SIX SIGMA TECHNIQUE USED IN RISK ANALYSIS IN TABLET FORMULATION

FMEA is a systematic method for evaluating a process to identify where and how it might fail and access the relative impact of different failure, in order to identify the part of the process that are most in change needed. Failure Mode and Effect Analysis (FMEA) is a procedure which is performed after a failure mode effects analysis. Tablet is formulated in different steps, so the failure mode is studied for every step and also consider human failure and the technical risks, all these consider in the study. Each failure mode is ranked on estimated frequency of occurrence (O), probability that the failure would remain undetected later in process (D) and severity (S). Failure risk were calculated by Risk Priority Number (RPNs) i.e O*D*S. Failure mode with highest RPN scores is concider and subjected to the corrective action and FMEA was repeated. This technique is very useful in the evaluating the new process prior to the implementation when the process change the existing process. The aim of this paper is to demonstrate an application of this technique on the basis of FMEA