Ok here it goes,

We were audited last week and our auditor asked us what we do if a gage is out of tollerance but still within customer tollerance specs. Now the person that did this job before me put some stickers on the gages that stated that the gage was ok because it did not exceed the 10% tollerance allowed by us. We have no idea how they figured out the 10% so we did not have a good answer for her. I have for some time now been trying to come up with a procedure to handle gage out of tollerance conditions but have had no luck. Nobody seems to know anything about this procedure. she also wanted to see an assessment of the gage out of tollerance. Does anyone have a suggestion or can tell me how they handle gage out of tollerance conditions and assessment? Thanks in advance :thanx:

A short list of steps would be:
First, you need to hold or quarantine all product measured with the suspect gauge before anymore is shipped to an internal or external customer. Then, in general, you need to be able to determine how far is the gauge out of tolerance and what was measured with that gauge from the last known point it was in tolerance to when it was found out of tolerance. From there you have to evaluate if any measurements made would be out of specification for your customer considering how far the gauge is out of tolerance. If you're lucky and they would not be, I'd update test results as needed for in stock material and document all actions taken.

If you're unlucky and have material that has shipped to the customer you should (ISO/TS requires that you notify them) notify them and arrange for use with deviation, or return.

Fianlly, you should evaluate your gauge calibration/checking to determine if the interval needs to be shortened or if other actions could be taken to eliminate future out of calibration issues that would potentially produce non-conforming product.

Sounds good, Problem is that we have approx 1000 jobs that we run and we have no way of tracking what job that particular gage was used for. Good news is that we have not yet had a gage out of tolerance that would be out for our customer.

If you don't mind my asking, Setting the assessment aside, What do you do if you have a gage that is out of manufacturers tolerance but still in for the customer? The person that did my job before me put a sticker on the cert that stated:

"The "out-of-tolerance" condition of ____% did not affect our product quality since it's within our minimum of 10% allowable tolerance" then the QA manager signs it.

I have no idea how they figure out the % or what formula they would have used. Any ideas?

I would say that the tolerance that matters is that which is acceptable for your use or customer requirements. The manufacturer's tolerance is useful, but the tolerance that matters is the one you assign - as long as you document how it was assigned.

As a calibration services provider, I run into your issue all of the time. Most companies do not have any way of knowing which gage was used on which product.

In an ideal world, you would have a gage database where gages are issued for jobs and every use gets tracked. You have to weigh the cost of tracking this information versus the benefit of having the information.

As for how the previous QA guy came up with the 10%, who knows! He probably looked at his typcial calibration data and saw that gages never seemed to be out by more than 10%. He then set the arbitrary value and ran with it becuase it was the easiest thing to do.