Out of spec. Gages

I'm having trouble finding anything definitive in either the IATF 16949 or MSA standards regarding fixtures/gages that are out of spec. Specifically from the supplier side.

If a fixture or gage is out of tolerance, yet is deemed ok to use and signed off by the Quality Engineer, is it ok for production use? Does it need to have the customer's written sign off or approval as well? I am referring to existing fixtures/gages that have been found out of tolerance during their scheduled calibration frequency and have already been used in production for X amount of time.

Is this an internal organizational issue or is this governed by IATF, MSA or some other body?

Well common sense and engineering physics would be the best regulation: do the out of spec fixtures create - or have the ability to create - out of specs parts? Will the OOT gage allow out of spec parts to be accepted as in spec? This is a simple and straightforward analysis for an OOT fixture. Was that done? Is there documentation of this? OOT reports are supposed to be created and recorded to allow a ‘use-as-is disposition…

In theory yes. Common sense doesn't always align with Auditors; some are very by the book. I just want to make sure that a QE sign off is enough. If there is no clause or governing document that states any fixture/gage that is out of tolerance can not be used on the production floor unless authorized by the customer, then we should be ok. However, if there is then we'd need to contact the customer in these instances.

Whether or not the QE signed off is NOT relevant: do you have the data that supports a use-as-is disposition? If not, you are in trouble no matter what. If you have the data that supports a use-as-is disposition, then you can check what yoru Customer requirements are concerning notification and possible approval.

QEs are not gods no matter what they were told by their parents….

We haven't come across this yet, so this is all theoretical. I was just looking over some work instructions that show an out of spec. gage being signed off by the QE, but no note requiring additional documentation from the customer. I understand what you're saying about the supporting documentation, it needs to accompany the sign off. I appreciate your help.

Bill Paskaruk said:

In theory yes. Common sense doesn't always align with Auditors; some are very by the book. I just want to make sure that a QE sign off is enough. If there is no clause or governing document that states any fixture/gage that is out of tolerance can not be used on the production floor unless authorized by the customer, then we should be ok. However, if there is then we'd need to contact the customer in these instances.

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Check 7.1.5.2.1. Subsection C -- tells you that you need a risk assessment when a gage is found "out of specification." So I would think you QE might want to have something more than a simple signature backing up his decision.

D goes further regarding past measurement. Etc.

Golfman25 said:

So I would think you QE might want to have something more than a simple signature backing up his decision.

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That’s the crux of the matter. Any auditor worth their (Himalayan) salt would definitely want to know the rationale behind the QE decision and a documented evidence of the past and future implications of using an OOT IMT&E device.

An example of a good risk assessment would be as follows:

• The gauge was out of calibration by +0.0001
• The USL for the dimension the gauge was used to measure was Nominal +0.001
• A review of the inspection/SPC records show no dimensions larger than Nominal + 0.0005
• +0.0005 + 0.0001 = +0.0006 which is less than the USL of 0.001
• The risk that any out-of-spec product was shipped to the customer is negligible, so there is no need to contact the customer.

On the other hand, if you found out that some product in the inspection records would have been out-of-spec by the +0.0001, you would have two possible courses of action depending on whether the product would still be deemed functional or not functional. In both cases, you would contact your customer. If functional, you could ask for a deviation, if not functional, you would take whatever action your customer deems necessary, such as recalling the product.

And why would you not calibrate an OOT gage???? Isn’t that the purpose of calibration?? Something is off here

Bev D said:

And why would you not calibrate an OOT gage???? Isn’t that the purpose of calibration?? Something is off here

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Sometimes there might be a reasonable explanation, such as the OOT condition being specific to a range of measurement never used to verify product conformity. E.g., a 0-20” micrometer that might have the 0-5” range OOT, but the 5-20” range within spec. If the device is only used to verify dimensions in the 5-20” range, the limited OOT condition would be acceptable.