文件和记录控制程序(中英文).docx

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1、文件和记录控制程序(中英文) XXX 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

2、适用于所有与管理体系等有关的文件、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 Responsibility 3.1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 p

3、rocedure files. 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 proc

4、edure documents and review the XXXX XXX 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 control

5、ling of technology, technique 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 re sponsible 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。 E

6、ach department is responsible 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 i

7、n accordance with this procedure. 4.0 程序Procedure 4.1 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 XXXX XXX 导书。 Manual , procedure documents, the supportive documents and records numbering rules reference Working instruction of numbering document and note 4.2 文件和记录编制、审批 Compilation and approval of documents and

8、records 4.2.1 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。Manuals 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 appr

9、oved by management representative. 4.2.3 产品图纸、技术文件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 d

10、ocuments and working instructions are compiled by relevant 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

11、manages and filed by ISO specialist and XXXX XXX Document Control 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 th

12、e end of the documents last page. As to persons wh o designed, 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. Rev

13、iew frequency can be increased when inadaptable to companys quality/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.

14、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 principle, 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

15、用斜线（从左下往右上）划去。 All the records content shall be true, current, complete and legible XXXX XXX 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

16、 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 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 documents 4.3.1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

17、, EHS Management Manual, procedure files and other documents are indicated by Version AX, namely Version A1, A2, A3 4.3.2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

18、. 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。 XXXX XXX Control status of Quality Control Manual, Environment Management Manual, procedure files and other documents includes “controlled”

19、and “uncontrolled”, which are respectively identified by whether there is a “Controlled” stamp on it. 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 i

20、nvalid or cancelled documents; Quality Control Manual and Environment Management Manual shall be managed according to 4.4.1 4.4 文件的发放和更换Release and replacement of documents 4.4.1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

21、，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 Office 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 (inclu

22、ding external documents), which are released after the approval of management representative. The release 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 m

23、anagement representative, while in light of approval proof, Document Control Office delivers “Uncontrolled” version of Quality Control Manual and Environmental Management Manual XXXX XXX (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

24、 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, Environ

25、mental Management Manual, program file and other documents. After the issue being finished, the issuing personnel shall 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

26、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 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.

27、 The issue No. of new Quality Control Manual, Environmental Management Manual and procedure files shall be in line with that of returns. In addition, the user shall keep documents tidy and clear. XXXX XXX 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 l

28、ost, document holder shall report to Document Control Office in time and apply for reissue. After approval of management representative, the Document Control Office will handle the reissue 4.4.5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 departmen

29、t is required to appoint a person to see to documents receiving, management and control in order to control documents effectively. 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

30、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 DatacenterHRDpublic 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 &records 4.5.1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

31、因。 Revision of document shall be applied by its alternation raiser or XXXX XXX department and fill out terms, contents to be revised and cause in Document Revision Requisition. While under examination and verification of ISO Commissioner and approval of management representative, Document Revision R

32、equisition 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，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

33、 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 documen

34、ts are the same as above. As to drawing revision, it shall be, after the approval of Technology Dept. manager, called back by the Document Control Office for revision and then reissued to holder. 4.5.3 文件经多次修订或需大幅度修订时，对质量管理手册、EHS管理手册和质量程序文件进行换版。新版发布时，旧版本即被废除。质量管理手册、EHS管理手册新版发布时，还要在质量管理手册、EHS管理手册的“颁布

35、令”中声明废除旧版本。其它质量文件新版发布时，旧版本即被废除。When a document needs several times or large scale revision, Quality Control Manual, Environmental Management Manual and quality control files shall be updated to a new version. The old version shall be cancelled upon the issuance of new one. Declaration of the old ver

36、sion XXXX XXX cancellation shall be made on “issuance order” for Quality Control Manual, Environmental Management Manual. As to other quality documents, the old version shall be cancelled as soon as the new one is issued. 4.5.4 采用电子档发放的文件，由文控员在Datacenter/HRD/public更新修订的文件，“作废”的文件统一存放在“作废文件夹”内。 All t

37、he E-file or E-document; only revised by file controller and put into the DatacenterHRDpublic; “Invalid” documents all put into “invalid documents” folder 4.5.5记录作为证实的文件，是不允许更改的，但如因各种原因造成错误需要涂改，则应做到：单线画去原有记录，在旁边清晰写上正确记录，注明更改人，非笔误应在表格上的适当位置注明涂改原因，每份记录不得超过3处更改，如超过3处更改视为作废，作废记录表单不允许丢弃，应注明作废，按流水号顺序装订归档。

38、 Records, as confirmative document, are not allowed to be modified. When modification is necessary due to various reasons, the following requires shall be met: cross out original record with single line and put down clear proper record aside as well as the modifier, if it is not clerical error, clea

39、r indication of reason for modification shall be made in proper space of the form. More than 3 modifications of each record are forbidden, if such case occurs, it shall be deemed as cancellation of the records. Cancelled record sheets shall not be discarded, but marked as invalid and bound up for fi

40、ling in numerical order. 4.5.6 特别注意ABB核电产品相关记录必须用黑色水笔填写，且核电记录单独存放，永久保存。 Except ABB nuclear power product records shall be fill black pen, saved XXXX XXX alone and forever 4.6文件和记录的借阅/复印Borrowing/copying of Documents & records 4.6.1 如需借阅/复印非本部门的文件或资料，借阅人须填制“文件/记录借阅/复印登记表”经文件或资料的权责部门主管批准，涉及到属于公司重要的文件或

41、资料时，需经管理者代表批准，方可借阅/复印。 Anyone needs to borrow/copy other departments documents or materials shall fill in File/Record Borrowing/Coping Registration Form, which shall be approved by the authorized department director of such documents or materials; when it comes to companys important documents or mat

42、erials, the borrower/copier shall borrow/copy under the approval of management representative. 4.6.2 组长（含）以上人员才能借阅记录,借阅时应填制“文件/记录借阅/ 复印登记表”当合同有规定时，在商定期内记录可提供给顾客或其代表查阅，但需部门经理/主管批准，用户可查阅或复制记录。 Foreman and above can borrow records and shall fill in Document/Record Borrowing/Copying Registration Form. W

43、ith the approval of record keeping departmental manager/director, records can be provided within the stated negotiated period to client and his/her representative for referring as stipulated in contract, and user can also refer to copies of such records. 4.6.3 公司外来人员查阅记录须经管理者代表的书面批准，并有保管人员在场(合同有规定和外部审核时除外)。 External persons shall have written approval of management representative and with the presence of record keeper when referring to record (excluding stipulated by contract and the case of external examination and verification) XXXX