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Corrective Action for Out of Spec Indicator testing in Environmental Monitoring

APC EB Environmental monitoring

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#1 ddaniels316

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Posted 10 February 2020 - 03:10 PM

In our dry blend food facility, we have a 4 zone environmental sampling plan.  We test APC, Enterobacter for zones 1 and 2  and Listeria spp and Salmonella for areas that are 3 and 4.

 

I have written into SOPs what to do if we would get a positive hit for Listeria spp and Salmonella, which is largely based on FDA guidance.  However, should that same response be for broad indicator tests like APC and EB?

 

I never see a need to vector or do other types of testing.  I could not find any guidance so I turn to the message boards.

 

Any guidance would be appreciated. 



#2 kfromNE

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Posted 10 February 2020 - 04:54 PM

You need to get your baseline for APC and enterobacter. Once established, if the number goes higher, then enhance your cleaning processes or test more often.

 

https://www.nal.usda...-and-guidelines - you may find what you're looking for.



#3 kingstudruler1

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Posted 10 February 2020 - 05:03 PM

yes, i think you need to have pass fail criteria for zone 1 and zone 2. Then when out of spec condition accur
there does need to be corrective actions. EB plates are meant to tell you that conditions are such that pathogen presence is possible.
I have never tested em swabs for apc, my guess is that it could result in counts very frequently depending on when you swab.
perhaps you could give that a amount that triggers a corrective action.

In short
Why bother testing if you are not going to react to any condition.



#4 ddaniels316

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Posted 10 February 2020 - 05:45 PM

It is not that we would not react to a high or out of spec count.  The question becomes what should the testing plan be?  In the case of a pathogen, the area is cleaned immediately (at the presumptive report) and vector swabs  to make sure the area is clean and it was just a spike.  Additional finding triggers other steps. 

 

But in the case of APC and EB I wouldn't break production to perform a clean on product contact and adjacent areas.  We would reclean the area at next opportunity (likely at end of week) then we would swab no vectors), Does that seem urgent enough?  What would be a good plan if the retest is also high? 



#5 Charles.C

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Posted 11 February 2020 - 06:31 AM

It is not that we would not react to a high or out of spec count.  The question becomes what should the testing plan be?  In the case of a pathogen, the area is cleaned immediately (at the presumptive report) and vector swabs  to make sure the area is clean and it was just a spike.  Additional finding triggers other steps. 

 

But in the case of APC and EB I wouldn't break production to perform a clean on product contact and adjacent areasWe would reclean the area at next opportunity (likely at end of week) then we would swab no vectors), Does that seem urgent enough?  What would be a good plan if the retest is also high? 

 

Hi ddaniels,

 

Data such as  APC, EB is typically associated with establishing the adequacy of  Environmental-Process  Hygiene, eg the Cleaning/Sanitizing Program. The latter should be a Prerequisite program where  APC, etc data provide validation and verification.

 

Ideally the PRP/micro. verification aspect  would be implemented within a daily Pre-operational program with a corrective action of investigation/immediate recleaning if failure of limits occurred. However the delay time for results from microbiological data exclude such an option. So the alternative is presumably asap+resampling which hopefully might be the next day, or two ?

 

PS - The verification data if significantly deviant would presumably also be analysed for potential implications to any parallel Pathogen monitoring scheme although these indicator programs are not generally regarded as having specific pathogen correlations.

 

The above is one reason  why ATP is popular for enabling rapid hygiene-related decisions.

 

PPS - there are a variety of published EMPG programs in these posts -

 

https://www.ifsqn.co...ls/#entry100060

https://www.ifsqn.co...am/#entry119334

 

(I quite liked the relatively short AIB document for a quick appreciation of the general problem)

(env9 also has a quite interesting portion on corrective action logics mainly oriented to Listeria)

 

P3S - i assume the "enterobacter"  in posts 1,2 are typos.


Kind Regards,

 

Charles.C


#6 GMO

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Posted 11 February 2020 - 07:59 AM

In the case of a pathogen, the area is cleaned immediately (at the presumptive report) and vector swabs  to make sure the area is clean and it was just a spike.

 

I do think the US approach to this is interesting.  I assume you're operating in high care or high risk?  Unless you have a process where you are likely to introduce Listeria (for example) into your factory from time to time, it's never just a "spike".  Perhaps I'm too battle hardened from seeing where these things end up but I remember someone saying to me "well to test the lab are testing your swabs properly, why not send a swab from that drain that always fails?  You know, every factory has one."  Er no!

 

Any positive pathogenic swab in a factory should be the subject of rigorous investigation and possibly a temporary change in cleaning processes (for example, switching from chlorine to quats or doing a double disinfection whammy of chlorine, 20 mins contact, rinse, quats).  I assume by "vector swabs" you mean swabs around the area it was found?  I'd also include reswabs of the original area.  You can get false negatives too.  The number of times I saw a presumptive return negative for reswabs or "vector swabs" to return positive is, well, many, many times and the time of the day you swab can really impact that.

 

I know this isn't in answer to your question but even a single pathogen swab in your high care area returning positive indicates a failure of processes, either a failure of your barriers, a failure of your cleaning processes after a barrier breach or a failure of your fabrication.  Personally I wouldn't take it lightly.  I've seen factories go from one or two failed environmental swabs, less than 1% of those taken to product positives within months.  Remember not all surfaces will give up the pathogens to a swab easily especially if they are rough (which floors often are to prevent slips).   Just don't assume that a single swab means a single pathogenic bacterium, you may have just discovered the tip of the iceberg...







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