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Producing IATF 16949 compliant calibration certificates
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Producing IATF 16949 compliant calibration certificates
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  Post Number #9  
Old 13th February 2018, 01:30 PM
Golfman25

 
 
Total Posts: 1,433
Re: Producing IATF 16949 compliant calibration certificates

You are going to have a real problem here. In general outside calibration labs must be 17025 certified -- so most customer are looking for the cert with that designation to file away and "show the auditor" when it comes up. Simple.

Your customers can have their own independent calibration done.

The second option is it allows an exception if the external lab is acceptable to the customer. So your customer's customer would have to sign off. Probably more likely to get an act thru Congress.

Your "out" is in the second part of 7.1.5.3.2 which says: "Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met." 7.1.5.3.1 is the requirements for internal labs -- scope and such. You'll need to figure out how to get yourself into that exception. Good luck.

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  Post Number #10  
Old 13th February 2018, 02:40 PM
mlee97's Avatar
mlee97

 
 
Total Posts: 32
Re: Producing IATF 16949 compliant calibration certificates

Quote:
In Reply to Parent Post by Golfman25 View Post

You are going to have a real problem here. In general outside calibration labs must be 17025 certified -- so most customer are looking for the cert with that designation to file away and "show the auditor" when it comes up. Simple.

..

Your "out" is in the second part of 7.1.5.3.2 which says: "Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met." 7.1.5.3.1 is the requirements for internal labs -- scope and such. You'll need to figure out how to get yourself into that exception. Good luck.
The outside calibrator is the manufacturer of the test unit and they are certified to the 17025 lab standard. Their software actually produces page two and three of the certificate package, but page one, the actual cert, needs to be dressed up to Name the calibration lab and place the serials and cal data as I see it.

But other than that we should be OK, right?

Last edited by mlee97; 13th February 2018 at 02:42 PM. Reason: skipped word
  Post Number #11  
Old 13th February 2018, 02:55 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 9,040
Let Me Help You Re: Producing IATF 16949 compliant calibration certificates

So a couple of things: Firstly terminology - it's accredited to ISO/IEC 17025. Not certified - an important difference.

Secondly, as the manufacturer, YOU aren't responsible for the calibration of the wrench, the buyer organization is. If you don't provide an accredited 17025 certificate, then the buy must go elsewhere and get their calibration done. Simples!
  Post Number #12  
Old 13th February 2018, 03:38 PM
Golfman25

 
 
Total Posts: 1,433
Re: Producing IATF 16949 compliant calibration certificates

Quote:
In Reply to Parent Post by mlee97 View Post

The outside calibrator is the manufacturer of the test unit and they are certified to the 17025 lab standard. Their software actually produces page two and three of the certificate package, but page one, the actual cert, needs to be dressed up to Name the calibration lab and place the serials and cal data as I see it.

But other than that we should be OK, right?
Idk, but lets break it down.

You make a wrench.
You calibrate the wrench during assembly based on calibrated testing equipment which is done by a 17025 lab.
You issue a calibration certificate that the wrench is "good" based on your testing.
Your customers complain because your certificate doesn't show you are 17025 accredited, because you are not.
They don't like it because now they have to explain something to "the auditor."

Well in order to meet the equipment manufacturer "exception" your customer has to ensure you meet the 7.1.5.3.1 requirements. Basically 5:
a) adequacy of procedures
b) competency of personnel
c) testing of the product
d) capability to perform correctly and traceability
e) customer requirements
f) review of related records.

I don't know if naming the calibration lab "works" because they are not calibrating the wrench. You're showing traceability which is on part. It sounds to me like you will have to show the balance of the requirements as well.

You may need to sit with your customer and figure out what they need. My guess is they haven't really thought about it.
  Post Number #13  
Old 13th February 2018, 03:40 PM
Golfman25

 
 
Total Posts: 1,433
Re: Producing IATF 16949 compliant calibration certificates

Quote:
In Reply to Parent Post by AndyN View Post

So a couple of things: Firstly terminology - it's accredited to ISO/IEC 17025. Not certified - an important difference.

Secondly, as the manufacturer, YOU aren't responsible for the calibration of the wrench, the buyer organization is. If you don't provide an accredited 17025 certificate, then the buy must go elsewhere and get their calibration done. Simples!
Actually most buyers would not want to do this as it is probably not necessary. After some use, then certainly they are on their own.
  Post Number #14  
Old 13th February 2018, 05:43 PM
mlee97's Avatar
mlee97

 
 
Total Posts: 32
Re: Producing IATF 16949 compliant calibration certificates

Quote:
In Reply to Parent Post by Golfman25 View Post

Idk, but lets break it down.

You make a wrench.
You calibrate the wrench during assembly based on calibrated testing equipment which is done by a 17025 lab.
You issue a calibration certificate that the wrench is "good" based on your testing.
Your customers complain because your certificate doesn't show you are 17025 accredited, because you are not.
They don't like it because now they have to explain something to "the auditor."

Well in order to meet the equipment manufacturer "exception" your customer has to ensure you meet the 7.1.5.3.1 requirements. Basically 5:
a) adequacy of procedures
b) competency of personnel
c) testing of the product
d) capability to perform correctly and traceability
e) customer requirements
f) review of related records.

I don't know if naming the calibration lab "works" because they are not calibrating the wrench. You're showing traceability which is on part. It sounds to me like you will have to show the balance of the requirements as well.

You may need to sit with your customer and figure out what they need. My guess is they haven't really thought about it.
From my point of view I consider the externally contracted lab to be the defacto calibrator as the testing is robotic and set up by them. We don't touch it. It could be considered the same as if it were magically shipped to their location, calibrated, and zapped back. Their procedures, conformance and their calibration records would be by their control and on their accreditation. The only action by our people is to place the wrench on the unit and press go.
If we set up the certification by the contractor's name, with their blessing of course, wouldn't this meet the IATF requirements without an exception?
  Post Number #15  
Old 13th February 2018, 06:20 PM
Golfman25

 
 
Total Posts: 1,433
Re: Producing IATF 16949 compliant calibration certificates

Quote:
In Reply to Parent Post by mlee97 View Post

From my point of view I consider the externally contracted lab to be the defacto calibrator as the testing is robotic and set up by them. We don't touch it. It could be considered the same as if it were magically shipped to their location, calibrated, and zapped back. Their procedures, conformance and their calibration records would be by their control and on their accreditation. The only action by our people is to place the wrench on the unit and press go.
If we set up the certification by the contractor's name, with their blessing of course, wouldn't this meet the IATF requirements without an exception?
I wouldn't think that your provider would allow you to "use their name" to issue certificates. From your customers perspective, I think you would still have to meet 7.1.5.3.1 -- such as competency of personnel to place the wrench on the test unit. It's a grey area and will depend on what your customer needs. Realize this is probably driven by someone getting ready for an audit, or maybe in an audit, who realizes your cert doesn't have the magic 17025 on it. At the end of the day, it might be easier for them to send it out to an accredited lab for calibration.
  Post Number #16  
Old 13th February 2018, 06:58 PM
mlee97's Avatar
mlee97

 
 
Total Posts: 32
Re: Producing IATF 16949 compliant calibration certificates

Quote:
In Reply to Parent Post by Golfman25 View Post

I wouldn't think that your provider would allow you to "use their name" to issue certificates. From your customers perspective, I think you would still have to meet 7.1.5.3.1 -- such as competency of personnel to place the wrench on the test unit. It's a grey area and will depend on what your customer needs. Realize this is probably driven by someone getting ready for an audit, or maybe in an audit, who realizes your cert doesn't have the magic 17025 on it. At the end of the day, it might be easier for them to send it out to an accredited lab for calibration.
The calibration provider would have to like it or they would cease getting paid of course. We would have no use for them if they refused to provide a useful service. Our requirements that the system provider pass their MSA using our personnel loading should cover the placing of the wrench on the unit fixture. Again, I don't see how having an on-site calibration provider makes any difference to having the wrench sent out to them for calibration. Why would the physical location of the service matter in any way and how would the IATF separate the two? Why do you insist that physical location at the time of calibration matters?

Remember, the calibration equipment provider and calibration company are one and the same and they are under contract to provide a TS worthy (before IATF change) calibration certificate as I understand it.

Last edited by mlee97; 14th February 2018 at 09:04 AM. Reason: skipped word & added line
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