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SQF 2.5.4.2, nonconformance for not validating environmental testing


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#1 hbrannan

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Posted 18 June 2019 - 12:34 PM

I am in need of some advice this morning.  We are a very low risk facility (dry environment producing injected molded cups/containers using Polypropylene, LDPE and Styrene resins).  We have an environmental monitoring program in place that passed our initial certification audit with no trouble.  We test for Enterobacteriacea using the Microsnap EB detector and enrichment devices, and have seen very low to negative results (well within passing range) on all surfaces we've tested.  We began swabbing monthly, then quarterly, then every 6 months based on the results of testing.

 

We just completed our first re-certification audit for SQF, Ed. 8 for Modules 2 and 13 (Manufacture of Food Packaging) and we have received a non-conformance for Clause 2.5.4.2 (Product Sampling, Inspection & Analysis).  

Specifically, the clause states: 2.5.4.2 On-site personnel that conduct testing of finished product shall participate in an applicable proficiency testing program at least annually to ensure accuracy of results.

 

The non-conformance we received states: The site has not checked the environmental results conducted in-house against an outside testing authority.

 

In a nutshell, the auditor had no problem with our program, frequency or methods of testing.  What he gave this non conformance for was that we didn't test our EMP results against a 3rd party authority.  My thoughts are this:

  • I don't see in the code anywhere in the Environmental Monitoring section where we need to verify/validate our test results with an outside party - this is a non-mandatory element anyway (and I realize this is currently somewhat hotly contested/discussed)
  • The non-conformance we received goes against clause 2.5.4.2 which does not relate to Environmental Testing in our process (visual inspections, tape tests, rub tests are performed, but no swabbing necessary, passive release is approved and all operators are given a proficiency/performance review annually).  

I perform the swabs/testing and what the auditor seemed to take issue with was that although I had done somewhat extensive research, and have on file very comprehensive instructions from Hygiena on how to use/calibrate the testing device(s), there was no outside verification that I was doing this correctly.

 

Would this be something that I should contest (we only received one other minor non-conformance unrelated to this topic)? And if so, who would be the best person to go to - the auditor, CB, SQFI?

 

And if I should accept this non-conformance and decide to move forward with finding an outside authority to verify our test results, what would be my best option?



#2 SQFconsultant

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Posted 18 June 2019 - 01:21 PM

We just assisted a company in contesting a certification withdrawel - so we understand the steps for contesting.

 

If you feel certain  - to contest - put everything in writing (letter form), your evidence as to what you do, how you do things, your backup evidence including your certifications for proficiency testing program (such as a2la, etc) and submit that formally to the CB with a copy to SQFI - making the CB aware that you are also sending a copy to SQFI, call SQFI for name of the person to send it to, this changes.

 

Looks like a miss-call.

 

However, you better back up this part -- the proficiency testing program, if you don't have this, the gig can be re-written to address it.

 

 

Be sure to stay on task and not add any fluff to your protest such as having done extensive research, etc, it's just un needed extra stuff.


Kind regards,

 

Glenn Oster
 
 
GOC GROUP / +1.800.793.7042 / Food - Food Packaging - Food Storage/DC

SQF, BRC & IFS System Development, Implementation & Certification Consultants

Serving Small-to-Mid-Size Businesses | International Cross-Border C-CUR Acceptance

Internal Auditor Training | eConsultant | SQF, BRC & IFS Pre-Development or Pre-Audit GAP

http://www.GlennOsterConsulting.com  -- 

 

 

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#3 hbrannan

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Posted 18 June 2019 - 03:30 PM

SQFconsultant, thank you for that bit of advice.  I think that we may go ahead and just take the non-conformance, as having it on record does not endanger us for a potential withdrawal of our certificate, nor does it drop us into the next lowest level (Good, vs Excellent).  I would hate to open a can of worms...

 

Having said that, what would you recommend for a method of having our results verified?  



#4 sqflady

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Posted 25 June 2019 - 05:59 PM

Hi hbrannan,

We just completed out annual proficiency testing here.  We do coliform swabs in-house.  I have our main swabber and the back-up person each take duplicate swabs.  One set of swabs is read in-house and the other set of swabs is sent out to a 3rd party lab.  As long as the results match up, you are good to go.  We have never had a problem with this approach.  



#5 MsMars

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Posted 25 June 2019 - 06:31 PM

Sounds to me you had an excellent audit and the auditor was grasping at straws. Although I agree that you could contest if you wanted to, I would recommend outside lab validation of in-house testing, especially if your testing involves ELISA, lateral flow, or other quick assay methods.  It doesn't have to be complicated - split a few samples and send to an outside laboratory to see how close results are to your in-house method.   


Edited by MsMars, 25 June 2019 - 06:33 PM.


#6 hbrannan

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Posted 27 June 2019 - 01:24 PM

Thank you everyone!  I appreciate the help and advice.  I did research some available outside labs and found one that would fit our needs, so I hope to have this completed within the next week or so.

 

This is why I joined this forum, everyone on here is so helpful and knowledgeable it's great to have somewhere to go to bounce ideas around.  :silly:






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