QRM Is Not a Severity Spreadsheet
Use ICH Q9 quality risk management to connect patient impact, process knowledge, controls, and risk review.
Risk management is reasoning before rating. A severity-probability-detectability table is not wrong, but it is incomplete if the team never explains the failure pathway. ICH Q9 quality risk management asks teams to use scientific knowledge and process experience to evaluate, control, communicate, and review risk to product quality. The first useful move is to describe the hazard and harm pathway in plain language. What could fail? How could that affect identity, strength, quality, purity, safety, or data reliability? Where would the failure be prevented or detected? What assumptions are we making? Only then does a score become meaningful. What Good…
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