LABORATORY QUALITY GLOSSARY
risk register
Last reviewed
Definition
A risk register is a structured record of identified risks, existing controls, planned responses, owners, and review decisions. In a medical laboratory it can cover threats to patient safety, result validity, service continuity, confidentiality, and impartiality. The format may include likelihood and consequence ratings, but a numerical score is an aid to judgement rather than a substitute for understanding the hazard.
Describe risks as plausible events with causes and consequences, not just broad topics such as staffing or equipment. Link controls to the specific failure mechanism and distinguish current controls from actions that have not yet been implemented. Record residual risk and escalation decisions after evaluating control effectiveness. A register should change when incidents, new services, audits, or operational changes reveal a different risk picture.
Why it matters for accreditation
For accreditation, the register can demonstrate that risks are actively considered and addressed, although the document title or format is not the objective. Assessors look for practical controls and follow-up. Prioritize credible patient harm and service vulnerability, assign accountable owners, and use management review to resolve risks that require resources or decisions beyond a single section.
