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  • neb2 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 9 years, 2 months ago

    I would like to add that FMEA is subdivided into two types:
    1) Design Failure Mode and Effects Analysis (DFMEA): is an application of FMEA especially for product design. It begins at the development stage. It is a procedure used basically in engineering to explore the possibility of a design failing in a real-world situation or use. It is a document which compiles the key functions in a design and analyzes the potential causes of failure modes. Once the causes of failure mode are identified, the team tries to reduce the causes of failure through an implementation of countermeasures.
    2) Process Failure Mode and Effects Analysis (PFMEA): It is used for analyzing failure modes for design inadequacies and their effect on manufacturing operations. PFMEA is helpful in identifying the causes of the failure mode and then using a team with prior experience and the data collected for the causes of failure modes to rectify or reduce the effects of the failure mode.