We are getting ready to start a year long project in which every aspect of our design must meet stringent Quality Assurance standards in accordance with the ASME Bolier and Pressure Vessel Codes (Section III) and other regulatory requirements. At the same time our SW user base has grown to the point where a PDM would be helpful in our day to day work outside the QA program. I am hoping to kill two birds with one stone, but I need some ammunition.
My goal would be to implement Enterprise PDM in such a way that all the QA paperwork/processes are handled through Enterprise PDM itself. We need to be able to properly route documents to various individuals in a particular order. They would each sign the documents (electronically, if acceptable) and then proceed to QA for final approval before release.
Various other documents would need to be attached to line items on Bills of Material in the PDM system. For example, each component in a bill must have a document categorizing the impact that a failure of the component would have on the nuclear power plant. A screw used in one assembly may be Category A, but the same screw in a different assembly may be Category C.
Documents need to have different revision schemes before and after release. Prior to release, revisions are letters (A,B,C...). After release revisions are switched to numbers (0,1,2...).
My question is:
Is anyone here in Forum-ville doing this sort of work, with these types of documentation requirements? If so, is it possible/acceptable to do it all inside the PDM system, or does everything have to be printed and walked around for hand signatures?
The more concrete examples I can provide, the more likely it is that I can convince our QA group that this is a proven, valid way to handle the upcoming paperwork nightmare.