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In Reply to: Three Strikes and you're OUT posted by pictureguy on August 23, 2022 at 23:17:01:
The underlying ideas are good, and durable: Try to focus, as best and as objectively as a group of human beings can, on what's important when developing a product -- or making changes to a product of more-or-less well-known qualities.
I have done quite a bit of this stuff for biopharmaceuticals. I can tell you the folks that develop the (complicated) manufacturing processess for these (complicated) products take their (our!) responsibilities for patient safety very, very seriously -- whether the public at large believes it or not. :-|
all the best,
mrh
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Follow Ups
- this is why risk assessment and failure analysis are "things" - mhardy6647 08/24/2206:20:54 08/24/22 (4)
- RE: this is why risk assessment and failure analysis are "things" - pictureguy 13:05:32 08/24/22 (3)
- Yes, Pharma mfg. is a (highly) regulated industry - mhardy6647 17:27:02 08/24/22 (2)
- RE: Yes, Pharma mfg. is a (highly) regulated industry - pictureguy 18:57:18 08/24/22 (1)
- yup (re: fishbone) - nt - mhardy6647 06:22:04 08/25/22 (0)
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