Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for evaluating a process to identify where and how it might fail and to access the relative impact of different failures, in order to identify the parts of the process that are most in need of change.

FMEA includes review of the following steps in the process,

Failure modes (what could go wrong),

Failure causes (why would the failure happen), and

Failure effects (what would be the consequences of each failure).

FMEA is used to evaluate processes for possible failures and to prevent them by correcting the process proactively rather than reacting to adverse events after failures have occurred. FMEA is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process. FMEA is a popular risk analysis methodology when it comes to failures of IT systems that can harm both people and organizations.

Source for more information: Comparison of the FMEA and STPA safety analysis methods – a case study. Sadar Muhamad Sulaman, Armin Beer, Michael Felderer, Martin Host, Software Quality Journal.

Managing Process Risk Line by Line: An FMEA case study. Fred Greulich, Jonathan Hardy. Pharma Manufacturing.