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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.It deals with design inadequacies and their effect on manufacturing operations
2) Process Failure Mode and Effects Analysis (PFMEA): addresses the occurrence and the detectability. Meaning that any identified failure mode should be addressed by either improving the process to reduce the chance of occurrence or by having a proper way to detect flawed products before shipping it to the customer. The intention behind the PFMEA process is to make sure that flawed products will not get to the customer.