Abstract

RISK ASSESSMENT BY USING FAILURE MODE EFFECTIVE ANALYSIS (FMEA) TOOL : AN OVERVIEW

V Vijayakumar Reddy, Gangadharappa H. V.* and Shashikanth D.

Abstract

The use of risk assessment is a growing trend within the pharmaceutical industry. One such analytical method for performing risk assessment is FMEA (Failure Mode Effective Analysis). Risk Management is a process of identifying hazards associated with a product or processes, estimating and evaluating the risks associated, controlling these risks, and monitoring the effectiveness of the control. Failure mode and effects analysis (FMEA) is a method (first developed for systems engineering) that examines potential failures in products or processes. It can be used to evaluate risk management priorities for mitigating known threat vulnerabilities. This article aims to provide detailed study of the risk assessment by using FMEA tool. By this tool severity (S), Probability/Occurrence (P), Detectability (D) numbering for each failure mode was given, RPN can calculate and accordingly the risk level can be classified (Low, Medium, High level). High and medium level risks having potential impact on product quality. low risks are not likely to affect the overall process very much.

Keywords: Risk assesment, FMEA.