Policies, Procedures, and Requirements 

 for the 

Approval of Facilities and Systems 

 United States Department of Commerce 

Seafood Inspection Program 

1315 East-West Highway 

Silver Spring, Maryland 20910 

January 1, 2008 
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Policies, Procedures, and Requirements for the Approval of Facilities and Systems 

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). 

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 be 

audited on a regular basis as defined later in the 

document and, while product bearing a USDC 

Inspection Mark is being produced, a USDC 

inspector is present ascertaining the quality level 

of the lot 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 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 document 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 
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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 document 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. 

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 

is 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. 

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 occurrence of a 

contaminant in fish due to microbial 

pathogens, chemicals, foreign material, 

spoilage, objectionable taints, unwanted or 

diseased matter, which may compromise 

fish safety or suitability. 

5. Control Point: Any step in a process 

whereby biological, chemical, or physical 

factors may be controlled. 

6. Corrective Actions: An action taken to 

eliminate the causes 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; 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. 
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11. Decomposition: A persistent and distinct 

objectionable odor 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 instrumentality or agency thereof, any 

State, county, municipality, or common 

carrier, and any authorized agent in 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 product in a 

“lot” may not exceed that quantity which is 

produced during a specific production shift. 

23. Low risk products: Seafood that poses no 

significant risk to the health of the public 

when prepared for consumption by 

conventional or traditional means. 

24. Major Deficiency: A significant deviation 

from plan requirements, such that 

maintenance of safety, wholesomeness, or 

economic integrity is inhibited. 

25. 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. 

26. Monitoring Procedures: Scheduled testing 

and/or observations recorded by the firm to 

report the findings at each CCP or DAP. 

27. Objective Evidence: Information, which 

can be proved true, based on facts, obtained 

through observation, measurement, test, or 

other means. 

28. Official Establishment: Any establishment 

which has been approved by the Program 

and utilizes inspection service on a contract 

basis. 

29. 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. 

30. Prerequisite Program: Procedures, 

including Good Manufacturing Practices 

that address operational conditions 
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providing the foundation for the HACCP 

system. 

31. Preventive Measure(s) (control measure):

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. 

32. Process: One or more actions or operations 

to harvest, produce, store, handle, distribute, 

or sell a product or group of similar 

products. 

33. 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. 

34. Product Form: Products which are similar 

in appearance, species, and/or processing 

method. For example, raw shrimp, cooked 

shrimp, breaded shrimp, etc. 

35. 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. 

36. Record: A document that furnishes 

objective evidence of activities performed or 

results achieved. 

37. Risk: The probability that exposure to a 

hazard will lead to negative consequences. 

38. 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. 

39. Severity: The seriousness of the effect(s) of 

a hazard or defect. 

40. Specification: A document stating 

requirements. A detailed document 

describing the materials, dimensions, and 

workmanship requirements of a product. 

41. Systems Audit: On-site NOAA evaluation 

of the firm’s effectiveness in following the 

plan after validation. 

42. 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. 

43. 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. 

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. 

Application for Services 

Firms which wish 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 interests of the 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 
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them of the program, its requirements, and 

policies. 

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 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. 

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. 

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 and 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 

NOTE: Firms which wish to have a more indepth 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.

Note: Firms may request the USDC perform 

the end item evaluation described above 

which can be done immediately prior to or 

during the validation of the system.
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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 

is effectively controlling the identified product 

hazards and/or defects and processes concerned. 

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 product verification. 

All reviews will be performed using accepted 

auditing practices 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 determined to 

be 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. In 

addition, 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) 

production days evaluation during the audit, 

eligible to bear the appropriate official marks or 

advertising claim. Otherwise a successful audit 

with significant deficiencies corrected or on a 

corrective action plan will be necessary prior to 

completing a contract with the Program. 

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. 

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 preapproval. 

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 one 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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System Audits--Surveillance 

Only with a valid contract and continued 

demonstrated compliance with all applicable 

laws and regulations and policies may 1) the 

firm be eligible to use official marks or other 

related statements and 2) firm-collected 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 quarter 

Once every six 

months 

Once every 

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. 

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. 

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 offloading. The other audits may be performed 

either by desk audit or during evaluation of 

storage of 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. 

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 visit at a 

minimum of twice during the year. The 

remaining audits may be performed by desk 

audit review of documentation and records. 

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. 

Retail and Food Service Establishments 

USDC personnel will conduct unannounced 

Systems Audits to determine the firm’s 

continued adherence to their plan. 

Tightened Audit Procedures 

A firm at the tightened frequency has 

demonstrated difficulties in administering their 

food safety and/or quality management 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 

Note: Audit frequency for firms operating on 

a seasonal basis will be determined on a caseby-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. 
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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 by 

USDC is given 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 respected 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. 

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 

2. Identification of the person or persons 

responsible for addressing the situation 

3. The methods to be used to correct the 

problem 

4. A schedule which details the time frame to 

correct the problem 

5. 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. 

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 in headquarters. 

The final determination will be communicated to 

the facility as soon as possible and a written 

report will follow. 

Analytical Testing and Product Verification 

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 
- 9 - 

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. 

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 

device and protecting it from misuse. 

Advertising Participation 

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 and will list the 

firm’s 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 if 

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. 
- 10 -

System Compliance Rating Criteria 

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 

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 
- 11 -

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. 

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 
- 12 -

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 

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 been certified by NOAA for this program. 

In addition, copies of all certified personnel’s 

certificates must on file with the firm. Per 21 CFR 

part 123, these duties are assigned only to properly 

trained personnel. For the IQA and QMP Program, 

properly trained will be any person who has passed 

the NOAA Certification Exam. 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 

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. 

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 prerequisite programs as well as the HACCP plan. 
- 13 -

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) 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 
- 14 -

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. 

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 

only 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 
- 15 -

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: 

1. Natural toxins; 

2. Microbiological contamination; 

3. Chemical contamination; 

4. Pesticides; 

5. Drug residues; 

6. 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 parasite-containing 

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 

sensorically) 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 

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 
- 16 -

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) 

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. 

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 
- 17 -

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 in-process 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 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 processmonitoring instruments and the performing of any 

periodic end-product and in-process 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 

re-adjusted 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 
- 18 -

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 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. 

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 
- 19 -

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. 

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. 

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. The name and location of the processor or 

importer; 

2. The date and time of the activity that the record 

reflects; 

3. The signature or initials of the person performing 

the operation; and 

4. 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 
- 20 -

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 or 

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 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 

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 

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; 

5. Protection of food, food packaging material, and 

food contact surfaces from adulteration with 
- 21 -

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, backsiphonage, 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, backsiphonage, or other sources of contamination. 

A facility will be in compliance when all crossconnections 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 

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) 

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. 
- 22 -

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. Productcontact 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 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 
- 23 -

inspections. If the rooms (including restrooms and 

employee breakrooms) 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 foodhandling 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 crosscontamination 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. 

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 noncompliance. 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 noncompliance 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) 
- 24 -

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 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, 

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 
- 25 -

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 

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 
- 26 -

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 

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 

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 
- 27 -

4.1.3 Quality system planning not properly 

performed. 

Top management shall ensure that quality objectives, 

including those needed to meet requirements for 

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, b) the integrity f 

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 

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. 

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 
- 28 -

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 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 
- 29 -

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 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. 

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 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 
- 30 -

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 customersupplied 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 

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 
- 31 -

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) 

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 

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 

Investigation of suspicious activity 

• 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 

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 inhouse 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. 

Deficiency: Serious 

Self-explanatory. 

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. 

Deficiency: Serious/Critical 

Self-explanatory. 
- 32 -

Appendix 1

HACCP Quality Management Program Audit Frequency 

 Systems Audit Target Frequencies Deficiencies 

Facility Rating Processors Retail Vessels Minor Major Serious Critical 

Reduced Once every 

calendar quarter 

Once every six 

months N/A 0-6 0-5 1 0 

Normal Once every month Once every 

calendar quarter 

Once every 

calendar quarter >7 6-10 2-4 0 

Tightened Daily until 

corrected 

Daily until 

corrected 

As necessary until 

corrected NA >11 >5 >1 

Requirements to be 

Audited at a Reduced 

Frequency 

Three 

consecutive audits 

at Reduced Rating 

Three 

consecutive audits 

at Reduced Rating 

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. 

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 Facilities Reduced Normal Tightened 

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 

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 re-approved. 

Appendix 2 

Product Verification for IQA Facilities 
- 33 -

To assess the plant’s QA 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 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 sampling and inspection. This independence of sampling 

and inspection, and recording of inspection findings is necessary to satisfy the verifications objectives 

under the IQA system. 

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, 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. When acceptance numbers have been 

reached, 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. When the “W” number has been exceeded, 

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. 

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 

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.
- 34 -

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. 

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. 

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. 

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 

Class 

Sample Size Required for 

Inspection 

1 3 

2 6 

3 13 

4 21 

5 29 
- 35 -

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. 

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. 

Product Examination and Quality Assurance Records Review: A 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. Net Weight 

2. Pressed Weight 

3. Count 

4. 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.) 

5. Total Score 

6. Percent Fish Flesh 

7. Flavor and Odor 

8. Container Integrity 

9. 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. 

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. 

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.
- 36 -

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: 

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 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 

X 

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 

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. 

Verification Acceptance Plan for Group 1 Deviations: 

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 
- 37 -

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. 

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.