How can you use FMEA in product development? I’ve talked at length about using FMEA as a means of rectifying problems in production. However, you can apply the methodology to the design process of any ...

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 ...

Table I. An example of the FMEA for bacterial endotoxin contamination risk for the injection molding step (Click to Enlarge). The next step was identifying occurrence (O), severity (S), and detection ...

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FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.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 ...

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 ...

This in-person course presents an overview of the Failure Mode and Effects Analysis (FMEA) approach to calculate risk and proactively avoid potential failures in a process or service. Participants ...