requirements-traceability-manager

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