《0501文件和资料控制程序（新英）——Audit technical file资料文档.docx》由会员分享，可在线阅读，更多相关《0501文件和资料控制程序（新英）——Audit technical file资料文档.docx（9页珍藏版）》请在taowenge.com淘文阁网|工程机械CAD图纸|机械工程制图|CAD装配图下载|SolidWorks_CaTia_CAD_UG_PROE_设计图分享下载上搜索。
1、1 目的 Objective对质量体系范围内与质量体系有关的文件和资料进行控制，确保各有关场所使用有效版本的 文件和资料。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 适用范围 Applicable Scope适用于与质量体系有关的质量文件和资料的控制，包括适当范围的外来文件，如顾客质量协 议、检测报告、路试报告、型式试验
2、报告等等。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 职责 Responsibility本程序由与质量体系有关的各部门负责实施。This procedure is to be conducted by t
3、he departments related to quality system.DCC负责质量体系文件的编号、发放、更改控制和管理。DCC is responsible to control and manage the numbering, release and revision of quality system documents.4 . 定义 DefinitionDCC： DOCUMENTS CONTROL CENTRE 的缩写。DCC: The abbreviation of Documents Control Centre.文件控制员:DCC (文件控制中心)的工作人员。Doc
4、uments Controlle匚 The functional personnel at DCC (Documents Control Centre).5 .程序 Procedure质量体系文件的分类 Classification of Quality System DocumentsAICQ的质量文件分为：质量体系文件和技术文件两大类。AICQ quality documents are classified into Quality System Documents and Technical Documents.5.1.1 质量体系文件又分为四类：质量手册、程序文件、作业指导书和记录/
5、表格等。质量记录的管 理按质量记录控制程序执行；质量表格的管理按质量记录控制程序执行，其它质量体 系文件的管理按本程序5.2及以后条款执行。本程序文件主要是控制质量文件和资料。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 技术文件分为工程设计图样、工程更改通知书，工艺文件，现场工艺操作指导书，材料用
7、量表， 标准件、外购（协）件用量表等技术性文件，技术文件管理按技术文件资料管理方法执行。 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 do
8、cuments are managed according to Technical Documents & Data Management Rules”.5.2 质量体系文件（指质量手册、程序文件和作业指导书，下同）的编号：质量手册的编 manua / Number: A ICQ- 0M- XX序号 Serial No.质量手册代码 qua / / ty manua / code 公 司彳弋码 pany code程序文件的编号 Procedure file : AJCQ/QP-XXXX程序文件顺序号（前2位表示对应的标准 条文编号,后 2 位表示顺序号）procedure f/ Ie num
9、ber （ the first two refer to the standard number, the last two refer to serial number）AICQ是公司代码;QP表示程序文件AI CO is pany code, OP is procedure file如,AICQ/QP-0501, 05表示标准条文4. 5, 01表示标准条文4. 5对应的第1个程序文件。e. g. AICQ/QP-0501, 05 is standard code 4. 5, 01 is the first one procedure fi Ie relevant to standard
10、code 4. 5.作业指导书的编号 working instruction No.:/CQ/W/-XXXX-XX在程序文件中的顺序号 serial No. in procedure fileU寸应程序文件的编号serial No. of relevant fi IeAI CO:公司代码;Wl:作业指导书（三级文 件）代码AI CO: pany code; Wl :Worki ng Instruction code 质量记录/表格(四级文件)编号: AICQ/QR-XXXX- XXQuality record/form (fourth-level file) code|顺序号 Serial N
11、o.对应程序文件编号Procedure file No.OR：质量记录/表格(四级文件)代码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 re
12、cords, refer to Numbering Rules of Quality Documents and Data”.质量体系文件的版本标识:质量手册,程序文件,作业指导书:用X/Y表表示,其中,X表示版本号,用大写英文字母A、B、C表示;Y表示修订号,用1、2、3表示。如A/1,表示A版，第1次修订;质量记录:用X表示,其中,X表示版本号,用大写英文字母A、B、C表示;质量体系文件的编写 Compilation of Quality System Documents质量手册由管理者代表负责组织编写，程序文件由管理者代表组织，相关对口职能部门负责编写， 作业指导书由对口的职能部门编写。
13、The Quality Manuals shall be piled by management representative. The Process Documents shall be piled by relevant functional departments under the organization of management representative. The Operation Instructions shall be piled by relevant functional departments.5.3 质量体系文件的审批 Examination and App
14、roval of Quality System Documents质量手册由总经理批准。The Quality Manuals shall be approved by General Manager.5.3.1 程序文件由编写部门经理审核,管理者代表批准。The Process Documents shall be reviewed by piling department manager and approved by management representative.5.3.2 作业指导书由编写部门经理批准。The Operation Instructions shall be app
15、roved by piling department manager.5.4 质量体系文件的发放 Release of Quality System Documents经审批的质量体系文件正本由DCC统一归档保存。The original of approved quality system documents shall be filed and retained by DCC.5.4.1 质量体系文件首次发放的范围以文件发放审批表为依据，文件发放审批表由文件编写 部门填写，部门经理审批核,管理者代表批准。The initial release scope of quality system
16、 documents is based on Document Release Approval Sheet，which shall be filled by document piling departments and reviewed by department chief / manager and approved by management representative.5.4.2 文件控制员根据文件发放审批表或文件领用申请单复印文件。The document controller copies the documents at witness of “Document Relea
17、se Approval Sheet1 or Application Form for Document Acquisition,5.5.4.3 文件发放时需填写文件发放登记表，并在每份副本的封面加盖红色“控制文件”印章、登 记分发号(作业指导书没有封面，所有页面都应加盖受控印章、登记分发号)。For releasing the files, fill in “Document Release Records55 and affix a red stamp Controlled Documents“ and release registration number on the cover of
18、each duplicate (Operation instructions have no covers, so all the pages must be affixed with Controlled DocumenC stamp and release registration number).5.4.4 收文部门的资料员在文件发放登记表上签名，领取文件。The department archivists shall sign on the Document Release Records and acquire the documents.5.4.5 严禁私自复印控制文件，如需追加发
19、放,需填写文件领用申请单或文件发放审批表，按本 程序办理发放手续。5.5.5 of this process.5.5 质量体系文件的修改和换版 Revision and Edition of Quality System Documents文件修改时，需由文件修改提出部门填写文件修改申请单，说明修改原因及修改内容，经 部门经理审核后向文件编写部门提出。To revise files, it is required to fill in Application Form for Document Revision by the department which put forward to fi
20、les revision. The reasons for revision and the parts to be revised shall be stated and submitted to the document piling departments after they are checked by the department chief / manager.5.5.1 文件编写部门/人应本着实事求是的工作态度虚心听取意见,如有必要应尽快修改,并在文 件修改申请单中签署意见。The document piling departments / persons, with an a
21、ttitude likely to listen to others, shall make revision as soon as possible, if necessary, and remark the opinion in the Files Revision Application.5.5.2 文件修改后须经原审批人（或其受权人）重新审批。The revised documents must be submitted to the original examiner （or its authorized representative） for another approval.5.
22、5.3 质量手册与程序文件不允许手写修改.质量手册修改后需重新打印修改页和质量手册修改履历 表;程序文件只需打印修改页,修改记录在文件修改申请单上填写；文件修改部门将修改 后的文件和批准后的文件修改申请单交到DCC,由DCC统一进行发放,并收回作废文件。 修改人员改动不大的作业指导书,需要时可由文件编写部门进行手写修改,但要注意:It is not allowed to revise the Quality Manual and Process Documents by handwriting. After revising Quality Manual, it is required to
23、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 documents and approved A
24、pplication 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 piling department through handwriting. But attention must be paid to the following points:a.不得使用涂改水修改；Do not use era
25、sing liquid;b.修改时用钢笔或圆珠笔将误处划去，在旁边加上正确内容；At revision, use pen or ball pen to line out the wrong parts and add correct contents beside.c.修改后应在修改处注明修改次数，并在修改记录栏签名；After revision, mark the times of revision at the revised parts and sign the revision record.d.需在一天内对DCC保存的原件及发出的所有副本作同样修改；修改后需由原审批人（或其授权人）审
26、批签名。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 质量体系文件修改后,需更改文件修订号。经过屡次修改(质量手册和程序文件不超9次，作 业指导书不超3次),或文件需进行大幅度修改时应
27、换版版本号用“A”表示第一版，表 示第二版，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 Instructions less than 3 times) or if the docum
28、ents are to be revised significantly, it is required to change document version. 7T indicates 1st Version, aB,f indicates 2nd Version, indicates 3rd Version .,质量体系文件的作废和处理 Scrap and Disposal of Quality System Documents5.7.1 质量体系文件失效后，文件编写部门或使用部门应及时填写文件取消申请单，经原审批人(或 其授权人)批准后予以取消。After invalidation of
29、 quality system documents, the document piling 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).5.7.2 质量体系文件取消或经修改/换版后，原正本和回收之副本随即作废，并作如下处理：After
30、 invalidation or revision of quality system documents, the original copies and returned duplicate copies shall be immediately scraped, and be disposed as below:a.作废之正本需及时加盖“作废”印章后隔离保存(以便追溯)，副本那么予以销毁；Stamp the “Scraped on the scraped original copies duly on time, and then keep them by isolation (to f
31、acilitate tracing). The duplicate copies shall be destroyed.b.盖“作废”印章之正本假设无追溯之需要后，山DCC填写文件销毁申请单经推进部主管批准 后予以销毁。如因积累知识的需要而需继续保存的作废文件，应加盖“参考”印章后隔离保存。 If the original copies stamped with uScrapped are not needed for traceability purposes, DCC is required to fill in Document Destroy Records“ and submit i
32、t 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内部质量体系文件的管理 Management of Internal Quality System Documents文件资料员接收质量体系文件正本后，应及时将其列入受控文件清单中。After receipt of
33、quality system documents, the archivist shall duly make them be listed in the Catalog of Controlled Quality System Documents.1.1.1 与质量体系有关的部门应指定一名兼职文件资料员,负责本部门质量体系文件的收发和保管。 包括：The department related to quality system shall appoint one part-time archivist, which is responsible for the collection, rel
34、ease and storage the quality system documents concerned to its own department, including:a.建立本部门之受控文件清单；Set up the “Catalog of Controlled Quality System DocumentsJ, for its own department.b.发放和回收文件时在文件发放登记表上加以登记。Make registration in “Document Release Records“ at release and collection of documents.1
35、.1.2 质量体系文件正本一律不外借，以防丧失或损环。借阅文件的人员需其他文件，经文件管理部 门批准后方可借阅文件，填写“文件借阅登记表:借阅者应在指定日期归还文件，否那么应重 新办理借阅手续。To avoid loss or damage, the original copy of quality system documents shall not be borrowed out. If needing other documents, the borrower shall get the approval from document management departments and
36、at the same time, fill in “Registration for Borrowing Documenf. The borrower shall return the documents before the designated date, otherwise it shall renew the borrowing formalities.1.1.3 对外发放质量体系文件时，需经相关部门主管同意，由文件控制中心登记发放（对外发放之质 量体系文件不在文件控制中心控制之列，不用加盖受控印章）。The external release of quality system do
37、cuments 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 required to affix a ucontrolled stamp.5.9 外部文件的控制 Control of
38、 External Documents591 DCC负责归口管理外来非技术类文件。外来文件接收部门接受到文件后,交到DCC登记、存档。由DCC根据需要复印分发。文件的发放领用管理参照55条和5.7条执行。DCC is responsible for managing the non-technical documents from the outside. The department should submit the external documents to DCC for registration and keeping at the receipt of the external d
39、ocuments. 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 functional departments. The release, acquisition and management
40、 of documents are conducted according to 5.5 and 5.7.各个部门应定期追踪外来文件的最新版本,OCC每年更新一次外来文件清单。Each department should track the updated version of the external documents periodically. DCC is responsible for updating the external documents.5.10 文件和资料的保存 Storage of Documents and Data各部门的受控文件由各部门文件档案员保存，需要使用的
41、人员按4.7借阅。The controlled documents shall be kept by the archivists of each department, and borrowed according to 4.7.5.10.1 各部门的受控文件清单由各部门自己保存,全公司受控文件清单由DCC保存。Each department should keep the controlled document list of their own. DCC should keep the all controlled documents of the pany.5.10.2 DCC每半年检
42、查一次各部门“受控文件清单”的有效性。The Quality Department shall check the validity of uList of Controlled Documents“ every half a year.5.10.3 文件和资料的贮存应防尘、防潮、防火、防虫蛀、鼠害及防丧失，并应易于查阅；软盘应注 意防磁、防晒、防挤压。At storage, the documents and data must be prevented from dust, moisture, fire, worms mice or losses. They shall be locate
43、d at a place easy to reach. The floppy disk must be prevented from magnetization, sunlight or squeezing.6 相关文件 Relational DocumentsAICQ/WI-0501-01技术文件和资料管理方法AICQ/WI-0502-016.2AICQ/QP-1601质量记录控制程序Technical Documents and Materials Management RulesAICQ/QP-1601Quality Records Control Procedures质量记录 Qual
44、ity Records7.1AICQ/QR-0501 -01受控文件清单AICQ/QR-0501-01List of Controlled Documents7.2AICQ/QR-0501-02文件领用申请单AICQ/QR-0501-02Document Acquisition7.3AICQ/QR-0501-03文件发放登记表AICQ/QR-0501-03Releasing Documents Records7.4AICQ/QR-0501-04文件借阅登记表AICQ/QR-0501-04Registration Form for Borrowing Documents7.5AICQ/QR-0501-05文件修改申请单AICQ/QR-0501-05Document Revision Application7.6AICQ/QR-0501-06文件销毁申请单AICQ/QR-0501-06Releasing Documents Approval Form7.7AICQ/QR-0501-07文件发放审批表AICQ/QR-0501-07Releasing Documents Approval Form