We live in a world full of risks. We cannot stop hazards but can make an effort to prevent them. Failure Mode and Effect Analysis (FMEA) is a structured tool for the evaluation of possible problems. This could occur while performing end number of things, from driving a vehicle, using public transportation, taking medicine or using a medical device. Its important to prevent risk at a very initial stage of designing devices.
FMEA methodology analyzes potential dependability problems early in the development cycle where it is simpler to take actions to overcome these issues, thereby enhancing reliability through design. FMEA is used to identify potential failure modes, find out their effect on the operation of the product, and categorize actions to reduce failures. A crucial step is anticipating what might go wrong with a product.
Failures are checked according to how grim their after effects are, how frequently they occur and how easily they can be resolved. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones. In case of medical device manufacturers, they are constantly challenged by stiff competition, liability law suits etc. For them it becomes crucial to develop safe, reliable, and cost-effective products, manage and reduce risk to reach their ultimate goal of manufacturing error free devices.
|
