Analytical Method and Solutions for Problems Found in Pharmaceutical Industry Self-audit

OBJECTIVE To find the root causes and primary aspects for problems found in pharmaceutical industry self-audit, and perform corrective measures to acquire the expected effects in a minimized manpower and material resource. METHODS A combination of Pareto, brainstorming, cause-and-effect diagram and “5 why” analytical methods were applied to analyze the problems found in self-audit. RESULTS The root causes and primary aspects for problems from pharmaceutical industry self-audit were found, thus carried out the corrective and preventive actions, which made the number of all kinds of defects in self-audit gradually reduced, and improved the GMP level of pharmaceutical industry. CONCLUSION A combination of Pareto, brainstorming, cause-and-effect diagram and “5 why” can effectively grasp the main aspects of the problems, then find the root causes, thereby we can invest the finite manpower and material resource in solving the primary problems, thus avoiding the recurrence of the problem and improving the resource utilization rate.