Design Review Facilitator

• Planning design phase gate reviews
• Conducting formal design reviews
• Documenting review outcomes
• Tracking design review action items

Prerequisites

• Design phase deliverables prepared
• Review team identified
• Review criteria established
• Risk management updates available

Best Practices

• Include all required functions in reviews
• Document all decisions and rationale
• Track action items to closure
• Integrate risk review at each phase gate

Process Integration

This skill integrates with the following processes:

• Design Control Process Implementation
• Verification and Validation Test Planning
• Design for Manufacturing and Assembly (DFMA)
• Medical Device Risk Management (ISO 14971)

Dependencies

• Design documentation systems
• Meeting management tools
• Action item tracking systems
• Risk management databases
• Review templates per FDA guidance

Configuration

design-review-facilitator:
  review-phases:
    - design-input-review
    - design-output-review
    - verification-review
    - validation-review
    - design-transfer-review
  required-functions:
    - engineering
    - quality
    - regulatory
    - manufacturing
    - clinical
  decision-types:
    - approved
    - approved-with-conditions
    - not-approved

Output Artifacts

• Design review agendas
• Phase-specific checklists
• Review meeting minutes
• Action item logs
• Decision records
• Review summary reports
• Attendance records
• Follow-up status reports

Quality Criteria

• All required functions participate in reviews
• Review records meet 21 CFR 820.30 requirements
• Action items tracked to closure
• Decisions clearly documented with rationale
• Risk considerations integrated
• Phase gate criteria objectively assessed