Failure mode and effects analysis (FMEA) is a tool for conducting asystematic, 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
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