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Failure Mode and Effect Analysis (FMEA) is a technique devised that facilitates the identification of potential problems in design or process that includes analyzing manufacturing process. It involves identifying all potential failure modes, determining the end effect of each potential failure mode, and determining the criticality of these failure effects.
As they say, an ounce of prevention is better than a pound of cure. FMEA Medical Device can be used to determine the most critical failure modes, and then verify how these critical failures can be minimized or eliminated. FMEA identifies single failure points that are critical and can also rank each failure according to the criticality of a failure effect and its probability of occurring.
FMEA Medical Device provides a basis for identifying root causes of failure and tries to rectify it. FMEA also evaluates current knowledge and actions about the risks of failures, for use in constant enhancement. |
