Permissible Exclusions - How is 6.2.2.1 Product design skills being handled

[db]

Permissible Exclusions

Sub-Clause 1.2 reads (in part): “The only permitted exclusions for this Technical Specification relate to 7.3…..”

If this is the case, how is 6.2.2.1 Product design skills being handled for a non-design organization? How can you meet the “shall” if you exclude product design?

IMNSHO, this is a hole in TS.

 

[db]

Speaking of Permissible Exclusions

16949 Allows 7.3 product design to be excluded. It specifically states that process design are not included. Hence my question. There are parts of 7.3 that call out process design, there are other parts that do not. For example: 7.3.1.1 Multidisciplinary approach, does not say "process". Does this apply to process design? 7.3.4 Design and development review, same thing. Does it apply? Or does process design only apply to those sub-clauses that actually say "process"? I think that if the sub-clause can be applied to process, it should be. But where is the "shall", and how should this be approached?

 

[db]

Sad state

It is not a good thing when I have to post replies to my own posts.

 

[Dean P.]

I'm not well-versed in TS, I just want to wait and see if you start arguing with yourself.

 

[E Wall]

ANY HELP?

Is there no-one out there that uses or is familiar with 16949 and can help out?

Dave, Not having the benefit of the spec...I will take a stab (you are at least forwarned to blow this off if it isn't a match )

If the 6 series is resources, like the 9001:2000...then I would say you should use this to point (refer) to whomever is actually performing the tasks and what your company will accept as the minimum requirements.

Does that make sense? Eileen

 

[Al Dyer]

Since the shall is under the banner of human resources and training I would say that "if" you are design responsible those individuals performing the function must be competant.

I would say that if a company is not design responsible, it will not formally have trained product design personnel therefore the shall could be covered by a simple statement.

Just a thought.

 

[Marc]

Re: Sad state

db said:

It is not a good thing when I have to post replies to my own posts.

Nope - it's not good. But, all in all, most questions get responses rather rapidly as you know because often you're answering someone elses - for which I and all the others thank you for. Sometimes you have to 'bump' your question as you did. You know how it is with free services!

I'll have a look when I get back to the house tonight, but I suspect it's one of those 'little' things which will end up in a 50 page interpretations list (which those who wrote the document will, of course, blame on auditor incompetence or lack of training!

Dean P. said:

I'm not well-versed in TS, I just want to wait and see if you start arguing with yourself.

I want to see this as well! :thedeal:

 

[M Greenaway]

db

Perhaps not a hole as such, but not very clever either.

I cant imagine that an auditor would expect to see trained product design personnel at a company that performs no product design.

But you never know.........

 

[km2red]

I agree with Marc. 6.2.2.1 is in that particular spot because it deals with training. If you do not do product design, and you are "officially" excluded from it, then I would not worry about that requirement.

As for the intermingling of product/process reqirements, you just need to look at the requirements and decipher the wording. Most of the areas that are specifically for design, say so. If it doesn't, it's probably applicable to both, and you need to apply it to process design.

Multi-disciplinary approaches should be used where necessary to ensure that your process will produce a product that conformes to customer requirements. You may need to use (probably will need to use) a multi-disciplinary approach even in process design. It's basically just asking you to get the necessary people involved. (especally when developing a PFMEA, etc.)

Hope this helps

 

[Qualiman]

Producto Design Skills



Nobody is perfect...

IMHO the case of 6.2.2.1 for non design responsible organizations could be a failure of "design" or control of IATF/TC176 and the rest of the team responsible for the 16949:2002... who knows?.

It is not logic a "shall " applicable in Product design skills if the audited DOES NOT HAVE THAT DESIGN RESPONSIBILITY....I repeat, is my opinion.

By the way, talking about mistakes (errors, natural human errors) I have in front of me an IATF final Draft dated July 4 of ISO/TS 2002( which is already obsolete). It says ...7.6.4 Laboratory requirements, but it has to be 7.6.3. The proper order should be:

.......7.6.1 MSA
7.6.2 Calibration Records
7.6.3 Laboratory requirements....

In the official release of ISO/TS Second Edition the mistake was fixed....But some day it happened..

OK .. No attack to anybody , just an asertive opinion and a pretext to say hello to my frends of Elsmar, after a while out of the WEB

Greetings from Mexico

Qualiman