Abstract

A REVIEW: ROOT CAUSE ANALYSIS IN PHARMACEUTICAL INDUSTRY

Navale S. A.*, Basarkar G. D. and Mundada A. S.

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Abstract

A methodical approach to identifying the underlying root causes of our process problems is called root cause analysis (RCA). In order to perform the proper improvement action and make sure that improvements are maintained over time, RCA is helpful in identifying the cause(s) of variation. Improvement actions that are not focused on the primary cause will not be effective, or at least will not last long, therefore in order to sustain the improvement over time, the fundamental causes must be identified and addressed. The main goal of corrective action and preventative action (CAPA) in any pharmaceutical or medical device company is to identify any weaknesses, deviations, or failures and to conduct a review and take the necessary corrective action to prevent a recurrence of those issues. CAPA is another approach in which preventive actions are conducted instantaneously to avoid any incidence from occurring. It is a prerequisite for a pharmaceutical company's regulatory framework and a component of the overall Quality Management System (QMS).

Keywords: Root cause, corrective action and preventive action (CAPA), Pareto Charts, Failure Mode and Effect Analysis (FMEA), 5 Whys, Ishikawa Fishbone Diagram, DMAIC template.