Fully Cooked, Not Shelf Stable Model their thinking: pathogenic organisms 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 ham and roast beef, there are eight 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 haccpteam check for completeness Note: If you are using this generic model to produce a different fully cooked, not 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 ppendix A. a member of your haccP team might want to review at least some of the p HACCP team in making sure the hazard anal ysis is complete. These references are found A 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 Djectives 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 safery hazards identified in accordance with paragraph(a)of this section, which must be controlled for each process
Fully Cooked, Not Shelf Stable Model their thinking: pathogenic organisms 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 ham and roast beef, there are eight 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 to produce a different fully cooked, not 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. 9
Fully Cooked, Not Shelf Stable Model Doints 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 establishment, including food &ned to control food safety hazards introduced outside the (ii) Critical control points desig afety 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 ( Include all corrective actions that have been developed in accordance with 5417.3(a) ofthis 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 plar (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 under417.(a))of this part Generic establishment X has prepared its haCCP plan for ham and roast beef on a six column
Fully Cooked, Not Shelf Stable Model (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 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 ham and roast beef on a six column 10
Fully Cooked, Not Shelf Stable Model 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 eight points on the hazard analysis form for ham and roast beef where food safety hazards reasonably likely to occur were identified Salmonella on raw meat at receiving, pathogen proliferation at cold storage, pathogen proliferation and metal contamination during preparation of raw meat, pathogen survival, including Listeria monocytogenes, at cooking, pathogen proliferation, including Listeria monocytogenes, at chilling, contamination with Listeria monocytogenes at portioning, and pathogen proliferation including Listeria monocytogeneS, at finished product storage(cold). The establishment HACCP team has chosen to have seven CCPs to address these eight hazards: salmonella certification, proper cold storage of raw meat, in-line magnets prior to packaging and labeling, proper time/temperature is reached after cooking is done, proper chilling after cooking, conduct environmental monitoring program for Listeria spp, and proper temperature maintenance at finished product storage(cold) 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 cooking, 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 cooking step, the establishment had Quality Assurance monitor time/temperature parameters to assure that the critical limit was met and the cooking temperature would be monitored using temperature recording charts for each batch their frequencies are written up in columns two and three of the HACCP Plaz orocedures and These decisions by the HACCP team regarding critical limits, plus monitoring 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
Fully Cooked, Not Shelf Stable Model 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 eight points on the hazard analysis form for ham and roast beef where food safety hazards reasonably likely to occur were identified: Salmonella on raw meat at receiving, pathogen proliferation at cold storage, pathogen proliferation and metal contamination during preparation of raw meat, pathogen survival, including Listeria monocytogenes, at cooking, pathogen proliferation, including Listeria monocytogenes, at chilling, contamination with Listeria monocytogenes at portioning, and pathogen proliferation, including Listeria monocytogenes, at finished product storage (cold). The establishment HACCP team has chosen to have seven CCPs to address these eight hazards: Salmonella certification, proper cold storage of raw meat, in-line magnets prior to packaging and labeling, proper time/temperature is reached after cooking is done, proper chilling after cooking, conduct environmental monitoring program for Listeria spp., and proper temperature maintenance at finished product storage (cold). 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 cooking, 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 cooking step, the establishment had Quality Assurance monitor time/temperature parameters to assure that the critical limit was met and the cooking temperature would be monitored using temperature recording charts for each batch. 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: 11
Fully Cooked, Not Shelf Stable Model (2) Ongoing verification activities. Ongoing verification activities include, but are not limited to (The calibration ofprocess-monitoring instruments (ii) Direct observations of monitoring activities and corrective actions, and (iii) The review ofrecords generated and maintained in accordance with $417.5(a)) of this part The HACCP team decided they could verify through the following procedures and frequency 1. QA supervisor will observe Qa technician perform monitoring activities once per shift 2. Maintenance supervisor will verify the accuracy of the temperature recording charts once per shift 3. QA will check all thermometers used for monitoring and verification activities for accuracy daily and calibrate to within 2 F accuracy as necessary 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) 8477.5 Records. (a) The establishment shall maintain the following records documenting the establishment's HAcCP plar ( The written hazard analysis prescribed in 5417. 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 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
Fully Cooked, Not Shelf Stable Model (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 through the following procedures and frequency: 1. QA supervisor will observe QA technician perform monitoring activities once per shift. 2. Maintenance supervisor will verify the accuracy of the temperature recording charts once per shift. 3. QA will check all thermometers used for monitoring and verification activities for accuracy daily and calibrate to within 2° F accuracy as necessary. 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; 12
Fully Cooked, Not Shelf Stable Model 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 ten record forms were necessary: Form Letter Confirming Salmonella Compliance with Performance Standards, Midshift Cleanup Log, Thermometer Calibration Log, Cooler Temperature Log, Metal Detection Log, Product Temperature Log, Cooking Log, Chilling Log, Corrective Actions Log, and Pre-Shipment Review Log. The form were designed to provide spaces for all entries necessary for the monitoring and verification activities at the drying step On its HACCP Plan, generic establishment X has listed the names of the forms it will be using for monitoring and verification records The Corrective Actions Log is used to create the records of any corrective actions taken becaus of deviations from critical limits at CCPs. On this log, column three 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 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 a 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 (4 No product that is injurious to health or othenwise adulterated as a result ofthe leviation enters commerce
Fully Cooked, Not Shelf Stable Model 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 ten record forms were necessary: Form Letter Confirming Salmonella Compliance with Performance Standards, Midshift Cleanup Log, Thermometer Calibration Log, Cooler Temperature Log, Metal Detection Log, Product Temperature Log, Cooking Log, Chilling Log, Corrective Actions Log, and Pre-Shipment Review Log. The forms were designed to provide spaces for all entries necessary for the monitoring and verification activities at the drying step. On its HACCP Plan, generic establishment X has listed the names of the forms it will be using for monitoring and verification records. The Corrective Actions Log is used to create the records of any corrective actions taken because of deviations from critical limits at CCPs. On this log, column three 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. 13