Raw. ground Model Note: Look at the entries for"Storage-Meat"on the second page of the six-column form the HACCP team has determined that there is a food safety hazard reasonably likely to occur at this step in the process. Column four contains the reason for their thinking: pathogenic organisms (including Salmonella) can grow in this product if it is not kept sufficiently cool. Column five contains their description of a measure that will prevent the growth of pathogenic organisms temperatures that are sufficiently low to preclude growth You will notice that on our generic hazard analysis for pork sausage, there are six safety hazards in which the HACCP team has identified a point in the process at which a food safety hazard is reasonably likely to occur. For each one of these they have identified a measure which can be used to control the hazard When your HACCP team has completed their hazard analysis( whether they use this format or not), it is a good idea to review the flow diagram, the product description and the hazard analysis itself to make sure they are complete. Part 4172(a)()includes a list of sources from which food safety hazards might be expected to arise. Reviewing that list could help the HACCP team check for completeness Note: If you are using this generic model to produce a different raw, ground product or if you use a different process flow, you may have different hazards which are reasonably likely to occur. For these different hazards, there may be different measures that could be used for control purposes This, and all other FSIS generic models, contains a list of references which can help your HACCP team in making sure the hazard analysis is complete. The references for raw, ground product are found in Appendix A. A member of your HACCP team might want to review at least some of the references to make sure hazards have not been omitted from the hazard If you are using this generic model to develop a HACCP plan for raw, ground beef, you may find the recently issued FSIS guidance material on producing this product to be useful. You may get a copy from the FSiS Docket Clerk in Room 102, Cotton Annex Building, 300 12 Street, SW, Washington, DC, 20250. An electronic version of the guidance material is available on line throughtheFsiSwebpagelocatedathttp://www.fsis.usda.gov. Completing the hazard analysis is a very significant and important element in developing you HACCP system. Your HACCP team should feel a real sense of accomplishment when they get this far, this is like completing the foundation of a house
Raw, Ground Model Note: Look at the entries for "Storage-Meat" on the second page of the six-column form: the HACCP team has determined that there is a food safety hazard reasonably likely to occur at this step in the process. Column four contains the reason for their thinking: pathogenic organisms (including Salmonella) can grow in this product if it is not kept sufficiently cool. Column five contains their description of a measure that will prevent the growth of pathogenic organisms: temperatures that are sufficiently low to preclude growth. You will notice that on our generic hazard analysis for pork sausage, there are six safety hazards in which the HACCP team has identified a point in the process at which a food safety hazard is reasonably likely to occur. For each one of these they have identified a measure which can be used to control the hazard. When your HACCP team has completed their hazard analysis (whether they use this format or not), it is a good idea to review the flow diagram, the product description and the hazard analysis itself to make sure they are complete. Part 417.2(a)(3) includes a list of sources from which food safety hazards might be expected to arise. Reviewing that list could help the HACCP team check for completeness. Note: If you are using this generic model to produce a different raw, ground product or if you use a different process flow, you may have different hazards which are reasonably likely to occur. For these different hazards, there may be different measures that could be used for control purposes. This, and all other FSIS generic models, contains a list of references which can help your HACCP team in making sure the hazard analysis is complete. The references for raw, ground product are found in Appendix A. A member of your HACCP team might want to review at least some of the references to make sure hazards have not been omitted from the hazard analysis. If you are using this generic model to develop a HACCP plan for raw, ground beef, you may find the recently issued FSIS guidance material on producing this product to be useful. You may get a copy from the FSIS Docket Clerk in Room 102, Cotton Annex Building, 300 12th Street, SW, Washington, DC, 20250. An electronic version of the guidance material is available on line through the FSIS web page located at http://www.fsis.usda.gov. Completing the hazard analysis is a very significant and important element in developing your HACCP system. Your HACCP team should feel a real sense of accomplishment when they get this far; this is like completing the foundation of a house. 9
Raw. ground Model Developing Your HACCP Plan The company HACCP team can now take the materials it developed while doing the hazard analysis and use them to build the HACCP Plan. Remember that one of the important objectives of the FSIS generic models is to provide examples that illustrate how to meet the regulatory requirements of Part 417, as well as to correctly apply the principles of HACCP Part 4172(c)and( d)are the regulatory requirements The contents of the HACCP plan. The HACCP plan shall, at a minimum List the food safery hazards identified in accordance with paragraph(a)ofthis section, which must be controlled for each process (2 )List the critical control points for each of the identified food safety hazards, including, as appropriate () Critical control points designed to control food safety hazards that could be introduced in the establishment, and (ii) Critical control points designed to control food safety hazards introduced outside the establishment, including food safety hazards that occur before, during, and after entry into the establishment B)List the critical limits that must be met at each of the critical control points. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSiS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met; (4List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits ( Include all corrective actions that have been developed in accordance with 417.3(a) ofthis part, to be followed in response to anmy deviation from a critical limit at a critical control point; and (6) Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring (7 List the verification procedures, and the frequency with which those procedures will
Raw, Ground Model Developing Your HACCP Plan The company HACCP team can now take the materials it developed while doing the hazard analysis and use them to build the HACCP Plan. Remember that one of the important objectives of the FSIS generic models is to provide examples that illustrate how to meet the regulatory requirements of Part 417, as well as to correctly apply the principles of HACCP. Part 417.2 (c) and (d) are the regulatory requirements: The contents of the HACCP plan. The HACCP plan shall, at a minimum: (1) List the food safety hazards identified in accordance with paragraph (a) of this section, which must be controlled for each process. (2) List the critical control points for each of the identified food safety hazards, including, as appropriate: (i) Critical control points designed to control food safety hazards that could be introduced in the establishment, and (ii) Critical control points designed to control food safety hazards introduced outside the establishment, including food safety hazards that occur before, during, and after entry into the establishment; (3) List the critical limits that must be met at each of the critical control points. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met; (4) List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits; (5) Include all corrective actions that have been developed in accordance with §417.3(a) of this part, to be followed in response to any deviation from a critical limit at a critical control point; and (6) Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring. (7) List the verification procedures, and the frequency with which those procedures will 10
Raw, ground Model be performed, that the establishment will use in accordance with4174 of this part (a Signing and dating the HACCP plan. ()The HaccP plan shall be signed and dated by the responsible establishment individual. This signature shall signify that the establishment accepts and will implement the HaCCP plan (2) The haccp plan shall be dated and signed o Upon initial acceptance (ii Upon anmy modification; and (iii) At least annually, upon reassessment, as required under s4174(a))of this part Generic establishment X has prepared its HACCP plan for pork sausage on a six column form (See Figure 4). You do not need to use this form, although some kind of a form is probably the easiest way to present your HACCP plan Identifying ccps The first column on this particular form is used to enter information developed and contained on the hazard analysis form. Part 417 2(c (1)and(2)require that the food safety hazards identified in the hazard analysis be listed on the haCCP plan and that there be a CCp for each identified hazard. You will notice that there were five process steps(six food safety hazards )on the hazard analysis form where food safety hazards reasonably likely to occur were identified: presence of Salmonella on incoming meat products; pathogen growth at the location where meat was stored metal shavings contamination at grinding; metal shavings contamination carried through into packaged product; presence of trichina in finished product being packaged and labeled; and pathogen growth in stored finished product The establishment haccp team has chosen to have five ccps to address these six hazards supplier Salmonella certification review at meat receiving; temperature controls in the raw meat storage area, and temperature controls in the finished product storage area; a metal detector on the packaging line overseen by the packaging line supervisor; and clear product labeling to show the product is raw and must be fully cooked to prevent any trichina survival. The metal detector is the control for metal shavings contamination whether introduced through the packaging process or at some earlier point Determining what will be the CCPs requires knowledge of HACCP, the establishment processes, and good practical judgment. When the team gets this done, it has passed an important milestone
Raw, Ground Model be performed, that the establishment will use in accordance with § 417.4 of this part. (d) Signing and dating the HACCP plan. (1) The HACCP plan shall be signed and dated by the responsible establishment individual. This signature shall signify that the establishment accepts and will implement the HACCP plan. (2) The HACCP plan shall be dated and signed: (i) Upon initial acceptance; (ii) Upon any modification; and (iii) At least annually, upon reassessment, as required under § 417.4(a)(3) of this part. Generic establishment X has prepared its HACCP plan for pork sausage on a six column form (See Figure 4). You do not need to use this form, although some kind of a form is probably the easiest way to present your HACCP plan. Identifying CCPs The first column on this particular form is used to enter information developed and contained on the hazard analysis form. Part 417.2(c)(1) and (2) require that the food safety hazards identified in the hazard analysis be listed on the HACCP plan and that there be a CCP for each identified hazard. You will notice that there were five process steps (six food safety hazards) on the hazard analysis form where food safety hazards reasonably likely to occur were identified: presence of Salmonella on incoming meat products; pathogen growth at the location where meat was stored; metal shavings contamination at grinding; metal shavings contamination carried through into packaged product; presence of trichina in finished product being packaged and labeled; and pathogen growth in stored finished product. The establishment HACCP team has chosen to have five CCPs to address these six hazards: supplier Salmonella certification review at meat receiving; temperature controls in the raw meat storage area, and temperature controls in the finished product storage area; a metal detector on the packaging line overseen by the packaging line supervisor; and clear product labeling to show the product is raw and must be fully cooked to prevent any trichina survival. The metal detector is the control for metal shavings contamination whether introduced through the packaging process or at some earlier point. Determining what will be the CCPs requires knowledge of HACCP, the establishment processes, and good practical judgment. When the team gets this done, it has passed an important milestone. 11
Raw. ground Model After identifying its CCPs, the HACCP team proceeded to consider critical limits, monitoring procedures and their frequencies, and verification procedures and their frequencies, and HACCP record were any regulatory requirements which had to be met and would function as critical limit a In deciding what would be the critical limits, the HACCP team first considered whether ther They knew about the pathogen reduction performance standards for Salmonella on raw carcasses and raw ground products(Part 3 10.25)because they would be subject to one themselves. The team determined that if a supplier establishment had failed two consecutive sample sets, the would not receive that product They did not find any specific temperature limits which applied to red meat storage areas. The team members knew that the Food Code, which had recently been adopted in their state, recommended a transport temperature of 41 F; and they knew that the European Union required a 42 F temperature. They decided that in order to be within the recommended limits for food safety and to assure that the thermometers used which measure in 2 degree increments assured safety the conservative 40 F critical limit was selected With respect to metal shavings, the team knew that their metal detector was capable of dentifying metal shavings as small as 1/32 of an inch, as long as it was working well. Therefore they decided that their critical limit would be 1/32 inch They were aware of regulatory requirements to prevent consumer confusion about which pork products were raw. Their product did not have any ingredients that would make it appear cooked. For their critical limit, the HACCP team decided that a label that met regulatory requirements for raw pork products, with clear cooking instructions, plus the FSIS safe handling label. would be their critical limits Once they had decided on their critical limits, they needed to identify how the monitorin procedures would be carried out and at what frequency For their Receiving-Meat control on Salmonella prevalence on incom ing products, they decided the operational personnel who normally checked arriving products would also check each shipment for the supplier certification about Salmonella results. The team determined that this might be an excessive frequency for suppliers with good performance, and decided that when they validated their HACCP plan(by actually trying it out and recording results), they would consider whether another frequency should be used For their two temperature CCPs, they decided that maintenance personnel would be in the best
Raw, Ground Model After identifying its CCPs, the HACCP team proceeded to consider critical limits, monitoring procedures and their frequencies, and verification procedures and their frequencies, and HACCP records. In deciding what would be the critical limits, the HACCP team first considered whether there were any regulatory requirements which had to be met and would function as critical limits. They knew about the pathogen reduction performance standards for Salmonella on raw carcasses and raw ground products (Part 310.25) because they would be subject to one themselves. The team determined that if a supplier establishment had failed two consecutive sample sets, they would not receive that product. They did not find any specific temperature limits which applied to red meat storage areas. The team members knew that the Food Code, which had recently been adopted in their state, recommended a transport temperature of 41° F; and they knew that the European Union required a 42° F temperature. They decided that in order to be within the recommended limits for food safety and to assure that the thermometers used which measure in 2 degree increments assured safety, the conservative 40° F critical limit was selected. With respect to metal shavings, the team knew that their metal detector was capable of identifying metal shavings as small as 1/32 of an inch, as long as it was working well. Therefore they decided that their critical limit would be 1/32 inch. They were aware of regulatory requirements to prevent consumer confusion about which pork products were raw. Their product did not have any ingredients that would make it appear cooked. For their critical limit, the HACCP team decided that a label that met regulatory requirements for raw pork products, with clear cooking instructions, plus the FSIS safe handling label, would be their critical limits. Once they had decided on their critical limits, they needed to identify how the monitoring procedures would be carried out and at what frequency. For their Receiving-Meat control on Salmonella prevalence on incoming products, they decided the operational personnel who normally checked arriving products would also check each shipment for the supplier certification about Salmonella results. The team determined that this might be an excessive frequency for suppliers with good performance, and decided that when they validated their HACCP plan (by actually trying it out and recording results), they would consider whether another frequency should be used. For their two temperature CCPs, they decided that maintenance personnel would be in the best 12
Raw. ground Model position to check the temperatures in the storage areas. They decided that the temperature checks should be performed every two hours. In making this decision, the team knew that if there was a deviation from a critical limit at a CCP, they would need to perform corrective actions on the product which had potentially been affected by the deviation; they determined that two hours worth of product was the most that they wanted to control and possibly rework at one For their metal detector CCP, the HACCP team decided that the packaging line supervisor would by putting a seeded sample through the detector every two hours. Company personnel have so be in the best position to assure that the metal detector was working well and that he could do worked with this metal detector for about six months and have found that when it is properly adjusted, it works very well and meets manufacturer's specifications. However, it can get out of alignment relatively quickly, and there are no overt signs on the machine itself that it is working less than optimally. Putting a seeded sample through is a reliable way to assure its proper which they might need to rework if there were a deviation from the critical limit of 1/32 inch The HACCP team decided that the best way to monitor that their labeling specifications were being met was at non-meat receiving, at this location receiving personnel routinely checked all incoming non-meat materials to make sure they met specifications. Since labels were manufactured in large lots by a single company, the receiving clerks would randomly sample each arriving These decisions by the HaCCP team regarding critical limits, plus monitoring procedures and their frequencies are written up in columns two and three of the HACCP Plan. By using the six column form, the team members can see that they are making good progress on developing their The team then went on to consider appropriate verification procedures; the team knew that there were different types of verification and that Part 417.4(a)(2)included specific regulatory requirements for each. The regulatory requirements for ongoing verification are (2) Ongoing verification activities. Ongoing verification activities include, but are not limited te (i The calibration of process-monitoring instruments (ii) Direct observations of monitoring activities and corrective actions, and (iii)The reve] of records generated and maintained in accordance with5417.(a))
Raw, Ground Model position to check the temperatures in the storage areas. They decided that the temperature checks should be performed every two hours. In making this decision, the team knew that if there was a deviation from a critical limit at a CCP, they would need to perform corrective actions on the product which had potentially been affected by the deviation; they determined that two hours' worth of product was the most that they wanted to control and possibly rework at one time. For their metal detector CCP, the HACCP team decided that the packaging line supervisor would be in the best position to assure that the metal detector was working well and that he could do so by putting a seeded sample through the detector every two hours. Company personnel have worked with this metal detector for about six months and have found that when it is properly adjusted, it works very well and meets manufacturer's specifications. However, it can get out of alignment relatively quickly, and there are no overt signs on the machine itself that it is working less than optimally. Putting a seeded sample through is a reliable way to assure its proper functioning. The team decided that putting the seeded sample through every two hours was a good frequency because they did not want to have more than two hours worth of product which they might need to rework if there were a deviation from the critical limit of 1/32 inch. The HACCP team decided that the best way to monitor that their labeling specifications were being met was at non-meat receiving; at this location receiving personnel routinely checked all incoming non-meat materials to make sure they met specifications. Since labels were manufactured in large lots by a single company, the receiving clerks would randomly sample each arriving lot. These decisions by the HACCP team regarding critical limits, plus monitoring procedures and their frequencies are written up in columns two and three of the HACCP Plan. By using the sixcolumn form, the team members can see that they are making good progress on developing their plan. The team then went on to consider appropriate verification procedures; the team knew that there were different types of verification and that Part 417.4(a)(2) included specific regulatory requirements for each. The regulatory requirements for ongoing verification are: (2) Ongoing verification activities. Ongoing verification activities include, but are not limited to: (i) The calibration of process-monitoring instruments; (ii) Direct observations of monitoring activities and corrective actions; and (iii) The review of records generated and maintained in accordance with § 417.5(a)(3) 13