FMEA
A bottom-up analysis of how each part or process step can fail and what follows. It is widely used within ISO 14971 risk management, but it does not by itself capture use errors or hazards that arise without a failure.
A bottom-up analysis of how each part or process step can fail and what follows. It is widely used within ISO 14971 risk management, but it does not by itself capture use errors or hazards that arise without a failure.