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Beyond “root cause: human error”. Five principles for investigators.

Root cause: human error.
Corrective action: retrain operator.
If you have worked in incident investigation for any length of time, you have read that pair of lines. Some of us have written them.
It gets the report closed. It satisfies the template. And a few months later something uncomfortably close to it happens again…

Matching Rigour to Risk: From Learning Teams to SCTA in GMP

If you work in pharmaceutical quality, you already live by a distinction this blog depends on: the difference between a useful discussion and a documented risk assessment. Both have their place. They are not the same thing, and you would never offer one where a regulator expects the other.