J
In the "death" case you cited, if the failure which has a death severity, after some control measure, turned out just to cripple
the subject, the severity would be reduced.
Cripple is a new failure mode. Death is still a viable failure mode that you can only reduce likelihood or occurrence. That's my point.
Due to the nature of the risk analysis of FMEA, you need to maintain a history of what you looked at and evaluated, thus the severity of a failure mode never changes, just it's likelihood or occurrence.
Hazardeous Situations is another form of risk analysis, ie, Fault tree Analysis-looking at top level hazards and hazardeous situations and driving down to failure modes.
If you cannot reduce the likelihood of a high severity failure mode and did your best to control it, then you need to do a Risk-Benefit analysis to determine if continuing to move ahead with your device is justified....all this risk analysis , control, mitigation, justification is summarized in your risk management report which encompasses everything you planned to do in your risk management plan at the beginning of your project which was done according to your risk management procedures.
Did that clear it up? =)
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