, for purposes of determining verification acceptance, not more
than one deviation may be counted for all scored grade factors.)
Total Score
Percent Fish Flesh
Flavor and Odor
Container Integrity
Other product characteristics per approved specifications, standards, standards of
identity, etc.

Once a product is selected for product verification, a complete examination is made for all factors which
can be determined on the product. Some factors such as net weight, flesh content, pressed weight, and
total score point will be verified by statistical means. The deviations noted between USDC verification
and plant-generated results will be the primary basis for determining continued reliability of a
processor’s QA program. Consideration by the inspector and his/her supervisor will be given to the type
of deviation, the severity, and the frequency of their occurrence when making decisions about the
processor’s continued reliability.
vi. Classifying Deviations:
The plant data and information needed for comparison with USDC examination results shall be obtained
from product score sheets, certificates, laboratory test reports, and other documents pertinent to
product evaluation. Deviations are classified into two categories: Minor and Major.
Minor Deviation: A minor deviation is a failure of a part of a quality assurance system, or a difference
between USDC and plant quality assurance product evaluation results which, in itself, is not likely to
reduce materially the effectiveness or reliability of the quality assurance system, or result in the
uncertainty of a product’s disposition.
Major Deviation: A major deviation is a failure of one or more parts of a quality assurance system, or a
difference between USDC and plant quality assurance product evaluation results which will reduce
materially the effectiveness or reliability of a quality assurance system, or results in the uncertainty of a
product’s disposition.
Following are some common deviations with their classifications:
Significant deviations are defined as: 1) USDC results statistically indicate that a product standard is not
satisfied, or 2) USDC/Plant results are not in statistical agreement.
vii. Verification Acceptance Plan for Group 1 Deviations:
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Minors
Number of
Verifications

Acceptance
Number

1–2

1

3–4

2

5–7

3

8 – 10

4

11 – 14

5

15 – 17

6

18 – 20

7

21 – 25

8

26 – 29

9

30 or more

10

Majors
Number of
Verifications

Acceptance
Number

1-7

1

8-16

2

17-28

3

29 or more

4

viii. Unreliable Status:
The plant’s QA program under product verification(s) will be considered to be unreliable when one or
more of the following occur:
1. No corrective action is initiated on program deviations.
2. Minor deviations exceed acceptance numbers during 3 out of any 5 consecutive product
verification periods of evaluation.
3. Major deviations exceed acceptance numbers during 2 out of 5 consecutive product
verification periods of evaluation.
Deviation

Minor Major

Plant QA evaluation indicates product is
one or more grade level(s) above USDC
verification.

X

Plant QA evaluation indicates product is
one or more grade level(s) below USDC
verification.

X

QA evaluation results for individual

X
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factor(s) or groups of factors which are not
statistically reviewed deviate from USDC
verification results by a substantial margin
as adjudged by the USDC inspector
Inaccurate, incomplete or missing records.

X

Verification(s) indicate QA evaluation or
records inaccurate as to meeting
requirements or specifications.

X

Verification(s) indicate statistical significant
deviation from QA evaluation for
measurable factors (averages only).

Attachment
7

Verification(s) of quality assurance records
show incorrect procedure(s).

X

Verification results indicate incorrect
assessment of acceptability and/or
disposition of lot(s).

X

Reporting Unreliability: Findings of unreliability will be reported by the Regional Inspection Office to the
Headquarters Office and the National Seafood Inspection Laboratory so that a determination can be
made as to an establishment’s continued participation in the IQA program. If a determination of
unreliability is made, certification will no longer be based on contractor QA results, and products will be
certified only when a USDC inspector is present during processing. This may require USDC to increase
inspection manpower during the unreliable period. The firm will be notified of this action in writing. To
regain IQA Program approval, reliability must be re-established. This will be determined by a system
audit and satisfactory review.
Appendix 3
a. Codex Recommended International Code of Practice – General Principles of Food Hygiene
(CAC/RCP 1) (Click here)
b. Approved Facilities Sanitation Inspection (coming soon)
i.
Processing Room
ii.
Vessels
iii.
Freezer/Cold Storage
iv.
Dry Storage
v.
Transportation
vi.
Exterior Surroundings
vii.
Hazardous Material Storage
viii.
Labeling
c. Instructions for Inspection of Fish Meal Establishments (coming soon)
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48

ATTACHMENT – Sample of Audit Report Template

Seafood Inspection Program
U.S. Department of Commerce
1315 East-West Highway
Silver Spring, Maryland 20910-3282
USA
______________________________________
Audit Report
(Template and Instructions)
Facility
(Place the full legal business name of the firm
here.)

(In this box of the template, you may place a
picture of the front of the business or a picture of
Site Visit Dates
the firm’s logo. Do not include any photos with
(List the range of the actual dates of the site visit personnel, yourself, team members, or product in
this area. If no appropriate photo exists, leave
portion of the audit.)
the box blank.)
Lead Auditor
(Place the name of the lead auditor, their title,
phone number and e-mail as contact
information.)
Purpose
•
•

To determine if the firm has implemented a program that will adequately address the applicable
requirements for exporting products to the U.S. market and to identified buyers.
To determine if the submitted HACCP plan meets U.S. Food and Drug Administration (FDA)
requirements (CFR Title 21, Part 123) and if the system meets USDC Seafood Inspection
requirements (e.g., the quality plan is being followed by the facility as written).
(These two statements are template language to provide an example in the case of overseas
audits. Keep the purpose statements simple, broad, and factual.)

Scope

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Full Systems Audit--All program requirements, documentation, records, work procedures, and facility
operations under the firm's financial and operational control and as referenced in their HACCP plan for
the applicable fishery products.
(This is template language and again should be left alone without a compelling reason.)
References
Applicable FDA regulations, including but not limited to:
•
•

CFR Title 21, Part 123
CFR Title 21, Part 110

Fish and Fisheries Product Hazards and Controls Guide
(List the main reference materials for this section.)
Introduction
The audit team, consisting of employees of the Seafood Inspection Program of the United States
Department of Commerce, was requested to verify the accuracy, validity, and the implementation of the
food safety and quality management plan at the [FACILITY NAME] facility in [STATE of COUNTRY]. The
request was made and the audit performed on behalf of the U.S. importing firm that purchases product
from the facility.
(Example language. However keep the introduction simple. It is not necessary here to add operations
information on the facility.)
Methodology
Upon arrival at the firm, the opening meeting was performed by procedure and was attended by the
audit team and [LIST ATTENDEES]. The firm’s food safety and quality management plan was received at
the start of the site visit and a desk audit was performed. The audit plan included evaluation of the
firm’s hazard analysis, critical control points (implementation, accuracy, efficacy), sanitation standard
operating procedures, verification procedures, and record keeping. The audit included an evaluation of
plant and food hygiene, final product, and analysis of the gas used in the treated product. Biotrace ProTect protein swabs and Millipore HPC Total Count Swab Kits were employed to assist in determining
cleanliness of selected equipment and utensils. Histamine analysis was performed on product during
processing using the Biomedix IDR HistaQuant analysis. Where possible, observations were verified by
interviews, records, photographs, or testing. Otherwise, observations were verified through both
members of the team. After gaining all necessary objective evidence findings were developed and are
listed below.
(This is template language and should be adapted to fit the audit. It is designed for a general description
of the methods of obtaining evidence of the audit only. In addition only include those tests and
evaluations actually performed.)
Findings
(listed in order of significance)
(In this section list out the findings providing sufficient information in which to lead a reader to
understand the scope of the issue, the evidence found, and the conclusions of the auditor, including why
the decision was made to assess a deficiency or not. An example of a write up is found
below. Photographs can be placed in a way to illustrate and define the issue. Be sure to caption the
50

photograph and keep the statements to fact. Justify paragraphs for the entire report to both sides and
keep margins to a minimum of 1 inch.)
Finding 1: No written HACCP Plan when one is required.
Chapter 6 of the U.S. Food and Drug Administration’s Fish and Fisheries Products Hazards and Controls
Guidance: Third Edition states “Ciguatera toxin is carried to humans by contaminated fin fish for the
extreme southeastern U.S., Hawaii, and subtropical and tropical areas worldwide.” It further states “In
Hawaii and throughout the central Pacific, barracuda, amberjack, and snapper are frequently ciguatoxic,
and many other species both large and small are suspect.” In reviewing the firms species produced it
was found that Red Snapper is often produced and sent to the United States but no HACCP plan was in
place for the product. Further investigation revealed that the country of Indonesia has not issued an
alert for any ciguatoxic species. As the control for this hazard is to not accept fish from known toxic
areas it was determined the hazard was still under control despite no written HACCP plan. However,
now that the hazard is well known by the firm, a HACCP plan for this hazard and product must be
developed. The USDC Seafood Inspection Program will provide templates and correction will be
monitored for the next visit.2.3.1 – SERIOUS
Finding 2: Monitoring procedure stated in the HACCP plan is inadequate.
Chapter 7 of the U.S. Food and Drug Administration’s Fish and Fisheries Products Hazards and Controls
Guidance: Third Edition provides for two control mechanisms for histamine producing species. One
control method relies upon records and data from the harvest vessel and does not require product
evaluation or testing. The other method requires histamine analysis on each lot received per
supplier. Further, only the primary processor is required to use one of these methods. Those who are
secondary processors may assume the firm providing them product has met the USFDA requirements
and are only required to ascertain the product was properly maintained during shipment and up to
receipt.
When evaluating the firm’s HACCP plan for the hazard of histamine, it was found they relied upon the
method of histamine analysis to accept product. However, insufficient samples were being taken and
improper compositing occurred. Further, the firm is still required to perform sensory analysis on
selected product and no sensory analysis elements are found at the receiving critical control
point. Records reviews indicate histamine analysis was performed and results indicated the hazard was
under control. Therefore, only a tightening of the monitoring procedure is necessary. 2.3.8 – SERIOUS

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HACCP plan illustrating the receiving critical control point.
Observations
(This section is for those observations (usually minor and major deficiencies) that are not significant but
should be noted. They do not need to be as prominent as findings, therefore using tables in the
document to place text next to any photographs is more appropriate.)

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3.9.1 – Harborage and attractant areas present.
Dry storage had all materials pushed up against the
wall. This not only prohibits effective sanitation
control, but pests can find harborage in the tight
areas. MAJOR

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Summary and Conclusions
(Again, this is template language and should not be changed.)
The USDC Seafood Inspection Program conducted an audit on [FACILITY] located in [CITY, PROVINCE,
COUNTRY] from [DATES OF AUDIT]. This audit included an examination of the company’s food safety
and quality management plan for the receipt, processing, and packaging of [PRODUCTS] and the
operation of the plan, including sanitation standard operating procedures, for compliance with the
applicable sections of the U.S. Food and Drug Administration (USFDA) regulations addressing
“Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products (21 CFR
Parts 123 and 1240). Based on this audit we have concluded that:
•

•
•

The firm has implemented the seven principles of HACCP as delineated within the guidelines of
National Advisory Committee for Microbiological Criteria for Foods, Codex Alimentarius, the
European Union, and complies with the applicable requirements of the USFDA,
The firm was in conformance to ISO 22000:2005-Requirements for Food Safety Management
Systems, and
The firm produced product that meets the specifications of [FIRM NAME] as identified on
[DATE].

The USDC Seafood Inspection Program can only provide such attestations on an audit-by-audit basis, as
an audit is a picture in time. It is believed that if the firm follows the HACCP plan as written, there is a
reasonable expectation that the products described above and produced by this firm will be acceptable
for import into the United States. This report, or any statements therein, is not a certification or
approval of a specific lot of product. It is only a report on the viability of the system and the processes in
place.
Corrective Action Request

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Corrective action is necessary to improve the process or to bring the system back into control. Even if
the firm does not desire to proceed with another audit or continue with the Program, it is still highly
recommended that the management provide a written corrective action plan to this agency for inclusion
in the report. In this way, the firm's commitment to quality and its due diligence in correcting
deficiencies could be documented. As no findings exist, no corrective action is necessary. (This last
sentence is added only if true.)
Please provide a written corrective action to the findings listed above. Be certain to include both shortterm solutions as well as long term more permanent solutions to each issue.
With respect to continued improvement, we have also enclosed the Systems Compliance Rating to this
report, which contains information and photographs of observed sanitation deficiencies noted during
the course of this audit.
Analytical Test Results
(Place results of tests in this section.)
Location

Protein Swabs

HPC Total Counts

Swabs were taken at locations where product would come into direct contact with product in various
forms. The results above indicate that the conditions are generally acceptable.
Histamine Analysis
Sample

USDC

Facility

Chiller Temperatures
(Insert Chart Here)
54

A Cox Datasource/Marathon Temperature recorder was used to evaluate the cooling capabilities of
chilled storage of the final product. No deficiencies were noted.
(Note: the spike in temperature at the end of the graph indicates when the device was removed from the
cooler and the delay in downloading the data.)
Supplemental Report
(In this section you are to give a general idea of the controls evaluated and found. The narrative below is
an example of the level of detail expected. Attempt to give statements of fact but you may also indicate
other issues, positive and negative, found during your audit.)
Management Controls and Responsibilities
The element of management controls and responsibilities was evaluated through interview,
documentation review, and records assessment. The firm takes reasonable care to place necessary
procedures in writing for consistency. Management commitment to food safety and quality is
implemented or communicated through posted memos and staff meetings. Food safety policy has been
prepared and implementation was demonstrated. The food safety management system planning was
not fully performed in that the hazard of ciguatoxin was not identified. Responsibility or authority for
food safety is clearly defined and communicated, and a food safety team leader is in place which reports
to top management. Effective external and internal communication is established, implemented, and
maintained. Emergency response procedures have not yet been established. Management review is
properly performed and documented through memos to staff and meeting notes. The necessary human
resource competencies have been minimally identified. Personnel have received training necessary for
the proper function of the food system and the training is documented. The infrastructure to
implement and maintain the food safety system is sufficient. The work environment is properly
established, managed, and maintained with regard to food safety. Continuous improvement activities
are minimally performed.
Food Safety Management
The firm’s food safety management plan was reviewed at the start of the site visit by the audit team.
Evaluation of the hazards through a properly developed hazard analysis was complete for all products
except those of ciguatoxic concern. Care was taken to review the controls and monitoring of the firm’s
histamine products relative to the USFDA requirements. The firm is controlling this hazard with a
receiving strategy and laboratory analysis. All elements of the HACCP Plan were developed correctly and
implemented properly and the firm’s plan was signed and dated within the last year. Traceability is
maintained sufficient to perform a mock recall. The firm maintains comprehensive records and reports
that control the hazards for histamine and non-histamine products. The firm’s record keeping system is
fully acceptable with the quality assurance staff competent in their abilities and responsibilities.
Sanitation and Prerequisite Programs
Sanitation standard operating procedures (covering the eight areas of sanitation listed in 21CFR Part 123
and 21CFR Part 110) and acceptable prerequisite programs are in place and sanitation is properly
monitored. The water used for processing in the facility is frequently tested and no deficiencies were
noted in its use and that of the making of ice. The risk of cross contamination between the fresh and
frozen processing areas is minimal, since all of the product is raw and frozen in the final state. Personnel
are well maintained and practice good hygiene within the operational facility. Pest control measures are
in place and no evidence of rodents was noted. Facility and food hygiene were both well maintained.
Quality Management
The element of quality management was evaluated through interview, documentation review, and
records assessment. The firm takes reasonable care to place necessary procedures in writing for
consistency. Quality management procedures are well defined and implemented, with the quality
55

assurance staff adequately performing control measures within their quality
management. Management commitment to quality is implemented or communicated through posted
memos and staff meetings. A quality policy has been prepared and implementation was
demonstrated. Quality planning was fully performed and well implemented. Responsibility or authority
for food quality is clearly defined and communicated, and a quality team leader is in place which reports
to top management. Effective communication is established, implemented, and
maintained. Management review is properly performed and documented through memos to staff and
meeting notes. The quality manual is adequate for the current needs. Customer needs are considered
and implemented where possible. The infrastructure to implement and maintain the food safety system
is sufficient. Non-conforming product is properly controlled. Equipment calibration and laboratory
testing is conducted by the firm’s personnel with private firms and governmental agencies conducting
periodic audits. Continuous improvement activities are minimally performed.
Food Security
Authorized personnel enter the facility through one guarded gated, that maintains security personnel.
All visitors are escorted at all times while on the grounds of the facility. Product is segregated and
secured to limit tampering, and all suppliers are approved prior to purchase. Chemicals are properly
stored, controlled and supervised during use. Raw materials, packaging and labels are stored with-in the
facility grounds, with access limited to authorized personnel. Product integrity is assured through
delivery of finished product to end-user. However, a comprehensive food security plan was not written,
an issue that is under correction.

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