by Mr. Tom Lucas, BSEE

This 1-day class starts with a discussion of the benefits of conducting a FMECA and how a FMECA can satisfy regulatory requirements, in the case of medical devices. Standards, both military and regulatory, are examined and related to the methodology used to conduct the FMECA. Using a real world example aided by the capabilities of Excel to create system graphics and failure mode entries, we will conduct a FMECA study that creates a Criticality List, and calculates BIT Effectivenes. A discussion will follow that shows how using the FMECA for diagnostic development improves failure detection and analysis during HALT and HASS. The FMECA also gives a good indication of whether the critical failures will be related to thermal, vibration or wearout stresses. It will also helps one know what will fail first and what stress levels will be required to stimulate that mode of failure.

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