Design Documentation Rqmnts


Blueberry Nut
Hello all,
I've got a bit of a dilemma with a Corrective Action Verification for Design Output...

We had an issue identified during an internal audit regarding Design Output Verification. A colleague found that our engineers and our procedures did not agree on what a Design Output is.
The final interpretation we wrote in our revised procedure states that the Design deliverables are listed in our checklist for each of the APQP phases ( ie phase 3 requires a PFMEA, Production flow diagram, Test Plan, etc)

The internal auditor is now insisting that not only do we need to list what the output should be but we also need to state somewhere in our quality system what each of the listed outputs should contain, ie we should say what information the Control Plan must contain, (like requiring it references work instruction #’s, etc. ). We are ensuring all QS requirements are met, but I don’t think we MUST spell these out in our quality system in order to be compliant. Yes, listing them is a good way to not forget them but we’re a small dept, and I review all those documents regularly anyway.

Personally I feel she is being anal-retentive about this… (as she is in many other things, but I digress…) and that although those are nice-to-have details they are not necessary to meet the QS9000 requirements and can even land you in hot water (I’ve been burned by this issue in the past) Plus our Registrar’s auditors have always been satisfied with our current documentation.

As I see it I have three choices,
a) try and talk some sense into her
b) shift the verification responsibilities to someone else who agrees with me
c) document the requirements to the level she described.

Any comments/ guidance would be appreciated…


Hmmmmmm - I thought Linda still worked for us.

Seriously, if you are following a design protocol, or whatever you call your procedure, simply refer to APQP/Control Plan Reference Manual. If you are QS-9000 you have no choice but to follow the format outlined there so use the same format for all your CPs. It would be redundant to list all the steps followed if you are following a prescribed format.

As in all audits, you should be advised where the requirement is coming from. The auditor's opinion of what you should do is sometimes a lot different to what the actual requirement says.

I fully agree with you in that you can paint yourself into a corner by trying to get to detailed. To quote Rad Smith, one of the authors of QS-9000, "Keep it simple".

Say hi to Linda for me.

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