buzzp wrote: "Where I work, it is understood that only hard copies are official. The understanding is that electronic (mostly CAD) copies can be manipulated. You said this is an ISO requirement?"
IRstuff wrote: "There is nothing that a paper document can do to prove that it is the most recent document and that there is no newer document."
There is certainly no requirement in ISO 9002 (or 9001) that a system be either electronic or paper based. The documentation needs to be controlled as part of a larger system. In a paper-based system (or a system in which the final manufacturing documentation is paper), it could be as simple as a filing cabinet with folders for each assembly to be built. Assemblers are trained to pull the documentation from the cabinets and return it when they're done. When a change is made through the ECO process, the folder is updated with the new information. Changes can't happen willy nilly whenever an engineer wants to make one; there is a formal change process in place that controls changes and they're implementation. If a job is in process or complete, the disposition of that job - rework, use as is - is resolved as part of the change process.
It's easy to envision how an electronic system would work. But if you think about it, most electronic systems would have the same problem as a hard copy one. The assembler pulls the PDF of the assembly print up on his massive D-size (34" X 22" for my non-American friends) monitor and gets to work. Meanwhile, the electronic copy is changed. The assembler is unaware of the change; the software doesn't notice, because the file was opened by the assembler as read-only. The assembly gets buuilt wrong. Of course, safegaurds can be built into the software (hopefully your company isn't footing the entire bill), but it adds more complexity and cost.
One practical solution is to use effectivity dates and procedures that dictate, for example, that documentation updates are made once a day at 8:00 am. Assembly training & procedures instruct assemblers to "refresh" (hit the refresh button on their browser or walk over and get any updates to the folder) at 8 every morning if they're in the middle of a job. If they're not, it's a nonissue.
Neither hard nor soft copies are a silver bullet gauranteeing control. It's the system and employees' adherance to it. Nothing can stop someone from wilfully ignoring the rules.
Rob Campbell