Problems and defects are expensive. Customers understandably place high expectations on manufacturers and service providers ...

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FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.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

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 ...

FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by ...

This asynchronous 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 ...

Participants will learn the purpose and benefits of FMEA, the different types of FMEAs and their focus, QS-9000 FMEA requirements and guidelines, FMEA timing and inputs, and steps required for ...