7.1.5.2.1 Calibration/Verification records

Good Morning

I am pretty new to this forum and very hopeful to find help to the following topic.

In our manufacturing we have several value adding operation steps, in this specific case:
turning (pre operation) & grinding.

All our measuring devices in the grinding department are well controlled with our calibration system.
In the turning department where we only have pre-operations (non-finished dimensions), it was decided to exclude the measuring devices from the calibration system (cost safing). These devices have of course identification numbers and are implemented in our software for measuring devices. But they are marked with an orange dot to indicate that they are only allowed to be used for the measurement of non finished parameters.

Some additional facts:
We have described this process in our Quality Handbook
The process is well known in the manufacturing & it is a specific work instruction for handling devices with the orange dot on each relevant work station
It is physically assured that devices with this dot can not be used in the department where finished parameters are measured

There are no problems existing that we have more waste in the grinding department when using non calibrated devices during the pre-operation turning. So no waste is generated.

How do you see this situation?
The Auditor is claiming that also these devices needs to be implemented in the calibration process but from the value add perspective this makes no sense for us.

Thanks to all for your opinion and experience.

Best Regards
Colorado

 

Morning Col,

I have had similar discussions around Tape Measures in our pre-production area where we slit materials down to very rough sizes (+/- 1-5mm) which are then further cut down in our finished process (+/- .1). My argument was the discrimination and accuracy we need is far lower and is not an actual "product" like you are saying. That said, this is how the auditor reasoned it to us:

"If not calibrated the measuring device could be infinitely inaccurate, are you saying the pre-product could be infinitely out of spec and the next process will be fine?"

Obviously the answer has to be no, so you do need SOME level of accuracy and the only way to ensure this to calibrate and do a GR&R to understand how well you can measure.

The only suggestion I have heard of to get round this is to use go/no go or some from of Poka-yoke so you do not need to use an actual "measuring device".

 

Chales, thanks a lot for your response.

I just came back from another meeting concerning this matter.
The outcome was similar to your suggestion to use some kind of go/no go check.

The current idea is to use calibrated "master parts" in the pre-production area for comparison measurements.
So even if the measuring device itself is not calibrated by an external support i will be able to assure that the device is not "infinitely inaccurate" as i know the exact value of the master part and the measuring value of the device which is not calibrated.
By defining a maximum difference of these two values i can assure that the deviation will stay within a controlled limit which has no negative influence on the following (final) operations.

What do you think?

 

Good day @Colorado and welcome to the site.

If my understanding is correct, ...
- your organization has devices that are used for preliminary measurement of in-process materials, and NOT used to verify product conformance.
'- calibrated and/or verified traceable measurement devices/activity are employed (once the product has matured through the process), to verify product
conformance.
Are these understandings correct ?

What exact clause is your auditor claiming non-conformity to ?

Assuming that your organization reference these as an "evaluation method" on your control plan (why not), then the requirement specific to your situation is as follows...


There is not even a requirement for "calibration" on the devices to which additional control applies (note the standard speaks of "calibration / verification").

Based on my understanding of your organization's situation (as defined above), I see no validity to your auditor's claim.

Reminder:
It doesn't matter how "...you (I/we) see this situation" .
It doesn't matter what the "The auditor is claiming...."....

...it only matters what the standard and your customers require.

Hope this helps.
Be well.

 

Morning all,

I could not agree more, but it does look like auditors are going round and making these claims and demanding things be calibrated, for the sake of a small calibration charge its just not worth pissing off an auditor who wants to flex their muscle, incorrectly or not. Every time I have challenged auditors it has almost always bitten me back. If its a measuring device I get 7.1.5 and 7.1.5.2.1 thrown at me.

 

Dear John!

Yes, your assumptions are correct.


The clause the auditor is claiming non conformity to is the following:

7.1.5.2.1
"....Records of the calibration/verification activity for all gauges and measuring and test equipment (....) needed to provide evidence of conformity to INTERNAL REQUIREMENTS, legislative and regulatory requirements and customer defined requirements shall be retained"

The argument of the auditor was, that the parameters (tolerances) we are measuring are INTERNAL REQUIREMENTS even if this is a pre-process requirement and therefore we are obliged by the IATF to perform calibration.

Pretty small room for argumentation.

But nevertheless all of you arguments to "show the auditor the door" are very appreciated. I think sometimes it is really necessary to stand up against the CB-auditor and not accept all of the non-conformities they are claiming

Thanks a lot
Colorado

 

The key here is 'evidence of conformity to INTERNAL REQUIREMENTS. As was already suggested, your internal requirement can be something very simple - verify that the end toggle is present, and that the markings on the tape itself are legible. There is NOTHING in the standard (at least not yet) that says HOW you have to perform calibration/verification of any gauges. Yes, they could always throw up the need for GRR studies to prove that your chosen method is reliable, but that is a (relatively) easy task.