文件控制程序-中英文对照

1、TITLE : CORPORATE PROCEDURE FOR DOCUMENT CONTROL文件控制之管制程序Document No.: DC20001Rev. No. :A00Page 1 of 13Revision HistoryREVDCN #INITIATEDBYEFFECTIVEDATE (MM/DD/YY)DESCRIPTIONA00D141601WilliamMagramo04/18/14Initial ReleaseApproved DCN on File in Document ControlAPPROVED BYMotoaki WakuiAUTHORIZED BYSK

2、LamCONFIDENTIALPROPERTY OF ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDThis document, and 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,

3、under any patent, copyright or other intellectualproperty right is granted or implied by the provision or possession of this document. No part ofthis document may be reproduced,transmitted, transcribed, stored in a retrieval system, translated into any language or computer language, in any form or b

4、y any means, whatsoever, without the prior written consent ofZhongshan Sunming Optical Technologies Limited.?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDALL RIGHTS RESERVED(Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled stamp)TITLE: CORPORATE PROCE

5、DURE FORDOC. NO.DC20001DOCUMENT CONTROLREVISIONA00文件控制之管制程序PAGE2_OF_131.1 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程序。1.2 SCOPE 范围.2.1 Thi

6、s 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 product documentat

7、ions.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 DEFINIT

8、IONS & 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 Draw

9、ings, 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 docu

10、ment.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。?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDConfidential（Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled stamp）DOC. NO.REVISIONDC20001A00TITLE: CORPORATE PROCEDURE FORDOCUMENT CONTROL文件控制之管制程

11、序PAGE5 OF 133.4 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 Ins

12、truction (WI) - a collection of detailed statement, including 川ustrations 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 Document Change Notice (DCN)- is used to initiate, revise or

13、 to obsolete an existing QMSdocument (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 Documentation.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

14、 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 document ' s intended use/s.目的-简要陈述文件的使用意图。3.10 Scope - briefly states the document ' s coverage or extent of use.范围-简要陈述文件的使用范围或程度。3.11 Definitions &

15、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-列出引用的其他文件和其他辅助作业指导书。3.13 General Requirements - the bod

16、y 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 of Failure Analysis 技术支援总监DQA - Director of Quality质量总监D

17、OP - 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 - Manager of Clean Room 净化间经理4.0 ASSOCIATED DOCUMENTS 相关文件

18、4.1DC300014.2DC300024.3DC300034.4DC300044.5DC30005:Work Instruction for Document Numbering文件编号作业指导书:Work Instruction for Document Change Notice (DCN) Generation文件变更通知生成作业指导书:Work Instruction for Engineering Change Notice (ECN)Generation.工程变更通知生成作业指导书:Work Instruction for Releasing Documents to Suppl

19、iers发布文档给供应商之工作指引: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 分类1System Manual体系手册2Procedure程序文件3Work Instruction 作业指导书4Forms & Locally

20、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 including 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

21、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 and completely rewritten documents shall undergo approval of the ISO Manag

22、ement 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 & ECN) to initiate, revise and obsolete a document shall be reviewed fo

23、r 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 Development新业务开发NBCEO / VPS / VPMProduct Qualification产品资格PQCEO / DFAHR

24、 & 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设计匕工程文件DECEO / DFAProduction Documents 生产义件生产义件PDCEO / DOP / MQAPurchasing Documents 采购文件PRCEO / DQA / MQA?2014 ZHONGSHAN SUNMING OPTICAL TECHNO

25、LOGIES LIMITEDConfidential(Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled stamp)DOC. NO.DC20001REVISIONA00PAGE7OF13TITLE: CORPORATE PROCEDURE FORDOCUMENT CONTROL文件控制之管制程序5.6 Document control staff is responsible for routing for approval “ of the Engineeri

26、ng 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. Urgent (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

27、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 the 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

28、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)5.7.6 General Requirements 一般要求5.8 Procedure should be updated, as required, as a res

29、ult 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: Work Instruction for Receiving and Control of Customer and Other Document).销售/市场部和相关

30、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 quality documents / records. A master list which identifies the document location s

31、hall 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

32、.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). The online version of document maintained in the QMS Document folder of SUNMING

33、 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) distribution.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

34、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. Uncontrolled documents are issued for reference only.任何文件在没有用红墨水印的CONTROLLED COP

35、Y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, is strictly prohibited.受控和未受控文件均为公司的机密文件，任何文件除了其唯一目的和合法使用以外严

36、禁任何未经授权的使用，复印，或拥有。5.14 SUNMING document may exist in both English and Chinese language. In case where of a difference of interpretation arise, the English language interpretation shall prevail.SUNMING文件可能存在英语和汉语版本。在出现不同解释的情况下，以英文解释为准。5.15 In case correction or changing of entry is unavoidable, the f

37、ollowing requirements shall apply. This requirement extends to SUNMING QMS documentation, Product Documentation.如修正和更改不可避免的情况下，以下规定适用。该规定涵盖 SUNMING (QMS)的质量管理 体系文件，产品文件。?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDConfidential(Any hard copy print out of this document is uncontrolled unless it

38、 bears DCC red controlled stamp)TITLE: CORPORATE PROCEDURE FORDOC. NO.DC20001DOCUMENT CONTROLREVISIONA00文件控制之管制程序PAGE8 _OF_ 135.15.1 Do not use correction fluid.不可使用涂改液。5.15.2 Do not use pencil instead, use dark ink pen for correction.不可使用铅笔，使用深色水笔修改。5.15.3 Cross out using one line with the correcte

39、d information still readable.修改划一道横线，使被更正的信息仍然可读。5.15.4 Write the correction legibly close to the crossed out information.紧靠所划除信息清晰填写修正信息。5.15.5 Sign next to the correction and write down the date of correction.在修正信息旁签名并写上修改日期。5.15.6 Initiator takes the responsibility to notify relevant party or sig

40、natory on the correction or changes made.发起人负责通知相关人员或签名人修正或更改事宜。?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDConfidential（Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled stamp）DOC. NO.REVISIONPAGEDC20001A0011 OF 13TITLE: CORPORATE PROCEDURE FORDOCUM

41、ENT CONTROL文件控制之管制程序Attachment 1附件1QMS Document Format Level 1 & 2质量管理体系(QMS) 1 & 2级文件格式Zhongshan Sunming Optical Tech no log ies LimitedSUNMKNS中山三鸣光学科技有限公司TITLE ： CORPORATE PROCEDURE FOR 3-直管程序Dogu巾修。t Ndi *-Rev, Nq. ： A<MJPas& 1 =f 2Re .-isisn Hi5dry?2014 ZHONGSHAN SUNMING OPTICAL T

42、ECHNOLOGIES LIMITEDConfidential(Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled stamp)REV DCN 4DATEDESCRlPTION3例?/品 DCN nn Fi ? i- CH-rrmF C3nfJAPPROVEnBY AUTHORIZED BY ONFILJEkTgLPROPERTY OF ZHONGSUftfH 3UNMISG OP 1rleAL TECHNOLOGIES LMTED和 s 二二匚备-二 i&

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45、n)附件1 (续表)QMS Document Format Level 1 & 2质量管理体系(QMS) 1 & 2级文件格式II TLE: CORPORATE PROCEDURE FORDOt 科白_RE'/iSlOl ADO .文怦控之管窜财2三空上1 .C PURPOSE 目的1.1 la iff*7 re a prDCBdtrg for -4 1 DC3Q81:晒F* lY忖用E fn”匚HE旨时 NUTigri” 号一 噌E V.4 2 DC3QXJ2:Vr'D(t Instrjctbr fQTDKjrBorn C-flngs Jlcs fDC) G&

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48、er Rgj Mo. ： AC。Page 1 of 2Revision HistoryREVDCh #INITIftTEDBYEFFECTIVE ATE 西卜DD.VT)DESCRIPTION_aAXI rD门诊InitialJy且nrrgk DCN 5n Fie in Docuti&tt CyitplAPPROVED BYAU THORIZED BYgNFIDEMi|ALPROPEFfTT OF ZKDh GMHAM 3UhHIMG OPFICAL TECrOLDOIC 3 LIM FTEDr-ii-5 3塞 F盟，： Sr-A士 音 力由野七弋旦-a £< ; A

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51、LE： WORK INSTRUCTION fb 门 手一小*善号节AZO竺 LREQU IR巨耐ENT安全次5t刍埠广纳，"：亡.4GEMERAL KE口 UI REM EIF 占 f /1.1 =rifi rt-ark infiiibzim is -a？p icab e lo率尼比扬里书埴三子1.2 -tiE .vork ins-Tucticn m3 cova-s - 在吃、，界芝书也包精ange Kafc CCtx' Gon&rs：'3r as-”辑静书ngi-iBBring C"iing»Mdc» iECj Gt"*r>lcri JJn <BCN）至僦叫小修号If4.1 二K-iman【二nntnl 二mFh ；匚二匚）。标 m f3T支械制中心1DCC3负责-4* IF.F *;门目 T