Mechanically Separated/Mechanically Deboned Model ook at the entries for "Receiving-Carcass Parts "on the first page of the six column form for mechanically separated pork; 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 the most recent Salmonella performance standard sampling results which demonstrated 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 Note: Look at the entries for"Storage -Carcass Parts"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 can grow in this product if not kept sufficiently cool. Column five contains their description of the 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 mechanically separated pork, there are five food 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 anal itself to make sure they are complete. Part 4172(a)()includes a list of sources from which 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 and 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 which 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. These references 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 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
Mechanically Separated/Mechanically Deboned Model Look at the entries for “Receiving – Carcass Parts” on the first page of the six column form for mechanically separated pork; 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 the most recent Salmonella performance standard sampling results which demonstrated 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. Note: Look at the entries for “Storage – Carcass Parts” 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 can grow in this product if not kept sufficiently cool. Column five contains their description of the 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 mechanically separated pork, there are five food 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 and 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 which 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. These references 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. 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 9
Mechanically Separated/Mechanically Deboned Model this far; this is like completing the foundation of a house 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 which 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 (c) The contents of the HacCP plan. The haccP plan shall, at a minimum 1)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 (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 () 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 (5 Include all corrective actions that have been developed in accordance with $417.3(a) of this 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
Mechanically Separated/Mechanically Deboned Model this far; this is like completing the foundation of a house. 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 which 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: (c) 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. 10
Mechanically Separated/Mechanically Deboned Model (7 List the verification procedures, and the frequency with which those procedures will 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) ) of this part Generic establishment X has prepared its HACCP plan for mechanically separated pork and mechanically deboned chicken on a six column form (See Figure 4 and Figure 8). 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)()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 points on the hazard analysis form for mechanicall separated pork where food safety hazards reasonably likely to occur were identified Salmonella on carcass parts at receiving, pathogen proliferation at cold storage, metal contamination during mechanical separation, Trichina at packaging/labeling, and pathogen proliferation at finished product storage(cold). The establishment HACCP team has chosen to have five CCPs to address these five hazards: Salmonella certification, proper cold storage of carcass parts, metal detectors after mechanical separation, proper labeling on packaging, and proper maintenance of finished product temperatures during storage 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 reco 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
Mechanically Separated/Mechanically Deboned Model (7) List the verification procedures, and the frequency with which those procedures will 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 mechanically separated pork and mechanically deboned chicken on a six column form (See Figure 4 and Figure 8). 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 points on the hazard analysis form for mechanically separated pork where food safety hazards reasonably likely to occur were identified: Salmonella on carcass parts at receiving, pathogen proliferation at cold storage, metal contamination during mechanical separation, Trichina at packaging/labeling, and pathogen proliferation at finished product storage (cold). The establishment HACCP team has chosen to have five CCPs to address these five hazards: Salmonella certification, proper cold storage of carcass parts, metal detectors after mechanical separation, proper labeling on packaging, and proper maintenance of finished product temperatures during storage. 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. 11
Mechanically Separated/Mechanically Deboned Model They found no regulatory requirements for receiving carcass parts, but realized that salmonella coming into the plant could result in cross-contamination with other product. The HACCP team knew that Salmonella may be present on incoming raw product, so they set the critical limit at requiring the supplier of the carcass parts to send a salmonella certificate with each shipment stating that the product has been sampled for Salmonella 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-carcass parts step, the establishment had the receiving personnel check each shipment for Salmonella certification 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 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))of this part The HACCP team decided they could verify the suppliers'Salmonella certifications by requesting Salmonella data results from the supplier for at least two suppliers every two months The HACCP team described the verification procedures and their frequencies in the fifth column of their HACCP plan The HACCP team for generic establishment X knew that their HACCP Plan needed to provide for a recordkeeping system. They wanted their records to be easy to create and understand They wanted to be sure their records met regulatory requirements, so they reviewed part 417.5(a) nd (b) 8417.5 Records (a) The establishment shall maintain the following records documenting the
Mechanically Separated/Mechanically Deboned Model They found no regulatory requirements for receiving carcass parts, but realized that Salmonella coming into the plant could result in cross-contamination with other product. The HACCP team knew that Salmonella may be present on incoming raw product, so they set the critical limit at requiring the supplier of the carcass parts to send a Salmonella certificate with each shipment stating that the product has been sampled for Salmonella. 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 – carcass parts step, the establishment had the receiving personnel check each shipment for Salmonella certification. 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. 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) of this part. The HACCP team decided they could verify the suppliers’ Salmonella certifications by requesting Salmonella data results from the supplier for at least two suppliers every two months. The HACCP team described the verification procedures and their frequencies in the fifth column of their HACCP plan. The HACCP team for generic establishment X knew that their HACCP Plan needed to provide for a recordkeeping system. They wanted their records to be easy to create and understand. They wanted to be sure their records met regulatory requirements, so they reviewed part 417.5(a) and (b): § 417.5 Records. (a) The establishment shall maintain the following records documenting the 12
Mechanically Separated/Mechanically Deboned Model establishment's HACCP plan ( The written hazard analysis prescribed in 417 2(a)of this part, including all supporting documentation the monitoring and verification procedures selected and the frequency of thoe ?g bo/ (2) The written HACCP plan, including decision making documents associated with th selection and development ofcCPs and critical limits, and documents suppot () Records documenting the monitoring of CCPs and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment's HACCP plan; the calibration ofprocess-monitoring instruments corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made (b) each entry on a record maintained under the haccp plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry The HACCP team decided that their records would be kept on some simple forms, some of which the team itself devised The HACCP team decided that since receiving personnel had a form that they had been using for receiving product, that they would modify that form. The form was modified to provide spaces for all entries necessary for the monitoring and verification activities at the receiving-carcass parts step On its HACCP Plan, generic establishment X has listed the names of the forms it will be using for monitoring and verification records There is one other form included in column four. where the establishment has described its recordkeeping system. That is the Corrective Actions Log; it is used to create the records of any corrective actions taken because of deviations from critical limits at cCPs. Column six references the planned corrective actions for each CCP. The HACCP team carefully reviewed the regulatory requirements for planned corrective actions found at 417.3(a) 8417.3 Corrective actions (a) The written HAcCP plan shall identify the corrective action to be followed in
Mechanically Separated/Mechanically Deboned Model establishment's HACCP plan: (1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation; (2) The written HACCP plan, including decision making documents associated with the selection and development of CCPs and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures. (3) Records documenting the monitoring of CCPs and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment's HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made. (b) Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry. The HACCP team decided that their records would be kept on some simple forms, some of which the team itself devised. The HACCP team decided that since receiving personnel had a form that they had been using for receiving product, that they would modify that form. The form was modified to provide spaces for all entries necessary for the monitoring and verification activities at the receiving – carcass parts step. On its HACCP Plan, generic establishment X has listed the names of the forms it will be using for monitoring and verification records. There is one other form included in column four, where the establishment has described its recordkeeping system. That is the Corrective Actions Log; it is used to create the records of any corrective actions taken because of deviations from critical limits at CCPs. Column six references the planned corrective actions for each CCP. The HACCP team carefully reviewed the regulatory requirements for planned corrective actions found at 417.3(a): § 417.3 Corrective actions. (a) The written HACCP plan shall identify the corrective action to be followed in 13