Requirements Traceability Manager Skill
Purpose
The Requirements Traceability Manager Skill ensures comprehensive traceability throughout the medical device design control process, linking user needs to design inputs, design outputs, and verification/validation activities per 21 CFR 820.30.
Capabilities
- Bidirectional traceability matrix generation
- Requirements coverage analysis
- Gap identification in V&V coverage
- Design change impact analysis
- Traceability report generation
- DHF (Design History File) completeness checking
- User needs to design input mapping
- Design output to verification linking
- Risk control to requirements tracing
- Regulatory requirement coverage tracking
- Orphan requirement identification
Usage Guidelines
When to Use
- Establishing design control traceability
- Conducting V&V coverage analysis
- Assessing design change impacts
- Preparing for regulatory audits
Prerequisites
- User needs documented
- Design inputs established
- Design outputs defined
- V&V protocols available
Best Practices
- Establish traceability from project inception
- Update matrices with every design change
- Verify bidirectional completeness regularly
- Integrate with requirements management tools
Process Integration
This skill integrates with the following processes:
- Design Control Process Implementation
- Verification and Validation Test Planning
- Software Development Lifecycle (IEC 62304)
- Medical Device Risk Management (ISO 14971)
Dependencies
- Requirements management tools (Jama Connect, Polarion, DOORS)
- Design documentation systems
- Test management platforms
- Change control systems
Configuration
requirements-traceability-manager:
traceability-levels:
- user-needs
- design-inputs
- design-outputs
- verification
- validation
- risk-controls
matrix-types:
- forward
- backward
- bidirectional
coverage-metrics:
- requirement-coverage
- test-coverage
- risk-coverageOutput Artifacts
- Bidirectional traceability matrices
- Requirements coverage reports
- Gap analysis documents
- Impact assessment reports
- DHF completeness checklists
- Orphan requirement lists
- V&V coverage summaries
- Change impact analyses
Quality Criteria
- Complete bidirectional traceability established
- All user needs traced to design inputs
- All design inputs traced to design outputs
- V&V activities cover all requirements
- Risk controls properly traced
- No orphan requirements exist