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Revision as of 19:47, 16 October 2018
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Failure Mode, Effects and Criticality Analysis (FMECA)
Because regulations on biomedical devices are so drastic, we decided very early in the process that this competition would not be just about producing a “proof of concept” but to go a step further in analysing beforehand the risks that would go with our prototype use and that wouldn’t need to be considered for an eventual industrial production.
The FMECA was originally developed by the National Aeronautics and Space Administration (NASA) to improve and verify the reliability of space program hardware. This method is a reliability evaluation/design technique which examines the potential failure modes within a system and its equipment, in order to determine the effects on equipment and system performance and on the environment of the device. Each potential failure mode is classified according to its impact on mission success and personnel/equipment safety.
For our study, we based ourselves on a MIL-STD report (US Military standards on Environmental Engineering Considerations and Laboratory Tests) explaining the process of a FMECA.
Here is a description of the different steps of the process:
1/ Definition of the system
This study will only address the the failure modes coming from us (and the manipulations we made to build the prototype) and the environment (user, external aggressions…). We will consider that the parts we ordered are guaranteed to work under normal conditions (described in the datasheets of the components) and that their risks of failure are negligible.
To carry out this study, we had to approaches:
- THE EXTERNAL ANALYSIS: We first considered the system as a whole and we listed undesirable events that could happen to it so that we could prevent them.
- THE INTERNAL ANALYSIS: Then we separated the system in sub-modules and we analysed their functions and the undesirable events that could occur.