Failure mode and effect analysis, or FMEA, is an attempt to delineate all possible failures, their effects on the system, the likelihood of occurrence and the probability that the failure will go undetected. FMEA provides an excellent basis for classification of characteristics such as identifying CTQs and other critical variables. As with Pareto analysis, one objective of FMEA is to direct the available resources toward the most promising opportunities. An extremely unlikely failure, even one with serious consequences, may not be the best place to concentrate preventative efforts. FMEA can be combined with decision analysis methods such as Analytical Hierarchy Process (AHP) and quality function deployment (QFD) to help guide preventive action planning.

FMEA came into existence on the space program in the 1960s. It was later incorporated into military standards, in particular Mil-Std-1629A. There are two primary approaches for accomplishing an FMEA:

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