Failure mode and effect analysis (FMEA) was initiated by the aerospace industry in the 1960s to improve the reliability of systems. It is a part of total quality management programs and should be used to prevent potential failures that could affect safety, production, cost or customer satisfaction. FMEA can be used during the design, service or manufacturing processes to minimize the risk of failure, improving the customer's confidence while also reducing costs.

FMEA (failure mode and effects analysis) is a method for gathering information about potential points of failure in a design, manufacturing process, product, or service. Failure mode (FM) refers to the manner in which something may fail. It includes potential errors that could occur, particularly errors that could have an impact on the customer. Deciphering the consequences of those breakdowns is part of effective analysis (EA). This is accomplished by ensuring that all failures can be detected, determining how frequently a failure may occur, and determining which potential failures should be prioritized. FMEA templates are commonly used by business analysts to aid in the completion of analyses.
FMEA is a risk assessment tool with a 1-10 scoring scale. A one indicates low risk, while a ten indicates extremely high risk.
FMEA is an effective method for development and manufacturing organizations to reduce potential failures throughout the product lifecycle.
Six Sigma's project team use FMEA in the Analyze stage of DMAIC because extraordinary quality is not only designed into the product, it is designed into the development process itself.