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Abstract
In the current widening global economy, failures can have profound impact on an organization's competitiveness. To be successful in business, every organization focuses on how to prevent failures in their manufactured products, processes, and operations. To reduce the loss, the only way out is to investigate their cause and prevent it from reoccurrence. Root cause analysis is an effective method to achieve this particular goal. Root cause analysis is a technique to address a non-conformance or problem to find out the real cause of particular problem. For investigation, various root cause analysis tools are used. The main aim of root cause analysis is to discover the actual cause of an observed problem, defect, or failure so as to utilize this particular information to correct it. After the investigation and identification of appropriate root cause the implementation of CAPA (Corrective Action and Preventive Action) should be done.
Keywords: Root Cause Analysis (RCA), Corrective Action and Preventive Action (CAPA), Investigation, RCA tools.
Introduction
In worldwide competitive markets, failures have been proved to be expensive and sometimes cause havoc to pharmaceutical organization. In order to be successful in business, every pharmaceutical organization focuses on how to prevent failures in their products or operations. A particular way to lessen the loss is to investigate their causes and prevent them from reoccurring.1 Effective science-based investigations lead to error prevention, operational excellence and patient safety. It is a challenge to the industry, to apply appropriate scientific rigor to investigations. Pharmaceutical organizations that put in place meaningful failure investigations and processes for investigations will not only strengthen their business base but also achieve sustainable improvements in their productivity and product quality.2
Root cause analysis
Root cause analysis (RCA) is performed to address a non-conformance or problem to get into actual cause of the problem. This method is used to either eliminate the cause or to prevent problem from reoccurring. Getting into the root of the cause means stopping that particular cause from ever happening again. Underlying causes are determined by using a structured problem solving approach. It avoids repetition of non-conformities; prevention of reoccurrences and provides permanent solutions. In some organizations it is a part of the policy and goal for facilitating improvement for a longer period and a strong...