FMEA

Failure Modes and Effects Analysis (FMEA) is a systematic, bottom-up process for identifying potential failures in a design or process, analyzing the effects of those failures, and prioritizing risks for mitigation. Required under IEC 61508, ISO 26262, and ISO 13849.

In functional safety contexts, FMEA feeds directly into the Failure Modes, Effects, and Diagnostic Analysis (FMEDA), which quantifies the probability of dangerous failures and calculates Safe Failure Fraction (SFF) and diagnostic coverage (DC): the two metrics that determine whether a hardware element achieves its target SIL.