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Annual Allergen Cleaning Validation


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#1 YNA QA

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Posted 22 July 2020 - 06:12 PM

Every year since being SQF our facility has validated our allergen cleaning program by running our product with the highest concentration of allergens, cleaning the equipment per our SOP, and then running a non-allergen containing material and then sending that product out for allergen testing.  

 

Past auditors have accepted this method, and even this past auditor did, but with a caveat: he explained that this was no longer an accepted validation procedure and we would need to look at different procedures moving forward.  He referenced a white paper ( I cannot remember the name) that I read thoroughly, but I cannot seem to find what he is referencing.  

 

Is my method outdated? If it is in fact outdated, I want to move to something more inline with current best practices, I just don't know what they are.  

 

I'd love some advice/ help on if my methods are in fact outdated, and what I can do in place of our current method.

 

Thanks!!



#2 olenazh

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Posted 22 July 2020 - 06:34 PM

Wow, would be interesting to know as I've always thought that validation methods are totally prerogative of a company as soon as they're effective, am I right? 



#3 YNA QA

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Posted 22 July 2020 - 06:46 PM

Wow, would be interesting to know as I've always thought that validation methods are totally prerogative of a company as soon as they're effective, am I right? 

 

That is what I had assumed.  The whole idea of validating your process is just proving that it works.  If I run a product full of allergens, clean, and then the very first bag off my line for the next product is completely free of allergens, then to me my procedure works.  

 

We also swab after mid-shift full sanitation cleans with an allergen/protein swab.  He also said that method was outdated, and we needed allergen specific swabs. He mentioned that the CB we operated under didn't like protein swabs and found them to be less effective, and wanted to encourage all their plants to move to allergen specific.  It's just exhausting.  

 

I am just trying to avoid changing an entire program because an auditor has a preference/desired method that they are trying to push.  



#4 olenazh

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Posted 22 July 2020 - 06:48 PM

There's something wrong rather with the auditor than with you:) Auditor cannot mandate what you have to do or object your methods.



#5 alemv15

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Posted 22 July 2020 - 07:16 PM

I just had this problem 2 weeks ago. We've validated our sanitation program the same way, testing specific allergen and using ATP to make a standard acceptable ATP with allergen... we have a few plants and we all validate the same way for years. Our auditor said it wasn't validation that we should test specific allergens. I don't think it's necessary or economically convenient to do specific allergen testing.



#6 YNA QA

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Posted 22 July 2020 - 08:42 PM

I just had this problem 2 weeks ago. We've validated our sanitation program the same way, testing specific allergen and using ATP to make a standard acceptable ATP with allergen... we have a few plants and we all validate the same way for years. Our auditor said it wasn't validation that we should test specific allergens. I don't think it's necessary or economically convenient to do specific allergen testing.

My biggest frustration with auditing and the various auditors I've worked with, is that they can sometimes let their personal biases or preferences interweave way too much into their issuing of a non-conformance.  I want nothing more than to do my job properly and make the safest food possible, but if my methods meet or exceed the criteria and they just "prefer" another one, I don't think it's cause for updating an entire program.  

 

I wonder if at some point, they will work specific allergen testing into the codes.  It will get so pricey for companies.  



#7 alemv15

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Posted 22 July 2020 - 09:21 PM

My biggest frustration with auditing and the various auditors I've worked with, is that they can sometimes let their personal biases or preferences interweave way too much into their issuing of a non-conformance.  I want nothing more than to do my job properly and make the safest food possible, but if my methods meet or exceed the criteria and they just "prefer" another one, I don't think it's cause for updating an entire program.  

 

I wonder if at some point, they will work specific allergen testing into the codes.  It will get so pricey for companies.  

How can one deal with that? I agree but i find myself wanting to show them the code and ask why but then i dont want them to get mad and make it worst. 



#8 SQFconsultant

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Posted 23 July 2020 - 12:36 AM

Take this from where it comes - I was one of the first SQF Auditors in the states - I would never give a place I inspected a "white paper" - that was a terrible overstep by an Auditor - this is not acceptable and you really need to contact your CB and file a complaint.

 

It is unfortunate that some Auditors attempt to play god and end up jerking people around for nothing.

 

What you have been doing is fine.

 

In our work, unfortunately we see a lot of crap coming from some Auditors and please understand there are a lot of good Auditors out there and then there are some really bad ones, this could be one of those.


Kind regards,

 

Glenn Oster
 
 
Glenn Oster Consulting / 800.793.7042 / Serving Food & Food Related Businesses

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Serving Small to Mid-Sized Businesses in the United States & Centro America

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#9 Charles.C

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Posted 23 July 2020 - 06:08 AM

My biggest frustration with auditing and the various auditors I've worked with, is that they can sometimes let their personal biases or preferences interweave way too much into their issuing of a non-conformance.  I want nothing more than to do my job properly and make the safest food possible, but if my methods meet or exceed the criteria and they just "prefer" another one, I don't think it's cause for updating an entire program.  

 

I wonder if at some point, they will work specific allergen testing into the codes.  It will get so pricey for companies.  

You may need to read the SQF Guidance material.

 

There are 4 pages of, allergen specific, explanatory text.  Referenced numerous times on this Forum.


Kind Regards,

 

Charles.C


#10 YNA QA

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Posted 23 July 2020 - 12:51 PM

You may need to read the SQF Guidance material.

 

There are 4 pages of, allergen specific, explanatory text.  Referenced numerous times on this Forum.

I have read the SQF Guidance Material including the Allergen Appendix Part 1 and 2.  It does mention the ELISA test for validation, which is what our Allergen Testing Lab uses, which is why I was confused.  I even showed proof that they use ELISA allergen specific testing to validation the absence of allergens.  The document does quote "there may be other acceptable tests for validation methods that can be used but the test must meet the "allergen specific" criteria or provide some other evidence that the validation is effective.  The SQF Institute does not endorse any particular technology or methodology and relies on the site to provide the evidence of a scientifically validated and effective cleaning method".  

 

I think this is why I'm still confused and asking for advise because I followed the Appendix and had my lab use the ELISA specific allergen tests.  If I did the tests in-house would that be any different?  The cost would be 5X what I pay now because I would never use all the individual tests in a kit for validation.  



#11 alemv15

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Posted 23 July 2020 - 01:59 PM

I really liked my auditor, he was really good. It was just the allergen validation I didn't really understand why it was wrong when that method was acceptable throughout the years in every other plant until now . 



#12 Charles.C

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Posted 23 July 2020 - 02:44 PM

I have read the SQF Guidance Material including the Allergen Appendix Part 1 and 2.  It does mention the ELISA test for validation, which is what our Allergen Testing Lab uses, which is why I was confused.  I even showed proof that they use ELISA allergen specific testing to validation the absence of allergens.  The document does quote "there may be other acceptable tests for validation methods that can be used but the test must meet the "allergen specific" criteria or provide some other evidence that the validation is effective.  The SQF Institute does not endorse any particular technology or methodology and relies on the site to provide the evidence of a scientifically validated and effective cleaning method".  

 

I think this is why I'm still confused and asking for advise because I followed the Appendix and had my lab use the ELISA specific allergen tests.  If I did the tests in-house would that be any different?  The cost would be 5X what I pay now because I would never use all the individual tests in a kit for validation.  

Hi YNA,

 

OP has -
 

 

Every year since being SQF our facility has validated our allergen cleaning program by running our product with the highest concentration of allergens, cleaning the equipment per our SOP, and then running a non-allergen containing material and then sending that product out for allergen testing.

 

 

Not sure yr precise procedure as noted above  but I speculate that the problem/auditor's comment  may derive from this Guidance paragraph  -

 

The  SQF  Code  requires  validation  and  verification  of  cleaning  and  sanitizing  procedures  for  the  product  contact
equipment, and therefore the use of finished product testing for validation of cleaning is not considered adequate.  A
program of verification needs to be built on an initial validation study that identifies the target allergen(s), threshold
levels, and the severity of contamination, and shows the cleaning process and testing used are effective to give the
desired  results  consistently.  Once  the  cleaning  process  has  been  validated  as  effective,  a
verification/monitoring/inspection program shall be established to assure that the validated cleaning process is being
used, is maintained and effective.

 


Kind Regards,

 

Charles.C





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