FMEA (Failure Mode Effects Analysis) is one of the best ways of analyzing potential reliability problems early in the development cycle, making it easier for manufacturers to take quick action and mitigate failure. Itis a powerful tool for summarizing the important modes of failure, factors causing these failures and the likely effects of these failures.
As per ICH guidelines,
FMEA provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance. Once failure modes are established, risk reduction can be used to eliminate, contain, reduce or control the potential failures.
FMEA relies on product and process understanding. FMEA methodically breaks down the analysis of complex processes into manageable steps. It is a powerful tool for summarizing the important modes of failure, factors causing these failures and the likely effects of these failures.
Potential Area of Uses
FMEA can be applied to equipment and facilities and might be used to analyze a manufacturing operation and its effect on product or process. It identifies elements/operations within the system that render it vulnerable. The output/ results of FMEA can be used as a basis for design or further analysis or to guide resource deployment.
A Typical Risk Analysis Format
A Typical Risk Reduction Format
