Just wondering how you all feel about this. Especially looking for replies from auto suppliers.

I see no reason why an internal lab shouldn't be 17025 compliant, but registration carries it too far. We ran into all sorts of problems when we were both A2LA and QS-9000. There are 2 seperate audits with 2 sets of opinions on how they want to interpret the standard. QS-9000 even states that 17025 would not satisfy all the requirements of QS-9000 requirements for a lab. This sets up the old "2 book system" we lived by before QS (I still don't think it is dead yet).

Just my opinion.

Dave

Hi all,

I'm of the 'other opinion'. I've been in internal QS labs that did exceptional work, with the added bonus of being able to tailor their calibrations and testing to their company's needs. I've also been in QS labs where the lead person was a machinist that got a 'promotion to this cushy job'. The problem is that I've met a number of QS auditors, and the majority that I've met know very little about the operations of a laboratory on a technical level, and these labs pass audits.

Herein lies my problem with the whole thing. QS9000 registration is not enough for a laboratory unless more auditors are drawn from a technical background, and that isn't going to happen.

Do I think that internal labs should be required to be 17025 accredited? Not in the least. From a metrologist point of view, it is a great idea, but from a business stance, it is pure folly. Companies are expected to do more with less, cut costs, improve quality, and dropping $100k (112.4k EUROs as of this morning) to improve quality while reducing unit prices is not a good way to stay in business.

I've seen '17025 compliant' labs, and usually, they are anything BUT 17025 compliant. If they were, they might as well spend the extra $5k and be accredited and be done with it, after all, to be compliant means that you could pass muster on an accreditation assessment. BUT, many make great measurements, which leads to great quality, even though 17025 compliance isn't met.

So what needs to be done? Something in between accreditation and QS9000 needs to be done. 17025 has a lot of measurement assurances, but also a lot of extra things that may not be necessary to ensure quality product. Internal labs need to understand and adhere to the measurement assurances that are practical (a rare term in ISO/QS lingo) and apply to their process. Such things as technically valid procedures (many aren't), uncertainty calculations (I've now seen an MSA study and I could shoot them so full of holes it is pitiful), and proficiency tests to prove a lab's abilities are necessary parts of the metrology world. The rest of 17025 is probably over the top for an internal lab, because the scope of an internal lab is much more focused. The problem is that so far, anything short of a true 17025 assessor doesn't seem to work. The assessor needs to understand the technical aspects of the lab, and be able to assess their abilities to make quality measurements. QS9000 doesn't provide that, and 17025 provides that, but also provides a lot of out-of-scope hassles.

So who wants to form a committee that can write a practical standard for internal labs?

Just some thoughts,
Ryan

I agree with Dave above. ISO17025 compliant, fine. ISO17025 registration, no.

I agree with Roger and Dave........

where did the $5K figure come from for registration cost? I see a heavier hit.

barb butrym said:

I agree with Roger and Dave........

where did the $5K figure come from for registration cost? I see a heavier hit.

The actual ACCREDITATION cost is about $5k. That pays for the assessment and accreditation body paperwork, nothing more. What I was saying is that if a lab claims that they are fully compliant with 17025, then the only cost they should have left is the accreditation body fee. What I've seen, however, is that most of the actual work involved in accreditation that adds to cost has not been done by labs claiming compliance. Time for validation of procedures and software, time and resources for uncertainty studies, interlaboratory comparisons, and check standards for in-process checks are the major costs of accreditation. In order to be truely compliant with ISO 17025, all of these things must be done, and done regularly.

What I meant was that all of those things may (or are) not necessary for an internal laboratory. You may not need true interlaboratory comparisons because of the tolerance the test equipment is used to measure (proving that a lab can calibrate a micrometer with an uncertainty of 2 µm makes no sense when your company makes products that have a dimensional tolerance of ±50 µm). Uncertainties may be able to be calculated with less detailed studies for the same reason. These are major costs that have no return on investment, and make no difference to product quality in such cases. Somewhere there needs to be a common sense approach, one that ensures quality without going over the top.

At this time, there is no common sense approach to laboratory quality. ISO 17025 is great for those of us that are strictly calibration and testing suppliers because we do not have a set group of measurements to temper what needs to be done. We have to be ready for everything from low accuracy and resolution needs to high-end laboratory standards. On the other hand, ISO and QS 9000 do absolutely nothing to ensure laboratory data validity or competence. What is in between? Nothing, nada, zilch. Do we need something? Yes, but it needs to be more tailored to application than ISO 17025, which is very minute in its requirements, regardless of application.

Ryan

When I originally started this, my vote was going to be a resounding NO. But, I changed to the 3rd choice mainly because if I was an OEM and receiving parts with tight tolerances and critical applications, I would want to make sure they absolutely meet the specification as measured by a competent lab.

However, being a supplier of acoustical and interior flooring applications, our company is really having a hard time finding a justification for being required to be ISO17025 accredited.
Most of our test specifications only require us to meet a minimum for physical properties with weight and thickness having a tolerance of +/- 10%. Rocket science it is not.

After all, I have never, ever read about someone being injured or killed because the carpeting in their vehicle failed causing them to lose control. :bonk:

I feel the cost of managing an accredited lab in a manufacturing enviornment would add more to the cost of the product than the benifit received, unless you are gage manufacture.

With OSHA, EPA, Taxes, and worst of all the Lawyers, American manufactures have a tough enough time trying to compete with other Countries that have little or none of the above.

At one time we allmost had ISO 10012 become the standard to have internal labs work to. In most companies this would be more than adaquate.

We just went through a surveillance and were hit on 4.10.6.1 because we didn't have our "scope" as a controlled document. Once again, we are a prototype shop, we have a very large tolerance that our CMM's can easily maintain. We don't have to be concerned with "soak time", our facility is not environmentally controlled, our equipment is calibrated by the OEM and each facility has a set of gage blocks that are calibrated by a certified lab. There is no added value to being certified to another standard and it would be a great expense to be bring our inspection area into compliance. Since we have never had an issue with the customer due to tolerances, we follow the MSA and our equipment is able to measure way above what is required by the customer standards, where would the company or the customer see benefit????
As for the non-conformance; we will generate a quality record showing that we understand the limitations of our equipment (we already have the personnel trained, equipment listed and the processes documented) that will only be used for audits. Totally Useless!!:bonk: :frust:

Ken K said:

When I originally started this, my vote was going to be a resounding NO. But, I changed to the 3rd choice mainly because if I was an OEM and receiving parts with tight tolerances and critical applications, I would want to make sure they absolutely meet the specification as measured by a competent lab.




Ken,
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.
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?
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.

James

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

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:bigwave:

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

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!!!!!!!!!!!!!!!!!!!!!!!
:mad: :mad: :mad: :mad:

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

:smokin:

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!!!!!!!!!!!!!!!!!!!!!!!
:mad: :mad: :mad: :mad:

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

:smokin:

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

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. :D


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.

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.