Exclusions clause 7.3 - Our organization doesn?t design products - ISO/TS 16949

I am new to the world of QMS and have some problems interpreting clause 7.3 of the ISO/TS 16949. I hope somebody can help me out.

If an organization doesn?t design products, they can exclude clause 7.3.2.1 (product design input) and 7.3.3.1 (product design outputs ? supplemental), correct? And how about clause 7.3.3 (design and development outputs) and 7.3.6.2 (prototype programme)? Can those be excluded?

Thanks for the help!

Re: Exclusions clause 7.3 - TS 16949

A Quick Bump!

Can someone help?

Thank you very much!!

Re: Exclusions clause 7.3 - Our organization doesn?t design products - TS 16949

hi,
it's quite simple.
You have to state this exclusion clearly in your top level Quality Manual in your QMS. List all the clauses your site/ organisation is excluded from and include a detailed justification.
example:
7.3.6.2 Prototype programme - our organisation is not responsible for design. Prototype programme and control plan are controlled by the Design Office.

Just make sure you don't get caught out on one of the clauses like design input because your site might be, for example, packing the product for the customer and this is a part of the design.
hope this helps
LK

No product design activities does NOT mean you can exclude the clauses related to the product design!

The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.

The responsibility of product design is NOT equal to the activity of product design.

For example, your company does not design the products, but you buy the drawings from someone else (except national/international standards). You do have the responsibility of product design. So you cannot exclude the clauses of product design.
Your company does design the products, including the changes of the products, but must be approved by the customers. Then you have no resposiblity of the product design. Therefore, you can exclude these clauses.

One more thing, you must provided evidences to the CB that you have no such responsibility if you claimed to exclude the cluases.

michield said:

I am new to the world of QMS and have some problems interpreting clause 7.3 of the ISO/TS 16949. I hope somebody can help me out.

If an organization doesn?t design products, they can exclude clause 7.3.2.1 (product design input) and 7.3.3.1 (product design outputs ? supplemental), correct? And how about clause 7.3.3 (design and development outputs) and 7.3.6.2 (prototype programme)? Can those be excluded?

Thanks for the help!

Click to expand...

We just went through this with our last surveillance audit. Our certifying body wanted proof that we were not design responsible turned in to them before the audit was finalized by the review board. They wanted a statement from our customers saying it.

That was a real pain to get so the CB settled on part drawings from three of our customers that had their names in the title blocks.

The IATF has been tightening down on the certifying bodies and they in turn have been doing the same to us.

Rick

Re: Exclusions clause 7.3 - Our organization doesn’t design products - ISO/TS 16949

Clause 7.3 also calls for Mfg. Process Design Input (7.3.2.2) and Output (7.3.3.2).
My question -'are you manufacturing same set of products as per customer design/drawings, or are you getting different designs from time to time?'

In the latter case you will be required to carry out Process Design for each new product. As such you cannot claim exemption for clause 7.3

Re: Exclusions clause 7.3 - Our organization doesn’t design products - ISO/TS 16949

michield said:

I am new to the world of QMS and have some problems interpreting clause 7.3 of the ISO/TS 16949. I hope somebody can help me out.

If an organization doesn’t design products, they can exclude clause 7.3.2.1 (product design input) and 7.3.3.1 (product design outputs – supplemental), correct? And how about clause 7.3.3 (design and development outputs) and 7.3.6.2 (prototype programme)? Can those be excluded?

Thanks for the help!

Click to expand...

It is a neverending story. You can exclude , but you cannot exclude the design and development of the process ( mfg process).