文件控制程序(中英文)

Revision HistoryApproved DCN on File in Document Control1.0 PURPOSE 目的1.1 To define a procedure for the generation, revision, handling, approval, retention, storage ofinternal documents as well as control of external documents.为内部文献的生成，修改，解决，同意，保存，保存以及对外部文献的控制订义程序。

2.0 SCOPE 范畴2.1 This procedure is applicable to quality management system (QMS) documentation such assystem manual, procedures & work instructions.本程序合用于质量管理体系（QMS）的系统文献，如体系手册，程序文献及作业指导书。

2.2 This procedure also covers the DCN & ECN generation and approval signatory for QMSdocumentation and product documentations.本程序还涉及质量管理体系文献和产品文献的文献变更告知（DCN）&工程变更告知（ECN）的生成和审批订立。

2.3 This procedure also covers control and handling of customer documents and otherregulatory requirements.本程序还涉及客户文献和其它法规规定的控制和解决。

2.4 This procedure also covers control and handling of supplier documents.本程序还涉及对供应商文献的控制和解决。

1.1 PURPOSE 目的1.1 This procedure provides guidelines for minimum control requirements necessary for a document tobe controlled, to ensure the suitability, adequacy and effectiveness of *** Automotive Technologies Co., Ltd. management system documents.本程序是规定了****汽车科技有限公司对管理体系文件和资料的控制与管理，确保管理体系文件的适宜性、充分性和有效性。

1.2 SCOPE 范围2.1 This procedure applies to controlled documents identified as part of the Management System for alldocuments issued and controlled in MMK:本程序适用于MMK的管理体系有关的受控文件2.1.1 Quality manual, procedures, working instructions质量手册，程序文件，作业指导书；2.1.2 Technical documents (including internal and customer)；技术文件(包括内部的和从客户处获得的)；2.1.3 External documents: e.g. legal and other standards etc.外来文件：法律法规以及相关标准。

3.0 DEFINITIONS 定义3.1 Controlled Document：Any document essential to the functioning of a process that needs to beavailable in its latest form.受控文件：流程运作的基本文件，这些文件必须保持最新版本。

CONFIDENTIALITY PROCEDURE 10 DECEMBER 2010SYNOPSISCONTENTSCONTENTS (3)1.PURPOSE 目的 (4)2.RESPONSIBILITYS 职责 (5)3.CONFIDENTIAL INFORMATION SCOPE (6)4.STORAGE，COPY, DISTRIBUTION, BORROW AND DISPOSAL (7)4.1Storage and Copy (7)4.2Distribution (7)4.3Disposal (8)APPENDIX 1– CONFIDENTIAL DOCUMENT DISTRIBUTION REGISTERAPPENDIX 2– CONFIDENTIAL DOCUMENT CHECKLIST1. PURPOSE 目的This procedure provides the necessary requirements and guidelines for controlling confidential documents to assure XX COMPANY personnel are aware of storage, copy, distribution, and disposal confidential documentation.本程序旨在提供了一些必要的要求和准则，用于控制保密级别的文件以确保XX公司员工明确保密文件的存储，复印，发布和销毁的程序。

2. RESPONSIBILITYS 职责XX Manager is responsible for the implementation of this procedure in order to protect the company and client intellectual property information.为了更好的对公司和业主的知识产权进行保护XX经理负责实施本程序。

文件管理与控制程序Documents management and control procedure1.目的Purpose确保环境管理体系文件、适用的外来文件（有关的法律、法规、标准、相关方提供的文件或规范）使用的有效性。

To assure the2.适用范围 scope适用于对环境管理体系相关文件及适用的外来文件的控制。

It is apply to theenvironment management system relation documents and usable external documents’ control.3.职责Responsibility3.1 环工组：负责环境管理体系文件及适用的外来文件的归口管理；负责监控文件的执行。

The environment team: to manage and be in charge of environment management documents and external documents.3.2 各部门individual department：确保各相关场所均使用现行文件的有效版本。

To ensureThe relative workplace is using the current effective documents.4.工作程序Work procedure4.1文件控制范围包括：documents control’s scopea）环境管理手册；environment management manual;b）环境管理体系程序文件；environment management system procedure documents;c）环境管理体系作业指导文件；the work instruction documents for environment management system;d）环境记录表格；environment record form;e）外来文件。

文件和记录控制程序1.0 目的 Purpose对与管理体系有关的文件、资料和记录(含电子版)进行控制，确保所有使用部门使用的文件和记录(含电子版)都有效。

Control over documents and materials related to management system so as to ensure that all the documents and materials and records (electronic)used by each department are current and valid. 2.0 范围Scope合用于所有与管理体系等有关的文件、资料和记录(含电子版)的控制。

Applicable to the control over documents and materials and records (electronic) related to management systems.3.0 职责 Responsibility3.1 管理者代表负责手册(质量手册、 EHS 手册)及程叙文件的批准。

Management Representative is responsible for the approval of manuals (quality manual,EHS manual) and procedure files.3.2 质量部经理负责质量手册、 EHS 手册的审核，程叙文件的复核。

QM is responsible for verification of quality manual, EHS manual , recheck procedure files.3.3 体系工程师负责质量手册、 EHS 手册的编制、更改和控制；程叙文件的编写和三级文件的审核。

ISO specialist is responsible for compilation, alternation and control of quality manual and EHS manual and procedure documents and review thesupportive documents.3.4 文控室负责检查文件编号、控制，外来文件的控制、管理。

1. 目的：对产品设计开发全过程进行控制，确保设计和开发的新产品满足规定的要求。

Purpose：Control the whole process of product design and development to ensure that the design and development of new product meet the stated requirements.2. 适用范围：适用于产品设计和开发的全过程。

Applicable Scope：Apply to the whole process of product design and development.3. 职责Responsibility：3.1董事总经理负责设计开发项目的立项、设计输入及试产交接会的组织和批准工作。

The Director General shall be responsible for approving the establishment of design and development project, design input and organizing the meeting for hand-over of pre-production .3.2技术总监领导负责产品的设计开发全过程的组织协调及审批工作。

The C.T.O will organize and coordinate the overall process of design and development of product, take charge of audit and approval as well.3.3项目工程师负责统筹产品的设计开发、型式试验及组织设计开发过程中产品的装配测试工作。

The project engineer shall be in charge of coordinating the design and development and type-test of product, organize the work related to assembly and test during the process of design and development.3.4 生产技术部负责配合执行产品测试及试验工作，组织产品试产，组织生产装配工艺文件和检验文件的编制及审核工作。

The rules hereinafter are as appendix to the QC Manual for design control.1.Authority and Responsibility1.1 Design QC Engineer1.1.1 To be responsible for design control of Code Items and assuring that the designwork done by other design agent is also in accordance with the Code requirements.1.1.2 To arrange the review and acceptance to customer documentations includingdrawing and referenced documents.1.1.3 To be responsible for overall engineering design work.1.1.4 To designate design engineer to review the Customer’s technical requirementsand the design documents prepared by the customer or his designated agent. 1.1.5 To prepare the Document List (QC Manual Form 3-2).1.1.6 To verify the design calculation and the stress analysis satisfy the Coderequirements.1.2 Design Engineer1.2.1 To prepare/check up design documents including drawings, calculation sheet andspecifications.1.2.2 To review the Customer’s Specificat ion to verify that the specificationcontains requirements and data detailed enough to constitute an adequate basis for selecting materials, designing, fabricating, testing and inspecting the Code Items, and that the Specification complies with the requirements of the Code .If necessary, design engineer shall get customer’s the supplemental information for checking.1.2.3 To perform proof test and/or perform experimental stress analysis, if necessary.1.2.4 To revise the design documents in accordance with part 4 of this rule.1.2.5 Review the design documents provided by user & his designed agent.1.3 Document KeeperTo receive, distribute, keep and file the documentations.2 Design Process Control2.1 Design ProcessThe design process of Code Item is divided into two stages,preliminary design and construction drawing design. The review process of construction drawing shall be in accordance with the QC manual. The preliminary design shall refer to thebasic design prepared for bidding or quoting purpose. For the cause of management, the quoting drawing shall be prepared by design engineer and approved by design QC engineer.2.2 The Work of Two Stages2.2.1 In the preliminary design, a comparison of technique and economy shall be madeto indicate that the technology is advanced, the expense is reasonable, safety is ensured, and the design is in compliance with requirements of the Code.2.2.2 The construction drawing design documents shall conform to therequirements of the ASME Code and the Customer’s Specification.3 Design Documents Control3.1 The design documents include the Customer’s Specification, Designing Assignment(issued by SURF), Drawings, Calculation Sheet, and the MaterialRequisition,Purchase Specification,etc.3.2 The documents prepared by Technical Department shall be registered and numberedby the Document Keeper.3.3 The documents such as the Customer’s Specification shall be registered bythe Document Keeper, and issued to the concerned personnel by Design QC engineer.3.4 The assignee of any document shall be registered in the Document Issuance Book.The obsolete documents shall be handled in accordance QC Manual and be handled by Design QC Engineer.4 Revision of Design Documents4.1 Responsibility and Procedure4.1.1 If the design revision is needed to be done during the fabrication period, therevision work should be done by the original designer whenever possible.4.1.2 The drawings issued for manufacturing shall be replaced by the latest ones.4.2 Methods of Revision4.2.1 The size, letter or figure to be revised shall be marked out by a thin line.The part marked out shall be still clearly visible for showing the content before revision. Then, the new size, letter or figure shall bemarked.4.2.2 The revision mark shall be shown near the original position. The entire partof revision shall be enclosed by a cloudy circle. See the followings:4.2.3 The main cause and content of revision shall be filled in the revision block4.2.4 The part number in the drawing and the title block shall be allowed to skip,if the part has been canceled from the original drawing due to revision. The words “Part number xx was canceled” shall be filled up in the revision description column of the revision block.。

Control Procedure of Documents 文件管理程序Prepared by Date _____________编制：日期：Approved by Date _____________批准：日期：********************Subsidiary Equipment Co., Ltd.*************1. General总则1.1 This procedure describes the responsibility and requirements for the Quality Control Manual, design documents, technology documents, working procedure’s numbering, preparation, approval, distribution, revision and maintaining.本程序规定了ASME规范产品的质量控制手册、质量管理程序、设计文件、工艺文件的编号、编制、审批、修改发放及保存的责任和要求。

2. Stipulate for numbering of QC Manual.质量控制手册编号规定2.1 Document number of QC Manual: XX01质量控制手册的文件号：XX012.2 The numbering of QC Manual:质量控制手册的编号：＊＊Is Natural Sequence No(01、02、03···)为自然顺序号01、02、03···2.3 The numbering of QC Manual is the same as shown in Controlled Manual Issuing List i.e. each Manual Holder has an applicable numbering manual.质量控制手册的编号和《在控手册发放表》上所示的编号相同，即每一个手册持有者有一本相应编号的手册。

文件控制程序Document Control Procedure（IATF16949-2016）1、目的确保公司管理体系文件使用及流转过程中的有效性，避免误用带来的问题和损失。

To ensure that management system documents are effective in the using and transferring process to avoid the trouble and loss due to misuse.2、适用范围适用于本公司所有管理体系文件，包括适用外来技术和质量文件。

It is applicable to control all management system documents including applicable external technology and quality document.技术文件：工程图纸、工程标准、材料规范。

Technology documents: Engineering drawing, engineering criteria, materials specification.质量文件：质量手册、程序文件、作业指导书、检验指导书及质量记录。

Quality documents: Quality manual, procedure documents, working instruction, inspection instruction and quality records.3、定义3.1受控文件：分发、修订或更换均须按书面规定程序进行控制的文件，以保证文件始终反映现行要求。

Controlled documents refer to the documents that its distribution, revision or change must follow documented procedure to ensure it is always up-to-date.3.2非受控文件：分发须按文件控制程序进行，但不保证其完全反映现行要求的文件。

ISO9001文件管理程序Document Control Procedure文件更改历史记录Amendment History版次Revision更改日期Change Date更改概要Description of Changes更改人Prepared by批准人Approved byPrepared by编制Reviewed by审核Approved by批准ISO9001文件管理程序Document Control Procedure1.0 Purpose目的Define the requirements and responsibilities for Document control.定义出文件控制的要求和权责。

2.0 Scope范围This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form.适用于与质量管理体系有关的所有文件。

包括:手册、程序文件、操作指导书、外来文件及表单。

3.0 Definitions定义3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active.3.1质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。

3.2 Procedure: Define the function of QMS requirement allocation bydepartment. Such as document control, management review, internalaudit procedure.3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。

Page: 1/12Status:PROCEDURE 程序文件Document Control Procedure 文件控制程序姓名Name职位Position签名Sign日期Date编写Author 审核 Reviewers 批准 Approval分发Diffusion 人事部 HR品质部 QA 船务部 SH 生产部 PRO. 采购部 PUR. 财务部 FA.开发部 PD. 货仓部 WH. 管代 M.R. 总经理 GM 接收人Applicable to版本号Version 日期 Date 修订描述Modification description修订人 By A0 2010-01-15无 /目的OBJECTIVE 2 范围SCOPE 2 定义与缩写DEFINITIONS/ ABBREVIATIONS 2 概述GENERAL TOPICS 2 特性PARTICULARITIES 2 正文PROCEDURAL ELEMENTS 3 流程FLOW CHART 3 任务描述TASKS DESCRIPTION 4 参考文件REFERENCE DOCUMENTS 12 记录RECORDS 12关键字Key words: 质量文件Quality documentPage: 2/12Status:PROCEDURE 程序文件Document Control Procedure 文件控制程序Objective 目的To specify the way to manage the document system and to help QF members to draft and use quality documents to avoid misusage of quality documents.确定文件系统的管理方法，提供质量文件的起草和使用方法，以防误用。

__________________________________________________________Scope 范围Applied to all quality documents established, including external origin documents适用于建立的所有质量文件，也包括外来文件。

1.0目的为了确保和格里森文件&记录控制管理系统的规定要求保持一致，特此为格里森刀具（苏州）（下文称GCTS）建立一个本地标准，并且明确职责和方法，GCMS-P-01。

2.0职责为文件和记录管理系统明确代表和/或指定人员是每个现场/设备（管理人员）的职责。

3.0定义控制文件：在安全的环境下被唯一地标识和维护的文件。

流程：为了进行一个活动或过程规定的方法。

表格：用于数据收集的文档记录。

记录：达成结果的文件说明或者活动执行的证据。

作业指导：为了完成一项作业而约定好的并且已经备有文件证明的方法。

受控拷贝：被一个或多个下列方法确定过的文件：被授权的人员标记，铭刻，凸字或者包含一个内嵌许可。

文件审批：授权对受控文件进行审查，更新和重新审核。

保留期限：维持一个受控文件所需的最小和/或最大时间。

微小变化：格式、语法或拼写纠正、标题的变化。

1.0PURPOSE:Establish a local standard for Gleason CuttingTools Suzhou (hereinafter referred to as GCTS)and define responsibilities and methods to ensureconformance to the requirements prescribed inthe Gleason Management SystemDocumentation for Document & Record Control,GCMS-P-01.2.0RESPONSIBILITY:It is the responsibility of each site/facility toidentify representative(s) and/or designee(s) forthe document and record management system. 3.0DEFINITIONS:Controlled Document: Document uniquelyidentified and maintained in a securedenvironment.Procedure: Specified way to conduct an activityor process.Form: Document for data collection of records.Record: Document stating results achieved orevidence of activities performed.Work Instruction: The agreed upon anddocumented way to complete a task.Controlled Copy: Document identified by one ormore of the following methods; signed, stamped,embossed or contains an embedded permissionby authorized personnel.Document Approval: Authorization to review,update and reapprove controlled documents.Retention Period: Minimum and/or maximumtime required to maintain a controlled document.Minor Change: Formatting, grammar and orspelling corrections, title changes.4.0流程4.1文件控制4.1.1作为最低要求，每一个受控的GCTS文件都应该包含一个唯一的标识，GCTS（Gleason CuttingTools Suzhou）前缀，标题，文件号，发行日期，修订号，修订日期，授权和发布地点。

汽车行业程序文件中英文版-程序文件目录汽车行业程序文件中英文版程序文件目录一、设计与开发程序1、产品概念设计程序 Product Concept Design Procedure市场调研与需求分析 Market Research and Demand Analysis创意构思与概念生成 Creative Conception and Concept Generation 概念评估与筛选 Concept Evaluation and Screening2、工程设计程序 Engineering Design Procedure详细设计与计算 Detailed Design and Calculation材料选择与规格确定 Material Selection and Specification Determination设计验证与优化 Design Verification and Optimization3、样车制作与测试程序 Prototype Manufacturing and Testing Procedure样车制造工艺规划 Prototype Manufacturing Process Planning样车组装与调试 Prototype Assembly and Debugging性能测试与评估 Performance Testing and Evaluation二、采购与供应链管理程序1、供应商选择与评估程序 Supplier Selection and Evaluation Procedure潜在供应商搜寻 Potential Supplier Searching供应商资质审核 Supplier Qualification Audit实地考察与评估 Onsite Inspection and Evaluation2、采购订单管理程序 Purchase Order Management Procedure采购需求确定 Purchase Requirement Determination订单下达与跟踪 Order Placement and Tracking交货验收与入库 Delivery Acceptance and Warehousing3、供应链风险管理程序 Supply Chain Risk Management Procedure风险识别与评估 Risk Identification and Evaluation风险应对策略制定 Risk Response Strategy Formulation风险监控与预警 Risk Monitoring and Early Warning三、生产制造程序1、生产计划与调度程序 Production Planning and Scheduling Procedure订单分解与排产 Order Decomposition and Production Scheduling资源配置与产能规划 Resource Allocation and Capacity Planning进度跟踪与调整 Progress Tracking and Adjustment2、工艺过程控制程序 Process Control Procedure工艺流程设计与优化 Process Flow Design and Optimization作业指导书制定 Work Instruction Formulation过程检验与质量控制 Process Inspection and Quality Control3、设备管理与维护程序 Equipment Management and Maintenance Procedure设备选型与采购 Equipment Selection and Purchase设备安装与调试 Equipment Installation and Commissioning日常维护与保养 Daily Maintenance and Repair四、质量控制与检验程序1、进料检验程序 Incoming Inspection Procedure原材料检验标准制定 Raw Material Inspection Standard Formulation 抽样方案与检验方法 Sampling Plan and Inspection Method不合格品处理 Nonconforming Product Handling2、过程检验程序 Inprocess Inspection Procedure工序检验点设置 Inspection Point Setting in Processes检验记录与统计分析 Inspection Record and Statistical Analysis质量问题反馈与处理 Quality Problem Feedback and Handling3、成品检验程序 Finished Product Inspection Procedure成品检验标准制定 Finished Product Inspection Standard Formulation 全项目检验与抽样检验 Fullitem Inspection and Sampling Inspection 检验报告与质量证书 Inspection Report and Quality Certificate五、销售与市场推广程序1、市场调研与分析程序 Market Research and Analysis Procedure市场趋势研究 Market Trend Research竞争对手分析 Competitor Analysis消费者行为研究 Consumer Behavior Research2、销售渠道管理程序 Sales Channel Management Procedure经销商选择与合作 Dealer Selection and Cooperation销售渠道拓展与优化 Sales Channel Expansion and Optimization渠道绩效评估与激励 Channel Performance Evaluation and Incentive3、客户关系管理程序 Customer Relationship Management Procedure客户信息收集与管理 Customer Information Collection and Management客户投诉处理与满意度调查 Customer Complaint Handling and Satisfaction Survey客户忠诚度培养 Customer Loyalty Cultivation六、售后服务程序1、售后服务政策制定程序 Aftersales Service Policy Formulation Procedure保修范围与期限确定 Warranty Scope and Period Determination售后服务费用标准制定 Aftersales Service Cost Standard Formulation 服务承诺与条款说明 Service Commitment and Clause Explanation2、维修与保养服务程序 Repair and Maintenance Service Procedure服务预约与接待 Service Reservation and Reception故障诊断与维修方案制定 Fault Diagnosis and Repair Plan Formulation维修作业与质量检验 Repair Work and Quality Inspection3、配件供应与管理程序 Spare Parts Supply and Management Procedure配件库存管理 Spare Parts Inventory Management配件采购与配送 Spare Parts Purchase and Distribution配件质量控制 Spare Parts Quality Control七、人力资源管理程序1、招聘与选拔程序 Recruitment and Selection Procedure岗位需求分析 Job Requirement Analysis招聘渠道选择 Recruitment Channel Selection面试与评估流程 Interview and Evaluation Process2、培训与发展程序 Training and Development Procedure培训需求调查 Training Requirement Survey培训计划制定与实施 Training Plan Formulation and Implementation 培训效果评估与反馈 Training Effect Evaluation and Feedback3、绩效考核与薪酬管理程序 Performance Appraisal and Compensation Management Procedure绩效指标设定 Performance Indicator Setting绩效考核评估 Performance Appraisal Evaluation薪酬计算与发放 Compensation Calculation and Distribution八、财务管理程序1、预算编制与控制程序 Budget Preparation and Control Procedure预算目标设定 Budget Target Setting预算编制流程 Budget Preparation Process预算执行监控与调整 Budget Execution Monitoring and Adjustment2、成本核算与控制程序 Cost Accounting and Control Procedure成本项目分类与核算方法 Cost Item Classification and Accounting Method成本分析与控制措施 Cost Analysis and Control Measures成本降低与优化方案 Cost Reduction and Optimization Plan3、财务报表编制与审计程序 Financial Statement Preparation and Audit Procedure财务数据收集与整理 Financial Data Collection and Arrangement报表编制规范与流程 Statement Preparation Specification and Process 审计配合与整改 Audit Cooperation and Rectification。