AgentSkillsCN

Traceability

可追溯性

SKILL.md
--- frontmatter
skill_id: DOC-TRACEABILITY
version: 1.0.0
last_updated: 2026-01-04
applies_to: [Class A, Class B, Class C]
jurisdiction: [Global]
prerequisites: [REG-IEC62304, REG-ISO14971, DOC-INLINE]

Requirements Traceability

Purpose

Ensure bidirectional traceability between requirements, hazards/risks, design, code, tests, and anomalies for medical device software.

When to Apply

  • •All lifecycle phases; especially during changes and release preparation.

Requirements (testable)

  1. •ID Schema: Use stable IDs for requirements (REQ-###), hazards (HZ-###), risks/controls (RISK-CTRL-###), design (DES-###), tests (TEST-###), and anomalies (ANOM-###). Rationale: unambiguous linkage.
  2. •Bidirectionality: Maintain trace both forward (REQ->DES->CODE->TEST) and backward (TEST->REQ). Rationale: completeness and impact analysis.
  3. •Automation: Generate traceability matrices from managed artifacts (reqs tool + code tags + test metadata). Rationale: reduce drift.
  4. •Change Impact: For each change, update trace links and assess affected items/tests. Rationale: controlled updates.
  5. •Evidence Storage: Store trace outputs as release artifacts; version them with builds. Rationale: auditability.

Recommended Practices

  • •Keep a traceability.yaml or use ALM exports to CSV/HTML for submissions.
  • •Include trace tags in code comments and test names.
  • •Integrate trace checks in CI (e.g., missing links).

Patterns

Traceability entry (YAML):

yaml
# REQ-TRC-01
REQ-62304-102:
  design: [DES-PUMP-01]
  code: [pump_stop_on_door_open]
  tests: [TEST-410, TEST-411]
  hazards: [HZ-07]
  risks: [RISK-CTRL-19]

CI check (concept):

text
Validate: every TEST-* references a REQ-*; fail build on missing link.

Anti-Patterns (risks)

  • •Trace only in one direction -> risk: missing coverage.
  • •Manual spreadsheets without automation -> risk: drift and errors.
  • •Unlabeled code/tests -> risk: broken trace in audits.
  • •Trace outputs not baselined -> risk: mismatch to released build.

Verification Checklist

  • • IDs consistent and present across artifacts.
  • • Forward/backward traces maintained; gaps resolved.
  • • Trace matrices generated automatically and stored per release.
  • • Change impact updates traces and triggers required tests.
  • • CI checks for missing/invalid links in code/tests.

Traceability

  • •Central traceability.yaml/tool export; code/test tags; release-stored matrices.

References

  • •IEC 62304 traceability (5.1–5.6).
  • •ISO 14971 for hazard-to-control linkage.
  • •FDA/MDR submission expectations for trace matrices.

Changelog

  • •1.0.0 (2026-01-04): Initial traceability skill with IDs, automation, and CI checks.

Audit History

  • •2026-01-04: Audit performed. Verified:
    • •IEC 62304 traceability (5.1-5.6) references accurate
    • •ISO 14971 hazard-to-control linkage correctly noted
    • •FDA/MDR trace matrix expectations appropriate