目的找出药品生产企业自检问题产生的根本原因以及主要方面,并有针对性地实施整改,达到预期效果,同时降低人力物力的投入。方法综合运用帕累托(Pareto)图、头脑风暴、因果图和5why分析法分析药品生产企业自检问题。结果找到了企业自检问题产生的根本原因以及主要方面,并落实整改,使自检中各类缺陷项数目逐步减少,提高了企业GMP水平。结论综合运用帕累托(Pareto)图、头脑风暴、因果图和5why分析法,能够有效的抓住问题的主要方面,找到问题的根本原因,将有限的人力物力投入到主要问题的解决当中,避免相同的问题反复发生,提高了资源利用率。 Objective To find out the root causes and main aspects of the self-test problems of drug manufacturers and implement corrective measures in a targeted manner to achieve the expected results while reducing the input of manpower and material resources. Methods The Pareto chart, brainstorming, causal chart and 5why analysis were used to analyze the self-testing problems of pharmaceutical manufacturers. The results found the root cause of the self-examination problems and the main aspects, and implement the rectification, so that the number of various types of defects in self-test gradually reduced, raising the level of corporate GMP. Conclusion The Pareto chart, brainstorming, causal chart and 5why analysis can be used together to find out the root causes of the problem and put limited manpower and resources into solving the main problems. Avoid the same problems recurring, improve resource utilization.