Failure modes and effects analysis (FMEA) is a systematic approach to reduce technical risks of a product or process by identifying all potential failure modes and their causes. Effective FMEA can anticipate and prevent problems, reduce costs, shorten product development times, and result in safer products and processes with high reliability.

The right time to start a FMEA is during the concept phase of the product life cycle. It could be a new design, a new technology, or a new process, but it also could be a new application of an existing design or process. A FMEA is a living document. When changes are made to an existing design or process because of new technology, new requirements, or new knowledge about the product, including experience gained during the product life cycle, the FMEA needs to be updated.