External calibration - Finding in our 3rd party audit

[Mikey324]

Good morning. I wanted to pick the brains of some experts here over a potential finding in our 3rd party audit.


The audit had moved into calibration. We calibrate digital micrometers and calipers using gauge blocks. The auditor asked to see our calibration records for the gauge blocks themselves. We provided it. This is outsourced to company A. The auditor then asked to see company A's accreditation and scope.

Issue - Company A doesn't include these gauge blocks in their Scope.

Since this process has been ongoing for 25 years, I didn't mention upfront that company A subcontracts the gauge block calibration to company B. When i told the auditor this, as expected he requested the accreditation and scope of company B. To his surprise, i provided this evidence. It demonstrates that this type of calibration is within their scope.

The auditor said he may raise a finding here. Potentially major??? I honestly don't see that. He asked me if i was just going to trust the calibration results...

Absolutely. I pay to have this calibration performed by an accredited laboratory. In 25 years, there have been no issues related to this calibration that could impact a customer.

So far, he hasn't issued a NC statement, or the standard requirement that was violated. My question to all; is this a legit N/C since we were able to provide all requested evidence? At worst, this is could be improved. Taking some of the confusion out of it by making clear notes on the calibration records that company B was contracted and performed the actual calibration. I feel a minor NC would be a stretch, but can't see how it could be a major???


Any insight or professional opinions are highly welcomed.

Thank you

 

[Jim Wynne]

I think you should be OK. I also think that your primary source should be listing gage blocks in their scope, with an appropriate explanatory note. This certainly doesn't rise to the level of major.

 

[Mikey324]

I think you should be OK. I also think that your primary source should be listing gage blocks in their scope, with an appropriate explanatory note. This certainly doesn't rise to the level of major.

I completely agree that this could be less confusing. Each year I get older and it takes a little longer for my memory to jog...

I've already mentioned it to the company. They said listing the outsourced lab will be no issue. The auditor seems to be questioning a name, and somehow using that to question the result. There is no evidence, historically or otherwise, that would lead one to question the validity of the results we are getting.

This one seems like there is intent to write a finding regardless of evidence to the contrary. I'm just trying to figure out what information would help to prove conformance that hasn't been supplied already.

And to clarify a little, the audit in continuing today at an extended site. So he said he will be looking at their calibration process as well. Any minor found would then definitely result in a major.

I want to be sure I give all the info, and not try to paint a rosier picture to attempt to swing forum support my way. I am truly at a loss on this one as to what is missing.

 

[Jim Wynne]

Nothing is missing. If the auditor does proceed with an NC, challenge it with the CB.

 

[Ron Rompen]

Jim is correct. You are able to provide traceability of your gauge blocks to a registered/acredited lab which lists the calibration of gauge blocks in their scope. Simply outsourcing it to a 2nd party (which you, the customer, were aware of) does NOT invalidate the results, or constitute a violation of the standard.
If the auditor DOES raise an NC, please share the wording of it with us here....would love to see how it is justified.

 

[dwperron]

I've already mentioned it to the company. They said listing the outsourced lab will be no issue. The auditor seems to be questioning a name, and somehow using that to question the result. There is no evidence, historically or otherwise, that would lead one to question the validity of the results we are getting.


A basic question here is what level of calibration are you working with?
Are these 17025 accredited calibrations, since you keep mentioning that is is or isn't within their scope?
If you are not working to 17025 then typically any "Traceable to NIST" declaration is adequate to an auditor.
If you need 17025 accreditation then your provider also needs to have this in their 17025 scope, otherwise there is no proof that they provided a 17025 calibration. That will break your traceability.
There are rules on how a 17025 lab can subcontract work to another 17025 lab, and if you do it right the results are clear.

 

[Mikey324]

These are 17025 accredited calibrations

I've already mentioned it to the company. They said listing the outsourced lab will be no issue. The auditor seems to be questioning a name, and somehow using that to question the result. There is no evidence, historically or otherwise, that would lead one to question the validity of the results we are getting.


A basic question here is what level of calibration are you working with?

There are rules on how a 17025 lab can subcontract work to another 17025 lab, and if you do it right the results are clear.

These are 17025 accredited calibrations. Both company A and company B are 17025 accredited. However, the gauge blocks are one item that is not within company A's scope. Therefor they sub this out to company B, also accredited. The gauge blocks are within their scope.

That said, I would see no danger signs to make the calibration results questionable. These reports have been looked at by multiple auditors from multiple registrars since the QS9000 days. With no issue.

Also, there has never in the history of our company been a complaint for an out of spec dimension due to an uncalibrated device. The gauge blocks are for micrometers. We use them to verify dims to the customer tolerance. We also had redundancy built in. We have a different type of measure device that measures this same dimension continuously. I struggle to see customer risk.

 

[Mikey324]

We have a different type of measure device that measures this same dimension continuously

And yes, this gauge is also calibrated by an accredited lab (different company), and the type of calibration is listed with the scope of accreditation.

 

[dwperron]

As long as you have a formal agreement with your calibration provider to subcontract the work, and they follow the guidance of 17025 section 6.6, then you should be safe.
It can get tricky because you need to perform the 17025 contract review process with the company that calibrates your blocks, but you do not do that. 17025 section 7.1.1 covers this.

 

[Mikey324]

I really appreciate all the feedback. I have been informed the audit has concluded, but the result has not been communicated yet. Feedback from our extended site looks like all was well.