Failure Mode and Effects Analysis (FMEA) is a systematic, proactive method for identifying and
evaluating the potential causes and impacts of failures in a process, product, or service1. It aims to
anticipate and prevent failures by assessing the relative effect and risk of different failure modes1.
The use of FMEA would be most appropriate prior to a new product introduction (NPI). During the
NPI phase, FMEA can be used to identify potential failure modes in the design of the product and
assess their potential effects on the product’s performance and reliability. This allows for proactive
measures to be taken to mitigate or eliminate these risks before the product is launched. FMEA is
particularly useful in the early stages of design, as it helps in making informed decisions that can
improve the quality and safety of the product1.
In contrast, using FMEA after a one-time quality incident investigation (A) or during evaluation of a
new market opportunity © may not be as effective, as these situations do not involve the design or
development of a product or process. While FMEA can be used during the define phase of a Six
Sigma project (B), its most impactful application is during the design phase of a new product, where
it can significantly influence the final outcome.
