Reliability/mistake-proofing using Failure Mode and Effect Analysis (FMEA)

Failure Mode and Effect Analysis (FMEA) is a structured way to identify and prioritize the failure modes in the system of interest. FMEA is one way to increase the reliability of a system before anything happens but can be used after an event. One of the methods to increase the time between failures/errors is to make the system mistake-proof. A small portion of a complete system for administration of chemotherapy is shown. The FMEA process is shown for only one task. FMEA does not demonstrate how to identify failure modes nor how to create solutions. Two methods (System Context and Gemba) to help identify failures are briefly presented. Four methods (Theory of Inventive Problem Solving, Lead Users, Mistake-proofing and Robust Design) to help identify solution concepts are briefly presented.