IKE Scenario 02-04 Performing 03B01 & 03B02 Procedures for Determining Compliance with the Food Safety Standard for Raw Product-Ground.

You are a Consumer Safety Inspector (CSI) in a beef slaughter facility that produces raw ground beef from beef trimmings. In addition to grinding their own trimmings, the facility receives and grinds trimmings from three other beef slaughter facilities. One of your duties includes verifying compliance with 9CFR Part 417 HACCP regulations.

You are scheduled to perform a 03B01 procedure and elect to review records to verify the establishment is meeting all regulatory requirements for record keeping. You know from reviewing FSIS Directive 5000.1, Revision 1, that when a HACCP 01 procedure is scheduled, you should randomly review one or more HACCP requirements (monitoring, corrective action, recordkeeping, verification, or reassessment). You decide to review compliance with the recordkeeping requirement. You know that you can verify any or all of these requirements using either review and observation or records review.

You start out by reviewing the hazard analysis, HACCP plan, and supporting documentation. In the hazard analysis, you see that the establishment has determined that E. coli O157:H7 is not a food safety hazard reasonably likely to occur in beef trimmings received from outside sources because the establishment has incorporated purchase specifications into a prerequisite program for receiving raw beef trimmings.

As part of the 03B01 procedure, you decide to review the prerequisite program in order to verify that it is actually being implemented as written. You know plant management should have written documents to support their prerequisite program. However, you decide to take your verification procedure one step further. Instead of just reviewing records, you decide you will also use review and observation to verify compliance with the plant’s pre-requisite program, to determine if the records are representative of the program being implemented.

The prerequisite supporting documents are maintained by the QA Manager. The establishment maintains copies of letters of guarantee from their suppliers stating they have validated interventions in place, which are verified quarterly. You review these records and find them adequate. You then go to the receiving dock to verify that establishment employees implement the receiving provisions of the prerequisite program. At the receiving dock, you watch one QA employee review documents associated with a load of beef trim. You also observe another QA employee collect samples of beef trimmings. The QA employee who is collecting samples informs you that the establishment samples and tests all incoming beef trimmings utilizing a commercially available lateral flow device for the rapid recovery of E. coli O157:H7 and rejects any shipment that tests positive. The employee shows you how the lateral flow device makes the results of the E. coli O157H:7 testing available immediately. Information about this testing program was not made available to you as part of the prerequisite program records, and it was not referred to in either the hazard analysis or the prerequisite program.

You return to the QA Manager’s office and request to see the establishment’s E. coli O157:H7 test results for incoming beef trimmings. The QA Manager states that these test results are not part of the HACCP plan or prerequisite program. The establishment samples strictly at their customers’ request and believes that the current prerequisite program and hazard analysis meet all regulatory requirements. The QA Manager insists that sampling per customer request is not part of the hazard analysis or HACCP plan.

1. You go back to the receiving dock to verify that the establishment is sampling and testing incoming beef trimmings, and making food safety decisions based on the test results. Since the lateral flow device makes results available immediately for the establishment’s use, it is obvious to you that they are making food safety decisions about this product.

2. You review FSIS Directive 5000.2 and 9 CFR 417.5. The results of any testing and of any monitoring activities that are performed by the establishment may have an impact on the establishment’s hazard analysis, whether or not such testing or monitoring is incorporated into an actual HACCP plan, referenced in a HACCP plan, or considered as separate activities. Therefore, records of these activities are subject to FSIS review and are to be available to FSIS personnel. Examples of such results and records include, but are not limited to, all records, results, and supporting documentation associated with each HACCP plan; records, results, and supporting documentation associated with prerequisite programs; and results and records of testing conducted for the establishment’s business customers. Some examples of records that do not have to be available are financial transactions, or customer specifications that have nothing to do with food safety.

You determine that since the establishment is making food safety decisions based on the test results, they do impact on the establishment’s hazard analysis. Based on your performance of the HACCP 01 procedure you determine that the sampling records are important decision making documents for the hazard analysis. You provide the establishment with an NR documenting regulatory noncompliance with 9 CFR 417.5(a)(1); failure to include all supporting documentation for the hazard analysis in the HACCP plan, and again request that the establishment provide the test results for you to review