Failure Mode and Effects Analysis (FMEA) is all about preventing a failure before any harm is done.
A well-documented FMEA process identifies and contextualizes the failure, providing insight into the scope of its effects.
Started as a U.S. military management procedure in the 1940s, today FMEA is a procedure for determining where processes, products or designs are most likely to fail and why. It is used to design a process, review and improve a process and also act as an efficient process control.
FMEA uses a step-by-step approach to identify each failure mode, with the analysis then estimating the effects of failure and devising ways of controlling the process so that failure can be averted.
The most commonly used and least complex is the Process FMEA, which is used to evaluate manufacturing and assembly processes. Another type is the System FMEA, which analyzes complete systems and/or sub-systems during the design concept stage. The Design FMEA examines product designs before their release to manufacturing.
The benefits for organizations using an FMEA approach are considerable. In business, FMEA improves quality, reliability and safety of a process. It also documents and tracks risk reduction activities. Bottom line, FMEA in business increases customer satisfaction.
In healthcare, FMEA is also useful by using a systemic approach that identifies and mitigates risks that could conceivably result in patient tragedy.
In healthcare, FMEA is commonly applied when:
- A new process, function or service with an associated hazard has not yet been implemented
- A current process, function or service with modifications / changes due to past failure or sentinel events
- A current process, function or service being used in a new or similar location
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.
Want to learn more? Tonex offers several courses in FMEA, such as:
FMEA for Medical Devices (2 days)
Applied Failure Mode and Effects Analysis Workshop (2 days)
For more information, questions, comments, contact us