最新偏差处理单.docxVIP

000 偏差处理单 Deviation Handling Form 编号 Document No. : QA REC 版本号 Edition: 00 事件编号Incident No: 偏差描述：见所付事件记录单复印件 Deviation description: See in the Incident Record Form copy Section A 由质重部填与 To be completed by Quality Dept. 偏差的种类Deviation Cate: 口检/化验结果超标 口 IPC缺陷 口混淆 □物料异常 □潜在的污染 Out of specification IPC defects Mixed up Material abnormity Potential contamination 口环境 □校验/预防维修 口包装缺陷 口设备故障/过程中断 Environment Calibration/Prevent maintenance Packaging defect Equipment Failure/Process Interrupted 口未按规程执行 □人员失误 □清场事故 □计算机系统 □文件错误 Operated obey procedure Human error Line clearance failure Computer systems Documentation errors 口收率和消耗超限 □不良趋势 □纠正与预防措施错误 □客户投诉 □其他 Yield and wastage OOS Adverse trends CAPA Failure Customer Complaints others 偏差初步评估Initial evaluation □新发生 New □—年内 U 复两次 Repeated twice in one year 口—年内 重复 阙次以上 Repeated more than twice in one year 偏差合并 Deviation Combination 偏差如重复发生，则将此偏差合并至原偏差 原偏差号： If deviation repeated, merge this deviation to former deviation Former Deviation No: 偏差分级 Deviation Classification 口严重事故 Critical incident □严重偏差 Critical deviation 口重大偏差 Major deviation □次要偏差 Minor deviation □通告 For information Only 签名/日期： Sign/Date: Section B 由质量总监填写 To be complete by Quality Director 确认 Section A 内容 Review Section A 确正偏差相关部门 Ensure the deviation relevant Department 口质量控制部QC □质量保证部QA □生产部PM 口工程部EM □综合管理部GM □其他other 指定调查负责人 Nominate Investigation Leader : 偏差调查期限（年月日） Deviation investigation period : （YYYY.MM.DD） 自： 至： From: To: 签名/日期： Sign/Date: 以上内容应该在 24 小时之内完成。Above details should be completed in 24 hours. *不得留有空格，若不涉及，请填 N/A”。 All blanks must be completed, if not applicable, please fill N/A” 偏差编号Deviation No: Section C 偏差调查（由调查负责人完成） Deviation Investigation（Completed by Investigation Leader) 偏差调查团队成员签名 Sign by members of Deviation Investigation Team 评估■所采取的应急处理 措施 Assess the immediate corrective action 调查偏差的根本原因或者最可能原因 Investigate the root cause or the most possible reason of the deviation. 根本原因类别： Root Cause Category 匚入员/行为 匚设备/设施 匚产品/物料 Personnel/