USDA Generic HACCP Model for United states Department of griculture Irradiated raw Food Safety and Inspection Meat and Service May 1999 Poultry HACCP-8 Products
United States Department of Agriculture Food Safety and Inspection Service May 1999 HACCP-8 Generic HACCP Model for Irradiated, Raw 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
Irradiated Ram 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 all haccp Model teams 19 References for Irradiated, Raw Meat and Poultry Products Appendix B Process Flow Diagram(Figure 1) Product Description Form( Figure 2) 26 Hazard analysis Form(Figure 3) 27 HACCP Plan Form(Figure 4) 32 Form letter requesting Salmonella data(1) Form letter requesting Salmonella data(2) Generic Establishment X: Product Temperature Lo Generic Establishment X: Room Temperature Log hermometer Calibration Log
Irradiated, Raw 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…………………………………….……………………………………. 12 Appendix A References for all HACCP Model Teams………………………………………… 19 References for Irradiated, Raw Meat and Poultry Products..…………………….. 21 Appendix B Process Flow Diagram (Figure 1)…………………………………………………. 25 Product Description Form (Figure 2)……………………………………………… 26 Hazard Analysis Form (Figure 3)…………………………………………………. 27 HACCP Plan Form (Figure 4)..…………………………………………………… 32 Form letter requesting Salmonella data (1)……………………………………….. 37 Form letter requesting Salmonella data (2)……………………….……………….. 38 Generic Establishment X: Product Temperature Log …………………………….. 39 Generic Establishment X: Room Temperature Log…………..…………………… 40 Thermometer Calibration Log………………………………………………..……. 41 1
Irradiated Ram Model Generic Establishment X: Irradiation/Dose Mapping Log Corrective Actions Log Pre-Shipment Review Log
Irradiated, Raw Model Generic Establishment X: Irradiation/Dose Mapping Log ……………………….. 42 Corrective Actions Log……………………………………………………………. 43 Pre-Shipment Review Log………………………………………………………… 44 2
Irradiated Ram Model GENERIC HACCP MODEL FOR IRRADIATED RAW 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
Irradiated, Raw Model GENERIC HACCP MODEL FOR IRRADIATED, RAW 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). 3
Irradiated Ram Model (b) The HaccP plan. (1) Every establishment shall develop and implement a written 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 following processing categories Slaughter--all species (ii) Raw product--ground (iii) Raw product--not ground (iv) Thermally processed--commercially sterile (y) 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 process subcategory: Irradiated, raw product HACCP team may develop a single HACCP plan for multiple products. This may be done wheo? The purpose of the process category listing in 417.2 is to set out the circumstances under which a 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
Irradiated, Raw Model (b) The HACCP plan. (1) Every establishment shall develop and implement a written 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 process subcategory: Irradiated, raw product. 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. 4
Irradiated Ram Model 3) Examine the list and group like products, considering common processing steps and equipment used 4)Compare the grouped products with the list of processes in the regulations; this step should eveal 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 diagram or during their hazard analysis. These are early stages in the process when it / z HACCP team will discover they have made this error when they develop their process flo relatively easy to make changes In any case, establishments must meet all regulatory requirements for their products Using This Generic Model product(s). The model can be used for all irradiated, raw meat and poultry product aw This generic model is designed to be used by establishments that produce irradiated 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 Since this generic model entails the use of ionizing radiation, at least one team member must be trained in quality control, food technology, irradiation processing, and radiation health and safety. This team member must have a working knowledge of FSIS regulations on irradiation (e.g. 9 CFR 381. 135, 381. 147, and 381. 149 for poultry ), and other requirements set forth by the FDA, National Regulatory Commission, and the Office of Safety and Health Administration It would be beneficial for other team members to ha ly 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
Irradiated, Raw Model 3) Examine the list and group like products, considering common processing steps and equipment used. 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 irradiated, raw product(s). The model can be used for all irradiated, raw meat and poultry 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. Since this generic model entails the use of ionizing radiation, at least one team member must be trained in quality control, food technology, irradiation processing, and radiation health and safety. This team member must have a working knowledge of FSIS regulations on irradiation (e.g. 9 CFR 381.135, 381.147, and 381.149 for poultry), and other requirements set forth by the FDA, National Regulatory Commission, and the Office of Safety and Health Administration. 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 5
Irradiated Ram Model 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 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 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 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 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 identified food safery 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 ora
Irradiated, Raw Model 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. 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 6
Irradiated Ram Model 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 (1) by a simple diagram which shows the steps the company uses when it produces the product (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 irradiated, raw product- fresh poultry. 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 irradiated fresh poultry in generic establishment X. Figure 2 is an example of a PRODUCT DESCRIPTION for the production of irradiated fresh poultry 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 facility for the irradiation process. If in your process, irradiation is to be done in the same er Note: In this generic model, it is assumed that packaged poultry will be transported to anoth establishment that the poultry is received and packaged, then the transporting step may omitted. That is generally, how you use these generic model examples--just omit the features which do not apply to your operation, or if your operation includes features not included in this example, they should be added 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
Irradiated, Raw Model 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: (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 irradiated, raw product - fresh poultry. 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 irradiated fresh poultry in generic establishment X. Figure 2 is an example of a PRODUCT DESCRIPTION for the production of irradiated fresh poultry 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: In this generic model, it is assumed that packaged poultry will be transported to another facility for the irradiation process. If in your process, irradiation is to be done in the same establishment that the poultry is received and packaged, then the transporting step may be omitted. That is generally, how you use these generic model examples--just omit the features which do not apply to your operation, or if your operation includes features not included in this example, they should be added. 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 7
Irradiated Ram Model step in the process and ask the question, "Is there a food safety hazard which is reasonably likel 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) 8417. 2 Hazard Analysis and HacCP plan (a) Hazard analysis.(1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards ply likely 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 afier 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. Once the HACCP team has considered all the steps in the flow diagran 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 8
Irradiated, Raw Model 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. (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. 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" 8
