统计过程控制在保健品片剂片重控制中应用

Application of statistical process control in the weight control of health care products tablets

中文关键词:  统计过程控制  片剂  片重控制

英文关键词:statistical process control  tablet  control of tablet weight

中文摘要:

      目的 研究统计过程控制(statistical process control, SPC)在保健品片剂片重控制中的应用。方法 以某企业保健品片剂压片过程中的片重控制为例, 收集压片装量数据, 计算样本标准差, 制作压片装量X-S控制图, 通过分析保健品片剂压片的过程能力指数发现过程异常点, 通过5WHY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 HACCP计划中执行。结果 4、5、6、9 h的样本标准差超出控制限, 属于异常现象, 分析找到的原因包括设备供料不及时、过程压力大和员工未按要求清洁等。采取改进措施后, 过程能力级别由Ⅴ级提高到了Ⅱ级, 过程能力指数提高了72%, 产品的不合格率降低。结论 统计过程控制作为压片片重控制的工具, 能够提高保健品片剂生产过程中片中的稳定性和过程能力。本研究可为统计过程控制在保健品片剂片重控制生产外的其他工序或其他保健食品生产过程中的应用奠定基础。

英文摘要:

      Objective To study the application of statistical process control (SPC) in the tablet weight control of health care product tablets. Methods Using the tablet weight control in the tableting process of a health care product tablet as an example, the tablet loading data was collected, the sample standard deviation was calculated, and the tablet loading X-S control chart was made. The process anomaly was discovered by analyzing the process capability index of tablet tablets for health products. Through 5WHY analysis, the root causes of the anomaly were found and corrective and preventive measures were developed to implement the measures into the HACCP plan. Results The standard deviations of the samples at 4, 5, 6, 9 h exceeded the control limit, which were an abnormal phenomenon. The reasons found in the analysis included that the equipment was not supplied in time, the process pressure was high, and the employees did not clean as required. After the improvement measures were taken, the process capability level was increased from level Ⅴ to level Ⅱ, the process capability index was increased by 72%, and the product failure rate was reduced. Conclusion SPC can improve the stability and process ability of tablets in the production process of health food tablets. This research can lay the foundation for the application of statistical process control in other processes of health product tablet production or other health food production processes.