Risk Reduction

Details

Risk reduction is the action actually taken to lower the probability or severity of harm, and within risk control it is the option set against acceptance — if control is deciding what to do, reduction is the act of actually lowering the risk. ICH Q9(R1) §4.4 gives, as means of reduction where a risk exceeds an acceptable level, measures that mitigate severity and probability and procedures that improve the detectability of the harm, and recommends that the risk assessment be repeated after the action because reduction measures may introduce new risks or increase existing ones. Inspections cite measures such as more training recorded as reduction although they do not actually lower probability, residual risk not reassessed after the action, reduction measures not connected to CAPA so that implementation cannot be traced, and improved detection treated as though it had addressed the root cause.

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Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.