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A Hazard Analysis (per FDA interpretation) speaks to health/safety related issues only. This has been further solidified by FDAs recent support of ISO 14971, which absolutely only speaks to health/safety issues. Product functionality is not an issue per ISO 14971. If it doesn't result in a degree of risk to human health or safety, it is not a consideration.
Conversely, an FMEA speaks to both health/safety and functionality. So my question is:
In an FMEA, what is the Severity Level of a failure mode whose impact on health is a 0 & whose impact on functionality is a 10? E.g., if this happens, the device will absolutely not work, but there is absolutely no impact to health or safety?
Or - should an FMEA ignore potential health/safety issues & a seperate Hazard Analysis be developed exclusively for health/safety related issues?
Conversely, an FMEA speaks to both health/safety and functionality. So my question is:
In an FMEA, what is the Severity Level of a failure mode whose impact on health is a 0 & whose impact on functionality is a 10? E.g., if this happens, the device will absolutely not work, but there is absolutely no impact to health or safety?
Or - should an FMEA ignore potential health/safety issues & a seperate Hazard Analysis be developed exclusively for health/safety related issues?
