4.10.6 Supplier laboratory requirements - applicability

[Paul Morrow]

My thinking is that the intent of this requirement is to address in-house laboratories that verify product (otherwise why under 4.10). However is it applicable to a lab that is only concerened with process control, e.g. solution analysis, and performs no product verification whatsoever? I beleive so but would appreciate comment. Anyone queried this with their assessors yet?

 

[Marc]

My interpretation is that a company lab which is concerened with process control (e.g. solution analysis, and performs no product verification whatsoever) is subject to 4.10.6 requirements (See 4.10.6.1).

 

[Frank Cardillo]

Regarding 4.10.6, we do not have an in-house cal lab, a process control lab or a met lab. We maintain what we call a reliability lab containing temp and humidity chambers, temp cycling chambers and high temp soak chambers. We use this equipment to continually assess our manbufacturing processes. This activity is not a contract requirement. Is this lab subject to 4.10.6? If so what would you suggest would be the "laboratory scope"? If not, how do I address it in my quality manual?

 

[Marc]

Frank - my interpretation is you are subject to the requirement.

If you think about it, you stated the scope:

Reliability lab testing with temp and humidity chambers, temp cycling chambers and high temp soak chambers to continually assess our manbufacturing processes.

 

[Marc]

I'm not sure what thread she was responding to, but I received this from a reader:

Nancy Foncannon wrote:

Subject: Wrong answer

Mark: As an auditor for ISO/QS and A2LA, the only tests that need to fall under 4.10.6 are those that are required for PPAP data. Process "Tests"(i.e. solution testing, pH for example) need not be included, as process solutions, are covered in 4.9(d) monitor and control of process parameters.

4.10 applies to inspection of product, incoming, in-process, and final. The intent of 4.10.6 is to verify that the tests defined in the Lab's Scope (right, lab determines the Scope, not the auditor) are subject to compliance with the 4 or 5 new requirements listed.

The purpose of evaluating lab tests is to determine the quality of DATA produced, regardless of how well (or poorly) the company's products perform during testing.

That is why GM requires (in Section II and PPAP manual) that PPAP data come from "accredited labs". The requirements of 4.10.6 represent only 25% of the full ISO/IEC Guide 25 requirements.

Hope this helps!

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\\ Nancy A. Foncannon
// Quality Systems Consulting, Inc.
\\ ISO 9000, QS-9000, AS 9000, & Guide 25
// Auditing, Training & Consulting
\\ RAB Lead Assessor, ASQ Fellow
//
===============================>>>>>

Folks - when I'm wrong or off base, you don't have to point it out, errrr... Ummm...

No - all kidding aside. I hope when I'm wrong or off base that you speak right up (type right up?) in a response. I'm still learning and sometimes I'm not thinking real clearly and sometimes I simply misunderstand.

Thanks for the 'heads up' Nancy! Your input is much appreciated! I hope you join in the fray more often!

[This message has been edited by Marc Smith (edited 01-27-99).]

 

[Ganesh Chidambarakrishnan]

4.10.6 applies to all the testing done inside the supplier's premises, whether product testing or testing for process control purposes, as long as the testing is in relation to the product(s) falling under the QS9000 registration scope. Nowhere, neither in 4.10.6 nor in the glossary, laboratory is defined only for products.

Ganesh

 

[Lyndon Diong]

The note at 4.10.6 says "Element 4.10.6 applies to supplier in-house lab facilities, not insp or testing performed outside of a lab facility." I take that to mean that not all testing done is considered "lab work". I am inclined to think that lab provides supporting services. E.g It provide highly accurate measurement or reliability test. Thus temp/humidity etc are tightly controlled. 4.10.6.3 seems to imply that the products are received by a supporting group. Any comment? P.S 4.10.6 is not applicable to Ford suppliers.

 

[Batman]

Forgive the tardiness, but this just became an issue at my facility. I would appreciate specifics from the experts. We have part of two QA offices that contain test equipment such as hardness tester, Instron, indicators, laser mic, comparator, plating thickness, etc. We perform some testing for the manufacturing folks as tensile testing, hardness testing, some dimensional test for less frequent and sometimes important features. Almost all of the testing is of the final type - is the tensile strength up to the customer's requirements, etc. We take in no outside work. The information is mostly recorded; in a few instances the data is included with forms or certs as required by the customer. There is no specific humidity or temperature controls, other than the equipment shares the same environment as the offices, cold in the morning, hot in evening. It is not A2LA, or otherwise certified. Each piece of equipment is calibrated by the manufacturer on schedule - a schedule maintained by the gage guy - and are mostly used for infrequent small samples. From this description, is it considered a "Laborotory" with respect to 4.10.6, and as such does it need a scope, list of equipment?

 

[Bryon C Simmons]

Well, having been there just a couple of weeks ago with our registrar, I would say that your "lab" IS subject to 4.10.6

The other thing......you mentioned the "lab guy". Make sure that ALL of your personnel that are making decisions in relation to testing and/or calibration, are qualified to do so, through education and experience, and make sure that those qualifications/experience are documented. Typically, this would be done in Human Resource records.

Be pragmatic about the "scope". I defined our lab scope in Level II documents. This was adequate.

Hope this helps.

Bryon

 

[Batman]

Bryon, thanks. I am convinced. May I belabor the point a little further. At my facility, we have 6 areas that do "lab" type testing. Some are little areas off production areas, a couple are included in offices. Each is under different supervision - Engineering, production, QA, etc.- and for the most part each does tests different from others. Do I need 6 scopes?