Failure Mode and Effects Analysis (FMEA) is a systematic method for evaluating a process to identify where and how it might fail, to assess the relative impact of different failures, and to identify the parts of the process that are most in need of change. FMEA includes review of the following:

Steps in the process: Identify what could go wrong during each step.

Failure modes: Identify potential failure modes for each step.

Failure effects: For each failure mode, identify potential effects.

Severity: Assign a severity rating for each effect of failure.

Occurrence: Assign an occurrence rating foreach failure mode.

Detection: Assign a detection rating for each failure mode and effect.

Risk Priority Number (RPN): Calculate the RPN for each effect.

FMEA is particularly useful in healthcare for risk assessment of a new or modified process because it not only identifies potential failures, but also prioritizes them based on their impact, frequency of occurrence, and detectability, allowing for targeted and efficient process improvement.