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name: process-fmea-generator description: Process Failure Mode and Effects Analysis (PFMEA) skill for manufacturing risk assessment allowed-tools:

• Read
• Write
• Glob
• Grep
• Edit
• Bash metadata: specialization: biomedical-engineering domain: science category: Sterilization and Manufacturing skill-id: BME-SK-028 graph: domains: [domain:biomedical-engineering] skillAreas: [skill-area:statistical-analysis, skill-area:data-analysis, skill-area:compliance-automation] workflows: [workflow:experiment-design, workflow:peer-review-cycle] roles: [role:biomedical-engineer, role:research-engineer]

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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

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