FAP验厂咨询-探秘FAP质量管理基本要求文件在审核中的核心作用

FAP 质量管理审核所需文件/证件清单
General Requirements 一般要求
Factory profile工厂概况
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
A. General Requirements基本要求
2.1 ISO 9000 certificate or other Quality Assurance systems. ISO9000证书或其他质量保证系统
2.2 Quality manual 质量手册 
2.3 Procedure 程序文件
2.4 Quality objectives 产品质量目标
2.5 External documents control records 外来文件的管控记录
2.6 Documents control records 文件更改收发记录
B. Management Responsibility管理职责
3.1 Internal audit plan and records 内部审核计划、记录
3.2 Records of corrective actions and preventative actions for internal audit内审纠正与预防措施记录 
3.3 Management review records 管理评审记录
3.4 Complaint handling procedure 客户投诉处理程序
3.5 Complaint handling records (if applicable) 客户投诉处理记录 (如果有)
C. Resources Management 资源管理
4.1 Worker training plan 员工培训计划
4.2 Worker quality training records 员工质量培训记录
4.3 ERP/MRP or relevant systems. ERP/MRP或类似系统
D. Product Realisation 产品实现
5.1 Order review and customer focus procedure and records 订单评审和客户关注程序及记录
5.2 Design control procedure 开发设计控制程序
5.3 Design planning and input review record 设计计划或任务书及审核记录
5.4 verification and validation records 验证和确认记录
5.5 Design testing and record 设计产品检测报告
5.6 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）
5.7 Engineering Change Notice 设计变更记录（ECN）
5.8 Monitoring procedure and records of suppliers 供应商评审程序及记录
5.9 Suppliers list and qualified supplier list 供应商清单/合格供应商清单
5.10 Purchase orders and purchase contracts 采购单、采购合同
5.11 Quality guaranty for exempt from inspection of incoming material 来料中免检产品的质量保证书
5.12 IQC standard and specifications 来料检验标准及规格书 
5.13 IQC reports 来料检查、测试报告
5.14 Incoming material receiving and distribution records 来料收发记录
5.15 Control procedure and concession records for defect incoming material来料不良品退货、让步接收记录 
5.16 Working instructions 作业指导书 
5.17 IPQC inspection standard and records 制程检验测试标准、记录
5.18 FQC/OQC inspection standard and reports 终检检验测试标准、记录
5.19 Finished products test records 成品测试记录
5.20 Release records 发货记录
5.21 Testing/measuring equipments calibration records 仪器设备清单、内外校记录报告
E.Measurement,Analysis and Improvement 测量、分析和改进
6.1 Defect goods control records 不良品处理记录
6.2 Customer satisfication investigation 客户满意度调查
Industry requirement 行业要求
Toys 玩具
7.1 Chemical 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
7.2 Sharp tool control procedure and records 利器控制程序和记录
7.3 Inspection and testing reports of finished products 成品检查和测试报告
7.4 Impact test and fitment test on injection parts (Plastic Toys) 注塑件的测试报告(塑料玩具)
7.5 Adhesive test reports for paints (Plastic Toys) 涂层附着力测试报告(塑料玩具)
7.6Testing 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)
7.7 Broken needle records 断针记录
7.8 Metal detection records (Stuffing Toys) 金属探测记录(毛绒玩具) 
7.9 Metal detector calibration records 验针机校验记录
7.10 Dispose records of the products when detector is disable 探测器失效时，产品处理记录
E&E 电子电器检验报告
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) 
8.3 Regular 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
8.5 Regular 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
Softline 家纺
9.1 Fabric shrinkage test records 布料缩水测试记录
9.2 Pre-production meeting records 产前会议记录
9.3 In-line inspection records 过程检验记录
9.4 Sharp tool control procedure and records 利器控制程序和记录
9.5 Broken needle control procedure and records 断针控制程序和记录
9.6 Metal detection records 金属探测记录
9.7 Metal detector calibration records 验针机校验记录