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  QS-9000
  4.10.6 Supplier Laboratory Requirements

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Author Topic:   4.10.6 Supplier Laboratory Requirements
Linda Jurasin
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Posts: 16
From:Amherst, Ohio USA
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posted 25 August 1998 09:25 AM     Click Here to See the Profile for Linda Jurasin   Click Here to Email Linda Jurasin     Edit/Delete Message   Reply w/Quote
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.

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Marc Smith
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From:West Chester, OH, USA
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posted 26 August 1998 06:28 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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.

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Bryon Simmons
unregistered
posted 30 August 1998 04:19 PM           Edit/Delete Message   Reply w/Quote
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

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rdparris
Lurker (<10 Posts)

Posts: 2
From:Auburn, IN, USA
Registered: Jan 99

posted 29 January 1999 08:48 PM     Click Here to See the Profile for rdparris   Click Here to Email rdparris     Edit/Delete Message   Reply w/Quote
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?

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Marc Smith
Cheech Wizard

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From:West Chester, OH, USA
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posted 29 January 1999 11:05 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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.

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Bryon C Simmons
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Posts: 65
From:Zeeland, MI USA
Registered: Dec 98

posted 30 January 1999 09:35 AM     Click Here to See the Profile for Bryon C Simmons   Click Here to Email Bryon C Simmons     Edit/Delete Message   Reply w/Quote
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

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