process-fmea-generator

# Process FMEA Generator Skill ## Purpose The Process FMEA Generator Skill supports manufacturing risk assessment through systematic Process FMEA methodology, identifying potential process failures and control measures per AIAG guidelines and ISO 13485. ## Capabilities - PFMEA worksheet generation - Process step decomposition - Failure mode identification by process type - Control plan development - Statistical process control recommendations - Inspection point identification - OOS/OOT handling procedures - Process capability linkage - Detection method specification - Risk reduction verification - Control plan integration ## Usage Guidelines ### When to Use - Developing manufacturing processes - Assessing process risks - Designing control plans - Planning process validation ### Prerequisites - Process flow documented - Equipment specifications available - Quality requirements defined - Historical process data accessible ### Best Practices - Include cross-functional team - Link to design FMEA outputs - Integrate with control plans - Update with process changes ## Process Integration This skill integrates with the following processes: - Design for Manufacturing and Assembly (DFMA) - Sterilization Validation - Design Control Process Implementation - Medical Device Risk Management (ISO 14971) ## Dependencies - AIAG PFMEA templates - ISO 13485 requirements - Process documentation - SPC tools - Control plan templates ## Configuration ```yaml process-fmea-generator: ...