Risk Matrix

Risk Matrix is the data object that encodes severity-of-harm × likelihood-of-occurrence into a structured grid that ranks risks and routes them to mitigation. It is the visual core of ISO 14971 medical-device risk management, ISO 26262 ASIL assignment, and most aerospace and process-safety hazard analyses.

What it covers

• Severity scale — clinical harm, financial loss, downtime, or safety class.
• Likelihood scale — qualitative (frequent / occasional / remote) or quantitative (1/M-hours).
• Cell-level risk priority — typically green/yellow/red zones with mandatory actions per zone.
• Linkage to FMEA / hazard log / risk file — every identified risk gets a matrix coordinate.
• Pre- and post-mitigation views — track residual risk after controls are applied.

Relationships (see sidebar)

• Conforms to ISO 14971 (medical-device risk management).
• Supports Risk Management, Quality Management, and Regulatory Submission.
• Implemented by ALM/QMS platforms including Siemens Polarion (Risk Management extension), PTC Codebeamer, Aras Innovator (Risk Management), and PTC Arena (Arena QMS).