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Action required when environmental testing sample comes back positive?


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#1 foodguy63

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Posted 14 December 2018 - 05:03 PM

Hey all,

 

Looking for some input on environmental testing after a sample comes back positive, an investigation is completed, and a corrective action is completed (in this case a deep clean):

 

Should you re-swab the impacted area immediately or wait to re-swab until after a predefined time into production? 

 

I understand that swabbing immediately poses a risk to indicate the organism has been removed even though it hasn't, but waiting a predefined amount of time may allow the impacted area to be recontaminated again from another source. I'm thinking like an area on the floor that is being impacted by boot traffic from another area that has yet to be discovered. Resulting in expending resources in an area while allowing the actual problem to go unchecked.

 

Again, I also understand the allure of sampling immediately as it will certainly have a higher likelihood to pass even if the organism hasn't been completely destroyed. Thoughts?

 

Thanks!



#2 Scampi

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Posted 14 December 2018 - 05:06 PM

How will you know if you're corrective actions are sufficient if you don't reswab now?  What if your deep clean wasn't deep enough?

 

I vote swab now AND at an increased frequency for a set period of time until you are sure you've actually fixed the problem


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#3 foodguy63

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Posted 14 December 2018 - 05:10 PM

Hey Sacmpi,

 

Thanks for the quick reply! I completely agree. For some reason, a few members of my team view the immediate re-swab as "cheating". 



#4 foodguy63

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Posted 14 December 2018 - 05:12 PM

Also to your point on the frequency, our policy does require consecutive re-swabs before the area is no longer deemed impacted.



#5 Scampi

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Posted 14 December 2018 - 05:30 PM

Are you going to hold all production until you've reached X negative results?  I would urge you too just in case

 

I would agree with your team IF you were only swabbing once.........but since you are following your corrective action and deviation plan, I think it's sound

 

I gather you are subject to an FDA swab a thon?


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#6 Scampi

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Posted 14 December 2018 - 05:35 PM

from the fda (although I am not assuming it was listeria, this is just for illustration)

7. Corrective action procedures We recommend that your written environmental monitoring procedures include corrective action procedures that describe the steps to be taken and assign responsibility for taking those steps, to: • Ensure that the cause of the contamination is identified and corrected; and • Minimize the potential for foods to be contaminated with L. monocytogenes from any source (e.g., equipment, people, and the processing or packing environment). We recommend that your corrective action procedures be risk-based from the perspectives of: • The environmental monitoring strategy for the food; • Whether the environmental contamination is on an FCS or a non-FCS; Contains Nonbinding Recommendations 39 • Whether testing environmental samples results in an isolated positive result or multiple positive results; and • The proximity of a contaminated non-FCS to FCSs. The types of corrective actions are highly varied (e.g., conducting intensified cleaning and sanitizing, conducting intensified sampling and testing, conducting a root cause analysis, and implementing "hold and test" procedures). Which corrective actions you take depends upon your specific situation. For specific recommendations for corrective actions if you detect Listeria spp. or L. monocytogenes in environmental samples collected during routine or follow-up sampling and testing, see sections XIII.E through XIII.G of this guidance and Appendix 6. We have not identified all manners in which foods or FCS can be contaminated, and it is not possible to provide a comprehensive set of corrective actions that apply in all situations. The actions you take should be based on the risk that contamination could result in contaminated food and consumer illness.

 

https://www.fda.gov/...n/ucm535981.pdf


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#7 Ryan H.

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Posted 14 December 2018 - 07:21 PM

A lot depends on what ZONE you swabbed that came back positive.. If it was zone #1 (Food Contact, then your going to be holding product, and possibility worse). It's it's for example: zone #3 or #4 then typically we do the following (Also note if you have a major customer account, many have a specific protocol in the event the line your getting a positive hit is from the same line or plant as their product is being produced on. 

 

A possible procedure when receiving a positive hit on your environmental monitoring: 

1. intensified cleaning/ Review of SSOP in that area (New cleaning procedure/ frequency or chemicals used?)

2. Investigation sampling: to try and find the SOURCE of the positive sample (Where is this pathogen coming from) - check floor/ wall junctures, wheels from carts, other places in the facility or entrance points, shoes?

2A. Then address any more positives you may find..

3. Intensified Sampling (Daily Swabbing possibility): For a pre-determined amount of time.. If you get though that time without more issues, then you would go back to routine sampling. 

 

 

Foot traffic is always a possible source of bacteria.. Look at the possibility of a shoe cleaning program or even a Captive Shoe Program. Of course it depends on your company and what your producing. 


All the best, 

 

Ryan Heavner 


#8 foodguy63

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Posted 14 December 2018 - 07:41 PM

Scampi, thanks for in the info. We aren't currently in a swab-a-thon, just trying to stay ahead. Eventually, the FDA is going to show up and expect answers. We would rather provide those answers than force them to find them.

 

Ryan, I agree with you completely on the importance of zoning. All of the samples in question came from zone 3. We've started looking around at things like foot traffic and potential cleaning equipment that could potentially be contaminated.



#9 Charles.C

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Posted 14 December 2018 - 09:56 PM

Hi Food Guy,

 

Positive for WHAT and in WHAT context ?

 

Surely this thread is simply meandering along a very winding road ?


Kind Regards,

 

Charles.C


#10 Ryan H.

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Posted 14 December 2018 - 10:47 PM

Cleaning equipment or mops and floor scrubbers are a great place to look for bateria and pathogens (which ever your attempting to seek out and destroy)

But as Charles stated above, if you could provide specific details others may be able to provide additional suggestions.


All the best, 

 

Ryan Heavner 


#11 foodguy63

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Posted 17 December 2018 - 09:35 PM

Hey, sorry for the delayed response. 

 

We are primarily concerned with Listeria spp. and the potential that wheeled items like hand jacks and floor scrubbers may simply be acting as a spreader. We operate in a pretty low moisture environment so cleaning tools like floor scrubbers are one of only a few potential inputs of water. However, getting team members to divert their focus from the issue immediately in front of them (regions of the floor getting hits) rather than the root cause has been difficult. 

 

All hits associated with these swabs have been zone 3 locations (drains and floors).



#12 Charles.C

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Posted 18 December 2018 - 01:59 AM

Hi foodguy,

 

Afraid there is still Insufficient context.

 

The significance of a positive Listeria finding is highly dependent on your Food Process type and where the finding occurred. And its frequency if >1.

 

eg is this RTE Production ?

 

eg Was the positive(s?) pre or post heat treatment (if any) ??

 

eg What do you interpret as Zone 3 (numerous terminologies exist) ?

 

If FSIS related (?) there are encyclopaedical documents related to Listeria. (I note yr earlier mention of FDA, just being cautious).


Kind Regards,

 

Charles.C


#13 foodguy63

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Posted 18 December 2018 - 12:47 PM

Charles,

 

"Raw" baked goods that require a consumer lethality step. However, we need to accept the fact as manufacturers that the potential for misuse is very high. Zone three is primarily floors and drains. That is correct we are an FDA facility. 



#14 Charles.C

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Posted 19 December 2018 - 03:35 PM

Charles,

 

"Raw" baked goods that require a consumer lethality step. However, we need to accept the fact as manufacturers that the potential for misuse is very high. Zone three is primarily floors and drains. That is correct we are an FDA facility. 

 

Hi foodguy,

 

I'm not in USA/unaware if FDA have any specific Regulatory/non-regulatory expectations regarding Listeria/L.mono in, as I anticipate, yr haccp low risk process.?? (FSIS offer well-known detailed  (Listeria) thoughts on some of their jurisdicted products)

 

IMO there are a variety of factors potentially related to evaluating the significance of yr finding, for example specific location sampling point, eg proximity to a "sensitive" activity, routine sampling plan (eg frequency), existence of L.mono, in reported finding, current Listeria/L.mono history of implemented sampling scheme, etc.

 

I'm unclear whether yr "zone 3" implies not in the vicinity of "final" process stages.

 

The relevance of yr result  relates fundamentally to risk assessment, eg the likelihood of Listeria/L/mono being probable (inevitable?) in the area concerned.

 

Some (RA) opinions would perhaps disregard drains altogether from an EMP POV, (as is IIRC the FSIS case for pre-thermal stages in an RTE process)

 

For context, I suggest to have a look at these (FDA/FSIS related but not for baking) earlier "drain" posts/threads which consider some of the pros/cons of involving/interpreting drains (et al) in EMP programs.

 

https://www.ifsqn.co...ns/#entry102854
https://www.ifsqn.co...om/#entry109717
https://www.ifsqn.co...em/#entry109592
 

 

 

 

 

 

 

.


Kind Regards,

 

Charles.C


#15 thatparksgal

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Posted 20 December 2018 - 01:35 PM

We resample as soon as the area was re-cleaned, but we also sample the site for three days. All three results have to be negative for the area to go back to routine testing.



#16 MsMars

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Posted 20 December 2018 - 01:56 PM

IME with "raw" baked goods production, a zone 3 positive would be re-swabbed during production simply to replicate the conditions in which the previous swab was taken and provide "worst case scenario" so that we were sure the source had been eliminated. We did not do a swab after cleaning typically, since 1. it was a non-contact area, and 2. one deep clean usually took care of the problem and we were usually able to get our consecutive negatives after this so it wasn't worth the extra cost.  However if you keep popping positives in the same location, I would certainly do another swab after your deep clean to eliminate inadequate cleaning techniques as a source. Like some have mentioned above, if you need to expand your investigation, be certain to look at floor scrubbers, traffic patterns, etc.

 

Slightly off-topic: At previously mentioned facility, implementation of a dry quaternary powder boot mat in the entryway to the production room drastically reduced Listeria spp. issues.  The powder was also approved for use on the floor and in drains.

 

Off topic - we did not sample zone 1 in raw production as we did not consider this RTE and neither did the FDA.  However I have a feeling that after the cookie dough incident a few years back and more recently the yeast roll incident that FDA may start looking at this more closely.






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