MGB验厂文件清单
1、Business License营业执照
2、Organization Chart组织结构图
3、Key Staff Job Description & Duty Vicegerent关键岗位的岗位职责/职务代理人
4、Production Flow Chart生产流程图
5、Equipment List设备清单
6、Machines Maintenance Plan & Records设备保养计划/记录
7、Machines Repair Records设备维修记录
8、Equipment Operation设备操作指引
9、Building/Equipment/ Products Cleaning Products and Records厂房(内,外部)/设备/产品的清洁程序/记录
10、Training Records for Cleaning Staff清洁人员的培训记录
11、Quality Policy质量方针
12、Quality Objective质量目标
13、Quality Manual 质量手册
14、Products Safety Procedure产品安全程序
15、Work Instruction作业指导书
16、Internal Audit Procedure & Records内审程序/记录
17、Management Review管理评审程序/记
18、Reports of the Functioning of QMS Including Suggestions for Improvement有关质量管理体系的业绩及改进需求的报告
19、Products Specifications产品规范
20、Record of Customers Requirement Review顾客要求评审记录
21、document Control Procedure文件控制程序
22、Record Control Procedure记录控制程序
23、Products Change Records产品变更记录
24、Suppliers / Sub-contractor Control Procedure供应商/分包商控制程序
25、Suppliers / Sub-contractor List and Assessment Record合格供方(供应商,分包商)清单及审核记录
26、CAPA Procedure and Record纠正预防措施程序/记录
27、Testing Record for the Traceability System可追溯性体系测试记
28、Legal Statutes and Mandatory Standards Applicable to Products/ Materials 产品,物料相关的法律法规和强制性标准(生产和拟销售地区的)
29、Products Risk Assessment Procedure/ Record产品风险评估程序/记录
30、Process Control Procedure过程控制程序
31、Products Risk Assessment Review Record产品风险评估的评审记录
32、Training Procedure/ Plan员工的培训程序/计划
33、Training Records (including Internal Rule and Work Skill training)员工的培训记录(规章制度,技能)
34、Training Records for Products Risk Assessment Staff执行风险评估人员的培训记录
35、Training evaluation Record培训有效性评估记录
36、Customer Complain & feedback Procedure/ Records 顾客抱怨反馈程序/记录
37、Incident Handle Procedure & Record事故处理程序/记录
38、Inside & Outside Communication System 内部/外部沟通机制
39、Inspection Instructions (IQC/IPQC/FQC)检验规范(原材料/过程/成品)
40、Inspection Records (IQC/IPQC/FQC)检验记录(原材料/过程/成品)
41、Products Preservation Procedure, Temperature and Humidity Definition & Records (if applicable)产品防护程序,温湿度规定及记录 (若适用)
42、Environment Policy 环境方针
43、Environment Objective 环境目标
44、Environment Impact Identified Procedure环境影响因素的识别程序
45、documents Compliance With the Local Environment Law and Regulation 符合当地环保要求的文件(例如:环评报告/排污许可证/委托处理液废/固废处理方的营业执照,双方协议,资质证明,发票/ 来自当地政府的符合性申明)
46、Hazardous Waste Disposal Record有害废弃物处理记录
47、Non-conforming Products Control Procedure 不合格品的控制程序
48、Non-conforming Products Review Record不合格品的评审记录
49、Assessment/Review Records of Product Test Need测试需求评审记录
50、Testing Procedure & Record产品的测试程序/记录
51、Testing Report Provided by Accredited laboratory (In-house or 3rd party)有资质的实验室(内部或第3方)提供的测试报告
52、Test Order/Request测试订单/申请
53、Review & CAPA Record of Failed Test Result测试失败的评审记录及相应的纠正措施记录
54、Re-inspection Records for the Re-worked Products返工重验记录
55、Recall Procedure/ Record召回程序/记录
56、Pre-Production Meeting Records产前会议记录
57、First Article Inspection Records 首件确认记录
58、Process Monitoring Procedure and record过程的监视和测量程序/记录
59、Measuring Machines/Equipments Calibration Plan and Records测量仪器的校准计划/记录
60、Shipment Release Instructions产品放行规定