Performing a HACCP 02 Procedure

In the last scenario the inspector performed a HACCP 01 procedure. It was noted by the inspector that the establishment had not documented a monitoring check. As a result of this HACCP non-compliance, the HACCP 02 procedure must be performed. So, when performing the 02 procedure what should the inspector be verifying? In other words, the establishment had either missed a monitoring check or did not document a result. How should the establishment react to this noncompliance and when performing the 02 procedure what should the inspector verify?

Let us start with the protocol of how a HACCP 02 procedure is performed, and as the inspector performs the procedure, information will be gathered and final conclusion will be reached.

Performing the 02 procedure:

The 01 procedure is used for a random review of the activities of the establishment to determine if HACCP requirements are being met. The 02 in comparison is used to verify if all regulatory requirements are being met and if the establishment is following the HACCP plan. All CCP’s and regulatory requirements (monitoring, record keeping, corrective action verification, & reassessment) at each CCP are verified. The HACCP 02 procedure cannot be completed until after the pre-shipment review has been completed. This is because the procedure looks at an entire given lot or shipment and inspection personnel are determining if the HACCP plan prevented the distribution of adulterated product.

The 01 and 02 procedures are similar in many ways. Both the 01 and 02 procedures utilize the record review and the review and observation components. What differs between the 01 and the 02 procedures is the scope of inspection. The 02 is deliberate and methodical in approach in comparison to the random nature of the 01 HACCP procedure. This again is because the 01 looks at a snapshot of the process itself and the 02 looks at the entire HACCP system to see if it is in control.

How do you perform the 02 Procedure?

In performing the 02 procedure all regulatory requirements must be verified at every Critical Control Point, for the identified lot. Using either the records review, the review and observation components, or a combination of both, the inspector will verify all regulatory requirements are being met as follows:

As an Inspector in the scenario performing the 02 procedure you could use the records review component at the CCP to determine if the regulatory requirements of 417.2(c)(3)(4) & (6) are being met. These regulatory references require the establishment to list critical limits and procedures, including frequencies in which the procedures will be performed, to monitor each CCP. The HACCP records maintained by the establishment should show procedures having been performed at this frequency. As outlined in regulation 417.5(a)(3) & (b), the establishment must record actual times, temperatures, and other quantifiable values. In addition, each entry should be made at the time the specific event occurs and include initials or a signature of the establishment employee making the entry. The records would also reveal if the critical limit was met.

Using the review and observation component, the inspector can verify that the monitoring procedure used by the QA technician is performed as indicated in their HACCP plan. The inspector could observe the QA technician perform the monitoring procedures, or the inspector might perform independent measurements and compare findings with those recorded by the establishment personnel for that CCP.

As an Inspector in the scenario performing the 02 procedure you could use the record review component at the CCP to determine whether the regulatory requirements in 417.2(c)(7) have been met. This regulation states the establishment must list verification procedures and frequencies with which those procedures will be performed. Also 417.5(a)(3) & (b) requires the establishment to document the results of verification. The inspector would also verify the requirements of 417.4(a)(2) are being met. This requires the establishment to perform on-going verification activities that would include but are not limited to:

Calibration of process-monitoring instruments
Direct observations of monitoring activities and corrective actions
Review of records generated and maintained in accordance with 417(a)(3).

Using the review and observation component the inspector can verify calibration of recording instruments and that the observation of the monitor by the verifier was performed at the frequency required by the HACCP plan. The inspector can also determine if the verification procedures outlined in the HACCP plan were followed. The inspector would also ensure that real results are documented for the verification procedures, e.g., which procedure was performed by the verifier, what was observed, and what were the specific findings of the direct observations of the monitor or records review. In this scenario the inspector observed on the verification record that the establishment had found the HACCP noncompliance during a records verification. While reviewing monitoring records establishment personnel performing a record review verification activity observed that a scheduled monitoring check was not recorded for the 8:00 hour. Verification personnel noted this on the verification records then performed an investigation to determine if the critical limit had been met during this time period. By reviewing additional processing and CCP monitoring records and interviewing employees, the establishment could assure that the critical limit was met.

Record Keeping
As an Inspector in the scenario performing the 02 procedure you could use the records review component at the CCP to determine if the requirements within 417.5 have been met. The HACCP plan stated every hour for CCP#1 and every lot for CCP#2. This should be reflected in the record. Similarly, the records will reveal if the critical limit was met as required in 417.5(a)(3). The inspector also could verify the presence and applicability of any documentation supporting the selection and development of CCPs and critical limits, and/or the selection of monitoring and verification procedures and the frequency of these procedures, as described in 417.5(a)(2). The inspector would look for data to show how the critical limit was determined and documents to show how the firm decided on the monitoring procedure and how often that the plant would check the critical limit at the CCP. In addition, the inspector would verify that prior to shipping the product, the establishment reviews the records associated with the production of that product as required in 417.5(c). The records review component of the 02 procedure could also be used by the inspector to determine if actual observations were annotated by the employee.

Corrective Actions
An Inspector in the scenario performing the HACCP 02 procedure could use the records review component at the CCP to determine if all four parts of corrective action 417.3(a) were completed in response to the deviation from the critical limit. The four parts of corrective action include:

Cause of deviation is identified and eliminated
CCP is under control after corrective action is taken.
Establish measures to prevent reoccurrence.
No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce.

The Inspector could verify the presence and applicability of the supporting documentation relative to the corrective action by reviewing the documents on file. Regulation 417.3(c) requires that all corrective action taken in accordance with 417.3, shall be documented in records that are subject to verification in accordance with 417.2(a)(2)(iii) and record keeping requirements of 417.5. Consequently, the inspector would look at records to show how the corrective action was enacted and if the measures were effective and if preventative action was documented. The inspector would also verify if the establishment has supporting documentation to support their decision that the product deviating from the critical limit is safe for human consumption. Preventative measures must be verified by the records review component as well as the review and observation component.

Pre-shipment review
While performing the HACCP 02 procedure the inspector cannot complete the procedure until AFTER the establishment completes the pre-shipment review. A records review component of the procedure could be used to verify the following points within 417.5(c):

  1. Verify that the documentation reflects that all critical limits were met at all CCP’s.
  2. Verify that the documentation shows that all corrective actions taken were appropriate and all parts of corrective action were addressed
  3. Verify that all process-monitoring records are complete.
  4. Verify that pre-shipment review is signed and dated.

The observation and review component of the HACCP 02 procedure could be used to observe the plant employee’s performance of the pre-shipment review.

Once the 02 procedure has been completed, using all information available, the inspector must determine if the establishment’s system had found the noncompliance, plant management had met their responsibility in reacting to the issue, and all other regulatory requirements outlined in Part 417 have been met. In this scenario the inspector found no other noncompliance through the performance of the HACCP 02 procedure. As a critical thinker what should the inspector conclude upon completing the procedure?

While reviewing the verification records it was noted that establishment verification personnel observed the noncompliance.
Verification personnel performed an investigation to determine what had happened and if the critical limit was met during this time period.
The establishment could verify the critical limit was met. Consequently no adulterated product was shipped.
The establishment enacted immediate and further planned action to correct the noncompliance.
The verification record reviewed by the inspector provided all of this information.
Consequently, the inspector was able to verify and conclude that the established had determined a monitoring noncompliance occurred and the critical limit had been met.

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