Clarification on Calibration/Verification Records 7.1.5.2.1d (IATF 16949)

M

mans442

#1
As it states:
d) when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use, documented information on the validity of previous measurement results obtained with this piece of of inspection measurement and test equipment shall be retained, include the associated standard's last calibration date and the next due date on the calibration report;

Does this mean that if, we find a gage out of calibration or defective during a planned calibration check or during normal use, we need to maintain the last calibration record of the now defective gage back to when it was in calibration?

Thanks,
Jason
 
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Sunday

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#2
Re: Clarification on Calibration/verification Records 7.1.5.2.1d

An effective calibration program should already have the last date of calibration (last known good date). If a piece of measurement equipment is found to be out of calibration, an investigation should be performed to determine the risk to outgoing product. This investigation should include an analysis of the time at which it may have gone out of calibration, the quantity of material affected, and the severity of the erroneous measurements. I recommend documenting this information with the calibration records including any adjustments that were performed on the tool to return it to good working order. An assessment should be made if product must be recalled as a result of the erroneous measurements (in the most severe cases). You could use your corrective action system as a good way of documenting this information, in the absence of a good asset tracking database.
 

Marc

Hunkered Down for the Duration
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#3
Re: Clarification on Calibration/verification Records 7.1.5.2.1d

Just to be clear - What standard are you referring to?
 

dgriffith

Quite Involved in Discussions
#4
Re: Clarification on Calibration/Verification Records 7.1.5.2.1d

For AS9100C(now D), our entire org is under that umbrella. Whether the out of tolerance/non-conforming asset belongs to the lab or the customer, we (the org) are required to report the OOT and research all measurements/results to determine if there was any impact on those measurements. If the customer, it is incumbent on them to figure out what to do once notified.
The lab would do the same, but it becomes a problem when a standard has calibrated dozens if not hundreds of customer assets, which may need to be recalled. :mg:
Whether AS9100 or 17025, if your lab equipment, you need to keep a record of this verification process and the results of any investigation.
 

DietCokeofEvil

Trusted Information Resource
#5
So question on this. We, of course, keep records on our equipment and list the equipment used, cert # and date due on our certifications for customers, but we do not list the date calibrated. This has never been an issue and is not required by 17025 to be reported on the cert.

However, when we have a 16949 customer who has a nonconformancy, do we need to report this?
 

Ninja

Looking for Reality
Trusted Information Resource
#6
So question on this. We, of course, keep records on our equipment and list the equipment used, cert # and date due on our certifications for customers, but we do not list the date calibrated. This has never been an issue and is not required by 17025 to be reported on the cert.

However, when we have a 16949 customer who has a nonconformancy, do we need to report this?
I keep reading this and re-reading this trying to make it make sense...

You make product, and send a cert with it?
Or you are a calibration lab calibrating customer equipment and sending a cal cert with that?

If the former...you don't need to report calibration date on your product cert...but you do need to know the last time the measuring equipment passed calibration before it failed...and have some way of knowing what lots were measured on that equipment in between.
All lots measured (passed) on that equipment become in question since you don't know when your equipment went "bad"...could have been the day after it passed calibration.
Been there, done that...We found the limit of risk and communicated "This happened, this is the extent, and this is why you shouldn't worry about it, and this is what we've done so it won't happen again" to the customer all at the same time. Trust needs to be maintained.

If the latter (cal lab), it's really your customer's problem to track equipment usage and cal dates. I figure you should be able to calculate them from the cal due date anyway...
If you're a cal lab, however, you find that your standards fail and you don't know how far back the issue goes...you've got issues...and so do your customers...
 

DietCokeofEvil

Trusted Information Resource
#7
Sorry- I did write that in a hurry. We are a calibration lab, and one of our customers approached us with this question. If we reject their gage, do we need to provide the date calibrated on the equipment we used to check it? Their auditor is insisting we need to provide the info.
 

Ninja

Looking for Reality
Trusted Information Resource
#8
You need to know your equipment works right...and use it to calibrate the customer's gage. I would ASSUME that you then tell the customer (on the report you give) what date it was done, pass or fail and support data.

If your customer is IATF16949, all the rest is on them...it's their gage to maintain and use, not yours.

If the gage fails...it's their issue to figure out when and to assess the impact of having used it.

I am surprised, however, that no such notification requirement is placed on you by your own accreditation...or do I misunderstand?

"If we reject their gage, do we need to provide the date calibrated on the equipment we used to check it? Their auditor is insisting we need to provide the info."
As a customer, I would insist on making sure your "Fail" pronouncement is justified...false-fail costs a lot of money. Why the customer's auditor is insisting on it is beyond me...it should be your customer themselves...but I'd give it to the customer just because they asked for it. Surely you know the last time your standard was verified??
Else how would you know it is still valid to use?
 

dwperron

Trusted Information Resource
#9
7.1.5.2.1 d) when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use, documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment shall be retained, including the associated standard's last calibration date and the next due date on the calibration report.

Your customer needs that information for 16949 compliance.
 

DietCokeofEvil

Trusted Information Resource
#10
We do have records on all of our equipment, but we do not list the date the equipment was calibrated on our certifications. We list the date it's due- our cert format has been the same since we became 17025 accredited and it's not an issue with our auditors. We only have so much room on our certs, and those fields are not editable by the technicians so we can't add it, nor do we want to make this significant change to our templates for one customer.

Our customer even noted that we are not the only ones who do not list this data on the certifications. We're just trying to figure out a logical solution, or if we are even required to provide that information at all since we are not 16949 accredited.
 
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