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  Supplier Laboratory Requirements 4.10.6

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Author Topic:   Supplier Laboratory Requirements 4.10.6
MaeB
Lurker (<10 Posts)

Posts: 1
From:Eugene,OR,USA
Registered: Nov 1999

posted 16 November 1999 05:22 PM     Click Here to See the Profile for MaeB   Click Here to Email MaeB     Edit/Delete Message   Reply w/Quote
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).]

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Dawn
Forum Contributor

Posts: 245
From:St. Marys, PA
Registered: Sep 98

posted 16 November 1999 10:01 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
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.

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dewie
Forum Contributor

Posts: 44
From:BKK
Registered: Sep 1999

posted 17 November 1999 10:08 AM     Click Here to See the Profile for dewie   Click Here to Email dewie     Edit/Delete Message   Reply w/Quote
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).]

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David Guffey
Forum Contributor

Posts: 49
From:St. Joseph MI, USA
Registered: Oct 1999

posted 19 November 1999 03:26 PM     Click Here to See the Profile for David Guffey   Click Here to Email David Guffey     Edit/Delete Message   Reply w/Quote
Here's mine, too. Please and thank you.

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


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Quirino A. Balderas
Lurker (<10 Posts)

Posts: 3
From:Indianapolis, IN, USA
Registered: Nov 1999

posted 22 November 1999 12:02 AM     Click Here to See the Profile for Quirino A. Balderas     Edit/Delete Message   Reply w/Quote
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


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barb butrym
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Posts: 637
From:South Central Massachusetts
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posted 22 November 1999 07:01 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
me too

bqa@os.com

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Steph
Forum Contributor

Posts: 20
From:Concord, Ontario, Canada
Registered: Mar 99

posted 22 November 1999 02:14 PM     Click Here to See the Profile for Steph   Click Here to Email Steph     Edit/Delete Message   Reply w/Quote
Could I also get a copy! It would be a great help,
stephanie_wilson@decoma.com

Thanks!

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mibusha
Forum Contributor

Posts: 60
From:Royal Oak, Michigan USA
Registered: Nov 98

posted 21 December 1999 01:15 PM     Click Here to See the Profile for mibusha   Click Here to Email mibusha     Edit/Delete Message   Reply w/Quote
Could I have one too, please?
mibusha@usol.com
Thanks

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wmccalla
unregistered
posted 22 December 1999 01:55 AM           Edit/Delete Message   Reply w/Quote
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.

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barb butrym
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From:South Central Massachusetts
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posted 22 December 1999 07:14 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
Its "guide 25" ...... and only a guide, not a standard.

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Bill M
Lurker (<10 Posts)

Posts: 8
From:Cary, NC, USA
Registered: Dec 1999

posted 23 December 1999 03:02 AM     Click Here to See the Profile for Bill M   Click Here to Email Bill M     Edit/Delete Message   Reply w/Quote
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. The 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).]

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

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
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posted 23 December 1999 04:55 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
See https://elsmar.com/ubb/Forum4/HTML/000133.html

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

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Frank
Lurker (<10 Posts)

Posts: 1
From:Russellville, AR 72802
Registered: Dec 1999

posted 30 December 1999 01:41 PM     Click Here to See the Profile for Frank   Click Here to Email Frank     Edit/Delete Message   Reply w/Quote
Dawn, could you please email me copies of your lab scope. Thanks.

email address is: frank.chapman@dana.com

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Elberth Ardila Tabera
unregistered
posted 31 December 1999 09:15 AM           Edit/Delete Message   Reply w/Quote
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)

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

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Sasikumar G M
Lurker (<10 Posts)

Posts: 4
From:Bangalore,Karnataka,INDIA
Registered: Nov 2000

posted 30 November 2000 12:57 AM     Click Here to See the Profile for Sasikumar G M   Click Here to Email Sasikumar G M     Edit/Delete Message   Reply w/Quote
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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lyman
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Posts: 19
From:Salem, Oregon
Registered: May 2000

posted 30 November 2000 10:50 AM     Click Here to See the Profile for lyman   Click Here to Email lyman     Edit/Delete Message   Reply w/Quote
Dawn:

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

susan.lyman@mitsubishisilicon.com

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vshields
unregistered
posted 30 November 2000 04:14 PM           Edit/Delete Message   Reply w/Quote
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).]

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Ron Taylor
unregistered
posted 01 December 2000 02:28 PM           Edit/Delete Message   Reply w/Quote
Dawn,
Could you send me a copy also?
ron.taylor@donnelly.com
Thanks,
Ron Taylor

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Cari
unregistered
posted 17 January 2001 02:11 PM           Edit/Delete Message   Reply w/Quote
Are research and development labs required to have a documented "laboratory scope?"

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Marc Smith
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From:West Chester, OH, USA
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posted 18 January 2001 01:19 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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.

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auditor16949
Lurker (<10 Posts)

Posts: 7
From:England
Registered: Sep 2000

posted 20 January 2001 05:08 PM     Click Here to See the Profile for auditor16949   Click Here to Email auditor16949     Edit/Delete Message   Reply w/Quote
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.

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J.R. Strickland
Forum Contributor

Posts: 24
From:Northbrook, IL, USA
Registered: Apr 2000

posted 25 January 2001 09:46 AM     Click Here to See the Profile for J.R. Strickland     Edit/Delete Message   Reply w/Quote
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.

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Lai
Lurker (<10 Posts)

Posts: 1
From:Malaysia
Registered: Mar 2001

posted 01 March 2001 08:28 PM     Click Here to See the Profile for Lai     Edit/Delete Message   Reply w/Quote
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

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Mkrickel
Lurker (<10 Posts)

Posts: 3
From:Erie, PA, USA
Registered: Feb 2001

posted 20 March 2001 07:47 AM     Click Here to See the Profile for Mkrickel   Click Here to Email Mkrickel     Edit/Delete Message   Reply w/Quote
It would be of great help if someone could send a sample a lab scope and supporting procedures.

Please help...

Thank you

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Alladin
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Posts: 3
From:
Registered: Mar 2001

posted 25 March 2001 02:39 AM     Click Here to See the Profile for Alladin     Edit/Delete Message   Reply w/Quote
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.

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Stuart Andrews
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Posts: 17
From:Denbigh, Wales, "Great" Britain.
Registered: Sep 2000

posted 26 March 2001 10:04 AM     Click Here to See the Profile for Stuart Andrews   Click Here to Email Stuart Andrews     Edit/Delete Message   Reply w/Quote
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

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
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posted 27 March 2001 02:00 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Does anyone have a copy of Dawn's procedure??

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