We recently changed our vendor approval process. It went from a 12-page questionnaire to a 6-page questionnaire. Really no skin off of me because the vendor is responsible for filling it out. But the vendors tend to call me instead of QA for clarification. I have never had a site visit go more than a day with QA. So figure that in your timing.
I’d say setting the spec takes the greatest time. And a big chuck of that time is determining your critical dims/specs and determining how QA tests to the critical dims/specs. We are a bit backwards because NPD really drives the testing procedures, not our QA department. But we have our own regulatory group within NPD and you don’t see that to often.
The next biggest hurdle is purchasing because they take a microscope to the vendor’s manufacturing process and capabilities. I’m surprised that our vendors disclose as much as they do.
All in all, not that bad but nothing like a start up. I was writing 510Ks for them. I can’t imagine that happening here.