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  Element 4.4

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Author Topic:   Element 4.4
Quality Diva
posted 08 January 2001 06:33 PM           Edit/Delete Message   Reply w/Quote
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?

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David Mullins
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Posts: 248
From:Adelaide, South Australia, Australia
Registered: Nov 1999

posted 08 January 2001 11:18 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
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. ?


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Quality Diva
posted 09 January 2001 11:47 AM           Edit/Delete Message   Reply w/Quote
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?

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Forum Contributor

Posts: 108
From:Illinois, USA
Registered: Jun 2000

posted 09 January 2001 04:46 PM     Click Here to See the Profile for CarolX   Click Here to Email CarolX     Edit/Delete Message   Reply w/Quote

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.


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Al Dyer
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Posts: 622
From:Lapeer, MI USA
Registered: Oct 2000

posted 10 January 2001 01:04 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
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.


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Jim Biz
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Posts: 275
Registered: Mar 2000

posted 10 January 2001 03:00 PM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
"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.

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