Calibration Purchasing Information - TS 16949 Audit Finding

howste

Thaumaturge
Super Moderator
#41
That's a good point. You do need to make sure that your procedures say that ISO 17025 accreditation is only required for labs doing work related to automotive customers.
 
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Raffy

Quite Involved in Discussions
#42
Hi howste,
Thank you for the input that you gave, what a relief in our part.
I'm currently revising our procedure to align to what you've recommended.
Btw, the Accredited Service Provider already replied to us and this was there answer as main root cause of not notifying the customer: " Nonconformity found is not properly notified customer for initiative or alternative chanelling to the other calibration provider"
And their corrective action is: Provide customer all significant supporting documents in support to the Calibration Service Provider.
Preventive Action: Re-orientation of all personnel.
Is this acceptable? For me, its so frustrating when people are contented of Re-orientation is enough.
For me this is a system failure on their part because of the requirement of ISO17025 Clause 4.5.2. Do they need an System Audit from a Customer just like us.
What do you think? Please advise.
Thank you very much in advance for the usual prompt attention you will give in this request.
Best regards,
Raffy
 

howste

Thaumaturge
Super Moderator
#43
That wasn't a root cause, it was a restatement of the problem. Also, as you hinted, there is no systemic change to ensure it won't happen again. I'd ask for them to go back and try again. If training their people didn't prevent it the first time, ask them why retraining (the same action) would prevent it now...

As far as a system audit, here are a few things to consider:
What would be the objective of the audit? In other words, what are you hoping to accomplish with the audit? Have they been a good supplier in the past except for this incident?

Also, what requirements would you audit? Do you or someone else in your organization have the competence to audit ISO 17025? Or would you audit them to ISO 9001 and their own documentation?
 

Raffy

Quite Involved in Discussions
#44
Hi Howste,
Thank you very much for the immediate reply.
As per discussion with our Purchasing, this is not their first time to commit the same problem of not informing the customer that they will outsurced calibration. But for us, this is our first time and I'm hoping that through audit we can evaluate and assess their standing (Calibration Management System) to our company as an accredited calibration service provider.
For audit, I, myself was trained on the documentation and internal audit for ISO17025. Would you think, this is enough for me to be competent to audit ISO17025. Please advise.
We can also audit them to ISO9001 and their own documentation. Since we are ISO9001 and TS16949 Certified Company. Or can I do both? Or do I have to choose between ISO17025 & ISO9001? Please advise.
Thank you very much in advance for the usual prompt attention you will give in this request.
Best regards,
Raffy
 

howste

Thaumaturge
Super Moderator
#45
I think you should be able to audit ISO 17025 with internal auditor training. Since ISO 17025 accredited companies should also conform to ISO 9001 you should be able to audit them to both.

If you do end up scheduling an audit, spend some time preparing and planning what you want to accomplish. Let them know in advance what the objectives of the audit are. If you don't already have it, ask for a copy of their quality manual (which should define their processes) and possibly their top level procedures. You might want to focus on their corrective action process, as it seems based on their response that they may not have a complete understanding of it.
 

Raffy

Quite Involved in Discussions
#46
Hi Howste,:applause:
Thank you very much for your continuous support.
It was a BIG help for us.:thanks:
We'll I hope, I can audit them both two weeks from now (depending on their availability), so that we could closed this issue before the month end.
Thank you so much.:thanx:
Best regards,
Raffy
 
#47
Looks like I missed this thread when it was fresh. I would add that all calibration services provided must be included in the supplier's ISO 17025 scope of accreditation. It seems that the scopes listed may be too generic to ensure that all services provided would fall into them.

Either that, or specify that the supplier must notify you if any items in the attached equipment list were not included in the supplier's ISO 17025 scope of accreditation
And I missed your answer while I was off. Both of our 17025 accredited calibration service providers warn us in advance and note on the calibration certificates if they must go outside their scope to calibrate something. While I appreciate the suggestion (and the guy who made it), I will probably not add it to our language for three reasons:
1) This was a 1/2a$$ed finding to begin with and I don't want to knock the top off of a dried pie.
2) I review all the calibration certificates to assure that any OOT conditions have no impact.
If no automotive customers have product affected by the equipment, then it's outside the scope of the TS 16949 requirements. If this is the case, then there is no problem.

3rd party TS auditors are only allowed to audit TS 16949 requirements on processes (including equipment) and products that affect automotive customers.
3) Since the TS portion of our business is small and pretty rigidly segmented as far as calibrated equipment goes, I would evaluate any out-of-scope calibrations to see if they have any impact. Therefore, I actually do accept out-of-scope calibrations if they don't impact my TS production processes.
 
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howste

Thaumaturge
Super Moderator
#48
I'm glad to see you back! After reading in another thread where you've been, it sounds like you have a lot more experience now with "scopes". :notme:
 
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