中英文文件控制程序

1、 Procedure 程序 Issue版本: 1 TITLE: Control of Document and Data標題： 文件和資料管制 DOC No. Rev文件號：FQP-DOC01 版次: APages 12 of 12Revision History更改记录Issue版本Page#页码Rev版次CHANGE更改內容WRITTEN BY编写DATE日期Review and Approval審查和批准Review x x x x x x x x x x x Signature / DateQS Officer:_QC Sup:_QE Sup: _QA Mgr&MR:_Prog

2、ram Director: _PM: _Store Mgr:_Purchasing Mgr:_PMC Sup:_Shipping Sup:_Facility Mgr: _Review x x x x x x x x x Signature / DateFacility Engineering Mgr:_ME Mgr:_1st process Mgr:_2nd Process Mgr:_PPC Mgr: _Tooling Repair & Maintenance Mgr:_HR Mgr: _ADM Mgr:_MIS Mgr:_ APP x Signature / DatePlant. M

3、anager:_Checked by DCC / Date: 文控審核/日期:Effective date Expiry date文件生效日期: _ 文件失效日期: _Confidential & Proprietary Information of ZJKC. 1.0 目的 Purpose:對品質保証系統和环境管理系统(包括Green Partner)文件及与之有關的資料規定控制方法，旨在确保使用有效版本，防止使用失效或作廢文件，确保其系統有效運作。Provide a guide for the effective operation of quality system and en

4、vironment system (including Green Partner) and ensure using valid version and avoid invalid or useless document being used.2.0 範圍 Scope:所有品質系統、环境系统(包括Green Partner)文件及与之相關的資料的控制。 Control of all the quality system and environment system (including Green Partner) and its relevant documents3.0 定义Defini

5、tions:3.1 DCC：是文件控制中心的英文缩写。DCC is the short form of Document Control Center.3.2 书面文件 Hardcopy: 从计算机输出资料打印在纸张上的文件。Documents printed or copied on paper from the PC.3.3 受控文件Controlled Document：受更改和分发控制，并盖有DCC红色“红印有效 控制文件”印章的书面文件，文控中心会自动以旧换新。The document is stamped with red “DOC CONTROL RED CHOP VALID”

6、seal. DCC will replace the obsolete document with the update revision automatically. 3.4 参考文件 Reference Document: DCC盖有兰色“参考文件”印章的文件，文件中心不会回收及进行更新。The document is stamped with blue “FOR REFERENCE ONLY” seal. DCC wont recall the obsolete reference document and distribute the update revision.3.5 作废文件O

7、bsolete Documents: 不适合使用的文件，可能被新文件所替换，或者是已失效。Documents that is not valid to use as they are either replaced with a new revision or expired. 3.6 GP: Sony绿色伙伴的简称GP is the short form of Green Partner.3.7 内部文件：3.8 外部文件：4.0 职责Responsibility:4.1 编写者应使用正确的文件格式并按照本文件的要求排版，并将文件档和电子档一起交由文件控制中心。Originator of p

8、rocedure is to properly fill up procedure using correct forms and typed neatly according to this FOP and submit the hard copy together with softcopy to Document Control Center.4.2 文件控制中心文件管理员Document Control Center clerk：4.2.1 负责文件的接收、复制、分发、维护和及时更新文件目录总清单。Is responsible to receive, duplicate, distri

9、bute, maintain and update master list in time.4.2.2 根据要求分发文件编号，并登记文件标题。Issue related DOC No. upon request and register title.4.2.3 检查文件的批准是否齐全及格式是否符合要求。Check completion of signature loop and whether the document format meet document control procedure.4.3 所有部门经理All department manager/head4.3.1 在3个工作日

10、内审阅文件并批复。Review related documents before signoff within 3 working days;4.3.2 在本人缺席的情况下，应指定代理人执行此项工作，帮助审阅并批复。During absence of any department head, he/she must appoint his/her agent to review and sign procedure on his/her behalf;4.3.3 当文件不再适用时，应主动召集更改相关文件。Initiate changes on procedure that are outdat

11、ed.4.3.4 新程序生效后或程序更新后，若需培训，则培训本部门人员，并将培训记录送培训部归档。After a new procedure enters into effect or an old procedure is modified/amended/revised/updated, if training is necessary, then trains all personnel belonging to his/her own department and complete the training record and send the training record to

12、Training Department for filing.4.4 生产主管 Production Supervisor 4.4.1 负责将所有作业指导书摆放在所使用位置并确保文件的执行。 Is responsible to display the working instruction at the location of use and ensure the manufacturing process is carried out;4.4.2 确保所有用于生产线的作业指导书为最新版本文件， 并确保其没有任何修正液或随意更正的情况。Is responsible to ensure all

13、working instruction displayed or used in production line are the latest revision and the working instruction does not have any white-wash and /or correction.4.5 各部门文件接收员： Document control clerk of every department/section:4.5.1 核对所接收文件的完整性。Check the completeness of received document.4.5.2 将DCC分发的受控文

14、件转交给各主管/组长张贴于工作需要的地方或交给本部门内各相关人员传阅后收回归档。Forward the controlled documents to supervisor/leader to post workstation, or sent it to all relative person to read and collect it for filing.4.5.3 负责将所有旧版文件及时还回文件控制中心文件管理员。Is responsible to return all obsolete controlled documents to DCC Clerk.5.0 程序 Procedu

15、re:5.1 文件分类、制定和审批Document classification , establishment , review and approval 從文件資料內容上分，分為四層文件，编写及审批权限具体如下Four levels of documents are classified, prepared, reviewed and approved as below:类别Category级别Level内 容Content编写Prepared by审核人Reviewed by批准人Approved by一级1st level公司质量手册 Quality ManualQS Office质量

16、管理代表ManagementRepresentative总经理General Manager二 级2ndlevel控制程序 Control ProcedureQS Office、各职能部门 Respectivefunction dept与文件内容有关的所有部门经理/主管All Dept. Manager /supervisor related to the document.总经理General Manager品质系统QualitySystem三 级3rd level操作指导Operation InstructionQC检查指导票QC inspection instruction产品作业指导书

17、 Work Instruction for Operation包装作业指导书Packing Instruction管理类文件Administration docuemt各职能部门Respectivefunction deptN/A部门经理/主管Dept Manager/supervisor外来文件（包括来自客户的文件）External document (including customer provided document)N/AN/A见FQP-DOC03See FQP-DOC03有关工作控制规范通用文件relevant operation control各职能部门Respectivefu

18、nction dept与文件内容有关的所有部门经理/主管All Dept. Manager /supervisor related to the document.质量管理代表ManagementRepresentative四 级4thlevel质量记录 Quality Record表格 Form各职能部门Respectivefunction deptN/A使用部门经理/主管Using Dept Manager/supervisor 5.2 文件格式：The standard format of document:5.2.1 程序文件和控制规范封面格式见QF-QA-026, 程序文件和控制规范

19、内容格式见QF-QA-027。The standard format of procedure and control work is as QF-QA-026 and QF-QA-027 ；5.2.2 QC检查指票格式见QF-QC-049。The standard format of QC inspection instruction is as QF-QC-049.5.2.3 第一工序产品作业指导书(含包装作业指导书)格式见QF-QA-034The format of operation instruction for the first process is as QF-QA-034 5

20、.2.4 第二工序产品作业指导书格式见QF-QA-029The format of operation instruction for the second process is as QF-QA-029.5.2.5 机械设备、仪器操作，维修和保养作业指导书及工艺操作指导书格式无特定要求。一般情况下用可采用表格QF-QA-028。若不适用时，各部门可根据实际运作需要自行编写格式。There is no special requirement for the format of work instructions of machine/equipment operation, repair, a

21、nd maintenance and process operation. Generally Speaking, the form of QF-QA-028 can be used. If N/A, Every dept. can work out the appropriate format to meet the actual need.5.2.6 仪器校验作业指导书格式见QF-QA-036 See QF-QA-036 for the format of working instrument of instruction calibration.5.2.7 产品质量控制计划格式见QF-Q

22、C-019A. Quality control is as QF-QC-019A。5.2.8 FMEA格式见QF-ME-005。 FMEA is as QF-ME-005.5.2.9 程序文件和控制规范的内容标准格式如下,但不局限于：The standard format of all procedure and control work is as below，but not limit to :1.0 目的 （编写此文件的目的）。Purpose (purpose of quality procedure to be written).2.0 范围 （此文件所适用的范围）。Scope (sc

23、ope that the quality document is applied for).3.0 定义Definition。如果没有，请写无。If none, state N/A.4.0 职责Responsibility。5.0 程序Procedure.6.0 相關文件和資料 Relevant document and data。 如果没有，请写无。If none, state N/A7.0 品质记录Quality Record. 如果没有，请写无。If none, state N/A.8.0 流程图 Flow chart. 如果没有，请写无。If none, state N/A.9.0 附

24、录（包括印章样本，表格等）Attachment including stamp sample, form etc.)5.2.10 针对作业指导书内容格式，除要求有文件编号，生效日期，版次，页码，修订历史记录，制作人和核准人外，无特定要求。由制作人根据实际需要而设定。For the content format of work instructions, there is no special requirement except for the following item: document no, effective date, revision, page, change/revisio

25、n history, originator and approver. 5.2.11 所有变更的内容应显示在文件的“历史记录”栏中。All updated portion in the document must be identified in the “Revision history”.5.2.12 对于一级，二级文件和控制规范类文件必须有版本和版次。所有文件版本用阿拉伯数字表示,从1开始，依次2，3，4；所有文件版次用大写26个英文字母表示, 从A开始,依次B,C D.。For 1st level documents and 2nd level documents, must have

26、 document issue and revision. Issue should be in alpha letters, start from 1, in turn 2, 3, 4,. ; Revision should be in Cap English letters, start from A, end to Z.5.2.13 对于三级文件（除控制规范外）只需用版次识别文件更改次数。用阿拉伯数字表示，从0开始，依次1,2,3,¼¼. For 3rd level documents (excluding control work document), we jus

27、t use revision to identify the change level. Revision should be in alpha letters, start from 1, in turn 2, 3, 4,.5.2.14 表格版次用“nn”表示，从00开始，依次01, 02, 0399止。The revision for form should be “nn”, start from 00, in turn 01, 02, 03., end to 99.5.3 受控文件的编号Numbering document：所有受控文件由文控中心文件管理員根据文件編碼与識別方法FQW-D

28、OC01或表格管理規定 FQW-DOC02统一进行编号。All controlled document no. should be allocated by DCC clerk according toDocument Numbering and Identifying Methods FQW-DOC01 orForm Management and Regulations FQW-DOC-02.5.3.1 文件起草者在编写文件时须向文控中心文件管理员申请文件编号。Anyone who need to write a new document must apply documents numbe

29、ring for DCC clerk.5.3.2 文控中心文件管理員接到申请后，根据电脑中的各类文件索引资料进行查询及确定文件编号，并将文件编号、文件标题、或产品名称、或产品编号、申请者姓名和申请日期等识别性标示输入电脑。After received the application, DCC clerk will check & number accordingly, and input Doc No., Doc Title or product name or product part no, the applicants name, date etc. to computer.5.

30、4 文件的接收：所有與品質及環境相關之質量控制文件，都交由文控中心文件管理员接收。文控中心文件管理員收到受控文件原稿时，须进行以下确认：All controlled documents regarding quality and environment shall be sent to DCC. After received the original document, DCC clerk will check the following items:5.4.1 标题、文件编号、版本号/版次号、页数是否完整。若有不完整的情况，退回编写人进行修正。Whether losing any of th

31、e following: title, numbering, version/issue, pages and the format is ；If yes, return to he writer for correction.5.4.2 文件格式是否符合，若不符合规定的格式，退回编写人重做。Whether the format meet document control procedure. If no, return to the originator to remake.5.4.3 检查文件的批准是否齐全及有效；Whether all signatures in loop are com

32、pleted and valid;5.4.4 文件是否有用涂改液涂改或直接涂改，若有退回文件起草人重做。 Whether the document is amended by correction fluid or handwriting. If any, return it to the originator.5.4.5 如果检查OK的是程序文件及控制规范，则DCC文员在文件封面页“文控审核/日期”栏签名及签日期，以示进行了所有检查及检查结果是OK的。 For procedures and work control, if check result is OK, then DCC clerk

33、 need to sign his/her name with date in “Checked by DCC / Date” on the cover page.5.4.6 将审核OK的文件或资料输入各类文件总清单表中。（说明：文件总清单共享于所有人员，路径为：Gmgnt002DOC_INDEX. ） DCC clerk enter new or updated document / data into every kind of master list in computer after check result is OK. (Note: all kinds of master list

34、 are shared by everyone. The path is: Gmgnt002DOC_INDEX.)5.4 文件的发放：5.4.1 文控中心文件管理員根据文件发放范围一览表FQW-DOC08填写“发文登记” QF-QA-001A，及复印相应份数文件副本，在副本上每一页加蓋紅色“紅印有效，控制文件”印章。DCC clerk fill out <Distribution List> (QF-QA-001) and copy according to Document Distribution Scope List （FQW-DOC08）. All copies of co

35、ntrolled document and data shall be stamped with red chop marked “Red Chop Valid in each page. Controlled Document” .5.4.2 文件发放范围一览表FQW-DOC08由文控中心编制，并按文件的类别进行管理，由QS系统工程师核准。Document Distribution Scope List is prepared by DCC clerk and approved by QS system engineer.5.4.3 文件接收者當場核對頁數、頁碼、印章、編號、版次后，需于發文

36、登記QF-QA-001A 上簽收, 并注明日期。The recipient should sign his/her name on Distribution List after checking page, sheet, chop, document no and revision No. etc. on the spot.5.4.4 對於換版本或某頁修訂(換版次)的文件發行時，需重新進行發文登記，收文者簽收。Re-registration shall be done by recipient when distribution new version or partly revised (

37、change revision).5.4.5 对于特急文件，文控员必须当场立即分发给所有使用部门。对于一般紧急的文件，文控员必须在1个工作日内完成分发。对于正常文件，应在2个工作日内完成分发。各部门接收人在收到更新版本文件后须于一周内将旧版受控文件交文控文员。For Emergency controlled document, it should be released immediately by DCC clerk; For urgent controlled document, should be release within 1 working day; For routine con

38、trolled document, should released within 2 working days. When receiving the updated document, the recipient must returned the invalid copy within one week.5.4.6 当需使用文件的人员未领到文件时，不得随意借用其他人的文件复印，应填写文件领用申请表QF-QA-014交部门经理/主管核准后到文控中心办理领用手续。公司内不得使用未加盖“紅印有效,控制文件”印章的受控文件复印件以指导员工操作，一经发现，由文控中心收回，并追究其责任。If anyb

39、ody need to use any controlled document but he/she didnt receive the copy of this document, he/she cant borrow from others to copy. He/she must fill in Application for usage of Doc.QF-QA-014 and get the approval of the manager/supervisor in his/her department. No duplication of all controlled copy w

40、ith “Red Copy Valid Controlled Document” stamp is allowed to use for instructing operator/technicians operation. If so, DCC will get the duplication back and blame related person.5.5 文件保存和使用管理。5.5.1 受控文件的原稿不须盖印任何印章，存放于文控中心指定文件夹,。The original copy of controlled documents must be preserved in the appo

41、inted file in DCC.5.5.2 任何人不可以在受控文件上加以标记或书写任何文字符号。No individual is allowed to mark or to sign any word or symbol in the controlled copy.5.5.3 所有紅印受控版本文件不得擅自复印，但在如下2种情况时可以复印：No duplication copy is allowed for any controlled copy with red control stamp apart from the following status:5.5.3.1 当客户要求本公司提

42、供盖有红色受控版本最新版本文件的副本时，提供者可以复印盖有红色受控版本的最新版本文件给客户；When customer request to provide the duplication of the updated documents with the red “control copy”, the provider can duplicate it. 5.5.3.2 当文件需要修改时，修改人可以复印盖有红色受控版本的最新版本文件，并在复印件上直接修改。 When the document needs to be modified, the originator can duplicate

43、 it and directly write down on the duplication.5.5.4 各部门经理需指派专门的人员接收本部门文件，妥善处理和保管所有红色受控版本文件。对于需要张贴于各工作现场的文件如若作业指导书类，各部门文件管理员将DCC分发的受控文件转交给各自主管/组长张贴于工作需要的地方（注意：生产现场/各生产车间使用之文件须置于作业场所，保証任何员工在需要的时候随时可以方便地获得相關文件以指导工作），对于不须张贴但需归档保管的文件如程序则交给本部门内各相关人员传阅后收回归档，并做好文件档案索引和标识，便于他人查阅。Each department/section must

44、 assign one special person receive and take care of all controlled copy. For operation instructions need to be posted in the location of use to instruct operators/technicians operation at all time, the depart/section document management clerk need to forward the controlled documents to his/her super

45、visor to post the appropriate work site. Dept manager/supervisor shall ensure relevant document is available wherever it is required to satisfy the customer requirements and actual needs. For those controlled copy need to be kept in file such as procedures, The department/section document management

46、 clerk need to pass the latest version to reader and kept it well after reader return it to her/him.5.5.5 文件如有缺页、破损、字迹模糊等需重新发放時，须到文件中心以旧换新。任何部门不可以以影印方式自行处理。If the document is missing a page, ripped or has blurry letterings, then the using dept must take it to DCC for replacing new one. It should not

47、 be self copied and replaced.5.6 文件修訂及更改、換版Revision & modify, version change of document5.6.1 文件如有更改、换版，需由原評審和/或批准人批准。所有巳生效的文件不可以手写更改和涂改，必须改正后用电脑打印出来交相关人员评审或核准。Any modification or elimination of released document shall be approved by original auditor or/and approval person. All released document

48、s must not be modified by handwriting and must be in computer and print out and submit it to relevant personnel for review or /and approval.5.6.2 如原審批人不在職時，由接替其崗位的人依“修订历史”和原件进行，所有更改在“修订历史”上標明其更改性質。 If the originally reviewed or approved person is no longer in that position，then the new person review

49、s the modification according to “Revision history ”and original version, any update shall be marked in the “ Revision history”.5.6.3 文件分发后，QS部门和各使用部门须根据公司的实际运作情况对文件进行评审，对不适用之处须提出修改的建议或进行修改。对于一.二級文件及与文件编号以FQW-开头的控制规范文件，须通知QS office，由QS Office组织修改。对于三级文件修改参见“作业指导书产生及修订”FQW-DOC04；对于表格的修改详见“表格管理规定”FQW-D

50、OC02。QS Office and all using department need to review the suitability and effectiveness and adequacy of released documentation and data based on the actual operation, If found any discrepancies, need to inform QS Office to correct it or correct it by the using department/section. For 1st 、2nd docs

51、and work control which document no starts with “FQW-” , if some using dept have any suggestion for change or update or modification, shall inform QS office of organizing change or update or modification. For operation instructions change/modification, please see the < Operation Instructions Gener

52、ating and updating> FQW-DOC04. For form change/modification, please see the < Form management and Regulations> FQW-DOC02.5.6.4 文件某頁最多經過五次小修改后或一次大幅修改(修改章節條款占50 %以上)時， 應進行換版， 原版本文件作廢，換發版本需增高一位。“版本”对应英文为 “Issue”，使用 “1，2，.”表示， “版次”对应英文为“Revision”, 使用 “A，B，.”表示。If any 5 minor changes to any page

53、 of the document or one major change (more than 50%) to the document, then the document shall be revised and update to next revision or issue. Old version shall be removed and eliminated. and English repress Issue for 版本, showing number “1,2.”; the Revision for 版次showing number “A,B.”。 5.7 文件的取消：所有需

54、取消的原受控文件由原审核或批准者或更高级管理者在正本文件封面上批准作废。If the controlled original document need be cancelled, it shall be approved by the original reviewer or approval person or higher ranking person.5.8 作廢或失效文件撤除管理以及文件遺失處理 Withdrawal and disposition of useless or invalid document and the control of docs missing, hand

55、ing over.5.8.1 規定事項和現行運轉狀況完全不符時；或同一事項已有新規定時；或文件更改時，原來文件自動過時或無效。The original document will automatically out of date or invalid in case that new regulation has been decided and executed in public known or document being modified because its non-conformance between regulated rules and practical operation.5.8.2 過時或無效的文件由文控員