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Environmental Monitoring Risk Assessment

Environmental Monitoring

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#1 Brendar1

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Posted 12 June 2019 - 09:25 PM

Hello,

Does anyone have an example of an environmental risk assessment that they wouldn't mind sharing?   SQF element 2.4.8.1 calls for a risk based environmental monitoring program however we do not have an initial risk assessment on file and I inherited the established program from the prior Quality Manager without evidence of why it was set up as it is.  Thank you very much!



#2 Sweet'n'low

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Posted 13 June 2019 - 08:28 PM

Brendar1, 

 

As a plastics packaging manufacturer, our risk assessment for 2.4.8.1 was resolved as this: 

 

"Rationale for Resolution:

 

1. The SQF code states a risk-based program be established. Since we have not experienced any issues with customer complaints or withdrawals/recalls associated with any applicable pathogen, we believe the risk for our product is low.

 

2. The SQF code states the monitoring program should be in place for known or expected concerns. We do not have any known or expected concerns. (see rationale #1).

 

 

3. Research into the amount of time a pathogen (i.e. viruses or bacteria) can live on a hard (plastic) surface:

            www.nhs.uk - The viruses can sometimes survive on indoor surfaces for more than 7 days. In general, viruses survive for longer on non-porous (water resistant) surfaces, such as stainless steel and plastics, than porous surfaces, such as fabrics and tissues. Although cold viruses have been shown to survive on surfaces for several days, their ability to cause an infection reduces rapidly and they don't often survive longer than 24 hours.

Therefore, the risk of a pathogen on our product to survive is minimal. If our raw material was to have pathogens, the heating process we use to form the material would likely kill the pathogen.

 

4. Our previous APC testing results demonstrated the highest number CFU’s found on our finished product was 100, with most tests reading at 10 or less.

 

5. The introduction of a pathogen to our products would likely occur by an infected employee contacting our parts. With all our above referenced prerequisite programs in place, previous APC test results, and the training we provide to our employees, we feel the risk for finding a pathogen on our product to be quite low. "

 

In the past the previous SQF Pracitioner had conducted APC testing and found nothing in regards to pathogens. There were never any customer complaints either. 

 

However, recently our auditor had mentioned to us that it would only be of benefit and further validate our risk assessment if we did some lab testing once a year. 

 

Currently I am about to gather some quotes from labs in the area and choose to which is the best fit for our product. 

 

Let me know if you have any questions pertaining to this topic and I'll do my best to answer. 

 

Best Regards,

 

Kiri 



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#3 lisahpw

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Posted 14 June 2019 - 06:00 AM

This is what we used.... It was accepted in our SQF V* audit last year. It may be of help  We are a winery so risk is low and we do not need to swab.

 

 

Attached Files


Edited by lisahpw, 14 June 2019 - 06:01 AM.


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#4 Charles.C

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Posted 14 June 2019 - 08:26 AM

This is what the Guidance for SQF8 Manufacturing states -

 

What does it mean?
An environmental monitoring program must be in place for food processes that are handled, exposed,
stored, processed or packed. This program should be included for food processes of all risk levels.  This
element outlines the specific conditions required in areas where foods are processed or handled. Conditions
like these may contain pathogenic microorganisms and will support the formation of toxins or growth of
pathogenic microorganisms, and has a likelihood of growth causing illness or injury to a consumer if not
properly produced, processed, distributed and/or prepared for consumption.  It may also apply to a food
that is deemed high risk by a customer, declared a risk by the relevant food regulation or has caused a
major foodborne illness outbreak (refer SQF Code, Appendix 2: Glossary).

What do I have to do?
The  process  flow  is  particularly  relevant  for  high  risk  processes  where  the  product  is  subject  to  handling  or
exposure  after  a “kill-step.”  This  includes  (refer  to  11.7.1) segregation of  the post-process end from  the raw
material end of the process; controlling pedestrian walkways to avoid personnel contamination; dedicated tools
and  equipment  post-process;  dedicated  staff  servicing  the  post-process  end;  and  dedicated  uniforms  for  staff
working post-process.
The  reference  to  the  environmental  monitoring  program  is  self-explanatory,  but  is  worth  repeating  as  it  is
considered mandatory for areas in which high risk food is processed, handled or exposed.  Failure to have an
effective environmental monitoring program will result in a major non-conformance.

An environmental monitoring program (EMP) is a program which includes pathogen swabbing to detect risk in the
sanitary  conditions  of  the  processing  environment  and  is  a  verification  of  the  effectiveness  of  the  pathogen
controls that a management site has in place for high risk foods (refer Appendix 2: Glossary of Terms).
Swabbing must include not only the smooth, accessible parts of the process, but also the transfer points,
bearings, etc., where product is likely to build up.

 

 

To my understanding, "risk-based" refers to the sampling/analysisng procedure (eg zoning) used in the monitoring function of EMP, ie not to the estimated intrinsic, so-called, risk "status" of the product. (the Guidance confusingly [IMO] mixes the 2 terminologies together).

 

To my understanding (eg "red" above), the Guidance  requires an EMP to be implemented regardless of the product's "risk" status.

 

One thread here reported that their auditor essentially "matched" the Guidance by insisting that the presence of multiple "shall" words in the Code necessitated implementing an EMP. Period.

 

Other auditors (eg Posts 2,3) seem to be ignoring the Guidance + "shall'  and interpreting "risk" as referenced to the Product's risk status.

 

As per my above opinion I found the content of Posts 2,3 incomplete however the appropriate SQF auditors obviously thought otherwise.

 

IMO the audit for clause 2.4.8  has currently become somewhat of a "Lottery".

 

PS - to illustrate an alternative interpretation, consider this extract -

 

Determination of Need for PEMP

Not every food manufacturing facility needs to have a PEMP. More testing does not necessarily equal more safety. Rather, the judicious use of food safety resources requires interventions and verifications to be targeted to the most appropriate areas for the greatest risk reduction. A thorough risk evaluation should be conducted to lead the food safety team to a determination of whether or not a PEMP is necessary, which organism or indicator group to monitor, and the degree of stringency of the PEMP. Any type of sampling and testing has the potential for “false” results. This is especially true for microbial testing. Therefore, if a product or process can be designed that precludes the need for a PEMP; this option should be carefully balanced with other considerations such as product safety and quality, consumer acceptance, regulatory requirements, and production expense. An example of a process change that could eliminate the need for a PEMP is to eliminate product exposure to the plant environment (hot filling or aseptic filling versus cold or ambient temperature filling) or pasteurization of the product in its final package. Another example is the reformulation of a product or changing distribution from refrigerated to frozen to prevent the growth of L. monocytogenes.

Risk Evaluation

The next component is a complete evaluation of the science-based food safety risk. We have designed a simple decision tree that can be used as a first step to aid in this risk evaluation. This decision tree has been used for hundreds of products in numerous production facilities and has been found to work well for most products/processes. However, it is meant to be used as a tool to assist in completing the risk evaluation and not used to replace a complete evaluation.

https://www.foodqual...toring-program/

(A rather ingenious-looking, generic, decision tree is included in the sub-link)(the tree was possibly designed to attempt to match FSMA's more specific "risk" requirements)


Edited by Charles.C, 14 June 2019 - 08:52 AM.
expanded

Kind Regards,

 

Charles.C


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#5 Hoosiersmoker

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Posted 18 June 2019 - 01:28 PM

This is the one we modified for our purposes. What do you manufacture, if I might ask?

Attached Files


Edited by Hoosiersmoker, 18 June 2019 - 01:28 PM.


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#6 Brendar1

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Posted 18 June 2019 - 02:41 PM

Hi,

Thank you for your replying!  We manufacture frozen bread dough- breads, buns and sweet breads (cinnamon rolls).  I appreciate your assistance!







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