Quality
Quality Risk Register
risk register · quality risk log
TL;DR
A living inventory of identified quality risks with severity, likelihood, controls, owner, and review cycle — the operational heart of an ICH Q9 risk-management programme.
A Quality Risk Register operationalises ICH Q9: every identified risk is scored, tied to controls (procedural, engineering, validation), assigned an owner, and re-reviewed on a defined cycle. Risks feed into change control, CAPA, audit planning, and management review.
V5 surfaces the risk register as a live view across CAPA, change control, deviations, and supplier risk so risk is not an annual document but a daily input.
Regulatory anchors
- ICH Q9(R1)
- ISO 14971:2019
Industries that live with this
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