> Should it be fully agentic? Should there be human intervention here to approve the CAPA? Open questions to be answered.
I think a point we are grappling with is, what necessitates human intervention, like philosophically. Is it accountability? I was thinking about this in terms of code review and it's not like we would fire someone if they broke prod, so at what point do we need someone accountable. Maybe it's for approvals for certain classes of risk (like those associated with actual harm to life). It's also not lost on me that many human systems lack accountability.
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I think there's a pretty clear and wide gulf between "nobody could have seen that coming", or "I just wasn't on my A game", and frank negligence.
I once worked at a very large company, and one of my coworkers was like "eh, I'm not going to do any of this work, because I don't have to", and that was a clear indicator that the problem wasn't (just) with the system, but with him individually.