8 replies to this topic

[IKE]

Hi,  we just had our first desk audit. We received  a couple of "major" non-conformances and some "minor" non-conformances. Most of them, whether major or minor, are going to be easy fixes but there is one program, environmental monitoring (EMP), that we as a company simply chose not to implement. It was deemed a "minor" non-conformance by the auditor. What I am wondering is whether or not the the site auditor will judge it as a minor or a major. Does the site auditor have the leeway to upgrade that from minor to major? I'm not sure how the rationale works when it comes to the auditor choosing minor or major. From our report it seems that our desk auditor used the term mandatory to determine how to ding us. On any mandatory program, any minor discrepancy resulted in Major's, however, we had a couple of non-mandatory programs missing altogether and they were only recorded as minors. In summary what I need to know is; if we choose to continue without an EMP will the next auditor have the authority to ding us as a major instead of a minor? For context- our rationale behind this decision is that EMP is a verification activity to verify that RTE product is being protected from cross contamination from the raw side and or environment. We do not produce any RTE foods, it is still raw when it leaves here. FDA requires only requires EMP for RTE areas. 

 

[TaylahH]

^Hey,

^{From what I understand and have been suggested, is that anything you do not have implemented create a page/conformity outlining why. It doesn't have to be a massive spiel just something that the auditor looks at ands knows that you are recognising the particular program in the code.}

^{For example my workplace does not do field packing and my consultant has mentioned to me to write a simple paragraph stating no packing is done in the field - gets brought into the packing shed to be packed.}

^{He has recommended this for both mandatory and non mandatory.}

[Scampi]

https://www.sqfi.com...bernewsletter18

 

 

This should help. Its a slide show of top non conformance's

 

For the record, my auditor originally wanted to give me a MAJOR for not having an EMP in place. Read the guidance and implementation guide carefully. The risk assessment portion of the EMP clause is mandatory, if your risk assessment shows that EMP swabbing is not required, than you shouldn't even get a minor for it.

 

If a section of the code is (mandatory) then you will need an exemption from your CB, and that requires you to apply for it

[CMHeywood]

For SQF, the first desk audit is usually done off-site (at the auditor's desk) prior to doing the site audit.  Feedback from the desk audit gives you time to revise any documents that have non-conformances.

 

If the auditor comes to your site and sees that the document has not been updated, and you are not even doing what the document states, or are missing required food safety elements, then I can see where a minor conformance during the desk audit can change into a major nonconformance during the site audit.

 

For example, you have pest control document that says you use traps, etc. but don't talk about screens on windows and doors.  This might be considered a minor nonconformance.  However, during the site audit the auditor notices that many windows don't have screens, exterior doors are left open, and there are no traps or bait stations as mentioned in your pest control document.  This might be enough for an auditor to claim that it is a major nonconformance.

 

The FDA (in FSMA) does state:  "Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control."

 

However, I think that you would need some sort of hard proof (test data) that you don't have an environmental risk and environmental monitoring is not necessary.  The auditor is not going to accept "we don't do it because the FDA does say we need to do it."   Whatever food safety scheme you are using (SQF, BRC, etc.) is not limited by what is and what is not stated in FDA regulations.

 

Hopefully you have some sort of sanitation program is the raw food is exposed during your processing.

[SQFconsultant]

You can't just decide not to do something (EMP) because you choose not to.

 

You don't have to do EMP for SQF - but you have to show proof as to why you feel you don't have to do so.

 

You must submit the request to be waived to the CB.

 

If you don't request a waiver you will get a minor on the desk audit and expect a major on the site audit.

[SQFconsultant]

And on the subject of understanding how the grades work, all that information can be found in the SQF 8.0 Manual.

 

As to can desk audit findings carry to the site audit. No.  Your corrective actions having to do with the non-scored desk audit will be checked again during the course of the site audit and only if an issue arises would a mark off occur.

[adamperry2235]

You are going to have to have a pretty solid explanation as to why you are not doing any environmental monitoring. Starting with the products listed, possible contaminates, and intended use as well as intended customers. You'll also want to write out your plan as part of the explanation as to why you wouldn't need it. From there you'll need to get an exemption and keep all of that documented because it will come up with every auditor ever and you'll have to explain why and show them why SQF gave you the exemption. (From my experience with auditors)

[CMHeywood]

I agree with SQFconsultant so I need to clarify my previous response:

 

One purpose of the desk audit is to flag any nonconformances in your documents prior to the site audit so you get a chance to make changes before the site audit.

 

If you corrected a minor nonconformance from a desk audit, then it may not show up as a nonconformance at the site audit.

 

If you did not make any changes, and the issue became worse, it is possible that it would be a major nonconformance at the site audit.

 

If a particular document had no nonconformances, but you aren't really doing the describe procedure, then you would get a nonconformance.

 

Also, I agree with adamperry2235 that you will need documented proof that you don't need to do environmental monitoring.  You can't say "we don't think we need to do it."  The best evidence would actually be some sort of 6 month to one year environmental monitoring to prove your claim that frequent monitoring is not needed.

[Charles.C]

Sad to say but just as a general comment, it seems to me that in the absence of  any specific Guidance most SQF people will soon be doing some swabbing just to minimize the likelihood of an audit problem.

 

Line of least resistance.