What is a Quality Risk Register?

• A. A living document listing identified quality risks with severity, likelihood, and mitigation plans.
• B. A static list of risks that never changes.
• C. A financial risk ledger unrelated to quality.
• D. A training schedule.

Answer: (A)

A Quality Risk Register is a living document that captures identified quality risks, with assessments of severity and likelihood, and the planned mitigations. It also lists risk owners, tracks actions and status, and records residual risk after controls are applied. It’s updated regularly as new risks emerge or conditions change, and as mitigation effectiveness is reviewed. The register helps prioritize actions based on risk level and ensures follow-up on whether controls actually reduce risk, integrating with CAPA and change-control processes to maintain product and process quality.

The other options don’t fit because a risk register is not static and should evolve; it isn’t a financial ledger unrelated to quality; and a training schedule is about learning plans, not tracking and mitigating quality risks.