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| IKE Scenario 06-06: Extended Cleanup
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Objective: Objective: To provide guidance to FSIS Personnel and Industry regarding alternative/extended cleaning of equipment and facilities.
You are a GS-9 / IIC assigned to a large processing facility that manufactures raw beef sub-primals and portion controlled retail cuts. Tuesday morning, you are scheduled to perform an 01C01 procedure, review of the Sanitation SOPs that are conducted during establishment operations and related records review, which include the alternative/extended cleaning procedures that the establishment chose to be a part of their Sanitation SOP. You have read in FSIS Notice 27-06, Availability of Cleaning Frequency Questions and Answers (dated 04/19/2006) and understand how establishments may choose to extend clean-up frequencies if they can demonstrate that the alternative sanitary procedures are effective in preventing the creation of insanitary conditions and prevent the contamination and adulteration of product.
You proceed to the Quality Assurance Office to review the written Sanitation SOP and the records generated from those performed procedures of the previous week, and focus on the factors that have an impact on sanitary conditions and the adulteration and/or contamination of product.
You find included in the alternative/extended cleaning procedures, protocols for microbiological testing of food product contact surfaces obtained during production and after operations. You are aware that, even though there is no regulatory requirement that an establishment conduct microbiological testing of food contact surfaces for extended cleaning, the establishment has determined that their microbiological testing further demonstrates that their alternative/extended cleaning procedures are effective in preventing the direct contamination/adulteration of product.
The establishment had conducted a base-line testing program representing normal operations to establish the criteria and limits for their micro testing program. You are aware that this is not a regulatory requirement for establishments using alternative/extended cleaning procedures but is an effective method for the establishment to demonstrate the maintenance of effective sanitation.
The testing program associated with the alternative sanitation program showed the average Aerobic Plate Count was 8,000 CFUs per square inch higher for that week than the average in the baseline study. However, checking the alternative/extended cleaning procedures and frequencies in the establishment's Sanitation SOP, you realize that the elevated microbial level did not exceed the establishment's microbial upper limit set by the establishment for a sanitary environment, even though they were comparatively higher than the baseline. You are aware that there is no regulatory requirement for microbial limits; however, the establishment is expected to demonstrate the effectiveness of their extended cleaning program.
The comparison of the microbiological results for the normal/ traditional program vs. the on-going microbial results for the alternative/extended cleaning procedure demonstrated that the Sanitation SOP was being maintained effectively per 9 CFR 416.14. The effectiveness was demonstrated because the microbial levels (APCs) in the alternative/extended cleaning procedures were not substantially higher than those found previously in the baseline and also met the validated control limits.
As a result of the thorough review of the extended cleaning program, including the microbiological data, the inspector was able to verify that the establishment met the regulatory requirements in 9 CFR 416.12-16 (i.e., development, implementation, maintenance of a Sanitation SOP, corrective actions if necessary, and recordkeeping).
For IKE related questions, send e-mail to Ike@fsis.usda.gov. For technical or regulatory questions, send e-mail to TechCenter@fsis.usda.gov.
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Last Modified: May 25, 2006 |
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