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(总结时间:)
一、上周/上月工作(学习)情况
序号 1 工作(学习)内容 1.1 Learn about the establishment, classification (including general class, position class, equipment class, cleaning class) ,and common problems of workshop documentation system. 1.2 Learn about the core of workshop documentation system is to prevent contamination,cross contamination,mix-up and error. 所在岗位 2 2.1 Understand validation’s purpose,key,function;realize that validation is the method of ensuring product quality. 2.2 Learn about validation life cycle-model V. 3 4 Get started with process procedure of the production line. Get started with major equipment of the position-automatic blending system. 5 Modify 2 standard operating procedure of equipment of the workshop. 二、本周/上月工作(学习)计划
序号 工作(学习)内容 所在岗位 1 Understand anti-tumor workshop’s flows of personnel, materials, process and waste. 2 Study and acquire critical process parameters of process flow as many as possible;cultivate awareness of risk assessment. 三、上周工作(学习)中存在的问题
1.How to assess risk before writing SOP for equipment operators? And where should we think?
2.Due to the poor understanding of products’ manufacturing principle,I can’t get a better understanding of manufacturing process from all the aspects.
3.When it happens,I should strengthen the ability to analyze and deal with deviations. 四、问题改进的思路和建议
1.Consult related literature about product and enhance understandings.
2. I should record deviation without delay to accumulate experience when it occur,and rethink that how to handle the same questions the next time.
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