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Risk Assessment on how many environmental swabs to take


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#1 HokeyPokey

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Posted 01 July 2019 - 02:01 PM

I need to do a risk assessment on the amount of swabs we do.  Why do we do 15 swabs per week.  Can anyone help me to get starting on this.  Any input would be helpful. 



#2 larissaj

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Posted 01 July 2019 - 02:03 PM

It has a lot to do with why you do 15 and in general what you are swabbing for. How long have you swabbed and what were the results? What kind of risk is your company? What product do you have? There is a lot of information still needed.



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#3 Charles.C

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Posted 01 July 2019 - 02:15 PM

I need to do a risk assessment on the amount of swabs we do.  Why do we do 15 swabs per week.  Can anyone help me to get starting on this.  Any input would be helpful. 

 

Additional to Post 2 -

 

Who/ or what Standard are you doing it for ??


Kind Regards,

 

Charles.C


#4 HokeyPokey

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Posted 01 July 2019 - 02:17 PM

SQF is asking for it.  But I think It might help with the FDA also. 



#5 HokeyPokey

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Posted 01 July 2019 - 02:26 PM

It has a lot to do with why you do 15 and in general what you are swabbing for.

 

How long have you swabbed and what were the results? - I have been here for 3 years now.  When I start here we was doing 20 per week.  We had a issues so we up it to 15 twice per week.  We address the issues and than we took it back to 15 per week.  This year our test result has been 99% Negative. 

 

What kind of risk is your company? We are testing for Listeria M. 

 

What product do you have? Ice Cream

 



#6 Charles.C

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Posted 01 July 2019 - 02:28 PM

It has a lot to do with why you do 15 and in general what you are swabbing for.

 

How long have you swabbed and what were the results? - I have been here for 3 years now.  When I start here we was doing 20 per week.  We had a issues so we up it to 15 twice per week.  We address the issues and than we took it back to 15 per week.  This year our test result has been 99% Negative. 

 

What kind of risk is your company? We are testing for Listeria M. 

 

What product do you have? Ice Cream

 

Results for FDA ??


Kind Regards,

 

Charles.C


#7 HokeyPokey

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Posted 01 July 2019 - 02:30 PM

FDA has been here.  Going to come back very soon. 



#8 Charles.C

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Posted 01 July 2019 - 02:41 PM

FDA has been here.  Going to come back very soon. 

 

The reason I asked was that I'm aware USDA /FSIS have detailed sampling requirements for L.mono. but FDA I have no idea if similar Regs exist for RTE products.

 

You seem to be doing a lot of (Zone?) sampling if have established a "low risk" scenario but maybe no choice if pre-required.

 

Maybe somebody here is familiar FDA sample size requirements.

 

.


Kind Regards,

 

Charles.C


#9 kfromNE

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Posted 03 July 2019 - 01:26 PM

Not sure if there are any recommendations. However I now work in a 'high' risk facility that has had a full FDA inspection. They take weekly 5 contact (zone 1) and 5 non contact (zones 2, 3, 4) samples to test for listeria and 3 non contact swabs to test for salmonella. This was established by either the recommendation of the FDA or someone at corporate. 

 

If you want to cut back - you'll need to justify it and use documentation, journal articles if you can find them, etc. You could also ask the FDA the next time they are there.



#10 Charles.C

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Posted 03 July 2019 - 01:37 PM

Not sure if there are any recommendations. However I now work in a 'high' risk facility that has had a full FDA inspection. They take weekly 5 contact (zone 1) and 5 non contact (zones 2, 3, 4) samples to test for listeria and 3 non contact swabs to test for salmonella. This was established by either the recommendation of the FDA or someone at corporate. 

 

If you want to cut back - you'll need to justify it and use documentation, journal articles if you can find them, etc. You could also ask the FDA the next time they are there.

 

Hi KfLA,

 

Thks for input.

 

I assume this is RTE production.

 

Sound like the OP may have to increase their sampling if the query was relevant to FDA. ( > + Salmonella)

 

Must cost somebody a small fortune.


Kind Regards,

 

Charles.C


#11 kfromNE

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Posted 03 July 2019 - 01:47 PM

Hi KfLA,

 

Thks for input.

 

I assume this is RTE production.

 

Sound like the OP may have to increase their sampling if the query was relevant to FDA. ( > + Salmonella)

 

Must cost somebody a small fortune.

 

This is RTE production. As for costing a fortune - I believe there feeling was - this is cheaper than a recall.



#12 kfromNE

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Posted 08 July 2019 - 09:21 PM

Just thought of it - there is a guide on how many you should test by the FDA - https://www.fda.gov/...ready-eat-foods

 

Page 36 - "3. Sample locations and number of sites to be tested" will help you determine how many you should do. This should also be sufficient evidence for SQF. 

 

So in your risk assessment state at the end "Based on the size of the plant, plant features, product flow, characteristics of the RTE food, the processing methods used to produce the food, and previous sampling results (if any) we will take (state how many, how often and which zones)



#13 Charles.C

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Posted 09 July 2019 - 04:47 AM

Just thought of it - there is a guide on how many you should test by the FDA - https://www.fda.gov/...ready-eat-foods

 

Page 36 - "3. Sample locations and number of sites to be tested" will help you determine how many you should do. This should also be sufficient evidence for SQF. 

 

So in your risk assessment state at the end "Based on the size of the plant, plant features, product flow, characteristics of the RTE food, the processing methods used to produce the food, and previous sampling results (if any) we will take (state how many, how often and which zones)

 

Thks. I think this is same file I posted here yesterday, -

 

https://www.ifsqn.co...nt/#entry144934

 

Note this is a draft Guidance. And focused on L.monocytogenes. And specific to RTE.

 

There are, IMO, some equally interesting (L.mono.) thoughts/observations (particularly for fresh produce) in the other Guidance file in same post.

 

PS - I am not in USA but a (quick) "Listeria" comparison for routine sampling/testing methodologies between FDA and FSIS appeared to suggest that -  for an RTE item supporting growth of L.mono where post-lethality Listeria control (ie freedom from re-contamination) is achieved by Sanitation Program only (eg Frozen Ice-Cream), FSIS (if it had jurisdiction this product [which it does not]) seems  potentially more processor-friendly inasmuch as -

 

(a) FSIS requires EMPG program to be applied to post-lethality surfaces only, (cf zones whole factory)

(b) FSIS prioritizes sampling frequency based on Contamination PotentialVolume of production (ice-cream > "2b" > quarterly). (cf weekly)

(c) FSIS accepts 3-5 FCS samples per Production Line at each sampling event. (cf minimum 5 [+5 non-FCS])

 

@HokeyP - looks like 5+5 (as per Post 9) for  L.mono (or Listeria) per week is the least amount sampling you can expect from FDA. Not sure why presently 15. An attempt to go from (current) 15 > 10 per week might arouse an FDA interest in Salmonella. :smile:

 

PPS - A corollary to the above from a BRC/SQF etc POV would appear to be that both FDA and FSIS are implicitly supporting a viewpoint that a non-RTE finished product should not require environmental monitoring for Listeria/L.monocytogenes.

 

Attached File  FSIS Listeria Guideline RTE meat,Poultry,2014.pdf   1.03MB   10 downloads


Kind Regards,

 

Charles.C





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