| 引用本文: | 董光辉,叶明良,赵柳入,黄海波,方玲,金朱明,曹王丽.药品生产企业自检问题的分析解决思路[J].中国现代应用药学,2014,31(5):624-627. |
| DONG Guanghui,YE Mingliang,ZHAO Liuru,HUANG Haibo,FANG Ling,JIN Zhuming,CAO Wangli.Analytical Method and Solutions for Problems Found in Pharmaceutical Industry Self-audit[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(5):624-627. |
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| 摘要: |
| 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。 |
| 关键词: 缺陷项 帕累托图 头脑风暴 因果图 5why分析法 |
| DOI： |
| 分类号:R284.1；R917.101 |
| 基金项目: |
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| Analytical Method and Solutions for Problems Found in Pharmaceutical Industry Self-audit |
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DONG Guanghui1, YE Mingliang1, ZHAO Liuru2, HUANG Haibo1, FANG Ling1, JIN Zhuming1, CAO Wangli1
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1.Zhejiang CONBA Pharmaceutical Co., Ltd., Zhejiang Provincial Key Laboratory of Traditional Chinese Medicine Pharmaceutical Technology, Hangzhou 310052, China;2.Zhejiang Hisoar Pharmaceutical Co., Ltd., Taizhou 318000, China
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| Abstract: |
| 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. |
| Key words: defect Pareto brainstorming cause-and-effect diagram 5why analytical method |
