Supplier Laboratory Requirements 4.10.6

[Linda Jurasin]

4.10.6 Supplier Laboratory Requirements


I need some help in interpreting this section of QS9000 3rd edition (including Tooling & Equipment Supplement). I am having difficulty with this entire section but specifically in two areas. In 4.10.6.1, does it mean that laboratories must be QS9000 or ISO registered? In 4.10.6.2 laboratory personnel, please interpret "appropriate". I reviewed 4.1.2.2 but still need clarification. I appreciate any and all help in this matter.

 

[Marc]

Note for 4.10.6 states 4.10.6 "...applies to supplier in-house laboratory facilities...." which all these paragraphs - 4.10.6.1, 4.10.6.2, etc. through 4.10.6.7.

From this the lab is essentially part of the scope of the supplier (your company) registration. No - the lab is not independently registered to QS.

As far as 'appropriate' goes in 4.10.6.2, that is really up to you to decide. Someone with formal education in calibration systems and related would qualify as well as someone with 10 years in the field. What they want to ensure is that, like in every other (almost) position in a company, people in a position are trained or in some way knowledgeable about what they are doing (read qualified).

The note with 4.10.6.2 is a bit much requiring theoretical experience, but I believe that would well be covered by an MSA course and a Metrology course (device physics at a low level). I have an integrated course which addresses both MSA and Metrology in general, by the way.

Don't let this stuff get you excited. Read every word and think about them. When I see appropriate, I expect an auditor to ask me to explain what and how so.

 

[Bryon Simmons]

I agree with Marc. At this point, I am writing the Level 2 Documentation to address these new requirements. At first, I panicked, but then I got to reading them, and they dont seem to require any more than what we are already doing, except now, we have to define it a bit better. Dont let this scare you. As far as having appropriate personnel, if you e doing any internal things, the personnel you currently have doing them, are very likely "appropriate", just need to document their training, etc...:show that they are appropriate.

Hope this helps.

Bryon

 

[rdparris]

Clarification. Our lab does meet all definitions for applicability. However, we calibrate all gages, measuring equip, etc in-house.

The interpretations of third edition lead me to believe for calibration, you must use a "qualified" in house lab. (this bumps you from 4.11 to 4.10 at this point)

4.10.6 is misleading. It consists of ISO/IEC guide 25 issues. It makes you think that at a minimum in order to do calibrations on site as a qualified lab, you must be compliant with ISO guide 25. But again, that's wrong. The note says compliance with guide 25 doesn't meet all the requirements. Go to the explanations at AIAG and you find that they say you don't need to be compliant with ISO guide 25.

So what gives? ISO guide 25 compliance according to the note in QS doesn't cover all QS requirements for a qualified lab.....but ISO guide compliance is not required.

Bottom line. Are we qualified to calibrate our own instruments and gages...or not? And would compliance with guide 25 reduce compliance issues?

 

[Marc]

Yes - you can calibrate them in-house. With the standard cavats - traceability to high level standards, calibration procedures, records of calibration (includes before & after readings), etc., etc.

 

[Bryon C Simmons]

Hi.

Actually, now, as far as calibration certs. go..you need only have any out of spec readings as received for calibration, and also a statement of conformance to specification after calibration, ( 4.11.3) Yes, you can calibrate in-house..just make sure the scope of your laboratory(4.11.2.b.1) includes calibration, and include the "masters" that you use to calibrate, (i.e. gage blocks, etc.) are included in the scope (4.11.2.b.1) See the glossary of QS-9000 for things to be included in the scope of the laboratory. All of your "masters" need to have NIST (or equivalent) traceability.

Hope this helps.

Bryon

 

[MaeB]

I have been asked to champion Supplier Laboratory Requirements for my company. I understand the requirement i just need a sample to get started, are there any out there? We manufacture flat panel displays for the automotive and aviation industries.
Thanks for any help.

[email protected]


[This message has been edited by MaeB (edited 22 November 1999).]

 

[Dawn]

If you post your e-mail, I can send you a copy of our procedure. We took a hit during assessment for the scope. It is a tough element. I would be glad to help.

 

[dewie]

Dawn
Could you please send me one of the copy? The document I plan to do for this requirement is to set a QM for laboratory. It's a bit tough for me. I would like to see the other way to reach the requirement.

My email address is [email protected]

[This message has been edited by dewie (edited 22 November 1999).]

 

[David Guffey]

Here's mine, too. Please and thank you.

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David A. Guffey, CQE, CQA, CQMgr
Director of Quality Assurance
Great Lakes Metal Stamping, Inc.
4607 Rambo Road
Bridgman MI 49106
616-465-4415
616-465-0805 (Fax)
[email protected]