Failure Mode and Effects Analysis / FMEA – Smart Factory Glossary

The Failure Mode and Effects Analysis (FMEA) is a method to detect possible failures and risks as early as possible during the design and manufacture of a product. FMEA aims at avoiding failures in the run-up, instead of correcting them after they occurred. Occurrence, severity, and detection are the criteria used to classify failures. The rating estimates the probability of a failure to occur, assesses the severity of the effect on the customer, and evaluates how likely it is to detect the failure. As the Failure Mode and Effects Analysis is a comprehensive approach, it also includes the actions that must be taken to eliminate or at least minimize failures. Inspection planning is therefore largely based on the FMEA results: the assessment of risks at an early stage hints at the characteristics that must be thoroughly checked during production.

In regulated environments such as the medical and pharmaceutical industries, Failure Mode and Effects Analysis can help companies comply with legal regulations and stipulated risk management. The applications of a Manufacturing Execution System (MES) such as the mApp FMEA of MPDV's MES HYDRA X are perfect solutions to support companies. The software can be used to link failures, failure causes, and their effects and visualize everything in a failure network. 

• Failure mode and effects analysis: Wikipedia, 30.12.2023 [online] https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis (requested on 25.03.2024).

>> Back to Smart Factory Glossary <<