This article presents risk analysis performed on manufacturing process of dry powder injection. 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 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. Each failure mode was ranked on estimated frequency of occurrence (O), 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. As part of a risk assessment, severity and probability need to be evaluated to establish the risk class. This is the first step of the risk assessment. In the second stage, the risk class is plotted against the possibility of the fault being detected before harm occurs; thus the risk priority is determined. 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.
Loading....