Background

Definitions

Procedures

System Audits

	Vessels
	Processing Establishments
	Retail and Food Service Establishments

Verification Audits

Determination of Fees and Charges

Table 1: Number of Analyses per Commodity

Table 2: Samples, Subs, and Composites Summary per Lot

Appendix A - Submission Guide & Sample HACCP Plan

	Organization Chart
	Process Flow Chart

Appendix B - Systems Audit Checklist

	Completion Instructions
	Checklist and Audit Frequency Schedule

Appendix C - Systems Audit Checklist Reference

Appendix D - Minimum Criteria for Quality Assurance Systems

I. SUBJECT: Development, Assessment, Approval, and Continuing

Compliance Evaluation of HACCP-based Inspection Systems.

II. AUTHORITY: 50 CFR 260.103(c)

III. POLICY: NMFS policy is to encourage and assist interested parties in the development and implementation of HACCP-based inspection systems to facilitate consistent distribution of safe, wholesome, and properly labeled fishery products of desired uniform quality. The development and implementation of HACCP-based inspection systems is optional. However, their use should result in more efficient use of NMFS resources to inspect, grade, and certify fishery products.

IV. PURPOSE: (1) To provide guidance for the development, implementation, and operation of HACCP-based inspection systems which will meet NMFS approval, and (2) to establish procedures for use by USDC inspectors to ensure uniformity in the evaluation of the completeness and effectiveness of the system.

V. GENERAL: In July 1992, NMFS published a Federal Register notice announcing the availability of a new seafood inspection program based on Hazard Analysis Critical Control Point (HACCP) principles. This program is a refinement of the Integrated Quality Assurance (IQA) Program that also uses HACCP principles. However, the IQA program, having unique methods for the inspection and grading of products, will continue as an option for applicants to the program.

Background

HACCP, is a non-traditional, non-continuous inspection technique recommended by the National Academy of Sciences as a more scientific, analytical, and economical approach than that provided by traditional inspection and quality control methods. HACCP, which focuses on problem prevention and problem solving, relies heavily on proper monitoring and record keeping by the industry. One of the primary economic benefits of HACCP is that it provides for reduced destructive sampling of the finished product as compared to the end-product sampling required under traditional inspection systems, including the current NMFS Integrated Quality Assurance program.

In addition, the application of HACCP principles to seafood inspection has been adopted by several countries, including Canada, Iceland, and Thailand, and is becoming more broadly recognized by the international community as a mechanism to apply uniform inspection procedures.

Industry and NMFS Benefits

The HACCP-based inspection program will allow participants an opportunity to apply their existing quality control 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. It will also allow for more efficient use of NMFS resources. The new program is structured so that NMFS inspection frequencies can be varied depending on an individual facility's compliance history. That is, firms that demonstrate the ability to maintain consistent control can be inspected less frequently.

In summary, the HACCP-based service is consistent with global activities to harmonize inspection protocols. In addition, NMFS believes that the HACCP-based service will enhance the safety, wholesomeness, and economic integrity of seafood available to consumers, as well as improve seafood industry quality assurance and regulatory oversight.

VI. DEFINITIONS:

A. Control Point: Any step in a process whereby biological, chemical, or physical factors may be controlled.

B. Corrective Actions: Procedures to be followed when a serious or critical deficiency is assessed or when a critical limit is reached or exceeded.

C. Critical Control Point (CCP): Any step in a process which, if not properly controlled, may result in an unacceptable safety, wholesomeness, or economic fraud risk.

D. 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.

E. Critical Limit: An established point which must not be exceeded if a hazard is to be controlled at a CCP.

F. HACCP Plan: A document that describes the firm's HACCP-based inspection system.

G. 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.

H. Low risk products: Seafood that poses no significant risk to the health of the public when prepared for consumption by conventional or traditional means.

I. Major Deficiency: A significant deviation from plan requirements, such that maintenance of safety, wholesomeness, or economic integrity is inhibited.

J. Minor Deficiency: A failure of the part of the HACCP-based system relative to facility's sanitation which is not likely to reduce materially the facility's ability to meet acceptable sanitation requirements.

K. Monitoring Procedures: Scheduled testing and/or observations recorded by the firm to report the findings at each CCP.

L. Preventive Measure(s): Any action that will inhibit the introduction of hazards into the product.

M. Process: One or more actions or operations to harvest, produce, store, handle, distribute, or sell a product or group of similar products.

N. 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.

O. Substantial risk products: Seafood that may pose a significant danger to the health of the public when prepared for consumption by conventional or traditional means. For example, ready-to-eat; heat and/or brown and serve products; products which may contain a microbial pathogen, biotoxin, or physical or chemical contaminant which may pose an unacceptable health risk at the time of consumption.

P. Systems Audit: On-site NMFS evaluation of the firm's effectiveness in following the plan after validation.

Q. Validation: On-site NMFS evaluation of the plant's completeness and workability, and the firm's effectiveness in following the plan.

R. Verification: Periodic review by the firm to determine the overall effectiveness of the HACCP plan.

S. Verification Audit: Unannounced on-site NMFS review of the effectiveness of NMFS field inspection personnel in following established procedures.

VII. PROCEDURES:

A. Application:

1. Firms who wish to participate in the Program may apply orally or in writing to the appropriate Regional Inspection Branch. If application is made orally, it must be confirmed promptly in writing.
2. Once an application is received by the Regional Inspection Branch, it is forwarded to the Regional HACCP Activities Coordinator for action.
3. The Regional HACCP Activities Coordinator will provide the applicant with all necessary materials to inform them of the program and its requirements. This material will also include the requirements for development and submission of a HACCP Plan.
4. The Regional HACCP Activities Coordinator will complete a Record of Contact for this activity and forward it to Division Headquarters for entry into the tracking system.
5. The firm develops its HACCP Plan and submits it for review according to the HACCP Plan Review Procedures below.

NOTE: Firms who wish to have a more in-depth presentation of the Program and its requirements may request a meeting of all interested parties. This may incur a cost for travel and should be discussed with the appropriate Regional Inspection Branch.

B. Development of HACCP Plans. Each applicant must submit a HACCP plan in accordance with the attached Submission Guide (Appendix A).

NOTE: At the request of the firm, NMFS will provide consultation toward the development of the HACCP plan on a fee basis (See paragraph IX.).

All processes included in the HACCP Plan must include the following elements. More detail can be found in the attached Submission Guide (Appendix A).

1. Organization Chart and Narrative: A diagram identifying the personnel responsible for the development, implementation, and maintenance of the plan; and narrative describing the duties of the identified personnel.
2. Description of Fishery Products: A list of all major groups of finished fishery products that are to be covered by the HACCP-based Inspection Program.
3. Process Flow Charts: A diagram(s) illustrating the operational steps involved with a product or similar products.
4. Critical Control Point Worksheet: A description of the following information for each CCP.

a) Location of the Critical Control Point

b) Hazards to be controlled at that Critical Control Point

c) Preventive Measures

d) Critical Limits

e) Monitoring Procedures

f) Corrective Actions

g) Records

5. Record Keeping System: A method to identify, describe, and locate the records associated with the plan. All plan records must be maintained by the firm for a period of six months beyond the expected shelf life of the product and be accessible at all times to NMFS inspection personnel.

6. Verification Procedures: A description of the methods the firm will use to determine the overall effectiveness of the HACCP plan.

7. Sanitation Standard Operating Procedures: A comprehensive description of the firm's program to ensure sanitation compliance.

8. Consumer Complaint File: A procedure for handling, addressing, and filing consumer complaints.

9. Recall Procedures: A method for identifying, locating, and retrieving products.

NOTE: Although not required, NMFS recommends that the firm'submit end-item verification records (as described in paragraph VII.E) with their HACCP Plan. This will allow the firm to test their controls, provide plan reviewers more information, and possibly reduce the Validation cost.

C. HACCP Plan Review and Approval: Submission and review of HACCP Plans will be handled using the following procedures:

1. Plans are submitted to the Regional HACCP Activities Coordinator.
2. The Regional HACCP Activities Coordinator, through Region management, assigns the plan to a qualified Consumer Safety Officer for initial review.
3. The assigned Consumer Safety Officer reviews the plan and requests changes, clarifications, deletions, etc., from the firm. In this activity, the assigned officer works with the firm to finalize the development of the HACCP Plan.
4. Once the assigned officer is assured the firm's HACCP Plan is complete, it is forwarded to the Regional HACCP Activities Coordinator. Included with the HACCP Plan is an outline of the activities of the reviewer which describes the controversies encountered and the decisions, if any, that were agreed to between the reviewer and the firm.
5. The Regional HACCP Activities Coordinator reviews the HACCP Plan for completeness and workability. A written review is sent to the firm indicating what changes, if any, are necessary prior to Validation.
6. Once it is decided by the Regional HACCP Activities Coordinator that the HACCP Plan is ready for Validation, it is forwarded to Field Operations Headquarters, National HACCP Activities Coordinator for final review. A complete description of all work by both the assigned Consumer Safety Officer and the Regional HACCP Activities Coordinator accompanies the HACCP Plan.
7. Field Operations performs a final review of the HACCP Plan ascertaining complete work by the Region. When the plan review is complete, Field Operations informs the Region as to approval/disapproval of the HACCP Plan and, if applicable, requests the Region to schedule the Validation with the firm.
8. All work of the assigned CSO and Regional HACCP Activities Coordinator is performed on a fee basis according to the Schedule. All time and charges are logged by all parties involved in their personal logs and a Daily Record of Charges is completed.
9. Modifications to the HACCP Plan: After the HACCP plan has been validated, modifications may be made under the following conditions:

a. The firm must notify NMFS, in writing (Faxes are acceptable), of any modifications in their HACCP plan before implementing the changes.

b. Any changes made to the plan due to unusual circumstances, such as to address a health or safety issue, must be documented in a corrective action plan.

c. The NMFS Regional Inspection Branch must be notified of these immediate changes within one working day.

D. Label Review Procedures:

1. All applicable labels must be approved prior to use in accordance with Part I, Chapter 3, Section 5 of NOAA Handbook 25, Inspection Manual except as listed below. (Labels previously submitted and approved under other existing NMFS Inspection Programs need not be resubmitted for approval)
2. Labels will be submitted to the HACCP Activities Coordinator for review. With respect to the HACCP-based Inspection Program only, the firm's HACCP Plan will act as the required specification for label review.
3. The HACCP Activities Coordinator will forward these labels for approval to a qualified Consumer Safety Officer. Once completed the HACCP Activities Coordinator will combine the review of labels with the plan review and forward all to the facility.
4. If a firm believes it is competent to review its own labels, the following procedures apply:

a. A sample of the labels of products covered in the firm's HACCP Plan will be submitted to the Consumer Safety Officer assigned to review the firm's HACCP Plan.

b. The sample size will consist of a minimum of six labels and a maximum of ten (10) percent of the firm's total applicable labels. At least one label for each identified process will be submitted.

c. The labels will be reviewed for accuracy and compliance. Preliminary reviews (general compliance to Part I, Chapter 3, Section 5, NOAA Handbook 25) will be conducted by the assigned Consumer Safety Officer, or other qualified field personnel. More specific and final reviews for compliance will be sent to the Label Approval Officer, Document Approval and Supply Services, Pascagoula, MS.

d. If after this review it is determined that the firm has control of the labeling requirements associated with its products (legal and programmatic), then the firm will be allowed to produce products under the HACCP Plan without routine NMFS label pre-approval.

e. If a firm is granted pre-approval authority for its labels, five copies of each label of products covered by the firm's HACCP Plan must be submitted to the Label Approval Officer, Document Approval and Supply Services, Pascagoula, MS.

f. These copies must be submitted within sixty (60) days of first use by the firm.

g. In addition, each label used by the firm will be considered a part of the records of the HACCP Plan and will be treated as such. Demonstrated failure of the firm to adhere to their responsibilities in this area will be considered a failure of the HACCP Plan and the firm will be assessed a deviation in the appropriate place on the Systems Audit Checklist. Failure will also result in the immediate suspension of this policy and the firm will be required to submit labels for approval prior to their use.

NOTE: Product labels bearing a Child Nutrition Statement must be approved prior to use in accordance with USDA requirements. There will be no exceptions.

E. Pre-Validation: Prior to Validation of the firm's HACCP Plan, the firm must operate using the plan for a specified time period. This will provide the Validation team with necessary information regarding the firm's ability to follow their own written procedures. To prepare for the Validation, the firm must follow the following procedures:

1. The firm'should begin following their plan as soon as possible.
2. The firm will adhere to the plan's provisions and keep all records associated with the approved HACCP plan for at least 10 consecutive production days.
3. The firm will contact the Regional Inspection Branch as soon as they believe the approved plan is functioning successfully and when they have records covering at least ten (10) consecutive production days.
4. The Regional Inspection Branch will schedule a Validation inspection with the firm. Once the Validation is scheduled the Regional Inspection Branch informs Field Operations of its date and location as well as all parties who will attend from NMFS.
5. The firm must verify through end-product examination that the process controls result in complying product. If documentation has not been previously provided, the firm must collect data during the pre-validation period which will be sufficient to demonstrate this relationship. Firms attempting to document this relationship during the pre-validation period must collect data on not less than 20 percent of their lots using sampling plans comparable to those in 50 CFR Part 260, with at least one lot representing each product form. The inspection records must be available to NMFS at the validation.

F. Validation:

The Validation will determine whether all of the hazards and CCPs have been identified, the plan is being followed and monitored by the firm, and is effectively controlling the identified hazards. Procedures for Validation are as follows:

1. The Validation will be conducted on a fee basis (See paragraph IX.) by a team of no more than three NMFS officials. The number and structure of the team will be determined by the size and complexity of the firm's process and nature of hazards associated with the products covered under the HACCP Plan.
2. The Validation team will have an assigned Consumer Safety Officer as lead who will have final authority of the facility's firm's rating based on the teams findings.
3. Validation includes conducting paperwork reviews, recording sanitation and in-process observations and inspecting samples of finished product. All reviews will be performed using accepted auditing practices.
4. Product evaluations will be completed by conducting a combination of statistical reviews of records and finished product sample inspections. At least one lot for each product form will be evaluated by inspecting samples of finished product. NMFS inspection personnel may, for cause, sample and inspect lots in excess of this guideline. Results will be recorded on the appropriate score sheet(s).
5. Firms will be rated using the appropriate Systems Audit Checklist. If the firm receives a Level IV rating or higher it will qualify as a participant in the program and may finalize a contract for services with NMFS.
6. 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 NMFS towards issuing official certification of the firm's products or facility compliance.
7. To build a compliance history, all firms will enter the program at Level IV. The results of subsequent Systems Audits, as described in Section G, will allow changes in the facility rating.
8. If a firm passes its Validation, all products under review during the Validation, including the previous ten (10) production days, are eligible to bear the appropriate official marks or advertising claim.

NOTE FOR VESSELS: Due to logistical factors, only one NMFS Consumer Safety Officer will perform the Validation. In addition, the pre-validation and validation periods may be combined. The NMFS Consumer Safety Officer will accompany the vessel for an appropriate time period during a fishing season, performing the background checks of critical control points and validating the plan at one time. The officer may assist the quality assurance/management group on board the vessel in any alterations to make to their HACCP Plan to work toward plan approval and a successful Validation. Once the HACCP plan is validated, 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.

G. Systems Audits:

1. VESSELS:

a. After the firm's HACCP Plan is validated, NMFS will conduct Systems Audits, at the frequency described below, to determine the firm’s continued adherence to their HACCP Plan:

* An on-board Systems Audit for facilities at these Levels shall be conducted on a frequency of not less than annually.

b. Firms must provide the appropriate NMFS Regional Inspection Branch with all necessary season schedules and off-loading schedules and sites as soon as they are known. Firms must give the Port NMFS Consumer Safety Officer a minimum of 24 hours notice of port arrival.

c. A visit will be composed of a minimum of one, to a maximum of ten (10) percent of, the scheduled fishing days for the trip in question. For example, if a trip is scheduled to last 30 days, the Systems Audit will be performed over approximately three days. Additional days may be necessary if the Consumer Safety Officer has encountered a problem during the audit.

d. A firm may move to the next higher rating after completing the above number of successive Systems Audits. A firm will move to a lower Level if one Systems Audit results in a rating that is lower than the current Level held by the firm. For example, a firm at Level III will have to complete 2 successive Systems Audits with a rating of Level II or higher in order to move up to the audit frequency of Level II. Conversely, a firm that is currently at Level I will move down to Level IV if any Systems Audit results in a rating of Level IV.

e. The results of each Systems Audit will determine the firm’s next rating and are based upon the findings as recorded on the appropriate Systems Audit Checklist.

f. The NMFS Consumer Safety Officer will complete the Systems Audit Checklist in accordance with the instructions in Appendix B and Appendix C. The information recorded on the checklist will indicate to the NMFS Consumer Safety Officer and the firm how well the plan is being followed.

g. To determine whether the product meets specification and/or U.S. grade standard requirements, NMFS will audit a percentage of the total lots produced by the firm since the last Systems Audit, as follows:

h. Product verifications will be completed by conducting records reviews and finished product sample inspections. Lots must be defined by the firm in their HACCP plan and approved by NMFS.

NOTE: Samples of finished product may be pulled while the NMFS Consumer Safety Officer is on board or at dockside. If samples are pulled while on board, they will be evaluated immediately for compliance.

i. A minimum of five (5) lots (or the above percentage, whichever is greater), and a maximum of fifty (50) lots will be evaluated by records reviews.

j. In addition to the records reviews, at least one lot and up to 50 percent of the lots selected for records review will be selected for product verification and evaluated by inspecting samples of finished product.

k. The results of each finished product inspection will be recorded on the applicable score sheet(s). All score sheets will be attached to the Systems Audit Checklist.

2. PROCESSING ESTABLISHMENTS:

a. NMFS will conduct unannounced Systems Audits, at the frequency identified below, to determine the firm’s continued adherence to their plan.

b. The results of each Systems Audit will determine the firm's next rating and are based upon the findings as recorded on the appropriate Systems Audit Checklist.

c. A firm may move to the next higher rating after completing the above number of successive Systems Audits that resulted in a higher rating than currently held by the firm.

d. A firm will move to a lower Level if one Systems Audit results in a rating that is lower than the current Level held by the firm. For example, a firm at Level III will have to complete 2 successive Systems Audits with a rating of Level II or higher in order to move up to the audit frequency of Level II. Conversely, a firm that is currently at Level I will move down to Level IV if any Systems Audit results in a rating of Level IV.

e. The NMFS Consumer Safety Officer will complete the Systems Audit Checklist in accordance with the instructions in Appendix B and Appendix C. The information recorded on the checklist will indicate to the NMFS Consumer Safety Officer and the firm how well the plan is being followed.

f. To determine whether the product meets specification and/or U.S. grade standard requirements, NMFS will audit a percentage of the total lots produced by the firm since the last Systems Audit, as follows.

g. Product verifications will be completed by conducting records reviews and finished product sample inspections. Lots must be defined by the firm in their HACCP plan and approved by NMFS.

h. A minimum of five (5) lots (or the above percentage, whichever is greater), and a maximum of fifty (50) lots will be evaluated by records reviews.

i. In addition to the records reviews, at least one lot and up to 50 percent of the lots selected for records review will be selected for product verification and evaluated by inspecting samples of finished product.

j. The results of each finished product inspection will be recorded on the applicable score sheet(s). All score sheets will be attached to the Systems Audit Checklist.

3. RETAIL AND FOOD SERVICE ESTABLISHMENTS:

a. NMFS will conduct unannounced Systems Audits, at the frequency identified below, to determine the firm's continued adherence to their plan.

b. The results of each Systems Audit will determine the firm’s next rating and are based upon the findings as recorded on the appropriate Systems Audit Checklist.

c. A firm may move to the next higher rating after completing the above number of successive Systems Audits that resulted in a higher rating than currently held by the firm.

d. A firm will move to a lower Level if one Systems Audit results in a rating that is lower than the current Level held by the firm. For example, a firm at Level III will have to complete 2 successive Systems Audits with a rating of Level II or higher in order to move up to the audit frequency of Level II. Conversely, a firm that is currently at Level I will move down to Level IV if any Systems Audit results in a rating of Level IV.

e. The NMFS Consumer Safety Officer will complete the Systems Audit Checklist in accordance with the instructions in Appendix B and Appendix C. The information recorded on the checklist will indicate to the NMFS Consumer Safety Officer and the firm how well the plan is being followed.

f. To determine whether the product meets specification and/or U.S. grade standard requirements, NMFS will audit a percentage of the total lots produced by the firm since the last Systems Audit, as follows.

g. Product verifications will be completed by conducting records reviews and finished product sample inspections. Lots must be defined by the firm in their HACCP plan and approved by NMFS.

NOTE: NMFS is interested in providing this program with a minimum possible burden to participants. Record keeping should not be so grand as to cause undue hardship on the retailer. Records should be of a precision only to show what products were received by what supplier on a particular day.

h. A minimum of five (5) lots (or the above percentage, whichever is greater), and a maximum of fifty (50) lots will be evaluated by records reviews.

i. In addition to the records reviews, at least one lot and up to 50 percent of the lots selected for records review will be selected for product verification and evaluated by inspecting samples of finished product.

j. The results of each finished product inspection will be recorded on the applicable score sheet(s). All score sheets will be attached to the Systems Audit Checklist.

k. Procedures for Chains with an Established Quality Assurance Program:

1) Firms which operate a chain of stores may have the stores under the program sampled at the frequency outlined below (provided they have an established approved Quality Assurance System):

In addition the following criteria apply:

Reduced 80% of the stores sampled must be at Level II or higher with a minimum of 5% at Level I. No stores in the sample may be at Level IV.

Normal 90% of the stores sampled must be at Level III or higher with no stores in the sample at Level IV.

2) All firms will begin at the Tightened level. After two successful calendar quarter at this level the firm may move up to the Normal level.

3) If the firm remains at the Tightened level for three calendar quarters, the firm will be subject to store by store auditing for a period of six months. After six months the firm may reapply for this sampling system under their quality assurance program.

4) The firm must achieve the Reduced level of compliance while at the Normal level for two calendar quarters in a three calendar quarter period in order to move to the Reduced level of auditing.

5) No stores in the sample will be permitted to fall to Level V. If a store in the sample falls to Level V, the Firm’s Quality Assurance System is suspect. NMFS will perform an audit on the total Quality Assurance System for the next thirty days. This audit will include the sampling of additional stores.

6) 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.

7) If the Quality Assurance System is deemed to not be performing as designed, all stores will be subject to inspection for the next six months. After that time, the firm may reapply for NMFS acceptance of the Quality Assurance System.

8) During this thirty day period the stores may continue to use all advertisement claims.

9) NMFS will evaluate the Quality Assurance Systems using the guidelines listed in Appendix D.

10) 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.

H. Laboratory Analyses Procedures:

1. Sample Selection

a. The Consumer Safety Officer must select, inspect condition of product, pack, and dispatch the sample. Plant personnel are NOT to handle the sample. The sampling process must be conducted in compliance with the National Marine Fisheries Service and the National Seafood Inspection Laboratory guidelines and procedures as identified in Tables 1 and 2.

b. The appropriate number of sample units must be removed for laboratory analysis from each lot according to the information contained in the body and footnotes of Tables 1 and 2. After the samples are removed, the Consumer Safety Officer must indicate on each sample bag with a "permanent marker" the following information: subsample number; sample description (commodity or product); lot or code number; subsample numbers per lot; quantity; size and weight; and date and time. The list of instructions and table for each type of sampling is furnished as Appendices 1-4.

c. The NMFS Consumer Safety Officer will select samples for laboratory analyses in accordance with Tables 1 and 2 or for cause. Where several product forms (e.g., cooked shrimp, cooked spiced shrimp, and cooked breaded shrimp, cooked crawfish, cooked lobsters, and cooked snow crabs) are produced under a single approved HACCP Plan, these are considered as one commodity. Sampling requirements for laboratory analyses apply to the commodity in this context, not to individual products or product forms (examples are stuffed trout or stuffed flounder, fish sticks or fish portions, cooked shrimp of different sizes or in different packages). In some cases multiple analyses can be conducted from a single set of subsamples.

2. Identifying and Documenting Samples

a. The Consumer Safety Officer must complete the Sample Submission Sheet with the required sample and subsample information for the samples being shipped. The sheet must contain the following information:

1) Date Submitted

2) Company - Name/Owner

Address and Phone Number

3) Consumer Safety Officer Name

4) Consumer Safety Officer Number

5) Consumer Safety Officer Phone Number

6) Date Collected

7) Time Collected

8) Product Code/Brand

9) Type of Analysis Requested

10) Sample Number

11) Type of Product Commodity

12) Lot or Code Number

13) Lot Size

14) Unit Size or Weight

15) Units Submitted

16) Other Information - When available provide the following information if possible:

a) Condition of raw material(s)

b) Condition of finished product.

c) Age of raw materials at time of production.

d) Length of time raw material held in storage.

e) Length of time finished product held in storage.

f) Storage temperature.

g) Raw material storage condition.

h) Finished product storage conditions.

i) Condition of production equipment.

j) Any additional information that will help in the analysis.

k) Species and country of origin.

3. Sample Shipment

a. The Consumer Safety Officer must use a leak-proof, insulated container for shipping fresh or frozen seafood product samples. It should be as light weight as possible to minimize shipping costs, yet sturdy enough to maintain the integrity of its contents during handling and shipping by common carriers. Containers for non-perishable samples, i.e., samples not requiring refrigeration, must be sturdy enough to retain the samples in their original condition.

1) Fresh Perishable Samples -- All samples of fresh perishable products will be packed with frozen gel packs in sufficient quantity to maintain the product at a temperature not to exceed 38 degrees F for at least three days. The container will be marked "Perishable Product."

2) Frozen Samples -- All samples of frozen products will be packed with sufficient frozen gel packs to maintain the product in a frozen state for at least three days. The container will be marked "Perishable Product."

3) Non-Perishable Samples -- Canned products shall be packed in a sturdy container acceptable by common carrier.

4) Dry Ingredient Samples -- Dry products shall be placed in a plastic bag, preferably of the whirl-a-bag type. Samples submitted for pesticide or other chemical tests should be placed in clean glass containers.

5) Time of shipment - Perishable samples must be shipped no later than Wednesday by overnight delivery to assure arrival no later than Thursday, 10:30 am.

6) The Consumer Safety Officer will also complete a Government Bill of Lading (GBL) as needed.

7) Shipments by overnight mail will be consigned to:

F/TS41 - Laboratory Director

C/O Sample Custodian

DOC/NOAA/NMFS

National Seafood Inspection Laboratory

3209 Frederic Street

Pascagoula, MS 39567

(601) 762-7402

I. Verification Audits:

1. NMFS will be responsible for verifying that the HACCP-based Inspection Program is functioning in accordance with established procedures.
2. The Verification Audits will be performed by a team which may include individuals from NMFS Inspection Headquarters, Regional Inspection Branch, and the NMFS National Seafood Inspection Laboratory.
3. Verification Audits will be performed at the following frequencies based on the risk of the product(s):

Substantial Risk products: at least once every two years unless the firm is rated below Level IV.

Low Risk products: at least once every two years for the first four years the firm is in the Program. Verification Audits will then be performed every four years as long as the firm does not drop below Level IV in those four years.

4. A Consumer Safety Officer from the Regional Inspection Branch will be present during all Verification Audits and will conduct a Systems Audit.

5. The Verification Team will also conduct a Systems Audit to compare with the Regional Inspector's results.

6. Any differences in the results of the Verification Team's results and the inspector's results will be discussed.

7. The rating identified by the Verification Team will be the final rating of the firm for that visit.

J. Procedures for Firms Which Fall Below Level IV: A firm rated at Level V has demonstrated difficulties in administering their HACCP Plan. Firms which fall to Level V at any time will be subject to the following procedures:

1. If a Consumer Safety Officer believes that a facility has fallen to Level V rating, he/she will contact the Regional HACCP Activities Coordinator and the officers Supervisor.
2. The three together will decide whether or not to recommend that the facility should drop to Level V. If so, the Regional HACCP Activities Coordinator will contact the National HACCP Activities Coordinator.
3. The Regional HACCP Activities Coordinator will FAX all necessary information to the National HACCP Activities Coordinator and then contact him/her by telephone. Present on the call will be the appropriate Supervisory CSO, the Regional HACCP Activities Coordinator, and the auditing CSO.
4. Once all information is received by the National HACCP Activities Coordinator, a decision will be made by the Inspection Services Division Management. The decision will be communicated to the Regional HACCP Activities Coordinator as soon as it is made. A written report will follow.
5. The decision to drop a facility to Level V will be made prior to the Consumer Safety Officer performing the exit interview.
6. Facilities who fall to Level V have a period of thirty days to obtain a rating of Level IV or higher. Failure to do so will result in the facility’s removal from the NMFS HACCP-based Inspection Program.
7. A firm who falls to Level V may continue to use the mark or other advertising privileges if consent by NMFS is given for daily auditing of the firm. Consent will be on a case by case basis and granted only if NMFS believes the nature of the condition which caused the firm to fall to Level V warrants daily auditing. Daily auditing will be acceptable to NMFS under the following conditions:

a. The firm must submit a corrective action plan to the NMFS Consumer Safety Officer detailing how they will correct the problem and obtain a Level IV (Faxes are acceptable). 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 handling the situation

3) The methods to be used to correct the problem

4) A schedule which details the time frame to correct the problem

5) A statement with signatures of top management attesting to their commitment to correct the deficiency

The corrective action plan must be written in sufficient detail to provide NMFS with all necessary information for its approval or disapproval.

b. The NMFS Consumer Safety Officer will review the corrective actions identified by the firm and send a copy to the Regional Inspection Branch and NMFS Headquarters.

c. NMFS Headquarters will approve or disapprove the corrective actions and notify the Regional Inspection Branch who will contact the firm. At this time, NMFS will discuss with the firm how long they must remain on daily auditing. In any case, daily auditing will be granted for only thirty calendar days.

d. Products may be certified during daily auditing. However, if any condition(s) exists that is considered critical, no product certification will occur until the condition is corrected to the satisfaction of NMFS.

e. At the inspector's discretion, product compliance will be verified by end-item inspection. No products covered by the HACCP plan will leave the firm without NMFS approval.

f. The firm must obtain a Level IV rating within thirty calendar days or be dropped from the HACCP-based Inspection Program.

g. Firms that drop to Level V rating twice in a twelve month period will be removed from the HACCP-based Inspection Program.

h. Firms who have been dropped from the HACCP-based Inspection Program may submit a request for reapplication into the program after a period of three calendar months. Application will be accepted by NMFS only if evidence of a change in management philosophy can be provided.

i. Firms who have been dropped from the NMFS HACCP-based Inspection Program may still be eligible to enter into the traditional Inspection Program.

K. Additional Requirements

1. Employment of Certified HACCP-based Inspection Person(s):

a. Each facility must employ a NMFS-certified person knowledgeable in the HACCP program's principles to be present during all processing times.

b. The certification must be kept on file and available to NMFS at all times.

2. Verification Procedures.

a. Periodic end-item verification of product compliance to program requirements must be performed by the firm. Frequencies and end-item requirements must be agreed upon by both the firm and NMFS.

b. In addition samples for analytical testing must be collected and tested at least once per year as part of their verification procedures. The level of analytical sampling per lot must be comparable to that found in Tables 1 and 2.

c. Records of all analytical findings will be made available to NMFS inspectors during Systems Audits and at other times as necessary.

3. 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.

VIII. Reporting and Documentation Control:

A. HACCP Plans:

1. HACCP Plans will be kept secured by the appropriate Regional HACCP Activities Coordinator.
2. Copies of the HACCP Plan may be made under the following conditions:

a. Each page of each copy must be stamped "Confidential" in red ink.

b. The copies must be numbered.

c. A log will be kept by the HACCP Activities Coordinator of which authorized individuals have checked out the HACCP Plan copy, the date of check out, and the date of return.

3. No unauthorized persons may receive a copy of the HACCP Plan.

B. Systems Audit Reporting:

1. The completed Systems Audit Report (working papers, narrative, Systems Audit Checklist, and supporting documentation) will be sent to the Regional HACCP Activities Coordinator by the assigned Consumer Safety Officer.
2. A copy of the Systems Audit Report (without the working papers) will be sent to the Supervisor of the assigned Consumer Safety Officer.
3. A copy of the Systems Audit Checklist will be given to the firm prior to exiting.
4. The Regional HACCP Activities Coordinator will complete a memorandum to the chief officer of the firm listing the serious and critical deficiencies, as well as positive results, found during the Systems Audit Checklist.
5. One copy of this memorandum will be forwarded to the Regional Inspection Branch Office.

IX. Determination of Fees and Charges. The fees and charges for the HACCP-based Inspection Program are established, assessed, and collected in accordance with the regulations set forth in 50 CFR Part 260. The fees and charges may be adjusted as necessary to recover costs. The current hourly fees for the services and laboratory costs for various analyses shall apply. Travel expenses associated with the HACCP-based Inspection Program are billed separately.

Since the costs associated with the HACCP-based Inspection Program are specific to each facility, NMFS will discuss fully the details of the costs with each applicant before any contractual arrangements are made.

A. HACCP Plan Development. At the request of the firm, NMFS will provide consultation for plan development, charged at the existing Type III rate for consultative services.

B. HACCP Plan Review. NMFS review of the final HACCP plan will be charged as a flat fee based on the current Type III rate for consultative services. The fee determination for HACCP plan review is as follows:

1. Type III rate x 8 hours, for the first process
2. Type III rate x 5 hours, for each process thereafter.

In the event that NMFS suggests changes to the HACCP plan, subsequent reviews will be charged based on actual review time at the current Type III rate.

C. Validation. The validation is charged at the current Type III rate, plus travel and laboratory costs, where necessary. The total cost of a validation inspection will vary depending on such factors as the size of the firm, the number and complexity of the processes covered under the HACCP plan, the risks associated with the products involved, and the completeness of the presented plan.

D. Systems Audits. After contract implementation, the fees for the HACCP-based service will be charged at the current Type I rate for in-plant inspection services, with additional charges for travel and analytical tests, where appropriate, at the current specific charge for each test. The fees for any services provided on an overtime basis or on Sunday or legal holidays will be charged at the current overtime or Sunday/holiday rates.

Appendix A

I. Introduction

This guide is designed to provide the reader with a method of developing their HACCP plan. It provides the format that must be followed as well as brief discussions on each important point in the HACCP plan. Also included in the guide is an example of a complete HACCP plan. The reader is encouraged to refer to this example when reading the guidance.

The plan must be submitted in the following format:

1. Organization Chart
2. Organization Chart Narrative
3. Description of Fishery Products
4. For Each Discrete Product Form:

a. Process Flow Chart

b. For Each Critical Control Point:

1) Location

2) Hazard/Defects to be Controlled

3) Preventive Measures

4) Critical Limits

5) Monitoring Procedures

6) Corrective Actions

7) Record Names

c. A copy of all forms associated with each Critical Control Point

5. Record Keeping Procedures

6. Verification Procedures

7. Sanitation Standard Operating Procedures

8. Recall Procedures

9. Consumer Complaint Procedures

10. Labels/Specifications

II. Organization Charts and Narrative

The facility must prepare an organization chart demonstrating the managerial responsibility of the firm. This chart must show a chain of command within the management of the facility. The facility must identify the organization of facility management to illustrate how the HACCP-based system fits into the firm's organization. The facility must also identify how the HACCP-based principles, directives, and strategies are exercised in the day-to-day operation of the facility. The relationship between the position(s) responsible for the HACCP-based system and the production manager(s) must be indicated.

The narrative should explain how each position relates to the HACCP-based system, its day-to-day operation, and the relation to the other positions on the chart.

III. Description of Fishery Products

A description of the finished product (e.g., product form) must be developed in order to prepare a systematic evaluation of the hazards and associated risks in a specific food and its ingredients or components. Some examples follow:

	Breaded Fish--Fish portions, sticks, fillets, etc., coated with batter and/or breading material which may or may not be precooked.
	Raw Fish--Whole Raw Fish (Fish that have not been cut in any way, except to be bled. Also called "round"); Gutted Raw Fish (Whole and eviscerated fish. Usually with scales removed.); Dressed Raw Fish (Whole, eviscerated, and scaled fish with the head, tail, and fins removed.)
	Cooked Shrimp--Headless, peeled, and deveined shrimp. The raw product has been subjected to a heat treatment. Product can be consumed without any further thermal processing.
	Pasteurized Crabmeat--Raw product that has received a heat treatment then hand or machine picked. The meat is treated with another thermal process sufficient to destroy or control the level of hazardous microorganisms. Product can be consumed without any further thermal processing.

IV. Process Flow Charts

To assist the facility in developing a HACCP plan, a flow chart depicting the operational steps of how the fishery product (e.g., raw fish, cooked crabmeat, surimi, etc.) is handled throughout the facility must be made. The chart must show the steps in numerical order from when the firm takes control of the product until the firm releases control of the product. For example:

	How is the product handled from receipt into the facility (e.g., is it stored in a refrigerated or frozen condition)?
	How is the product handled prior to processing (e.g., is the product thawed)?
	How is the product handled on the processing line(s) (e.g., is the product cut frozen; put on a conveyor belt; dipped in a liquid batter; is it breaded; deep-fried; is it individually quick frozen; is it peeled; soaked in water prior to deveining; do you have multiple production lines, etc.?)
	How is the product stored?
	How is it packaged?
	How is it shipped?

These operational steps are the control points for your process. A process is defined as "one or more actions or operations to harvest, produce, store, handle, distribute, or sell a product or group of similar products." The company may design any type flow chart for their process that is easy to follow and represents their process. An example is found on page 17 of this document. Other examples of flow charts for various product forms may be obtained through your Regional NMFS Inspection Branch.

V. Critical Control Point Worksheet

Note: Thermal processes used in the facility must have been established by a qualified person(s) having expert knowledge acquired by appropriate training and experience in the processing of the product. Any critical limits designated by the person(s) will be in writing and will be used in the monitoring of the processing step.

A. Identification of Hazards Associated with Each Step

For each control point identified on the flow chart, an assessment must be made as to whether hazards relating to food safety, wholesomeness, or economic fraud can be associated with that particular step. Some categories of hazards are:

	Microbiological
	Chemical
	Physical
	Hygiene
	Species substitution
	Over-breading
	Net weight

When identifying hazards at a control point it may be helpful to ask yourself some basic questions. For example:

Receiving

Question: What is the fishery product coming into my facility?

Answer: Fresh domestic fillets and frozen imported fish blocks.

Question: What hazards can be encountered?

Answer: Mislabeling; decomposition; filth; package integrity; bones; foreign/extraneous material; pathogens; thermal abuse; and physical damage.

Hazard analysis is a basic procedural step required in the development of the HACCP plan. Products have been placed into two groups for the Program: Substantial Risk and Low Risk. Products that pose a Substantial Risk are those products that are ready-to-eat; heat, brown, and serve; and some microwaveable products. Products which may contain a microbial pathogen, biotoxin, or physical or chemical contaminant which may pose an unacceptable health risk at the time of consumption are also considered to be Substantial Risk. All other potential risks will be considered Low Risk.

The hazard analysis step can be performed by one individual but works better when a team of specialized persons work together. Whichever your facility chooses, the methods remain the same. The hazard analysis is performed on the product as it relates to its final form. Each step of the process must be analyzed to identify any hazards that may affect the final product. Then the hazard is placed at the points on the flow chart where it can be controlled. There may be more than one point of control for a particular hazard. That is not of concern as yet. Remember that the hazards may be of a safety, wholesomeness, or economic fraud nature.

B. Determine Preventive Measures

The next step is to determine the preventive measures. Preventive measures are defined as any action that will inhibit the introduction of hazards into the product. Preventive measures can include:

	Vendor certification of species
	Purchasing specifications
	Maintenance of proper temperature
	Refrigeration maintenance
	Training programs for employees
	Proper time and temperature control
	Production scheduling
	Adherence to Good Manufacturing Practices
	Equipment sanitation and maintenance
	Scale calibration
	Certificate of water potability
	Proper packing
	Supervisory checks
	Inventory control

For each hazard listed in your critical control points, list the preventive measures you can employ to reduce the possibility of that particular hazard of occurring.

C. Identify Critical Control Points

A "Control Point" (CP) is defined as any step in a process whereby biological, chemical, or physical factors may be controlled.

A "Critical Control Point" (CCP) is defined as any step in a process which, if not properly controlled, may result in an unacceptable safety, wholesomeness, or economic fraud risk. In order for a control point to be critical, one must be able to monitor and document the control of hazard(s) at that control point.

Types of critical control points may include, but are not limited to:

	Raw material receiving
	Cooking
	Chilling
	Blending/mixing/adding ingredients
	Product cooling
	Packaging
	Storing
	Shipping/transport

This is an opportunity to evaluate compliance with regulatory requirements, and if necessary, to correct any defects, deviations, or deficiencies that may be found.

Identify on the flow chart the steps that have been deemed critical control points.

D. Establish Critical Limits

A critical limit is defined as an established point which must not be exceeded if a hazard is to be controlled at a CCP. There may be more than one critical limit for a CCP. If any one of those limits is out of tolerance, the process will be out of control and a potential hazard or unacceptable risk can exist.

The critical limit is used by the firm to signal the fact that a potential hazard/problem exists at a particular critical control point. At this point, the firm will determine the possible solutions and decide which solution(s) will correct the hazard/problem.

The criteria most frequently utilized for limits are temperature, time, humidity, moisture level (Aw), pH, titratable acidity, preservatives, salt concentration, available chlorine, net weight, amount of breading, and fill of container. Critical limits can be quantitative (i.e., a number value) or qualitative (e.g., evidence of decomposition as determined by an organoleptic evaluation). They can be a maximum, minimum, or range value. Many different types of limit information may be needed for control of a critical control point.

It is important to establish reasonable critical limits that will ensure control of the potential hazard. The firm should set limits that are more stringent than regulatory limits or product purchasing specifications to ensure that product will be found acceptable.

E. Establish Monitoring Procedures

Monitoring is the scheduled testing and/or observations recorded by the firm to report the findings at each CCP. Monitoring results must be documented. Failure to exercise control of a critical control point is a critical deficiency in the Program.

A critical deficiency is defined as a hazardous deviation from plan requirements such that maintenance of the safety, wholesomeness, and economic integrity is absent, ultimately resulting in unsafe, unwholesome, or misbranded product. Because of the potentially serious consequences of a critical deficiency, monitoring procedures must be effective.

Ideally monitoring should be at the 100% level. Continuous monitoring is possible with some types of physical and chemical methods. However, when this is not possible, it is necessary to establish monitoring intervals that will reliably indicate that the hazard is under control.

Most monitoring procedures for critical control points will need to be done rapidly because they relate to on-line processes of the product. There will usually not be time for lengthy analytical testing. Physical and chemical measurements are usually preferred because they may be done rapidly. Microbiological testing, for example, is seldom effective for monitoring critical control points due to their time consuming nature. This is not to say these tests and methods cannot be effectively used for verification of the effectiveness of process controls.

For each critical control point list the procedures you will use to monitor your control of that specific critical control point. When listing these procedures be specific. List:

1. Who will perform the procedures
2. The frequency at which the procedure will be performed
3. Any associated criteria for the procedure. For example; sampling plans used, definitions of samples and/or lots, etc.

F. Establish Corrective Actions

Corrective Actions are defined as procedures to be followed when a serious or critical deficiency is assessed or when a critical limit is reached or exceeded. When critical limits are exceeded at a critical control point corrective actions must be taken to eliminate the hazard created by the deviation. These actions must also assure proper disposition of the product involved. Specific procedures for each critical limit of a critical control point must be developed. This is due to variations in product and the diversity of associated deviations.

Corrective Actions will involve:

1. A statement of the problem (usually in an “If… then” format)
2. Procedures for handling of the product
3. Identify the person responsible for the corrective action
4. Testing to establish the acceptability (if applicable)
5. Final disposition of the product
6. Documentation and signatures

G. Establish Records

For each critical control point you must provide a record that demonstrates monitoring procedures and corrective actions are being followed. Existing company forms or records may be adequate. The types of records that would demonstrate adequate documentation that critical control points are being controlled are:

Records showing that critical control points are being monitored. The critical limit should be incorporated on the monitoring record as a constant reminder to the examiner or observer.

Records documenting an unusual occurrence and the corrective action taken if critical limits are not met/or are exceeded. These records should include disposition of the product(s) involved. If the decision is made to use the product, indicate under what conditions it was maintained pending evaluation. All reports of corrective actions must be kept in a separate file or log with copies attached to the monitoring record where the problem occurred.

NOTE: Documenting an unusual occurrence and the corrective action may also be called a NUOCA (Notice of Unusual Occurrence and Corrective Action), a commonly used acronym within industry and government.

· Records showing that instrumentation or other equipment necessary to the monitoring process has been properly checked for accuracy and reliability, and is being properly maintained.

VI. Establish a Record Keeping System

Developing a strict record keeping system that demonstrates control over critical control points will:

	Advise facility management and government officials of the performance of a plant’s HACCP plan on a day-to-day basis.
	Provide evidence of a proper and safe operation.
	Serve as a mechanism for indicating potentially serious problems and assisting the responsible individual(s) in the determination of a proper corrective action.

An efficient filing system must be set up for all of these records and forms. All of the records and forms in this filing system must be accessible to NMFS at all times.

If the record keeping system has been properly set up and maintained it will provide the following information:

	Early detection of areas of concern,
	Isolation of a problem or potential problem is made easier, and
	Trends can be identified which may require more supervision

Records should be looked upon as a means for the facility to illustrate their compliance to the HACCP plan and applicable regulations.

VII. Establish Verification Procedures

Verification consists of a periodic review by the firm to determine the overall effectiveness of the HACCP plan.

Both the facility and the regulatory agencies have a role in verifying HACCP plan compliance. Verification confirms that all hazards and were identified in the HACCP plan when it was developed. Verification measures may also include:

	Inspection of the facility as to conformance with the facility's HACCP plan and established federal regulations.
	Records review.
	Sample collection and analysis to support inspectional observations.
	Physical, chemical, and sensory examinations for conformance with specification/grade standard criteria.
	Testing for conformance with microbiological criteria where established.
	Inspection of the contract laboratory to ensure that the samples received for analysis are being examined correctly.

A facility's verification of its HACCP plan involves substantial self-monitoring of critical control points by the facility. It may include analysis of the raw material, in-line environmental testing, or finished product testing depending on the possibility of emerging problem areas.

Sample analyses by approved screening methods may be appropriate. If a potential problem is identified, the result of the analysis is to be reported using AOAC methods or their equivalent.

Analysis can be performed in-house at the facility or the samples can be analyzed by a contract laboratory.

VIII. Establish Sanitation Standard Operating Procedures

You must also develop standard operating procedures for the sanitation practices of your facility. Standard operating procedures should be specific as to how sanitation practices are performed. List who will perform these procedures, the frequency of the procedures, and any associated information. Standard operating procedures should be written with the following assessment areas in mind:

	Pest Control
	Structure and Layout
	Maintenance
	Cleaning and Sanitizing
	Personnel
	Restrooms
	Water Supply

· Ice

	Chemicals
	Ventilation
	Waste Disposal

You should establish a monitoring procedure for the sanitation standard operating procedures. This monitoring procedure should include who will perform the monitoring, the frequency of monitoring, and any forms or records used to document this monitoring.

All the above areas will be assessed by the government Consumer Safety Officer using the appropriate form(s) for your style of operation. You may use this format to aid you in writing your standard operating procedures for sanitation.

Remember that these sanitation assessment areas are cross-cutting throughout the facility. This is why the HACCP-based Submission Guide has been developed to discuss items relating to "process" and "economic" factors separately from "sanitation".

IX. Recall Procedures.

Develop a standard operating procedure for recall of product. When developing these recall standard operating procedures, keep in mind that you need to be able to identify specific lots of finished products. Finished product must bear a code which represents the:

	Production facility
	Date of production

You may also want to include information which represents the:

	Production Line
	Shift
	Production Period

It is also advisable to identify a Recall Coordinator.

X. Consumer Complaint Procedure

Develop a consumer complaint file and a standard operating procedure for handling consumer complaints. It is suggested that a matrix of the type of complaints be developed and presented to the NMFS Consumer Safety Officer to illustrate the firm’s adherence to their Consumer Complaint Procedures. The NMFS is interested in the firm’s use of Consumer Complaints as a tool for verification of the effectiveness of the HACCP Plan. When performing a Validation or a Systems Audit, the Consumer Safety Officer will be assessing whether or not the firm followed their Consumer Complaint Procedures. No routine review or assessment of specific consumer complaints will be performed. However, if it is shown that a firm did not follow their Consumer Complaint Procedures as written and a consumer complaint is listed that may have a health or safety impact, the officer will have to take action appropriate to the issue. In conducting Systems Audits, NMFS will take into account the number and type of consumer or trade complaints that the agency receives.

XI. Sample HACCP Plan

Floppy Fish Company

Fresh Fish HACCP Plan

Organization Chart & Chart Narrative

Example -- For Illustrative Purposes Only

President - President and owner of Floppy Fish Company. He reviews the overall HACCP plan with the Production, Quality Assurance, and Sales Managers.

Production Manager - Responsible for day-to-day operations of the facility. Responsible for directing production and any new processes or procedures for the facility. Reviews the HACCP plan with President, Quality Assurance Manager, and the Sales Manager. Responsible for purchasing all of the raw materials, packaging and labeling materials.

Production Supervisor - Oversees the daily production in the facility. Reports to the Production Manager. Works closely with the Production Manager on directing raw material into finished product. Decides what the production schedule for the day will be. Responsible for overseeing all personnel in the production and refrigerated storage areas.

Quality Assurance Manager - Reports to the President of the Company. Responsible for the HACCP plan and any changes and paperwork that are related to the plan. Responsible for handling customer complaints and initiating recalls. Oversees the Quality Assurance Technicians, and production personnel who perform all of the duties specified in the HACCP plan. Reviews HACCP plan with the President, Production Manager, and Sales Manager.

Sales Manager - Reports to the President. Responsible for setting up and maintaining customer accounts. Oversees all sales representatives and handling of customer or consumer complaints. Reviews HACCP plan with the President, Production Manager, and Sales Manager.

Sanitation Manager - Reports to the Production Manager. Oversees the daily cleanup and sanitation of the facility.

Example -- For Illustrative Purposes Only

Description of Fishery Products

Whole Raw Fish - Whole fish that have not been gutted, trimmed or headed.

Gutted Fish - Whole fish that have had the viscera removed. Sometimes with the scales removed sometimes with the scales intact.

Headed and Gutted Fish - Fish that has had the viscera and head removed.

Skin-on Fish Fillets - Fish fillets that still have the skin attached. Sometimes the scales are removed prior to the filleting step. Sometimes the bones are trimmed out of the fillets. Sometimes the napes are trimmed off.

"Chowder" Fish - Trimmings of fish from the fillets.

Floppy Fish Company

Process Flow Chart

All fish is sold as fresh fish. None is frozen.

Control Point: Receiving

Hazards:

1) Decomposition

2) Contamination (chemical, petroleum etc.)

3) Species Substitution

4) Time/Temperature Abuse.

Preventive Measures:

1) Company purchasing specifications. Train personnel to recognize decomposition.

2) Company purchasing specifications. Train personnel to recognize contamination.

3) Company purchasing specifications. Train employees to recognize species. Buy raw material from reputable suppliers.

4) Company purchasing specifications. Identify histamine-producing fish. Calibrate thermometers used for taking temperatures.

Critical Limits:

1) Fish sampled for decomposition must meet the acceptance numbers in the attached sampling plan.

2) No contaminated fish will be accepted.

3) Any species received that are not correctly represented will not be used for that misrepresented species.

4) All known histamine-producing fish will not be accepted if the temperature is higher than 45 degrees F.

Monitoring Procedures:

1) Each species in each load of fish that is received is examined for decomposition following the attached sampling plan by a QC Technician and recorded on the Incoming Receiving Voucher.

2) While each species in each load of fish is examined for decomposition, it will also be examined visually and organoleptically for contamination by a QC Technician and recorded on the Incoming Receiving Voucher.

3) While each species in each load of fish is examined for decomposition, it will be examined visually for correct species representation by a QC Technician and recorded on the Incoming Receiving Voucher.

4) All histamine-producing fish in each load received will be checked for temperature using a dial thermometer according to the sampling plan below by a QC Technician and recorded on the Incoming Receiving Voucher. Thermometers used to check product temperatures will be calibrated against a mercury in glass (MIG) thermometer (traceable to the National Bureau of Standards) once per month by a QC Technician and recorded on the Calibration Log.

Example -- For Illustrative Purposes Only

Receiving Critical Control Point Continued

Nearly all fish is received as whole or gutted fish in 100 pound tubs. Some large fish are received in 1000 lb. totes or individually on pallets. For fish that is in tubs, the entire tub will be a sample. For large fish each fish is used for determining the lot and sample size. The number of samples to be examined for each load is listed below.

Number of Tubs Number of Acceptance

in load Samples Number*

1 - 10 1 0

10 - 20 2 0

20 - 40 3 0

40 - 60 4 0

60 - 100 5 0

100 - 200 13 1

* acceptance number is for decomposition only

Corrective Actions:

1) If the acceptance number is exceeded for decomposition the lot is segregated and culled prior to use in production. All corrective actions are recorded on a NUOCA.

2) If there is any contamination in any of the samples, the fish will not be used for production. All corrective actions are recorded on a NUOCA.

3) If any fish are received that are misrepresented, they will be directed into the proper product during production. All corrective actions are recorded on a NUOCA.

4) Any histamine-producing fish that exceeds 45·F. will not be used for production. All corrective actions are recorded on a NUOCA.

Records:

1) Incoming Receiving Voucher. NUOCA.

2) Incoming Receiving Voucher. NUOCA.

3) Incoming Receiving Voucher. NUOCA.

4) Incoming Receiving Voucher. NUOCA. Calibration Log.

Example -- For Illustrative Purposes Only

Control Point: Product Storage

Hazards:

1) Decomposition

2) Time/Temperature Abuse

Preventive Measures:

1) All product is tagged with date of receipt. All finished product is labeled with a production date.

2) All product is sufficiently iced.

Critical Limits:

1) All whole or dressed fish will be used for production within five days of receipt. All finished product will be shipped within three days after production.

2) The product will be maintained at 40 degrees F. or lower.

Monitoring Procedures:

1) When product is initially received a tag is placed on the tubs or directly on the fish to indicate the supplier and the date the product was received. All product in the storage area will be checked once a day, in the morning, for the dates and to make sure the product is properly iced by a QC Technician and recorded on the Daily Sanitation Log. Any whole or dressed fish that is more than five days old will be recorded on the Daily Sanitation Log. Any product that is noticed will be noted on the Daily Sanitation Log. Any finished product that is more than three days old will be recorded on the Daily Sanitation Log.

2) Temperatures of the product will be checked by a QC Technician and recorded on the Daily Sanitation Log twice a day, once before production in the morning and once after lunch in the afternoon. These temperatures will be taken from internal probes of the product. The thermometers are checked against a standard mercury in glass thermometer (traceable to the National Bureau of Standards) once per month by a QC Technician and recorded on the Calibration Log.

Example -- For Illustrative Purposes Only

Product Storage Critical Control Point Continued

Corrective Actions:

1) If any whole or dressed fish in the storage areas is older than five days it will be examined tub-by-tub for decomposition and recorded on an Exceeded Date Examination Report.

Any decomposed product will not be used for production. All corrective actions will be recorded on a NUOCA.

If any finished product in the storage areas is older then three days, each package will be examined for decomposition and recorded on the Exceeded Date Examination Report. Any product that is decomposed will be discarded. All corrective actions will be recorded on a NUOCA.

Any product that is not properly iced will be properly iced. All corrective actions will be recorded on a NUOCA.

2) If the temperature of any product is above 45·F, all fish will be checked for decomposition and recorded on the Daily Sanitation Log. If the product is found to be decomposed it will not be used. All corrective actions will be recorded on a NUOCA.

Any product that is not properly iced will be properly iced. All corrective actions will be recorded on a NUOCA.

Records:

1) Daily Sanitation Log. Exceeded Date Examination Report. NUOCA.

2) Daily Sanitation Log. Exceeded Date Examination Report. Calibration Log. NUOCA.

Control Point: Trim/Candle/Bone

Hazards:

1) Bones

2) Nematodes

Preventive Measures:

1) Train employees to recognize bone structure of fish and cutting patterns of fillets.

2) Use candling tables for species that pose a nematode problem (see critical limits).

Critical Limits:

1) No bones greater or equal to 10 mm in length, or greater or equal to 1 mm in diameter or 5 mm in length and greater than 2 mm in diameter of fish for boneless fillets.

2) No more than one parasite per kilogram with a capsular diameter greater than 3 mm or not encapsulated and greater than 10 mm in length of fillets for cod, all flatfish species, and salmon.

Monitoring Procedures:

1) Fillets that are labeled and sold as boneless will be inspected by a Production Foreman for bones and results will be recorded on the Finished Product Inspection Sheet. The Foreman that inspects the product will initial the sheet next to the inspection results. One sample will be taken at least once every half hour on each line. Every time there is a change in the cut, style (skin-on, skinless), or species at least one sample will be taken. A sample is the entire contents of the unit being packed. None of the sample units may exceed the critical limits if more than one sample is taken.

2) The species indicated under critical limits at this control point will be checked for nematodes by a production Foreman. Results will be recorded on the Finished Product Inspection Sheet. The Foreman that inspects the product will initial the sheet next to the inspection results. One sample will be taken at least once every half hour on each line. Every time there is a change in the cut, style (skin-on, skinless), or species at least one sample will be taken. A sample is the entire contents of the unit being packed. None of the sample units may exceed the critical limits if more than one sample is taken.

Trim/Candle/Bone Critical Control Point Continued

Corrective Actions:

1) If the critical limit for bones is exceeded, all of the product produced since the last change (cut, style, or species) or the last sample taken will be set aside and reworked to remove any excessive bones. All corrective actions will be recorded on a NUOCA.

2) If the critical limit for nematodes is exceeded, all of the product produced since the last change (cut, style, or species) or the sample taken will be set aside and reworked to remove any excessive nematodes. All corrective actions will be recorded on a NUOCA.

Records:

1) Finished Product Inspection Sheet. NUOCA.

2) Finished Product Inspection Sheet. NUOCA.

Control Point: Weigh/Pack/Label

Hazards:

1) Low Net Weight

2) Improper Label.

Preventive Measures:

1) One person on each packing line is responsible for packing product into the finished product container. These people will be trained for proper weight addition to the package. Product specifications. All scales are calibrated daily.

2) The same person on each packing line that is responsible for proper weight addition is also trained for proper labeling of all products that the Floppy Fish Company produces. These people will put the labels on the packages. All new labels are approved by the Quality Assurance Manager.

Critical Limits:

1) The average net weight of all the samples pulled for a particular species, cut, or style must equal or exceed the stated net weight. If only one sample was taken for the net weight, then that one sample must equal or exceed the stated net weight.

2) All products must be labeled properly.

Monitoring Procedures:

1) One package will be checked for net weight by a Production Foreman at least once every half hour on each line. Everytime there is a change in the cut, style (skin-on, skinless), species, or package size on each line, at least one sample will be checked. The results will be recorded on the Finished Product Inspection Sheet and put their initials next to the results.

For whole or dressed fish each lot will be sampled for net weight. A lot is the same cut, style, and species of fish and the same unit package size. At least three samples per lot will be pulled for whole fish.

The Scales used to weigh the product will be checked with a 5, 10, and 25 pound standard weight each morning before production begins by a QC Technician and recorded on the Calibration Log. Each scale will be identified with a number. Once per year Densco Scale Company performs maintenance and calibrates the scales. They put a dated sticker on each scale.

2) One package will be checked for labeling by a Production Foreman at least once every half hour on each line. Every time there is a change in the cut, style (skin-on, skinless), species, or package size on each line, at least one sample will be checked. The results will be recorded on the Finished Product Inspection Sheet and put their initials next to that results.

For whole or dressed fish each lot will be sampled for net weight. A lot is the same cut, style and species of fish and the same unit package size. At least three samples per lot will be pulled for whole fish.

Corrective Actions:

1) If the average net weight of a particular lot of product is not equal to the stated net weight, the entire lot will be reweighed and any short weights will have product added to them to make them equal to or exceed the stated net weight. All corrective actions will be recorded on a NUOCA.

2) If the label is incorrect on any of the products, each package in the lot will be examined for correct labeling. Any mislabeled product will be relabeled to show the proper product. All corrective actions will be recorded on a NUOCA.

3) If the scales are not reading properly they will be adjusted to read the proper weight. If they cannot be adjusted properly they are taken out of the process until they can be serviced by the scale company. All corrective actions are recorded on a NUOCA.

Records:

1) Finished Product Inspection Sheet. Daily Sanitation Log. Calibration Log. Densco Scale Company Service Record. NUOCA.

2) Finished Product Inspection Sheet. NUOCA.

Record Keeping Procedures

All records pertaining to the HACCP plan will be kept in the Quality Assurance Managers Office. These records will be accessible to the NMFS representatives during all operating hours. All records will be kept together and filed according to the date. A copy of all NUOCAs will be kept in a separate folder.

Verification Procedures

All records that are generated by the Floppy Fish Company will be reviewed and initialed daily by the Quality Assurance Manager. All records received from outside contractors are reviewed by the Quality Assurance Manager but are not initialed.

Any new supplier of known histamine-producing fish will have samples of the first three shipments tested for histamine. All suppliers of histamine-producing fish will have one sample per year tested for histamine.

The President, Production Manager, Sales Manager, and Quality Assurance Manager will meet once per year to evaluate the effectiveness of the HACCP plan. Minutes of the meeting will be kept.

Appropriate analytical analysis will be performed on selected products every calendar quarter to assist in the determination of control of Critical Control Points. NMFS testing guidelines will be used as criteria.

End item product assessment will be performed by Quality Assurance personnel to verify product compliance to U.S. Grade Standards, FDA Defect Action Levels, and other applicable federal, state, and local program and regulatory requirements.

Sanitation Standard Operating Procedures

All Equipment is broken down daily, at the end of the production day. All equipment is hosed down with water to remove any loose debris. The walls and floors in the production areas are hosed down to remove any loose debris. The equipment, walls, and floors are sprayed with a alkaline foaming agent. All compounds used will conform to either EPA requirements or can be found in the USDA's List of Proprietary Substances and Nonfood Compounds and will be used in accordance with manufacturers instructions. The foaming agent is allowed to sit for 15 minutes. The equipment, floors, and walls are then scrubbed using plastic bristle brushes and pads. After the equipment, walls, and floors are scrubbed down, they are rinsed with water. Any areas that need recleaning are recleaned with an alkaline detergent until effectively cleaned. These areas are then rinsed down again. The equipment, walls and floors are rinsed with an iodine (or comparable) sanitizer in the morning before production starts. The sanitizer is used in accordance with the manufacturers instructions.

The refrigerated storage areas are swept every night after the end of production. Once per month the ice room is emptied and cleaned using the foaming agent and sanitizer method as described above. The refrigerated storage areas are emptied and cleaned using the same method once per month.

There are non-hand operated sinks adjacent to the production lines. There are also soap dispensers and sanitizing solution dispensers next to these sinks. The sanitizing solution used in the dispensers is premixed by the supplier. Employees wash, then sanitize their hands: 1) at the beginning of the day when they go to their work stations, 2) after each break, 3) each time they return to their work stations, 4) at any time they believe they have contaminated their hands. Hair restraints must be worn by everyone entering the production areas. Clean outer garments must be worn by all employees. No eating, chewing gum, or use of any tobacco is permitted in the production or refrigerated storage areas. Employees shall not be allowed to wear any loose jewelry.

All processing wastes must be collected and removed when the receptacles for wastes are full.

All chemicals used in the facility will be kept locked in the chemical storage room. No chemicals will be stored anywhere else in the facility.

All restrooms are to be cleaned nightly and an adequate supply of water, paper towels, soap, toilet paper, etc., will be furnished for the next day.

The company uses the city water supply.

Once every morning a QC Technician will perform a pre-operational sanitation inspection to verify that all the equipment and areas have been sufficiently cleaned and sanitized. If anything has not been sufficiently cleaned and sanitized it will be recleaned and re-sanitized before production begins. Once per week microbiological counts will be performed on the equipment surfaces to verify the effectiveness of the cleaning of the facility by a QC Technician. The microbiological counts are made using RODAC plates. These results will be used to guide the sanitation crew on areas for improvement.

The entire facility will be examined during the day to monitor for personnel hygiene and areas of concern. Any notes will be made on the Daily Sanitation Log. The results of the weekly microbiological counts will also be noted on the Daily Sanitation Log.

Recall Procedures

All product will be labeled with a production code. This is an example of the code: 0901911. The first two digits represent the month, the second two the day, the third two the year and the final digit the production line. The example above would be a production day of September 01, 1991 from line one. Each product will have a corresponding code to represent that date of production and the production line.

All customer complaints are directed through the sales representative who handles that account. The sales representative fills out a complaint memo and gives it to the Quality Assurance Manager.

The Quality Assurance Manager decides if a product recall should be initiated, whether it be from a customer complaint or an internal finding. Once the Quality Assurance Manager decides to initiate a recall he will first identify the product and production dates that need to be recalled. Next all of the sales representatives are notified of the recall. The sales representatives then notify the customers that are under their responsibility. Each sales representative will then notify the Quality Assurance Manager which customers have the affected product and how much of the product they have. All recalled product will be delivered back to Floppy Fish Company.

If the recall is of a serious nature, i.e. illness, death or injury, the Quality Assurance Manager will notify the media and the local FDA district office of the recall. If the recall is of a serious nature the product will be destroyed by the Floppy Fish Company.

Consumer Complaint Procedure

All consumer complaints are directed through the sales representative that handles the account where the complaint was originated. The sales representative fills out a complaint memo and gives it to the Quality Assurance Manager. The Quality Assurance Manager fills out a Customer Complaint Form and investigates the cause of the complaint. Action is taken to correct the cause of the complaint if it is a legitimate complaint. If any action is taken because of a complaint it is recorded on the Customer Complaint Form.

All of the Customer Complaint Forms and memos from the sales representatives are kept on file in the Quality Assurance Managers office.

Appendix B

The Systems Audit

This document provides instructions for completing the Systems Audit Checklist. The Systems Audit Checklist will be used by the NMFS Inspector during Validations and Systems Audits. The Systems Audit Checklist will also be used by the Verification Team during Verification Audits of the HACCP-based Inspection Program.

The NMFS Inspector will perform a Validation or Systems Audit and note any deficiencies. Deficiency areas include a firm's adherence to their HACCP plan, completeness of records, and sanitation inadequacies.

Complete the form as follows:

1. Enter the complete name and address of the firm in the Name and Address of Facility Inspected area.
2. Enter all of the owners (company or individuals) in the Facility Owner area.
3. Enter the associated products which are being Validated or Audited in the Products Concerned area. The associated products can be taken from the products list in the submitted plan.
4. Enter the names and numbers of all Inspectors that are taking part in the validation or audit in the Name and Number of Inspector area.
5. If a representative from the firm is accompanying you during the validation or audit, enter the individual's name and title in the Name and Title of Accompanying Individual area.
6. Enter the NMFS region where the facility is located in the NMFS Region area.
7. Enter the State where the facility is located in the State area.
8. Enter the facility number that has been assigned to the facility in the Facility Number area.
9. Enter the month, day(s), and year the validation or audit has taken place in the Date (mm/dd/yy) area. If the validation or audit takes more than one day, include all of the dates in the appropriate areas.
10. Enter the phone number of the facility in the Phone Number area.
11. Each deficiency found during the validation or audit will be checked in the appropriate box on the Systems Audit Checklist. The weight of the deficiency (Minor, Major, Serious, Critical) cannot be changed. There are two areas on the checklist that have two or more boxes. If a deficiency is found in that area the Inspector must decide which to check. Where a box and a circle appear at the same area on the Systems Audit Checklist, check the box if the plan covers low risk products and the circle if the plan covers substantial risk products.

    For all items of the records review, use the following guidance for determining the weight of the deficiency, based on the percentage of lots that were found to be inaccurate:

    MAJOR: equal to or greater than 5, but less than 8 percent

    SERIOUS: equal to or greater than 8, but less than 10 percent

    CRITICAL: equal to or greater than 10 percent

12. An explanation for each box checked on the Systems Audit Checklist will be recorded under the Systems Audit Listing of Observations section. This explanation will list out each deficiency and include the specifics of the deficiencies. For example, if monitoring procedures are not being followed at several critical control points, the box under B. PROCEDURES, Monitoring Procedures not followed would be checked. The Systems Audit Listing of Observations would then have each instance of this deficiency noted in detail. This detail would include specifics such as the critical control point, person(s) not following the monitoring procedures, and references to the monitoring procedures in the plan.
13. Total the Minor, Major, Serious, and Critical boxes and/or circles that have been checked in the SUMMARY:Total Deficiencies area.
14. Use these totals to arrive at a Systems Audit frequency schedule for the facility. Enter the Systems Audit frequency schedule in the Final Facility Rating area. The facility will be placed on a Systems Audit frequency by numbers as they correspond to the table on the checklist.
15. Sign your name and enter the date in the Inspector Signature and Date area.
16. The Regional HACCP Activities Coordinator or the Supervisory Consumer Safety Officer will review the accuracy of the document and sign and date in this area.

Systems Audit Checklist and Frequency Schedule

Appendix C

Systems Audit Checklist Reference

Adherence to HACCP-based Plan

A. RECORDS

REASON:

Records are used to record the success of the facility’s HACCP system. Non-compliance in record keeping can make it difficult to prove control of the process.

1. Records are not up-to-date.

COMPLIANCE:

All records must be kept up-to-date. Entries must be made as they are measured. All time schedules outlined in the HACCP 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 records are not up to date, the Major box for this deficiency should be checked.

All labels must be up-to-date. All labels must be kept on file by the firm. If labels are not up-to-date, the Serious box for this deficiency should be checked.

2. Records are inaccurate.

COMPLIANCE:

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. This deficiency will also be used for the compliance of product leaving the firm. If inspector verification shows that lots deemed to be acceptable by the firm’s records are indeed not acceptable, the deficiency will be checked at the following level (percentage of lots verified):

MAJOR: equal to or greater than 5, but less than 8 percent

SERIOUS: equal to or greater than 8, but less than 10 percent

CRITICAL: equal to or greater than 10 percent

3. Records are not available for inspection.

COMPLIANCE:

If the firm for any unreasonable amount of time does not surrender the applicable record 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.

4. Any documents or records are falsified.

COMPLIANCE:

This item is self explanatory. However, intent on the part of the firm or its representatives must be shown. For example, if an item on a record was shown to be corrected with correction fluid or other means of obliteration, the inspector must show that someone with, full knowledge, changed the entry to reflect a value that was not the value measured or observed. Otherwise, this will be considered an inaccurate entry.

B. PROCEDURES

REASON:

The procedures outlined in a firm’s HACCP plan must be followed as written. The plan was approved by NMFS as a whole, not procedure-by-procedure. Not following a procedure could affect the entire critical control point.

1. Preventive Measures not followed.

COMPLIANCE:

Although no documentation is required, preventive measures provide a buffer for the firm in keeping control of a particular critical control point. Not following these measures affects the other subsequent procedures at that critical control point. If any preventive measure outlined is not followed and if a corrective action report is not filed, the firm is not in compliance for this item.

2. Monitoring Procedures not followed.

COMPLIANCE:

Monitoring procedures must be followed to maintain control of the process. If any monitoring procedure has not been followed and a corrective action report is not filed, the firm is not in compliance with this item.

3. Corrective Action not taken.

COMPLIANCE:

A firm is provided room for error in their plan through a system of corrective actions. If an error or problem arises in the conducting of the HACCP plan, the firm must file a corrective action report (Notice of Unusual Occurrence and Corrective Action--NUOCA). All other deficiencies may possibly be averted in this checklist if corrective action reports are filed for each problem or situation. Failure to file a corrective action report will be considered a failure to take a corrective action and the firm will then not be in compliance with this item.

C. OTHER

1. Modification to HACCP plan use without approval.

COMPLIANCE:

Any change in procedures whether they are written or not will be considered non-compliance by the firm for this item. This includes all procedures at critical control points, sanitation procedures, recall procedures verification procedures, and consumer complaint procedures. Exceptions will be allowed for those procedures the firm can justify that were necessary to avert or control a public safety or health situation provided a corrective action report is on file for the incident and a request for plan modification is filed with the servicing NMFS Regional Inspection Branch within a 24 hour period.

2. Modification to critical limits without approval.

COMPLIANCE:

No modifications to critical limits will be accepted without prior approval from NMFS. Any deviation noted for this item will be considered non-compliance.

3. Certified trained personnel not available.

COMPLIANCE:

Each firm must employ a person who has been certified by NMFS for this program. At least one NMFS HACCP-certified person is required to be present during production. In addition, copies of all certified personnel's certificates must on file with the firm.

Facility Sanitation

1. PEST CONTROL

REASON:

The presence of rodents, insects, and other animals in the facility should not be allowed because they are sources for the contamination of food with foreign material, filth, and bacteria, etc.

1.1 Harborage and attractant areas present.

COMPLIANCE:

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 properly constructed.

1.2 Pest control measures not effective.

1.2.1 Exclusion

COMPLIANCE:

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 width of the 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.

1.2.2 Extermination

COMPLIANCE:

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.

2. STRUCTURE AND LAYOUT

REASON:

Care must be taken to not allow contamination to enter a food product through non-direct means. This usually requires observation around food production areas and planning ahead. Improperly maintained outside conditions can cause contamination to enter the plant through a variety of means, such as airborne (wind), foot traffic, etc. In addition, improper layout of operations within a facility can inadvertently adulterate or contaminate the food product through employee traffic, wind drafts, or other means.

2.1 Grounds condition can permit contamination to enter the facility.

COMPLIANCE:

There shall be no conditions on the grounds such as dusty roads or parking lots, mud puddles, 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. Design of the facility structure should be such that access is easily obtained to all areas. This is necessary for proper cleaning and sanitizing of floors, walls and ceilings, as well as for visual inspections.

2.2 Facility

2.2.1 Design, layout of materials used cannot be readily cleaned and sanitized; does not preclude product contamination or adulteration.

COMPLIANCE:

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 improper materials for walls, ceilings, etc., as well as hard-to-reach rooms or corners even when the equipment is removed from the room.

2.2.2 Insufficient separation by space or other means allows product to be adulterated or contaminated.

COMPLIANCE:

There must be sufficient separation between different activities in the processing, packaging and handling of food products. This includes the complete separation of living/sleeping quarters or heavy maintenance areas from food-handling areas. The food product should flow easily from one stage to another and not be allowed to come into contact with non-food surfaces if exposed. In addition, the layout of the facility should not be such that product contamination is likely due to heavy employee traffic through work areas.

Retail product displays should be arranged so that there is sufficient separation to assure that no cross-contamination can occur between raw, cooked, and live product.

2.3 Equipment and utensils' design, construction, location, or materials cannot be readily cleaned and sanitized; does not preclude product contamination or adulteration.

COMPLIANCE:

Any equipment used in the manufacturing or handling of the food product must be designed or constructed so that it can be easily taken apart for regular cleaning and inspection. 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. MAINTENANCE

REASON:

Food handling establishments must be maintained at a high level. Deterioration of the building such as a leaky roof, cracks or depressions in the floor, or unprotected glass lighting fixtures can be reservoirs for bacteria or can cause direct contamination of food products being manufactured in the facility. Equipment and utensils that are not well maintained also pose a risk of bacterial harborage or direct product contamination. Conditions such as rusted or pitted product-contact surfaces and frayed conveyor belts are examples of non-compliance.

3.1 Condition of roof, ceilings, walls, floors, or lighting not maintained; lights not protected.

3.1.1 Areas directly affecting product or packaging material.

COMPLIANCE:

For those areas that will directly affect product or primary packaging materials, (packaging immediately surrounding product), the roof, ceiling, walls, floors, 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.

3.1.2 Other.

COMPLIANCE:

For areas in the facility other than in 3.1.1 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.

3.2 Insufficient lighting.

COMPLIANCE:

Lighting in areas where food is handled, processed, stored, packaged, or displayed and where sanitation is performed, must be adequate to allow the intended operation to be performed in a sanitary and wholesome manner. Lighting of the display should not be so excessive as to affect the temperature of the product.

3.3 Equipment, primary packaging materials, and utensils not maintained in proper repair or removed when necessary.

3.3.1 Product-contact surfaces.

COMPLIANCE:

All product 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. Primary packaging materials should be adequately covered when stored or not in use. Failure to provide these conditions will result in non-compliance.

3.3.2 Other.

COMPLIANCE:

All non-food contact surfaces should also be maintained in good repair. The facility is in non-compliance when the maintenance of all additional equipment or areas of equipment and utensils not referred to in item 3.3.1 above is insufficient and may allow indirect product contamination or adulteration.

4. CLEANING AND SANITIZING

REASON:

A sound cleaning and sanitizing operation is vital to plant and food hygiene. Product contact surfaces are most important and the most obvious. However, improper cleaning of non-product contact surfaces can cause adulteration or contamination to occur through indirect means. Good housekeeping of all areas including employee locker rooms and restrooms is necessary to allow the inspector proper observance of rooms and areas to determine if they are in fact clean. In addition, the methods used shall be such that the product will not be adulterated or contaminated.

4.1 Product contact surfaces not cleaned or sanitized before use.

COMPLIANCE:

Product contact surfaces must be cleaned using proper techniques to remove dirt and debris. Sanitizers must be used before product contacts the surface. Sanitizing without cleaning is insufficient. Any violation will be considered non-compliance.

4.2 Non-product contact surfaces not cleaned before use.

COMPLIANCE:

Non-product contact areas must also be cleaned prior to use. However, sanitizing is not required. This includes wall, ceilings, floors, and other room areas as well as equipment.

4.3 Inadequate housekeeping.

COMPLIANCE:

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.

4.4 Cleaning methods permit adulteration or contamination.

COMPLIANCE:

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 caused the facility to be in non-compliance. Examples of non-compliance include but are not limited to inadvertent touching of product or product surfaces with wash water, detergent, sanitizers, etc., during production.

5. PERSONNEL

REASON:

A high degree of personnel compliance is necessary for a sanitation program to work properly. The best systems can easily be defeated if the facility personnel do not maintain high ideals in the production and handling of the food product.

5.1 Processing or food handling personnel do not maintain a high degree of personal cleanliness.

COMPLIANCE:

All persons, while in food preparation or handling areas shall wear clean outer garments, use clean cloths, 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.

5.2 Processing or food handling personnel do not take necessary precautions to prevent contamination of food.

COMPLIANCE:

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 using the company-provided hand dip stations.
2. Remove all insecure jewelry, and when food is being manipulated by hand, remove from hands any jewelry that cannot be adequately sanitized.
3. If gloves are used in food handling, maintain them in an intact, clean, and sanitary condition. Such gloves shall be of an impermeable material except where their usage would be inappropriate or incompatible with the work involved. If gloves are used they will be washed and sanitized at the same frequency as employees hands as described in number one of this list.
4. Wear hair nets, caps, masks, or other effective hair restraint. Other persons that may incidentally enter the processing areas shall comply with this requirement.
5. Not expectorate; nor store clothing or other personal belongings; not eat food or drink beverages; nor use tobacco in any form in areas where food or food ingredients are exposed, or in areas used for food processing, storage of food ingredients and/or packaging materials, washing of equipment and utensils, or in production areas.
6. Take other necessary precautions to prevent contamination of foods with microorganisms or foreign substances including, but not limited to perspiration, hair, cosmetics, tobacco, chemicals, and medicants.

5.3 Controls

5.3.1 Facility management does not have in effect measures to restrict people with known disease from contaminating the product.

COMPLIANCE:

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.

5.3.2 Hand washing and hand sanitizing stations not present or conveniently located.

COMPLIANCE:

Hand washing and hand sanitizing stations must be present and located conveniently and in sufficient numbers to provide employees ease of their use.

6. RESTROOMS

REASON:

Sufficient restroom facilities and restroom supplies not only provide for the comfort of employees, but are necessary for good, healthy, and wholesome conditions for the production of food.

6.1 Insufficient number of functional toilets.

COMPLIANCE:

The facility must have one operable, in good repair, conveniently accessible toilet per fifteen (15) employees, per gender. For men, urinals may be substituted for toilet bowls, but only to the extent of one-third (1/3) of the total number of bowls required.

6.2 Inadequate supplies.

COMPLIANCE:

The restrooms must provide supplies such as toilet paper, soap, etc., sufficient enough to meet employees’ needs.

7. WATER SUPPLY

REASON:

Process water must be of very high 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 of the product. Available water must pass potability standards established by federal, state, and local authorities. Water that is supplied to the plant must meet certain minimum standards. However, processing water must also be reasonably protected in the facility. Conditions that allow contamination to occur cannot be allowed. These may include cross-connection of plumbing, back-siphonage, or back flow from a contaminated source to the supply system or open vessels of water.

7.1 Unsafe water supply.

COMPLIANCE:

The water supply, including sea water, 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. Private supplies shall have testing performed a minimum of every six (6) months. Certification of municipal or community systems should be secured at a minimum of once per year.

7.2 No protection against backflow, back-siphonage, or other sources of contamination.

COMPLIANCE:

A facility will be in compliance when all cross-connections are eliminated, backflow prevention devices are installed wherever backflow or siphonage may occur, or where other possible forms of contamination may be present.

7.3 Inadequate supply of hot water.

COMPLIANCE:

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.

8. ICE

REASON:

Due to its close proximate use to fishery products, ice should be considered a product contact surface as well as a possible product constituent that could impart filth or contaminants to the food. Therefore, ice should be made from safe, potable water, and be handled in the same manner as a food product.

8.1 Not manufactured, handled, or used in a sanitary manner.

COMPLIANCE:

A facility will be in compliance when potable water is used for manufacturing, when the manufacturing equipment is clean, and the ice only touches 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 not reused on ready-to-eat product. 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.

9. CHEMICALS

REASON:

Plant chemicals are cleaners, sanitizers, rodenticides, insecticides, 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.

COMPLIANCE:

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 or USDA approval.

9.1 Chemical(s) improperly used or handled.

9.2 Chemical(s) improperly labeled.

9.3 Chemical(s) improperly stored.

10. VENTILATION

REASON:

The lack of proper ventilation in a facility may cause condensation or foul odors to occur. Both are due to inadequate air exchange in the building. Condensation in a plant environment may cause filth, bacteria, or other contaminants to adulterate food products through drippage on exposed food, processing equipment, or packaging material. Foul odors normally reveal the presence of bacterial activity within the plant.

10.1 Condensation.

10.1.1 Areas directly affecting product or primary packaging material.

COMPLIANCE:

If any condensation is found in areas in the facility where the condensation has the potential to come in contact with product or primary packaging material, the facility is in non-compliance.

10.1.2 Other

COMPLIANCE:

Any areas other than those noted above where food is stored, handled, processed, packaged, or displayed shall be condensation-free. If condensation is noted in these areas, the facility shall be in non-compliance.

10.2 Adequate air exchange does not exist.

COMPLIANCE:

A facility is in compliance when adequate air exchange exists to preclude the development of foul odors.

11. WASTE DISPOSAL

REASON:

In a manufacturing environment raw material is either utilized in the product or is discarded as waste which may be eliminated via the sewerage system or physically removed. Sewage should be regarded as anything that accesses the sewerage system including bodily wastes, gurry, process water, etc. Any failure to eliminate these wastes allows fecal and other human disease organism to possibly contaminate the food product through splash, foot traffic, or other means. Processing waste is likely to carry filth, decompose quickly, and be an attractant to rodents, insects, and other vermin.

11.1 Improper disposal of:

11.1.1 Sewage.

COMPLIANCE:

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 sewerage system.

11.1.2 Processing waste.

COMPLIANCE:

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.

Appendix D

Minimum Criteria for Quality Assurance Systems

A. General.

A quality assurance system must include:

1. Effectively established controls.
2. Objective evidence, including a written detail of the system, showing conclusively that the controls are reliable and effective.

B. Elements of a quality control system.

1. A quality assurance system shall contain effective procedures for detecting and preventing production of material which does not meet the acceptable level specified in the appropriate standards, specifications, etc. The essential elements of such a system are as follows:

a. A quality assurance organization which is independent to the extent that the demands to improve quality, when required, shall he effective and not subject to external pressures from other facets of manufacturing, sales, or administrative operations.

b. A procedure for identifying the inspection status of material. Necessary identification may he accomplished by means of codes, tags, routing cards, or other labeling devices.

c. A procedure for handling non-conforming material. Such material shall be adequately controlled to prevent its movement into distribution channels prior to correction of the defective aspects of the products.

d. A procedure for maintaining adequate inspection and testing of incoming materials (raw materials, ingredients, packaging materials, etc.) to determine acceptability or conformance to appropriate standards or specifications.

e. A procedure for feedback of test and inspection results which is used as a basis for corrective action by the responsible party.

f. A procedure for maintaining quality assurance records in an efficient and orderly manner. Any unusual causes adversely affecting product quality, together with corrective action taken, must be recorded.

g. A procedure for calibration of scales, measuring instruments, and other devices used as media of inspection to assure accuracy and standardization at established intervals.

2. A quality assurance system must contain the essential elements listed above, in addition, the contracting party must agree to:

a. Make pertinent reports and quality assurance records available to NMFS. The records may consist of control charts, frequency distributions, number of defects in each lot, reasons for defects, corrective actions taken, and others, as suitable.

b. Submit a written plan of the Total Quality Assurance System to NMFS for evaluation as it pertains to the item(s) intended to be handled under USDC contract inspection. This plan may be produced with the help of NMFS personnel. The written plan, accompanied by a request to the NMFS Regional Inspection Branch to have the system evaluated, will be forwarded to Field Operations Headquarters, Inspection Services Division.

C. Quality Assurance System Written Plan

1. A detailed plan of a Quality Assurance System shall consist of four sections, which are:

a. A statement associating the firm and the QAS plan.

b. A schematic drawing associating operations with the auditing points related to particular operations.

c. A narrative report that details the following five aspects of any inspection or auditing points as they pertain to each step appearing in the schematic diagram.

i. Inspection or audited for (enter tests, evaluations, observations, etc., performed at this station)

ii. Person responsible to (enter name of department having responsibility for performing inspection and disseminating result, for required actions)

iii. Amount and frequency of inspection or auditing (enter number of sample units inspected and rate of sample extraction per lot)

iv. Acceptance criteria (enter standard, specification, or other criteria, and limits of acceptability)

v. Corrective action (enter administrative details used to correct production failures)

d. A statement of intent of conformance signed by the contracting party or his authorized representative (QA manager).

2. The Quality Assurance System plan, together with a request by the contracting party for evaluation of the quality assurance system, shall he forwarded to NMFS as directed in preceding subparagraph B.2.b.