Should QS/TS certified internal test/calibration labs be required to be ISO17025

[Ryan Wilde]

Re: Competent = Accredited?

JRKH said:
I agree wholeheartedly. Where in a situation with critical tolerances I want my lab to be competent to make the measurments. But the origional question was not about competance or compliance, but accreditation.

[Devil's Advocate]
The reason we are accredited is proof with a single audit. I can write a manual, I can state that I am competent to test the presence of mercury in drinking water, but it isn't true. I can also state that I can produce 10 VDC with an uncertainty of 0.8 PPM, but without a qualified, competent assessor, you have no way to prove that, because if you, as my customer, could produce 10 VDC with an uncertainty of 0.8 PPM, you wouldn't need to pay me to make the measurement in the first place.
[/Devil's Advocate]

If we take the time and expense to set up a competent lab, and we have no complaints from customers re: measurements what is the point of getting certified?

But if you are making measurements that your customer relies upon, measurements that they have no means to prove or disprove, again, how can they know?

Before being forced to become certified to QS, we had a system in place based (somewhat loosely) on ISO-9000. In the preamble of the Quality Manual I stated that the system is ....."Designed to comply with the intent of ISO 9000....."
This both indicated a what we were shooting for and an out for anything we felt was superfluous. This system was just fine with our customers.
It strikes me that a similar statement in regards your internal lab should be sufficient.

Statements are fine, but they are not proof of competence, which is what an Accreditation is. The major difference between a Registration/Certification to a quality system and an Accreditation is proof of competence. Our assessors (two of them) spent three days at our location (eight employees), and all was actually reviewing our measurement process, not just documentation and paperwork, but the actual process. A statement is not proof, it is a leap of faith.

Now, I still don't think that everyone that makes measurements needs, or should, be accredited. Accreditation for wide-tolerance measurement is ludicrous. A statement of compliance shouldn't even be necessary. It's akin to putting makeup on a pig.

I agree with Ken, when the tolerances are tight, and the customer cannot prove nor disprove your measurements, then the only recourse for proof is third party assessment of competence, therefore Accreditation rears its ugly (time-consuming, expensive) head.

What I still feel is that something needs to be in between - something that is not full accreditation but is proof of competence. QS9000 manufacturers are not generally making measurement devices or standards, they are generally making P/N XXXXXX-XXX that goes into the 3.0L engine. The customer has no use for the data (a requirement of 17025) other than a warm fuzzy feeling. If the customer has proof of competence, the part should fit, and last as long as it was engineered to last. That is what everyone is shooting for, but the shift is from the old "handshake" sytem of trust to the "prove it" system. A statement of compliance is a written "I'm competent, trust me" system, which doesn't hold much water with corporations anymore.

Ryan

 

[JRKH]

Ryan

You make excellant points in your response.
As to the something in between.....

1) Set up a lab
2) Have tools and equipment that are traceable to NIST
3) Measure items and record results
4) Send items to certified oustide source and have measured.
5) Evaluate results.

Do I now have proof of competance without accreditation?


James

 

[Ryan Wilde]

James,

You are very close at this point. The only thing that I think you would be missing is:

A) Method and standards/equipment adequacy evaluation (it's usually very easy);

B) Acceptance criteria for evaluated results (assuming that items 3-5 are basically an interlaboratory comparison, how close do you need to be to the other lab's results?)

C) Review by an Competent outside source that you haven't made technical mistakes that could invalidate your measurements. (Note: Quality system auditors are rarely technically competent in specific measurement disciplines and cannot make the call as to competence.) This shouldn't actually take that long in the auditing phase, as all of the bells and whistles have been removed.

Note that I didn't mention uncertainty as required by 17025. Uncertainty is a great concept when passing along traceability down a chain of standards/measuring equipment, but close to useless on an end-item, such as a screw hole placement.

I also didn't metion a requirement for data to be taken on all measurements for the same reason. On a manufactured part, it is either good or scrap, and the only use for data is to monitor trend to readjust a system prior to making a bunch of scrap parts. IMHO, this should not be a requirement, but instead up to the company if it finds that the cost of scrap outweighs the extra time and systems required to keep such data. As long as you don't send out bad parts, calling them good, it's no one's business how many you threw away.

Most of this stuff companies already have in place, but no, not to the level of 17025, nor do they need it to that level of minute detail. You don't have methods that are out of line with what you are doing, you have your equipment/standards calibrated, you basically know that your results have an inherent amount of inaccuracy due to sytematic and random errors. I'd love to see a practical person at AIAG write the technical requirements into the next version of QS9000, and require that the auditing companies hire technically competent people to ensure it, all in a single audit for you.

Adding requirements that heap more on a company, most of which is overkill for what they do, is not practical. QS9000 is not set up to ensure what I would call "adequate and appropriate" measurement quality (competence), but the question is, why not?

Ryan

 

[Ken K]

Excellent replies Ryan. You have made many valid points, as did James.

I guess what really bugs me about this whole situation is one person, at a huge company that receives thousands of products per day from suppliers, can put such burden and expense on a supplier whose product really isn't that critical as far as tolerances go. Does an internal lab really need to be ISO17025 accredited to measure the weight of material with a tolerance of +/- 10%? Does it need it for measuring thickness of the same part with the same tolerance? Does it need it for the final product whose trim line tolerance is 6mm?

Maybe if all companies we supply to would require ISO, I wouldn't disagree so strongly. But they don't and they won't, at least for now.

So, here I am, seeking ISO accreditation for one test specification that uses 17 test methods, of which we use 15. Is that value added for suppliers who are constantly asked for price cuts for their products, even though the profit margins are already slim?

Our lab has been supplying test data for 12 years without any problems. We have been QS since 1996 (GP-10, which was a joke, since 1994) and all of a sudden our lab pack gets bounced back in our face.

Can you say utterly frustrated!!!!!!!!!!!!!!!!!!!!!!!


But then again, should we expect anything less from the
Big 2 1/2?

 

[Ryan Wilde]

Ken K said:

I guess what really bugs me about this whole situation is one person, at a huge company that receives thousands of products per day from suppliers, can put such burden and expense on a supplier whose product really isn't that critical as far as tolerances go. Does an internal lab really need to be ISO17025 accredited to measure the weight of material with a tolerance of +/- 10%? Does it need it for measuring thickness of the same part with the same tolerance? Does it need it for the final product whose trim line tolerance is 6mm?

Somewhere along the line, practicality took a backseat to rhetoric. In a case such as yours, with tolerances you could nearly meet by lifting the material and saying "feels about right" and using a wooden school ruler for dimensions, ISO 17025 is beyond ludicrous. My line will continue to be "adequate and appropriate". Adequate and appropriate in your case should be very minimal, if your equipment is calibrated it would be difficult to screw up, therefore quality is assured by the process itself being simple by nature. Now if you were measuring the orifice on a diesel injector, I'd prefer there would be something in place to verify that you know what you are doing.

Maybe if all companies we supply to would require ISO, I wouldn't disagree so strongly. But they don't and they won't, at least for now.

Don't give them any ideas.

So, here I am, seeking ISO accreditation for one test specification that uses 17 test methods, of which we use 15. Is that value added for suppliers who are constantly asked for price cuts for their products, even though the profit margins are already slim?

It's not value added if you are making a huge profit margin. It's just plain not value added.

Our lab has been supplying test data for 12 years without any problems. We have been QS since 1996 (GP-10, which was a joke, since 1994) and all of a sudden our lab pack gets bounced back in our face.

Can you say utterly frustrated!!!!!!!!!!!!!!!!!!!!!!!


But then again, should we expect anything less from the
Big 2 1/2?

It seems that what is needed is arbitrators. You are supplying a customer that has a single person that truly has no concept of quality, but knows what he/she has read. Have you considered slapping him/her on the side of the head with a mackerel, stating something to the effect that he/she is functionally illiterate?

Ryan

 

[Ken K]

It seems that what is needed is arbitrators. You are supplying a customer that has a single person that truly has no concept of quality, but knows what he/she has read. Have you considered slapping him/her on the side of the head with a mackerel, stating something to the effect that he/she is functionally illiterate?

I would prefer using a road killed moose.


It's hard fighting a single person backed by a huge corporation. You end up giving them what they want and hope they'll be happy ever more. What else can one do?



I just hope this journey doesn't take us down a yellow brick road.

 

[Ken K]

Well, our journey has begun. We were asigned an assessor on Tuesday. Turns out he spent 35 years working at GM, retired and is now a consultant. How totally ironic!

My boss, bless his heart, put us on a three month schedule. Should be an interesting ride.