| 田磊,陈玉文.FMEA法在药品生产偏差处理过程中的应用[J].中国药事,2020,34(7):776-780 |
| FMEA法在药品生产偏差处理过程中的应用 |
| Application of FMEA Method in the Processing of Drug Production Deviation |
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| DOI：10.16153/j.1002-7777.2020.07.007 |
| 中文关键词: 质量风险管理 失效模式及影响分析 偏差 |
| 英文关键词: quality risk management failure mode and effect analysis deviation |
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| 中文摘要: |
| 目的：结合质量风险管理理念，制定偏差处理流程，研究失效模式与影响分析(FMEA)法在偏差处理过程中的应用。方法：以两个实际偏差事件为例，阐述FMEA法在药品生产偏差处理过程中的应用。结果与结论：FMEA法通过对风险事件失效模式赋值来确定风险的等级，再对风险进行排序。在偏差处理流程中，FMEA法的应用主要体现在风险评估、风险控制及风险评审3个方面，它能够将风险结果量化，可为风险是否可控提供数据证明。在偏差处理过程中合理运用FMEA法，可不断提高企业偏差处理有效性，完善质量管理体系，保证产品质量。 |
| 英文摘要: |
| Objective: To combine the concept of quality risk management, formulate a deviation handling process, and study the application of the failure mode and effect analysis (FMEA) method in the deviation handling process. Methods: Take two actual deviation events as examples to explain the application of FMEA method in processing drug production deviations. Results and Conclusion: The FMEA method determines the level of risk by assigning values to the failure modes of risk events, and then ranks the risks. In the deviation processing, the application of the FMEA method is mainly reflected in three aspects: risk assessment, risk control and risk review, which can quantify the risk results and provide data proof for whether the risk is controllable. Reasonable application of the FMEA method in processing deviation can continuously improve the effectiveness of enterprise deviation processing, improve the quality management system, and ensure product quality. |
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