Environmental and Finished Dairy Product Sampling Monitoring for Listeria monocytogenes
1.7 Follow-up for Unsatisfactory FCS Results
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An unsatisfactory result for Listeria monocytogenes under D222 (Lm environmental in cheese plants) indicates that the establishment is not operating according to Good Manufacturing Practices (GMP's).
Initiate the follow-up procedure explained below any time a CFIA FCS sample result is unsatisfactory for Lm.
- Inform the operator of the unsatisfactory test result as soon as possible, either in person or electronically.
- Open an IMS file and include all pertinent information and references, (e.g. establishment information, LSTS report, FCS sites tested, results of CFIA inspections (if applicable), company's corrective action plan, findings from establishment's root cause analysis, follow up, etc.).
- Review the test result of the product that was sampled simultaneously under plan D221 (Lm in cheese) from the same production lot and line that revealed unsatisfactory FCS results. If the result for finished product is unsatisfactory for Lm, follow procedures specified under Section 1.8 "Follow-up on Unsatisfactory Finished Product Results". If the finished product is satisfactory for Lm, communicate this result to the manufacturer. The Area Program Specialist is to be consulted and all available data for this case will be assessed to determine recommended actions on all possible affected product. A Health Risk Assessment or formal opinion may be requested depending of the level of concern for the specific situation.
- The plant must complete a written action plan and forward it to the CFIA office within 5 working days. This action plan must indicate all the corrective measures they will implement to eliminate Lm in the RTE environment. At a minimum the corrective actions must include:
- Assessment and possible testing of all production lots produced between the date of the unsatisfactory finding and the date of intensive cleaning.
- Implementation of intensiveFootnote 1cleaning/sanitation actions;
- Revision of appropriate sections of the plant's process controls (including GMP's, sanitation procedures, etc.);
- Verification of environmental conditions as soon as possible following CFIA notification. This needs to include sampling during production and individual testing of FCS, by an accredited lab for three consecutive production runs to ensure that these surfaces are free of Listeria spp.(or Lm) (see Appendix 1). It is recommended that each lot of product should be held and tested for Lm until the results demonstrate that control has been achieved.
- (The operator should sample the same FCS sites which triggered the unsatisfactory result when performing the first FCS follow-up swabbing. For the second and third FCS follow-up swabbing, there are no specific requirements for sampling sites (as long the operator is targeting the same implicated line).
- Review the action plan for acceptability and sign-off in conjunction with the Regional Program Officer or Area Program Specialist. Notify the plant in writing immediately if the action plan is not acceptable or if it is not received on time.
- Verify that the establishment has implemented follow-up actions by reviewing records during a follow-up visit. FCS environmental samples can be taken for verification purposes if deemed necessary.
- Schedule another FCS environmental sampling (using sampling plan D222D) and finished product sampling on the same packaging line (using sampling plan D221D), within a three month period. It is recommended to swab the same FCS sites which triggered the initial follow-up procedure.
- Close the IMS when this follow-up is performed and assessed as satisfactory.
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