ISO/TS 16949 Section 7.6.3 - Use of Manufacturer to Calibrate

[AndyN]

The manufacturer is preferred for service for not only business reasons (Low cost) but for their expertise. You should not be forced to use an inferior source in order to pass an audit.

Not always true! I know of at least a couple of OE's where they possessed ZERO capabilities to calibrate their equipment! In one (bizarre) situation, the equipment was actually a safety related item and the manufacturer's response was 'it self calibrates'...

 

[miken11]

Not always true! I know of at least a couple of OE's where they possessed ZERO capabilities to calibrate their equipment! In one (bizarre) situation, the equipment was actually a safety related item and the manufacturer's response was 'it self calibrates'...

I know it is not 'always'; true. I was only offering another option to explain the decision to the auditor. I believe the auditor 'should' allow them to use good business judgment and protect their own customers by use of the manufacturer for service and calibration in the case cited. I was not trying to make a general case for all manufacturers.

 

[Jim Wynne]

Howard pointed out earlier that the manufacturer's ISO 9001 status is irrelevant. You must either use a 17025-accredited calibration provider or get customer approval for a non-accredited source. Those are the only options available.

There is a third option. If the manufacturer refuses to adopt a lab scope, tell the auditor that a corrective action is beyond your resources. The manufacturer is preferred for service for not only business reasons (Low cost) but for their expertise. You should not be forced to use an inferior source in order to pass an audit.

Not always true! I know of at least a couple of OE's where they possessed ZERO capabilities to calibrate their equipment! In one (bizarre) situation, the equipment was actually a safety related item and the manufacturer's response was 'it self calibrates'...

I know it is not 'always'; true. I was only offering another option to explain the decision to the auditor. I believe the auditor 'should' allow them to use good business judgment and protect their own customers by use of the manufacturer for service and calibration in the case cited. I was not trying to make a general case for all manufacturers.

There is no third option. If an auditor decides on her own to create one where none exists, the auditor is wrong. The OP is talking about a "shadowgraph" or optical comparator there are lots of qualified, 17025-accredited sources available, so lack of providers isn't in question. Just this week I had two optical comparators and four surface plates calibrated by an accredited supplier and the total bill was less than US$1000, so expense shouldn't be an issue either. Maybe the OP needs to shop around.

 

[howste]

A third option is to acquire the equipment and expertise to do the calibration internally.

 

[AndyN]

I know it is not 'always'; true. I was only offering another option to explain the decision to the auditor. I believe the auditor 'should' allow them to use good business judgment and protect their own customers by use of the manufacturer for service and calibration in the case cited. I was not trying to make a general case for all manufacturers.

Jim Wynne made the point in his post, the requirement is the requirement. The auditor cannot and shouldn't be 'bent' to a persuasive client, using such statements as 'good business judgement'. Good in whose eyes? A cheap, unqualified calibration could come home to haunt that decision.

 

[miken11]

There is no third option. If an auditor decides on her own to create one where none exists, the auditor is wrong. The OP is talking about a "shadowgraph" or optical comparator there are lots of qualified, 17025-accredited sources available, so lack of providers isn't in question. Just this week I had two optical comparators and four surface plates calibrated by an accredited supplier and the total bill was less than US$1000, so expense shouldn't be an issue either. Maybe the OP needs to shop around.

The information provided did not indicate any issue withe competence of the manufacturer or their ability to calibrate their own equipment. All this discussion of the 'what ifs' is a waste of time. As I said, in MY OPINION, the case cited should have fallen within the scope of using a qualified manufacturer. The auditor was being way too picky IN MY OPINION.

 

[howste]

The auditor was being way too picky IN MY OPINION.

The standard clearly states the requirements. The requirements were not met. The auditor did what was required.

 

[Golfman25]

So let me get this straight. They can manufacture the shadow graph, and all that entials, but they can't calibrate it, even though they provide those services?

If you have no other choice but to use a more expensive source (who has the required piece of paper), then maybe you can consider putting it on a longer calibration schedule. Good luck.

 

[AndyN]

So let me get this straight. They can manufacture the shadow graph, and all that entials, but they can't calibrate it, even though they provide those services?

If you have no other choice but to use a more expensive source (who has the required piece of paper), then maybe you can consider putting it on a longer calibration schedule. Good luck.

Indeed! I'd be intrigued to see why a shadowgraph needs calibration on a yearly schedule! This may be another clear indication that the company doesn't understand that, if they use the data, the periodicity can be extended - they just want your money! In actual fact, by using an accredited lab, you may save money over what you're currently paying! Go figure!

 

[BatteryHen]

The equipment is not stated on any control plan for a specific part. It is used to help calibrate a visual camera system that is tho - we compare the readings of the shadowgraph against the camera readings - and becasue we use it for internal calibration we have to ensure that it was covered by clause 7.6.3.2.

Indeed! I'd be intrigued to see why a shadowgraph needs calibration on a yearly schedule!

- something we had not considered either!

So, to get round this we have decided to develope a different calibration method that will use normally externally calibrated items, such as slips, which we send to an accredited house anyway. The shadowgraph will continue to be used for comparison work in house but not used as an aid for calibration.

Many thanks to everyone for your invaluble insights and assistance!