Risk Assessment to exclude Environmental Monitoring Program (EMP)

Hello Folks, can someone provide me with guidance on how to conduct a risk assessment to be able to exclude the Environmental Monitoring Program from my documentation, Thanks!

I'm unfamiliar with exclusions in SQF Packaging, but I would think that you would need to at least do a few rounds of environmental testing to prove that you are not a source of micro contamination before you can risk-assess it out if you are manufacturing food-contact packaging.

YOu could try googling the survival of pathogens on your finished goods........you may luck out and find reams and reams of data that proves product X cannot support the growth of pathogen Y

Well in my pre-assessment my auditor just told me in the report to do a risk assessment, she never mentions to do a few rounds of environmental testing, we low risk and we don't handle food. so I think a risk assessment could be fine. Let's see where folk's inputs goes!

Well in my pre-assessment my auditor just told me in the report to do a risk assessment, she never mentions to do a few rounds of environmental testing, we low risk and we don't handle food. so I think a risk assessment could be fine. Let's see where folk's inputs goes!

I feel like that is a typical canned answer from an auditor... :) I would first try Scampi's suggestion, followed by an on-site study of your environmental pathogens if needed.  You need validation (a.k.a. data or other study) to support that your product would not transmit environmental pathogens to the food product it is intended to package in order to qualify for exclusion.

My company produces food packaging and does not handle food. I went ahead and did the environmental monitoring testing. My thought process was that we occasionally have roof leaks and also employees can bring pathogens into the plant on their feet.  I conducted swabbing in "zones". We did end up having a finding in zone 4 (salmonella). The samples was taken from an entry way floor and edge of a rug.  Come to find out, the rug had not been changed in years and was not in our normal rug cleaning rotation. The rug was changed and the floor was cleaned. We re-tested and had a negative result.  Our environmental monitoring program is going to test quarterly. I also wrote a risk assessment and corrective action for the positive result. 

Hello Folks, can someone provide me with guidance on how to conduct a risk assessment to be able to exclude the Environmental Monitoring Program from my documentation, Thanks!

Hi jean,

It may depend on yr Process/Environment ??

Based on previous packaging threads, I suspect that currently sqf auditors are themselves unsure as to the response to yr OP.

Scampi previously posted a hopefully definitive answer to yr query for food and the packaging text is very similar.

This also apparently involves mandatory/non-mandatory clauses just to blur the issue.

I suggest you compare yr process to those in the 3-4 other sqf packaging threads here.

Alternatively, we can all raise our voices and push hard back on SQFI to have this clause amended to reflect clear requirements. For some of us there is either zero risk or zero net gain for the $$$

Alternatively, we can all raise our voices and push hard back on SQFI to have this clause amended to reflect clear requirements. For some of us there is either zero risk or zero net gain for the $$$

Hi Scampi,

Plus - I know it's free but  where is the Guidance Material ?

Very Low Risk so equally Low Urgency ? Or indecision ?

Hi, Jeanc.

This is what I would consider.

1. Is my product can easily be contaminated from my environment and can it support the growth during manufacture and/or its shelf life.
2. Who is my target consumer or my customer's consumer.
3. What is my cleaning scheme.
4. Am i open processing or closed processing. Is there addition in the process after the kill step.
5. After the risks were assessed, what is my layout and barriers.

Hi Jean, 

Need to have environmental monitoring at intervals as scheduled based on risk criteria. 

Its good to know and ensure the environment safe for food packaging storage and transportation.

Once confirmed its safe and with in the limits based on the systems in the factory, further in future you have sigh of relief. 

Though its packaging material end product for you and may be its primary packaging raw material for other company.

Here is the guidance for food manufacturing.....while I understand it's not packaging.....if it works for FOOD then by nature, should also work for food contact packaging

https://www.sqfi.com...-with-cover.pdf

The SQFI website got an update yesterday, but alas, still no guidance for packaging and I cannot even get the code section to load so I cannot have a good look at the language used

However, this is where some of the confusion stems from 

"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.Which is not quite TRUE, the actual requirement is for a RISK ASSESSMENT that covers all possible entry and contamination points. If you perform this portion well and come up with a negligible risk, then I don't understand why you would even perform baseline sampling---particularly in something like plastic extrusion or glass containers.

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.

Here's some research into packaging and pathogens

https://www.ncbi.nlm...les/PMC5743701/

https://www.ncbi.nlm...les/PMC4695511/

https://www.agricult...5_2014-CJFS.pdf

https://www.research...aging_and_board

http://jfoodprotecti...?code=FOPR-site

So, like any other process, you really need to understand WHAT pathogens you should be concerned with and HOW likely they are to be present on your finished goods BEFORE you even start a risk assessment

SQFI explained to me that the reason this was changed for V8 was that they were seeing alot of really poorly composed risk assessments that were put together in a haphazard way of trying to eliminate swabbing............like the basic risk analysis for a HACCP plan, garbage in, garbage out. You have to be willing and able to be objective and impartial when performing a risk assessment.

The research above all relates to food contact paperboard only.........on a quick scan it seems MOLD is the #1 concern followed by Bacillus spores........so if you have reason to believe you've got bacillus in the plant, then your RA would tell you to swab for it............

 

 

SQFI explained to me that the reason this was changed for V8 was that they were seeing alot of really poorly composed risk assessments that were put together in a haphazard way of trying to eliminate swabbing............like the basic risk analysis for a HACCP plan, garbage in, garbage out. You have to be willing and able to be objective and impartial when performing a risk assessment.

 

 

Hi Scampi,

Did the source elaborate more specifically on the meaning of  "poorly" in that, IMO, rather nebulous opinion ?

I don't know what you think guys but with this rush, I have my final audit in December and I have to start creating the records, IMO, that is too much work for a minor NC.

P.S. we handle inorganic materials for food packaging, low risk, level 2 of certification. I don't think there is a must to swab here.

Charles, No unfortunately they didn't elaborate

I will give you my example however, to put it in context.....we produce high pH product heat treated in a glass jar with a vacuum seal.....my industry is fortunate enough to have a world class scientist who works independently on research only to prove log reductions based on pH and type of acid used; this is peer reviewed, published data. No wiggle room whatsoever..........it has even been proven that at our equilibrium pH we do not need a heat treatment and can achieve a 5-6 log reduction in 5 days at 10C.........and this research is directed SPECIFICALLY at e coli, listeria and salmonella; most often using the most acid resistant strains (worst case scenario)

SO my FG CANNOT support the even the survival of those pathogens..........and CFIA has even posted our type of product as 

So my risk assessment is very thorough.  The response? "I didn't take into consideration what if an employee brushed against the wall then touched your product" um hello I thought I just told you the reason

No, we also have a robust sanitation schedule...........but the EMP is designed to prevent FG from being contaminated

So you can see why I am so jaded about this whole thing......................my impression was that ACME making the same FG would have had an RA that just said "pathogens cannot survive our process".....so we are all being punished (those of us who ARE low/no risk) for the failings of the AUDITORS before us.

And let me be clear here, we are a regulated product at the moment, with random inspections by CFIA and this is not something they require..............so I do not understand why a 3rd party (who for all I know don't know what they are talking about) can tell me I'm wrong???  I met the standard and was basically told "you didn't do it correctly"

Scampi:

Would you do your RA based on the same steps/process of the HACCP plan?

So Jean, I would put a good RA together and forget the swabbing IF your RA deems it unnecessary, according to the code and SQFI only the RA is.....

 

"Environmental monitoring is not a mandatory requirement so exemption by a risk assessment is allowed.

 

Please let me know if you need further clarification or have additional questions.

 

All the best, LeAnn Chuboff"

Scampi:

I found in this thread "https://www.ifsqn.co...e-2#entry126586" a risk assessment that you posted. I'm doing something similar for my business if you have any updates that you are willing to share I'll be thankful. 

so they did try to give me an automatic major until I pulled out the guidance. Then i emailed Leann--------but still ended up with a minor on this which has left me scratching my head

They still insisted I revise my RA to include things like touching a wall and then touching the product (um like i showed you, pathogens cannot survive so ZERO risk)

I believe the issue is that the code is basically OK (i groan as I type that) but due to the shortage of "auditors" they are sending auditors with meat and only meat experience out to facilities that make toaster pastries (if you get what I mean)

A CFIA MEAT inspector cannot go to a greenhouse and inspect it...............but suddenly an auditor with zero experience can????  

So unless the auditor has MORE scientific information than I had regarding pathogens and my product...........my scientific research should have sufficed IMHO

Scampi:

did they say why specifically a wall? because they can touch forklifts, machine parts, pallets, tools, desk tools, water cups, I mean anything, they can even go to the mechanical shop and touch whatever they want, I don't see the point here, I don't want to put effort on something that they will be putting an NCR anyway. 

I'm already scratching my head

Scampi: Did you make any changes to the File that you share in the post? "https://www.ifsqn.co...-2#entry126586"

The only thing I added was if someone touched the wall then our raw product---pH and heat would deal with it

K pal thank you for all your help. I'll try my best, got my desktop audit in 2 weeks I will give you any updates from auditor if you want to.

Please do!  Best of Luck

I am just starting to set up my organization's SQF Program and visited one of our sister plants this week regarding how they're currently maintaining their program - They recieved two excellents in a row. I asked about EMP and the Quality Manager stated that they perform random micro tests on finished goods product to prove that all their programs are working, in addition, this is also how they validate. An operation risk management assessment is also completed for this process. They have not had their audit on Ed. 8 yet, but I'll reply to this thread sometime in December after their audit if this sufficed the EMP.