统计过程控制在软胶囊压丸装量控制中的应用

Application of statistical process control in the loading control of soft capsule

目的研究统计过程控制在软胶囊装量控制中的应用,为统计过程控制在软胶囊生产的其他工序或其他保健食品生产过程中的应用奠定基础。方法以某企业压丸过程中的装量控制为例,收集压丸装量数据,计算样本标准差,制作压丸装量x-s控制图,通过分析压丸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。结果第2个小时和第16个小时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无自动补充料液功能、物料研磨不充分和员工未按要求清洁等。采取改进措施后,过程能力级别由Ⅳ级提高到了Ⅲ级,过程能力指数提高了12%,产品的不合格率降低。结论 SPC作为压丸装量控制的工具,能够提高软胶囊生产过程中装量的稳定性和过程能力。

Objective To investigate the application of statistical process control（SPC） in soft capsule loading control,so as to establish a foundation for the application of SPC in other processes of soft capsule production or other health food production processes.Methods Taking the loading control of soft capsule in the production process of a certain enterprise as an example,the 3c-s control chart of capsule loading was made by collecting the data of loading control and calculating the standard deviation of samples.Then the abnormal points of process were analyzed by calculating the process capability index（Cp）.Based on the above analysis,the corrective and preventive actions for loading control were developed through 5WHY analysis,which were implemented in HACCP plan.Results The standard deviations of samples produced in the second and sixteenth hour exceeded control limits,which was a abnormal phenomenon.The reasons included lack of automatic material replenish function of the equipment,insufficient material grinding,and staff＇s improper cleaning operations by 5WHY analysis.After taking improvement measures,the process capability level increased from grade IV to grade III,the Cp increased by 12%,and the percentage of unqualified products decreased.Conclusion As a loading control method,SPC can improve the stability of loading and the process capability in the production of soft capsules.