Environmental Monitoring Risk Assessment

Hi all,

I work at a dairy plant and I was curious about Environmental Monitoring risk assessments. We had an SQF auditor a few months ago that said we should provide more documentation to prove that we are doing a thorough job monitoring for pathogens (mostly Listeria spp. but also Salmonella once a year). 

Using the US Dairy guidance for L mono control authored by the Innovation Center for US Dairy and the FDA's guidance for Listeria control, I wrote a risk assessment based on the intrinsic properties of the products we produce, however this doesn't take into account facility design, traffic flow, or processes. 

I'm curious what the industry standard is for designing a risk assessment. Is it ok if I type up a document and just write a few paragraphs for each of the above criteria and explain how it elevates or decreases risk? What does a EM risk assessment look like? Should it be formatted like a HARPC risk analysis/ food defense vulnerability assessment?

Also, I'd like some thoughts on if an EMP hasn't detected any Listeria spp. positives in about 5 years. I read in the FDA guidance that you should increase number of swabs in this case or choose new locations to test. What if you already rotate swab locations to eventually swab everything in the -plant and you still find nothing? Is this evidence that your sanitation program is highly effective or that your EMP is inadequate?

Sorry for the long post, I appreciate any feedback people are willing to give.

Hi Colby,

Your risk assessment may be as simple as prioritising areas where products are open post pastuerisation and then identify key parts of equipment in that area and the environment itself. You are looking to ensure the number and location of sampling sites demonstrate your current preventive controls are effective. See attached example.

Environmental Monitoring Priorities.pdf   868.45KB   652 downloads

Kind regards,

Tony

Hi all,

 

I work at a dairy plant and I was curious about Environmental Monitoring risk assessments. We had an SQF auditor a few months ago that said we should provide more documentation to prove that we are doing a thorough job monitoring for pathogens (mostly Listeria spp. but also Salmonella once a year). 

 

...

I'm not sure what your current frequencies and level of documentation are but this might fall into the mysterious zone where a string of glowing reports becomes suspicious looking and gets used as an excuse to perform a swab-a-thon to "find the truth" by a regulator.

There is really no standard way of doing the risk assessment.  Most would say that using the 4 zone system is a form of risk assessment.   

I have attached a risk assessment that I have used.   The jist is that every surface, parts of equipment, area, etc  is evaluated.   In this case the risk assessment is by zone and post vs pre lethality.   Some people - maybe most don't swab pre-lethality.   I personally think there is some value in it.   

Another way I have seen the risk assessment done is by zone and difficulty to clean.   It would follow a similar rubric as the HACCP severity and likelihood.    Using this method, a hard to clean zone 1 would be the highest risk and an easy to clean zone 4 area would be the least  risk.   It is described in more detail in the document below. 

https://multimedia.3...ng-handbook.pdf

It SOUNDS like they were a little uncomfortable with the amount of samples taken (you/they used the term though).   Not some much and issue with the RA.   

Hi all,

 

I work at a dairy plant and I was curious about Environmental Monitoring risk assessments. We had an SQF auditor a few months ago that said we should provide more documentation to prove that we are doing a thorough job monitoring for pathogens (mostly Listeria spp. but also Salmonella once a year). 

Hi CH,

Tiny nitpick - "Listeria spp" is not a pathogen whereas Salmonella spp is, although afaik this terminological style is not in common usage.

A concise explanation of the Logic of using Zoning as an Environmental  Risk Assessment tool is available here (eg Pages 1-8) -

Guide to Environmental Micro. Testing.pdf   214.26KB   329 downloads

Some examples of EMPG Zoning Risk assessments for various Process Scenarios are compiled in this attached excel -

EMPG zone testing examples.xlsx   3.45MB   415 downloads

(For Dairy example, see sheet env6)

A usefully (practical)  detailed (2012) Canadian document regarding control of L.monocytogenes in meat processing is here -

meat EMPG for L.mono.pdf   645.22KB   146 downloads

(But note the enormous [ie near impossible for in-house lab] number of samples involved, currently, nicely logical schemes with far less samples are on, IIRC, Health Canada's website).

A Kraft EMPG for Dairy Suppliers is here -

Zoning Requirements fo rDairy Suppliers.pdf   1.07MB   216 downloads

PS -  the reference linked in Post 2 is also excellent.

PPS - Based on previous threads here, FDA seem to routinely take an exceedingly high number of samples also.

There is really no standard way of doing the risk assessment.  Most would say that using the 4 zone system is a form of risk assessment.   

 

I have attached a risk assessment that I have used.   The jist is that every surface, parts of equipment, area, etc  is evaluated.   In this case the risk assessment is by zone and post vs pre lethality.   Some people - maybe most don't swab pre-lethality.   I personally think there is some value in it.   

 

Another way I have seen the risk assessment done is by zone and difficulty to clean.   It would follow a similar rubric as the HACCP severity and likelihood.    Using this method, a hard to clean zone 1 would be the highest risk and an easy to clean zone 4 area would be the least  risk.   It is described in more detail in the document below. 

 

https://multimedia.3...ng-handbook.pdf

 

It SOUNDS like they were a little uncomfortable with the amount of samples taken (you/they used the term though).   Not some much and issue with the RA.   

Thanks for the link and sampling summary kingstudruler1,

I am wondering why there is so much raw sampling?

Kind regards,

Tony

Hi,

We are packaging manufacturer certified under BRC.

We already do risk assessment on the environmental monitoring risk assessment, which the outcome from the risk assessment is conducting ATP swab test.

However, our auditor mention that the program not enough and there was no risk assessment conducted for air monitoring.

May i know, do we need to do separate risk assessment?

If yes, is there any example or guidelines?

Thank you.