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FMEA was formally introduced in the late 1940s for military usage by the US Armed Forces. Later it was used for aerospace/rocket development to avoid errors in small sample sizes of costly rocket technology. An example of this is the Apollo Space program. The primary push came during the 1960s, while developing the means to put a man on the moon and return him safely to earth. In the late 1970s the Ford Motor Company introduced FMEA to the automotive industry for safety and regulatory consideration after the Pinto affair. They also used it to improve production and design.

Each potential cause must be considered for its effect on the product or process and, based on the risk, actions are determined and risks revisited after actions are complete. Toyota has taken this one step further with its Design Review Based on Failure Mode (DRBFM) approach. The method is now supported by the American Society for Quality which provides detailed guides on applying the method.

In FMEA, failures are prioritized according to how serious their consequences are, how frequently they occur and how easily they can be detected. An FMEA also documents current knowledge and actions about the risks of failures for use in continuous improvement. FMEA is used during the design stage with an aim to avoid future failures. Later it is used for process control, before and during ongoing operation of the process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service.

FMEA can provide an analytical approach, when dealing with potential failure modes and their associated causes. When considering possible failures in a design – like safety, cost, performance, quality and reliability – an engineer can get a lot of information about how to alter the development/manufacturing process, in order to avoid these failures. FMEA provides an easy tool to determine which risk has the greatest concern, and therefore an action is needed to prevent a problem before it arises. The development of these specifications will ensure the product will meet the defined requirements.

Uses of FMEA

• Development of system requirements that minimize the likelihood of failures.
• Development of methods to design and test systems to ensure that the failures have been eliminated.
• Evaluation of the requirements of the customer to ensure that those do not give rise to potential failures.
• Identification of certain design characteristics that contribute to failures, and minimize or eliminate those effects.
• Tracking and managing potential risks in the design. This helps avoid the same failures in future projects.
• Ensuring that any failure that could occur will not injure the customer or seriously impact a system.
• To produce world class quality products.