3.原因分析 Cause Analysis
3.1引发原因 Cause：
3.2 投诉是否成立 Complaint established
客户投诉记录
Customer Complaint Record
投诉记录编号
Complain Record No.客户名称
Customer name
2.1投诉内容 Complaint content：
1.基本信息 Basic Information
投诉时间Time
2.投诉详情 Complaint Detail
客户SCRA编号(如有)Customer SCRA No.(if applicable)
2.2产品信息 Product information
产品名称Product Name
产品编号Product No.
批号Lot No.
数量Quantity
不适用Not Applicable
投诉成立Yes
投诉不成立(跳至第5.部分) No(Go to Part 5)
FM 018 A
验证人 Verified
by ：
验证日期Verification
签署：Signature ：
日期：Date ：
调查结果 Inspection results 纠正行动计划
Corrective action Plan 验证结果 Effectivness
Ⅰ：第1.、2和6.部分由市场部填写
Ⅱ：第3.和4.部分由责任部门或责任人填写Ⅲ：第5.部分由验证人填写Ⅳ：由管理者代表进行审查Note ：
Ⅰ:Part 1 , 2 & 6 to be filled by Marketing Department Ⅱ:Part 3 & 4 to be filled by Person/Department-in-Charge Ⅲ:Part 5 to be filled by Verifier Ⅳ:To be reviewed by reviewer 5.1改善措施验证结果 Validati
on of Result of improvement measures：
5.处理结果 Result
纠正或预防措施完成日期Improvement Measures Finished Date
纠正或预防措施实施负责人
Improvement Measures Implementer
CPAR号CPAR No.
5.2不良事件呈报 Adverse Event Report：
4.改善措施情况 Improvement Measures
审查 Reviewed by
姓名：Name ：责任部门/责任人
Person/Department-in-Charge
纠正或预防措施计划日期Improvement Measures Plan Date
纠正或预防措施计划人Improvement Measures Planner
5.3其他相关处理结果描述(退货/召回等) Other related results(Return/Recall etc.)：
customer的中文意思
6.通知记录 Notification record
通知项目Notification item 通知人 Responsible
通知日期 Notification
Date
备注Remark
不适用Not Applicable
不适用Not Applicable
不适用Not Applicable
不适用Not Applicable
FM 018 A
Ⅰ：第1.、2和6.部分由市场部填写
Ⅱ：第3.和4.部分由责任部门或责任人填写
Ⅲ：第5.部分由验证人填写
Ⅳ：由管理者代表进行审查
Note：
Ⅰ:Part 1 , 2 & 6 to be filled by Marketing Department Ⅱ:Part 3 & 4 to be filled by Person/Department-in-Charge Ⅲ:Part 5 to be filled by Verifier
Ⅳ:To be reviewed by reviewer
FM 018 A