Environmental and Finished Dairy Product Sampling Monitoring for Listeria monocytogenes
1.8 Follow-up on Unsatisfactory Finished Product (CFIA's or Industry's)

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Initiate the follow-up procedure explained below when an unsatisfactory finished product result for Lm is reported to CFIA as part of an establishment's Lm verification procedures or through CFIA's own testing (see Appendix 2)

  1. Create an IMS file to track all activities related to the finding.
  2. Notify industry immediately of the unsatisfactory result. Detain the implicated production lot(s) as per the policies prescribed by the Dairy program.
  3. Determine if the product has been distributed. If the implicated product is in distribution, contact the Area Food Recall Coordinator and the Area Program Specialist to gather information for a food safety recall.
  4. Assess all lots produced since the unsatisfactory finding together with plant's information to determine any need for more sampling.
  5. The operator must take immediate corrective actions and submit an action plan to CFIA within 5 days. This action plan must indicate all the corrective measures which will be implemented to address the root cause and prevent product contamination by Listeria monocytogenes. As a minimum requirement the following points should be covered in the planFootnote 2:
    • Action that will be taken on the unsatisfactory product (recovery, hold and disposition of the product)
    • Verification that no other product is affected by the unsatisfactory result (e.g. all lots produced since date of unsatisfactory finding)
    • Implementation of an intensiveFootnote 3 sanitation and cleaning plan
    • Appropriate corrective action (e.g. review of sanitation program, HACCP/written plan, etc.)
    • Investigative FCS sampling to identify source(s) of contamination (samples should be analyzed individually).
    • Implementation of a product hold-and-test procedure:
      • Finished product (5 sub-samples per lot) from the same implicated production line analysed by an accredited lab until 10 consecutive lots are satisfactory for Lm (2 out of 10 samples are sampled and analysed by CFIA).
      • If a sample test is unsatisfactory during the above hold and test, the cycle starts again from the beginning. The operator must reassess their corrective action plan which should be reviewed with the Regional Program Officer or Area Program Specialist. Repetitive Lm findings may increase frequency of in-depth inspections, GMP's, sampling, etc.
  6. It is important to review the plant's information, as applicable, and pay attention to locations where water/humidity favour microbial growth (e.g. stagnant water, condensation, drains):
    • Complaint files, GMP reports
    • Pasteurization records, deviations
    • Equipment design
    • Equipment maintenance records including calibration records
    • Process control records e.g. aw, pH, preservatives, microbiological testing records, slow fermentations
    • Quality and handling of incoming materials including water, brine, and ripening cultures (washed rind cheeses)
    • Packaging materials (integrity)
    • Sanitation frequency vs. production cycles
    • Pest control records
    • Observation of employee hygienic practices
    • Steps in process flow susceptible to contamination and/or growth (e.g. product returns, production down time)
    • Ripening and smearing cheese practices
    • Post process handling, storage, distribution of finished product (time and temperature)
    • Segregation of raw and finished areas (product and employee flow)
    • Sanitary cutting practices, separation of retail sale counters (e.g. with foot baths)
    • Ventilation (air supply), positive pressure in areas of manufacture
    • Lot determination/definition
  7. Review and sign the action plan if acceptable and keep on file. Notify operator immediately in writing if not acceptable or not received on time.
  8. Verify that corrective actions taken by the operator are implemented during a follow-up visit.
  9. Update and track all results in IMS.
  10. After all 10 consecutives lots are found satisfactory for Lm, schedule another finished product sampling and FCS within a three month period.
  11. Close the IMS when this follow-up is performed and assessed as satisfactory.
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