Design Fmea Generator

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 documentation
• Historical failure data
• Industry failure mode databases

Configuration

design-fmea-generator:
  rating-scales:
    severity: 1-10
    occurrence: 1-10
    detection: 1-10
  risk-thresholds:
    rpn-action-limit: 100
    severity-critical: 9
  output-formats:
    - worksheet
    - summary-report
    - action-tracker

Output Artifacts

• DFMEA worksheets
• Failure mode catalogs
• RPN summary reports
• Recommended action lists
• Control plan inputs
• Design review inputs
• Risk management file updates
• Mitigation tracking logs

Quality Criteria

• All design functions analyzed
• Failure modes comprehensively identified
• Ratings consistently applied
• High RPN items addressed
• Actions tracked to completion
• Linkage to ISO 14971 maintained