Design Failure Mode and Effects Analysis (DFMEA) skill for systematic design risk identification
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.
This skill integrates with the following processes:
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