* Failure mode and effects analysis (FMEA) is a tool for conducting a systematic, proactive analysis of a process in which harm may occur12.
* In an FMEA, a team representing all areas of the process under review convenes to predict and record where, how, and to what extent the system might fail12.
* FMEA is used to identify all possible failures in a design, a manufacturing or assembly process, or a product or service, and to study the consequences of those failures2.
* FMEA is a prospective assessment that identifies and improves steps in a process and reasonably ensures a safe and clinically desirable outcome1.
* FMEA is a common process analysis tool that can help healthcare quality professionals to prevent errors, reduce variation, and improve patient safety1234.
* FMEA is applied when a new or modified process, function, or service with an associated hazard has not yet been implemented, or when improvement goals are planned for an existing process, function, or service2.
* FMEA procedure involves the following steps2:
* Assemble a cross-functional team of people with diverse knowledge about the process, product, or service, and customer needs.
* Identify the scope and boundaries of the FMEA.
* Fill in the identifying information at the top of the FMEA form.
* Brainstorm potential failure modes and their causes and effects.
* Assign a risk priority number (RPN) to each failure mode based on the severity, occurrence, and detectability of the failure.
* Prioritize the failure modes for action based on the RPNs.
* Identify and implement corrective actions to eliminate or reduce the high-risk failure modes.
* Evaluate the results and monitor the effectiveness of the actions.
* Update the FMEA as needed. References: 1: Failure Modes and Effects Analysis - Ministry of Health 2: What is FMEA? Failure Mode & Effects Analysis | ASQ 3: Failure Mode and Effects Analysis | Digital Healthcare Research 4: Healthcare FMEA | Healthcare Failure Mode & Effects Analysis - Quality-One