Costco QMS & GMP审核所需文件(SGS版)

来源:  发布时间:2017/7/11 17:05:38

costco验厂是好市多集团在对跨国企业工厂下订单时根据自己的企业行为守则对跨国企业工厂的标准审核,审核分为三大方面:社会责任、质量体系、反恐审核,实行审核时,一般情况会委托第三方公证机构STR和ITS(Intertek)来验证其供应商社会责任行为准则的执行情况。

 (Costco QMS & GMP Audit)所需文件:

1.1 Brief introduction of factory 工厂简介

1.2 Business license 营业执照 
1.3 Organization chart 公司组织架构图 
1.4 Factory’s plane figure-factory floor plans (公司)厂区/厂房平面图
1.5 Production process chart 生产工序流程图 
1.6 ISO 9000 certificate or other Quality Assurance systems. ISO9000证书或其他质量保证系统
1.7 产品测试报告Relevant product lab test reports
2.1 Quality manual 质量手册
2.2 Quality policy 质量方针
2.3 Procedures 程序文件 (文件,记录,不合格,内审,纠正措施和预防措施控制程序)
2.4 Quality objectives and monitoring records 质量目标和监控记录
2.5 Management review records 管理评审记录
2.6 Documents control records 文件更改收发记录
3.1 External documents list and control records 外来文件清单和管控记录
3.2 Products risk assessment procedure and records 产品风险评估程序和记录
3.3 Products risk assessment action and validation 产品风险评估措施和验证
4.1 Design control procedure 开发设计控制程序
4.2 Design input and review record 设计输入和评审记录
4.3 Verification and validation records 验证和确认记录
4.4 Design testing and record 设计产品检测及报告
4.5 Design output (technical file, BOM, Packing and using description) 设计输出(技术文件,物料单, 包装、使用说明)
4.6 Engineering Change Notice 设计变更记录(ECN)
4.7 Monitoring procedure and records of suppliers/subcontractor 供应商/分包商评审程序及记录
4.8 Qualified supplier list 合格供应商清单
4.9 Order review and customer focus procedure and records 订单评审和客户关注程序及记录
4.10 Complaint handling procedure 客户投诉处理程序 □ □ □
4.11 Complaint handling records (if applicable) 客户投诉处理记录 (如果有) □ □ □
4.12 Customer satisfication investigation and action records 客户满意度调查和改善措施记录
4.13 Recall procedure and records召回程序和记录
4.14 Internal audit plan and records 内部审核计划、记录
4.15 Records of corrective actions and preventative actions for internal audit 内审纠正与预防措施记录
4.16 Business emergency contingency plan业务紧急意外事件计划
5.1 Potable water test report(Cosmetic products)饮用水测试报告(化妆品厂)
5.2 Microbiological test procedure and record(Cosmetic products)微生物测试程序和记录 (化妆品厂)
5.3 Testing/measuring equipments calibration list and records 测试仪器设备清单、内外校记录报告
5.4 Equipment maintenance plan and records 设备维护计划和记录
5.5 Master Sanitation Schedule (MSS)主清洁计划
5.6 Standard Sanitation Operating Procedure (SSOP)卫生标准操作规程
5.7 Sanitation inspection record卫生管理记录 
5.8 Foreign materials control procedure and records异物(玻璃, 利器,化学品,虫害)控制程序和记录
5.9 Factory drinking, smoking policy厂内饮食,抽烟政策
5.10 Chemical control program化学品控制程序
5.11 MSDS-Material Safety Data Sheet 化学品物料安全数据表
5.12 Wood control policy 木材控制政策
6.1 Materials storing environment control procedure原料存储环境控制程序
6.2 Container inspection procedure货柜检查程序
6.3 Purchase orders and purchase contracts 采购单、采购合同
6.4 Quality guaranty for exempt from inspection of incoming material 来料中免检产品的质量保证书
6.5 IQC standard and specifications 来料检验标准及规格书
6.6 IQC reports 来料检查、测试报告
6.7 Incoming material receiving and distribution records 来料收发记录
6.8 Control procedure and concession records for defect incoming material 来料不良品退货、让步接收记录
6.9 Pre-production meeting records产前会议记录
6.10 Working instructions 作业指导书
6.11 First sample inspection records首件检验记录
6.12 IPQC inspection standard and records 制程检验测试标准、记录
6.13 FQC/OQC inspection standard and reports 终检检验测试标准、记录
6.14 Release records 发货记录 
6.15 Defect goods control records 不良品处理记录
7.1 Worker training plan for QC, operators, machine maintenance employees,test employees, calibration operator, internal auditor, risk assessment member, GMP (检验人员,操作人员,设备保养人员,测试人员,计量员,内审员,风险评估人员,GMP内容)培训计划
7.2 Training records 员工质量培训记录
8.1Chemical analysis for raw materials (plastics, pigments, paints, solvents etc.) 原材料(塑料,颜料,涂料,溶剂等)的化学分析报告
8.2 Sharp tool control procedure and records 利器控制程序和记录
8.3 Inspection and testing reports of finished products 成品检查和测试报告
8.4 Impact test and fitment test on injection parts (Plastic Toys) 注塑件的测试报告(塑料玩具)
8.5 Adhesive test reports for paints (Plastic Toys) 涂层附着力测试报告(塑料玩具)
8.6 Testing reports against standards of EMC Directive, EN 62115, ESD etc (Electrical Toys) 产品按EMC Directive, EN 62115, ESD等标准测试的报告(电子玩具)
8.7 Broken needle records 断针记录
8.8 Metal detection records (Stuffing Toys) 金属探测记录(毛绒玩具) 
8.9 Metal detector calibration records 验针机校验记录
8.10 Dispose records of the products when detector is disable 探测器失效时,产品处理记录
8.1 CE/ EMC/ Relevant product lab test reports. CE/EMC/相关的产品测试化验报告
8.2 Hi-pot mark test records (if applicable) 高压测试记录 (如果有) 
8.3Regular analyses of the tin bath of soldering machine (if applicable) 焊线机锡槽定期分析的记录 (如果有)
8.4 Reworked products re-inspection records 返工产品重检记录
8.5Regular validation records of key parameter settings / key items 关键参数设定/重点项目的定期验证记录
8.6 Finished products test records 成品测试记录
8.1 Fabric shrinkage test records 布料缩水测试记录
8.2 Pre-production meeting records 产前会议记录
8.3 In-line inspection records 过程检验记录
8.4 Sharp tool control procedure and records 利器控制程序和记录
8.5 Broken needle control procedure and records 断针控制程序和记录
8.6 Metal detection records 金属探测记录

8.7 Metal detector calibration records 验针机校验记录 

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