Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration.

[BradM]

Really appreciate each of your responses. Each of them have merits. I really like this site. I can't believe I have been missing it all these years.

Hey!! We're glad you found us!! We get a little spirited sometimes, just cause we believe strongly in our discipline.

For the sake of discussion, the OOT of tolerance condition is in the neighborhood of 10 microns while our tightest part tolerance is no less than +/- 0.5 mm. Would it be acceptable to simply state the ratio between the OOT condition and the minimum customer tolerance meets a 50:1 ratio and therefore would not influence the stated results of measurements taken prior to the roamer arm calibration?

My opinion.... yes. Write this up to demonstrate that the amount of error assessed at calibration time was insignificant in terms of potential process impact ( 10 microns versus .5mm) and thus no potential process risk. Or... however the language is acceptable within your industry/ organization.

Like Paul mentioned, I would invest in seeing if you can avoid future calibration failures. Maybe see if you can establish a suitable acceptance tolerance for the roamer arm. So mfg. tolerance is... ±10 micron but your process acceptance tolerance is say... ±.05mm. Make sure the calibration vendor adjusts the arm to maximum accuracy (remove error) even if it is found within specifications. Otherwise that error can build and become a failure in the future.

 

[ChrisM242021]

Hey!! We're glad you found us!! We get a little spirited sometimes, just cause we believe strongly in our discipline.



My opinion.... yes. Write this up to demonstrate that the amount of error assessed at calibration time was insignificant in terms of potential process impact ( 10 microns versus .5mm) and thus no potential process risk. Or... however the language is acceptable within your industry/ organization.

Like Paul mentioned, I would invest in seeing if you can avoid future calibration failures. Maybe see if you can establish a suitable acceptance tolerance for the roamer arm. So mfg. tolerance is... ±10 micron but your process acceptance tolerance is say... ±.05mm. Make sure the calibration vendor adjusts the arm to maximum accuracy (remove error) even if it is found within specifications. Otherwise that error can build and become a failure in the future.

I total agree with your assessment. Ultimately I settled on using T.U.R. to demonstrate effectiveness. I am somewhat new to the automotive industry. Have always been in plastics, but much like yourselves I believe our discipline is a worthwhile and lifelong endeavor. Thanks for all your help.

 

[jerry bambach]

Really appreciate each of your responses. Each of them have merits. I really like this site. I can't believe I have been missing it all these years.

The response about ISO9001-2015 not requiring is in error
Clause 10.2 Nonconformity and corrective action.
ISO 9001:2015 requires that when a nonconformity occurs, including any arising from customer complaints, organizations to take the following steps:

1. Immediate containment actions. IE: React to the nonconformity and as appropriate, take action to control and correct it and deal with the consequences.
2. Identify Root Cause / Similar products or processes consideration. IE: Evaluate the need for action to eliminate the cause(s) of the nonconformity, so that it does not recur or occur elsewhere, by: Reviewing and analyzing the nonconformity, Establishing the cause(s), Determining if any similar nonconformities exist, or could potentially occur elsewhere.
3. Implement Corrective Action to address root cause(s) and review effectiveness.
4. Update Risks and Opportunities planning and any changes to the management system as appropriate. It is also noted that corrective actions must be appropriate to the effects of the nonconformities under review and that documented information (records) must be retained as evidence of:

 

[Mike S.]

The response about ISO9001-2015 not requiring is in error
Clause 10.2 Nonconformity and corrective action.
ISO 9001:2015 requires that when a nonconformity occurs, including any arising from customer complaints, organizations to take the following steps:

1. Immediate containment actions. IE: React to the nonconformity and as appropriate, take action to control and correct it and deal with the consequences.
2. Identify Root Cause / Similar products or processes consideration. IE: Evaluate the need for action to eliminate the cause(s) of the nonconformity, so that it does not recur or occur elsewhere, by: Reviewing and analyzing the nonconformity, Establishing the cause(s), Determining if any similar nonconformities exist, or could potentially occur elsewhere.
3. Implement Corrective Action to address root cause(s) and review effectiveness.
4. Update Risks and Opportunities planning and any changes to the management system as appropriate. It is also noted that corrective actions must be appropriate to the effects of the nonconformities under review and that documented information (records) must be retained as evidence of:

If you're trying to say this clause "requires a CAR (corrective Action report)" for an OOT condition found during calibration, or for any other nonconformity, I disagree.

 

[BradM]

I look at it like this. Instrument exceeded tolerance. It was adjusted, the error had no impact. We close and review the next calibration. I might... write up an internal document extending the acceptance tolerance where we don't have to label it a "failure" or whatever at the next calibration event. This thing might not ever fail again, or fail every time. Until we have that data, it's kind of pointless (in my opinion...) to throw a bunch of stuff in place. I've seen that happen before. The calibration department ends up with (many times) ridiculous hoops to jump through, simply in the name of "Corrective Action".

However (different scenario)... suppose outgoing product is incorrectly labeled and the wrong stuff is shipped to the wrong customer. Now... we KNOW our process has a problem. We must figure out what really happened, and put measures in place to keep that from happening again.

This is where we need to inject some common sense and risk-based thinking in the quality system. We need to really address failures when they occur to prevent them again. But not necessarily construct some burdensome/ expensive CAPA program on calibration instruments, simply because a vendor identified they exceeded a tolerance.

 

[Funboi]

OOT doesn’t equate to non-conforming. Hence, corrective action cannot be an option, until non-conformity is determined.

 

[dwperron]

OOT doesn’t equate to non-conforming. Hence, corrective action cannot be an option, until non-conformity is determined.

The only time I could see an OOT directly equating to being a non-conformance is if you are a calibration laboratory, and your OOT condition caused your customer's instruments to be OOT. Then your product, the calibration, would be non-conforming.