袁公明的博客复制网址 | 设为主页| 加入收藏

Document Control Procedure文件控制程序

1 Purpose目的
Establish methods of managing the company’s files concerning the quality & environment management system and effectively control it. Meantime, ensure that the effective documents are available in all work places which are essential to the efficient operation of the system and withdraw the obsolete ones from the places which get and use the document.
确立本公司与质量环境管理体系有关的文件的管理方法，并对其进行有效控制，以确保对体系有效运行起重要作用的工作场所都能使用相应文件的有效版本，且能及时从所有发放和使用场所收回作废文件。
2 Scope适用范围
This procedure is applicable to the control of all our company’s files concerning the quality & environment management system.
本程序适用于公司所有与质量环境管理体系有关的文件的控制。
3 Definition定义
3.1 Controlled Original Files: the original piece of the controlled files which is written by the file compiler and has been approved.
受控正本文件：由文件编写人编写并经审批后的受控文件原件。
3.2 Controlled Duplicated Files: the copy of the controlled original file for use
受控副本文件：因需要用受控正本文件复印的受控文件。
3.3 Uncontrolled Files: files not to be withdrawed or renewed.
非受控文件：不作更新及回收的文件。
3.4 Cancelled Files: files not to be used again in working places but only to be marked as reference when needed
作废文件：不能在使用场所再使用的文件，需要时需做好标识仅供参考。
3.5 Reference Files: files having no direct connection with the product quality or environment system, and only used for reference.
参考文件：与产品质量或环境体系无直接关系的文件，是只供参考用途的文件。
3.6 External Files: International standard, National standard, professional standard and related laws or regulations, files/ criterions provided by interested party.
外来文件：国际、国家或行业标准、相关的法律/法规或相关方提供的文件或规范。
4 Responsibility职责
4.1 General Manager总经理
a. Organize to establish and approve the quality & environment policy and objective and approve it.
组织制定并批准质量环境方针、目标；
b. Approve the issue of the quality & environment manual
批准发布质量环境管理手册。
4.2 Management Representative管理者代表
a. Organize to compile quality & environment management manual and confirm it.
组织编写及审核质量环境管理手册；
b. Approve the issue of procedure documents
批准发布程序文件。
4.3 Each department各部门
a. Compile its own managerial procedure files which have to be signed jointly by relevant departments;
编写本部门归口管理的程序文件，程序文件需经相关部门会签；
b. Compile and modify the 3-level documents of each department, and the department representative has to confirm those documents.
编写及修改部门三级文件，部门负责人审批部门编写的三级文件；
c. Prepare document list which is a collective of those compiled files of the department;
编制本部门编写的文件的《文件清单》；
d. Preserve all the issued controlled duplicated files.
保管所有分发的受控副本文件。
4.4 Document control center controller文控员
a. Manage files according to the requirements of this procedure;
按本程序要求管理文件；
b. Preserve all approved controlled original files;
保存所有经审批后的受控正本文件；
c. PrepareDocument list which is a collective of all the files of the company.
编制本公司所有文件的《文件清单》。5 Procedure Contents程序内容
5.1 Composing of the document文件的构成
一级文件/二级文件/三级文件
5.2 File Numbering文件编号
5.2.1 Principle of Quality & environment manual numbering 质量环境管理手册编号原则
5.2.2 Principle of procedure documents numbering程序文件编号原则
5.2.3 Principle of working instruction files numbering作业指导文件编号原则
5.2.4 Principle of record numbering记录编号原则
5.2.5 Edition and order number of files文件的版本/次
5.2.6 Extra Codes (including product packing directions, product inspecting directions, assembly process directions, injection process directions and drawings)例外编号（包括产品包装指示书、产品检查指示书、装配作业指示书、注塑作业指示书及图纸）
5.2.7 External files can be converted to our files can be numbered according to our principles of numbering when needed.外来文件如需转为公司文件时可按公司文件的编号原则进行编号。
5.3 Document control center controller keeps external files, prepares the List of Documents Come Form Outside and updates them when a newest edition comes into being; External files provided by customers and suppliers have to be checked by related departments and to be issue or preserved as needed.
外来文件由文控文员进行管理，并编制《外来文件一览表》，如有最新版本由文控员更新；顾客或供货商提供的外来文件由相关部门确认，视需要进行发放与保存。
5.4 Marking of files文件的标识
The files of the company are divided into controlled ones and uncontrolled ones:
本公司的体系文件有 “受控”和“非受控”之区别：
a. Controlled files are to be controlled when being modified and stamped the controlled chapter, and make sure that the valid edition can be available in all places which use them.
“受控”文件必须对其更改进行跟踪管理并加盖受控印章，确保其起作用的场所使用其有效版本。
b. Control-lost and canceled files are to be withdrawed and stamped the red ‘Cancelled’ chapter, and can be kept to use as reference after getting the approval of related file control department, avoiding misusing.
失控、作废的受控文件必须收回并加盖红色“作废”印章，若留用必须经过该文件控制部门批准方可参考使用，防止误用。
c. Files or records concerning the operation of the system are to be coded according to the item 5.2 by the document control center controller.
与体系运行相关的文件或记录由文控员按5.2条规定进行下统一编号。
d. ‘Reference only’ are files provided to the customers and suppliers and stamped ’reference’ chapter on the cover by the document control center controller when she distributing these files. No need to register the distribution of these files and no need to inform of its edition renewal.
“仅供参考”是指提供给顾客或供方的文件，文控员发放这类文件时在文件封面加盖“仅供参考”印章，对这类文件不做发放登记，换版时不予以通知。
5.5 File issuing and managing文件的发放及管理
5.5.1 Document control center controller prepares theDocument Issue/Retrieve Record Sheet and issues the first, second, third level files to related departments after these files have been approved
一、二、三级文件经批准后，由文控员根据发放范围编制《文件发放\回收记录表》，并发放至相关部门。
5.5.2 Document control center controller stamp ‘Controlled Document Copy’ chapter on the cover before issuing the file.
文件发放前由文控员在文件封面及正文每页上加盖“受控副本文件”印章。
5.5.3 As to the scope of issuing, ensure the effective edition of the files are available to the users.
文件的发放范围必须确保文件的使用人员能方便地得到该文件的有效版本。
5.5.4 The files with black chapter used in working places inside the company are the invalid ones.
公司内部现场使用的黑色印章文件均是无效的。
5.5.5 The controlled files are to be withdrawed by document control center controller after their holders transferred from their positions because of the work or other reasons, and this is to be noted in Document Issue/Retrieve Record Sheet.
持有受控文件的人员，因工作调动或其他原因离开原工作岗位，文控员应收回其持有的受控文件，并在文件《文件发放\回收记录表》注明。
5.5.6 When the holder lost his file, he needs to fill out an application of reissue document sheet and get a new one from document control center controller after his application is approved. The new file has a new issuing code, and the lost one is to be announced void.
当文件持有人所持文件丢失后，填写《文件补发申请单》，经批准后文控员补发，补发文件给予新的分发号，同时注明丢失文件的分发号作废。
5.5.7 When one’s file is severely damaged and can’t be used, he can go to document control center controller to apply for a new one and the new one will still use the former distribution code. The damaged one will be announced void.
当文件持有人的文件破损严重并影响使用时，可到文控员处办理更换手续。新文件仍沿用原分发号；破损文件由文控员作废处理。
5.6 If any modification to the files is needed, the applicant should fill an application sheet in first. The files will be modified after getting the approval, then issued by document control center controller according to the scope of issuing. At the same time the document control center controller has to take back those replaced files as canceled ones.
文件如需修改，由要求更改的部门填写《文件更改申请单》，经审批后实施修改，修改后交由文控员按规定范围发放，并回收被换下的文件作废处理。