(OOT) Measurement Equipment after the calibration at a third Party lab



(OOT) measurement Equipment Problem,

I have a question how you are handling the documentation and the risk analysis after measurement device is out of tolerance --> e.G. after the calibration at a third Party lab. --> our regular calibration cycle ist 1 year.
we don't have an really good description how to do the risk analysis after reject of an measuring device. --> until now we made an comment on the cert that there were e.g. no risk for this spec because we measure this spec as well with an another device in the second measuring circle. (caliper nok , CMM will catch the Problem in the firs approval part --> set up)
Now the Auditor likes to have an very detailed procedure with an standardized documented risk Evaluation)
Does somebody have here an good example --> description with forms for the risk Evaluation (checklist or similar)

we have also already made an Brainstorming what we can include in this checklist, question is now how you guys have fixed this Problem in practice.
Thanks ahead



Re: (OOT) measurement Equipment

Hi, Robbob:

If you are ISO 9001 certified, you will need to record how you handled this situation once you determined that your gauge was OOT, specifically how you determined whether or not the product met specification.

Even if you are not ISO certified, this is still a good idea.

We have a simple inspection form specifically for "Special Inspections" such as this which fall outside of our regular inspection practices.

You might want to revisit your calibration schedule, at least for that particular tool, if it was found to be normal use which caused the OOT situation. Of course, determining what was the cause should be your first step. The fix will be determined by that.

I would worry less about what your auditors will think, and more about what your customers will think.


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PaulJSmith is correct. However, first, I would get with the cal lab and make sure it did not become OOT in transit, as that does happen. It may be worth a trip to the lab and observe.

Depending on how far it is, perhaps it may be easily addressed by uncertainty analysis and/or guardbanding.

Still, if truly out, then you MAY be looking at a product recall, which for a year could be a lot.

Charles Wathen

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We handle it a little different. First, we review the calibration certificate looking for errors in calculations. You would be surprised that errors do occur. Next, we determine the amount of the error that exceeded our requirement in maintaining a 4:1 calibration ratio.

If the amount of error still maintains a 4:1 calibration ratio on the assets that were calibrated, then we say there was no impact to product. If the error diminishes the 4:1 ratio, then we have to discuss the issue with process owners for determination of potential impact. All this is thoroughly documented using one of our internal forms. We also attach an Excel spreadsheet showing the assets that were calibrated, and the calibration ratio of each.
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