文件和資料控制程序（新英）

1、1 目的objective 對質(zhì)量體系范圍內(nèi)與質(zhì)量體系有關的文件和資料進行控制，確保各有關場所使用有效版本的文件和資料。the objective is to control the documents and data related to quality system and to ensure that the documents and data for relevant sites are of valid version.2 適用范圍applicable scope 適用于與質(zhì)量體系有關的質(zhì)量文件和資料的控制，包括適當范圍的外來文件，如顧客質(zhì)量協(xié)議、檢測報告、路試報告、型式試驗報告

2、等等。this is applicable to the control of documents and data related to quality system, including appropriate external documents, e.g. customer quality agreement, inspection report, road test report, model test report, etc. 3 職責responsibility3.1 本程序由與質(zhì)量體系有關的各部門負責實施。this procedure is to be conducted by

3、 the departments related to quality system.dcc負責質(zhì)量體系文件的編號、發(fā)放、更改控制和管理。dcc is responsible to control and manage the numbering, release and revision of quality system documents.4. 定義definitiondcc：documents control centre的縮寫。dcc: the abbreviation of documents control centre. 文件控制員:dcc（文件控制中心）的工作人員。docum

4、ents controller: the functional personnel at dcc (documents control centre).5. 程序procedure5.1 質(zhì)量體系文件的分類classification of quality system documentsaicq的質(zhì)量文件分為：質(zhì)量體系文件和技術文件兩大類。aicq quality documents are classified into quality system documents and technical documents.5.1.1 質(zhì)量體系文件又分為四類：質(zhì)量手冊、程序文件、作業(yè)指導書和記錄

5、/表格等。質(zhì)量記錄的管理按質(zhì)量記錄控制程序執(zhí)行；質(zhì)量表格的管理按質(zhì)量記錄控制程序執(zhí)行，其它質(zhì)量體系文件的管理按本程序5.2及以后條款執(zhí)行。本程序文件主要是控制質(zhì)量文件和資料。the quality system documents are classified into quality manual, process documents, operation instructions and records/forms. the quality records are managed according to “quality records control procedures”. the

6、quality forms are managed according to “quality forms management rules”. the other quality system documents are managed according to 5.2 of this procedure and the following. this procedure documents are mainly aimed to control quality documents and data.5.1.2 技術文件分為工程設計圖樣、工程更改通知書，工藝文件，現(xiàn)場工藝操作指導書，材料用量

7、表，標準件、外購（協(xié)）件用量表等技術性文件，技術文件管理按技術文件資料管理辦法執(zhí)行。the technical documents are classified into engineering design drawings, engineering revision notice, process documents, site operation instructions, material consumption sheet, and consumption sheet for standard parts & outsourced parts. the technical docum

8、ents are managed according to “technical documents & data management rules”. 5.2 質(zhì)量體系文件（指質(zhì)量手冊、程序文件和作業(yè)指導書，下同）的編號：質(zhì)量手冊的編 manual number：aicq- qm- xx 序號 serial no. 質(zhì)量手冊代碼 quality manual code 公司代碼company code程序文件的編號procedure file ：aicq/qp-xxxx 程序文件順序號（前2位表示對應的標準條文編號，后2位表示順序號）procedure file number ( the f

9、irst two refer to the standard number, the last two refer to serial number) aicq是公司代碼；qp表示程序文件 aicq is company code, op is procedure file如，aicq/qp-0501，05表示標準條文4.5，01表示標準條文4.5對應的第1個程序文件。e.g. aicq/qp-0501，05 is standard code 4.5，01 is the first one procedure file relevant to standard code 4.5.作業(yè)指導書的編

10、號working instruction no.：aicq/wi-xxxx-xx 在程序文件中的順序號 serial no. in procedure file 對應程序文件的編號 serial no. of relevant fileaicq：公司代碼；wi：作業(yè)指導書（三級文件）代碼aicq: company code; wi:working instruction code質(zhì)量記錄/表格（四級文件）編號 : aicq/qr-xxxx- xx quality record/form (fourth-level file) code 順序號 serial no. 對應程序文件編號 proce

11、dure file no. qr：質(zhì)量記錄/表格（四級文件）代碼 quality record/form (fourth-level file) codenumbering of quality system documents (referring to quality manuals, process documents and operation instructions): for the numbering of quality manuals, process documents, operation instructions and quality records, refer

12、to “numbering rules of quality documents and data”.質(zhì)量體系文件的版本標識：質(zhì)量手冊，程序文件，作業(yè)指導書：用x/y表表示，其中，x表示版本號，用大寫英文字母a、b、c.表示；y 表示修訂號，用1、2、3.表示。如a/1，表示a版，第1次修訂；質(zhì)量記錄：用x表示，其中，x表示版本號，用大寫英文字母a、b、c.表示；5.3 質(zhì)量體系文件的編寫compilation of quality system documents質(zhì)量手冊由管理者代表負責組織編寫，程序文件由管理者代表組織，相關對口職能部門負責編寫，作業(yè)指導書由對口的職能部門編寫。the qu

13、ality manuals shall be compiled by management representative. the process documents shall be compiled by relevant functional departments under the organization of management representative. the operation instructions shall be compiled by relevant functional departments.5.4 質(zhì)量體系文件的審批examination and a

14、pproval of quality system documents5.4.1 質(zhì)量手冊由總經(jīng)理批準。 the quality manuals shall be approved by general manager.5.4.2 程序文件由編寫部門經(jīng)理審核，管理者代表批準。 the process documents shall be reviewed by compiling department manager and approved by management representative.5.4.3 作業(yè)指導書由編寫部門經(jīng)理批準。 the operation instruction

15、s shall be approved by compiling department manager.5.5 質(zhì)量體系文件的發(fā)放release of quality system documents5.5.1 經(jīng)審批的質(zhì)量體系文件正本由dcc統(tǒng)一歸檔保存。the original of approved quality system documents shall be filed and retained by dcc.5.5.2 質(zhì)量體系文件首次發(fā)放的范圍以文件發(fā)放審批表為依據(jù)，文件發(fā)放審批表由文件編寫部門填寫，部門經(jīng)理審批核，管理者代表批準。 the initial release s

16、cope of quality system documents is based on “document release approval sheet”, which shall be filled by document compiling departments and reviewed by department chief / manager and approved by management representative.5.5.3 文件控制員根據(jù)文件發(fā)放審批表或文件領用申請單復印文件。the document controller copies the documents a

17、t witness of “document release approval sheet” or “application form for document acquisition”.5.5.4 文件發(fā)放時需填寫文件發(fā)放登記表，并在每份副本的封面加蓋紅色“控制文件”印章、登記分發(fā)號（作業(yè)指導書沒有封面，所有頁面都應加蓋受控印章、登記分發(fā)號）。for releasing the files, fill in “document release records” and affix a red stamp “controlled documents” and release registrat

18、ion number on the cover of each duplicate (operation instructions have no covers, so all the pages must be affixed with “controlled document” stamp and release registration number).5.5.5 收文部門的資料員在文件發(fā)放登記表上簽名，領取文件。the department archivists shall sign on the “document release records” and acquire the d

19、ocuments.5.5.6 嚴禁私自復印控制文件,如需追加發(fā)放,需填寫文件領用申請單或文件發(fā)放審批表,按本程序5.5.25.5.5辦理發(fā)放手續(xù)。it is forbidden to copy the controlled documents without getting approval. if additional copies are needed, it is required to fill in “application form for document acquisition” or “document release approval sheet” and complete

20、 the release procedures according to 5.5.35.5.5 of this process.5.6 質(zhì)量體系文件的修改和換版revision and edition of quality system documents5.6.1 文件修改時，需由文件修改提出部門填寫文件修改申請單，說明修改原因及修改內(nèi)容，經(jīng)部門經(jīng)理審核后向文件編寫部門提出。to revise files, it is required to fill in “application form for document revision” by the department which pu

21、t forward to files revision. the reasons for revision and the parts to be revised shall be stated and submitted to the document compiling departments after they are checked by the department chief / manager. 5.6.2 文件編寫部門/人應本著實事求是的工作態(tài)度虛心聽取意見，如有必要應盡快修改，并在文件修改申請單中簽署意見。 the document compiling department

22、s / persons, with an attitude likely to listen to others, shall make revision as soon as possible, if necessary, and remark the opinion in the files revision application. 5.6.3 文件修改后須經(jīng)原審批人（或其受權人）重新審批。the revised documents must be submitted to the original examiner (or its authorized representative)

23、for another approval. 5.6.4 質(zhì)量手冊與程序文件不允許手寫修改.質(zhì)量手冊修改后需重新打印修改頁和質(zhì)量手冊修改履歷表；程序文件只需打印修改頁，修改記錄在文件修改申請單上填寫；文件修改部門將修改后的文件和批準后的文件修改申請單交到dcc，由dcc統(tǒng)一進行發(fā)放，并收回作廢文件。修改人員改動不大的作業(yè)指導書，需要時可由文件編寫部門進行手寫修改，但要注意：it is not allowed to revise the quality manual and process documents by handwriting. after revising quality manua

24、l, it is required to reprint the revised pages and “quality manual revision records”. for process documents, it is only necessary to print the revised pages and fill the revision records in “application form for document revision”. the department that revises the documents should submit the revised

25、documents and approved application form for document revision to dcc for releasing and callback the invalid documents. the operation instruction with less revision, if necessary, might be revised by document compiling department through handwriting. but attention must be paid to the following points

26、:a. 不得使用涂改水修改；do not use erasing liquid;b. 修改時用鋼筆或圓珠筆將誤處劃去，在旁邊加上正確內(nèi)容；at revision, use pen or ball pen to line out the wrong parts and add correct contents beside.c. 修改后應在修改處注明修改次數(shù)，并在修改記錄欄簽名；after revision, mark the times of revision at the revised parts and sign the revision record.d. 需在一天內(nèi)對dcc保存的原件

27、及發(fā)出的所有副本作同樣修改； 修改后需由原審批人（或其授權人）審批簽名。it is required to revise the original retained by dcc and all the released duplicates within 1 day. after revision, it shall be submitted to the original examiner (or its authorized representative) for approval and signature.5.6.6 質(zhì)量體系文件修改后，需更改文件修訂號。經(jīng)過多次修改（質(zhì)量手冊和程序

28、文件不超9次,作業(yè)指導書不超3次），或文件需進行大幅度修改時應換版.版本號用“a”表示第一版，“b”表示第二版，“c”表示第三版it is required to change the revision number after revision of the quality system documents. if the quality system documents have been revised many times (quality manual and process document less than 9 times, while operation instructio

29、ns less than 3 times) or if the documents are to be revised significantly, it is required to change document version. “a” indicates 1st version, “b” indicates 2nd version, “c” indicates 3rd version .5.7 質(zhì)量體系文件的作廢和處理scrap and disposal of quality system documents5.7.1 質(zhì)量體系文件失效后，文件編寫部門或使用部門應及時填寫文件取消申請單

30、，經(jīng)原審批人（或其授權人）批準后予以取消。after invalidation of quality system documents, the document compiling departments or use departments shall fill in “application form for document invalidation”. the documents are invalidated subject to the approval of the original examiner (or its authorized representative).5.7

31、.2 質(zhì)量體系文件取消或經(jīng)修改/換版后，原正本和回收之副本隨即作廢，并作如下處理： after invalidation or revision of quality system documents, the original copies and returned duplicate copies shall be immediately scraped, and be disposed as below:a. 作廢之正本需及時加蓋“作廢” 印章后隔離保存（以便追溯），副本則予以銷毀；stamp the “scraped” on the scraped original copies du

32、ly on time, and then keep them by isolation (to facilitate tracing). the duplicate copies shall be destroyed.b. 蓋“作廢”印章之正本若無追溯之需要后，由dcc填寫文件銷毀申請單經(jīng)推進部主管批準后予以銷毀。如因積累知識的需要而需繼續(xù)保存的作廢文件，應加蓋“參考” 印章后隔離保存。if the original copies stamped with “scrapped” are not needed for traceability purposes, dcc is required

33、to fill in “document destroy records” and submit it to advance dept manager for approval. the scrapped documents that are kept for the purpose of accumulating knowledge shall be stamped with “reference only” and then be stored in isolation.5.8 內(nèi)部質(zhì)量體系文件的管理management of internal quality system documen

34、ts5.8.1 文件資料員接收質(zhì)量體系文件正本后，應及時將其列入受控文件清單中。after receipt of quality system documents, the archivist shall duly make them be listed in the “catalog of controlled quality system documents”.5.8.2 與質(zhì)量體系有關的部門應指定一名兼職文件資料員,負責本部門質(zhì)量體系文件的收發(fā)和保管。包括：the department related to quality system shall appoint one part-ti

35、me archivist, which is responsible for the collection, release and storage the quality system documents concerned to its own department, including:a. 建立本部門之受控文件清單；set up the “catalog of controlled quality system documents” for its own department.b. 發(fā)放和回收文件時在文件發(fā)放登記表上加以登記。make registration in “documen

36、t release records” at release and collection of documents.5.8.3 質(zhì)量體系文件正本一律不外借，以防丟失或損環(huán)。借閱文件的人員需其他文件，經(jīng)文件管理部門批準后方可借閱文件，填寫“文件借閱登記表”。借閱者應在指定日期歸還文件，否則應重新辦理借閱手續(xù)。 to avoid loss or damage, the original copy of quality system documents shall not be borrowed out. if needing other documents, the borrower shall

37、get the approval from document management departments and at the same time, fill in “registration for borrowing document”. the borrower shall return the documents before the designated date, otherwise it shall renew the borrowing formalities.5.8.4 對外發(fā)放質(zhì)量體系文件時，需經(jīng)相關部門主管同意，由文件控制中心登記發(fā)放（對外發(fā)放之質(zhì)量體系文件不在文件控制

38、中心控制之列，不用加蓋受控印章）。the external release of quality system documents must be approved by the chief of relevant department, and be registered and conducted by documents control center (the document system documents for external release are not under the control of the documents control center and not re

39、quired to affix a “controlled” stamp.5.9 外部文件的控制control of external documents5.9.1 dcc負責歸口管理外來非技術類文件。外來文件接收部門接受到文件后，交到dcc登記、存檔。由dcc根據(jù)需要復印分發(fā)。文件的發(fā)放領用管理參照5.5條和5.7條執(zhí)行。 dcc is responsible for managing the non-technical documents from the outside. the department should submit the external documents to dcc

40、 for registration and keeping at the receipt of the external documents. dcc will copy and release them based on the requirement. the document management is in line with 5.5 and 5.7 article. the external documents to be cited directly can only be used after they are approved by the chief of relevant

41、functional departments. the release, acquisition and management of documents are conducted according to 5.5 and 5.7.5.9.2 各個部門應定期追蹤外來文件的最新版本，dcc每年更新一次外來文件清單。 each department should track the updated version of the external documents periodically. dcc is responsible for updating the external documents. 5.10 文件和資料的保存storage of documents and data5.10.1 各部門的受控文件由各部門文件檔案員保存，需要使用的人員按4.7借閱。 the controlled documents shall be kept by the archivists of each