10 replies to this topic

[JTQualityControl]

I am the SQF Practitioner at my facility. My question pertains to an environmental monitoring program (EMP).

 

We just went thru our SQF Audit in mid May. We do not have an EMP so we received a minor non-conformance for this.

 

I am working on our corrective actions and have received resistance from the Plant Manager. I have a good deal of experience with EMPs so would like to just implement one and be done with my corrective action.

 

The plant manager does not feel like we are in need of an EMP due to the low pH of our product (liquid drink bases and a small amount of dry powder drink bases). He has asked me to find a risk assessment tool that will show we are not in need of an EMP and submit that as my corrective action.

 

Does anyone either have a risk assessment tool that would be helpful and show what he is looking for or just feed back on this? I am new at this company (was hired only a couple weeks before the audit) and do not feel as though I have the strength to come into conflict with the plant manager on this topic.

 

Thanks in advance. 

[Scampi]

We run low pH finished shelf stable products and DO NOT have an EMP. I will also add that we are farm to fork, so I am not about to swab for listeria, as I would expect a hit (naturally occurring, but killed during processing)

 

For me, running an EMP does not make any sense. If my process is in deviation, product has to be reworked, if my process is not in deviation, the schedule process we follow, plus low pH does not allow the survival of any pathogens.

 

https://www.research...risk_assessment

 

https://mcgeepharma....ring-programme/

 

https://www.slidesha...ntal-monitoring

 

My advice, don't over think....if you know the pathogens CANNOT survive in your finished product, then ask yourself, where is the risk?  Do you have a hold and release program for finished goods to ensure parameters are met prior to shipping?  (our products stays in warehouse until 30 pH is completed)

 

I would also add, since your new to this job, review all CCP records for the last 12 months to verify if and when product was in deviation and add that to your risk assessment

[Charles.C]

My advice, don't over think....if you know the pathogens CANNOT survive in your finished product, then ask yourself, where is the risk?  Do you have a hold and release program for finished goods to ensure parameters are met prior to shipping?  (our products stays in warehouse until 30 pH is completed)

 

 

Hi Scampi,

 

It depends on what the Code (or auditor?) says of course but if EMP  is requested, the least confontational route might be to use a matrix as you have posted elsewhere to simply demonstrate lack of need for EMP monitoring.

 

I recall SQF have previously had internal debates over how their auditors should interpret certain topics in SQF's published Code. This may be going to be another one.

 

I also remember that for various commodities FDA do not expect monitoring for Listeria in some raw stages of a cooking process due same logic as yr post.

[Gerard H.]

Dear JT,

 

Don't underestimate the auditor. And second, you have to check the code (certification norm + interpretations), as advised here above.

 

Kind regards,

 

Gerard Heerkens

[Scampi]

Absolutely Charles, but I do not agree with "satisfying the auditor to pass an audit" when the request is either A) outside the code or B) no scientific basis, and IMEX NO ONE benefits from always taking the least confrontational route (expense, lack of actual knowledge to push for something out side of the box/code)  The auditors we have had here have not had near enough experience or good auditing practices to actually make an assessment (I will add that I am extremely jaded by the auditing process....infer what you will)

 

The SQF code specifically says "risk based" EMP......an auditor worth their salt should look at the assessment and then can either agree to disagree. If you know your process inside and out, have spent time understanding how pathogens behave etc then the risk assessment should be adequate, no matter the outcome

[Charles.C]

Absolutely Charles, but I do not agree with "satisfying the auditor to pass an audit" when the request is either A) outside the code or B) no scientific basis, and IMEX NO ONE benefits from always taking the least confrontational route (expense, lack of actual knowledge to push for something out side of the box/code)  The auditors we have had here have not had near enough experience or good auditing practices to actually make an assessment (I will add that I am extremely jaded by the auditing process....infer what you will)

 

The SQF code specifically says "risk based" EMP......an auditor worth their salt should look at the assessment and then can either agree to disagree. If you know your process inside and out, have spent time understanding how pathogens behave etc then the risk assessment should be adequate, no matter the outcome

 

Hi Scampi,

 

I daresay the auditors are also a bit confused over the changes SQF have made regarding this EMP topic. Memories of "Validation".

 

Also see my (revised after some detailed Guidance reading) comments here -

 

http://www.ifsqn.com...e-2#entry126586

[SQFconsultant]

I agree with Charles, the Auditors (having been one of the first SQF auditors in the US) got a wallop of new stuff in 8.0 and are having to deal with these new things, changes, etc. Sometimes in practice what and how something is written does not always work out too well when actually applied at the facility.

 

I agree with running a risk assessment to determine whether or not you need an EMP, but I would not submit that as your corrective action.

 

If you find that you do not require an EMP after doing your risk assessment you should contact the CB directly and based on a submission to them of  your risk assessment you should request a written exemption for this code and request the CA be taken off the list and the point added back on.

 

Otherwise you get to go thru this again at next years audit.

 

There are not too many exemptions granted under SQF - this however is one of the ones that is.

[dfwdilemma]

Does the facility itself have a history? I am a big fan of having EMP just to validate your sanitation practices. Maybe you do this already and refer to it as something else? 

[Scampi]

An EMP to validate cleaning is not the same as an EMP for PATHOGENS present in the facility

 

BTW, my CB has decided not to grant me an exemption...........even though at last audit my risk assessment showing 1 was needed was sufficient................i am so frustrated and angry at the moment

 

The "technical manager" sent me a link for pathogens in MADE AT HOME refrigerated acidified foods and called that justification for his stance (uneducated fool)  I have the companies trainer on tape saying my product would be grounds for an exemption and my TM still said NO!!!!!!  

 

Scientifically, my FG cannot support the growth/life of the top 3 pathogens...........plus there's no contact with surfaces (everything done by hand) GRRRRRRRRRRRRRRRR

[Charles.C]

An EMP to validate cleaning is not the same as an EMP for PATHOGENS present in the facility

 

BTW, my CB has decided not to grant me an exemption...........even though at last audit my risk assessment showing 1 was needed was sufficient................i am so frustrated and angry at the moment

 

The "technical manager" sent me a link for pathogens in MADE AT HOME refrigerated acidified foods and called that justification for his stance (uneducated fool)  I have the companies trainer on tape saying my product would be grounds for an exemption and my TM still said NO!!!!!!  

 

Scientifically, my FG cannot support the growth/life of the top 3 pathogens...........plus there's no contact with surfaces (everything done by hand) GRRRRRRRRRRRRRRRR

 

Hi Scampi,

 

My sympathies and appreciation of yr selected thread.

 

I wonder if you may have collided with an (unpublicised) Policy Decision.

 

Would be interesting to see some SQF Exemption Statistics.

[Scampi]

It would be really nice if all of the GFSI's released statistics...........I find the general lack of transparency appalling and all of the "hidden" requirements frustrating to say the least!

 

 

I have filed a formal complaint in this matter..............I shall post the result!