Failure Mode and Effects Analysis: Lowering the Odds of Disaster
Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process.
Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead to waste, defects or harmful outcomes for the customer. Failure Mode and Effects Analysis is designed to identify, prioritize and limit these failure modes.
Although initially developed by the military, FMEA methodology is now extensively used in a variety of industries including semiconductor processing, food service, plastics, software and healthcare. Toyota has taken this one step further with its Design Review Based on Failure Mode (DRBFM) approach.
Failure Mode and Effect Analysis is often used when a process, product, or service is being designed or redesigned, after quality function deployment (QFD), or when an existing process, product, or service is being applied in a new way.
FMEA is also used by organizations before developing control plans for a new or modified process, or when improvement goals are planned for an existing process, product or service.
Developed in the 1950s, FMEA was one of the earliest structured reliability improvement methods. Today it is still a highly effective method of lowering the possibility of failure.
Experts in this area believe there are seven critical steps that should be followed in order to carry out an FMEA successfully:
1. FMEA Pre-Work and Assemble the FMEA Team
2. Path 1 Development (Requirements through Severity Ranking)
3. Path 2 Development (Potential Causes and Prevention Controls through Occurrence Ranking)
4. Path 3 Development (Testing and Detection Controls through Detection Ranking)
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5. Action Priority & Assignment
6. Actions Taken / Design Review
7. Re-ranking RPN & Closure
Want to learn more? Tonex offers several courses in FMEA, such as:
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