Risk Management

Risk Management is the cross-lifecycle process of identifying, analyzing, evaluating, controlling, and monitoring risks that a product creates for users, patients, operators, the environment, or the business. It is mandatory under ISO 14971 (medical devices), ISO 26262 (automotive functional safety), DO-178C / ARP-4761 (aerospace), and increasingly required under cybersecurity regimes for connected products.

Scope

The process covers risk-management planning, hazard identification, risk analysis (severity × probability), risk evaluation against acceptance criteria, risk-control implementation (design changes, protective measures, information for safety), residual-risk evaluation, and post-market surveillance. PLM hosts the linked artifacts — requirements, FMEA, hazard log, design changes, post-market events — so that traceability from a hazard to its mitigation to the implementing change is preserved.

Relationships (see sidebar)

• Realizes Product Quality and Regulatory Compliance.
• Supported by the Risk Matrix, ALM Traceability, Requirements Traceability Matrix, and the QMS capability.
• Tightly coupled with Quality Management, Regulatory Submission, and Warranty and Field Feedback (post-market loop).