How to appeal a major audit finding

[Eredhel]

Re: How to appeal a major finding?

But this isn't what was reported.

According to the original post, yes it is. I might be misreading something but it looks like the non conformance was due to using tools for acceptance which had been marked in the system as lost but when later found were used for acceptance checks without being calibrated in the system:

"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."

 

[Sidney Vianna]

Re: How to appeal a major finding?

According to the original post, yes it is. I might be misreading something but it looks like the non conformance was due to using tools for acceptance which had been marked in the system as lost but when later found were used for acceptance checks without being calibrated in the system:

Actually, that was the evidence provided to support the NC. The problem, according to the write up, has to do with the lack of a reliable database to enable an effective recall of the I,M&TE. As I mentioned earlier, the auditor makes a reference to an OFI about cleaning up the database. What was observed to reflect that finding?

We don't know if this auditor has a history of assessing this system, or not. At face value, the issue alone does not warrant a major NC, but I caution against reaching overarching conclusions with a one-sided account of the problem. What if this is an ongoing problem, reported previously as OFI's or minor NC's?

While I also share the concern with incompetent 3[sup]rd[/sup] party auditors reporting baloney, as someone who has been the recipient of NC appeals in the past, I do know, for a fact that, any story has always, at least, two sides.

 

[Eredhel]

Re: How to appeal a major finding?

This could get interpretive quickly. But to me it looks like the auditor is saying they wrote it up because parts were checked using out of calibration gaging and the calibration system needs to be done better, thus the OFI there. I agree that it's a messy write up, and to assign an OFI for the root cause of a major NC is silly. But the original poster is asking how to avoid getting written up for not following calibration. The auditor or CB could just correct their NC to be better written and then the OP is back to square one, "How can I avoid a write up for not following calibration?"

Edit: I would rather use political capital to come alongside a registrar and help find a solution for a situation like this and save the more aggressive political spending for bigger things. Especially when there is actually a problem with the system that is easily corrected.

 

[AndyN]

"...because parts were checked using out of calibration gaging..."

Calibration isn't a function of the recall date (alone). No-one can determine if they were "out of calibration" until the condition of the items has been established, by evaluation. This myth of dates must stop being used as a reason to write an nc against the calibration system. Once a date arrives it doesn't automatically mean the equipment is now, magically, invalid. Plenty of organizations choose arbitrary, time based recalls and lazy auditors (who don't get it) issue bizarre ncs. Nothing in the OP has established the condition of the items to be suitable for use (which is what the standard actually requires...)

 

[howste]

...measuring equipment shall be: a. calibrated or verified, or both, at specified intervals...

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.

Clearly it's a nonconformity and should have been written as such. The judgment for major vs. minor will depend on a variety of factors including the CB's definitions for classifications and the evidence found during the audit that we don't see.

Pin gages can be used for a lot of different applications. One that was seen by the auditor was an incoming inspection that seems trivial. We don't know what else the pins could have been used on in the three and a half years since the date the company defined for the pins to have been verified.

Here are a few questions in my auditor mind about the situation:
1) Is there a chance that the pins could have been used to accept final product before going to a customer?
2) If the system was unable for 3.5 years to identify that this gage was past its (company defined) due date without being caught, how many other gages in the system are past their (company defined) due dates?
3) Are any of the pins out of tolerance? How could anyone know?

Regardless of the classification of major vs. minor this nonconformity needs to be addressed at a systemic level to eliminate the possibility of recurrence.

 

[Eredhel]

Calibration isn't a function of the recall date (alone). No-one can determine if they were "out of calibration" until the condition of the items has been established, by evaluation. This myth of dates must stop being used as a reason to write an nc against the calibration system. Once a date arrives it doesn't automatically mean the equipment is now, magically, invalid. Plenty of organizations choose arbitrary, time based recalls and lazy auditors (who don't get it) issue bizarre ncs. Nothing in the OP has established the condition of the items to be suitable for use (which is what the standard actually requires...)

We agree on far more in this situation than it seems. I'm a big fan of pushing against the dates as well. I constantly remind people most standards just say regular intervals. Our regular intervals are just driven by GageTrak for convenience, we stagger things so it's not all up at once, and some things get done every 3 years (again defined by us not a standard.) But if we ever said something was missing and it went out of our defined calibration criteria and then it got used to check parts, I'd fix that. And if they didn't determine their own criteria then that's another systemic problem too.

 

[dsanabria]

Clearly it's a nonconformity and should have been written as such. The judgment for major vs. minor will depend on a variety of factors including the CB's definitions for classifications and the evidence found during the audit that we don't see.

Pin gages can be used for a lot of different applications. One that was seen by the auditor was an incoming inspection that seems trivial. We don't know what else the pins could have been used on in the three and a half years since the date the company defined for the pins to have been verified.

Here are a few questions in my auditor mind about the situation:
1) Is there a chance that the pins could have been used to accept final product before going to a customer?
2) If the system was unable for 3.5 years to identify that this gage was past its (company defined) due date without being caught, how many other gages in the system are past their (company defined) due dates?
3) Are any of the pins out of tolerance? How could anyone know?

Regardless of the classification of major vs. minor this nonconformity needs to be addressed at a systemic level to eliminate the possibility of recurrence.

Well Said - in fact, I would add another one - Personal gauges and ALL equipment that accepts product.

Time well spend that would add value to your system and don't get caught up in making a point of Minor vs Major definition - you are not going to win.