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Failure Mode and Effect Analysis (FMEA) is a methodology for analyzing potential problems early in the product development cycle where it is easier to take action to overcome potential issues, thereby enhancing reliability through design. The tool is used to identify relationships between process and product requirements and the potential for unacceptable outputs and their effects.

FMEA was initially developed in 1949 by the US Armed Forces to classify failures "according to their impact on mission success and personnel/equipment safety." It was later adopted in the Apollo space program to mitigate risk. In the 1980s, the automotive industry began implementing FMEA by standardizing the structure and methods through the Automotive Industry Action Group. Although developed by the military, the FMEA methodology is now extensively used in a variety of industries including semiconductor processing, foodservice, plastics, software, and healthcare to name a few.

ImageFMEA takes time to perform, but if done accurately it provides a valuable tool to plan, detect, and react to ensure a successful product life cycle. Continuing to use the tool throughout the product life cycle will significantly improve safety, quality, delivery and cost. Additional benefits from the tool can be gained through cause chain analysis and mistake-proofing (i.e. poke yoke) to reduce Risk Priority Numbers (RPN).

The FMEA is developed prior to the launch of a new job or process and is maintained throughout its life. As a tool embedded in Six Sigma methodologies, FMEA also helps identify the controls (through development or production) that must be implemented to ensure that the product can be produced continuously within specification. During the life of a product/process, the tool — considered a living document — should be modified whenever an existing design, product or process is changed, or even when a derivative is in development. Furthermore, the tools should be used when a new design, product or process is in the discovery process.

There are several applications for FMEA, including:

  • design, which focuses on components and subsystems;
  • process, for manufacturing and assembly processes;
  • system, which orients on global system functions;
  • service functions;
  • software functions. This article will focus on two primary formats: DFMEA (design) and PFMEA (process).