文件和记录控制程序中英文.docx

1、文件和记录控制程序中英文文件和记录控制程序1.0目的Purpose对与管理体系有关的文件、资料和记录（含电子版）进行控制，确保所有使用部门使用的文件和记录（含电子版）都有效。Control over documents and materials related to management system so as to ensure that all the documents and materials and records (electronic)used by each department are current and valid. 2.0 范围 Scope适用于所有与管理体系等

2、有关的文件、资料和记录（含电子版）的控制。Applicable to the control over documents and materials and records (electronic) related to management systems.3.0 职责 Responsibility3.1管理者代表负责手册（质量手册、EHS手册）及程序文件的批准。Management Representative is responsible for the approval of manuals (quality manual,EHS manual) and procedure file

3、s. 3.2质量部经理负责质量手册、EHS手册的审核，程序文件的复核。 QM is responsible for verification of quality manual, EHS manual , recheck procedure files. 3.3体系工程师负责质量手册、EHS手册的编制、更改和控制；程序文件的编写和三级文件的审核。ISO specialist is responsible for compilation, alternation and control of quality manual and EHS manual and procedure document

4、s and review the supportive documents.3.4文控室负责检查文件编号、控制，外来文件的控制、管理。 Document Control Office is responsible for checking and controlling document numbers as well as regulation and management of external document. 3.5技术部负责技术、工艺、图纸的控制。Technology Dept. is responsible for controlling of technology, techn

5、ique and drawings.3.6各部门负责三级文件的编写、编号及本部门所使用文件的管理。Each department is responsible for correlative files establishment and numbering as well as examination and verification together with the documents management used by the said department. 3.7各部门对本部门产生的记录（含电子版）的准确性、完整性负责。Each department is responsible

6、 for accuracy, integrity of record produced in it.3.8各部门对本部门归口管理的记录（含电子版）进行标识、收集、编目、归档、保管和处理。Each departments personnel concerned shall conduct identification, collection, cataloging, filing, keeping and handling of the records under the management of such department in accordance with this procedur

7、e.4.0 程序Procedure4.1 手册、程序文件、三级文件及记录编号规则根据文件和记录编号作业指导书。Manual , procedure documents, the supportive documents and records numbering rules reference Working instruction of numbering document and note4.2 文件和记录编制、审批Compilation and approval of documents and records4.2.1 手册由体系工程师负责编写，质量部经理审核，管理者代表批准。Manu

8、als are compiled by ISO specialist., examined & verified by QM and approved by management representative.4.2.2 程序文件由体系工程师编写，部门经理审核，质量经理复核，管理者代表批准。Procedure files are compiled by ISO specialist，reviewed by departmental managers, checked by QM, and approved by management representative.4.2.3 产品图纸、技术文件

9、的管理按技术文件控制办法执行。Management of product drawings and technological documents shall be in accordance with Control Procedure for Technical Documents.4.2.4 支持文件及作业指导书由相关部门按文件编写作业指导书负责编写，体系工程师审核，由部门经理批准发布。各种表单由部门有关人员编写，本部门经理批准，经体系工程师及文控室备案后发布。Supporting documents and working instructions are compiled by re

10、levant departments according to Working Instruction for Document Compiling, examined & verified by ISO specialist and approved to issue by department manager. Various forms are compiled by departments personnel concerned and approved by department manages and filed by ISO specialist and Document Con

11、trol Office before issue.4.2.5 每一编号的文件为一独立文件，其它文件在文件的末页的末端明示编写、审核、批准人。对于图纸的设计、校对、审核、批准可直接在图纸上签名。Each numbered document is a unique file, and names of persons who compiled, examined & verified and approved the document shall be shown at the end of the documents last page. As to persons who designed,

12、proofed, examined & verified a drawing can directly sign on it.4.2.6 公司至少每年对管理体系文件评审一次，当不能适应公司质量/环境/职业健康安全管理时，可增加评审频率，修改后还要按4.2.1至4.2.5进行批准。The company shall conduct review procedure or supportive documents at least once every year. Review frequency can be increased when inadaptable to companys qual

13、ity/EHS management, and shall be approved according to 4.2.1- 4.2.5 after revision.4.2.7 手册、程序文件及支持性文件均以文件批准日期为正式实施日期。Manual，procedure documentations and supportive documentation are formally issued as per the document approving date.4.2.8记录（含电子版）原则上使用体系文件所规定的记录格式，如确因工作需要可用其它方式作记录，必须能有效保存。In princip

14、le, records adopt recording format stipulated in system file; due to working requirements, other method can also be used in records, but it must be able to be stored effectively.4.2.9记录的内容应真实、及时、完整，字迹清晰，能够准确辨识。如有某些原因导致表格未能填写完整，则由填表人用斜线（从左下往右上）划去。All the records content shall be true, current, comple

15、te and legible for accurate identification. If some reasons cause the fillers incompletion in the form, he/she shall make a slash (from left bottom to right top).4.2.10记录（含电子版）应进行编号，以方便查询和追溯。Records shall be numbered for the convenience of inquiry and tracing.4.2.11记录只能用圆珠笔或钢笔填写，不得用铅笔。Records can be

16、 made with ball pens or pens, pencils are not allowed.4.3 文件的版本、标识和受控状态Version, identification and control status of documents4.3.1质量管理手册、EHS管理手册和程序文件及其它文件的版本以第AX版即第A1、A2、A3来表示。The version of Quality Control Manual, EHS Management Manual, procedure files and other documents are indicated by Version

17、AX, namely Version A1, A2, A34.3.2质量管理手册、EHS管理手册、程序文件和其它文件都以文件编号为标识。Document serial numbers are the identifications for Quality Control Manual, Environmental Management Manual, procedure files and other documents.4.3.3 质量管理手册、EHS管理手册、程序文件和其它文件的受控状态分“受控”和“非受控”两种状态。分别用“受控”印章和未盖“受控”印章为标记。为此负责文件发放部门的文控室

18、要编制出“管理体系文件清单”，以确保得到相应文件的有效版本，以防止使用失效或作废文件，质量管理手册、EHS管理手册的管理按4.4.1执行。Control status of Quality Control Manual, Environment Management Manual, procedure files and other documents includes “controlled” and “uncontrolled”, which are respectively identified by whether there is a “Controlled” stamp on it

19、. To this end, Document Control Office of the releasing department shall compile Management System Document List so as to ensure acquiring valid version of the corresponding documents to avoid using invalid or cancelled documents; Quality Control Manual and Environment Management Manual shall be man

20、aged according to 4.4.14.4 文件的发放和更换Release and replacement of documents4.4.1质量管理手册、EHS管理手册、程序文件和其它文件（包括外来文件）都由文控室负责在“文件发放/回收表”上造册来确定发放范围，经管理者代表批准后实施发放。发放应确保在使用处可得到有效版本的适用文件。顾客或来访者索取本公司质量管理手册、EHS管理手册，须经管理者代表批准，文控室凭批准单发给“非受控”本的质量管理手册、EHS管理手册，该本质量管理手册、EHS管理手册不予编号。程序文件及三级文件不对外提供给顾客。Document Control Offi

21、ce is responsible for tabling on Document Release/ Withdrawal Sheet to determine release scope of Quality Control Manual, Environmental Management Manual, procedure files and other documents (including external documents), which are released after the approval of management representative. The relea

22、se shall ensure that the valid versions are available. The companys Quality Control Manual and Environmental Management Manual requested by clients or visitors shall be subject to the approval of management representative, while in light of approval proof, Document Control Office delivers “Uncontrol

23、led” version of Quality Control Manual and Environmental Management Manual (not numbered) to them. Procedure and supportive documents are not available to clients.4.4.2 受控文件的领取Receiving a controlled document文件领用人在“文件发放/回收表”上签名领取。对质量管理手册、EHS管理手册和程序文件和其它文件注明分发号和加盖“受控”印章。发放完毕，发放人员在“文件发放/回收表”上填写修订状态，以便对

24、发放文件修订状态的控制，以防止误用。Document receiver shall sign on Document Release/ Withdrawal Sheet for the receipt. Issue No. and “Controlled” stamp shall be marked on Quality Control Manual, Environmental Management Manual, program file and other documents. After the issue being finished, the issuing personnel s

25、hall fill in revision status on the Document Release/ Withdrawal Sheet so as to control the revision status of released files and prevent from misusing.4.4.3有关人员所使用文件严重破损而影响使用时，持有者提出口头申请，经体系工程师同意后，才可向文控室以旧换新。新发的质量管理手册、环境管理手册和程序文件的分发号要与交回的保持一致，使用者要确保文件保持整洁、清晰。When document used by personnel concerned

26、 is seriously damaged and affects using, the holder shall make verbal request, after consent of ISO specialist and then replace old document with new one from Document Control Office. The issue No. of new Quality Control Manual, Environmental Management Manual and procedure files shall be in line wi

27、th that of returns. In addition, the user shall keep documents tidy and clear.4.4.4受控文件如有丢失，文件持有者应及时报告文控室，并申请补发，经管理者代表批准后，由文控室办理补发手续。In case that a controlled document is lost, document holder shall report to Document Control Office in time and apply for reissue. After approval of management represe

28、ntative, the Document Control Office will handle the reissue4.4.5为了文件得到有效控制，各职能部门需指定一名人员负责文件的接收、管理和控制。收到文件时应在“文件接收登记表”上进行登记，同时各部门应相应做好本部门的文件控制工作。Each functional department is required to appoint a person to see to documents receiving, management and control in order to control documents effectively.

29、 When receiving a document, he/she shall record on the Document Receiving Registration Form, and each department shall implement document control accordingly.4.4.6 采用电子档发放的文件，加盖相关印章后，由文控员存放在公司内部局域网Datacenter/HRD/public相应的文件夹内，相关人员可以在电脑上阅读文件。Stamp the E-files or E-documents and put into DatacenterHRD

30、public relevant folders by file controller!4.5 文件和记录的修订、换版和作废Revision, update and cancellation of documents &records4.5.1文件修订时，由文件更改提出者或部门提出申请，并在“文件修订申请单”中填写修订条款、内容及原因。Revision of document shall be applied by its alternation raiser or department and fill out terms, contents to be revised and cause i

31、n Document Revision Requisition. While under examination and verification of ISO Commissioner and approval of management representative, Document Revision Requisition shall be submitted to Document Control Office.4.5.2 文件修订批准后，若是质量管理手册、EHS管理手册及所包含的程序文件，由文控室统一收回，由文控室进行修订换页或划改。换页后或划改好后再由文控室发给持有者，与此同时，

32、文控室在“修改记录”中填写修订内容。对于其它文件也由文控室统一收回，由文控室组织部门修订，进行换页或划改，修订并经审批后再由文控室发给持有者。After approval of documents revision, Quality Control Manual, EHS Management Manual and procedure files included to be revised shall be called back, revised, changed page or corrected by Document Control Office, and the Document Control Office shall deliver them to holder after page-changing or correcting while fill in revision content on Revision Record; revision of other documents are the same as above. As