Thermally Processed, Commercially sterile establishment. Therefore, the team decided that the hazard can be controlled by the thermal process or by using irradiated spices You will notice that on our generic hazard analysis for thermally processed, commercially sterile beef stew, there are seven 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 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 thermally processed commercially sterile 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 thermally processed, commercially sterile 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 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 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 (c)The contents of the HACCP plan. The HaCCP plan shall, at a minimum
Thermally Processed, Commercially Sterile establishment. Therefore, the team decided that the hazard can be controlled by the thermal process or by using irradiated spices. You will notice that on our generic hazard analysis for thermally processed, commercially sterile beef stew, there are seven 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 thermally processed, commercially sterile 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 thermally processed, commercially sterile 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. 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 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: (c)The contents of the HACCP plan. The HACCP plan shall, at a minimum: 9
Thermally Processed, Commercially sterile () 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 B)List the critical limits that must be met at each of the critical control points. Critical standards established by FS/S, and any other requirement set forth in this chaple ance limits shall, at a minimum, be designed to ensure that applicable targets or perfor 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 of this part, to be followed in response to any deviation from a critical limit at a cilla 9 (5 Include all corrective actions that have been developed in accordance with $417.3( 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 ( Upon initial acceptance
Thermally Processed, Commercially Sterile (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 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; 10
Thermally Processed, Commercially sterile (ii) Upon any modification; and (iii) At least annually, upon reassessment, as required under4174(a))of this part Generic establishment X has prepared its HACCP plan for thermally proces sterile beef stew 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 4172(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 seven process steps on the hazard analysis form where food safety hazards reasonably likely to occur were identified microbial growth on incoming meat;presence of foreign material on non-meat food ingredients; presence of foreign materials in cans and packaging materials; presence of foreign materials after can washing; improper product formulation; improper filling of can; and, improper application of the thermal process and cooling The establishment haccp team has chosen to have seven CCps to address these seven hazards temperature monitoring of incoming meat; visual inspection of incoming meat; letter of guaranty for non-meat food ingredients; visual inspection of non-meat food ingredients; visual inspection of cans and packaging on receipt; visual inspection of cans after exiting washer; and the processing authority specifications for product formulation, filling of cans, and the process schedule 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. If the plant decided to use the current regulations for thermally processed, commercially sterile product to address bacterial hazards, only physical and chemical hazards would have to be addressed in the haccP plan however the team decided to address bacterial hazards in their plan and set limits that met or exceeded regulatory requirements Although meat would remain frozen below 32 F. the team decided that 10 f or below would be
Thermally Processed, Commercially Sterile (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 thermally processed, commercially sterile beef stew 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 seven process steps on the hazard analysis form where food safety hazards reasonably likely to occur were identified: microbial growth on incoming meat; presence of foreign material on non-meat food ingredients; presence of foreign materials in cans and packaging materials; presence of foreign materials after can washing; improper product formulation; improper filling of can; and, improper application of the thermal process and cooling. The establishment HACCP team has chosen to have seven CCPs to address these seven hazards: temperature monitoring of incoming meat; visual inspection of incoming meat; letter of guaranty for non-meat food ingredients; visual inspection of non-meat food ingredients; visual inspection of cans and packaging on receipt; visual inspection of cans after exiting washer; and the processing authority specifications for product formulation, filling of cans, and the process schedule. 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. If the plant decided to use the current regulations for thermally processed, commercially sterile product to address bacterial hazards, only physical and chemical hazards would have to be addressed in the HACCP Plan. However, the team decided to address bacterial hazards in their plan and set limits that met or exceeded regulatory requirements. Although meat would remain frozen below 32°F, the team decided that 10°F or below would be 11
Thermally Processed, Commercially sterile more conservative and protective of the frozen product. There would be less chance of the product reaching thaw temperature before use and, thus, reducing the chance for temperature In addition to the critical limit regarding metal in the packaging and non-metal containers, the team decided that any other visible hazardous non-food material, such as glass, was unacceptable not only at receipt of packaging materials and containers but also during the washing of the cans For non-meat ingredients, the bacterial spore load in spices is the bacteriological concern However, the bacteriological load is incorporated before the non-meat ingredients reach the thermal processing establishment. The team therefore decided that purchase specifications and/or letters of guarantee would be the best method for controlling the bacterial hazards With respect to metal contamination, the team knew that their detector was capable of identifying particles as small as 1/32 of an inch, as long as it was working well. Therefore, they decided that their critical limit would be the capability of a properly functioning metal detector The processing authority determines the formulation, container filling, and thermal process and cooling specifications that will produce a safe and stable product. Therefore, the critical limits for these steps in processing are those specified by the processing authority for the specific product 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- Frozen Cooked Diced Beef and Non-meat Food Ingredient controls on incoming product, they decided the operational personnel who normally checked arriving products would check product temperature for each load. This individual would also visually spect each load of frozen cooked diced beef, non-meat ingredients, and packaging in addition to checking letters of guarantee and ensuring that all goods are from approved suppliers. 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 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 fo or ondol ng verification are
Thermally Processed, Commercially Sterile more conservative and protective of the frozen product. There would be less chance of the product reaching thaw temperature before use and, thus, reducing the chance for temperature abuse. In addition to the critical limit regarding metal in the packaging and non-metal containers, the team decided that any other visible hazardous non-food material, such as glass, was unacceptable not only at receipt of packaging materials and containers but also during the washing of the cans. For non-meat ingredients, the bacterial spore load in spices is the bacteriological concern. However, the bacteriological load is incorporated before the non-meat ingredients reach the thermal processing establishment. The team therefore decided that purchase specifications and/or letters of guarantee would be the best method for controlling the bacterial hazards. With respect to metal contamination, the team knew that their detector was capable of identifying particles as small as 1/32 of an inch, as long as it was working well. Therefore, they decided that their critical limit would be the capability of a properly functioning metal detector. The processing authority determines the formulation, container filling, and thermal process and cooling specifications that will produce a safe and stable product. Therefore, the critical limits for these steps in processing are those specified by the processing authority for the specific product. 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 – Frozen Cooked Diced Beef and Non-meat Food Ingredient controls on incoming product, they decided the operational personnel who normally checked arriving products would check product temperature for each load. This individual would also visually inspect each load of frozen cooked diced beef, non-meat ingredients, and packaging in addition to checking letters of guarantee and ensuring that all goods are from approved suppliers. 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. 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: 12
Thermally Processed, Commercially sterile (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 review of records generated and maintained in accordance with 417.5(a)) of this part The HACCP team determined that since receiving personnel were performing the temperature checks on incoming meat, their supervisor would be a good person to involve in verification. He will review the temperature logs and receiving logs, and may either observe the employee taking the temperature or take a temperature of his own, once per shift There is a regulatory requirement(Part 417. 4(a)(2)() for including as a verification, the calibration of process-monitoring instruments, the thermometers being used to take the temperature checks are obviously process monitoring instruments, so someone outside the maintenance unit, in this case the Quality Assurance unit, will check those thermometers for accuracy on a daily basis, and calibrate them to within l degree 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) 8417.5 Records. (a) The establishment shall maintain the following records documenting the s HACCP plan 1) The written hazard analysis prescribed in$417 2(a)of this part, including all supporting documentation selection and development of CCPs and critical limits, and documents supporting bal G (2) The written HACCP plan, including decision making documents associated with th 13
Thermally Processed, Commercially Sterile (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 determined that since receiving personnel were performing the temperature checks on incoming meat, their supervisor would be a good person to involve in verification. He will review the temperature logs and receiving logs, and may either observe the employee taking the temperature or take a temperature of his own, once per shift. There is a regulatory requirement (Part 417.4(a)(2)(i)) for including as a verification, the calibration of process-monitoring instruments; the thermometers being used to take the temperature checks are obviously process monitoring instruments, so someone outside the maintenance unit, in this case the Quality Assurance unit, will check those thermometers for accuracy on a daily basis, and calibrate them to within 1 degree 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 13