葛兰素史克-换模具程序.pptxVIP

培训资料Training Material －EN033:换模程序Format Change (version 3.0) 12-Aug-2010目的Objective1. 掌握换模的流程 Know the flow of format change2. 换模过程中各个人员的职责 Know the responsibilities of everyone范围Scope所有生产线以更换产品模具时使用 The usage of all the production line for all the format change GlaxoSmithKline Biologicals Shanghai4.1模具更换指令的准备和批准The preparation and approval of format change order在本SOP中In this SOP在相关SOP中Not in this SOP4.2待换模具及其操作工具的准备The preparation of the format changed and the tools问题Question4.3生产线的移交The handover of the production line4.4试机材料的准备和领用，参见SOP：WH041The preparation and receiving of the test materials. Refer to SOP: WH041参见SOP QA053(风险管理)和SOP QA028（异常操作）Refer to SOP QA053(Risk Management) and SOP QA028(Abnormality handling)4.5换模操作The operation of format change数据异常Abnormality？4.6故障维修MaintenanceYes参考EN017 Refer to EN017 4.10设备表现监控和改进Performance monitoring and improvementNo4.7换模试机Machine test for format change4.9换下模具的维修、清洁和入库The maintenance, cleaning and storage of the formats changed4.8生产线清场，清洁Production line cleaning流程 FlowGlaxoSmithKline Biologicals Shanghai表格1 Table 1换模指令单发起人 Organiger ： VS 协调员VS coordinator操作人 Operator ： 维修技术人员 Maintenance technician确认Checker ： WH 操作员 WH operator保存Keeper ： 维修技术人员 Maintenance technicianGlaxoSmithKline Biologicals Shanghai表格2 Table 2模具使用入库记录单操作人 Operator ： 维修技术人员 Maintenance technician（S:\Technical Service\Engineering\备件）GlaxoSmithKline Biologicals Shanghai表格3 Table 3工具清单Format and Tools Checklist操作人 Operator ： 维修技术人员 Maintenance technicianGlaxoSmithKline Biologicals Shanghai设备清洁标签换模结束之后:设备清洁标签生产线清洁清空后：表格4 Table 4设备日常使用记录”，参见EN017-F20file:///\\shasx012\shared\SOP\Controlled%20Documents\Electronic%20Doc\EN\Form\EN017\EN017-F20_machine%20log%20book.docS:\SOP\Controlled Documents\Electronic Doc\EN\Form\EN017\EN017-F20_machine log book.doc定期数据回顾：TS部门，每月council 会议回顾－换模时间和换模后生产状况（S:/Excellence/KPI…）GlaxoSmithKline Biologicals Shanghai