Process Fmea Generator

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

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