ISO 9001 Design & Development - 7.3.4 Review, 7.3.5 Verify, 7.3.6 Validate

[Big Jim]

We are a subsidiary company in Australia, out parent company is in USA who hold Design Authority (that pesky ITAR...) for pretty much all engineering design we built to. They hold AS9100 and follow their own D&D, Configuration processes etc.. We are, in effect, subcontractors for engineering design and satisfy their SOW requirements (when they stop changing their minds) in the form of engineering technical data packages that we eventually manufacture to.

1. When developing processes for D&D and Config Management, is it enough to "point" to their QMS or do local processes need to contain a subset of theirs to some degree?

2. Control of D&D Changes AS9100 Sect 7.3.7: Is this applicable to any stage of D&D activity, or is it more geared to change control after final design is approved (aka revision control) ? I ask this because of reference to "...product already delivered" , which only makes sense if the D&D is complete and product is actually being manufactured against that design.

Bit confused here...

Hi Mike,

It may help us to know if location is registered to either ISO 9001 or AS910.

If you are not registered to AS9100, you would still benefit getting a copy of AS9100C and reading exactly what is says for both configuration management and control of design changes.

As to control of design changes, what I have often observed is that until the design is released changes are recorded in any convenient manner, often as part of design review records. Once the design is released, it very common to use an Engineering Change Notice (ECN) or Engineering Change Record (ECR) system to control and record the change. Pretty much you can do whatever works.

You may also benefit from seeing whatever configuration management procedure or design procedure your parent company may have.