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