Producing IATF 16949 compliant calibration certificates

[AndyN]

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!

 

[Golfman25]

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.

 

[Golfman25]

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.

 

[mlee97]

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?

 

[Golfman25]

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.

 

[mlee97]

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.

 

[Golfman25]

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 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.

They are calibrating your equipment and providing you with a certificate. If you where seeking IATF certification you would be good.

But now you are sending the wrench to your customer. It's calibrated off your calibrated equipment. Your certificate is the issue. Your customer needs something that will pass an audit. It's really their problem, not yours. You can help if they tell you what to do. But I don't think you'll get your calibration house to let you issue their certificate to your customers. You just have to figure out the easiest work around.

It's no different than when we have our scales calibrated by the manufacturer. Problems always arise because they don't have 17025. It's easier to have the guy that does our cmm do our scales as well.

 

[mlee97]

They are calibrating your equipment and providing you with a certificate. If you where seeking IATF certification you would be good.

But now you are sending the wrench to your customer. It's calibrated off your calibrated equipment. Your certificate is the issue. Your customer needs something that will pass an audit. It's really their problem, not yours. You can help if they tell you what to do. But I don't think you'll get your calibration house to let you issue their certificate to your customers. You just have to figure out the easiest work around.

It's no different than when we have our scales calibrated by the manufacturer. Problems always arise because they don't have 17025. It's easier to have the guy that does our cmm do our scales as well.

No, I think it is different because the certificate is generated off contracted equipment, maintained and monitored by that contractor, from the equipment manufacturer and that contractor/manufacturer is ISO/IEC 17025 accredited.

In your example - Suppose you hired a company to calibrate your gage weights that you make. The company is long term contracted to maintain the robotic scale and equipment at your site as opposed to theirs. They perform a MSA with the operators provided by your company to place the weights on a robotic fixture for loading and measuring with a cert printing out at the end of the line with the recorded values being networked to the manufacturer/contractor. The manufacturer contractor is up to date and accredited ISO/IEC 17025.

Now according to the external lab requirement of IATF, it appears that we only lack having to have the company update their certs with their name and the ISO/IEC 17025 accreditor logo. Do you agree?

 

[Golfman25]

No, I think it is different because the certificate is generated off contracted equipment, maintained and monitored by that contractor, from the equipment manufacturer and that contractor/manufacturer is ISO/IEC 17025 accredited.

In your example - Suppose you hired a company to calibrate your gage weights that you make. The company is long term contracted to maintain the robotic scale and equipment at your site as opposed to theirs. They perform a MSA with the operators provided by your company to place the weights on a robotic fixture for loading and measuring with a cert printing out at the end of the line with the recorded values being networked to the manufacturer/contractor. The manufacturer contractor is up to date and accredited ISO/IEC 17025.

Now according to the external lab requirement of IATF, it appears that we only lack having to have the company update their certs with their name and the ISO/IEC 17025 accreditor logo. Do you agree?

Sure. But I think your obstacles will be their cert and what it means to their accreditation to have off site certs generated. What do they say?

 

[mlee97]

Sure. But I think your obstacles will be their cert and what it means to their accreditation to have off site certs generated. What do they say?

Well while their C of A does mention a satellite location, it doesn't mention ours. So that is the big hole they'd have to fix. I think corporate will have to decide if they want to spend or fight to get their accreditation updated, or throw in the towel and take over the whole shebang.

I think we have paid way too much to throw in the towel just yet. Perhaps the agency will cut them a break to add the one machine satellite location. Even $20k would be cheaper than shipping the wrenches out at this point. Maybe even cheaper would be to just pay for a recalibration to any company that complained..