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:
process-types:
- machining
- molding
- assembly
- cleaning
- packaging
- sterilization
rating-scales:
severity: 1-10
occurrence: 1-10
detection: 1-10
control-types:
- prevention
- detection
Output Artifacts
- •PFMEA worksheets
- •Process flow diagrams
- •Control plans
- •SPC implementation plans
- •Inspection procedures
- •OOS/OOT procedures
- •Action item tracking
- •Risk reduction verification
Quality Criteria
- •All process steps analyzed
- •Failure modes comprehensively identified
- •Controls address high-risk items
- •Detection methods effective
- •Control plans complete
- •Integration with design FMEA