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.

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.

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

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?

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.

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

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.

mbrownlee@rosenproducts.com


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

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.

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 dewieo@yahoo.com

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

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)
dguffey@GLAKESMETALSTAMPING.COM

I just had a surveillance audit for QS-9000.
The auditor said that at this time their company accepts that our company does not have to comply to 4.10.6 if your company does not have a laboratory. Meaning, if your company only calibrates the gages, and measuring equipment. We send all our masters out for calibration to outside calibration suppliers and their certifications document they follow ISO Guide 25 and are NIST traceable. Moreover, our company does not have a metallurgical, nor other testing facility.

Hey Dawn, please send me a copy of your manual also to be prepared if my condition changes in the future.

Thanks,

Quirino A. Balderas
qbalderas@email.msn.com

me too

bqa@os.com

Could I also get a copy! It would be a great help,
stephanie_wilson@decoma.com

Thanks!

Could I have one too, please?
mibusha@usol.com
Thanks

For QS-9000, 3rd edition 4.11.2.b.1 - Be careful about suppliers stating that they are ISO 25 compliant per the 11/22/99 post above. I've seen this on many certificates of calibration. This isn't good enough. You need to get a copy of their ISO 25 certificate as real evidence.

Its "guide 25" ...... and only a guide, not a standard.

I'm not sure if my last reply message took, but you are correct that ISO 25:1990 is a guide, however it is to be replaced by the ISO 17025 Standard which may already be available. Nevertheless, many independent or commercial calibration shops / labs may not be aware they have to have a third party audit to ISO 25 or equivalent. http://www.aiag.org /quality/agencies.html provides a list of agencies that can do the assessment.

[This message has been edited by Bill M (edited 23 December 1999).]

See http://Elsmar.com/ubb/Forum4/HTML/000133.html

[This message has been edited by Marc Smith (edited 27 March 2001).]

Dawn, could you please email me copies of your lab scope. Thanks.

email address is: frank.chapman@dana.com

Dawn, could you please email me copies of your lab scope. Thanks.
emai: elardila@hotmail.com

According to the QS9K glossary, Laboratory scope is "A quality record (4.16) containing ...".
I thing the laboratory scope is a document within a manual or procedure (level 2 or 3), not a quality record (level 4), because a quality record is document evidence that the process were executed. (e.g. inspections and test RESULTS, internal audit RESULTS, etc)

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

Dear Dawn,
Could you please send me a copy too... I think everybody is very ancious to receive the copies from you including me.

Thanks & Bye...

Sasikumar G M
mailto:sasikumar.g.m@hical.soft.net

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Dawn:

Could you also send a copy of your procedure to me. Thanks in advance.

susan.lyman@mitsubishisilicon.com

Dawn, Please send me a copy also.

at vshields@icsindy.com

Dawn, I have not received a copy yet. Hate to bug you but I am writting ours right now, I received a hit during our audit 12-11-00.

[This message has been edited by vshields (edited 15 December 2000).]

Dawn,
Could you send me a copy also?
ron.taylor@donnelly.com
Thanks,
Ron Taylor

Are research and development labs required to have a documented "laboratory scope?"

I hadn't thought of that. In QS implementations I have been involved in the tst labs all had to be part of the calibration system (I was suprised how many companies did not calibrate R&D equipment - go figure) and if they did testing the testing part was considered a test facility and you had to have a scope and such.

I'd like to hear from a registrar on this one.

Marc
I work for a registrar but that doesn't mean this response will be of any help!
The definition of a laboratory for both QS-9000 and TS 16949 includes a test facility which may include reliability testing or test validation. For most design responsible suppliers, this definition will include the R&D labs so I would include them in the audit.
The QS-9000 sanctioned interpretations dated February 29, 2000 item C4 specifically excludes clauses 4.10.7 (external labs) and 4.11.2.b.1 (calibration services)for parts under design or development. However, I can't find any equivalent exclusion for 4.10.6 or any part of TS 16949.
I'd be interested to hear other opinions as laboratory issues are frequently controversial during audits.

The key here is to answer the question..."What is the primary purpose of the lab?" The QS-9000 glossary defines a laboratory as "...a test facility that may include chemical, metallurgical, dimensional, physical, electrical, reliability testing or test validation." The operative words in this definition are TEST FACILITY. If the primary purpose of the lab is to produce a test or inspection result, it is a lab and requires a scope as defined in the standard. If the primary purpose of the lab is for engineers and scientists to play, tinker, and design a new product, it probably doesn't meet the definition even if it may have a couple pieces of measuring equipment they use as an aid in their development. With this in mind, a scope of operations would not be required. Again, the operative words are TEST FACILITY. This certainly does not exclude a development lab from following other resident procedures such as calibration, safety, ESD, chemical handling, housekeeping, cleanliness, etc that may be established.

This position is further supported by looking at the context of the 4.10.6 requirement...Inspection and Testing. 4.10.6.1 starts right off by saying, "The laboratory (supplier's testing facility..." The clear intent of this element is to ensure that when decisions are made about a product's integrity or quality, the test data or inspection results used in that decision are from a reliable and credible source.

We have used this approach without any argument from any of our assessors for 4 years now. It is a common sense approach and has not even been debated. (Except for Incoming Inspection...which our registrar stated was a lab, we didn't agree. In the end, we applied the logic stated above and agreed. The primary purpose of Incoming Inspection is to produce a test or inspection result.

As far as R&D labs being included in the audit...audit away! Just don't ask for a scope if it is not a test facility. They should still be using calibrated equipment, follow safety procedures, etc...etc...and be auditable to those procedures.

Dawn,

I have been assigned to lead the Supplier Laboratory Requirements for QS9000 certification. I found that you have offered
to share your Lab procedure, appreciate if you can send me a copy also, my e-mail address is mlfl@ti.com

Thank you very much.
Lai

It would be of great help if someone could send a sample a lab scope and supporting procedures.

Please help...

Thank you

QS treated lab as not part of the process and required a subsystem for it, Policy, scope separate process entity with the works but yu can always link the lab system to your main system requirement. This method is accepted by the auditors....well at least the one from TUV.

Dawn

I would be very grateful if you could forward your much sought-after scope and additional information on Supplier Laboratory Requirements.

saa@henrob.co.uk

Thank you in advance!

Stuart

Does anyone have a copy of Dawn's procedure???

This clause seems to be a contentious issue. I’ve looked through the other posts on this subject within the Cove Forums and have concluded that it would be best to include this element within my procedures.

I was wondering if anyone had a sample of his or her scope and procedure that they would like to share. We could pass it on to the moderators and they could ensure it was circulated to other helpless quality people!

Is any one willing to help! Please!

saa@henrob.co.uk

Stuart,

The following sites are a repost from an earlier response from Marc to another post:

Check out the following:
http://Elsmar.com/ubb/Forum1/HTML/000088.html
http://Elsmar.com/ubb/Forum1/HTML/000185.html
http://Elsmar.com/ubb/Forum1/HTML/000159.html
http://Elsmar.com/ubb/Forum4/HTML/000074.html

I have some other samples at work (I think), I will root around and see what I can come up with.

ASD...

[This message has been edited by Al Dyer (edited 04 April 2001).]

Please may I have a copy as well. Kokoku Rubber's Lab looks like a mad scientist lives there with all of the equipment we use. In house would help cost savings:bigwave: :smokin:

gmaggard@kokoku-ky.com
Thx

Dawn, can I also have a copy of your procedure? I think that's helpful to me. Thank you.

link_xue@hotmail.com

Dawn,

If you are still motivated to help out, inspite of the number of requests, can I have a copy too?

Appreciate your gesture.

If anybody is interested, I've got an MS Word copy of our Lab procedure/work instruction and an MS Excel copy of our lab scope, just for reference. If people need help they can compare a few examples and choose the best points.
Mail me on stuartandrews@hotmail.com