Irradiated Ram Model introduced at a certain point in the process, column five is used to describe a measure which could be applied to"prevent, eliminate, or reduce to acceptable levels"the food safety hazard identified in column three Look at the entries for"Receiving -Raw Poultry" "on the first page of the six column form; 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 instructions on labels alone to be an adequate CCP for any pathogenic mi bacteria and viruses You will notice that in our generic hazard analysis for irradiated fresh poultry, there are five 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)(3)includes a list of sources from which food safety hazards might be expected to arise. Reviewing that list could help the haccp team check for completeness Note: If you are using this generic model to produce a different raw irradiated product or if you use a different process flow, you may have different hazards which are reasonably likely to occur. For these different hazards, there may be different measures that could be used for control purposes This, and all other FSIS generic models, contains a list of references which can help your HACCP team in making sure the hazard analysis is complete. The references for raw, irradiated 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
Irradiated, Raw Model introduced at a certain point in the process, column five is used to describe a measure which could be applied to "prevent, eliminate, or reduce to acceptable levels" the food safety hazard identified in column three. Look at the entries for “Receiving-Raw Poultry” on the first page of the six column form; 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 instructions on labels alone to be an adequate CCP for any pathogenic microorganisms such as bacteria and viruses. You will notice that in our generic hazard analysis for irradiated fresh poultry, there are five safety hazards in which the HACCP team has identified a point in the process at which a food safety hazard is reasonably likely to occur. For each one of these they have identified a measure which can be used to control the hazard. When your HACCP team has completed their hazard analysis (whether they use this format or not), it is a good idea to review the flow diagram, the product description and the hazard analysis itself to make sure they are complete. Part 417.2(a)(3) includes a list of sources from which food safety hazards might be expected to arise. Reviewing that list could help the HACCP team check for completeness. Note: If you are using this generic model to produce a different raw irradiated product or if you use a different process flow, you may have different hazards which are reasonably likely to occur. For these different hazards, there may be different measures that could be used for control purposes. This, and all other FSIS generic models, contains a list of references which can help your HACCP team in making sure the hazard analysis is complete. The references for raw, irradiated 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 9
Irradiated Ram Model this far; this is like completing the foundation of a house Developing Your HACCP Plan analysis and use them to build the HACCP Plan. Remember that one of the importall ard The company HACCP team can now take the materials it developed while doing the ha 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 ()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 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, (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 $.(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
Irradiated, Raw 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 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: (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 10
Irradiated Ram Model control points. The records shall contain the actual values and observations obtained during monitoring. be performed, that the establishment will use in accordance with s 417.4 of thisP pill (7 List the verification procedures, and the frequency with which those procedures (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$417.4(a) ) of this part Generic establishment X has prepared its HACCP plan for irradiated fresh poultry 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 are five points on the hazard analysis form where food safety hazards reasonably likely to occur were identified: Salmonella on raw poultry at receiving, pathogen proliferation at packaging and labeling, pathogen proliferation at storage (cold)/transporting, pathogen survival and/or proliferation after irradiation, 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, use of approved packaging material for irradiation and clear product label features to indicate the product is irradiated, raw, and must be fully cooked, proper temperature maintenance during transport and storage, compliance with FSIS/FDA requirements for the process of irradiation, and proper temperature maintenance at finished product storage (cold)
Irradiated, Raw Model 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 irradiated fresh poultry 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 are five points on the hazard analysis form where food safety hazards reasonably likely to occur were identified: Salmonella on raw poultry at receiving, pathogen proliferation at packaging and labeling, pathogen proliferation at storage (cold)/transporting, pathogen survival and/or proliferation after irradiation, 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, use of approved packaging material for irradiation and clear product label features to indicate the product is irradiated, raw, and must be fully cooked, proper temperature maintenance during transport and storage, compliance with FSIS/FDA requirements for the process of irradiation, and proper temperature maintenance at finished product storage (cold). 11
Irradiated Ram Model After identifying its CCPs, the HACCP team proceeded to consider critical limits, monitoring procedures and their frequencies, and verification procedures and their frequencies, and HACCP record were any regulatory requirements which had to be met and would function as critical limifs o In deciding what would be the critical limits, the HACCP team first considered whether ther The team was aware of regulatory requirements for the packaging material and labeling of adiated products as stated in 9 CFR 381. 135 and 21 CFR 179.45. For their critical limit, the HACCP team decided that air permeable packaging material, and a label with features to indicat a raw, irradiated product has the irradiation logo, the radura, along with the statement"Treated with radiation or Treated by Irradiation", handling statement, clear cooking instructions, and safe handling instructions The team set the critical limits for the minimum and maximum absorbed dose for irradiation of poultry as found in 9 CFR 381. 147. For developing a HACCP plan for irradiation of pork, the required absorbed dose will be different Once they had decided on their critical limits, they needed to identify how the monitorin procedures would be carried out and at what frequency The hacCP team decided that receiving personnel check the packaging and labeling materials for irradiated products at Receiving-packaging materials. At this location, receiving personnel also routinely check all letters of guarantee and Incoming packaging materials to make sure the met specifications. Since labels are manufactured in large lots by a single company, the receiving clerks would randomly sample each arriving lot. Some packaging materials do not have their labels and safe handling instructions printed on them and therefore these need to be applied to the packaging material later in the process. Monitoring at the packaging and labeling step ensures that the necessary pressure sensitive sticker labels are applied to the package For the CCp on the irradiation process, the HACCP team decided that the production supervisor would be in the best position to assure that the irradiation unit was functioning properly by checking the data log printout from the irradiation control board or"process monitoring instrument as the product goes through the irradiation process. The irradiation control board shows all function movement which take place within the irradiation chamber during the irradiation process. It will indicate whether the unit is functioning properly, and will alert the operator for any abnormal movements These decisions by the HACCP team regarding critical limits, plus monitoring procedures and
Irradiated, Raw Model After identifying its CCPs, the HACCP team proceeded to consider critical limits, monitoring procedures and their frequencies, and verification procedures and their frequencies, and HACCP records. In deciding what would be the critical limits, the HACCP team first considered whether there were any regulatory requirements which had to be met and would function as critical limits. The team was aware of regulatory requirements for the packaging material and labeling of irradiated products as stated in 9 CFR 381.135 and 21 CFR 179.45. For their critical limit, the HACCP team decided that air permeable packaging material, and a label with features to indicate a raw, irradiated product has the irradiation logo, the radura, along with the statement “Treated with radiation” or “Treated by Irradiation”, handling statement, clear cooking instructions, and safe handling instructions. . The team set the critical limits for the minimum and maximum absorbed dose for irradiation of poultry as found in 9 CFR 381.147. For developing a HACCP plan for irradiation of pork, the required absorbed dose will be different. Once they had decided on their critical limits, they needed to identify how the monitoring procedures would be carried out and at what frequency. The HACCP team decided that receiving personnel check the packaging and labeling materials for irradiated products at Receiving-packaging materials. At this location, receiving personnel also routinely check all letters of guarantee and incoming packaging materials to make sure they met specifications. Since labels are manufactured in large lots by a single company, the receiving clerks would randomly sample each arriving lot. Some packaging materials do not have their labels and safe handling instructions printed on them and therefore these need to be applied to the packaging material later in the process. Monitoring at the packaging and labeling step ensures that the necessary pressure sensitive sticker labels are applied to the package. For the CCP on the irradiation process, the HACCP team decided that the production supervisor would be in the best position to assure that the irradiation unit was functioning properly by checking the data log printout from the irradiation control board or “process monitoring instrument” as the product goes through the irradiation process. The irradiation control board shows all function movement which take place within the irradiation chamber during the irradiation process. It will indicate whether the unit is functioning properly, and will alert the operator for any abnormal movements. These decisions by the HACCP team regarding critical limits, plus monitoring procedures and 12
Irradiated Ram Model 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 with4175(a)() of this part The HACCP team decided that they could verify the raw poultry irradiation step through the following procedures and frequency 1. QA will verify the irradiation data log printout 2. QA will verify the letter of guarantee for calibration of the dosimeter every 12 months 3. QA will verify that absorbed doses received by product are within the minimum and maximum limits from results of dose mapping 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 establishment's HACCP plan ( The written hazard analysis prescribed in 4172(a)of this part, including all 13
Irradiated, Raw Model 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 that they could verify the raw poultry irradiation step through the following procedures and frequency: 1. QA will verify the irradiation data log printout. 2. QA will verify the letter of guarantee for calibration of the dosimeter every 12 months. 3. QA will verify that absorbed doses received by product are within the minimum and maximum limits from results of dose mapping. 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 13