How to appeal a major audit finding

[AlienraverX]

Hi Everyone,
We are registered to ISO 9001:2015, we just had our recertification audit at which time a major finding was issued. The verbiage is below, and we wish to appeal. The only thing is I have never (in my 18yrs as an auditor and quality professional) seen a major finding issued, hence I don't know how to formulate an appeal. Does anyone have any experience here? The auditor found no other calibrated items "out of cal" or "in use". Is one gage set enough to constitute major, more so since the operator realized his mistake and placed the product on hold? I don't think I'm sold that it should.

Statement of non
conformance:​

The recall system for calibration is reliant on the calibration admins maintaining and controlling tools in the calibration database as active or inactive or lost
During the audit, it was learned that the calibration database was not well maintained resulting in Pin gages which were lost and made inactive to be put
back in service and used during incoming inspection. The recall records still showed the equipment to be inactive.
There is a significant doubt that effective process control is in place (essential part of providing confidence in the validity of measurement results). See also the OFI regarding clean up of this database.​

Objective
evidence​

Pin gage set 61790 was not calibrated at the specified interval. Pin gages seen in use during incoming inspection were beyond their next calibration due date.
During the audit the inspector used these pin gages to accept incoming product. Objective evidence: Pin gage set 61790 next due calibration on sticker said 4/7/2014. Calibration database showed measuring equipment to be inactive.​

 

[Sidney Vianna]

The auditor found no other calibrated items "out of cal" or "in use". Is one gage set enough to constitute major, more so since the operator realized his mistake and placed the product on hold?

According to the write up, the inspector accepted the product. Was the product put on hold, AFTER the auditor identified the problem?

I will not get into the discussion of adequacy of the categorization of the NC, but, based on the information offered, the auditor's concern has to do with the data integrity of the database supporting the recall process. S/he mentioned other evidence offered: See also the OFI regarding clean up of this database.

As for the how to appeal the NC and/or the categorization, that should normally be done with an email to the CB Technical Manager, or equivalent. Be aware that, at least one CB that I know of charges you a fee for evaluating an appeal.

 

[Coury Ferguson]

Hi Everyone,
We are registered to ISO 9001:2015, we just had our recertification audit at which time a major finding was issued. The verbiage is below, and we wish to appeal. The only thing is I have never (in my 18yrs as an auditor and quality professional) seen a major finding issued, hence I don't know how to formulate an appeal. Does anyone have any experience here? The auditor found no other calibrated items "out of cal" or "in use". Is one gage set enough to constitute major, more so since the operator realized his mistake and placed the product on hold? I don't think I'm sold that it should.

Statement of non
conformance:​

The recall system for calibration is reliant on the calibration admins maintaining and controlling tools in the calibration database as active or inactive or lost
During the audit, it was learned that the calibration database was not well maintained resulting in Pin gages which were lost and made inactive to be put
back in service and used during incoming inspection. The recall records still showed the equipment to be inactive.
There is a significant doubt that effective process control is in place (essential part of providing confidence in the validity of measurement results). See also the OFI regarding clean up of this database.​

Objective
evidence​

Pin gage set 61790 was not calibrated at the specified interval. Pin gages seen in use during incoming inspection were beyond their next calibration due date.
During the audit the inspector used these pin gages to accept incoming product. Objective evidence: Pin gage set 61790 next due calibration on sticker said 4/7/2014. Calibration database showed measuring equipment to be inactive.​

In my experience appealing (I have had a few) any nonconformances found during a 3rd party Audit would be appealed just like any other nonconformance would be. Have your facts, supporting data, and any actions that were planned or scheduled and submit to your Registrar for possible reversal.

As I am reading what they are saying in the Statement of NC, I see that they identified this before during a previous audit (not this particular issue), and it appears that no action was taken by the Organization. Now if they identified it as an OFI previously, then I stand by many answers before, in regards to OFI's of taking any OFI identified as a potential nonconformance down the road and I take action on any OFIs identified, even though it not a requirement.

Now if I am seeing it as a "one off" in the Objective Evidence it should not have been written as a Major NC, in my opinion.

Were any other gages found to outside of calibration cycle during the review? If there were, then it would reflect a breakdown in Monitoring and Measurement system and could be identified as a Major.

Just make sure you have all necessary documentation, to present this in a professional way, and review, I believe it is 17021 that provides guidance on the appeal process.

Just my opinion.

 

[AlienraverX]

Re: How to appeal a major finding?

In my experience appealing (I have had a few) any nonconformances found during a 3rd party Audit would be appealed just like any other nonconformance would be. Have your facts, supporting data, and any actions that were planned or scheduled and submit to your Registrar for possible reversal.

As I am reading what they are saying in the Statement of NC, I see that they identified this before during a previous audit (not this particular issue), and it appears that no action was taken by the Organization. Now if they identified it as an OFI previously, then I stand by many answers before, in regards to OFI's of taking any OFI identified as a potential nonconformance down the road and I take action on any OFIs identified, even though it not a requirement.

Now if I am seeing it as a "one off" in the Objective Evidence it should not have been written as a Major NC, in my opinion.

Were any other gages found to outside of calibration cycle during the review? If there were, then it would reflect a breakdown in Monitoring and Measurement system and could be identified as a Major.

Just make sure you have all necessary documentation, to present this in a professional way, and review, I believe it is 17021 that provides guidance on the appeal process.

Just my opinion.

You are correct in assuming this was a "one off" The OFI was presented during the SAME audit. So is it an OFI or is it a major? Sees fishy to me. The product was put on hold during inspection, when the associate realized his gages were out of calibration. The gages were then processed to be submitted for calibration. No other tools were found to be out of calibration during this audit or during our investigation. It seems to me that the auditor should have investigate other tooling to determine if we had a system problem, which it is evident that we do not. We also explained that the recall system is not the final system of recall, that system is managed by our calibration house which performs all of our calibration and recall.

 

[Golfman25]

Re: How to appeal a major finding?

You are correct in assuming this was a "one off" The OFI was presented during the SAME audit. So is it an OFI or is it a major? Sees fishy to me. The product was put on hold during inspection, when the associate realized his gages were out of calibration. The gages were then processed to be submitted for calibration. No other tools were found to be out of calibration during this audit or during our investigation. It seems to me that the auditor should have investigate other tooling to determine if we had a system problem, which it is evident that we do not. We also explained that the recall system is not the final system of recall, that system is managed by our calibration house which performs all of our calibration and recall.

So it sounds like your appeal is whether it is a major or a minor, not whether it is a nonconformance. Not sure what the effects of a major are in the ISO world, but is it that big of deal how it is classified? (In IATF/TS world, major's require a lot more work, additional audits, etc. and take on a life of their own).

As to your example, I agree once the auditor finds an issue that he wants to escalate to a major, he should probably do a bit more investigation. How bad is it really?

 

[AlienraverX]

Re: How to appeal a major finding?

Yes, the appeal is to downgrade to a minor since in all honesty the issue is a finding, but a one off is a minor all day long. In the ISO world a major requires a lot more than a minor. They must come on site to validate the action has been closed, typically you get 90 days, however since our certificate expires at the end of November we got 21 days. If the actions are not found to be "good enough" for the auditor, our certificate can be suspended. In my business, this is not good.

 

[Sidney Vianna]

Re: How to appeal a major finding?

but a one off is a minor all day long.

That is a paradigm that needs re-assessing. You can have a single, isolated instance of non conformance, but the criticality and risks involved are so dire that, in the assessment of the auditor, that could represent a major risk. The fact that pin gages were being used to assess the hardware indicates very tight tolerances are at play. The fact that the gage set had not been calibrated verified since 2013 or 2014 is also a significant aspect. The sooner you appeal, the sooner you will get the response from the CB, but if the CB is half decent, they will contact the auditor to understand his reasoning for the categorization, before they agree to downgrade the finding.

 

[AndyN]

In reading the nc, I'm reminded of Shakespeare... : "Much Ado About Nothing". It appears to me the grading is arbitrary and simply relying on dates for calibration recall is, frankly, absurd. There's been zero recorded attempt by the auditor to evaluate the situation with respect to the affect on measurements. Sure, some pin gauges might not have been calibrated for a while, but what does that MEAN? Does not changing your oil EXACTLY at 5,000 miles ruin an engine? I'd be appealing this based on zero evidence of the affect on product quality (one reason for a major, if product was nonconforming), secondly, was it something which could have been detected (the pins were used at receiving where there's possibly lower risk a product issue slipping through the whole process) and thirdly, that given the total number of gauges present in the database, what was significant about these pins? Once again, no evidence.

It's an undesirable situation, but with much more digging, I'd only make it a "minor" at best...

 

[Big Jim]

I'm on the side that agrees that this is a valid nonconformance. As to if it should have been treated as a minor or major I'm neutral on since I wasn't there.

Generally, a nonconformance can be considered a major if there is significan't risk of nonconforming product to escape. That may very well have been the case here.

This wasn't a one of situation. The gauges had been in use and past their verification due date for a significant period of time, and the user of the gauges seemed oblivious to the problem.

Take it up with your CB, but don't have high expectations of it being reduced or removed.

 

[Randy]

Your CB is required to give you the information as to how to file an appeal, if they don't or won't then you can file a complaint with ANAB if that's their accreditation body (Check your certificate)