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["ECRECO Initiator/Owner:"]
["ECR Date:"]
["Design Release Date:"]
["Material Impact"]
["old",null,null,"公司库存",{"$nulls":5},"供应商库存",{"$nulls":5},"维修备件库存",null,"客户现场",null,"New"]
["内部物料号","版本信息","存货名称/物料名称 Material name or model","Raw Material数量","Raw Material处置方案","WIP数量","WIP处置方案","Finished Product数量","Finished Product处置方案","Raw Material数量","Raw Material处置方案","WIP数量","WIP处置方案","Finished Product数量","Finished Product处置方案","Service Part 数量","Service Part处置方案","Shipping Qty出货数量","Field Action顾客现场措施","内部物料号","版本信息","存货名称/物料名称 Material name or model"]
[1100160,"REV3.0","MLP-FS96-1",1,"返工",2,"返工",3,"返工",11,"报废",12,"报废",13,"报废",20,"返厂返工",25,"发出忠告性通知",1100160,"REV4.0","MLP-FS96-1"]
[1100162,"REV2.0","MLP-FS96-1",1,"返工",2,"返工",3,"返工",11,"报废",12,"报废",13,"报废",20,"返厂返工32541",25,"发出忠告性通知",1100162,"REV2.0","MLP-FS96-1"]
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{"sheet":"Document Change","index":1,"n_rows":3,"n_cols":6,"rows_kept":3,"cut":false,"hidden":false,"merged":[]}
["Document Impact"]
["old",null,null,"New"]
["文件号","版本信息","文件名称","文件号","版本信息","文件名称"]

{"sheet":"ECR Form","index":2,"n_rows":56,"n_cols":18,"rows_kept":56,"cut":false,"hidden":false,"merged":[[0,14,0,19],[1,12,1,13],[1,14,1,19],[2,13,2,15],[2,17,2,19],[15,0,15,3],[15,4,15,11],[15,12,15,19],[21,0,21,7],[21,8,21,19],[24,5,24,8],[24,9,24,11],[24,12,24,15],[24,16,24,19],[25,5,25,8],[25,9,25,11],[25,12,25,15],[25,16,25,19],[26,5,26,8],[26,9,26,11],[26,12,26,15],[26,16,26,19],[27,5,27,8],[27,9,27,11],[27,12,27,15],[27,16,27,19],[28,0,28,19],[29,0,29,16],[30,9,30,12],[42,0,42,16],[44,0,44,19],[46,0,46,9],[46,10,46,19],[48,0,48,6],[49,0,49,6],[51,0,51,19],[52,2,52,3],[52,4,52,7],[52,8,52,9],[52,10,52,13],[52,14,52,15],[52,16,52,19],[53,2,53,3],[53,4,53,7],[53,8,53,9],[53,10,53,13],[53,14,53,15],[53,16,53,19],[54,2,54,3],[54,4,54,7],[54,8,54,9],[54,10,54,13],[54,14,54,15],[54,16,54,19],[55,0,55,1],[55,2,55,3],[55,4,55,7],[55,8,55,19],[13,0,14,19],[18,0,20,19],[23,0,24,4],[25,0,27,4],[52,0,54,1],[35,0,36,1],[37,0,38,1],[39,0,40,1],[33,0,34,1],[29,17,40,19],[41,17,42,19]]}
[{"$nulls":14},"            飞依诺科技股份有限公司"]
[{"$nulls":12},"ECR Number:",null," "]
[{"$nulls":12},"Owner:",null,null,null,"Date:"]
[{"$nulls":14},"  CUST REF :"]
["1. Why to Change变更原因:"]
["1-1. Main Change Reason:变更主要原因"]
["(    )Customer Complaint客户抱怨",{"$nulls":10},"(    )DFS Issue维修问题"]
["(    )Customer or clinical request客户或临床需求",{"$nulls":10},"(    )Procurement reason 采购原因"]
["(    )Supplier Change Request供应商变更请求",{"$nulls":10},"(    )Document correction文档修正"]
["(    )Design Defect 设计缺陷",{"$nulls":10},"(    )Parts obsolete部件停产\n"]
["(    )DFM Issue可生产性问题",{"$nulls":10},"(    )RA request 法规注册要求"]
["(    )Improve robustness提升鲁棒性",{"$nulls":10},"(    )Other (specify): 其他"]
["1-2. Detail Change Reason详细变更原因: "]
[]
[]
["2. Change Type变更类型:",null,null,null,"       "]
["3. What to Change变更内容:"]
[" 3-1. Description描述:"]
[]
[]
[]
[" 3-2 Impacted R&D department涉及到的设计部门："]
[" 3-3. Part Change零部件变更:"]
["Project or Product Name Affected\n影响的项目或产品 \n（国家版本需要列明，如软件图像等变更对非人用产品影响不同时需要单明）",{"$nulls":4},"Item Name Affected影响的零部件 "]
[{"$nulls":5},"Material name or model\n材料名称或型号 ",null,null,null,"IPN内部料号",null,null,"Material name or model\n材料名称或型号 ",null,null,null,"IPN内部料号"]
[]
[]
[]
["确认以上影响的零部件有没有未关闭的ECRECO："]
["4. Risk Assessment(Safety and effectiveness)风险评估(安全性和有效性):",{"$nulls":16},"RA review by\nRA评审人：\n\n\n\n\n\n\nDate日期：\n\n\n\n\n"]
[{"$nulls":9},"                                                                                                     "]
[" 风险管理表格：                                                                                                                                                                  "]
["5.Regulatory Impact Assessment法规影响评估: "]
["NMPA注册"]
[]
["CE注册"]
[]
["巴西注册"]
[]
["俄罗斯注册"]
[]
["6. DHF/DMR Impact 设计文档影响: ",{"$nulls":16},"产品经理签名/日期：\n"]
["(     )Product labling产品标识   (     )Intended use of the product产品的预期用途   (     )Design input/Product specification设计输入/产品规格 "]
["7. Service Impact 售后影响: "]
["Service Upgrade Action售后升级: \n(     )Service center information only仅告知售后服务中心.                                          (     )Field Recall产品召回.\n(     )Failed & returned products upgrade故障和返回品升级.                                       (     )No service communication needed不需要告知售后服务.     \n(     )Service BOM维修备件清单                                                                                                                                                             "]
["8. Other Impact Assessment其他方面的影响评估: "]
["(     )The third party design第三方设计\n(     )Production and inspection tool or fixture生产和检测治工具 \n(     )Continuous production产品持续生产\n(     )OEM 型号产品                                                                           ",{"$nulls":9},"(     )The compatibility with other products or parts与其他产品或部件的兼容性\n(     )Material or parts procurement 材料或部件的采购 \n(     )Configuration sheet of customer orders客户可订购产品配置\n(     )软件运行效率提升的影响、第三方动态库更新换代、已知安全漏洞补丁更新                     "]
["9. EHS Impact Assessment环境安全健康影响评估: "]
["变更是否有影响到环境因素？ ",{"$nulls":6},"是否当前环境因素识别和评价清单已经包含？"]
["变更是否涉及有危险源？",{"$nulls":6},"是否当前危险源识别评价清单已经包含？"]
["10. 备注:  "]
[]
["Reviewed by评审人",null,"Department\n 部门",null,"Signature/Date\n签名/日期",null,null,null,"Department\n 部门",null,"Signature/Date\n签名/日期",null,null,null,"Department\n 部门",null,"Signature/Date\n签名/日期"]
[null,null,"RD",{"$nulls":5},"Sourcing",{"$nulls":5},"Supplier Chain"]
[null,null,"PE",{"$nulls":5},"Service",{"$nulls":5},"QA"]
["Approved by批准人",null,"Champion",null,"Signature/Date\n签名/日期"]

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[{"$nulls":14},"            飞依诺科技（苏州）有限公司"]
[{"$nulls":14},"ECO Number:"]
[{"$nulls":14},"ECR Number:"]
[{"$nulls":14},"  CUST REF :"]
["MODE:","Immediately Change立即导入",{"$nulls":4},"      ","Running Change逐步导入",{"$nulls":4},"Owner:                                       Date:"]
["1、Description of change变更的描述"]
[]
[" "]
[]
["2、Design Verification and Validation Report设计验证和确认报告"]
[]
["3、Product and Material Impact产品和材料影响"]
["Project or Product Name Affected影响的项目或产品 ",null,null,"Item Name Affected影响的零部件 "]
[null,null,null,"OLD旧",{"$nulls":7},"NEW新"]
[null,null,null,"Material name or model\n材料名称或型号 ",{"$nulls":4},"IPN内部料号",null,null,"Material name or model\n材料名称或型号 ",{"$nulls":4},"IPN内部料号"]
[null,null,null," ",{"$nulls":4}," ",null,null," ",{"$nulls":4}," "]
[null,null,null," ",{"$nulls":4}," ",null,null," ",{"$nulls":4}," "]
[" ",null,null," ",{"$nulls":4}," ",null,null," ",{"$nulls":4}," "]
[null,null,null," ",{"$nulls":4}," ",null,null," ",{"$nulls":4}," "]
[]
["4、Document Impact文件影响 "]
["OLD旧 ",{"$nulls":8},"NEW新"]
["Doc.# 文件号",null,null," Title 文件名",{"$nulls":4},"(Rev.)版本 ","Doc.# 文件号 ",null,null," Title 文件名  ",{"$nulls":4},"(Rev.)版本"]
[null,null,null," "]
[]
[]
[]
[]
["                             Reviwed By审核人:                                                                           Approved By批准人:"]
["5、Process  validation过程确认",{"$nulls":8},"Need validation or not是否需要validation：              "]
["Design Transfer  to production设计转化到生产",null,null,"Production Files\n工艺、设备、SIPSOP文件"]
[null,null,null,"Process validation Plan"]
["Pilot execution试生产执行",null,null,"Supplier OQC Report"]
[null,null,null,"VINNO FAI Report"]
[null,null,null,"Process validation Report"]
["6、Risk Management Summary风险管理总结"]
[]
["7、Regulatory Impact Summary法规影响总结"]
[" "]
["8、Service Impact Summary售后影响总结 "]
[" "]
[]
["9、Other Impact Assessment其他方面的影响 "]
[" "]
["Vinno Stock \nDisposition公司库存处理",null,"Raw Material   Qty(                   )"]
[null,null,"WIP                  Qty(                   )"]
[null,null,"Finshed Goods Qty(                   )"]
["Supplier Stock Disposition\n供应商库存处理",null,"WIP                  Qty(                   )"]
[null,null,"Finshed Goods Qty(                   )"]
["Service Disposition\n售后处理",null,"Service Part  Qty (                     )"]
[null,null,"Field action "]
["10、备注:"]
[]
["11、期望完成时间:"]
["Reviewed by评审人",null,"Receiver\n接收",null,"Signature/Date\n签名/日期",null,null,null,"Receiver\n接收",null,"Signature/Date\n签名/日期",null,null,null,"Receiver\n接收",null,"Signature/Date\n签名/日期"]
[null,null,"RD",{"$nulls":5},"Sourcing",{"$nulls":5},"RA"]
[null,null,"PE",{"$nulls":5},"RD QA",{"$nulls":5},"Service"]
[null,null,"Operation QA"]
["Approved by批准人",null,"Champion",null,"Signature/Date\n签名/日期"]
["分发",null,"外部供应商"]