Begun in the 1940s by the U.S. military, failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service.
The term “failure modes” in FMEA refers to the ways in which something might fail. Failures are any errors or defects, especially ones that affect the customer, and can be potential or actual.
The term “effects analysis” refers to studying the consequences of those failures.
Failures are prioritized according to how serious their consequences are, how frequently they occur, and how easily they can be detected. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones.
Failure modes and effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement. FMEA is used during design to prevent failures. Later it’s used for control, before and during ongoing operation of the process.
Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service.
When performed successfully, FMEA should reduce the time spent considering potential problems with a design concept, and keeps crucial elements of the project from slipping through the cracks.
As each FMEA is updated with unanticipated failure modes, it becomes the baseline for the next generation design. Reduction in process development time can come from increased ability to carry structured information forward from project to project, and this can drive repeatability and reproducibility across the system.
Benefits of FMEA include:
- Captures the collective knowledge of a team
- Improves the quality, reliability and safety of the process
- Logical, structured process for identifying process areas of concern
- Reduces process development time, cost
- Documents and tracks risk reduction activities
- Helps to identify critical-to-quality characteristics
- Provides historical records; establishes baseline
- Helps increase customer satisfaction and safety
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