Document Control文件控制程序(中英文).docx

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1、批准：审核：作成：Change History变更记录Revision 版本Effective Date生效日期Originator编写人Reasons for Change修改原因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 Technologie

2、sCo., 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,

3、 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 nee

4、ds 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。3.2 Document： The term document5 is used in the context of whatever means are used to makeinformation and or data available to the user. It could be, for example; written on paper, held oncomputer disk, video, audiotape or graphic post

5、ers. The type of information contained indocuments includes; policies, procedures, recipes, regulations, standards, codes, specifications etc.文件：能让使用者获得信息或数据的文字即为术语的“文件”。文件的形式可以多种多样，包括书面的文字、电脑中的电子文档、录像、录音、图片或海报等。文件所传达的信息包括：方针政策、程序、图纸、规章制度、标准、编号以及规格说明书等3.3 Document Control: Quality manual, procedures

6、, working instructions, legal and other standards ofMMK are controlled by document controller; Program department is responsible for control oftechnical documents from MMK and customers.文件控制：质量手册，程序文件，作业指导书，法律法规及相关标准的控制由公司文控人员负责；项目部负责控制本公司内部及来自客户的技术文件。3.4 OEMS Representative： The Quality / Environme

7、ntal Management System Representative: Aperson who has been appointed by top management to establish, implement and maintain theQuality / Environmental Management System of MMK, and report to top management on theperformance of the quality management system and any need for improvement.质量/环境管理者代表：质量

8、管理体系管理者代表和/或者环境管理体系管理者代表，由最高管理层指定的负责本公司质量管理体系和/或者环境管理体系所需的过程得到建立、实施和保持，并向最高管理者报告质量管理体系的业绩和任何改进的需求的管理人员；3.5 External Documents： Documents issued to an area from another area outside.外来文件：由公司外部的区域（如顾客、供应商、政府机构等）发放到公司内部供使用和参考的文件；3.6 Technical documents: including compound recipe, drawing, engineering s

9、tandards/specificationswhich specify the characteristics or parameters of products or process. It can be from customers ororiginated by MMK技术文件：包括产品配方、图纸、工程标准或规范等用来规定产品特性或过程参数的文件资料，它可以是由本公司制定或者由顾客提供。4.0 PROCEDURE 流程4. 1 Preparing and authorizing /文件的编写和批准4.1.1 Documents numbering is defined in uWD-Q

10、A-072 Numbering of Documents”. Documentcontroller will number for the documents.文件的编号参见“WD-QA-004文件编码规则”，由公司文控人员统一编制.4.1.2 Quality / Environmental Management System Manual prepared by QEMS Rep and authorizedby MMKG.M.质量/环境手册由公司管理者代表编写，公司最高管理者批准；4.1.3 Based on respective function, each department pre

11、pares related procedures. Dept managercheck the contents and QEMS Rep should approve those procedures.程序文件按照职能分配，由各相关部门编写，各部门经理审核，管理者代表批准；4.1.4 WD documents prepared by related supervisor or process owner and approved by relevantmanagers.工作指导书由各责任部门相关人员编写，部门经理批准；4.1.5 Department managers should chec

12、k all documents.部门负责人应参与文件的编写和检查工作；4.1.6 Management System documents should be approved by authorizing officer before issuing.文件必须得到授权人员的批准；4.2 Document initiation/文件的起草：4.2.1 Based on respective function, document writer prepares the document and creates a draft.根据职能分工，文件编写人，编写并提供草稿；4.2.2 Documents

13、 shall be reviewed and approved by the document owners supervisor ordepartment manager.相关人员对文件的草稿进行审批，批准由文件持有人的上级主管或部门经理执行；4.2.3 Approved document is sent to MMK Document controller.得到审批后的文件，提交给MMK文控人员。4.2.4 The document is distributed or notified to related area after document controller numbering

14、thedocument and filling it into documentation system. Technical documents are controlled byProgram department.文控人员为文件编号，将文件归档，并分发或通知到相关区域。技术文件由项目部负责控制。4.3 Document review and revision/文件评审/修订4.3.1 Reason for review or revision/评审/修订原因a) The documents shall be reviewed and re-approved as necessary, d

15、ocument reviewreportshould be kept必要时应对文件进行评审和重新批准，保留文件评审报告b) Document review/revision shall occur for any of the following reasons:以下情况都应该及时进行文件评审/修订- Periodic review as notified by the System Engineer.体系工程师发出周期评审的通知- Document no longer reflects the actual procedure that is used for a function.文件不再适用于某项功能的实际操作流程- An improvement in the method of conduct of a function has been identified.过程方法进行了改善并得到确认- A referenced document has been changed.参考文件已修改When receiving new or revised customer en