Environmental and Finished Dairy Product Sampling Monitoring for Listeria monocytogenes
1.9 Directed Environmental Sampling
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This biased environmental sampling is performed to investigate or verify any suspected problems (i.e. poor GMP or new registrations) in any dairy establishment. Lab analysis will include both Listeria monocytogenes and Salmonella spp. A maximum of ten (10) samples are to be taken (can include FCS and non-FCS sites). Since these are considered surveillance samples, they will be analyzed individually.
1.9.1 Preparation for Environmental Sampling and Selection of FCS and Non-FCS
It is the inspector's discretion to select the sample sites according to the type of establishment and conditions/concerns observed during the visit. As general guidance, it is recommended to select 5 FCS and 5 non-FCS to get a better understanding of the effectiveness of the establishment's control programs. Due to the small number of samples taken in a plant, it is imperative that sampling sites be selected that will generate the most information possible such as sites that may favour microbial growth (water, nutrient and incubation time) and any area of the establishment or equipment that contains uncontrolled water (roof leaks, standing water or condensate). It is not recommended to swab drains unless they are in close proximity to unprotected product.
It is critical that the inspector avoids contaminating the sampling kit supplies, the samples, the equipment and the product being sampled by following the sampling technique described in section 1.6.3.
1.9.2 Follow-up for Unsatisfactory FCS and Non-FCS Results
An unsatisfactory result for under D212D indicates that the establishment is not operating according to Good Manufacturing Practices (GMP's).
If the unsatisfactory result is linked to a FCS site, initiate the follow-up procedure explained in section 1.7 "Follow-up for unsatisfactory FCS results" (with the exception of steps #3 and #7 which are specific to the environmental monitoring plan D221).
If the unsatisfactory result is linked to a non-FCS site, initiate the follow-up procedure explained below :
- 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, non-FCS sites tested, results of CFIA inspections (if applicable), company's corrective action plan, findings from establishment's root cause analysis, follow up, etc.).
- 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 control Lm in the environment. At a minimum, the corrective actions must include:
- Implementation of intensive cleaning/sanitation actions;
- Revision of appropriate sections of the plant's process controls (including GMP's, sanitation procedures, etc.);
- Verification of environmental conditions including the testing of the non-FCS originally tested and the inclusion of FCS to ensure that these surfaces are free of pathogens (see Appendix 3).
- Review the action plan 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.
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