Performing a HACCP 01 Procedure
The purpose of this scenario is to cover the methodology for performing a HACCP 01 procedure. As you can see the HACCP plan used in this scenario is very generic. The reason for this is, the example is to be used for illustration purposes to explain the performance of the 01 procedure, it is not to focus on the specifics of a HACCP plan.

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.

In the scenario when the inspector reviewed the record they observed the annotation of the date, time, initials and observation (temperature) of the current monitoring check. The inspector also observed previous checks conducted earlier in the day. The inspector observed that the CCP had been monitored at 6:00, 7:02, and 9:00 am. The product temperature had been documented as well as dates and initials on each entry. At this point the inspector has determined the establishment has not documented a monitoring check for 8:00 as required by the HACCP plan resulting in a HACCP noncompliance. The establishment would be required to demonstrate the critical limit was met during this time period that monitoring was not performed. To verify this the inspector will immediately perform the HACCP 02 procedure for that specific production. The next IKE scenario will cover the performance of the HACCP 02 procedure.



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