Failure Mode & Effect Analysis (FMEA)




Is a structured approach to:

  • Identify the ways in which a process can fail to meet critical customer requirements
  • Estimate and Quantify the risk of specific causes with regard to these failures
  • Evaluate the current control plan for preventing these failures from occurring
  • Prioritize the actions that should be taken to improve the process
  • Document and track actions taken to reduce risk
  • Improve the quality, reliability, and safety of products
  • increase customer satisfaction
  • Reduces product development timing and cost

Applicability and Uses of FMEA

  • Used to analyze systems and subsystems in the early concept and design stages. Focuses on potential failure modes associated with the functions of a system caused by design.
  • Used to analyze products before they are released to Development/production.
  • Used to analyze the entire process of developing software applications, transactional processes.
  • When new systems, products, and processes are being designed
  • When existing designs or processes are being changed
  • When carryover designs/processes will be used in new applications, or new environments
  • After completing a Problem Solving Study (to prevent recurrence of problem)
  • For a System FMEA, after System functions are defined, but before specific Technology/Hardware is selected
  • For a Design FMEA, after product functions are defined, but before the design is approved and released to Coding/Manufacturing
  • For a Process FMEA, when preliminary design/drawings of the product/Software Application are available


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