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  #1  
Old 19th March 2000, 04:31 PM
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Lightbulb 4.10.6 - Calibration services are conducted by a supplier's laboratory

Greg Gogates on 02/23/2000 01:00:00 PM

Date: Wed, 23 Feb 2000 08:11:23 -0600
From: Terry Conder
Subject: ISO/TS 16949

ISO/TS 16949, Section 4.10.6 states that where calibration services are conducted by a supplier's laboratory facility, the laboratory shall "comply" with ISO/IEC 17025. Commercial/independent laboratory facilities used for calibration services by the supplier shall be "accredited" to ISO/IEC 17025. What is the difference between "compliance" and "accreditation", and what is the process by which 3M Corporate Metrology Services, which provides calibration services to 3M plants producing products for automotive companies, can meet these requirements. Thank you.

Terry Conder
Manager, Corporate Metrology Services


Date: Wed, 23 Feb 2000 16:35:43 -0500
From: Tripp Martin
To: Greg Gogates
Subject: Re: ISO/TS 16949

The difference is:

External laboratories must be independently accredited by a third party, e.g. A2LA, L-A-B, SCC, etc.

Internal laboratories do not need to pay for their laboratories to be accredited, but they must meet the requirements of ISO 17025. How significant this is will depend upon how well the cert. body auditors are in the field. It appears to be a significant increase from QS-9000 4.10.6, but if the auditors don't understand much about 17025, then it may not mean much.

Tripp Martin

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Old 19th March 2000, 04:36 PM
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Date: Fri, 25 Feb 2000 16:54:15 -0500
From: "Peter S. Unger"
To: 'Greg Gogates'
Subject: RE: ISO/TS 16949

Terry Conder's question raises an interesting problem. The original intent of Guide 25 as authored by the international laboratory accreditation community was to have a uniform criteria for evaluation of the competence of a laboratory to carry out specific tests/calibrations. Guide 25 was never originally intended solely to be used as a set of "compliance" requirements to which laboratories must adhere. The intent was to have these requirements complemented by the specific requirements associated with each test/calibration for which accreditation is desired. And there would always be some degree of judgement associated with this competence recognition, with appropriate proficiency testing activity to support such judgements. Thus, there is the need for technical experts in each field to be part of the assessments for accreditation.

Some might suggest that there is no distinction between compliance and accreditation. If that is what you believe, then there is no need for further debate. But, if you believe as I do that there is indeed a significant distinction, then we have a double standard depending upon whether the calibrations are performed by in-house laboratories or third-party laboratories. This is unfortunate because it significantly disadvantages the third-party laboratories that must undergo the rigor of a competency assessment by an accreditation body instead of a less technically-rigorous compliance audit by a quality management system registrar. More importantly, it would also allow for the acceptance of calibrations from laboratories that merely comply with Guide 25, but may not have had to demonstrate their competence. To most in the international laboratory accreditation community, this situation is unacceptable.

To illustrate the distinction on a personal level, I am an RAB-certified lead auditor for all types of laboratories. In effect, I have been qualified to audit any type of laboratory for ISO 9001/2 compliance. One can perhaps infer that I am also qualified to perform a Guide 25-compliance audit based upon this credential. But, because I have been away from working in a laboratory for 25+ years, I am not qualified to perform a Guide 25 accreditation assessment by myself. No laboratory in their right mind would want me solely making judgements about their technical competence with that old of a track record.

Based on the above, the current reference to ISO 17025 in ISO/TS 16949 should be revisited by the committee with jurisdiction.

Sincerely,

Peter Unger
A2LA President
5301 Buckeystown Pike, Suite 350
Frederick, MD 21704
Direct Line: 301 644 3212; Fax: 301 662 2974
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Old 19th March 2000, 04:38 PM
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Date: Fri, 25 Feb 2000 22:59:09 -0800
From: Sham Beri
Subject: ISO/TS 16949 RE3 -Reply

Dear friends:

I understand the difference between ISO Guide 25 "accreditation" versus "compliance". Sure, the former is more technical, proficiency based and "compliance" is programmatic .. However, "compliance" also pays nothing to A2LA and NVLAP!! So they cannot be expected to like it! ! The fact is that QS 9000 says if you "buy" testing/calibration, go to an "accredited" laboratory. This lab sells specialized service - it has to be accredited. But if you do it in-house, just comply with QS 9000 element 4.10. That was not unfair to accredited labs - because you are not selling these services - you affect your own product - not others!!

Similarly, now TS16949 says if you are buying these services they should be from an accredited lab. However, for in-house work, just comply with ISO Guide 25 - which is a bit better than just meeting section 4.10 of QS 9000.

Conclusion IMHO:

Requiring ISO Guide 25 compliance for in-house testing/calibration in TS 16949 is a step in the right direction. It will never be practical for all manufacturers to obtain accreditation for in-house labs!! For out-side labs we should continue to insist on accreditation!!

Best regards,
Sham Beri
503-556-6486
BSEE, MBA
Lead Auditor, ISO 9000 RAB/ICA, QS 9000
Lead Audior ANSIN45. 2. 23
  #4  
Old 19th March 2000, 04:41 PM
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Date: Sun, 27 Feb 2000 15:05:27 -0600
From: David Hussar
To: Greg Gogates
Subject: Re: ISO/TS 16949 RE3

Regarding Peter's comment:

"This is unfortunate because it significantly disadvantages the third party laboratories that must undergo the rigor of a competency assessment by an accreditation body instead of a less technically rigorous compliance audit by a quality management system registrar. "

This is the main reason why my company has not sent our five grand to the fine folks at A2LA. I'm sure one or two other cal labs have noticed that the Metrology and QC labs of their larger customers are trying to increase the size of their departments. I even have one customer that we strongly suspect is increasing the amount of reporting and paperwork required, simply for the sake of increasing our costs. They have already taken over the calibration of equipment that other cal labs were previously doing.

Anyone who has been in the calibration business for a while probably knows what the long term outcome of this will be: The one guy at the company who knew a little bit about calibrating a lot of things eventually quits and the calibration program, which was barley getting by, turns to ruin. Procedures can never eliminate the need for experience. (e.g.. I talked to a guy who said it was not necessary to do a corner check because his balance was round.)

However, by the time it takes for Joe the cal guy to retire, or management to realize that they are spending a $100,000 for $10,000 worth of calibration, I have lost a customer. Than I'm fired for spending my time and my company's money on obtaining and retaining accreditation. In the mean time my competition, using temporary laborers is making a fine living charging $25 dollars an hour for calibrations.

Sorry about the ranting Peter, I deeply appreciate your concern, I just hope enough people share it.
  #5  
Old 19th March 2000, 04:54 PM
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Lightbulb

Some more thoughts....

Date: Mon, 28 Feb 2000 12:07:48 -0500
From: Lynne
To: Greg Gogates
Cc: Brenda Dusek
Subject: Re: ISO/TS 16949 RE5

Why would L-A-B have to be recognized by A2LA or NVLAP to be referenced in the same light? So far, A2LA and NVLAP have not been given the authority by anyone to "recognize" accreditation bodies, and I can't imagine anything that would be a greater conflict of interest. L-A-B derives its authority from the Big Three auto makers and others who recognize their accreditations. They do not need, nor can they expect authorization from other accreditation bodies. There seems to be some misunderstanding about, where and/or from whom, an accreditation body derives its authority. Their authority comes strictly from those organizations that recognize their accreditations and are willing to use the results of those accreditations.

At some point in time I am sure that L-A-B will seek mutual recognition with A2LA and NVLAP, but that is certainly not anything that bestows any authority. A2LA and NVLAP have both signed mutual recognition agreements with each other, but if other companies or regulatory agencies have not given them the authority to do accreditations on their behalf they, don't have a reason to exist. All an MRA does, is indicate that the signatories agree that their systems are equivalent.(and a couple of other things that aren't relevant to this discussion) Just how much authority do you believe this bestows on an accreditation body, not much if you can't find anyone willing to use your accreditations. The fact that L-A-B has been authorized for use by the Big Three auto makers, gives them all the authority they need.

Tom, I realize your loyalty lies with A2LA, and that is admirable. Just remember they are not the ones, nor is NVLAP, that will ever give L-A-B the authority to exist. The users of their accreditations give L-A-B the authority to exist.

Best Regards,
Lynne

------------

Date: Tue, 29 Feb 2000 00:06:35 -0600
From: TSmith
To: Greg Gogates
Subject: Re: ISO/TS 16949 RE6

Lynn,

I am pro-accreditation. Yes, I am a A2LA Auditor and believe in their management and track record of maintaining a credable and Clear position on accreditation. Even to the point of having a meaningful "conflict of interest policy " . I'm sure that you would want any readers to clearly understand that L-A-B is granted its existance by the big three to serve the big threes efforts in allowing the suppliers of calibration services to the big three and that is where it ends. I did not want to confuse anyone to think that a L-A-B certistification or recregisteration lab services will be accepted by testing or calibration labs not serving the Big Three efforts. When I use A2LA and NVLAP in the same light, I am only referencing Accreditation bodies that have mutual recognition agreements. I thought if you were to use L-A-B with the other 2 accreditation bodies( that are also recognized by THE BIG THREE) in the same light, You might want the "rest of the story" to be clear for all readers. The only conflict here is representation.

Tom Smith
Pro Accreditation
Anti-confusionistic about certifistation or accregistration or what ever
you call tha thing that looks like , sounds like but IS NOT ACCREDITATION

----------------

Date: Tue, 29 Feb 2000 08:32:26 -0500
From: "gortakowski, charles"
To: 'Greg Gogates'
Subject: RE: ISO/TS 16949 RE6

As far as I know A2LA, and NVLAP have not signed an agreement to recognize each other in the US. They have signed an agreement under APLAC. But I have tried to get something in writing from NVLAP, or A2LA that they see each other as the same, or agreement to recognize each other. I could not get it. I am now NVLAP, and A2LA accredited. This was required by NVAIR because they did not see them as the same. If there is a signed document other then APLAC, I could really use it. This is a big problem in the US we have MRA's with other countries, but non internal. I just had to vent having lived through this issue. I am now going for a third accreditation. The cost of testing will have to go up some day. If there is a signed US internal MRA I could use a copy.

---------------

Date: Tue, 29 Feb 2000 10:53:11 -0500
From: Lynne
To: Greg Gogates
Subject: Re: ISO/TS 16949 RE7

Tom, It would be impossible for me to question your belief in accreditation. Yes, I agree that the whole story is important, not just for L-A-B clients, but for all accreditation body's clients. To my knowledge L-A-B has not misinformed anyone, on their authority or policies. Also to the best of my knowledge, you have never contact L-A-B, and inquired about their services, so I don't know where your innuendoes are coming from. I have seen and heard quite a bit of misinformation about L-A-B, presented, unfortunately, by well respected people in the laboratory industry, who, by the way, have not inquired about the L-A-B services, and are only spreading rumors and speculation. If one wishes to speak authoritatively about a subject, one must first know the subject.

The program that L-A-B has developed is based on the same standards (guide 65 & 25) used by both A2LA and NVLAP, and it is an accreditation body. All of the accreditation bodies have programs that suit the needs of their users. A2LA and NVLAP have great programs, and L-A-B has taken some lessons from them; why reinvent the wheel. If you want more information about L-A-B and their program, why not contact them. That way your statements about them will be based in fact, and not hearsay. I would hope that anyone considering accreditation would shop ALL of the options, and pick the one that is best suited to their business needs and budget.

Best Regards,
Lynne

--------------

Date: Tue, 29 Feb 2000 11:21:31 -0500
From: Ross Hansen
To: Greg Gogates
Subject: ISO/TS 16949 RE7

Tom -

While I do not imply to defend or speak for LAB, I must comment. The "Big 3" do not grant existence - they provide a need for a service which LAB (and others) provide. Second, LAB also claims to accredit testing labs (not just cal labs) - this is of particular interest to we in the EMC testing community. Third, acceptance of an LAB accreditation beyond the automotive industry will be dependent on the individual user. Many of our customers accept our data on the merits of our NVLAP or A2LA accreditation, solely on the basis of it being Guide 25 based. Finally, LAB is a relatively new accreditation body. Who is to say that they will not attempt to enter into MRA's with other agencies in the future? And regarding MRA's - if this was a major selling point, then our NVLAP EMC accreditation would be considered acceptable by the big 3. It is not.

Thanks for listening.

Regards,

Ross Hansen
QA Manager - Retlif Testing Labs
Visit our WEB Site - www.retlif.com

---------------

Date: Tue, 29 Feb 2000 14:21:18 -0500
From: "Loebach, David" david.loebach@cincinnati-tc.osha.gov
To: 'Greg Gogates'
Subject: RE: ISO/TS 16949 RE7

I fear something is going wrong with our system. Accreditation should serve as a voluntary mechanism to assure users of laboratories of some minimum level of competency. The purpose of accrediting bodies should be to serve the community at large rather than to become self-serving and an entity in themselves. I fear that this is what is happening. LAB serves the automobile industry by identifying minimum levels of competency in those that are accredited. LAB provides the same service to the automobile industry as A2LA and NVLAP provide to their clientele. It meets the definition of accrediting body. LAB exists because of the shortcomings of the accrediting bodies available to the automotive industry at the time. Instead of accepting the deficiencies in the existing systems, the automotive industry was big enough to form their own system. Power corrupts and absolute power corrupts absolutely. It is only a matter of time before an over concentration of power results in self-serving behavior, high cost, and general disregard for the customer.

Dave Loebach

---------------

Date: Wed, 1 Mar 2000 06:23:53 -0500
From: "Peter S. Unger" punger@a2la.org
To: 'Greg Gogates'
Subject: RE: ISO/TS 16949 RE8

I do not recall receiving a request from Chuck Gortakowsk, but A2LA recognizes NVLAP accreditation as equivalent to its own. This is a clear provision of the APLAC Mutual Recognition Arrangement (MRA). We would expect all APLAC MRA signatories to make the same statement in writing or otherwise.

The problem for the accredited labs is that users of accreditation do not necessarily accept this equivalence and, therefore, end up requiring one type of accreditation to the exclusion of others. The more clients that a laboratory has the more likely the demand will be for multiple accreditations. Every accreditation body that exists is going to have its users. Otherwise, it won't exist for long.

We hope that the situation of multiple accreditations would be lessened for US-based labs with the existing mutual recognition arrangement, such as APLAC's, and the emerging MRA under the National Cooperation for Laboratory Accreditation (NACLA). Come to the April 10th NACLA annual meeting to hear about progress on this subject.

Sincerely,

Peter Unger
A2LA President
5301 Buckeystown Pike, Suite 350
Frederick, MD 21704
Direct Line: 301 644 3212; Fax: 301 662 2974
Email: punger@a2la.org; Web: www.a2la.org
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Old 19th March 2000, 05:04 PM
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Date: Mon, 6 Mar 2000 19:32:19 -0500
From: Lynne
To: Greg Gogates
Subject: Re: ISO/TS 16949 RE20

To the contrary Ms. Foncannon, L-A-B can and does ACCREDIT laboratories to G25.

Lynne
  #7  
Old 1st April 2000, 08:15 AM
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ISO guide 25 is gone, replaced by iso 17025.
According to 4.10.6 from ISO 16949, internal labs must be compliant to and external labs must be accredited to ISO 17025 or national equivilant (a2la is listed in the deffinitions section as an equivilant)no exceptions as of yet.

The bad part of all of this is they have killed the chance of the 16949 being widely accepted and used, in my situation, my customer dictates that I use lab XXX in Japan for testing of my product. This lab is my subcontractor, they are not registered to 17025 or the Japan national equivilant and have no plans to do so.

Where does this leave me? With a complete ISO 16949 system that has been working fine for over a year but can not be registered because I can not use a different lab and there is no exemption to tell my registrar that I need to comply with my customers wishes.

My only way to become registered would be to have the testing done at my customers supplied lab for big, big, bucks then have the complete testing done again at a 17025 lab for big, big, bucks {assuming that one exists, I havent been able to find one yet}

Catch 22??????
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Old 1st April 2000, 08:50 AM
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Seems like QS had a little more room for
using customer waivers in situations like this - since they owned the document, I guess. Sure sounds like a catch 22 - is there an "interpretation" organization like they have had for QS?

By the way, if you were to have used a different lab than specified by the customer, would you have received a Contract Review non-conformance?

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