Too many NC's/ Deviations and CAPAs galore

[Zero_yield]

There is plenty room for improvement. Additionally, I believe when you say, "Deviations", do you categorize under "Planned" and "Unplanned" as its typically done in the Pharma space?

I would suggest revisiting your existing procedures and work instructions, putting a risk-based approach, having a process to record incidents, nonconformance and all that good stuff that goes as part of the quality system requirements.

Agreed, especially on the "risk-based" portion.

You've got a good thing going if everyone is already reporting potential issues. The next step could be properly categorizing those reports and assigning appropriate action based on the risk of those incidents.

For example, a machine might throw an error. If the procedure explains how a technician is supposed to respond to the issue and document the error, and the technician follows the procedure and documents accordingly, I would say you likely have no deviation: The process and product remained within predetermined guidelines. If the technicians reports the issue, that's great, but it doesn't have to result in an investigation. On the other side, if a technician bypassed machine controls, you could have a very serious deviation.

I think the original concern is that the risk of the deviations doesn't warrant the response?