HACCP体系与统计过程控制在片剂保健品生产中的结合应用
目的 研究危害分析临界点控制(hazard analysis critical control point, HACCP)体系与统计过程控制(statistical process control, SPC)的基本理论与思想在片剂保健品生产中的应用。方法 利用HACCP的原理与SPC进行相结合的理论基础, 从片剂保健品人员、设备、物料、法规、环境、软件、公用介质等几个方面进行结合分析, 找到异常的根本原因并制定纠正预防措施, 将措施落实到生产中执行。结果 从生产过程中得出某产品压片工序为异常和高风险工序, 工序过程能力指数(process capability index)CPK为0.22, 分析原因为压片工序转台不稳定, 装量波动大, 采取改进措施后CPK为1.45, 过程能力级别由Ⅴ级提高到了Ⅱ级, 工序过程能力得到提高, 产品的不合格率降低。结论 该研究有效和科学地保证了片剂保健品质量安全, 降低企业管理成本, 提高企业行业竞争力和社会知名度。
Objective To investigate the application about basic theory and thought of hazard analysis critical control point (HACCP) system and statistical process control (SPC) in the production of tablet health care products. Methods Based on the theory of HACCP combined with SPC, this paper analyzed the personnel, equipment, materials, regulations, environment, software and public media of the tablet health care products, finded out the root cause of the abnormality, and formulated corrective and preventive measures, which could be implemented in production. Results From the production process of a product, it was concluded that the tableting process was abnormal and high-risk process, and the CPK of process capability index was 0.22. The reason for analysis was that the rotary table of the pressure plate process was not stable and the loading quantity fluctuated greatly. After improvement measures the CPK was 1.45, and the level of process capability increased from Ⅴ to Ⅱ. The process capacity was improved and the failure rate of the product was reduced. Conclusion This study ensures the quality and safety of tablet health care products effectively and scientifically, reduces the cost of enterprise management, and improves the enterprise industry competitiveness and social visibility.
标题：HACCP体系与统计过程控制在片剂保健品生产中的结合应用
英文标题：Combinative application of hazard analysis critical control point system and statistical process control in tablet health products production
作者：
冯波 汤臣倍健股份有限公司
中文关键词:统计过程控制,片剂,片重控制,体系,
英文关键词:statistical process control,tablet,tablet weight control,system,
发表日期：2018-08-17
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