FMEA is based on the assumption that “what can go wrong will go wrong.” FMEA provides a step-by-step approach for identifying all possible failures in a design, manufacturing or assembly processes, or in a product.
Failures are any errors or defects, especially ones that affect the medical professional or patient, and can be potential or actual.
“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.
Begun in the 1940s by the U.S. military, FMEA was further developed by the aerospace and automotive industries. Several industries maintain formal FMEA standards.
From the American Society for Quality: https://asq.org, 2018.
Empower Medical Devices uses FMEA tools and practices to identify, assess and mitigate risk associated with failures or defects. We use FMEA in two stages of our overall product development process:
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