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-coverage

Output 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