文件管理程序中英文对照

1、Document Control Procedure文件管理程序 Purpose目的Define the requirements and responsibilities for Document control.定义出文件控制的要求和权责。2.0Scope范围This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form.适用于与质量管理体系有关的所有文件。包括:手册、程序文件、操作指导书、外来文件及表单。3.0 Def

2、initions定义3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active.质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。3.2 Procedure: Define the function of QMS requirement allocation by departme

3、nt. Such as document control, management review, internal audit procedure.3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。如文件控制程序、管理评审控制程序、内部审核控制程序。 3.3 Working Instruction: Operation procedures, inspection standards, design drawing and etc.3.3操作指导书：操作规程、检验标准、加工图纸等。3.4 Form: Records of operation results.3.4表单：

4、用于记录作业结果所用的文件。4.0 Procedure 程序4.1 Responsible for the formulation of documents to file the proper approval, and timely send the electronic document and the paper version to DCC, ensure that the relevant departments to understand the change. Once the document released, the relevant departments must f

5、ollow procedures. When the file changes do not affect the contents of the file (such as correcting typos, wording changes), it will not requires re-approval, but such changes must be notify DCC to ensure the consistency of documentation.文件的制订者负责使文件得到适当的审批后,及时将文件的电子版本和批准后的纸张版本交给文控,并确保相关部门理解文件。一旦文件发放，

6、各相关部门必须依程序执行。当文件的修改不影响到文件内容(如纠正错别字,措辞修改)时,可以不进行版本升级,也就不需要重新审批,但是类似修改必须经过文控,以确保文件的各种形式保持一致。 Classification and description of controlled documents 文件的分类及受控说明4.2.1 Documents classification文件的分类：Quality management system documents chart as below:质量管理体系文件分为以下几类：A一级:Quality Manual质量手册®B二级:Procedure程

7、序文件®C三级:WI作业指导书®D四级:Form记录表®External documents, including the customer documents (procedure, products standards, drawing and etc. , standards organization documents (national/ international products/system standards.) laws and regulations, design operational instruction.外来文件，包括来自顾客的文件

8、程序文件、产品标准、图纸等、来自标准化组织的文件国家和国际的产品标准及体系标准及来自法制机构的文件、设施操作说明书等。4.2.2 Document control 文件的受控说明DCC issue the paper files with controlled stamp, issue the electronic files on S drive, Only DCC has the authority to amend the document, other users only has the authority to read.经文控中心发行的纸档文件，每页均有跨页受控章的为受控文件;

9、受控的电子版文件保存在公共盘上，仅文控中心有修改权限，其它用户仅有只读权限。4.3 Creation and review of documents 文件制定及评审过程4.3.1 Creation of documents 文件的制定:The author apply DCC for documents formulate, amend or repeal, DCC will release the latest electronic version and provide a new number to the author. 文件编写者向文控中心申请对文件进行制订、修订或废止，文控将释放最

10、新的电子版本供其修订，对新增文件，文控将提供新的编号。4.3.2 Document review and approve 文件的评审和 Responsibilities are as follows:相关权责如下：Document文件类别Create, amend or repeal制定、变更、废止Review/Countersign审核/会签Approve批准Doc. No.发行编号Original Control原稿管理Manual手册Management representative or authorized person管理者代表或其授权人Department Manager部门经理

11、General Mgr.总经理DCC文控中心DCC文控中心Procedure程序文件Various Dept.各部门Relevant department Mgr. and quality system engineer相关部门经理+质量体系工程师Responsible Dept. Mgr.责任部门经理DCC文控中心DCC文控中心WI作业指导书Various Dept.各部门Relevant department Mgr. 相关部门经理Responsible Dept. Mgr.责任部门经理DCC文控中心DCC文控中心Form表单Together with relevant documents

12、 reviewed and approved随相关文件一同审核,批准DCC文控中心DCC文控中心 Document No. 文件的编号：The document conformed revision with R1, R2, R3, R10, R11.文件编号版本采用R1, R2, R3, R10, R11.的方式。Code at all levels of the documents各级文件的代码为：Classification 类别Code 代码类别代码Manual 手册QMRecord记录表单QRProcedure 程序文件QPWI作业指导书WI The code No. of qual

13、ity manual is QM01. 质量手册的编号用QM01。 The code No. of procedure is XXX/QPXX. 程序文件编号用XXX/QPXX；XXXQP.X.Serial number 流水号Quality Procedure质量程序文件Dept. Code 部门代码4.3.3 WISuch as：Operation procedures, inspection standards, design drawing and etc.作业指导书如：操作规程、检验标准、加工图纸等： XXXWI.X.Serial number 流水号Quality WI 质量作业指

14、导书Dept. Code 部门代码Department Code as following部门代码如下：Code代码Dept.部门Code代码Dept.部门Code代码Dept.部门Code代码HR人事部HRDQuality质量部QADPMC物料方案部PMDEngineering工程部PEDCS客服部SADTooling模具部TLDProduction生产部PRDME制造工程部MEDITITDPurchasing采购部PUDVBSSVBDFacility设备维护部FAD4.3.4 Records and form： Follow the code No. of procedure or WI,

15、 add the serial No. after the code No. For example: The first form belongs to QADQP01 is QR-QADQP01-01, the second is QR-QAD/QP01-02; The version is¼A, B, C, D. 记录表单：以程序文件或作业指导书之编码后面再加二码流水号。例如：QAD/QP01所产生的第一张表单，其编号为QR-QAD/QP01-01，第二张表单其编码为QR-QAD/QP01-02；版本采用A、B、C、D¼的方式。 Document Release an

16、d reclaim 文件的发放和回收 DCC is in charge of document release and reclaim, quality manual need release to the department managers and general manager, procedures are not release paper form; working instructions need release to the using place; record and form can be printed by the users themselves. Electr

17、onic versions of all files are read-only on S:Quality Resource DCC Quality system document.受控文件的发放、回收由文控中心统一进行处理，质量管理手册发放对象为部门经理及总经理；程序文件不以纸张形式发放;作业指导书发放到各使用单位容易取阅的地方;记录表单可由各使用者自行打印。所有文件的电子版本均以只读形式保存在S:Quality Resource DCC Quality system document. DCC fill all the files based on "QMS document l

18、ist." The latest version on the list should be match with the version listed in the file 文控中心根据对所有文件填列?质量管理体系文件一览表?。表中的最新版本与使用文件中列的版本号要相一致，以掌握现行版本文件状态。 DCC should copy the appropriate number of document in accordance with the requirements from the file-makers, stamp on the copies and reclaim th

19、e last version Ask the receiptor to signature on “document release/ reclaim form. 文控中心根据文件制订者的要求影印相应的份数，加盖相关印章后发行，同时回收对应的旧版文件,并请收文单位于?文件分发/回收登记表?上签字确认。 External documents need confirmed by relevant departments, then send to DCC to stamp “External Document on it. DCC will release the external documen

20、t. The documents should not be forwarded to other personnel without permission. 外来文件须由相关部门确认其有效性后,交至文控进行登记, 并加盖 外来文件章后发放。未经允许任何人不得将客户指定的机密性文件转发给其他无关人员。4.5 Document update 文件的更新 For the document which has not been updated for 3 years, the responsibility Dept. should review and evaluation for it.4.5 对

21、于三年未进行更新的文件，必须对文件的适合性及符合性再做评估。4.6 Document repeal文件的作废If the last version document is confidential, it can not be reutilization. DCC should stamp "voided" or "void reservations" on the original immediately for identification. Obsolete documents number can not be reused.4.6 旧版的影印文

22、件如果涉及客户机密或公司机密，不可做二次使用。原始文件那么由文控中心即时加盖“作废或“作废保存以作识别。作废的文件其编号不可重复使用。4.7 Document management 文件的管理4.7.1 The documents which consulted on site must be placed at the work station. 现场使用的文件须置于作业现场。 The documents which neednt to consulted on site, should kept by document users.4.7.2非现场使用的文件须由各使用人自行集中管理。 No

23、 person shall use non-controlled documents. Once discovered, DCC should recover the files immediately.4.7.3任何人都不得使用受控文件的复印件，一经发现立即由文控中心收回。 DCC should update the "QMS documentation list" timely, and notify the relative departments by e-mail.4.7.4文控中心视变更情况及时更新?质量管理体系文件一览表?,并以电子邮件的形式发出通知. The

24、 users should ensure the documents are remain legible, when the file has missing pages, damaged, illegible, etc., the user should apply for a replacement. The new version of the file still use the original, DCC should scrap the voided document.4.7.5文件使用和保管部门妥善保管文件以确保文件保持清晰，易于识别，当文件有缺页、破损、字迹模糊等情况时，也应向文控中心申请补发新文件。新文件的版本号仍沿用原文件版本号，同时文控中心将破损文件销毁。 When the paper version and the electronic version are conflict, follow the electronic version. Discoverer shall immediately notify DCC to correct. 当文件的