Design FMEA Generator Skill

Purpose

The Design FMEA Generator Skill facilitates systematic identification and evaluation of potential design failure modes for medical devices, supporting ISO 14971 risk management through structured DFMEA methodology.

Capabilities

• DFMEA worksheet generation
• Failure mode brainstorming support
• Severity, Occurrence, Detection rating guidance
• RPN (Risk Priority Number) calculation
• Recommended action tracking
• Control plan linkage
• Failure mode categorization
• Root cause analysis templates
• Design mitigation recommendations
• DFMEA revision management
• Cross-reference to risk management file

Usage Guidelines

When to Use

• Initiating design risk analysis
• Evaluating design alternatives
• Supporting design reviews
• Updating risk assessments for design changes

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