The successful implementation of a HACCP plan is facilitated by commitment from top management. The next step is to establish a plan that describes the individuals responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP coordinator and team are selected and trained as necessary. The team is then responsible for developing the initial plan and coordinating its implementation. Product teams can be appointed to develop HACCP plans for specific products. An important aspect in developing these teams is to assure that they have appropriate training. The workers who will be responsible for monitoring need to be adequately trained. Upon completion of the HACCP plan, operator procedures, forms and procedures for monitoring and corrective action are developed. Often it is a good idea to develop a timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of the HACCP system involves the continual application of the monitoring, record-keeping, corrective action procedures and other activities as described in the HACCP plan.

Maintaining an effective HACCP system depends largely on regularly scheduled verification activities. The HACCP plan should be updated and revised as needed. An important aspect of maintaining the HACCP system is to assure that all individuals involved are properly trained so they understand their role and can effectively fulfill their responsibilities.

National Advisory Committee on Microbiological Criteria for Foods. 1997. The principles of risk assessment for illness caused by foodborne biological agents. Adopted April 4, 1997. An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. 1985. National Academy of Sciences, National Academy Press, Washington, DC.

National Advisory Committee on Microbiological Criteria for Foods. 1994. The role of regulatory agencies and industry in HACCP. Int. J. Food Microbiol. 21:187-195.

APPENDIX A

Examples of Common Prerequisite Programs The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Common prerequisite programs may include, but are not limited to:

Facilities. The establishment should be located, constructed and maintained according to sanitary design principles. There should be linear product flow and traffic control to minimize cross-contamination from raw to cooked materials.

Supplier Control. Each facility should assure that its suppliers have in place effective GMP and food safety programs. These may be the subject of continuing supplier guarantee and supplier HACCP system verification.

Specifications. There should be written specifications for all ingredients, products, and packaging materials.

Production Equipment. All equipment should be constructed and installed according to sanitary design principles. Preventive maintenance and calibration schedules should be established and documented.

Cleaning and Sanitation. All procedures for cleaning and sanitation of the equipment and the facility should be written and followed. A master sanitation schedule should be in place.

Personal Hygiene. All employees and other persons who enter the manufacturing plant should follow the requirements for personal hygiene.

Training. All employees should receive documented training in personal hygiene, GMP, cleaning and sanitation procedures, personal safety, and their role in the HACCP program.

Chemical Control. Documented procedures must be in place to assure the segregation and proper use of non-food chemicals in the plant. These include cleaning chemicals, fumigants, and pesticides or baits used in or around the plant.

Receiving, Storage and Shipping. All raw materials and products should be stored under sanitary conditions and the proper environmental conditions such as temperature and humidity to assure their safety and wholesomeness.

Traceability and Recall. All raw materials and products should be lot-coded and a recall system in place so that rapid and complete traces and recalls can be done when a product retrieval is necessary.

Pest Control. Effective pest control programs should be in place. Other examples of prerequisite programs might include quality assurance procedures; standard operating procedures for sanitation, processes, product formulations and recipes; glass control; procedures for receiving, storage and shipping; labeling; and employee food and ingredient handling practices.

APPENDIX C

Examples of Questions to be Considered When Conducting a Hazard Analysis The hazard analysis consists of asking a series of questions which are appropriate to the process under consideration. The purpose of the questions is to assist in identifying potential hazards.

A. Ingredients

1. Does the food contain any sensitive ingredients that may present microbiological hazards (e.g., Salmonella, Staphylococcus aureus); chemical hazards (e.g., aflatoxin, antibiotic or pesticide residues); or physical hazards (stones, glass, metal)?
2. Are potable water, ice and steam used in formulating or in handling the food?
3. Intrinsic Factors - Physical characteristics and composition (e.g., pH, type of acidulants, fermentable carbohydrate, water activity, preservatives) of the food during and after processing.

B.

1. What hazards may result if the food composition is not controlled?
2. Does the food permit survival or multiplication of pathogens and/or toxin formation in the food during processing?
3. Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps in the food chain?
4. Are there other similar products in the market place? What has been the safety record for these products? What hazards have been associated with the products?

C. Procedures used for processing

1. Does the process include a controllable processing step that destroys pathogens? If so, which pathogens? Consider both vegetative cells and spores.
2. If the product is subject to recontamination between processing (e.g., cooking, pasteurizing) and packaging which biological, chemical or physical hazards are likely to occur?

D. Microbial content of the food

1. What is the normal microbial content of the food?
2. Does the microbial population change during the normal time the food is stored prior to consumption?
3. Does the subsequent change in microbial population alter the safety of the food?
4. Do the answers to the above questions indicate a high likelihood of certain biological hazards?

E. Facility design

1. Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat (RTE) foods if this is important to food safety? If not, what hazards should be considered as possible contaminants of the RTE products?
2. Is positive air pressure maintained in product packaging areas? Is this essential for product safety?
3. Is the traffic pattern for people and moving equipment a significant source of contamination?

F. Equipment design and use

1. Will the equipment provide the time-temperature control that is necessary for safe food?
2. Is the equipment properly sized for the volume of food that will be processed?
3. Can the equipment be sufficiently controlled so that the variation in performance will be within the tolerances required to produce a safe food?
4. Is the equipment reliable or is it prone to frequent breakdowns?
5. Is the equipment designed so that it can be easily cleaned and sanitized?
6. Is there a chance for product contamination with hazardous substances; e.g., glass? What product safety devices are used to enhance consumer safety?
   • metal detectors
   • magnets
   • sifters
   • filters
   • screens
   • thermometers
   • bone removal devices
   • dud detectors
7. To what degree will normal equipment wear affect the likely occurrence of a physical hazard (e.g., metal) in the product?
8. Are allergen protocols needed in using equipment for different products?

G. Packaging

1. Does the method of packaging affect the multiplication of microbial pathogens and/or the formation of toxins?
2. Is the package clearly labeled "Keep Refrigerated" if this is required for safety?
3. Does the package include instructions for the safe handling and preparation of the food by the end user?
4. Is the packaging material resistant to damage thereby preventing the entrance of microbial contamination?
5. Are tamper-evident packaging features used?
6. Is each package and case legibly and accurately coded?
7. Does each package contain the proper label?
8. Are potential allergens in the ingredients included in the list of ingredients on the label?

H. Sanitation

1. Can sanitation have an impact upon the safety of the food that is being processed?
2. Can the facility and equipment be easily cleaned and sanitized to permit the safe handling of food?
3. Is it possible to provide sanitary conditions consistently and adequately to assure safe foods?

I. Employee health, hygiene and education

1. Can employee health or personal hygiene practices impact upon the safety of the food being processed?
2. Do the employees understand the process and the factors they must control to assure the preparation of safe foods?
3. Will the employees inform management of a problem which could impact upon safety of food?

J. Conditions of storage between packaging and the end user

1. What is the likelihood that the food will be improperly stored at the wrong temperature?
2. Would an error in improper storage lead to a microbiologically unsafe food?

K. Intended use

1. Will the food be heated by the consumer?
2. Will there likely be leftovers?

L. Intended consumer

1. Is the food intended for the general public?
2. Is the food intended for consumption by a population with increased susceptibility to illness (e.g., infants, the aged, the infirmed, immunocompromised individuals)?
3. Is the food to be used for institutional feeding or the home?

APPENDIX D

APPENDIX E

Example I of a CCP Decision Tree
Important considerations when using the decision tree:

1. The decision tree is used after the hazard analysis.
2. The decision tree then is used at the steps where a hazard that must be addressed in the HACCP plan has been identified.
3. A subsequent step in the process may be more effective for controlling a hazard and may be the preferred CCP.
4. More than one step in a process may be involved in controlling a hazard.
5. More than one hazard may be controlled by a specific control measure.

* Proceed to next step in the process.

APPENDIX F

Example II of a CCP Decision Tree
*Proceed to next step in the described process

APPENDIX G

Examples of Verification Activities

A. Verification procedures may include:

1. Establishment of appropriate verification schedules.
2. Review of the HACCP plan for completeness.
3. Confirmation of the accuracy of the flow diagram.
4. Review of the HACCP system to determine if the facility is operating according to the HACCP plan.
5. Review of CCP monitoring records.
6. Review of records for deviations and corrective actions.
7. Validation of critical limits to confirm that they are adequate to control significant hazards.
8. Validation of HACCP plan, including on-site review.
9. Review of modifications of the HACCP plan.
10. Sampling and testing to verify CCPs.

B. Verification should be conducted:

1. Routinely, or on an unannounced basis, to assure CCPs are under control.
2. When there are emerging concerns about the safety of the product.
3. When foods have been implicated as a vehicle of foodborne disease.
4. To confirm that changes have been implemented correctly after a HACCP plan has been modified.
5. To assess whether a HACCP plan should be modified due to a change in the process, equipment, ingredients, etc.

C. Verification reports may include information on the presence and adequacy of.

1. The HACCP plan and the person(s) responsible for administering and updating the HACCP plan.
2. The records associated with CCP monitoring.
3. Direct recording of monitoring data of the CCP while in operation.
4. Certification that monitoring equipment is properly calibrated and in working order.
5. Corrective actions for deviations.
6. Sampling and testing methods used to verify that CCPs are under control.
7. Modifications to the HACCP plan.
8. Training and knowledge of individuals responsible for monitoring CCPs.
9. Validation activities.

APPENDIX H

Examples of HACCP Records A. Ingredients for which critical limits have been established.

1. Supplier certification records documenting compliance of an ingredient with a critical limit.
2. Processor audit records verifying supplier compliance.
3. Storage records (e.g., time, temperature) for when ingredient storage is a CCP.

B. Processing, storage and distribution records

1. Information that establishes the efficacy of a CCP to maintain product safety.
2. Data establishing the safe shelf life of the product; if age of product can affect safety.
3. Records indicating compliance with critical limits when packaging materials, labeling or sealing specifications are necessary for food safety.
4. Monitoring records.
5. Verification records.

C. Deviation and corrective action records.
D. Employee training records that are pertinent to CCPs and the HACCP plan.
E. Documentation of the adequacy of the HACCP plan from a knowledgeable HACCP expert.