design-fmea-generator

# Design FMEA Generator Skill ## Purpose The Design FMEA Generator Skill facilitates systematic identification and evaluation of potential design failure modes for medical devices, supporting ISO 14971 risk management through structured DFMEA methodology. ## Capabilities - DFMEA worksheet generation - Failure mode brainstorming support - Severity, Occurrence, Detection rating guidance - RPN (Risk Priority Number) calculation - Recommended action tracking - Control plan linkage - Failure mode categorization - Root cause analysis templates - Design mitigation recommendations - DFMEA revision management - Cross-reference to risk management file ## Usage Guidelines ### When to Use - Initiating design risk analysis - Evaluating design alternatives - Supporting design reviews - Updating risk assessments for design changes ### Prerequisites - Design concept defined - Functional requirements documented - Intended use established - Similar device failure data available ### Best Practices - Conduct DFMEA early in design phase - Include cross-functional team members - Link to ISO 14971 risk management file - Update with design iterations ## Process Integration This skill integrates with the following processes: - Medical Device Risk Management (ISO 14971) - Design Control Process Implementation - Design for Manufacturing and Assembly (DFMA) - Verification and Validation Test Planning ## Dependencies - AIAG FMEA templates - ISO 14971 risk management framework - Design documen...