Thermally Processed, Commercially sterile le monitoring and verification procedures selected and the frequency of those procedures () Records documenting the monitoring of cCPs and their critical limits, including recording of actual times, temperatures, or other quantifiable values, as prescribed in 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 team created a separate form to be used by the Qa personnel ho were checking the thermometers and calibrating them as necessary. Each employee who was performing a temperature check had a thermometer assigned to him, which was identifiable y its serial number. QA personnel picked up thermometers from employees throughout the day when employees were not using them, and checked them against a known standard; recalibration was performed immediately if it was necessary. There were only four different employees and different thermometers being used in the HACCP monitoring and verification activities, and they were to be checked once a day, so the haCCP team decided that this form could be used by Qa for more than one day. QA personnel were located in a different part of the plant; employees delivered their thermometers to Qa once a day immediately after they had performed a temperature check. QA checked the thermometer and returned it to the employee with a copy of the record showing results; in addition, QA e-mailed the results to the haccp coordinator at the end of each day, and each time there was a variation of more than 2 F noted when the thermometer was checked The hACCP team also created a form to be used by employees with assigned tasks concerning the functioning of the metal detector. The Metal Detector Performance Log includes both monitoring and verification checks results; the form has entries from both the packaging supervisor and from QA personnel. The form is kept near the metal detector and is turned in to the haCCP coordinator at the end of each day The Process Operating Log was designed to include all the information required by the regulations Part 318.306. The team also designed a form to be used in the event of a deviation processing. The Process Deviation Log includes date of the deviation, product information, and position of the product after evaluation by the processing authority
Thermally Processed, Commercially Sterile 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 team created a separate form to be used by the QA personnel who were checking the thermometers and calibrating them as necessary. Each employee who was performing a temperature check had a thermometer assigned to him, which was identifiable by its serial number. QA personnel picked up thermometers from employees throughout the day when employees were not using them, and checked them against a known standard; recalibration was performed immediately if it was necessary. There were only four different employees and different thermometers being used in the HACCP monitoring and verification activities, and they were to be checked once a day, so the HACCP team decided that this form could be used by QA for more than one day. QA personnel were located in a different part of the plant; employees delivered their thermometers to QA once a day immediately after they had performed a temperature check. QA checked the thermometer and returned it to the employee with a copy of the record showing results; in addition, QA e-mailed the results to the HACCP coordinator at the end of each day, and each time there was a variation of more than 2° F noted when the thermometer was checked. The HACCP team also created a form to be used by employees with assigned tasks concerning the functioning of the metal detector. The Metal Detector Performance Log includes both monitoring and verification checks results; the form has entries from both the packaging supervisor and from QA personnel. The form is kept near the metal detector and is turned in to the HACCP coordinator at the end of each day. The Process Operating Log was designed to include all the information required by the regulations Part 318.306. The team also designed a form to be used in the event of a deviation in processing. The Process Deviation Log includes date of the deviation, product information, and disposition of the product after evaluation by the processing authority. 14
Thermally Processed, Commercially sterile On its HACCP Plan, generic establishment X has listed the names of the forms it will be using for monitoring and verification records Another form is included in column four. where the establishment has described its recordkeeping system. That is the Corrective Actions Log; it is used to create the records of any corrective actions taken because of deviations from critical limits at CCPs. Column six references the planned corrective actions for each CCP. The HACCP team carefully reviewed the regulatory requirements for planned corrective actions, found at 417.3( 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 (4)No 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 417.3(a). For example, this is the establishment's planned corrective action whenever there is a deviation from the thermal processing and cooling critical limit, i. e, an improper application of the process schedule as specified by the processing authority Planned Corrective Actions for CCP 9 The plant designee will apply a filed alternate process schedule appropriate for the situation 2. The plant designee will place product on hold pending evaluation of the process deviation by author
Thermally Processed, Commercially Sterile On its HACCP Plan, generic establishment X has listed the names of the forms it will be using for monitoring and verification records. Another form is included in column four, where the establishment has described its recordkeeping system. That is the Corrective Actions Log; it is used to create the records of any corrective actions taken because of deviations from critical limits at CCPs. Column six references the planned corrective actions for each CCP. The HACCP team carefully reviewed the regulatory requirements for planned corrective actions, found at 417.3(a): § 417.3 Corrective actions. (a) The written HACCP plan shall identify the corrective action to be followed in 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). For example, this is the establishment's planned corrective action whenever there is a deviation from the thermal processing and cooling critical limit, i.e., an improper application of the process schedule as specified by the processing authority. Planned Corrective Actions for CCP 9: 1. The plant designee will apply a filed alternate process schedule appropriate for the situation or 2. The plant designee will place product on hold pending evaluation of the process deviation by the processing authority. 15