IKE SCENARIO 05-02: HACCP 01 PROCEDURE:
The plan used in this scenario has two Critical Control Points (CCP’s). CCP #1 is monitored at a frequency of every hour and CCP#2 is monitored per lot of production.
The HACCP 01 & 02 procedures have two components, record keeping and review and observation. The record keeping component is used to review records to determine regulatory compliance. The review part is used by the inspector to verify requirements by taking measurements and comparing findings with what the establishment has recorded at that CCP. The observation part verifies requirements by observing establishment personnel perform activities listed in their HACCP plan.
The 01 procedure is used for a random review of the activities of the establishment to determine if HACCP requirements are being met. When performing the HACCP 01 procedure the inspector can use either of the components or a combination to verify regulatory requirements. The regulatory requirements are monitoring, verification, corrective action, record keeping, and reassessment. In this situation the inspector elects to use both components (record keeping and review and observation). He/she also elects to verify the monitoring and record keeping requirements at CCP#1. So how does the inspector perform the HACCP 01 procedure?
The Inspector first reviews the establishment’s HACCP plan. Through reading the plan he/she will become familiar with the CCPs, monitoring, critical limits and corrective actions outlined within the plan.
Performing the review and observation component.
The observation component is that part when the Inspector verifies the regulatory requirements are met by observing the plant perform the activities as listed in the HACCP plan. This would include observing how the plant monitors a CCP and critical limit. Observations would be made to verify if the methods the plant employee utilizes to monitor the CCP is consistent with the written HACCP plan and verify that the CCP is being monitored at the frequency stated in the HACCP plan as required in 417.2(c)(4). This section of the regulation requires the establishment to list, within the HACCP plan, procedures and frequencies that will be used to monitor each of the CCPs. In addition, the inspector will verify whether the critical limit has been met. In performing the observation component the inspector will determine if the employee is actually writing down what he/she finds as required within 417.5(a)(3). This section of the regulation requires the establishment to document their monitoring of CCPs which would include documenting actual times temperatures, or other quantifiable values. In addition the record should include the time the actual event took place, date and initials of employee performing the monitoring. In this scenario the QA Technician is scheduled to take a monitoring check. The inspector observes the employee perform the monitoring procedures and the employee annotates their finding (which met the critical limit), time, date, and initials on the CCP#1 monitoring record.
Performing the Records Review Component.
The records review component is used to ensure that all regulatory
requirements within 417.5 are met. As stated above this would include the date,
time, initials or signature as appropriate, and if the critical limit has been
met. In addition, if the critical limit had not been met records detailing
corrective actions must be generated by the establishment. The records would
also be verified for product identification, data integrity, and frequency of
monitoring. In reviewing records the inspector would review the recording of the
current monitoring checks as well as previous checks. Previous checks could be
monitoring checks done earlier that day or on other days.
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