UsDa Guidebook for the United states Preparation of Agriculture HAcCP Plans Food Safety and Inspection Service September 1999 HACCP-1
United States Department of Agriculture Food Safety and Inspection Service September 1999 HACCP-1 Guidebook for the Preparation of HACCP Plans
Additional copies of the Guidebook for the Preparation of HACCP Plans and the generic haccP Models are available from U.S. Department of Agriculture Food Safety and Inspection Service(FSis Office of Policy, Program Development, and Evaluation(OPPDE) Inspection Systems Development Division Room 202, Cotton Annex Building 300 12Street Sw Washington. D. C. 20250-3700 Phone:(202)720-3219 Fax:(202)690-0824 This material is also available on the fsis homepage http://www.fsisusdagov/index.htm
Additional copies of the Guidebook for the Preparation of HACCP Plans and the Generic HACCP Models are available from: U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) Office of Policy, Program Development, and Evaluation (OPPDE) Inspection Systems Development Division Room 202, Cotton Annex Building 300 12th Street SW Washington, D.C. 20250-3700 Phone: (202) 720-3219 Fax: (202) 690-0824 This material is also available on the FSIS Homepage: http://www.fsis.usda.gov/index.htm
United States Food Safety Washington, D.C Department of and Inspection 20250 Agriculture Service September 8, 1999 TO THE USERS OF THESE VOLUMES As some of you may know, the Food Safety and Inspection Service(FSIS)received a substantial package of comments on its Guidebook for Hazard Analysis and Critical Control Point(HACCP) Plan Development and the 13 Generic HACCP models, from a coalition of industry and trade associations. This package represents a large and thoughtful effort on the part of these organizations. FSIS intends to give it the careful attention and response that it deserves The comments included many technical suggestions for improvements in the FSIS documents. It also included reiteration of longstanding differing policy viewpoints that have been frequently discussed by the agency and the regulated industry For the first time, the comments revealed substantially differing expectations on the part of these organizations and FSIS with respect to the purpose of the FSiS documents and their intended use. We want to address some aspects of this latter point When the Pathogen Reduction/Hazard Analysis and Critical Control Point systems(PA/HACCP) final regulation was published on July 25, 1996, the DRAFT Guidebook was included as an appendix. The Generic Models, developed for FSIS under contract, were available shortly thereafter in April 1997. It was probably inevitable that there were significant differences between the final regulatory language of CFR Part 417 and the dRaFT Generic Models as they were developed independently. It would have been inappropriate for FSIS to discuss its final regulatory language with any outside group The contractor was appropriately proceeding from what it knew best, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) documents on the subject of HACCP. Therefore, FSIS accepted that work product with full knowledge that significant revisions would be necessary As time passed, FSIS managers became increasingly uncomfortable with the situation in which its major technical assistance documents did not appropriately and completely inform the regulated industry of Agency expectations regarding regulatory compliance. Because the intended audience for these technical assistance materials was primarily the very small began the systematic re vision of the documents to overcome this problem. We targeted the z stablishment, which the Agency believed to have the least HACCP-experience, the agency summer of 1999 as the completion date for this effort FSIS now believes that others had very different ideas about the purpose and use of the documents than it did. As is consistently reiterated in the documents themselves, they are not designed to be used"as is. "That is, they cannot be copied and used by an establishment to meet all the regulatory requirements of 9 CFR Part 417. Nor were they designed to be the ultimate teaching and training materials, as some would suggest. The development of ideal generic models is left to others who may have an interest in doing so. The generic models are not FSIS Form26309(6/86 EQUAL OPPORTUNITY IN EMPLOY MENT AND SERVICES
United States Food Safety Washington, D.C. Department of and Inspection 20250 Agriculture Service September 8, 1999 TO THE USERS OF THESE VOLUMES As some of you may know, the Food Safety and Inspection Service (FSIS) received a substantial package of comments on its Guidebook for Hazard Analysis and Critical Control Point (HACCP) Plan Development and the 13 Generic HACCP models, from a coalition of industry and trade associations. This package represents a large and thoughtful effort on the part of these organizations. FSIS intends to give it the careful attention and response that it deserves. The comments included many technical suggestions for improvements in the FSIS documents. It also included reiteration of longstanding differing policy viewpoints that have been frequently discussed by the Agency and the regulated industry. For the first time, the comments revealed substantially differing expectations on the part of these organizations and FSIS with respect to the purpose of the FSIS documents and their intended use. We want to address some aspects of this latter point. When the Pathogen Reduction/Hazard Analysis and Critical Control Point systems (PA/HACCP) final regulation was published on July 25, 1996, the DRAFT Guidebook was included as an appendix. The Generic Models, developed for FSIS under contract, were available shortly thereafter in April 1997. It was probably inevitable that there were significant differences between the final regulatory language of CFR Part 417 and the DRAFT Generic Models as they were developed independently. It would have been inappropriate for FSIS to discuss its final regulatory language with any outside group. The contractor was appropriately proceeding from what it knew best, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) documents on the subject of HACCP. Therefore, FSIS accepted that work product with full knowledge that significant revisions would be necessary. As time passed, FSIS managers became increasingly uncomfortable with the situation in which its major technical assistance documents did not appropriately and completely inform the regulated industry of Agency expectations regarding regulatory compliance. Because the intended audience for these technical assistance materials was primarily the very small establishments, which the Agency believed to have the least HACCP-experience, the Agency began the systematic revision of the documents to overcome this problem. We targeted the summer of 1999 as the completion date for this effort. FSIS now believes that others had very different ideas about the purpose and use of the documents than it did. As is consistently reiterated in the documents themselves, they are not designed to be used "as is." That is, they cannot be copied and used by an establishment to meet all the regulatory requirements of 9 CFR Part 417. Nor were they designed to be the ultimate teaching and training materials, as some would suggest. The development of ideal generic models is left to others who may have an interest in doing so. The generic models are not FSIS Form 2630-9 (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES
designed to extend or further interpret existing regulations; rather, they are designed to send the user back to the regulations so he/she can become familiar with the requirements as well as the flexibility they permit. The generic models are not designed to present new or alternativ methods of producing and processing meat and poultry products. That is also left to others with an interest in doing so FSIS envisioned that the generic models might be used in the following way: Suppose a HACCI team leader of a three-person haCCP team in a very small establishment attended a training course, but the others on his/her team were not able to do so. Suppose the HaCCP training course met all the requirements of 417.7 but did not prons and answers, access to follow-up or ide participants with much in the w take away materials"like workbooks, practical questic resources, etc, which the Research Triangle Institute(RTi needs assessment indicated were so important to these establishments. The trained hacCp team leader returns to the establishment and begins the process of attempting to develop haCCp plans for the company's products and processes. He/she is quite confident that he/she has grasped the material presented in the training course and begins to work with this team immediately, while the concepts are fresh in his/her First he/she has the rest of the team review the Canadian video and the guidebook from FSiS so that all members of his team have a basic level of information The team members begin their work, and as they proceed, some questions arise as to whether what they have developed is appropriate. This is the point when FSIS expects the team to pick up the appropriate generic model and get a sense of whether they are on the right track. They should be able to determine whether the forms that they have developed, while different from the various ones in the generic models and not the same as what other companies use, are acceptable because they include the required information. They will also be able to discover what are some pical food safety hazards that are reasonably likely to occur, as explicitly defined in 417. 2, and how to think through the problems that these hazards represent for their own products. They can see how critical limits might arise from existing regulatory requirements like the ones for rapid chilling of poultry products. They can also see that in the absence of settled regulator requirements, there may be several sources of scientific expertise, and they can choose to make a conservative decision to provide a good margin of safety. They can find out the essential differences between monitoring and verification and have a basis for making their choices about erification activities and their frequencies. FSIS believes that these are useful, beneficial and worthwhile functions for which its generic models can be used FSIS is publishing these updated revisions of the generic models, beginning with the Guidebook and the Generic Model for Raw, Ground Product, because a large backlog of requests exists for these two documents. FSiS intends to publish revisions of all the generic models no later than September 30, 1999. Moreover, as a result of public consultation, it may publish an additional revision of some of these models, but given the backlog and the impending HACCP implementation date, we considered it important to get a version of these documents out now We hope that these documents are helpful
2 designed to extend or further interpret existing regulations; rather, they are designed to send the user back to the regulations so he/she can become familiar with the requirements as well as the flexibility they permit. The generic models are not designed to present new or alternative methods of producing and processing meat and poultry products. That is also left to others with an interest in doing so. FSIS envisioned that the generic models might be used in the following way: Suppose a HACCP team leader of a three-person HACCP team in a very small establishment attended a training course, but the others on his/her team were not able to do so. Suppose the HACCP training course met all the requirements of 417.7 but did not provide participants with much in the way of "take away materials" like workbooks, practical questions and answers, access to follow-up resources, etc., which the Research Triangle Institute (RTI) needs assessment indicated were so important to these establishments. The trained HACCP team leader returns to the establishment and begins the process of attempting to develop HACCP plans for the company's products and processes. He/she is quite confident that he/she has grasped the material presented in the training course and begins to work with this team immediately, while the concepts are fresh in his/her mind. First, he/she has the rest of the team review the Canadian video and the Guidebook from FSIS so that all members of his team have a basic level of information. The team members begin their work, and as they proceed, some questions arise as to whether what they have developed is appropriate. This is the point when FSIS expects the team to pick up the appropriate generic model and get a sense of whether they are on the right track. They should be able to determine whether the forms that they have developed, while different from the various ones in the generic models and not the same as what other companies use, are acceptable because they include the required information. They will also be able to discover what are some typical food safety hazards that are reasonably likely to occur, as explicitly defined in 417.2, and how to think through the problems that these hazards represent for their own products. They can see how critical limits might arise from existing regulatory requirements like the ones for rapid chilling of poultry products. They can also see that in the absence of settled regulatory requirements, there may be several sources of scientific expertise, and they can choose to make a conservative decision to provide a good margin of safety. They can find out the essential differences between monitoring and verification and have a basis for making their choices about verification activities and their frequencies. FSIS believes that these are useful, beneficial and worthwhile functions for which its generic models can be used. FSIS is publishing these updated revisions of the generic models, beginning with the Guidebook and the Generic Model for Raw, Ground Product, because a large backlog of requests exists for these two documents. FSIS intends to publish revisions of all the generic models no later than September 30, 1999. Moreover, as a result of public consultation, it may publish an additional revision of some of these models, but given the backlog and the impending HACCP implementation date, we considered it important to get a version of these documents out now. We hope that these documents are helpful
Guidebook Table of contents Introduction Developing a haccp plan Policy notices Preliminary Steps 1. Assemble the HACCP team, including one person who is HACCP-trained...5 2. Describe the food and its method of production and distribution 3. Develop and verify process flow diagram(s) 4. Decide whether products can be grouped using the process categories 7 PRINCIPLE I: CONDUCT A HAZARD ANALYSIS Biological hazards Chemical hazards Physical Hazards PRINCIPLE IL: IDENTIFY THE CRITICAL CONTROL POINTS PRINCIPLE III: ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT 11 PRINCIPLE IV: ESTABLISH MONITORING PROCEDURES PRINCIPLE V: ESTABLISH CORRECTIVE ACTIONS PRINCIPLE VI: ESTABLISH RECORDKEEPING PROCEDURES PRINCIPLE VIL: ESTABLISH VERIFICATION PROCEDURES Validation Ongoing verification 15 ATTACHMENTS Attachment 1- PRODUCT DESCRIPTION 17 Attachment 2-PROCESS FLOW DIAGRAM (Raw product-ground).....18
Guidebook Table of Contents Introduction………………………………………………………………………………. 3 Developing a HACCP Plan..………………………………………………………….….. 3 Policy Notices………………………………….…………………………………………. 4 Preliminary Steps..………………………………………………………………………… 5 1. Assemble the HACCP team, including one person who is HACCP-trained…… 5 2. Describe the food and its method of production and distribution………………. 6 3. Develop and verify process flow diagram(s)…………………………………….6 4. Decide whether products can be grouped using the process categories………… 7 PRINCIPLE I: CONDUCT A HAZARD ANALYSIS…………………..……………….. 8 Biological Hazards………………………………………………………………… 8 Chemical Hazards…………………………………………………………………. 8 Physical Hazards…………………………………………………………………... 9 PRINCIPLE II: IDENTIFY THE CRITICAL CONTROL POINTS.…………….………. 10 PRINCIPLE III: ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT……….……………………………………………... 11 PRINCIPLE IV: ESTABLISH MONITORING PROCEDURES……………………….... 12 PRINCIPLE V: ESTABLISH CORRECTIVE ACTIONS……………………………….. 13 PRINCIPLE VI: ESTABLISH RECORDKEEPING PROCEDURES……………….…… 14 PRINCIPLE VII: ESTABLISH VERIFICATION PROCEDURES…………………….… 15 Validation………………………………………………………………………….. 15 Ongoing verification……………………………………………………………….. 15 Reassessment………………………………………………………………………. 15 ATTACHMENTS Attachment 1 – PRODUCT DESCRIPTION……………………………………… 17 Attachment 2 – PROCESS FLOW DIAGRAM (Raw product-ground)……………18 1
Guidebook Attachment 3-PROCESS FLOW DIAGRAM(Beef Slaughter) Attachment 4-Checklist of Questions(Hazard Analysis Process) Attachment 5-HAZARD IDENTIFICATION/ PREVENTIVE MEASURES.. 24 Attachment 6-HAZARD ANALYSIS-RAW PRODUCT GROUND Attachment 7-HACCP PLAN DEVELOPMENT FORM: MONITORING PROCEDURES AND FREQUENCY Attachment 8- HACCP PLAN DEVELOPMENT FORM: CORRECTIVE ACTIONS Attachment 9-HACCP PLAN Attachment 10- List of Some Typical Records of a HACCP System in Operation APPENDIX A PART 417-HAZARD ANALYSIS AND CRITICAL CONTROL POINT(HACCP)SYSTEMS APPENDIX B References for HACCP Teams APPENDIX C Livestock Carcasses and Poultry Carcasses Contaminated with Visible Fecal Material Contents of HAcCP Plans Critical Control Points Contents of haccP plans Establishment review of product Production records HACCP Plan Requirements and Meat and Poultry Product Processing Categories; Policy Clarification Listeria Monocytogenes Contamination of Ready-to-Eat Products 65
Guidebook Attachment 3 – PROCESS FLOW DIAGRAM (Beef Slaughter)..….……………..19 Attachment 4 – Checklist of Questions (Hazard Analysis Process)………………..20 Attachment 5 – HAZARD IDENTIFICATION/ PREVENTIVE MEASURES..…. 24 Attachment 6 – HAZARD ANALYSIS – RAW PRODUCT, GROUND………… 25 Attachment 7 – HACCP PLAN DEVELOPMENT FORM: MONITORING PROCEDURES AND FREQUENCY……………..………….…. 30 Attachment 8 – HACCP PLAN DEVELOPMENT FORM: CORRECTIVE ACTIONS………………………………………………….……… 31 Attachment 9 – HACCP PLAN……………………………………………….…… 32 Attachment 10 – List of Some Typical Records of a HACCP System in Operation……………………………………………..……… 33 APPENDIX A PART 417 – HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS……………………………….………. 36 APPENDIX B References for HACCP Teams…….……….……………………………………… 45 APPENDIX C Livestock Carcasses and Poultry Carcasses Contaminated with Visible Fecal Material……………………………………………………………………………. 49 Contents of HACCP Plans: Critical Control Points..……………………………… 53 Contents of HACCP Plans…..…………………………………………………….. 56 Establishment Review of Product Production Records……………………………. 59 HACCP Plan Requirements and Meat and Poultry Product Processing Categories; Policy Clarification…………………………………………………….62 Listeria Monocytogenes Contamination of Ready-to-Eat Products……………….. 65 2
Guidebook GUIDEBOOK FOR THE PREPARATION OF HACCP PLANS Introduction On July 25, 1996, the Food Safety and Inspection Service(FSIS)of the United States Department of Agriculture(USDA) published a final rule on Pathogen Reduction; Hazard Analysis and Critical Control Point(HACCP) Systems(PR/HACCP). The PR/HACCP rule requires meat ind poultry plants under Federal inspection to take responsibility for, among other things, reducing the contamination of meat and poultry products with disease-causing(pathogenic bacteria. Reducing contamination with pathogenic bacteria is a key factor in reducing the number of deaths and illnesses linked to meat and poultry products. The Preamble to the final rule describes an overall system in which preventive and corrective measures are instituted at each stage of the food production process where food safety hazards could occur The HACCP requirements that plants must meet are set out in 9 CFR Part 417. HACCP is a scientific system for process control that has long been used in food production to prevent problems by applying controls at points in a food production process where hazards could be controlled, reduced or eliminated. a plant must have an effective HACCP system to comply with regulatory requirements and prevent adulteration of product The HACCP regulatory requirements become effective on different dates for plants of differing sizes Large plants-those with 500 or more employees-on January 26, 1998; Smaller plants- those with fewer than 500 but at least 10 employees on January 25, 1999; and Very small plants-those with fewer than 10 employees or annual sales less than $2.5 million on January 25, 2000 Note: This Guidebook and other fsis technical assistance materials are designed to assist different from the various explanations of HACCP developed by the National Advisor e s/iotse establishments subject to the regulatory requirements of 9 CFR Part 417 in complying with th requirements. Part 417 is reproduced in Appendix A. These regulatory requirements ar Committee on Microbiological Criteria for Foods(NACMCF), the most recent version of which was published in 1997 Developing a haCCP Plan FSIS is providing this Guidebook for the Preparation of HACCP Plans to help plants develop and set up their HACCP systems. There are other FSiS publications, which may be helpful. This Guidebook is the most basic of the FSIS materials. FSIS has also developed thirteen generic models that plants can use to see if their specific plans are generally on target or help them get started. The generic models are more specific than this guidebook and each one has at least one fully developed product example which establishment HACCP teams can study. However,even
Guidebook GUIDEBOOK FOR THE PREPARATION OF HACCP PLANS Introduction On July 25, 1996, the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) published a final rule on Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems (PR/HACCP). The PR/HACCP rule requires meat and poultry plants under Federal inspection to take responsibility for, among other things, reducing the contamination of meat and poultry products with disease-causing (pathogenic) bacteria. Reducing contamination with pathogenic bacteria is a key factor in reducing the number of deaths and illnesses linked to meat and poultry products. The Preamble to the final rule describes an overall system in which preventive and corrective measures are instituted at each stage of the food production process where food safety hazards could occur. The HACCP requirements that plants must meet are set out in 9 CFR Part 417. HACCP is a scientific system for process control that has long been used in food production to prevent problems by applying controls at points in a food production process where hazards could be controlled, reduced or eliminated. A plant must have an effective HACCP system to comply with regulatory requirements and prevent adulteration of product. The HACCP regulatory requirements become effective on different dates for plants of differing sizes: Large plants – those with 500 or more employees – on January 26, 1998; Smaller plants – those with fewer than 500 but at least 10 employees on January 25, 1999; and Very small plants – those with fewer than 10 employees or annual sales less than $2.5 million – on January 25, 2000. Note: This Guidebook and other FSIS technical assistance materials are designed to assist establishments subject to the regulatory requirements of 9 CFR Part 417 in complying with those requirements. Part 417 is reproduced in Appendix A. These regulatory requirements are slightly different from the various explanations of HACCP developed by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), the most recent version of which was published in 1997. Developing a HACCP Plan FSIS is providing this Guidebook for the Preparation of HACCP Plans to help plants develop and set up their HACCP systems. There are other FSIS publications, which may be helpful. This Guidebook is the most basic of the FSIS materials. FSIS has also developed thirteen generic models that plants can use to see if their specific plans are generally on target or help them get started. The generic models are more specific than this Guidebook and each one has at least one fully developed product example which establishment HACCP teams can study. However, even 3
Guidebook though the generic models have more detailed information, they are not designed to be used"as is. A company will still need to tailor the plan to suit the specific circumstances of its own production process Policy notices In order to clarify issues, which were raised in conjunction with the first implementation date, FSIS published a series of Policy Notices in the Federal Register. Copies are included as Appendix C. The issues addressed include Livestock Carcasses and poultry carcasses Contaminated with visible fecal Material(November 28, 1997) Contents of HACCP Plans; Critical Control Points ( January 30, 1998) Contents of HACCP Plans (January 30, 1998) Establishment Review of Product Production Records(March 6, 1998) HACCP Plan Requirements and meat and poultry product Processing Categories: Policy Clarification(April 1, 1998) Listeria Monocytogenes Contamination of Ready-to-Eat Products(May 26, 1999) Establishments may wish to refer to these Policy notices if they need further clarification about the aspects of the regulations that are addressed In addition to written materials fsis has held a number of events to assist establishments in meeting regulatory requirements in a timely manner; these include both implementation conferences and technical assistance workshops Finally, FSiS has developed and put in place resources which are available to answer specific questions; the FSIS Technical Service Center operates a HACCP Helpline(1-800-233-3935 ext 2 which provides answers to technical questions from inspection personnel and establishments Also fsis has organized haccP contacts in each of the states to which establishments can turn for help with their specific problems. The District Office can provide information on the State HACCP Network Advice and assistance on developing HACCP systems can be obtained from many sources other thanFsis(usetheInternetwebsitewww.nal.usdagov/fnic/foodborne/haccp/index.shtml) FSIS encourages establishment officials to consult and use a variety of resources as they go about planning, documenting, and validating their HACCP systems. Also included in this Guidebook is a list of references that can be used by all haCCP teams that have been included as appendix B. However when hACCP regulations become effective in an establishment it is the requirements of Part 4 17 that must be met. Establishment employees with a thorough understanding of HACCP concepts should still review the regulatory requirements of this part to
Guidebook though the generic models have more detailed information, they are not designed to be used “as is.” A company will still need to tailor the plan to suit the specific circumstances of its own production process. Policy Notices In order to clarify issues, which were raised in conjunction with the first implementation date, FSIS published a series of Policy Notices in the Federal Register. Copies are included as Appendix C. The issues addressed include: Livestock Carcasses and Poultry Carcasses Contaminated with Visible Fecal Material (November 28, 1997) Contents of HACCP Plans; Critical Control Points (January 30, 1998) Contents of HACCP Plans (January 30, 1998) Establishment Review of Product Production Records (March 6, 1998) HACCP Plan Requirements and Meat and Poultry Product Processing Categories; Policy Clarification (April 1, 1998) Listeria Monocytogenes Contamination of Ready-to-Eat Products (May 26, 1999) Establishments may wish to refer to these Policy Notices if they need further clarification about the aspects of the regulations that are addressed. In addition to written materials, FSIS has held a number of events to assist establishments in meeting regulatory requirements in a timely manner; these include both implementation conferences and technical assistance workshops. Finally, FSIS has developed and put in place resources which are available to answer specific questions; the FSIS Technical Service Center operates a HACCP Helpline (1-800-233-3935 ext.2) which provides answers to technical questions from inspection personnel and establishments. Also FSIS has organized HACCP contacts in each of the states, to which establishments can turn for help with their specific problems. The District Office can provide information on the State HACCP Network. Advice and assistance on developing HACCP systems can be obtained from many sources other than FSIS (use the Internet web site: www.nal.usda.gov/fnic/foodborne/haccp/index.shtml). FSIS encourages establishment officials to consult and use a variety of resources as they go about planning, documenting, and validating their HACCP systems. Also included in this Guidebook is a list of references that can be used by all HACCP teams that have been included as Appendix B. However, when HACCP regulations become effective in an establishment, it is the requirements of Part 417 that must be met. Establishment employees with a thorough understanding of HACCP concepts should still review the regulatory requirements of this part to 4
make sure they achieve compliance. This guidebook has been revised to make it easier for users to relate its practical advice with the need to be in compliance with regulatory requirements Preliminary ste FSIS and most HACCP experts believe that a company will do a better job of HACCP plan development if it takes some preliminary steps before it attempts to apply the seven principles and write a plan. FSiS believes that a company should take the following steps to get started 1. Assemble the HACCP team, including one person(consultant, employee, or other resource) who is HACCP-trained 2. Describe the food and its method of production and distribution; identify the intended use and consumers of the products 3. Develop and verify pr 4. Decide whether products can be grouped using the process categories in 4172(b)(1) The first part of this Guidebook discusses how companies, especially small or very small companies, can go about taking these preliminary steps. Numbers 2-4 are parts of the regulatory requirements in $4172(a) 1. Assemble the HACCP team, including one person who is HACCP-trained Assembling a HACCP team may seem like a daunting task, especially for the owner of a very small or family-centered company. However, FSIS strongly encourages companies to have more than one person working on the development of HACCP system(s). This is because HACCP system development is one of those tasks that are probably better done by more than one person, even in a very small company. HACCP is an overall process control system and we believe it takes a variety of different kinds of knowledge and experience to develop a good system. If your company has only a few people in it, they may all need to be on the HACCP team, because they all probably have multiple roles and responsibilities in the company's operations You should consider including on your HACCP team, some resources which may be outside your company. You may be able to get help from a trade association or from a local college, university or extension office which has people in it who know about HACCP process control systems. It is possible that companies which supply or receive your products and have already implemented HACCP may be interested in and willing to provide assistance. FSis has offered technical assistance workshops to groups of plants that came together to a central location and worked through the process of system development in small steps One resource you must include is an individual who has been trained in HACCP in accordance with the requirements of Sec. 417.7. These requirements are that the individual has successfully completed a course in applying the seven principles of hACCP to meat or poultry product processing, the course needs to have included a segment on HACCP plan development for a specific product and a segment on record review. This HACCP-trained individual does not
Guidebook make sure they achieve compliance. This Guidebook has been revised to make it easier for users to relate its practical advice with the need to be in compliance with regulatory requirements. Preliminary Steps FSIS and most HACCP experts believe that a company will do a better job of HACCP plan development if it takes some preliminary steps before it attempts to apply the seven principles and write a plan. FSIS believes that a company should take the following steps to get started: 1. Assemble the HACCP team, including one person (consultant, employee, or other resource) who is HACCP-trained. 2. Describe the food and its method of production and distribution; identify the intended use and consumers of the products. 3. Develop and verify process flow diagram(s). 4. Decide whether products can be grouped using the process categories in 417.2(b)(1). The first part of this Guidebook discusses how companies, especially small or very small companies, can go about taking these preliminary steps. Numbers 2-4 are parts of the regulatory requirements in §417.2(a). 1. Assemble the HACCP team, including one person who is HACCP-trained. Assembling a HACCP team may seem like a daunting task, especially for the owner of a very small or family-centered company. However, FSIS strongly encourages companies to have more than one person working on the development of HACCP system(s). This is because HACCP system development is one of those tasks that are probably better done by more than one person, even in a very small company. HACCP is an overall process control system and we believe it takes a variety of different kinds of knowledge and experience to develop a good system. If your company has only a few people in it, they may all need to be on the HACCP team, because they all probably have multiple roles and responsibilities in the company’s operations. You should consider including on your HACCP team, some resources which may be outside your company. You may be able to get help from a trade association or from a local college, university or extension office which has people in it who know about HACCP process control systems. It is possible that companies which supply or receive your products and have already implemented HACCP may be interested in and willing to provide assistance. FSIS has offered technical assistance workshops to groups of plants that came together to a central location and worked through the process of system development in small steps. One resource you must include is an individual who has been trained in HACCP in accordance with the requirements of Sec. 417.7. These requirements are that the individual has successfully completed a course in applying the seven principles of HACCP to meat or poultry product processing; the course needs to have included a segment on HACCP plan development for a specific product and a segment on record review. This HACCP-trained individual does not 5
need to be a company employee, but does need to be available to you for plan development and for certain other functions, like reassessing your HACCP plan(s) Describe the food and its method of production and distribution; identify the intended use and consumers of the products The next preliminary step to take is to have the hACCP team describe the product(s )and their methods of production and distribution. If your team includes the people who know how things work in your operations, they should be able to do this quite easily. The important thing for them to keep in mind is that they need to include every step in the process. In order to help you make sure you include all the key information, we have prepared a form which could be used to accomplish this task. Attachment 1 is this form and like all the forms in this Guidebook, its use Whether you use the form or not, the following questions should be answered when you aesc the product 1. What is the common name of the product? How is the product to be used? 3. What type of packaging encloses the product? 4. What is the length of shelf life of the product, at what temperature? 5. Where will the product be sold?*Who is the intended consumer and what is the intended use? 6. What labeling instructions are needed? 7 Is special distribution control needed? s Regulatory requirement After your team has described the products in words, they can move on to the next preliminary 3. Develop and verify process flow diagram(s). A flow diagram is a simple schematic picture of the process you use in your plant to produce the product. You do not need any fancy equipment, such as a computer, to produce a flow diagram However, it does need to be an accurate, clear sketch of the process used in your plant to make the product. Attachment 2 is an example of a simple flow diagram for a relatively simple ocess Attachment 3 is a more complex flow diagram for a more complicated process. Either one would be an adequate flow diagram if it accurately pictured what was actually happening in the plant The best means to make sure your flow diagram is accurate is to have the haccp team verify it by walking through the plant and making sure all the steps in the process you carry out are included in the flow diagram. Verifying the flow diagram is a step your team should be sure to de carefully. It is also a common means by which auditors or inspectors verify that a particular flow diagram is correct and complete
Guidebook need to be a company employee, but does need to be available to you for plan development and for certain other functions, like reassessing your HACCP plan(s). 2. Describe the food and its method of production and distribution; identify the intended use and consumers of the products. The next preliminary step to take is to have the HACCP team describe the product(s) and their methods of production and distribution. If your team includes the people who know how things work in your operations, they should be able to do this quite easily. The important thing for them to keep in mind is that they need to include every step in the process. In order to help you make sure you include all the key information, we have prepared a form which could be used to accomplish this task. Attachment 1 is this form and like all the forms in this Guidebook, its use is optional. Whether you use the form or not, the following questions should be answered when you describe the product: 1. What is the common name of the product? 2. How is the product to be used? 3. What type of packaging encloses the product? 4. What is the length of shelf life of the product, at what temperature? 5. Where will the product be sold? *Who is the intended consumer and what is the intended use? 6. What labeling instructions are needed? 7. Is special distribution control needed? * Regulatory requirement After your team has described the products in words, they can move on to the next preliminary step. 3. Develop and verify process flow diagram(s). A flow diagram is a simple schematic picture of the process you use in your plant to produce the product. You do not need any fancy equipment, such as a computer, to produce a flow diagram. However, it does need to be an accurate, clear sketch of the process used in your plant to make the product. Attachment 2 is an example of a simple flow diagram for a relatively simple process; Attachment 3 is a more complex flow diagram for a more complicated process. Either one would be an adequate flow diagram if it accurately pictured what was actually happening in the plant. The best means to make sure your flow diagram is accurate is to have the HACCP team verify it by walking through the plant and making sure all the steps in the process you carry out are included in the flow diagram. Verifying the flow diagram is a step your team should be sure to do carefully. It is also a common means by which auditors or inspectors verify that a particular flow diagram is correct and complete. 6
