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.
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