USDA Generic HACCP Model for raw United states Department of griculture Ground meat Food Safety and Inspection Service and Poultry September 1999 Products HACCP-3
United States Department of Agriculture Food Safety and Inspection Service September 1999 HACCP-3 Generic HACCP Model for Raw, Ground Meat and Poultry Products
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 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.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
Raw. ground Model Table of contents Introduction Using This Generic Model Process Flow Diagram and Product Description 3578 Hazard analysis Developing Your HACCP Plan 10 Identifying CCPs Appendix a References for HACCP teams References for Raw, Ground Meat and Poultry Products 23 Part I- Prevalence of Pathogens Found in ground Beef and Fresh Pork ausage 23 Part II-Effects of Processing Procedures on the growth of Pathogens Appendix B Process Flow Diagram(Figure 1) 28 Product Description Form(Figure 2) Hazard analysis Form( Figure 3) HACCP Plan Form(Figure 4) FORM LETTER Confirming Salmonella compliance with Performance Standards
Raw, Ground Model Table of Contents Introduction………………………………………….……………………………………. 3 Using This Generic Model………………………….…………………………………….. 5 Process Flow Diagram and Product Description….………………………………………. 7 Hazard Analysis…………………………………………………………………………… 8 Developing Your HACCP Plan………..………………………………………………….. 10 Identifying CCPs…………………………………….……………………………………. 11 Appendix A References for HACCP Teams………………………………………….............. 21 References for Raw, Ground Meat and Poultry Products…..…………………….. 23 Part I – Prevalence of Pathogens Found in Ground Beef and Fresh Pork Sausage…………………………………………..………………… 23 Part II – Effects of Processing Procedures on the Growth of Pathogens……………………………………….………………… 25 Appendix B Process Flow Diagram (Figure 1)…………………………………………………. 28 Product Description Form (Figure 2)……………………………………………… 29 Hazard Analysis Form (Figure 3)…………………………………………………. 30 HACCP Plan Form (Figure 4)..…………………………………………………… 35 FORM LETTER Confirming Salmonella Compliance with Performance Standards……………………………………………………… 40 1
Raw, ground Model Generic Establishment X: Room Temperature Log Thermometer Calibration Log Generic Establishment X: Metal Detection Lo 43 Corrective Actions Log Pre-Shipment Review Log
Raw, Ground Model Generic Establishment X: Room Temperature Log ……………………………… 41 Thermometer Calibration Log…………………………………………………….. 42 Generic Establishment X: Metal Detection Log……………………….................. 43 Corrective Actions Log……………………………………………………………. 44 Pre-Shipment Review Log………………………………………………………… 45 2
Raw. ground Model GENERIC HACCP MODEL FOR RAW. GROUND MEAT AND POULTRY PRODUCTS Introduction The Hazard Analysis Critical Control Point(HACCP) system is a scientific approach to process control. It is designed to prevent the occurrence of problems by assuring that controls are applied at any point in a food production system where hazardous or critical situations could occur. Hazards include biological, chemical, or physical contamination of food products The Food Safety and Inspection Service(FSIS) published a final rule in July 1996 mandating that HACCP be implemented as the system of process control in all inspected meat and poultry plants. As part of its efforts to assist establishments in the preparation of plant-specific HACCP plans, FSiS determined that a generic model for each process defined in the regulation would be made available for use on a voluntary basis by inspected establishments The generic models have been revised since their initial publication and distribution as DRAFTS. The most important change in the revised versions is to make certain that these models are fully consistent with the features of the final regulation. Also, other technical and editorial improvements have been made Throughout this generic model, FSIS discusses a HACCP team, with members from different departments. In many very small establishments, there will not be separate departments with different employees. But there will be employees who perform these different functions -often several of them. For purposes of explaining concepts, it is easier to speak as if these were different people, even though in many cases, they may be the same person carrying out more than one responsibility Each generic model can be used as a starting point for the development of plant-specific plan(s) reflecting actual plant environments and the processes conducted. The generic model is not ntended to be used"as is"for plant specific HACCP plans The generic models are designed for use in conjunction with the list of process categories found in the HACCP regulations in section 417 2(b)(1 (b) The haccP plan. (1) Every establishment shall develop and implement a written
Raw, Ground Model GENERIC HACCP MODEL FOR RAW, GROUND MEAT AND POULTRY PRODUCTS Introduction The Hazard Analysis Critical Control Point (HACCP) system is a scientific approach to process control. It is designed to prevent the occurrence of problems by assuring that controls are applied at any point in a food production system where hazardous or critical situations could occur. Hazards include biological, chemical, or physical contamination of food products. The Food Safety and Inspection Service (FSIS) published a final rule in July 1996 mandating that HACCP be implemented as the system of process control in all inspected meat and poultry plants. As part of its efforts to assist establishments in the preparation of plant-specific HACCP plans, FSIS determined that a generic model for each process defined in the regulation would be made available for use on a voluntary basis by inspected establishments. The generic models have been revised since their initial publication and distribution as DRAFTS. The most important change in the revised versions is to make certain that these models are fully consistent with the features of the final regulation. Also, other technical and editorial improvements have been made. Throughout this generic model, FSIS discusses a HACCP team, with members from different departments. In many very small establishments, there will not be separate departments with different employees. But there will be employees who perform these different functions – often several of them. For purposes of explaining concepts, it is easier to speak as if these were different people, even though in many cases, they may be the same person carrying out more than one responsibility. Each generic model can be used as a starting point for the development of plant-specific plan(s) reflecting actual plant environments and the processes conducted. The generic model is not intended to be used “as is” for plant specific HACCP plans. The generic models are designed for use in conjunction with the list of process categories found in the HACCP regulations in section 417.2(b)(1). (b) The HACCP plan. (1) Every establishment shall develop and implement a written 3
Raw, ground Model HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph(a) ofthis section, including products in the follow ing processing categories (i Slaughter--all species (ii) Ra product--ground (iii) Ra product--not ground (iv) Thermally processed--commercially sterile () Not heat treated--shelf stable (vi) Heat treated--shelf stable (vii Fully cooked--not shelf stable (viii) Heat treated but not fully cooked--not shelf stable (ix) Product with secondary inhibitors--not shelf stable This generic model is designed for use with the second process category: Raw product-ground The purpose of the process category listing in 4 17.2 is to set out the circumstances under which a HACCP team may develop a single HACCP plan for multiple products. This may be done when products are in the same process category, and food safety hazards, critical control points, and other features are essentially the same. There is a generic model for each process category, plus two for subcategories that present special issues: irradiated products and mechanically separated In order to select the model or models that will be most useful for the activities performed in any specific plant, the following steps should be taken 1)For slaughtering operations, select the model for the appropriate species 2)For processed products, make a list of all products produced in the plant 3) Examine the list and group like products, considering common processing steps and quipment used
Raw, Ground Model HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section, including products in the following processing categories: (i) Slaughter--all species. (ii) Raw product--ground. (iii) Raw product--not ground. (iv) Thermally processed--commercially sterile. (v) Not heat treated--shelf stable. (vi) Heat treated--shelf stable. (vii) Fully cooked--not shelf stable. (viii) Heat treated but not fully cooked--not shelf stable. (ix) Product with secondary inhibitors--not shelf stable. This generic model is designed for use with the second process category: Raw product--ground. The purpose of the process category listing in 417.2 is to set out the circumstances under which a HACCP team may develop a single HACCP plan for multiple products. This may be done when products are in the same process category, and food safety hazards, critical control points, and other features are essentially the same. There is a generic model for each process category, plus two for subcategories that present special issues: irradiated products and mechanically separated products. In order to select the model or models that will be most useful for the activities performed in any specific plant, the following steps should be taken: 1) For slaughtering operations, select the model for the appropriate species. 2) For processed products, make a list of all products produced in the plant. 3) Examine the list and group like products, considering common processing steps and equipment used. 4
Raw. ground Model 4)Compare the grouped products with the list of processes in the regulations; this step should reveal how many and which of the generic models might be useful Deciding on a generic model and which products can be covered by a single plan is an important achievement. If the team does it well, it can save a lot of unnecessary effort and paperwork Selecting an inappropriate generic model reduces its potential benefits. However, often the HACCP team will discover they have made this error when they develop their process flow diagram or during their hazard analysis. These are early stages in the process when it is relatively easy to make changes In any case, establishments must meet all regulatory requirements for their products Using This Generic Model This generic model is designed to be used by establishments that produce raw product(s), the second process category. The model can be used for all raw, ground products either meat or poultry; with or without spices or condiments; whether fresh or frozen. The generic model is not suitable for ground products with preservatives or secondary inhibitors or for partially cooked ground products. The model can be used for those products generally referred to as comminuted. Because mechanically separated products present some unique issues, FSIS has prepared a separate generic model for these products The model will be most useful to a haccP team that includes access to one trained individual as specified in 417.7(b) (b) The individual performing the functions listed in paragraph(a)of this section shall have successfully completed a course of instruction in the application of the seven HACCP principles to meat or poultry product processing, including a segment on the development ofa haccp plan for a specific product and on record review It would be beneficial for other team members to have reviewed any of the various guidance materials available on how to develop a haccp plan for your company, including several useful videos, handbooks, or computer programs. Once the haCCP team has prepared itself as thoroughly as possible in general HACCP principles and how to use them, this model should be helpful Note: This generic model includes a number of forms that can be used to record various types of required information. The forms themselves are samples; a company HACCP team can develop whatever forms it finds most useful. All the forms mentioned in this document are included in Appendix B; they appear in the order in which they are discussed in the text
Raw, Ground Model 4) Compare the grouped products with the list of processes in the regulations; this step should reveal how many and which of the generic models might be useful. Deciding on a generic model and which products can be covered by a single plan is an important achievement. If the team does it well, it can save a lot of unnecessary effort and paperwork. Selecting an inappropriate generic model reduces its potential benefits. However, often the HACCP team will discover they have made this error when they develop their process flow diagram or during their hazard analysis. These are early stages in the process when it is relatively easy to make changes. In any case, establishments must meet all regulatory requirements for their products. Using This Generic Model This generic model is designed to be used by establishments that produce raw, ground product(s), the second process category. The model can be used for all raw, ground products: either meat or poultry; with or without spices or condiments; whether fresh or frozen. The generic model is not suitable for ground products with preservatives or secondary inhibitors or for partially cooked ground products. The model can be used for those products generally referred to as comminuted. Because mechanically separated products present some unique issues, FSIS has prepared a separate generic model for these products. The model will be most useful to a HACCP team that includes access to one trained individual, as specified in 417.7(b). (b) The individual performing the functions listed in paragraph (a) of this section shall have successfully completed a course of instruction in the application of the seven HACCP principles to meat or poultry product processing, including a segment on the development of a HACCP plan for a specific product and on record review. It would be beneficial for other team members to have reviewed any of the various guidance materials available on how to develop a HACCP plan for your company, including several useful videos, handbooks, or computer programs. Once the HACCP team has prepared itself as thoroughly as possible in general HACCP principles and how to use them, this model should be helpful. Note: This generic model includes a number of forms that can be used to record various types of required information. The forms themselves are samples; a company HACCP team can develop whatever forms it finds most useful. All the forms mentioned in this document are included in Appendix B; they appear in the order in which they are discussed in the text. 5
Raw. ground Model All FSiS generic models are designed to assist establishments in applying the seven HACCP principles to their meat and poultry processing operations And to meet the regulator requirements of Part 417. Therefore, the definitions used in this and all other FSIS generic models are those found in 417.1 8417. 1 Definitions. For purposes of this part, the following definitions shall apply Corrective action. Procedures to be followed when a deviation occurs Critical control point, A point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels Critical limit. The maximum or minimum value to which a physical, biological, or reduce to an acceptable level the occurrence of the identified food safety hail te, or chemical hazard must be controlled at a critical control point to prevent, elimina Food safery hazard. Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption HACCP System. The HACCP plan in operation, including the HACCP plan itself. Hazard. SEE Food Safety Hazard Preventive measure. Physical, chemical, or other means that can be used to control an dentified food safety hasara Process-monitoring instrument. An instrument or device used to indicate conditions during processing at a critical control point Responsible establishment official. The individual with overall authority on-site or a higher level official of the establishment Process Flow Diagram and Product Description To begin using this model, the company's haCCP team should first describe the product(s), which are part of this process category and covered by this HACCp plan. The product(s) should be described in two ways
Raw, Ground Model All FSIS generic models are designed to assist establishments in applying the seven HACCP principles to their meat and poultry processing operations AND to meet the regulatory requirements of Part 417. Therefore, the definitions used in this and all other FSIS generic models are those found in 417.1: § 417.1 Definitions. For purposes of this part, the following definitions shall apply: Corrective action. Procedures to be followed when a deviation occurs. Critical control point. A point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels. Critical limit. The maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. Food safety hazard. Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption. HACCP System. The HACCP plan in operation, including the HACCP plan itself. Hazard. SEE Food Safety Hazard. Preventive measure. Physical, chemical, or other means that can be used to control an identified food safety hazard. Process-monitoring instrument. An instrument or device used to indicate conditions during processing at a critical control point. Responsible establishment official. The individual with overall authority on-site or a higher level official of the establishment. Process Flow Diagram and Product Description To begin using this model, the company's HACCP team should first describe the product(s), which are part of this process category and covered by this HACCP plan. The product(s) should be described in two ways: 6
Raw. ground Model (1) by a simple diagram which shows the steps the company uses when it produces the product, and (2)in a brief written description which provides key facts about the product and its use In this generic model, there is an example for fresh pork sausage, one of the products in this process category. FSIS has developed certain forms as part of the examples in the generic models; company HACCP teams are not required to use these forms. Figure 1 is an example of a PROCESS FLOW DIAGRAM for the production of fresh pork sausage in generic establishment X. Figure 2 is an example of a PRODUCT DESCRIPTION for the fresh pork sausage produced by generic establishment X Once the company HACCP team in your establishment has prepared your Process Flow Diagram, they should verify it by walking through the establishment following the flow of product and making sure that all the steps of the process are included in the flow diagram. The team should also review the information provided on the Product Description to make sure all the key facts are included, such as identifying consumers, especially those with particular health problems or known to be at risk Note: If you are producing a raw, ground product which does not have any non-meat ingredients, such as raw, ground beef patties, you would not include the left side of the flow diagram i.e receiving non-meat ingredients, storage of non-meat ingredients, etc. That is generally, how you use these generic model examples--just omit the features which do not apply to your operation By completing a Process Flow Diagram and a Product Description, you have met the requirements of 4172(a)(2). You can use the Process Flow Diagram in particular to help you complete the rest of the hazard analysis. Use the flow diagram to systematically review each step in the process and ask the question, "Is there a food safety hazard which is reasonably likely to occur which may be introduced at this step? In answering the question, your HACCPteam needs to consider biological (including microbiological), chemical, and physical hazards Hazard analysis Once your product(s)are accurately described through the flow diagram and product description the haCCP team should begin work on the HAZARD ANALYSIS. The hazard analysis is fundamental to developing a good haCCP plan and one that meets regulatory requirements The regulatory requirements for a hazard analysis are found at 417 2(a) 8417. 2 Hazard analysis and hacCP plan
Raw, Ground Model (1) by a simple diagram which shows the steps the company uses when it produces the product, and (2) in a brief written description which provides key facts about the product and its use. In this generic model, there is an example for fresh pork sausage, one of the products in this process category. FSIS has developed certain forms as part of the examples in the generic models; company HACCP teams are not required to use these forms. Figure 1 is an example of a PROCESS FLOW DIAGRAM for the production of fresh pork sausage in generic establishment X. Figure 2 is an example of a PRODUCT DESCRIPTION for the fresh pork sausage produced by generic establishment X. Once the company HACCP team in your establishment has prepared your Process Flow Diagram, they should verify it by walking through the establishment following the flow of product and making sure that all the steps of the process are included in the flow diagram. The team should also review the information provided on the Product Description to make sure all the key facts are included, such as identifying consumers, especially those with particular health problems or known to be at risk. Note: If you are producing a raw, ground product which does not have any non-meat ingredients, such as raw, ground beef patties, you would not include the left side of the flow diagram i.e., receiving non-meat ingredients, storage of non-meat ingredients, etc. That is generally, how you use these generic model examples--just omit the features which do not apply to your operation. By completing a Process Flow Diagram and a Product Description, you have met the requirements of 417.2(a)(2). You can use the Process Flow Diagram in particular to help you complete the rest of the hazard analysis. Use the flow diagram to systematically review each step in the process and ask the question, "Is there a food safety hazard which is reasonably likely to occur which may be introduced at this step?" In answering the question, your HACCP team needs to consider biological (including microbiological), chemical, and physical hazards. Hazard Analysis Once your product(s) are accurately described through the flow diagram and product description, the HACCP team should begin work on the HAZARD ANALYSIS. The hazard analysis is fundamental to developing a good HACCP plan and one that meets regulatory requirements. The regulatory requirements for a hazard analysis are found at 417.2(a). § 417.2 Hazard Analysis and HACCP Plan. 7
Raw, ground Model (a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type ofproduct being processed, in the absence of those controls (2)A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified. Generic establishment X, which we are using for our example, is capturing these regulatory requirements on a 6-column Hazard Analysis Form( See Figure 3). a good way to use a form like this is to create the first column by using the Process Flow Diagram and the second by answering the question of whether there is a food safety hazard. Once the HACCP team has considered all the steps in the flow diagram and determined if a food safety hazard could be introduced, it needs to consider whether the hazard is"reasonably likely to occur", using the meaning of this phrase included in 4172(a). On the 6-column form used by generic establishment X. the third and fourth columns address this issue. If the establishment's HACCP team has decided that the hazard is not reasonably likely to occur, they enter"No"in column three, explain the basis for their determination in column four, and do not need to further consider activity at this point in the process If, however, the team has determined there is a"food safety hazard reasonably likely to occur" introduced at a certain point in the process, column five is used to describe a measure which could be applied to"prevent, eliminate, or reduce to acceptable levels"the food safety hazard identified in column three Look at the entries for"Receiving- Meat on the first page of the six column form; the HACCP team has determined that Salmonella may be present at high levels in incoming raw product, so it has put a"Yes" in the third column. Column four explains the basis for the teams determination. In the fifth column, the HACCP team has described the preventive measures it will use to make sure that each hazard has been prevented, eliminated, or reduced to an acceptable level. For the Salmonella hazard, the haCCp team decided to tell its suppliers that product could not be accepted unless it was accompanied by certification that the supplier had not failed two consecutive Salmonella performance standard sets. FSiS does not consider safe handling labels alone to be an adequate CCP for any pathogenic microorganisms such as bacteria and viruse
Raw, Ground Model (a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls. (2) A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified. Generic establishment X, which we are using for our example, is capturing these regulatory requirements on a 6-column Hazard Analysis Form (See Figure 3). A good way to use a form like this is to create the first column by using the Process Flow Diagram and the second by answering the question of whether there is a food safety hazard. Once the HACCP team has considered all the steps in the flow diagram and determined if a food safety hazard could be introduced, it needs to consider whether the hazard is "reasonably likely to occur", using the meaning of this phrase included in 417.2(a). On the 6-column form used by generic establishment X, the third and fourth columns address this issue. If the establishment's HACCP team has decided that the hazard is not reasonably likely to occur, they enter "No" in column three, explain the basis for their determination in column four, and do not need to further consider activity at this point in the process. If, however, the team has determined there is a "food safety hazard reasonably likely to occur" introduced at a certain point in the process, column five is used to describe a measure which could be applied to "prevent, eliminate, or reduce to acceptable levels" the food safety hazard identified in column three. Look at the entries for “Receiving-Meat” on the first page of the six column form; the HACCP team has determined that Salmonella may be present at high levels in incoming raw product, so it has put a “Yes” in the third column. Column four explains the basis for the team’s determination. In the fifth column, the HACCP team has described the preventive measures it will use to make sure that each hazard has been prevented, eliminated, or reduced to an acceptable level. For the Salmonella hazard, the HACCP team decided to tell its suppliers that product could not be accepted unless it was accompanied by certification that the supplier had not failed two consecutive Salmonella performance standard sets. FSIS does not consider safe handling labels alone to be an adequate CCP for any pathogenic microorganisms such as bacteria and viruses. 8