IATF 16949 7.1.5.3.2 External Laboratory - Calibration of Nikon machine in factory

#1
Hi all,

Hopefully anyone can help me with this External Laboratory requirement.

We are using Nikon machine in factory and engage Nikon members to calibrate the machine all this while. During last year audit, auditor have highlight to us that Nikon is not certified with ISO 17025 and they explain the content of IATF standard clause 7.1.5.3.2
My understanding is we need to find external lab which certified with ISO 17025 OR get customer approval for next calibration. Easy way we find external lab to calibrate the machine rather than ask approval from customer.

The problem is now, external lab can perform the calibration but not able to do adjustment on the machine (data out calibration tolerance). So my queries now is:
1) Can we call Nikon to calibrate & service the machine and use their calibration cert instead? (note Nikon not certified with ISO 17025). And we attached external lab report as an evidence to show that we unable to find external lab to calibrate the mc and relate with below statement.
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2) Or after Nikon calibrate & adjust machine, we call external lab to once again perform calibration (double pay for calibartion)

Please help me. Because now I'm in argument with my purchasing team due to this external lab requirement.
 

Sebastian

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#2
Option 2 is partially "acceptable," as Nikon is not authorised to even verify or when needed adjust your equipment.
Auditor probably won't notice it, unless you tell him, but still it is not what is required by standard.
Option 1, there is another laboratory, but you are going to create document saying, there is no such laboratory.
I know people who are happy to have this kind of staff on board.
 
#3
Option 2 is partially "acceptable," as Nikon is not authorised to even verify or when needed adjust your equipment.
Auditor probably won't notice it, unless you tell him, but still it is not what is required by standard.
Option 1, there is another laboratory, but you are going to create document saying, there is no such laboratory.
I know people who are happy to have this kind of staff on board.
Option 1, actually external lab came over to calibrate but the report shows data out spec and they cant do adjustment. So think of using the report to show that external lab unable to do calibration.
 

Sebastian

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#4
One comment - calibration is verification followed by adjustment/correction of errors observed during verification.
Nikon does both, even not authorised.
External lab does verification only.
 
#5
I would go with the approval from the customer option. No reason to have to providers for the one piece of equipment. Nikon built the darn thing, I am sure they can adjust and calibrate regardless of what IATF people say. Just tell the customer they will need to pay for the extra provider. :)
 
#6
One comment - calibration is verification followed by adjustment/correction of errors observed during verification.
Nikon does both, even not authorised.
External lab does verification only.
Thanks for the comment. That is why we call Nikon for calibartion & adjustment. Now I stand with my opinion for option 1 but not sure whether it is acceptable or not =)
 
#7
I would go with the approval from the customer option. No reason to have to providers for the one piece of equipment. Nikon built the darn thing, I am sure they can adjust and calibrate regardless of what IATF people say. Just tell the customer they will need to pay for the extra provider. :)
You just dont now how complicated it will be if I go with cust approval (especially they have to pay for extra provider =)). by the way thanks for the comment.
 
#8
I am a little surprised the auditor picked you up on that. My experience, particularly with complex measurement systems (CMMs, roundtesters, etc), is that the manufacturer has generally been accepted even without ISO17025. As Sebastian says above, calibration is more than just checking that the measurement is correct. It also includes adjustment where necessary. Generally, commercial calibration houses would not have the knowledge/training to make the adjustments, even if they are ISO 17025 accredited. In that case it is normally the manufacturers engineers or even their agents that would do the work.
 
#9
I am a little surprised the auditor picked you up on that. My experience, particularly with complex measurement systems (CMMs, roundtesters, etc), is that the manufacturer has generally been accepted even without ISO17025. As Sebastian says above, calibration is more than just checking that the measurement is correct. It also includes adjustment where necessary. Generally, commercial calibration houses would not have the knowledge/training to make the adjustments, even if they are ISO 17025 accredited. In that case it is normally the manufacturers engineers or even their agents that would do the work.
The problem is the standard. It's pretty specific and an auditor just can't ignore it if he finds it. We used to have all kinds of this "trouble" with our weight scales. We would have the scale people in to calibrate and verify in accordance with state rules. Auditors always questioned it. It was a real PIA.
 
#10
I am a little surprised the auditor picked you up on that. My experience, particularly with complex measurement systems (CMMs, roundtesters, etc), is that the manufacturer has generally been accepted even without ISO17025. As Sebastian says above, calibration is more than just checking that the measurement is correct. It also includes adjustment where necessary. Generally, commercial calibration houses would not have the knowledge/training to make the adjustments, even if they are ISO 17025 accredited. In that case it is normally the manufacturers engineers or even their agents that would do the work.
previously no issue with this. in 2018 we have customer audit and IATF audit, auditor have highlight this issue. It already stated in standard and we have to comply to it. luckily we do not get NC. Thats y we find external lab to perform calibration. but the issue is they cannot do adjustment. now our purchasing call Nikon to do calibration and adjustment and call external lab to do 2nd time calibration to get cert with iso17025.
my dept need to bare cost for 2 times calibration.
 

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