檔案名稱: 環境管理手册 頁 第 1頁 共 4頁 版次 1 由環境管理者所認可 日期: 2007-02-02
7-文件管理與控制程序
7-Document management and control procedure
1.目的Purpose
確保環境管理體系文件、適用的外來文件(有關的法律、法規、標準、相關方提供的文件或規範)使用的有效性。 To assure the ***not translated!!!!! 2.適用範圍 scope
適用于對環境管理體系相關文件及適用的外來文件的控制。
Relates to the environmental management system documents as well as external environmental documents. 3.職責Responsibility 3.1 環工組:負責環境管理體系文件及適用的外來文件的歸口管理;負責監控文件的執行。
The environment team: to be responsible for environment management documents and external documents. 3.2 各部門individual department:確保各相關場所均使用現行文件的有效版本。Individual department managers to
ensure that the relative documents in the workplace are effective and current.
4.工作程序Work procedure
4.1文件控制範圍包括:document control scope
a) 環境管理手册;environment management manual;
b) 環境管理體系程序文件;environment management system procedure documents;
c) 環境管理體系作業指導文件;work instruction documents for the environment management system; d) 環境記錄表格;environmental forms; e) 外來文件。External documents.
4.2 文件的編寫Writing the documents
4.2.1環境管理手册和環境管理體系程序文件由環境管理者代表組織各部門人員編寫。
The Environment management manual and the environment management system procedure documents
will be written by the environmental representative, in consultation with other key departments.
4.2.2環境管理作業指導文件由各部門主管或其授權人員編寫。The environment management instruction documents
will be written by relevant people in each department.
4.2.3環境記錄表格由相應文件的編寫人員進行編制。The environment record forms will be written by relevant
people in each department.
4.2.4外來文件由環工組負責收集、整理和匯總。The environment team will be responsible for editing, assembling,
and controlling all documents relating to the Environment Management system.
4.3 文件的審批Document’s authorization
4.3.1 總經理負責批准環境管理手册。The QC Director is responsible for the authorization of the environment
management manual.
4.3.2 管理者代表負責審核環境管理手册,批准環境管理程序文件。The environment representative is responsible for editing the environment management manual, and to authorize the environment management procedure documents.
4.3.3 環工組負責審核環境管理程序文件。The environment team is in charge of editing the environment management procedure documents.
4.3.4 環境作業指導文件由各部門經理或主管審核,管理者代表批准。The environment work instruction documents will be edited by each department’s manager and authorized by the environment representative.
4.3.5所有文件在批准前,編制部門主管應組織與文件相關的部門主管一起對文件的適宜性進行評審。Before authorizing the documents, the department manager of the person who wrote the document should verify that the documents are suitable then pass to the environment representative for authorization. 4.4 文件的標識Document Control Markings
4.4.1 文件標識的內容包括:文件編號、受控文件的發放編號、受控與非受控、頁碼、版本及修改標識。文件和記錄的編號按《文件編號規定》執行。All controlled documents should be marked with: document No, the issue No, what are controlled or uncontrolled, pages and any modifications made to the issue. The controlled document and records numbering should be listed and follow the procedure <
4.4.2文件標識應在文件正式發布前由環工組負責進行。The environmental team will be responsible for the numbering and management / issuing of controlled documents.
4.4.3一份有效文件或記錄只能有唯一的標識。Controlled document or records should be marked clearly “Controlled Documents”.
4.4.4對外來文件只進行受控和發放編號標識。For external documents a record needs to be kept of which external documents we have on hand and to whom they are issued. No controlled documents stamp is required. 4.4.5文件和記錄版本的標識 How to identify Controlled documents and records
本文檔爲受控文件,不准複製、分發或者公開。
檔案名稱: 環境管理手册 頁 第 2頁 共 4頁 版次 1 由環境管理者所認可 日期: 2007-02-02
4.4.5.1文件版本的標識:原版文件爲1,第一次換版爲2,第二次換版爲3,……以此類推。Each version should be clearly marked: the original document is issue 1, the first time update is issue 2, the second time update is issue 3 etc
4.4.5.2記錄版本的標識:原版記錄不作標識,修改換版後在原記錄編號後加版本號,第一次換版爲A,第二次換版爲B,以此類推。For Records: Each version should be clearly marked: the original document is issue 1, the first time update is issue 2, the second time update is issue 3 etc
4.4.6文件換版時,文件中提出的記錄如未做換版,修改時則其記錄編碼和標識可不予變動。
If the document format needs to be altered but there is no changes made to the document content there is no need to reissue a new version of the document.
4.4.7 文件和記錄修改狀態的標識the documents and records’ mark at the status of modifying
a) 文件修改後,應在被修改的文件中版本/修改的“修改”部位作出標識,第一次修改從0改爲1,第二次修改從1改爲2,以此類推;after modified the document, should clear mark at the blank of “modification” , the first time correction change 0 to 1, the second time correction, change 1 to 2….to mark like this…
b) 由于增加或减少總頁數,導致原文件中頁碼的變化,應對文件的所有頁碼進行修改。If the number of pages alters with changes to formatting, the original document needs to be corrected and reissued. c)
4. 4.9 受控文件與非受控文件的標識Identification of controlled and uncontrolled documents
文件分爲“受控文件”和“非受控文件”,公司內部使用的均爲“受控文件”。幷在封頁和內文中加蓋紅色“受控文件”印章。發往外部的文件除認證機構外,一般均爲“非受控文件”,僅在封頁加蓋藍色“非受控文件”印章。The documents ARE divided into “ controlled documents” and “uncontrolled documents”. All key internal documents relating to the Environmental
Management system are controlled documents and will be stamped with red “controlled document” stamp. Most external documents are not controlled, except for the certification beau. Uncontrolled documents will not be stamped. 4.5 文件的發布issue the document
4.5.1 文件發布前需經相關人員審核批准,審批手續不齊全的文件不得發布使用。Before issuing any documents, they must be checked and authorized by the environment representative. If the documents are not checked and authorized they cannot be issued for use.
4.5.2 環工組在文件發布前應填寫《文件發放清單》,報管理者代表代表審批,確保只有經過批准的文件才能發布。Before issuing the documents, the environment team should fill in the <
4.6.1 文件的發放由環工組實施。The environment team will be in charge of issuing all documents relating to the environment management system. 4.6.2 發放的文件爲副本,正本連同《文件發布清單》一幷歸檔,歸檔的文件不編號,不加蓋受控狀態的印章。The environment team will issue the document copies to each relevant department. The original will be held in the original Environmental Management Manual or Environmental Management Form Manual, along with the << document issue list>> which will be kept in these manuals. Copies of original documents do not need numbering and will be not marked as a “controlled document”.
4.6.3 受控文件發時應予編號,編號用阿拉伯數字表達,如01,02,……。非受控文件發放時不予編號,但應做好發放記錄。When issued the controlled documents, should give them numbers, like 01,02,….. The uncontrolled documents don’t need to be identified but records need to be kept of whom has been given copies. 4.6.4 環工組建立幷保留《文件發放回收記錄表》。The environment team makes and keeps the << Document issue return record form>>.
4.6.5文件的補發 Document replenishment
由于工作的需要而又沒有文件或原文件丟失、破損時,應按下列規定辦理:If a department needs copies of a document or if a copy has been lost or damaged follow the below process for obtaining a new copy.
a)申請方填寫《文件補發申請表》經所在部門負責人審核,管理者代表批准後,貫標辦方可予以補發。 The department requesting a new copy to fill in<< document replenishment application>> After checking by the departmental manager the environment representative can authorize a new copy..
b)文件補發需執行文件發放的相關規定. When replenishing documents it is necessary to follow the above document issuing (4.6) procedures.
4.7 文件的使用 Documents use
4.7.1 環工組應確保公司工作需要的部門或人員均能及時得到適用的有效版本的文件。The environment team should ensure that all departments or staff can get the usable and effective documents in time. 4.7.2 各部門及所有工作人員應確保不持有、不使用作廢/失效的文件。 Each department and all staff should ensure they are not using or holding invalid documents.
4.7.3 文件的持有部門和持有人員不得將持有的文件轉借、複製或作非授權的塗改。 Once issued documents cannot be lent, copied or changed.
本文檔爲受控文件,不准複製、分發或者公開。
檔案名稱: 環境管理手册 頁 第 3頁 共 4頁 版次 1 由環境管理者所認可 日期: 2007-02-02
4.7.4環工組每年組織對公司的環境管理體系文件進行一次全面的評審,根據體系的運行情况確定文件是否需要修改或更新,如需要修改或更新按4.9條執行。The environment team is responsible for the assessment of all environment management system documents a minimum of one time per year. The decision as to whether the documents need modification or updating is made by the environmental team and if change is needed they will follow procedure 4.9 below. 4.8文件的保管 documents’ keeping
a) 文件的保管環境應適宜于防止文件的丟失、損壞和污染; the environment where documents are stored should keep them clean and uncontaminated as well as safe from going missing.
b) 保管時應保持文件的完整、齊全;Documents should be kept in the form they were issued and not split up. 4.9 文件修改的控制 Modification to documents
4.9.1 文件的修改由相關部門提出申請,幷填寫《文件修改申請和審批單》,說明申請原因和理由,填寫需修改的內容,報環工組。If the documents need to be altered the person / department wishing to have the documents changed should fill in the << document modification and check form>>. On this form the reason for the change must be stated as well as the content to change, and then this form should be passed to the environment team.
4.9.2環工組根據環境管理體系運行的需要或收集到的意見,對擬修改的內容和修改可能導致的影響進行評估和預測。確定修改是否必要,幷在《文件修改申請和審批單》簽署意見,如確需修改,經文件原批准人批准後方可進行修改。若原批准人發生變動,則應由其職務的接任人負責批准。The environment team will assess the content that needs to be modified and assess the consequences if changed. They will consider the effect on the environment management system and the
reasons why the change has been suggested. Their decision will be added to the <
The environment team will make the document changes as per the << document modification application and check sheet>> and will keep records.
4.9.4環工組將修改後的受控文件派發至文件的持有部門和持有人。環境管理手册換版時,同時將換版後的手册送達第三方認證機構。The environment team will reissue modified controlled documents to people holding existing documents. When the environment management manual’s version is changed, all controlled copies should be updated.
4.9.5 文件修改的方式:劃改、換頁、換版,劃改時,應能辨認修改前的內容。具體采用何種修改的方式在《文件修改申請和審批單》中確定,幷由環工組具體實施。Any modifications made to documents should be approved first by the environment team. The <
4.9.6 文件修改時,應同時對文件的版本或修改狀態進行標識,幷在文件修改記錄上作好記錄,以便核對、追溯。When modifying documents it is important to highlight on the new document the new version and where the change has been made. The environmental team will keep the document modification record form so as to check and track back. 4.9.8文件的換版Change of the document version style
換版是文件修改方式的一種,下列情况之一時,文件應予以換版:Changes to the document version will be made when….
a) 同一文件修改10次以上時; the same document has been modified more than 10 times; b)同一文件一次修改內容達70%以上時。One document has more than 70% modified content at one time. 4.10 作廢/失效文件的處置To dispose of superseded and invalid documents
4.10.1 文件換頁、換版修改時,環工組應在更換新頁或新版的同時,撤回舊頁或舊版。
When documents are changed the old documents must be taken back and superseded.
4.10.2 撤出的舊頁或舊版文字檔案,環工組應在《作廢文件清單》上予以記錄,幷在每頁上加蓋藍色“作廢”印章。When superseded documents are taken back the environment team should record it in<< cancelled documents list>>, and have the blue “cancellation” stamp.
4.10.3 作廢文件應在適當的時間(如一年)集中銷毀,銷毀後在《作廢文件清單》上予以記錄。For superseded documents they should be held on file for a minimum of 1 year.
4.10.4留作資料以供追溯/累計知識需要的作廢文件,應經環工組同意,幷在其每頁上加蓋藍色“參考”印章。If a superseded document is still required in the system it can be used but must be stamped with “reference Only”. 4.11 外來文件的控制 for control the external documents
4.11.l 屬于本程序控制的外來文件,在其封面或首頁上加蓋紅色“受控文件”印章,需分發的,還應編號幷辦理發放簽收。For external documents that are under control this procedure, they must be stamped with a red “controlled document” stamp. If these documents must be issued to a department, then the environmental team will assign a document number and issue the document.
4.11.2 外來文件的控制按《法律和其他要求控制程序》執行。Control of external documents will be implemented based on<<
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檔案名稱: 環境管理手册 頁 第 4頁 共 4頁 版次 1 由環境管理者所認可 日期: 2007-02-02
law and other requirements control procedures>>. 5.相關/支援文件 some relative support documents
5.1《文件編號規定》<
5.2《法律和其他要求控制程序》<< law and other requirements control procedures>> 6.記錄Record
6.1《文件發放清單》<< Document issue list>>
6.2《文件修改申請和審批單》<
6.5《文件發放回收記錄表》<< Document issued and returned record>> 6.6《文件補發申請表》< 本文檔爲受控文件,不准複製、分發或者公開。