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> and checking that we actually followed what we wrote down We never got that. For the most part, checking that we followed what we wrote down involved reading
by jordigh 10y ago
> and checking that we actually followed what we wrote down
We never got that. For the most part, checking that we followed what we wrote down involved reading more documents that said that we did what we wrote down. The auditors weren't even allowed to walk around freely in our office, nor even be left alone without supervision, and we were all carefully coached on how to answer interviews with non-compromising responses. "I do what the SOP says. I cannot quite recall at the moment, but if you let me refresh my memory by reading the SOP, I will gladly clear it up for you."
It's just smoke and mirrors to pretend like important testing took place. Probably also to make sure whom to blame when things go bad. Some testing does frequently happen, between the document writing about the testing.
- vacri 10y agoOur FDA inspector hung around the QA manager and staff, didn't go into R&D much at all, and spent some time on the factory floor checking processes. I guess that they function as regular police do - the actual experience is less than ideal and leaves a lot to be desired, but without any at all, the world would be horrible.