In support of the Preliminary Hazard Analysis model in Aligned Elements, here are five PHA Harms based on the example Five Qualitative Severity Levels from ISO 14971 Table D. 3.
The example Harms are:
- Catastrophic
- Critical
- Severe
- Minor
- Negligible
To use the Harms, unzip the file and import the xml file with the settings "Recreate Chapters" ticked. Consult the Aligned Elements User Manual for instructions on import.
