1、Document management procedure文件管理程序1. Purpose 目的：The purpose of this document is to ensure management system operates efficiently and under control, and every department has latest version of document.为确保本公司管理体系有效运作和受控，各部门均能持有最新版的受控文件2. Scope 范围：This procedure applies to all levels of controlled doc
2、uments and external documents.适用于本公司管理体系中各级文件以及外来文件。3. Definition 定义：Management system documents are of 4 levels: Manual; Procedures, Criterion, and Check list 管理体系中文件分四级：手册；程序文件；工作指导书、规范或标准；表单3.1 Manual 手册：Level 1 doc, a comprehensive description of the system, which include policy and target.第一级文件
3、，对体系进行综合描述，包括方针、目标。3.2 Procedure 程序：Level 2 doc, explains how to work and how to complete the policy and target in Manual.第二级文件，详述如何进行工作及完成手册中所规定的政策及目标。3.3 Work instruction or Criterion:工作指导书、规范或标准：Level 3 doc, important basis or guide documents for management procedure execution.第三级文件，为支持各项管理程序于执行阶
4、段时重要的依据或指导之文件、标准。3.4 Check list and Record表单及记录 ：Level 4 doc, test and verify management system s efficiency from constantly recording all the procedures.第四级文件，为验证管理体系有效运作，而对各个事项持续不断加以记录。3.5 External documents 外来文件:Include customer drawing, international/national criterion, relevant laws and regulat
5、ions, industrial standards, customer/supplier technical documents, and etc.指客户图面、国际、国家标准、相关法律法规、行业标准、客户或供应商提供的技术文件等。3.6 Controlled document : DCC released document.受控文件：由DCC发行的文件属受控文件3.7 Draft documents: onsite rework instruction shall be issued as draft documents(e.g. rework instruction ect.), mark
6、ed with expire date, and its validity period should be no longer than 1 month.临时文件：现场需要临时使用的受控文件，如返工作业指导书等，临时文件上需注明失效日期，临时文件有效期不超过1个月C3.8 In this document DCC stands for document control center文控中心，本文件中均以DCC表示4. Responsibility 权责：4.1 DCC is responsible for managing all the company s documentsDCC负责公司
7、所有管理体系文件的管理工作。4.2 Each department is responsible for managing their own documents.其他部门负责各自体系文件的管理工作。Each department is responsible for managing their own documents.5. Procedure 流程：输入(Input流程(Procedure )输出(Output )权责(Owner )相关说明(Explanation )精选资料6 Content 内容:6.1 Document preparation and approval文件的编写
8、与审批(Level 2 documents of the management representative shall be drafted by quality manager, checked by management representative and approved by general manager)(管理者代表的二阶文件由副总经理审核，总经理批准。)If the approver ask for leave or be on a business trip, the document can t be approved in time . it should be com
9、pletedby the agent当文件审批人由于请假或出差等原因不能及时完成文件审批时，则由该责任人的代理人完成文件的审批工作。Doc Category文件类别Prepared by 制定Reviewed by/sign审核/会签Approved by 批准Quality/EHS/HSF Policy质量/EHS /HSF方针Quality/EHS/HSF objective质量/EHS /HSF目标Quality /EHS manual质量/EHS手册Management representative管理代表EHS EngineeringEHS工程师/General Manager总经理
10、QP/EP程序文件Related Department相关部门Head of department相关部门主管/经理Management representative 管理代表WI三级文件Related Department相关单位Head of department相关单位主管PM / Manager项目经理/部门经理External document外来文件Document is reviewed by project team, its distribution is determined by receivingdepartment, then issued by DCC.由项目组评审
11、，接收部门确认需要分发部门，DCC发行Form表单QP and WI shall be checked and approved together.随附QP与WI文件被审核，批准。6.2 Preparation of document: Document shall be prepared according to ，经批准后交于DCC。6.3 Distribution/ Return分发/回收作业6.3.1 When DCC receive approved document, DCC shall confirm document No. and version, and issue the
12、n form and keepdocument in the Public drive 192.168.19.11ST-QualityDCCor in the ERP and update inDocument masterlist. Document can only be revised by DCC and be read-only by other departments. IT should back up the P drove document on periodically, in case of the lost.DCC收到签核完成之文件后，确认文件编号、版本版次符合性，确认
13、合格后将文件发行，并存档，地址存于公共盘： 192.168.19.11ST-QualityDCC,或ERP中，同时更新到文件总览表中，该地址文件只有DCC中心可以修改，其他部门人员权限为只读。公共盘 DCC文件定期由IT备份一份，以防资料丢失。6.3 . 2 The following documents shall be issued in paper, others in e-document.下表文件需要发行纸文档，其他文件一律发行电子档。具体见下表：CategoryNameReceiving DepartmentIssue methods文件类别文件名称接收部门/单位发行方式OExte
14、rnal Document外来文件Operation Center / Quality Dept./Development Center运营中心/质量部/开发中心Paper发行纸档WI注塑标准工艺Operation Center运营中心Paper发行纸档WI注注塑生产作业员操作指导书Operation Center运营中心Paper发行纸档WIVGP12作业指导书Operation Center运营中心Paper发行纸档WI检验指导书Operation Center / Quality Dept.运营中心/质量部Paper发行纸档WI包装规范Operation Center运营中心Paper发
15、行纸档WI(Fixture Drawing For Internal Inspection Quality Dept.质量部Paper发行纸档WICriterion and regulation documents for work site现场使用相关操作规范或规章制度类文件Operation Center / Quality Dept./Development Center运营中心/质量部/开发中心Paper发行纸档6.3.3 DCC is responsible for distributing documents to related department and is require
16、d to keep a record of issuance/ return of a hard copy into Document issuance/return record form. Recipient representing the receiving department has to sign the Document issue return record form and recycling the old document. If a soft copy is distributed, DCC shall inform related department by E-m
17、ail.DCC负责分发受控文件至相关部门，纸档文件发放/回收需记录在文件发行/回收登记表上。领取部门需在文件发行/回收登记表上签收并同时回收旧版本文件。电子档文件发行时， DCC以Email方式通知相关部门。6.4 Document/Form Application need to be filled and approved by the requesting department head and the management representative when document is insufficient, missing or damaged, before a new cop
18、y of document shall be reissued to related department for work purposes.由于工作的需要而又没有文件或原文件丢失、破损时，申请方填写 文件/表单申请表经所在部门负责人审核、管理者代表后，可补 发。6.5 Document or copies of documents without stamp of受控文件 are ineffective.文件未盖有“受控文件”章之文件或复印的“文件受控”，视同无效文件。6.6 Change of document 文件的变更6.6.1 . Modified content should b
19、e shown in italic fond marked with underline and keep a record in the document issue/revision record, at the same time training to relevant personnel.文件修改时，在修改部分用斜体加下划线体现并记录在文件制/修订履历表上，同时需对相关人员进行培训。6.6.2 In the operation, when one of following cases happens and need to change document, the engineeri
20、ng change application should be raised.本公司生产运营中遇下列情况并涉及文件变更时，需提出工程变更申请。6.6.2.1 Changes put forward by customer客户端发起的变更6.6.2.2 Changes of product performance characteristics, and specifications 产品性能，规格的变更6.6.2.3 Material or its source change 材质或者其来源变更6.6.2.4 Significant improvement of production proc
21、ess 制造过程或生产方式重大改善6.6.2.5 The use of new production equipment 利用新的生产设备生产6.6.3 When the document to update because of customer complaint or internal 8D, only remark the 8 d number, don tneed to do ECN process6.6.4 当客户投诉/内部8D等引起文件更新时，则在变更备注中备注8D单号即可，无需 ECN流程。6.6.5 When other documents /form need changi
22、ng, the changing requests in Document/Form Revision and Approval shall be filled by the related department and submitted to the head of the department and other related departments who will need to give estimate and review on the changes and their possible impacts, then to decide if the change is ne
23、cessary. If yes, they will need to sign on theDocument/FormRevision and Approval. Any change on a document need to be approved by the original approver of the document. When original approval personnel is out of duty, it can be approved by the personnel who acts for his/her position.6.6.6 其他文件/表单修改时
24、由相关部门提出申请，并需填写文件/表单修改和批准表,报部门经理以及各部门，对修改的内容和修改 可能导致影响进行评估和预测，确定修改是否必要，并在文件/表单修改和批准表签署意见，如确需修改，经文件原批准人批准后可 进行修改。若原批准人发生变动，则由原职务的接任人负责审批。6.6.7 level3 document of medical医疗产品三级文件6.6.7.1 level 3 document list of medical which relate to medical product should be recorded the list, this list need todefine
25、 the document approver and training participants, and issue to relevant department according to Level3 document list of medical and execute.6.6.7.2 医疗产品相关的三级文件识别出后要记录在医疗产品三级文件清单中，该清单需定义各文件的审批及培训对象，同时将该表单发行到相关单位依医疗产品三级文件清单要求进行文件的审批及培训；6.6.7.3 When the document which inlevel3 document list of medicali
26、s changed,approving must be confirmed by the original or appointed department,ac cording to the definition of the list to do training.At the time of publishing DCC,we need update the lists edition.6.6.5.2 医疗产品三级文件清单中的文件更改时，审批必须得到原始部门或指定部门的确认，培训对象依清单中定义的人员进行培训。DCC在发行的同时需更新医疗产品三级文件清单中的对应文件版本；6.6.5.3 W
27、hen the list training participants is changed, supervisor need to inform DCC update the list. Then the direct supervisor or document writer to do training6.6.5.4 医疗产品三级文件清单中的培训对象有变更时，所在单位主管第一时间通知到DCC更新医疗产品三级文件清单,并由直接主管或文件撰写人进行培训。6.6.5.5 The person who is responsible for approving Medical document sh
28、all have the corresponding professional background.6.6.5.6 医疗产品文件的审核和批准人应具有相应的专业背景 6.7 Maintain/Obsolete保存/作废作业1.1.1 The corresponding files should be reviewed and revised/ abolished by of each department based on its situation, in which process the soft copy, hard copy and document/form application
29、 shall be hand over to the DCC for issuance or obsoleting.各部门视需要对相应文件进行评审修订/废止，然后将电子文档、打印文件、文件/表单申请表交于DCC发放或作废.1.1.2 Old version or obsolete documents should be stamped with作废its soft copy should be maintained in”作废旧文件file of E dive in DCC computer or ERP system.旧版及作废文件纸档盖作废章作废，电子档存于DCC电脑E盘“作废旧文件”夹或
30、 ERP系统中1.1.3 Maintain at least one obsolete document for medical products. Its old version minimum saving period is referring to the relevant laws and regulations for the product ife cycle or the prescribed time limit. The obsolete medical documents should be record into Document/Form Obsolete Maste
31、r针对医疗器械产品应至少保存一份作废文件，旧版文件保存时，保存期限至少为产品的相关法律法规寿命周期或规定的期限，医疗 类作废文件需登录与文件/表单作废一览表中.1.1.4 The control file holding department is responsible for receiving and updating file, and verify with DCC to ensure has the latest version.文件持有之部门，负责文件接收及更新记录，并定期到DCC处核对文件版本，以确保文件为最新版本。1.8 Control of external documen
32、ts外来文件的控制6.8.1External documents should be verified for its feasibility upon receiving, and given an auditing if necessary, whichshall be completed with no more than 2 weeks before submitted to DCCand update in Document master list.外来文件接收后，应由接收单位确认其适宜性，必要时进行评审，评审时间不超过两周，然后转交DCC并登陆文件总览表。1.8.1 The ext
33、ernal documents issued based on 6.3 外来文件发行时，依 6.3执行.1.8.2 Changes and introduce of a New Version for External Documents 外来文件之变更和新版登入The validity of external documents and data must be verified through issuing organization regularly, if changes, revisions or new versions are available they need to be
34、 introduced and recorded in the Document Master list, and issued based on 6.3.外来文件及数据应定期与发放机构确认保证是有效版本，如有变更或修订、新版文件于接收后登入文件总览表,发放时依6.3执行。1.9 Document review文件评审Departments shall review the system documents of their departments regularly to ensure the suitability, compliance and effectiveness of the
35、documents.各部门应定期对其部门的体系文件进行评审，以确保各文件的适宜性、符合性和有效性。7 Related document 相关文件：工程变更管理程序文件编号、版次、格式及书写规范 Document /Records management specification 文件/记录管理规范8 Forms and annex 表单及附件：8.1 Forms attached to this document 此文件衍生表单：8.1.1 Document/Form Application 文件/表单申请表8.1.2 Document Issue/Recall Record Form文件发行
36、/回收登记表 8.1.3 Document Obsolete List 文件表单作废一览表8.1.4 Document master list 文件总览表8.1.5 Document/Form Revision Record文件/ 表单修订履历表8.1.6 Document/Form Revision And Approval”文件表单修改和批准表8.2 .Related forms : Non相关表单：External Files(Specification)Review Report外来文件评审表Drawing Identification Report判图记录Level 3 document list of medical医疗产品三级文件清单 Attendance record 培训 I签至1J表Annex : None 附件：无Document issue/revision record 文件制 / 修订履历表：Prepared by制/修订人Content制/修订内容Page 页次Version版本/版次Date of issue发行日期
