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麦德龙验厂审核需要哪些文件?

人气:4502发表时间:2017-08-31

        下面是MGB验厂所需文件清单供大家参考:
        01 Business License     营业执照
        02 Organization Chart    组织结构图
        03 Key Staff Job Description & Duty Vicegerent      关键岗位的岗位职责职务代理人
        04 Production Flow Chart      生产流程图
        05 Equipment List                  设备清单
        06 Machines Maintenance Plan & Records     设备保养计划记录
        07 Machines Repair Records      设备维修记录
        08 Equipment Operation Instructions      设备操作指引
        09 BuildingEquipment 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 Procedure and Record 管理评审程序记录
        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录
        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 (IQCIPQCFQC) 检验规范(原材料过程成品)
        40 Inspection Records (IQCIPQCFQC) 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 AssessmentReview 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 OrderRequest 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 MachinesEquipments 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