Risk
Manage hazards and risk in context — registers with severity, probability, and priority, each risk linked to the items it touches.
Risk in TraceUnified is assessed in context, never in isolation. Built on the ISO 14971 model, risk registers carry severity, probability, priority, and mitigation status, and each risk links to the requirements, tests, and components it touches — so the impact of a change on your risk picture is always visible.
This section covers building registers, scoring risk, tracking mitigations, and reducing risk to an acceptable residual level.
Risk assessed in context, never in isolation
A risk register kept in a spreadsheet drifts away from the design it’s supposed to describe the moment either one changes. TraceUnified assesses risk in context: built on the ISO 14971 model, each risk links to the requirements, tests, and components it touches, so the effect of a design change on your risk picture is visible immediately rather than discovered at the next review. Risk isn’t a parallel document — it’s part of the same connected record as the work that creates and mitigates it.
Scoring, matrices, and FMEA
Registers carry the dimensions that regulated risk management needs: severity, probability, resulting priority, and mitigation status. Scoring supports the risk matrix and FMEA-style analysis, so the method matches how your quality system expects hazards to be evaluated. Because scores live on linked records, a change that raises the severity of a hazard is connected to the requirements and tests that address it.
Mitigation down to acceptable residual risk
The purpose of the register is to drive risk down to a defensible level. Mitigations capture the controls you introduce and track their status, and the ALARP and residual-risk view makes the final judgment explicit: what risk remains after mitigation, and the reasoned basis on which it’s accepted. That full path — hazard identified, scored, mitigated, and accepted with evidence — is exactly what an ISO 14971 file needs to show.
What’s in this section
- Risk registers — organizing hazards and risks on the ISO 14971 model
- Scoring risk — severity, probability, the risk matrix, and FMEA
- Mitigations — reducing risk with controls and tracking status
- Linking risk — connecting risk to requirements, tests, and components
- ALARP & residual risk — accepting what remains
- Assess & treat a risk — a step-by-step walkthrough from hazard to acceptance