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BRC 4.11.8 Environmental Monitoring


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#1 CVBC

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Posted 21 May 2019 - 09:03 PM

Hello, 

 

Just had our 2019 Audit and received a minor on 4.11.8 because we did not do any environmental monitoring.   I had a RA that explained since we have low risk, low water activity product, and do dry cleaning, we do not need to do environmental monitoring.   (We're a bean elevator - receive beans from farmers, mill to remove FM, and ship in railcars/totes/bags)

 

Any suggestions on how to do a environmental monitoring program for a product/situation like ours?

 

Thank you for the help



#2 CarinaC

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Posted 21 May 2019 - 11:34 PM

Our company produce teabags and it is also a low risk manufacturing facility. We have weekly SEM (on machine) and PEM(on floor) and testing for yeast and mold, Salmonella and Listeria respectively. 



#3 Charles.C

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Posted 22 May 2019 - 03:25 AM

Hello, 

 

Just had our 2019 Audit and received a minor on 4.11.8 because we did not do any environmental monitoring.   I had a RA that explained since we have low risk, low water activity product, and do dry cleaning, we do not need to do environmental monitoring.   (We're a bean elevator - receive beans from farmers, mill to remove FM, and ship in railcars/totes/bags)

 

Any suggestions on how to do a environmental monitoring program for a product/situation like ours?

 

Thank you for the help

 

from BRC8

Risk-based environmental monitoring programmes shall be in place for pathogens or spoilage organisms. At a minimum, these shall include all production areas with open and ready-to-eat products.

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The design of the environmental monitoring programme shall be based on risk, and at a minimum include:

•  sampling protocol

•  identification of sample locations

•  frequency of tests

•  target organism(s) (e.g. pathogens, spoilage organisms and/or indicator organisms)

•  test methods (e.g. settle plates, rapid testing and swabs)

•  recording and evaluation of results.

 

 

As you say, a risk assessment is required.

 

Why did auditor not accept yr "No Need" RA conclusion ?

 

(My guess is that -

 

(1) yr product will potentially generate pathogenic, etc contamination from external environment to internal environment")

(2) ditto  Personnel.

(3) no micro. data to support adequacy of  cleaning

 

And, regardless of ptoviding satisfactory environmental micro.data,  ultimately, based on results from SQF's forum, BRC may, despite their "risk-based" comment, simply adhere to the red "shalls" above.

 

Theoretically, the target organisms could be an encyclopedia. I suggest you check the BRC Interpretation Guidelines.


Kind Regards,

 

Charles.C


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#4 pHruit

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Posted 22 May 2019 - 08:22 AM

The "Statement of Intent" for the new 4.11.8 section stipulated that: as a minimum, these shall include all production areas with open and ready-to-eat products.

I'd guess that CVBC's process/site does include at least some open product areas, so would read the requirement of the standard as mandating at least some monitoring (and associated definition of acceptable limits), with the risk assessment part used to determine frequency, scope etc.

The Guide to Changes could be read as implying that part of the intent of the addition of these new clauses is to force monitoring for these types of area, such that one can't risk-assess oneself out of it.



#5 McForman

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Posted 28 May 2019 - 05:02 PM

I am also from a  bean elevator - receive beans from farmers, mill to remove FM, and ship in railcars/totes/bags, and we don't have any ready- to -eat- product, it is shipped to the next customer/processor to be repackaged (washed) or canned (cooked). I was also going to do a RA with the same information as above, So Thanks for posting the question CVBC, because were are we going to find acceptable limits, FSMA allows for us to place a Disclosure statement for next manufacturing/processing facility for microorganims of public heath significance.



#6 CVBC

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Posted 28 May 2019 - 06:42 PM

Our company produce teabags and it is also a low risk manufacturing facility. We have weekly SEM (on machine) and PEM(on floor) and testing for yeast and mold, Salmonella and Listeria respectively. 

 

How do you sanitized if Salmonella or Listeria is found?   I don't want to introduce water into our process, since that brings its own problems.

 

Thank you for your help.



#7 CVBC

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Posted 28 May 2019 - 06:44 PM

 

I am also from a  bean elevator - receive beans from farmers, mill to remove FM, and ship in railcars/totes/bags, and we don't have any ready- to -eat- product, it is shipped to the next customer/processor to be repackaged (washed) or canned (cooked). I was also going to do a RA with the same information as above, So Thanks for posting the question CVBC, because were are we going to find acceptable limits, FSMA allows for us to place a Disclosure statement for next manufacturing/processing facility for microorganims of public heath significance.

 

 

Yes you are doing the same process as us.   So are you going to use a Disclosure statement instead of environmental monitoring?  Are you certified under BRC?

 

Thank you for your help.



#8 McForman

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Posted 28 May 2019 - 07:00 PM

Yes, I am certified under BRC and I have been working on the updates, I was going to do a RA like you to get out of this, but according to your post it didn't fly, I read the the interpretation guide also which does say."Sites are not expected to 'opt out' of this requirement by determining they are a low-risk product or environment." But the wording at the very being,"At a minimum, these shall include all production areas with open and ready-to eat products." Which brings us back to the fact we don't have RTE products so why can't we RA to 'opt out', So I am hoping your post gives us some help, because this is going to be crazy to perform in a dry clean environment if you ask me.



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#9 Charles.C

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Posted 29 May 2019 - 02:13 AM

@ CVBC

 

Maybe you would now like to respond to my initial query in Post 3 ?

 

Perhaps you just didn't query the auditor's NC ?

 

IIRC, BRC do offer a contact link on their website to "welcome"  such foundational questions ?

 

PS - Maybe the BRC text was a typo and shd have been << open and/or RTE Products >>?

 

How about the I.Guidelines ?? (= "Guide to Changes"/Post4?)


Kind Regards,

 

Charles.C


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#10 pHruit

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Posted 29 May 2019 - 08:29 AM

 

IIRC, BRC do offer a contact link on their website to "welcome"  such foundational questions ?

 

 

Possibly also worth trying the "Discussion" section of BRC Participate - BRC technical people do seem to pop in from time to time, and you'll also potentially get further input from those who've been through the audit for Issue 8.



#11 McForman

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Posted 29 May 2019 - 02:17 PM

Okay, I posted your original question to the BRC Patricipate along with my FSMA statement, lets see if someone reply's :)



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#12 CVBC

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Posted 29 May 2019 - 02:21 PM

@ CVBC

 

Maybe you would now like to respond to my initial query in Post 3 ?

 

Perhaps you just didn't query the auditor's NC ?

 

IIRC, BRC do offer a contact link on their website to "welcome"  such foundational questions ?

 

PS - Maybe the BRC text was a typo and shd have been << open and/or RTE Products >>?

 

How about the I.Guidelines ?? (= "Guide to Changes"/Post4?)

 

 

Sorry I hadn't responded to your initial query, I'm new posting a topic and am working on responding to them.



#13 CVBC

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Posted 29 May 2019 - 02:33 PM

from BRC8

 

As you say, a risk assessment is required.

 

Why did auditor not accept yr "No Need" RA conclusion ?

 

(My guess is that -

 

(1) yr product will potentially generate pathogenic, etc contamination from external environment to internal environment")

(2) ditto  Personnel.

(3) no micro. data to support adequacy of  cleaning

 

And, regardless of ptoviding satisfactory environmental micro.data,  ultimately, based on results from SQF's forum, BRC may, despite their "risk-based" comment, simply adhere to the red "shalls" above.

 

Theoretically, the target organisms could be an encyclopedia. I suggest you check the BRC Interpretation Guidelines.

 

The auditor did not accept my "No Need" RA because of the word "shall" in the BRC 8.  He said since it said "Shall" we are not able to RA our way out of it.   Even though he disregarding the second sentence of "at a minimum, these shall include all production areas with open and ready-to-eat products"    We do NOT have a ready-to-eat product. It also has a low water activity that does not support microbiological growth.

 

I'm checking on the BRC Interpretation Guidelines.   Also I've heard from other facilities in our industry and they were able to satisfy their auditor with a RA.  



#14 CarinaC

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Posted 29 May 2019 - 03:27 PM

How do you sanitized if Salmonella or Listeria is found?   I don't want to introduce water into our process, since that brings its own problems.

 

Thank you for your help.

Yes, we use Oxonia Active to sanitize when there is a positive finding.



#15 Charles.C

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Posted 29 May 2019 - 08:51 PM

The auditor did not accept my "No Need" RA because of the word "shall" in the BRC 8.  He said since it said "Shall" we are not able to RA our way out of it.   Even though he disregarding the second sentence of "at a minimum, these shall include all production areas with open and ready-to-eat products"    We do NOT have a ready-to-eat product. It also has a low water activity that does not support microbiological growth.

 

I'm checking on the BRC Interpretation Guidelines.   Also I've heard from other facilities in our industry and they were able to satisfy their auditor with a RA.  

 

Hi CVBC,

 

Thks for response.

 

TBH the text quoted above in Post 3 seemed fairly explicit to myself other than perhaps the end phrase.

 

JFI, BRC8 contains -

 

48 should

902 (!) shall

64 must.

 

A lot of semantics.

 

The difference in meaning (if any) between "shall" and "must" appears to be (legally) "contentious", eg, do both imply = "mandatory" ?

 

Existence of a "shall" is the typical auditor defense for "mandatory" although I anticipate that exceptions are known.

 

As  already commented the phrase " ...........open and RTE products" seems to me slightly ambiguous.

 

Any BRC comments (eg in I.G./Participate) will of course be interesting however  afaik, in theory, only the text of the Code itself is directly auditable.


Kind Regards,

 

Charles.C


#16 McForman

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Posted 30 May 2019 - 11:52 AM

Charles. C

 That's just it, in one comment you said maybe BRC has a typo

-PS - Maybe the BRC text was a typo and shd have been << open and/or RTE Products >>?

and then you just said

-Any BRC comments (eg in I.G./Participate) will of course be interesting however  afaik, in theory, only the text of the Code itself is directly auditable.

I had an auditor this year that used the text of the code down to every word so again it says RTE if its a typo then BRC should send out a letter or something for the typo if that is the case.

 

Best Regards



#17 McForman

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Posted 10 June 2019 - 01:18 PM

Hello, 

 

Just had our 2019 Audit and received a minor on 4.11.8 because we did not do any environmental monitoring.   I had a RA that explained since we have low risk, low water activity product, and do dry cleaning, we do not need to do environmental monitoring.   (We're a bean elevator - receive beans from farmers, mill to remove FM, and ship in railcars/totes/bags)

 

Any suggestions on how to do a environmental monitoring program for a product/situation like ours?

 

Thank you for the help

I heard back from BRCS and they weren't very helpful just repeated the Interpretation Guideline back to me, but did say there isn't a typo but it is to read like, " open products and all sites with RTE products should have an environmental monitoring programme in place." So I have contacted NSF to see if there is any training for Environmental Monitoring.

Best Regards



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#18 pHruit

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Posted 10 June 2019 - 02:23 PM

Hmm, interesting - roughly: "there is no typo, it says exactly what it's supposed to say, except if you read it wrong, in which case it says exactly what it says but that's different to what we mean, which is what we wrote, and that would be clear to everyone if they could read what we wrote instead of what we wrote"  :ejut:

Nonetheless the gist does seem to be that anyone with open product is expected to do some environmental monitoring irrespective of whether they're RTE.



#19 Ivy101

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Posted 05 July 2019 - 12:11 AM

How do you sanitized if Salmonella or Listeria is found?   I don't want to introduce water into our process, since that brings its own problems.

 

Thank you for your help.

 

There are available alcohol-based/volatile sanitizers. You may query from your chemical supplier.






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