Risk Analysis of Controlled Release Tablet Formulation by Six Sigma Technique

Abstract

Failure Mode and Effects Analysis (FMEA) is a procedure which is performed after a failure mode effects analysis to classify each potential failure effect according to its severity and probability of occurrence. 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 part of the process that are most in need of change. Subjected a controlled release tablet formulation to a Failure Mode and Effects Analysis, including technical risks as well as risks related to human failure which broke down the formulation into the process steps and identified possible failure modes for each step. Each failure mode was ranked on estimated frequency of occurrence (0), probability that the failure would remain undetected later in the process (D) and severity (S). Human errors turned out to be the most common cause of failure modes. Failure risks were calculated by Risk Priority Number (RPNs) O*D*S. Failure modes with the highest RPN scores were subjected to corrective action and FMEA was repeated. 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 which depends on product and process understanding. FMEA is most effective when it occurs before a design is released rather than "after the fact". The aim of this paper is to demonstrate an application of process failure mode and effect analysis (process FMEA) as a performance improvement tool, based on a case analysis of process improvement conducted in an early drug discovery project.