文件控制程序中英文对照.docx

1、文件控制程序中英文对照Revision HistoryREVDCN #INITIATEDBYEFFECTIVEDATE (MM/DD/YY)DESCRIPTIONA00 D141601William Magramo04/18/14Initial ReleaseApproved DCN on File in Document ControlAPPROVED BYMotoaki WakuiAUTHORIZED BYSK LamCONFIDENTIALPROPERTY OF ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDThis document, an

2、d the information it contains, are the property of Zhong shan Sunming Optical Technologies Limited and are protected by law. Both must be held in strict confidence at all times. No license expressed or implied, under any patent, copyright or other intellectual property right is granted or implied by

3、 the provision or possession of this document. No part of this document may be reproduced, transmitted, transcribed, stored in a retrieval system, translated into any language or computer language, in any form or by any means, whatsoever, without the prior written consent of Zhongshan Sunming Optica

4、l Technologies Limited.2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDALL RIGHTS RESERVED1.0 PURPOSE 目的1.1 To define a procedure for the generation, revision, handling, approval, retention, storage of internal documents as well as control of external documents.为内部文件的生成，修改，处理，批准，保留，保存以及对外部文件的控制定义

5、程序。2.0 SCOPE范围2.1 This procedure is applicable to quality management system (QMS) documentation such as system manual, procedures & work instructions.本程序适用于质量管理体系（QMS）的系统文件，如体系手册，程序文件及作业指导书。2.2 This procedure also covers the DCN & ECN generation and approval signatory for QMS documentation and produ

6、ct documentations.本程序还包括质量管理体系文件和产品文件的文件变更通知（DCN）&工程变更通知（ECN）的生成和审批签署。2.3 This procedure also covers control and handling of customer documents and other regulatory requirements.本程序还包括客户文件和其他法规要求的控制和处理。2.4 This procedure also covers control and handling of supplier documents.本程序还包括对供应商文件的控制和处理。3.0 D

7、EFINITIONS & ABBREVIATIONS术语与定义3.1 Quality Management System (QMS) Documentation - refers to a document category comprising of System Manual, Procedure and Work Instruction.质量管理体系（QMS）文件-指的是由体系手册，程序文件和作业指导书组成的文件类。3.2 Product Documentation - refers to a document category comprising of BOM, Product Dr

8、awings, Product Specifications and Product Manufacturing Procedure. 产品文件-指的是由BOM ，产品图纸，产品规格书，产品制造程序组成的文件类。3.3 System Manual - a document describing the policies, procedures and practices applicable to SUNMING. to attain the quality of products and services. A system manual is classified as Level 1 d

9、ocument.体系手册 -描述适用于 SUNMING的政策，程序和实践，实现产品和服务质量的文件。体系手册归类为1级文件。3.4 Procedure - a set of logical steps in which we perform planned task or execute a process. It may be a general description of activities supporting the system manual. A procedure is classified as Level 2 document. 程序 一套我们执行计划或执行任务的过程中合

10、乎逻辑的步骤。它可以是支持体系手册活动的一个概括的描述。程序归类为2级文件。3.5 Work Instruction (WI) - a collection of detailed statement, including illustrations on how to perform a step in a process or an activity. A work instruction is classified as Level 3 document. 作业指导书（WI） - 详细陈述的汇集，包括在某一过程或活动中如何执行某个步骤的说明。作业指导书归类为3级文件。 3.6 Docum

11、ent Change Notice (DCN) is used to initiate, revise or to obsolete an existing QMS document (System Manual, Procedure, Work Instruction).文件变更通知（ DCN ）- 是用来发起，修改或废止现有的质量管理体系文件（体系手册，程序文件，作业指导书）。3.7 Engineering Change Notice (ECN) - is used to initiate, revise or to obsolete an existing Product Documen

12、tation.工程变更通知（ECN） - 是用来发起，修改或废止现有的产品文件。 3.8 ISO Management Representative- QA Manager is appointed to be the ISO Management Representative.ISO管理代表- QA经理为指定的ISO管理代表3.9 Purpose - briefly states the documents intended use/s. 目的 - 简要陈述文件的使用意图。3.10 Scope - briefly states the documents coverage or extent

13、 of use.范围 - 简要陈述文件的使用范围或程度。3.11 Definitions & Abbreviations - defines the terminology used in the text so as to be understood at the level of the user. 定义与术语 - 定义正文中使用的术语，以便使用者在此基础上更容易理解。3.12 Associated Documents - list of other documents referenced and other supporting work instructions. 相关文件 - 列出

14、引用的其他文件和其他辅助作业指导书。3.13 General Requirements - the body or detailed content of the procedure; a step by step instruction 一般要求 - 程序本身或详细内容;逐步说明。3.14 Approval Signature list abbreviations: 批准签名名单缩写CEO - Chief Executive Officer首席执行官VPS - VP of Sales 销售副总VPM - VP of Global Marketing全球市场副总DFA - Director o

15、f Failure Analysis 技术支援总监 DQA - Director of Quality 质量总监DOP - Director of Production 生产总监MAC - Manager of Accounts 财会经理MPR - Manager of Purchasing 采购经理MQA - Manager of Quality Assurance QA经理MHR - Manager of Admin / Human Resources行政与人力资源经理MME - Manager of Advanced Manufacturing Engineering 高级制造经理MCR

16、 - Manager of Clean Room 净化间经理4.0 ASSOCIATED DOCUMENTS相关文件4.1 DC30001 : Work Instruction for Document Numbering文件编号作业指导书4.2 DC30002 : Work Instruction for Document Change Notice (DCN) Generation 文件变更通知生成作业指导书4.3 DC30003 : Work Instruction for Engineering Change Notice (ECN) Generation. 工程变更通知生成作业指导书

17、4.4 DC30004 : Work Instruction for Releasing Documents to Suppliers 发布文档给供应商之工作指引 4.5 DC30005 : Work Instruction for Retention of Quality Documents and Records 品质文件/记录保存作业指导书5.0 GENERAL REQUIREMENTS一般要求5.1 Quality Management System (QMS) Documentation hierarchy品质管理系统（QMS）文件等级 Level等级 Classification分

18、类1System Manual体系手册2Procedure 程序文件3Work Instruction作业指导书4Forms & Locally Controlled Documents 表格 & 当地控制文件5.2 Document Control Center (DCC) shall be responsible in the assignment and control of document numbers. Refer to DC30001 (Work Instruction for Document Numbering) for details of nomenclature in

19、cluding the revision numbering.文控中心（DCC）应负责文件编号的分配和控制。参考DC30001 （文件编号作业指导书）关于命名包括版本编号的细节。5.2.1 A specimen of working forms shall be incorporated in each document as attachment. DCC shall provide soft copies of these forms upon request. 工作表格的样本应在每个文件中纳入附件结合。文控中心应根据申请提供这些表格的电 子档。5.3 Initial released a

20、nd completely rewritten documents shall undergo approval of the ISO Management Representative.初期发行和重写的文件必须经过ISO管理代表审批。5.4 DCC shall print hard copies of approved documents and will make it available for staff reading in the DCC room.文控中心应打印已批准文件供SUNMING的职员在文件控制中心查看。5.5 Changes issued (through DCN &

21、ECN) to initiate, revise and obsolete a document shall be reviewed for adequacy before approval by the following signatory:发起，修改和废止一份文件须审查其适当充分后由下列人员签名批准才可发行变更（通过文件变更通知&工程变更通知）。QMS Document CategoryCategory CodeApproval Signature ListGeneral Management日常管理GMCEO / VPS / DQA / MQANew Business Developm

22、ent新业务开发NBCEO / VPS / VPM Product Qualification产品资格PQCEO / DFA HR & Admin Documents 人力资源&行政文件HRCEO / MHRDocument Control文件控制DCCEO / DQA / MQAQuality Assurance品质保证QACEO / DQA / MQADesign and Engineering Documents设计与工程文件DECEO / DFAProduction Documents生产文件生产文件PDCEO / DOP / MQA Purchasing Documents 采购文件

23、PRCEO / DQA / MQA5.6 Document control staff is responsible for “routing for approval” of the Engineering Change Notice (ECN). A normal Change Notice Forms shall be completely signed within 2 working days for ECN and 5 working days for DCN otherwise the initiator shall be informed of the delay. Urgen

24、t (same day) changes shall be routed by initiator. 文件控制工作人员负责跟进工程变更通知（ECN)的安排和批准。正常工程变更通知（ECN)应在2个工作日内完成签署以及在5个工作日内完成DCN的签署，若有延误应通知发起人。紧急的（当天）变更，应由发起人负责跟进。5.7 The following format shall be use as a general guideline in generating new system manuals, procedures and work instructions. A specimen of th

25、e standard document format is shown in attachment 1 & 2.下面的格式应作为生成新的体系手册，程序文件和作业指导书的一项通用指南来使用。标准文件格式的样本详见附件1和25.7.1 Purpose 目的(For Level 1 & 2 only)5.7.2 Scope范围5.7.3 Definitions & Abbreviations 术语与定义(For Level 1 & 2 only)5.7.4 Associated Documents相关文件5.7.5 Safety Requirements 安全要求(For Level 3 only)

26、5.7.6 General Requirements一般要求5.8 Procedure should be updated, as required, as a result of process review for compliance and effectiveness. 按照要求以及工序评审的一致性和时效性的需要来更新程序。5.9 Sales & Marketing Team shall determine the need for review of customer documents with relevant departments (refer to DC30004: Wor

27、k Instruction for Receiving and Control of Customer and Other Document).销售/市场部和相关部门应确定对客户文件评估的需求（参考DC30004 ：客户和其他文件的接收和管控作业指导书）。5.10 Supplier Quality Engineer shall determine the need for review of supplier documents respectively.供应商质量工程师应确定对供应商的文件评审的需求。 5.11 DCC shall be responsible for archiving q

28、uality documents / records. A master list which identifies the document location shall be maintained for traceability. This applies to both hardcopy and soft copy formats (refer to DC30004: Work Instruction for Retention of Quality Documents / Records).文控中心应负责质量文件/记录的归档。应保持标示文件位置的主列表以便查找，此要求同时适用于印刷版

29、和电子档。（参考DC30004 ：质量文件/记录保管作业指导书）。5.12 Controlled documents identification. 受控文件鉴定5.12.1 CONTROLLED Document that shall be used as regulatory procedures and work instructions in areas affected by such document, shall be marked as CONTROLLED COPY in red ink on all pages (see specimen in attachment 3).

30、 The online version of document maintained in the QMS Document folder of SUNMING intranet is also considered controlled copy. This document shall be automatically recalled and updated by DCC whenever changes are officially made. DCC shall maintain a record of controlled documents (hard copy) distrib

31、ution.规范程序和受此类文件影响范围内的作业指导书应受控使用，该类文件的每页应附有CONTROLLED COPY标识的红色水印，（见附件3样本） 。保存在SUNMING内联网的质量管理体系文件的文件夹中的网络电子版本也视为受控文件。本文件在任何时候提出的正式变更都应由文控中心自动回收和更新。文控中心应保持一个分发受控文件（印刷版）的记录。5.12.2 Any document which does not bear CONTROLLED COPY in red ink shall by default be considered as uncontrolled document. Unco

32、ntrolled documents are issued for reference only. 任何文件在没有用红墨水印的CONTROLLED COPY标识默认的情况下被视为未受控的文件，不受控的文件印发只作参考。5.13 Both CONTROLLED and uncontrolled documents are proprietary documents of the company; any unauthorized use, photocopying, or possession of any document other than for its sole purpose and legitimate use