FMEA, Different from Root Cause Analysis

Failure Mode and Effect Analysis is an analytical technique used by product design team as a means to identify, define, and eliminate, to the extent possible, known or potential failure modes of a product or system. FMEA is an ongoing quality improvement process that is carried out in healthcare organizations by a multidisciplinary team. It can be employed to examine the use of new products and the design of new services and processes to determine points of potential failure and what their effect would be before any error actually happens.

Failure Modes and Effects Analysis (FMEA) differs from Root Cause Analysis (RCA). RCA is a reactive process, employed after an error occurs, to identify its underlying causes. And FMEA is a proactive process used to look more carefully and systematically at vulnerable areas or processes. A systematic, proactive method is for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change.

RCA is a method of problem solving that tries to identify the root causes of faults or problems that cause operating events. RCA practice tries to solve problems by attempting to identify and correct the root causes of events, as opposed to simply addressing their symptoms. Root Cause Analysis seeks to identify the origin of a problem. It uses a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can determine what happened, why it happened, and figure out what to do to reduce the likelihood that it will happen again.

FMEA provides a basis for identifying potential system failures and unacceptable failure effects that prevent achieving design requirements from postulated failure modes. FMEA is used in many system design analyses including assessing system safety, planning system maintenance activities, defining provisions for fault recovery, fault tolerance, and failure detection and isolation, and identifying design modifications and corrective actions needed to mitigate the effects of a failure on the system. Quality systems management is based on FMEA that allows you to analyze the potential effects of failure and determine what control mechanisms are worthwhile.


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