design-review-facilitator: Скилл для структурированных ревью дизайна

--- name: design-review-facilitator description: Design review planning and execution skill for structured design phase gate reviews per 21 CFR 820.30 allowed-tools: - Read - Write - Glob - Grep - Edit - Bash metadata: specialization: biomedical-engineering domain: science category: Design Control skill-id: BME-SK-006 --- # Design Review Facilitator Skill ## Purpose The Design Review Facilitator Skill supports planning and execution of structured design phase gate reviews for medical devices, ensuring compliance with 21 CFR 820.30 and effective cross-functional evaluation. ## Capabilities - Design review agenda generation - Review checklist by phase (input, output, verification, validation, transfer) - Action item tracking - Review record documentation - Cross-functional reviewer identification - Risk review integration - Design stage gate criteria definition - Review meeting facilitation support - Decision documentation templates - Follow-up tracking automation - Review metrics and trending ## Usage Guidelines ### When to Use - 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 ```yaml 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