Corrective Actions for a FCS tested positive on Listeria spp

Hi , 

 

I am working on drafting corrective action for a positive FCS test for Listeria spp . The facility produces RTE product with a shelf life of less than 9 days . 

 

My question is , if we get a positive FCS test for Listeria spp. we would not be able to hold the product as it will already be out for distribution. What to do in a scenario like that is the retest also comes as positive? Should the corrective action state notification to CFIA before waiting for the retest or should we wait for the retest results and then notify the CFIA. 

 

Also , we do end product testing for Listeria monocytogenes however due to limited shelf life , we cannot implement the hold and release program . How do I do a risk assessment for it?

 

Thanks in advance.  

I'm not familiar with Canadian law so someone who is will I'm sure be along (there are a few posters on here who are) but I am familiar with control for Listeria monocytogenes.

 

What I think you're saying is that if you have a fail for Listeria spp, you do a speciation test (not a retest) for monocytogenes.  Is that correct?

 

Even under UK and EU law this is a little bit grey because strictly speaking you need to inform if you have "reason to believe" a product could be injurious to health.  Strictly speaking a presumptive is "reason to believe" but I would say in reality, nobody is instigating escalation to the food standards agency unless it's a Listeria monocytogenes positive and then the count is also important.  If I'm honest it just gives a lot of opportunity to delay informing the regulator and often the product is out of life (cynic...)

 

Aside from all that...  Because we all know it's a thorny business and food safety issue, my advice is, don't get there.  Concentrate your testing on environment.  Concentrate your verification activities beyond the product and environment testing onto behaviours and indicators those behaviours are being followed. 

I'm not sure how much people really say it out loud that a product failure is a failure of your HACCP plan.  Of course, it's not 100% but put all your energy into making that a really robust, well monitored, well verified plan.  I really get sad when I see product testing as the only verification on HACCP.  The source of HACCP is FMEA and the process which is almost equivalent to verification in FMEA has a measure in it to look at how detectable the defect is while it's in your control.  I know that in a way that's monitoring but I think bringing in some of that mindset into HACCP as an earlier warning that things are going wrong is vital.  

Are you following the CFIA listeria policy to the letter?   And did you have the sample re-tested to confirm the species?  

 

https://www.canada.c...ocytogenes.html

https://inspection.c...nocytogenes#a71

 

You really do need to send your product out for testing, you NEED to know if it is present in the food and not just your facility (or not).  

7.1 Food Contact Surface samples positive for Listeria 7.1.1 Examples of corrective actions

• Intensify and increase the cleaning and sanitation of the equipment and the processing environment
• Equipment disassembly and cleaning
• On-site observations and/or employee interviews to determine whether sanitation and operational procedures are being adhered to. Employee re-training if necessary
• Review previous weekly and monthly results for both the food and environmental samples to determine trends that could identify a possible source or reason for positive result(s)
• Consult with your supplier to determine if the detergents and sanitizers  being used are appropriate (concentration, contact time, water temperature) and which alternates may be applied
• Review sources and controls for raw materials and ingredients, or imported foods
• Address equipment or facility design flaws that may be an obstruction and not allow for an adequate cleaning and sanitation
• Review the process flow and plant floor diagram to ensure that the potential for cross-contamination is controlled (for example the restrictions of employees flow or establishment of sanitary zones)
• Review the sanitation program to determine if anything has changed, such as new staff, different cleaning chemicals or new cleaning equipment being used

Verify the effectiveness of corrective actions in accordance with figures 2 and 3 of the HC Listeria Policy.

7.1.2 Persistent contamination

If two or more FCS samples from the same production line (for example: using the same equipment) are found positive for Listeria within a short timeframe, this is considered persistent contamination and an indication that the sanitation procedures or Listeria control measures are inadequate.

As indicated in the HC Listeria Policy, section 7.2.1.1, what constitutes a "short" timeframe is operation-specific and will vary based on factors such as production volume, production seasonality and testing frequency. It should be considered that persistent contamination exists when an increase in the rate of FCS contamination is observed in the establishment's trend analysis.

In these situations it is recommended to:

• Implement corrective actions as suggested in section 7.1.1
• Verify the effectiveness of corrective actions in accordance with figures 2 and 3 of the HC Listeria Policy. Note corrective actions are only considered effective when the results for FCS and RTE food samples are negative for 3 or more consecutive days of production
• Inform the CFIA when L. monocytogenes is detected in a food sample
• Identify:
  • the foods that may be affected
  • how many days of production since the last negative result
  • the status on inventory and product distribution for the production period in question
  • the shipping information for traceability of affected product

Sorry, I didn't mean to say don't test your product.  Although rereading my comment, I realise that's how it could have come across.  I meant, make sure your internal processes and testing are so rigorous that you almost never get to product failure.  

 

Really interesting to read the Canadian legislation on it.  Thank you.

I'm not familiar with Canadian law so someone who is will I'm sure be along (there are a few posters on here who are) but I am familiar with control for Listeria monocytogenes.

 

What I think you're saying is that if you have a fail for Listeria spp, you do a speciation test (not a retest) for monocytogenes.  Is that correct?

 

Even under UK and EU law this is a little bit grey because strictly speaking you need to inform if you have "reason to believe" a product could be injurious to health.  Strictly speaking a presumptive is "reason to believe" but I would say in reality, nobody is instigating escalation to the food standards agency unless it's a Listeria monocytogenes positive and then the count is also important.  If I'm honest it just gives a lot of opportunity to delay informing the regulator and often the product is out of life (cynic...)

 

Aside from all that...  Because we all know it's a thorny business and food safety issue, my advice is, don't get there.  Concentrate your testing on environment.  Concentrate your verification activities beyond the product and environment testing onto behaviours and indicators those behaviours are being followed. 

I'm not sure how much people really say it out loud that a product failure is a failure of your HACCP plan.  Of course, it's not 100% but put all your energy into making that a really robust, well monitored, well verified plan.  I really get sad when I see product testing as the only verification on HACCP.  The source of HACCP is FMEA and the process which is almost equivalent to verification in FMEA has a measure in it to look at how detectable the defect is while it's in your control.  I know that in a way that's monitoring but I think bringing in some of that mindset into HACCP as an earlier warning that things are going wrong is vital.  

 

Hi ! Thanks for sharing . 

 

I understand your POV , and my corrective actions currently are drafted keeping CFIA Listeria policy as reference . However , I don't think I drafted my question properly. My real challenge is that some products have a shorter shelf life of 3-5 days . So by the time our results come in for product testing or even a positive retest of presumptive FCS for Listeria , the product is already consumed or at the end of the shelf life. Given the circumstance , what should be the risk assessment in such scenarios?Apart from finding the source, assessing the issue , reviewing HACCP , cleaning and Sanitation procedure and notifying CFIA , is there something more needed? 

Given the incredibly short shelf life of your product, what you should be doing is a shutdown and deep clean, you've already proven it's present in your facility, doing the same thing over and over again isn't going to remove it from your facility

 

so the cleaning and sanitation program needs to be reviewed/reassessed and changes made

 

do you frequently find listeria in the facility, has it even been L mono?

Given the incredibly short shelf life of your product, what you should be doing is a shutdown and deep clean, you've already proven it's present in your facility, doing the same thing over and over again isn't going to remove it from your facility

 

so the cleaning and sanitation program needs to be reviewed/reassessed and changes made

 

do you frequently find listeria in the facility, has it even been L mono?

 No , we haven't found it . This question was drafted for drafting corrective actions for the EMP program . The current corrective actions do not cover all the possible scenarios e.g what if the product has left the facility and there was no mention of confirmation testing on L. mono on FCS . So wanted to enhance them . 

 

Thank You for your inputs.