Backstory: A part with "new" dimension was ordered by R&D to be ran on a CNC. It was then to be measured on a CMM. When the part was delivered to R&D, it was not the correct dimensions. Both operations were ran on an old revision of the part drawing. My boss's concern is that we currently do not have adequate control of the programs in these particular machines (and maybe others). We may program the CNC and name that program after a certain part number, but when a revision is made, this is not easily recognizable. In addition, when we run part number A, we may use program B, because this particular assembly of both parts are exactly the same. Valid concern. He feels we should be performing software validation. I'm not sure he using the correct terminology. I'd like some input on what we could do to prevent this. - IQOQ = Not sure if this has been performed or not. If not this should be completed, however I don't believe this will have any effect on this particular problem. - Software Validation = Not completed, but if the IQOQ was very robust, It may be covered as part of that document. However since this covers the equipment functions, this wouldn't affect part differences (assuming that it would currently pass software validation) - Process Q = We have not validated this particular process because it affects the function of our device, and we believe in our testing it is fully verified. - Part Qualification = Again I need to investigate this, but my guess is that every part had been checked on the CMM during design qualification at the very least. I think we may be getting closer to the issue here, in that during that part qualification, the program would be set, named, and the program backed up elsewhere. Change control seems like the issue here. I also need to investigate how one off parts for R&D are programmed and saved. What am I missing?