HACCP Participant Applicant - current respondents

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

Policies, Procedures, and Requirements for the Approval of Facilities and Systems
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.

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.

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.

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.

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.

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.

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

There are three systems of participation as an
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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.

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.

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
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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

21.

22.

23.

24.

25.

26.

27.

28.

29.

30.

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may pose an unacceptable health risk at the
time of consumption.
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.
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.
Low risk products: Seafood that poses no
significant risk to the health of the public
when prepared for consumption by
conventional or traditional means.
Major Deficiency: A significant deviation
from plan requirements, such that
maintenance of safety, wholesomeness, or
economic integrity is inhibited.
Minor Deficiency: A failure of the part of
the HACCP-based system relative to facility
sanitation which is not likely to reduce
materially the facility’s ability to meet
acceptable sanitation requirements.
Monitoring Procedures: Scheduled testing
and/or observations recorded by the firm to
report the findings at each CCP or DAP.
Objective Evidence: Information, which
can be proved true, based on facts, obtained
through observation, measurement, test, or
other means.
Official Establishment: Any establishment
which has been approved by the Program
and utilizes inspection service on a contract
basis.
Plant: The premises, buildings, structures,
and equipment (including, but not limited to,
machines, utensils, and fixtures) employed
or used with respect to the manufacture or
production of processed products.
Prerequisite
Program:
Procedures,
including Good Manufacturing Practices
that
address
operational
conditions

31.

32.

33.

34.

35.

36.

37.
38.

39.
40.

providing the foundation for the HACCP
system.
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.
Process: One or more actions or operations
to harvest, produce, store, handle, distribute,
or sell a product or group of similar
products.
Processed Product: Any fishery product or
other food product covered under the
regulations in this part which has been
preserved by any recognized commercial
process, including, but not limited to,
canning, freezing, dehydrating, drying, the
addition of chemical substances, or by
fermentation.
Product Form: Products which are similar
in appearance, species, and/or processing
method. For example, raw shrimp, cooked
shrimp, breaded shrimp, etc.
Quality: Totality of characteristics of an
entity that bear on its ability to satisfy stated
and implied needs. The inherent properties
of any processed product which determine
the relative degree of excellence of such
product, and includes the effects of
preparation and processing, and may or may
not include the effects of packing media, or
added ingredients.
Record: A document that furnishes
objective evidence of activities performed or
results achieved.
Risk: The probability that exposure to a
hazard will lead to negative consequences.
Serious Deficiency: A severe deviation
from plan requirements such that
maintenance of safety, wholesomeness, and
economic integrity is prevented; and, if the
situation is allowed to continue, may result
in unsafe, unwholesome, or misbranded
product.
Severity: The seriousness of the effect(s) of
a hazard or defect.
Specification:
A
document
stating
requirements.
A detailed document
describing the materials, dimensions, and
workmanship requirements of a product.

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.

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.

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.
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.

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 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.
Additional Requirements for IQA and
HACCP Quality Management Program Plan
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Inspection Program.

with significant deficiencies corrected or on a
corrective action plan will be necessary prior to
completing a contract with the 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.

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.
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.

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

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.
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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.

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.

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.

Resident and IQA Systems Audit Target Frequencies
Processors
Retail
Vessels
Once every
Once every six
Once every
calendar quarter
months
calendar quarter

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.

IQA firms will have their systems audited at the
above frequency as well, but will have their
product quality audited at least once per week,
as the workload demands. Firms in the HACCP
QMP Program will be audited at the frequencies
illustrated in the tables found in Appendix 1.
Note: Audit frequency for firms operating on
a seasonal basis will be determined on a 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.

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.

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.

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

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
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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:

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

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.

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.

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

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
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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.

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.

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
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System Compliance Rating Criteria

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

1.0 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

1.2.0
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

1.1.2
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

1.2.3
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

1.1.3
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

1.3.0
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

1.1.4
Responsibility and authority not properly
defined or communicated.
Top management shall ensure that responsibilities
and authorities are defined and communicated within
- 10 -

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.

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

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

1.5.0
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.

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 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.

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

1.6.1
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
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• 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

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.

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

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.

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

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.

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.
- 12 -

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.

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

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.

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.

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.

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)

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
- 13 -

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 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 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.

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).

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.

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

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.

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

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.

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
- 14 -

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

2.3.5
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

2.3.3
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

2.3.7
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

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

- 15 -

identified allergens are not declared on product labels
where appropriate, a critical deficiency will be
assessed.
Deficiency:
Serious/Critical

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.

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).

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

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

2.3.12 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.

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.

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

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
- 16 -

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.

procedure, including the review of a consumer
complaint, reveals the need to take a corrective
action. (21CFR123.8b)(See Corrective Action
sections listed above.)

The system shall be modified immediately
whenever a reassessment reveals that the plan is
no longer adequate to fully meet the requirements.

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)

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)

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.

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.

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

4. Processors shall immediately follow corrective
action procedures whenever any verification
- 17 -

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.

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

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.

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

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.

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.

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

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.

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

Each lot of product affected by the nonconformity
shall only be released as safe when any of the
- 18 -

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.

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

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

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

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.

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.

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

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.

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

The maintenance of records on computers is
acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic
- 19 -

data and signatures.
Deficiency:
Major (Serious for Labels)

Otherwise, this will be considered an inaccurate
entry.
Deficiency:
Critical

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

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

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.

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

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.

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

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.
- 20 -

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.

acceptability of the water
geographic area.
Deficiency:
Serious

source

from

that

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

The firm shall define the applicable frequencies of
monitoring in their sanitation standard operating
procedures and must adhere to these frequencies.
Deficiency:
Serious

3.2.4
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

3.2.0
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.

3.2.5
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.

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

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.

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
- 21 -

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

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)

3.2.7
Other areas covered by the CGMPs.
Deficiency:
Minor

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

3.3.0
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.

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

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

3.3.5
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

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
- 22 -

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

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

3.4.3.2 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

3.4.2.2 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.

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

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

3.4.6
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)

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
- 23 -

ingredients and/or packaging materials, washing
of equipment and utensils, or in production areas.

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

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.

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

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)

3.4.9
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.

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

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.

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

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

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
- 24 -

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.

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

3.7.1
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

3.5.5
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

3.7.5
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

3.6.2
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

3.8.2
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.

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

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:
- 25 -

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

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

3.9.6
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

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

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

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

- 26 -

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

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

4.1.4
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

4.5.0
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.

4.2.0
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

4.5.1
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

4.3.0
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

4.5.3
Insufficient infrastructure to implement and
maintain the food quality system.
The organization shall provide the resources for the
establishment and maintenance of the infrastructure
needed to implement a proper quality management
system.
Deficiency:
Serious

4.4.0
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.
- 27 -

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

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.

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

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.

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

The organization shall identify statutory and
regulatory quality requirements to the above and
these descriptions are to be kept properly updated.
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

4.7.2
Intended use and reasonably expected
handling of the product not properly considered.
The intended use, the reasonably expected handling
of the end product, and unintended but reasonably
expected mishandling and misuse of the end product
shall be considered and be described in documents to
the extent needed to conduct the hazard and defect
analysis. Groups of users and where appropriate,
groups of consumers shall be identified for each
product, and consumer groups known to be
especially vulnerable to specific food safety hazards,
or product defects, shall be considered.
The
descriptions shall be kept updated.
Deficiency:
Major

4.7.0
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
- 28 -

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

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

4.7.4
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.

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

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

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
- 29 -

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

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

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

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

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
- 30 -

•
•

•
•

•

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)

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.

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

5.3.0
Facility
5.3.1
Facility, including outside premises,
grounds, and perimeter, are not properly secure.
Self-explanatory.
Deficiency:
Critical

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

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.

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
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Appendix 1
HACCP Quality Management Program Audit Frequency

Facility Rating
Reduced
Normal
Tightened
Requirements to be
Audited at a Reduced
Frequency

Systems Audit Target Frequencies
Processors
Retail
Vessels
Once every
Once every six
N/A
calendar quarter
months
Once every
Once every
Once every month
calendar quarter
calendar quarter
Daily until
Daily until
As necessary until
corrected
corrected
corrected
Three
Three
consecutive audits consecutive audits
N/A
at Reduced Rating at Reduced Rating

Minor

Deficiencies
Major Serious

Critical

0-6

0-5

1

0

>7

6-10

2-4

0

NA

>11

>5

>1

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
Number of Facilities
2-4
5-8
9 - 12
13 - 16
17 - 20
21 - 30
31 - 40
41 - 70
71 - 100
101 or more

Stores to Sample Per Calendar Quarter
Reduced
1
3
4
6
8
9
10
10
10
10

Normal
2
4
6
8
10
13
15
18
19
20

Tightened
ALL
5
8
10
13
18
21
25
30
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
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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.
Note: The independent sampling and inspection for product verification does not mean that the USDC
inspector takes no action if his/her inspection results indicate a potential or actual rejection of a
production lot currently being processed.
There are three instances where the inspector will notify the plant QA department of potential or actual
product rejections when verifying a product being processed.
Absolute Factors: For factors such as flavor and odor, health hazard situations, scores
below 81 – in the case of a US Grade A product, or for any reason that the product cannot
pass inspection, the plant QA will be notified immediately. If the plant QA has found
similar results and is taking appropriate action, 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
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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
1
2–4
5–8
9 – 13
14 – 19
20 or more

Minimum Number of Products
to Verify
1
2
3
4
5
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
1
2
3
4
5

Sample Size Required for
Inspection
3
6
13
21
29
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Note: Lot size class 5 includes all lot sizes requiring (per 50 CFR 260.61) sample
sizes of 29 or more. For lots in this class a sample size of 29 will be drawn.

For example, those lots of a product to be verified that would require a sample of 3 units make up lot size
class 1. Then from each lot size class, randomly select 25 percent of the applicable lots. More than 25
percent of the lots may be selected and verified if results indicate the need. If less than 4 lots are
available, select 1 lot at random to verify. Otherwise, use the following rule: When the percentage
calculation yields a decimal part of 0.25, round down; if the decimal part is 0.50 or 0.75, then round up.
For example, if 9 lots are available, then 2 lots would be verified; whereas, if 10 or 11 lots are available,
then 3 lots would be verified.
The inspector has the option of using either of the above two methods. In some cases the lot size class
method may reduce the total number of sample units needed to perform product verification. The
product(s)/lot(s) rates specified above serve only as minimum requirements. The inspector may increase
these rates provided that the total number of products, lot, and sample units are within the inspector’s
capability to verify.
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.
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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
Plant QA evaluation indicates product is one or more grade level(s) above USDC verification.
Plant QA evaluation indicates product is one or more grade level(s) below USDC verification.
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
Inaccurate, incomplete or missing records.
Verification(s) indicate QA evaluation or records inaccurate as to meeting requirements or
specifications.
Verification(s) indicate statistical significant deviation from QA evaluation for measurable
factors (averages only).
Verification(s) of quality assurance records show incorrect procedure(s).
Verification results indicate incorrect assessment of acceptability and/or disposition of lot(s).

Minor

Major
X

X
X
X
X
Attachment 7
X
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
1–2
3–4
5–7
8 – 10
11 – 14
15 – 17
18 – 20
21 – 25
26 – 29
30 or more

Acceptance
Number
1
2
3
4
5
6
7
8
9
10

Majors
Number of
Verifications
1–7
8 – 16
17 – 28
29 or more

Acceptance
Number
1
2
3
4
- 36 -

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.

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