ISO 9001 Clause 4.4 - We don't have design responsibility

[Quality Diva]

We manufacture parts where we don't have design responsibility. We receive a customer print, transfer this print into our system (create a BOM and our own drawing/work instruction on how to build)and build the product. Where should these procedures be documented in our quality manual since there is no 4.4?

 

[David Mullins]

Since you appear to be talking 9002:1994, I'd say they fit in a variety of places, including 4.2, 4.3, 4.5, 4.8 & 4.9

Principally the work instruction is a controlled document subject to 4.5

The BOM could relate to 4.8 or 4.9

No doubt others will view things differently.

NOTE - the customer print suits your organisations production processes? You don't have to design in injection points, bleed holes, die locators, etc, etc. ??

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

 

[Quality Diva]

All we have to do is translate their part numbers to our part numbers (BOM creation) and create a work instruction. We only question the print or suggest changes when we feel the customer has made an error. My trouble is finding a spot to place the procedures for the BOM creation and work instruction. It isn't really design, so what is it?

 

[CarolX]

QD,

We do basically the same thing. I put this under "Document and Data Control".

BTW - I addressed "Design Control" in my policy manual. One line stating we do not have design authority. Auditors and customers like to see that. Shows them you did not ignore or overlook that element.

Carol

 

[Al Dyer]

I like putting them in 4.2.3 Quality Planning and also make reference in 4.3.2 Contract Review.

Our first reference is 4.3.2 as it is our driver for 4.2.3 Quality Planning.

ASD...

 

[Jim Biz]

"We call them Process control sheets and address them in 4.9 (found it too confusing to our operators to call "part" specific data "Work instructions")

In our world the ISO system "work instruction" details how the part specific "PROCESS instructions" are created and controled.