Not Heat Treated, Shelf stable Model 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 analy 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 this model to produce a different not heat treated, shelf stable roduct or if a different flow, you may have different hazards which are reasonably likely to occur. For these different hazards, there may be different measures which ould be used for control p 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 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 () List the food safety 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 safery hazards that could be introduced in the establishment. and
Not Heat Treated, Shelf Stable Model 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 not heat treated, shelf stable 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 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 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 9
Not Heat Treated, Shelf stable Model (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; (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 5417.3(a) ofthis part, to be followed in response to anmy deviation from a critical limit at a critical control point; ana (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 be performed, that the establishment will use in accordance with5.4 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. ( Upon initial acceptance (ii) Upon any 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 pepperoni and salami 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 plar Identifying CCPs The first column on this particular form is used to enter information developed and contained
Not Heat Treated, Shelf Stable Model (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 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 pepperoni and salami 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 10
Not Heat Treated, Shelf stable Model 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 six points on the hazard analysis form for pepperoni and salami where food safety hazards reasonably likely to occur were identified Salmonella on raw heat/poultry at receiving, pathogen proliferation at cold storage, metal contamination during mechanical processing, pathogen proliferation at fermentation, pathogen proliferation at drying and Listeria monocytogenes contamination at slicing/peeling. The establishment HACCP team has chosen to have six CCPs to address these six hazards Salmonella certification, proper cold storage of raw meat, metal detectors prior to packaging and labeling, correct pH reached after th fermentation process is done, proper moisture: protein ratio(MPR) is reached after drying, and proper sanitizer is used at slicing/peeling 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 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 did find FSiS regulatory requirements and guidelines for slicing/peeling, so they set the critical limit(s) using criteria as specified by FSiS for the control of pathogens 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 slicing/peeling step, the establishment had Quality Assurance monitor the application and record the time of sanitizer application 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 (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
Not Heat Treated, Shelf Stable Model 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 six points on the hazard analysis form for pepperoni and salami where food safety hazards reasonably likely to occur were identified: Salmonella on raw meat/poultry at receiving, pathogen proliferation at cold storage, metal contamination during mechanical processing, pathogen proliferation at fermentation, pathogen proliferation at drying, and Listeria monocytogenes contamination at slicing/peeling. The establishment HACCP team has chosen to have six CCPs to address these six hazards: Salmonella certification, proper cold storage of raw meat, metal detectors prior to packaging and labeling, correct pH reached after the fermentation process is done, proper moisture: protein ratio (MPR) is reached after drying, and proper sanitizer is used at slicing/peeling. 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 did find FSIS regulatory requirements and guidelines for slicing/peeling, so they set the critical limit(s) using criteria as specified by FSIS for the control of pathogens. 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 slicing/peeling step, the establishment had Quality Assurance monitor the application and record the time of sanitizer application. 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. 11
Not Heat Treated, Shelf stable Model The HACCP team decided they could verify through the following procedures and frequency Quality Assurance will conduct a Listeria sampling program(both environmental and end product) as detailed in the FSIS issuance"Listeria Guidelines for Industry to verify effectiveness of the sanitizer and its method of usage The HACCP team described the verification procedures and their frequencies in the fifth column of their haccp 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) 8417.5 Records (a) The establishment shall maintain the following records documenting the establishment,'s HACCP plan 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 ofCCPs and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those proce 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 six forms would be used: Sanitizer Usage Log. Thermometer Calibration Log, Room Temperature Log, Metal Detection Log, Fermentation Log, and MPR
Not Heat Treated, Shelf Stable Model The HACCP team decided they could verify through the following procedures and frequency: Quality Assurance will conduct a Listeria sampling program (both environmental and end product) as detailed in the FSIS issuance “Listeria Guidelines for Industry” to verify effectiveness of the sanitizer and its method of usage. 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 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 six forms would be used: Sanitizer Usage Log, Thermometer Calibration Log, Room Temperature Log, Metal Detection Log, Fermentation Log, and MPR 12
Not Heat Treated, Shelf stable Model Log. The form was designed to provide spaces for all entries necessary for the monitoring and erification activities at the slicing/peeling 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 in HACCP plan references the planned corrective actions for each CCP. The HACCP team arefully reviewed the regulatory requirem Its 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 response to a deviation from a critical limit. The HacCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure The cause of the deviation is identified and eliminated (2) The CCP will be under control after the corrective action is taken B) Measures to prevent recurrence are established; and (4No product that is injurious to health or othenwise adulterated as a result of the deviation enters commerce The HACCP team has developed a specific corrective action plan which will be followed whenever there is a deviation from a critical limit at a CCP; each of the planned corrective actions meets the four regulatory requirements of 4 17.3(a) Planned Corrective actions for ccp 6 1. QA will address positive Listeria samples as detailed in the FSis issuance" Listeria Guidelines for Industry 2. QA will stop slicing/peeling operations if time since the last application of sanitizer exceeds ours 3. All end product produced after the 2 hour limit is exceeded will be held until Listeria monocytogenes test results are final. If positive, product will be condemned and additional environmental and end product testing will be done until the source is determined. Further corrective actions will be done as detailed in FSIs regulations 417.3 The hACCP team also develops planned corrective actions for each of the other CCPs and
Not Heat Treated, Shelf Stable Model Log. The form was designed to provide spaces for all entries necessary for the monitoring and verification activities at the slicing/peeling 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 in HACCP plan 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 response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure: (1) The cause of the deviation is identified and eliminated; (2) The CCP will be under control after the corrective action is taken; (3) Measures to prevent recurrence are established; and (4) No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce. The HACCP team has developed a specific corrective action plan which will be followed whenever there is a deviation from a critical limit at a CCP; each of the planned corrective actions meets the four regulatory requirements of 417.3(a). Planned Corrective Actions for CCP 6: 1. QA will address positive Listeria samples as detailed in the FSIS issuance “Listeria Guidelines for Industry”. 2. QA will stop slicing/peeling operations if time since the last application of sanitizer exceeds 2 hours. 3. All end product produced after the 2 hour limit is exceeded will be held until Listeria monocytogenes test results are final. If positive, product will be condemned and additional environmental and end product testing will be done until the source is determined. Further corrective actions will be done as detailed in FSIS regulations 417.3. The HACCP team also develops planned corrective actions for each of the other CCPs and 13