There's been endless (but meaningful) discussion on how FMEA does not meet ISO 14971 requirements since the latter requires identification of hazards and hazardous situations in both normal and fault conditions.
It's pretty clear that a design FMEA (and HA and FTA) are good tools to incorporate with a risk management process to cover off fault conditions.
What are some tools that might be included within a risk management process to identify hazards and hazardous situations related to normal conditions? Is including usability engineering process per IEC 62366-1 within a risk management process considered sufficient to address this requirement?
Many thanks ~
It's pretty clear that a design FMEA (and HA and FTA) are good tools to incorporate with a risk management process to cover off fault conditions.
What are some tools that might be included within a risk management process to identify hazards and hazardous situations related to normal conditions? Is including usability engineering process per IEC 62366-1 within a risk management process considered sufficient to address this requirement?
Many thanks ~
