APPENDIX 1

EXAMPLE CANNED SALMON HACCP MANUAL WITH SANITATION STANDARD OPERATING PROCEDURES

A RECOMMENDED GUIDE

This example canned salmon HACCP manual was developed by the National Food Processors Association and members of the seafood processing industry trained in the principles of HACCP. It is intended as a guide for the development of a safety based HACCP manual. It is intended to be modified as necessary to meet the specific needs of individual processing facilities.

ABC SALMON PACKING COMPANY

HACCP MANUAL

CANNED PACIFIC SALMON

IN RIGID METAL CONTAINERS

Accepted: Name:

Title:

Date:

TABLE OF CONTENTS

SECTION PAGE

I. INTRODUCTION 5

A. Scope 5

B. Facilities 5

C. HACCP Coordinator and HACCP Team 6

II. PRODUCT DESCRIPTION AND INTENDED USE 7

III. PROCESS FLOW DIAGRAM AND DESCRIPTION 7

Figure 1. HACCP Flow Diagram for Canned Pacific Salmon 8

IV. HAZARD ANALYSIS 9

A. Ingredients 9

B. Plant Operations/Processing 10

Table 1. Canned Salmon Hazard Analysis 12

V. CANNED SALMON HACCP PLAN 14

A. HACCP Plan Summary 14

Table 2. Canned Salmon HACCP Plan Summary 15

B. Critical Control Points 17

C. Verification 19

1. Verification Procedures 19

2. Validation Procedures 19

VI. RAW INGREDIENTS 19

A. Fresh/Frozen Fish 19

1. Inspection upon receipt 19

2. Storage requirements 19

B. Carrier/Vessel Inspection Procedures 19

VII. EMPTY CANS AND ENDS 19

A. Letters of Guarantee 19

B. Specifications/Manufacturing Defects 19

C. Empty Container Inspection Procedures 19

1. Cans 19

2. Ends 19

VIII. CAN SEAMING REQUIREMENTS 19

A. Seaming Machine Adjustment Procedures 19

B. Can Seam Evaluation 19

1. Visual Examination Procedures 19

2. Teardown Procedures 19

IX. THERMAL PROCESS REQUIREMENTS 20

A. 21 CFR 113 Requirements 20

B. Process Establishment 20

C. Scheduled Process 20

D. Operating Instructions 20

E. Process Deviations 20

X. MISCELLANEOUS PROCEDURES 20

A. Container Coding 20

B. Formal Hold Procedures 20

C. Warehouse Container Integrity Examination 20

D. Equipment Calibration Procedures 20

Figure 2. Detailed Flow Chart for Canned Pacific Salmon 21

XI. RECORDKEEPING 22

A. Recordkeeping Procedures 22

B. Recordkeeping Requirements 22

C. Forms 22

XII. PREREQUISITE PROGRAMS 22

A. Salmon Control Plan 22

B. Sanitation/GMP Compliance Program 22

C. Preventive Maintenance Program 22

D. Product Recall/Withdrawal Program 22

ATTACHMENT 1 - SANITATION STANDARD OPERATING PROCEDURES 23

I. INTRODUCTION

A. Scope

This HACCP Manual is designed for canned Pacific salmon packed by the ABC Salmon Packing Company. It is based upon the principles and guidelines contained in the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), "Hazard Analysis Critical Control Point System" adopted by the NACMCF in 1992. This HACCP Manual is intended to comply with the requirements of 21 CFR 123 and equivalent programs, e.g. those of the Codex Alimentarius Commission and the European Union.

Note: Substantial portions of Sections 2-5 of this manual were adapted from material in the MODEL HACCP PLAN FOR CANNED PACIFIC SALMON AND SALMON IN RETORT POUCHES which was developed by the National Food Processors Association.

B. Facilities

1. Processing facility. The ABC Salmon Packing Company processing facility is located at 123 Kodiak Drive, Cold Tail Lake, Alaska. The building that houses the processing facility was built in 1965 for the purpose of processing seafood.

This establishment employs approximately 100 employees, and the principal products manufactured and packaged at this location are frozen salmon and canned salmon.

2. Forward Labeling Warehouse. The ABC Salmon Packing Company forward labeling warehouse is located at 456 Monsoon Drive, Clouds Rest, Washington. The warehouse facility was built in 1966.

C. HACCP Coordinator and HACCP Team

1. HACCP Coordinator. The HACCP Coordinator is the person with primary responsibility for ABC Salmon Packing Co.’s HACCP program. The HACCP Coordinator is also in charge of the HACCP Team.

HACCP COORDINATOR:

Name Position

Training Received

2. HACCP Team. The ABC Salmon Packing Co. HACCP Team consists of the HACCP Coordinator and 3 additional HACCP Team Members. A consultant, Seymore Dolers, helped the HACCP Team develop the HACCP plan.

HACCP TEAM MEMBERS:

Name Position

Training Received

Name Position

Training Received

Name Position

Training Received

CONSULTANT:

Name Position

Training Received

II. PRODUCT DESCRIPTION AND INTENDED USE

Canned salmon is made from fresh or frozen salmon. "Regular" packs are made from sections or steaks, and the contents normally contain skin and bones. Other types of packs include "skinless and backbone removed," "minced salmon," "salmon tips or tidbits," and "no salt added." Edible salmon oil is the only optional ingredient, other than salt, permitted by the standard of identity for canned Pacific salmon (21 CFR 161.170).

The raw salmon is filled into 307 x 200.25 cans, which are then hermetically sealed, and processed in retorts. The processes, which are scientifically designed to produce commercially sterile products, also soften the bones. The shelf-life for quality is several years under normal conditions, and there is no threat to public health at the end of this shelf-life.

Canned Pacific salmon is a low-acid food with a pH above 6.0 and a relatively high water activity. In addition, the salt is not present at levels which would inhibit the growth of bacteria.

There are no special handling instructions required on the product label, nor special distribution controls required to ensure the safety of the product. The product is sold to retail, foodservice and institutional customers. The product may be heated before serving (casseroles, main dishes, garnishes, etc.), or be served unheated (appetizers, salads, pates, etc.). It is intended for the general public, and consumers could include at-risk populations, such as the infirm, immunocompromised, or elderly.

III. PROCESS FLOW DIAGRAM AND DESCRIPTION

A HACCP process flow diagram for the ABC Salmon Packing Co. processing facility and warehouse operations for canned salmon is presented in Figure 1. A more detailed flow chart can be found in Section X. The following is a process description for the salmon processing facility and warehouse facilities.

Figure 1. HACCP Flow Diagram for Canned Pacific Salmon

The salmon packing season in Alaska normally runs from late June or early July through September. The fish are harvested using gill nets, purse seines, set nets, troll lines and, on rare occasions, traps. Although some fishing boats convey their catch directly to the processing facility, most fisherman off-load their catch onto a tender, which may use refrigerated brine or champagne ice, or, on rare occasions, a dry scow.

Once at the processing facility, fish are unloaded using bucket elevators or wet vacuum systems. The fish are sorted by species, condition and size, and they are also routinely examined for quality characteristics. The sorted fish are either processed immediately, or cooled and held before processing in large holding tanks or "fish" bins, which contain refrigerated brine or champagne ice, or in totes with ice.

The butchering operation consists of four steps -- heading, removal of eggs, eviscerating, and cleaning (sliming). The cleaned fish are cut and proceed to the filling machines. The fillers usually consist of piston fillers arranged on a carousel. The filled cans are passed by a check weigher and onto an inspection area or "patch table" where employees add or remove product from under- or overweight containers. Skin and bones overhanging the can flanges are trimmed or removed. Covers are applied, and the cans are sealed. The sealed cans are loaded into retort baskets by use of a Busse loading system. The canned product is processed in horizontal retorts using saturated steam to achieve commercial sterility per NFPA Bulletin 26-L and NFPA processing authority recommendations. The processed product is partially cooled in the retort, using chlorinated water, and allowed to continue cooling to ambient temperature while air-drying in a warehouse area.

After cooling, cans are put into cartons or brite-stacked on pallets and shipped from the processing facility in container vans to the "forward labeling" warehouses at Clouds Rest, Washington. After storage, the cans are check-weighed, double dud-detected, labeled and cased prior to shipping.

IV. HAZARD ANALYSIS

The hazard analysis was conducted by considering the risk (likelihood of occurrence) and severity of each potential food safety hazard to determine which hazards are "significant" and, therefore, must be controlled by the HACCP plan. Epidemiological data indicate that canned Pacific salmon has rarely been reported to be the source of foodborne illnesses or injuries.

A. Ingredients

Fresh or frozen salmon is considered to be a possible source of biological hazards. These include spores and vegetative cells of bacterial pathogens, notably Clostridium botulinum, and various parasitic pathogens. Water, including untreated sea water, and ice used on the vessels and in the processing facilities may also be sources of pathogenic bacteria and parasites. The salt, edible salmon oil and packaging materials are not considered to be significant sources of biological hazards. Due to the nature of the product, containers and processes, C. botulinum is the primary biological hazard associated with canned salmon. Microbial growth and decomposition resulting from time/temperature abuse (holding the product for prolonged periods at elevated temperatures) prior to receipt of the fish at the processing facility, may greatly affect the quality, but not the safety, of the thermally processed products.

There are no significant chemical hazards associated with the packaging materials or use of any of the ingredients. Raw fish are not considered to be a source of any potentially hazardous chemicals, including heavy metals or natural toxins. Contamination of salmon by industrial chemicals derived from the harvest area or transport vessel has occurred. However, this is an insignificant hazard due to the infrequency of these events, the notification/publicity associated with local industrial chemical spills, and the inspection of vessels, raw fish and processed product which are required when Alaska has made the determination of an emergency situation. Species substitution is not considered to be a significant chemical hazard. Since ABC Salmon Packing Co. does not process other seafood, there is little or no possibility of other seafood contaminating the containers filled with salmon.

The nature of the non-fish ingredients results in a low risk for physical hazards, and they are not considered to be significant sources of physical hazards. At receipt the salmon may contain foreign objects which could result in injury to consumers. Empty containers may also contain some foreign objects. However, since injuries from physical hazards associated with canned Pacific salmon are not likely to occur, these physical hazards present a low risk and are addressed using normal Good Manufacturing Practices.

B. Plant Operations/Processing

Prior to thermal processing, the fresh salmon could be subjected to time/temperature abuse leading to microbial growth and decomposition. Although prevention of detectable decomposition is a quality control priority, this condition does not represent a significant safety hazard. Since C. botulinum is the primary biological hazard associated with these products, subjecting the filled and seamed cans to a proper thermal process is the primary control in producing a safe product. Thus, the thermal process must be scientifically designed to provide the appropriate destruction of C. botulinum spores, the thermal processing equipment must be designed and operated correctly, and all critical factors associated with the delivery of the process must be properly controlled and documented.

For processed salmon, there is a significant biological hazard associated with the integrity of the filled container. Once the cans are processed, hermetic seals are responsible for keeping the products safe by excluding pathogens, particularly C. botulinum. Inspection and/or testing protocols are used to assure that the correct can bodies and ends are used, that they are free of serious plate defects, and that double seams of empty cans, where appropriate, and filled cans are within specifications.

During water cooling, minute quantities of moisture may enter the cans. If pathogens enter the cans, this could lead to foodborne illness. Potable water is used to cool containers in the retort. Under circumstances where retort cooling water is not recirculated, FDA regulations (21 CFR 113) do not mandate use of a sanitizer. However, State of Alaska regulations do require a measurable residual of sanitizer when cooling containers in the retort with potable water. Due to the use of chlorinated cooling water in the retort and the GMP procedures followed during air cooling and drying of the containers, recontamination with pathogens is not likely to occur. Both water and air cooling procedures are considered in the following hazard analysis.

No significant biological hazards are associated with the operations in the "forward labeling" warehouse. Checkweighing and double dud detection operations are used to verify the integrity of the containers in compliance with the Salmon Control Plan. In addition, procedures are currently in place to handle the disposition of questionable lots or culled containers.

In-plant contamination with chemicals (e.g. cleaners, sanitizers, lubricants) is minimal due to GMPs and cleaning and sanitizing SOPs which are in place and being followed. Also, over-use or elimination of the optional ingredients, salt and/or edible salmon oil, does not represent a chemical hazard, and the handling of the packaging materials does not present sources of hazardous chemicals. Thus, there are no significant chemical hazards associated with the processing facility or warehouse operations.

Adherence to GMPs and proper training of personnel appropriately reduces the likelihood of physical hazards being incorporated into containers prior to sealing. In addition, prerequisite programs help minimize the potential for metal, hard plastic, glass, or other physical hazards to enter the cans prior to sealing. Thus, there are no significant physical hazards associated with the processing facility or warehouse operations.

Note: Subsequent sections of this manual contain detailed information related to raw ingredients; cans and can ends; seaming, processing and miscellaneous procedures; recordkeeping; and, ABC Salmon Packing Company’s prerequisite programs. In particular, the prerequisite programs, such as the Sanitation/GMP Compliance, are essential to the success of the HACCP plan.

A summary of the hazard analysis is presented in Table 1.

Table 1. Canned Salmon Hazard Analysis

Process Step	Potential Hazard (added, enhanced or controlled)	Rationale for Inclusion or Exclusion as Significant Hazard	Significant Hazard? Yes / No	Preventive Measures or Controls	Critical Control Point? Yes / No
Fish Receiving	Chemical (heavy metals, natural toxins, industrial chemicals)	Not reasonably likely to occur.	No	Inspection of vessels and incoming fish.	No
	Physical (foreign objects)	Not reasonably likely to occur.	No	Inspection of vessels and incoming fish.	No
	Biological (pathogens) (decomposition)	Fish-borne pathogens can potentially cause illness. Microbial toxins are not reasonably likely to occur during decomposition of salmon.	Yes No	Thermal processing. Inspection of incoming fish.	No No
Storage of raw product.	Biological (decomposition)	Microbial toxins are not reasonably likely to occur during decomposition of salmon.	No	Proper storage temperature/use of ice.	No
Water and ice	Biological (pathogens)	Pathogens may be found in water and ice.	Yes	Acceptable water source and thermal processing.	No
Butchering Operations and Cutting	Physical (foreign objects)	Not reasonably likely to occur.	No	Employee practices and preventive maintenance.	No
Empty cans and ends	Biological (recontamination of product with pathogens)	Defective containers could allow entry of pathogens.	Yes	Inspection of empty cans and can ends.	Yes
Filling (addition of salt)	Chemical (food additives) Biological (pathogens)	Salt does not represent a chemical hazard. Salt is not necessary to inhibit and/or destroy microorganisms.	No No	Meeting ingredient specification. Control of addition of salt.	No No

Table 1. Canned Salmon Hazard Analysis (cont.)

Process Step	Potential Hazard (added, enhanced or controlled)	Rationale for Inclusion or Exclusion as Significant Hazard	Significant Hazard? Yes / No	Preventive Measures or Controls	Critical Control Point? Yes / No
Patching table	Biological (recontamination of product with pathogens)	Skin and bone in seaming area present a low risk of product recontamination.	No	"Patching table" procedures, container integrity evaluation, checkweighing and dud detection.	No
Seaming	Biological (recontamination of product with pathogens)	Hermetically sealed container necessary to exclude pathogens.	Yes	Maintain appropriate hermetic seal.	Yes
Thermal processing per 21 CFR 113	Biological (C. botulinum)	Adequate thermal process and related operations are necessary to destroy spores of C. botulinum.	Yes	Adequate thermal process.	Yes
Water cooling	Biological (recontamination of product with pathogens)	Acceptable water source necessary to prevent recontamination.	Yes	Adequately sanitized water.	Yes
Air cooling	Biological (recontamination of product with pathogens)	Recontamination not reasonably likely to occur.	No	Adherence to SSOP’s and GMP’s that apply to container cooling.	No
Warehouse operations, including check weighing	Biological (recontamination of product with pathogens)	Check weighing is a procedure used to verify container integrity.	No	Removal of containers which do not meet weight specifications.	No
Warehouse operations, including double dud detection	Biological (recontamination of product with pathogens)	Double dud detection is a procedure used to verify container integrity.	No	Removal of containers which do not meet end deflection specifications.	No

V. CANNED SALMON HACCP PLAN

A. HACCP Plan Summary

The HACCP Plan Summary for ABC Salmon Packing Co. canned salmon is presented in Table 2.

Note: Detailed information concerning each Critical Control Point is provided in the next section.

Table 2. Canned Salmon HACCP Plan Summary

Critical	Hazard	Critical		Monitoring				Corrective	Records	Verification
Control Point		Limit(s)	What		How	Frequency	Who	Action
Empty cans and ends	Biological (recontamination of product with pathogens)	Meets empty container specifications for safety	Acceptable seams and container/ end condition		Letter of guarantee from can supplier and container exams by packer	Each lot	Quality control	Reject lot	Letter of guarantee, inspection, can seam evaluation records, and QC Hold Log	Audit inspection and seam evaluation practices, and review records
Seaming	Biological (recontamination of product with pathogens)	Meets container seam specifications	Acceptable seams		Visual exam and container seam exams per 21 CFR 113	Visual at least every 30 min.; teardown evaluation at least every 4 hours. Additional exams at start-up and after seamer jam.	Quality control	Notify responsible person, hold lot if necessary, adjust and restart	Visual container exam log, seam evaluation records, seamer adjustment log, and QC Hold Log	Audit seam evaluation procedures; review records; conduct check weighing and dud detection procedures; audit check weighing and dud detection procedures and records

Table 2. Canned Salmon HACCP Plan Summary (cont.)

Critical	Hazard	Critical		Monitoring				Corrective	Records	Verification
Control Point			Limit(s)	What	How	Frequency	Who	Action
Thermal processing procedures specified by process authority	Biological (C. botulinum)		Vent for at least 10 minutes and to at least 230°F	Vent time and temperature	Operator logs time and temperature.	Each retort load	Retort operator	Repeat procedure before retort process starts, or hold lot	Retort operator’s log and QC Hold Log	Audit process room procedures, review records, calibration of appropriate instruments
per 21 CFR 113	Biological (C. botulinum)		Minimum initial temperature at least 35°F	Initial temperature	Temperature of the coldest container per retort load	Each retort load	Retort operator	Repeat procedure before retort process starts, or hold lot	Retort operator’s log and QC Hold Log	Audit procedures, review records, calibrate appropriate instruments
	Biological (C. botulinum)		Minimum retort temperature at least 240°F	Retort temperature	Operator thermometer readings and temperature recorder	Each retort load	Retort operator	Follow procedures recommended by process authority and comply with 21 CFR 113	Retort operator’s log, retort temperature recorder chart and QC Hold Log	Audit procedures, review records, calibrate thermometer and temperature recorder
	Biological (C. botulinum)		Minimum time at least 82 minutes at retort temperature (for 307 x 200.25 cans)	Time at retort temperature	Recorder, and operator measures time	Each retort load	Retort operator	Follow procedures recommended by process authority and comply with 21 CFR 113	Retort operator’s log, retort temperature recorder chart and QC Hold Log	Audit procedures, review records
Water cooling	Biological (recontamination of product with pathogens)		Measurable residual of sanitizer	sanitizer residual	sanitizer test kit	Two times per day during production	Designated person	Hold product for evaluation	Cooling water sanitizer report	Audit procedures, review records

B. Critical Control Points

CCP-1 - EMPTY CONTAINERS

Operational Step: Receiving empty cans and ends.

Hazard: Biological: For processed salmon, there is a significant biological hazard associated with the integrity of the filled container. Defective seams, ends and/or bodies may lead to post-processing contamination of the product with pathogenic microorganisms, particularly C. botulinum.

Critical Limit: All 3-piece cans must meet container specifications for safety. All can bodies, either 2 piece or 3 piece, and ends must be free of serious defects.

Monitoring Procedures: Letters of guarantee from each supplier of cans and ends will be kept on file. Each lot of empty cans and ends will be sampled and subjected to visual inspections and seam teardown examinations.

Frequency: Each lot received.

Monitoring Responsibility: Quality Control personnel.

Corrective Action: If unacceptable seams or other serious container defects are found, the corresponding lot will be placed on hold for evaluation.

Documentation: Letters of guarantee from each can/can end supplier. All can examination measurements and observations are recorded on the appropriate form. Lots with serious defects are documented on the QC Hold Log.

Verification: All can evaluation and QC Hold documents are reviewed daily by the Quality Control Supervisor or designated management personnel.

The seam teardown practices are evaluated monthly.

CCP-2 - CAN SEAMING

Operational Step: Can seaming operation.

Hazard: Biological: For processed salmon, there is a significant biological hazard associated with the integrity of the filled container. Defective seams may lead to post-processing contamination of the product with pathogenic microorganisms, particularly C. botulinum.

Critical Limit: All cans must meet container specifications for safety.

Monitoring Procedures: Sealed cans are visually inspected and the seams torn down per 21 CFR 113.

Frequency: Cans from each head are visually inspected at least every 30 minutes; and a complete seam teardown is performed at least every 4 hours. Additional examinations are performed at start-up and after a seamer jam.

Monitoring Responsibility: Quality control personnel.

Corrective Action: If commercially unacceptable seams are found, the packing line is shut down and the plant superintendent and the QA manager are informed. All product produced since the last "good" check is put on hold. The root cause of the problem is identified and appropriate adjustments are made before the line is started up again.

Documentation: All can inspection observations are recorded on the Visual Can Examination Log. The seam teardown measurements are recorded on the Seam Teardown Log. Any adjustments to the closing machines are recorded on the Seamer Adjustment Log. Held product is documented on the QC Hold Log.

Verification: All can evaluation and product hold documents are reviewed daily by a representative of plant management who is qualified by suitable training and experience. The seam teardown practices are evaluated monthly. The check weighers and dud detectors are calibrated daily.

CCP-3 - THERMAL PROCESSING

Operational Step: Thermal processing operations.

Hazard: Biological: C. botulinum is the primary biological hazard associated with canned salmon. Therefore, subjecting the filled and sealed cans to a proper thermal process is the primary control in producing a safe product.

Critical Limits: Retort venting for at least 10 minutes to at least 230ºF.

Minimum IT at least 35ºF.

A thermal process of at least 82 minutes at 240ºF or equivalent per NFPA Bulletin 26-L is required for the 307 x 200.25 size can.

Other critical factors for thermal processing as specified by process authority and 21 CFR 113.

Monitoring Procedures: Times and temperatures are monitored during venting and retorting by the operator. Also, times/temperatures are recorded on the retort temperature recorder chart. Other critical factors are monitored by appropriate procedures.

Frequency: Each retort load.

Monitoring Responsibility: Retort operator.

Corrective Action: If the venting schedule is not adhered to, venting must be repeated prior to processing. If product was processed without adequate retort venting, all affected product must be put on hold. If process time/temperature requirements or other critical factors are violated, as indicated by Cook Chex or records review, product should be placed on hold and procedures recommended by the process authority must be followed.

Documentation: Venting time/temperature are recorded on the Retort Operator’s Log. In particular, "time steam on," "time vent closed," and "temperature vent closed" are documented. Process time/temperature are recorded on the Retort Operator’s Log. Specifically, "time temperature up," "actual time steam off," "mercury thermometer temperature," and "recorder temperature" are documented. The retort temperature recorder chart is also used to document the process. Appropriate records are kept for other critical factors. Product placed on hold is documented on the QC Hold Log.

Verification: Appropriate documentation, which includes Cook Chex, is reviewed daily by a representative of plant management who is qualified by suitable training and experience. Processing room operations and monitoring procedures are reviewed monthly. The thermometers and retort temperature recorders are calibrated as indicated below, or more frequently if necessary, to ensure accuracy:

Mercury-In-Glass Thermometer Annually or as necessary

Retort Temperature Recorder As needed

I.T. Thermometer Weekly

CCP-4 – WATER COOLING

Operational Step: Water cooling cans in the retort.

Hazard: Biological: For processed salmon, improperly sanitized cooling water may recontaminate product with pathogenic microorganisms, particularly C. botulinum.

Critical Limit: There must be a measurable residual of sanitizer in the cooling water.

Monitoring Procedures: Samples of cooling water are tested for residual sanitizer.

Frequency: At least two times per day during production.

Monitoring Responsibility: Designated person.

Corrective Action: Affected retort load is placed on "hold" for further evaluation.

Documentation: Cooling Water Sanitizer report.

Verification: Cooling water sanitizer reports are reviewed daily. Test kits and test procedures are checked weekly against water samples containing no sanitizer vs. water samples with sanitizers.

C. Verification

The ABC Salmon Packing Company uses a variety of verification and validation procedures to comply with the requirements in 21 CFR 123.8. A brief description of the verification procedures and validation procedures is presented below.

1. Verification Procedures. Per the requirements in 21 CFR 123.8(a), on-going verification activities include: a review of consumer complaints to determine if they relate to the performance of CCPs or unidentified CCPs, calibration of process-monitoring instruments, and reviews of appropriate records (see Section XI). In addition, details concerning prerequisite programs and various verification activities can be found in subsequent sections of the HACCP Manual.

2. Validation Procedures. Under the direction of an appropriately trained (per 21 CFR 123.10) individual, a reassessment of the HACCP plan will be conducted as needed and at least once a year per the requirements in 21 CFR 123.8(a)(1). The procedures used during the reassessment will include evaluations of the HACCP plan to determine if it is adequate and appropriate, relevant records to determine if the HACCP plan is implemented and maintained properly, and prerequisite programs to determine if they are effective and adequate. A report will be issued describing the results of the reassessment, and, if warranted, the HACCP plan will be modified immediately.

VI. RAW INGREDIENTS

A. Fresh/Frozen Fish

1. Inspection upon receipt

2. Storage requirements

B. Carrier/Vessel Inspection Procedures

VII. EMPTY CANS AND ENDS

A. Letters of Guarantee

B. Specifications/Manufacturing Defects

C. Empty Container Inspection Procedures

1. Cans

2. Ends

VIII. CAN SEAMING REQUIREMENTS

A. Seaming Machine Adjustment Procedures

B. Can Seam Evaluation

1. Visual Examination Procedures

2. Teardown Procedures

IX. THERMAL PROCESS REQUIREMENTS

A. 21 CFR 113 Requirements

(INSERT COPIES OF APPLICABLE SECTIONS OF 21 CFR 113)

B. Process Establishment

(INSERT DOCUMENTS RELATED TO PROCESS ESTABLISHMENT)

C. Scheduled Process

(INSERT SCHEDULED PROCESS)

D. Operating Instructions

(INSERT PROCESSING ROOM OPERATING INSTRUCTIONS)

E. Process Deviations

(INSERT PROCESS DEVIATION PROCEDURES)

X. MISCELLANEOUS PROCEDURES

A. Container Coding

B. Formal Hold Procedures

C. Warehouse Container Integrity Examination

D. Equipment Calibration Procedures

Figure 2. Detailed Flow Chart for Canned Pacific Salmon

XI. RECORDKEEPING

A. Recordkeeping Procedures

(INSERT COPY OF SOPs FOR RECORDKEEPING)

B. Recordkeeping Requirements

Records - The following records are kept in compliance with 21 CFR 123.9: monitoring records, corrective action records, verification records, and sanitation control records. Those records contain the name and location of the processor, date and time of the activity being recorded, signature or initials of the person making the record, identity of the product, the production code, if any, and signature and date of review. In addition, records associated with HACCP training of personnel are maintained in the HACCP files. (Note: Processors are required to have and implement written sanitation standard operating procedures per 21 CFR 123.11. The requirements include sanitation monitoring and maintenance of sanitation control records.)

Record Reviews - In compliance with 21 CFR 123.8(a)(3), records related to CCP monitoring, corrective action procedures, calibration, and in-process and end-product testing are reviewed by appropriately trained (in compliance with 21 CFR 123.10) personnel. The monitoring and corrective action records are reviewed within one week, and calibration and in-process or end-product testing records are reviewed in a timely manner.

Record Retention and Access - All records required by 21 CFR 123 are kept for at least two years. In some instances, e.g., thermal processing records, the records are kept for longer periods as required by regulations. The records of the processing facility operations are stored at the processing facility, and the records of the warehousing operations are accessible at the warehouse. They are accessible to regulatory personnel upon appropriate request. (Note: If the records are transferred to another facility during the off-season, this should be specified, and the records must be made available promptly to regulatory personnel upon appropriate request.)

C. Forms

(INSERT COPIES OF ALL FORMS)

XII. PREREQUISITE PROGRAMS

A. Salmon Control Plan

(INSERT COPY OF SALMON CONTROL PLAN HERE)

B. Sanitation/GMP Compliance Program

(INSERT SSOP DOCUMENT - ATTACHMENT 1 HERE)

C. Preventive Maintenance Program

(INSERT COPY OF SPECIFIC PREVENTIVE MAINTENANCE PROGRAM HERE)

D. Product Recall/Withdrawal Program

(INSERT COPY OF SPECIFIC RECALL/WITHDRAWAL PROGRAM HERE)

ATTACHMENT 1

SANITATION STANDARD OPERATING PROCEDURES

TABLE OF CONTENTS

Introduction

Goal
Scope
Facility

Procedures

Water
Food Contact Surfaces
Cross-Contamination
Employee Practices
Protection From Adulteration
Storage, Cleaning Chemicals
Employee Health
Exclusion of Pests

Recordkeeping

Report Forms
Examples of Forms

INTRODUCTION

The goal of the ABC Salmon Packing Company is to produce a safe, wholesome, unadulterated product to be consumed by our customers.
This manual covers the production of canned Pacific salmon from receipt of raw product to the shipping of finished product to the labeling warehouse. Operations normally occur from early June through the end of August.
The facility is located at 123 Kodiak Drive, Cold Tail Lake, Alaska.

PROCEDURES

The following procedures should be monitored by a management designated individual.

Water - The water used in processing at the ABC Salmon Packing Company is treated by chlorine injection. Before production each day the chlorine injection system will be checked for correct operation. Production will not begin until the system is operating correctly. The injector will be monitored at each break. Non-compliance and corrective action will be noted on the Sanitation Monitoring Report. During production, testing for chlorine content will be performed hourly at the furthest point from the injector. There must be a measurable residual at this point. Failure to detect a residual at this point will be noted on the log and corrective action, specific to each operation, will be taken and recorded on the Chlorine Log.

Food Contact Surfaces - Before production each day, all food contact surfaces will be checked for cleanliness. Production will not begin until cleanliness is satisfactory. All food contact surfaces will be rinsed down at each break to remove particulate material. At the end of production a thorough cleaning and sanitizing of all food contact surfaces will take place. Procedures should list each piece of machinery and include a step by step clean-up procedure with chemicals used. Any non-compliance and corrective action will be noted on the Sanitation Monitoring Report.

Cross-Contamination - Raw products and employees handling raw products are to be kept away from the area where finished product is handled. Backflow preventers are to be installed on water lines used for processing and drinking. The methods of separation of raw product from finished product, and the procedures for preventing cross-contamination such as employee practices and movement of materials, should be listed. The corrective action for non-compliance should be listed. Non-compliance and corrective action will be noted on the Sanitation Monitoring Report.

Employee Practices - Hand washing facilities with hot water, soap, and single service towels will be available in restrooms. Before production each day, the restrooms and break areas will be checked for cleanliness and adequate supplies of soap, towels, and toilet paper. Hand dip stations will be ready for production with specified concentrations of chlorine or iodine sanitizers. Hand dip solutions should be changed as frequently as necessary to maintain effectiveness. Production will not begin until conditions are satisfactory.

Protection from Adulteration - Throughout production until shipment, product will be monitored periodically for adulteration. The area and frequency of monitoring and the corrective action for non-compliance should be specified.

Before production each day each item of machinery should be checked to see that it is in good repair, and properly cleaned and sanitized. Production will not begin until equipment is properly cleaned, sanitized, and in good repair. During each break and after each breakdown of equipment, machinery will be checked to ensure all damaged and broken parts are accounted for.

Fresh fish are examined on receipt. The general condition of the fish should be surveyed to determine the examination procedure. The fish temperature should be used to determine handling priorities. Decomposed fish should be discarded. Fish should be sorted for species.

Storage, Cleaning Chemicals - Before production each day the warehouse/storage area will be checked for cleanliness. Container storage, salt storage, and chemical storage areas will be in compliance with requirements in 21 CFR 110. Chemicals used will be in the USDA List of Proprietary Substances and Nonfood Compounds. Material Safety Data Sheets should be available for each chemical used.

Employee Health - Employees with communicable diseases and other factors covered by 21 CFR 110 will be restricted. The chain of command for reporting illness should be listed.

Exclusion of Pests - Before production each day, provisions for exclusion of pests will be checked. Insectocuters will be cleaned daily, or as needed. Requirements in 21 CFR 110 will be met. The corrective action for non-compliance should be listed.

RECORDKEEPING

Report Forms - Information collected and corrective action taken should be recorded on appropriate report forms. The following Sanitation Monitoring Report may be used as a check list for plant areas which must be monitored. The following Chlorine Log may be used for chlorine monitoring information. Other logs or report forms should be used for other examinations such as the examination of fresh fish on receipt.

Examples of Forms - Sanitation Monitoring Report. Chlorine Log.

ABC SALMON PACKING COMPANY

SANITATION MONITORING REPORT

	COMPLIANCE		DESCRIBE
DESCRIPTION	YES	NO	NON-COMPLIANCE	CORRECTIVE ACTION
Water:
Fresh
Sea
Ice
Food Contact Surfaces:
Fish Pump
Fish Bins
Fish Totes
Conveyors
Header
Butchering
Cleaning Line
Cross-Contamination:
Water
Product
Employee Practices:
Rest Rooms
Hand Dip
Break Area
Employees Clothing
Protection From Adulteration:
Fresh Fish
Butchering
Filler
Seamer
Storage:
Container Storage
Salt Storage
Chemical Storage
Brite Stack
Employee Health:
Illness
Unprotected Abrasion
Exclusion of Pests:
Grounds
Receiving Area
Processing Area
Storage Area

Monitored By:

Date:

ABC SALMON PACKING COMPANY

CHLORINE LOG

DATE	TIME	RESIDUAL	LOCATION	SAMPLER INITIALS