文件管理程序

-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 documents 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，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 systems 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 regulations, 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.), marked 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。3.8 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 companys documentsDCC负责公司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）Standard demands标准化需求Law/regulation relevant standards/customer drawing法律法规/相关标准/客户图纸Engineering change, standard demands工程变更、标准化需求 Creation of document / revisions文件制定/修订Approved审批 NGTrain 培训OK Document release文件发行 Document using keeping and maintaining文件使用保管维护External document receiving外来文件接收 External document review外来文件评审 NG External document release 外来文件发放 OKDocument using keeping and maintaining 文件使用保管维护ECN or Document / Form Revision and Approval & modified document工程变更通知单/文件表单修改和批准& 修改好的文件 Review countersign审批 会签 OK. Train 培训Document using keeping and maintaining 文件使用保管维护Change invalid continue to use original document 变更无效，沿用原文件Document release文件发行NGdocument/form application文件/表单申请表Approved document审批后的文件Attendance record 培训签到表Controlled document受控文件 Document master list文件总览表Document Issue / Recall Records文件发放回收记录表External Files(Specification)Review Report Drawing Identification Report外来文件评审表 判图记录文件总览表Document Issue / Recall Records文件发放回收记录表 Controlled document受控文件Document/Form Revision And Approval文件表单修改和批准表ECN Application工程变更通知及申请Approved document审批后的文件Attendance record 培训签到表Controlled document受控文件Document master文件总览表Document Issue/Recall Records文件发放回收记录表Document management文件管理Demand document需求部门Department manager/manager representative/GM/project manager部门经理/管代/总经理/项目负责人DCCDCC and Document Controller DCC及各部门文件管理人Duty Departmen各职能部门Team项 目小组DCCDCC and Document Controller DCC及各部门文件管理人Document change initiator文件变更发起人Department manager/manager representative/GM/project manager部门经理/管代/总经理/项目负责人DCCDCC and Document Controller DCC及各部门文件管理人Document shall comply with文件编写时需符合,Document issued based on 6.1文件审批依此文件6.1执行Document issued based on 6.3文件发行依本文6.3执行Document using keeping and maintaining issued based on 6.8文件使用保管维护6.8执行External documents should be reviewed for its feasibility, but no more than 2 weeks, and review the result feedback to the customer, in two weeks外来的客户图纸发行前需得到项目组的评审（评审时间不可超过两周）并在2周内将评审结果反馈给客户Document issued based on 6.3文件发行依本文6.3执行Document using keeping and maintaining issued based on 6.7文件使用保管维护6.7执行Demanding departments put forward the changing application for revised document.需求部门提出修改好的文件及提出变更申请。Each department reviews whether the modification complies to requirements of system .各职能部门评审相应的修改是否符合系统及实际操作的要求。Document issued based on 6.3文件发行依本文6.3执行Document using keeping and maintaining issued based on 6.7文件使用保管维护依6.7执行6 Content内容：6.1 Document preparation and approval 文件的编写与审批(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 cant be approved in time . it should be completed by 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 Engineering EHS工程师/General Manager总经理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 receiving department, then issued by DCC.由项目组评审，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 . After approval, shall be submitted to DCC together. 文件制定: 文件制作需符合 ，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 then form and keep document in the Public drive 192.168.19.11ST-QualityDCC or in the ERP and update in Document master list. 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：Category文件类别 Name文件名称 Receiving Department接收部门/单位Issue methods发行方式OExternal 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WIMolding Data Sheet注塑标准工艺Operation Center运营中心Paper发行纸档WIMolding Production Operator Work Instruction 注塑生产作业员操作指导书Operation Center运营中心Paper发行纸档WIGP12 Work InstructionGP12作业指导书Operation Center运营中心Paper发行纸档WIInspection Instruction检验指导书Operation Center / Quality Dept.运营中心/ 质量部Paper发行纸档WIPacking Specification包装规范Operation Center运营中心Paper发行纸档WI内部检治具图纸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 required 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-mail.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 copy 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 be 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 engineering 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。6.6.2.1Changes 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 process 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, dont need to do ECN process6.6.3 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。6.6.4 When other documents/form need changing, 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 necessary. If yes, they will need to sign on the Document/Form Revision 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.6.6.4其他文件/表单修改时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。 6.6.5 level3 document of medical 医疗产品三级文件6.6.5.1 level 3 document list of medical which relate to medical product should be recorded the list，this list need to define the document approver and training participants, and issue to relevant department according to Level3 document list of medical and execute.6.6.5.1 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；6.6.5.2Whenthedocument which in level3documentlistofmedicalischanged,approvingmustbeconfirmedbytheoriginalorappointeddepartment,accordingtothedefinitionofthelisttodotraining.AtthetimeofpublishingDCC,weneedupdatethelistsedition. 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 When the list training participants is changed, supervisor need to inform DCC update the list. Then the direct supervisor or document writer to do training 6.6.5.3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。6.6.5.4 The person who is responsible for approving Medical document shall have the corresponding professional background.6.6.5.4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 6.7.1 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 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.6.7.2 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ERP系统中6.7.3 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 Master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.6.7.4 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。6.8 Control of external documents 外来文件的控制6.8.1 External documents should be verified for its feasibility upon receiving, and given an auditing if necessary, which shall be completed with no more than 2 weeks before submitted to DCC and 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