Failure Mode Effect Analysis is an analytical technique that goes in for combining Technology and Experience of people to identify foreseen failures in a product or process and planning to eliminate the Failure. Definition FMEA is a group of activities to understand and evaluate potential failure of product or process and its effects, and identify actions that eliminate or reduce the potential failures.
Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method 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. FMEA includes review of the following:
Steps in the process
Failure modes (What could go wrong?)
Failure causes (Why would the failure happen?)
Failure effects (What would be the consequences of each failure?) Types of FMEA Major Classification * Design FMEA * Analyzes product design before release to production, with a focus on product function * Analyzes systems and subsystems in early concept and design stages
* Process FMEA * Used to analyze manufacturing and assembly processes after they are implemented
Sub Classification * Equipment FMEA * Maintenance FMEA * Service FMEA * System FMEA
Teams use FMEA to evaluate processes for possible failures and to prevent them by correcting the processes proactively rather than reacting to adverse events after failures have occurred. This emphasis on prevention may reduce risk of harm to both patients and staff. FMEA is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process.
Major benefits derived from a properly implemented FMECA effort are as follows: 1. It provides a documented method