Changelog
Safety Risks release notes
Release notes for Safety Risks. Each entry lists what’s new, improved, or fixed in that version.
Initial release
NewThe Safety Risk space page, with tables for safety characteristics, hazards, harms, and risks, plus a Traceability tab linking each risk to the requirements that control it.
NewSafety characteristics, hazards, and harms as work items, each ruled applicable or not applicable with its own evidence and justification, and reopened through Outdated. Build a list by hand, from CSV, or by cloning the Standard & Regulations space.
NewFour risk assessment methods on one work item: hazard analysis, design FMEA, process FMEA, and use-related risk assessment, each validating the fields its own method needs at every status change.
NewTwo-probability scoring to ISO 14971. P1 and P2 are scored before and after control, and severity is inherited from the linked harm, so it stays consistent across every risk naming that harm.
NewRisk control through requirements. Each mitigation links to a requirement carrying the Risk Control category, so Design Control carries its implementation and its verification.
NewSigned approvals on a safety risk, with a one-time password sent to each approver, and an overdue state when a due date passes.
NewConfigurable risk definitions, risk matrix, and acceptability criteria per space, plus a health check that installs and repairs the space configuration.