A Failure Mode and Effects Analysis (FMEA) is a “bottom-up” type of system analysis that is required for the standards certification of functional safety: IEC 61508 and all the standards deriving from ...

If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date. And you might be asking why do you need to ...

Google “FMEA” and you’re likely to find a variety of definitions. Risk assessment tool. Process methodology. Predictive failure analysis. It’s used as a noun, a verb and an adjective. So, what is it ...

Failure mode and effects analysis (FMEA) is an effective model that identifies the potential risk in the management process. In FMEA, the priority of the failure mode is determined by the risk ...

Effective occupational health and safety management requires a structured approach to hazard identification and risk assessment, which is best achieved by a management system. The implementation of an ...