Requirements traceability manager

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/requirements-traceability-manager

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Design control traceability skill for managing user needs, design inputs, design outputs, and verification/validation linkages

SKILL.md

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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