IKE SCENARIO 07-02:  9 CFR 416.12:  MAY 8,2002

An inspector is assigned to an establishment that is building a large addition onto their existing facility. They will be producing a new breaded product that has required them to purchase new equipment to perform this process. The plant management has totally revised the Sanitation SOP. The inspector has discussed some of the new cleaning procedures required for this breading equipment at the weekly meetings for several weeks. The inspector reminds the establishment that as per 416.12 (c) and (d), each procedure they have in the SSOP for pre-operations and during operations must have a frequency at which they will perform that procedure and identify who will implement and maintain the procedure. The company has informed the inspector that they will start using the new addition tomorrow. What should the inspector do at this point?

As a critical thinker, the inspector realizes that the changes to the SSOP are very extensive and feels that they need to perform a Sanitation SOP Basic Compliance Checklist to verify all regulatory requirements are met when the new sanitation procedures are implemented. The inspector performs an unscheduled 01A01 procedure for the Sanitation Basic Compliance Checklist.

The inspector would check to see that:

1. The company has described the procedures that they conduct at least daily before and during operations to prevent direct contamination or adulteration of product. (416.12(a))

For example, the SSOP states that the pre-operational procedures will be completed before the start of operations and that the operator will remove the excess breading from the product contact and non-product contact surfaces of the machine to prevent product contamination during operations.

2. The company has identified the pre-operational procedures and that they have described, at a minimum, the cleaning of the food contact surfaces of facilities, equipment, and utensils. (416.12(c))

For example, the SSOP states that all equipment will be disassembled, rinsed, scrubbed and sanitized before the start of operations.

3. The company has specified the frequency at which they conduct each procedure and identified the title of the person responsible for implementing and maintaining the procedures. (416.12(d))

For example, the SSOP states the pre-operational procedures will be performed daily and implemented by the Sanitation Manager. The Breading Machine Operator will remove excess breading from the machines at frequency of once per hour.

4. The company has identified the record where they document the implementation and the monitoring of the Sanitation SOP and any corrective actions taken. (416.16(a))

For example, the SSOP states that all SSOP results will be recorded on the Pre-Operational and Operational Sanitation Reports.

5. The company has had the individual with authority on-site or a higher level official sign and date the revised/modified Sanitation SOP. (416.12(b))

For example, the SSOP has been resigned and dated by the Plant Manager who has overall authority on-site.

Based on the review of the revised SSOP the inspector has determined that the requirements of 416.12 have been met. At this point the inspector will verify the establishment’s ability to implement and maintain the SSOPs, and the SSOPs effectiveness in preventing direct product contamination or adulteration.
Future IKE scenarios will cover the implementation and maintenance of SSOPs.




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