文件控制程序(中英文)
文件控制程序中英文对照
Revision HistoryApproved DCN on File in Document Control1.0 PURPOSE 目的1.1 To define a procedure for the generation, revision, handling, approval, retention, storage ofinternal documents as well as control of external documents.为内部文献的生成，修改，解决，同意，保存，保存以及对外部文献的控制订义程序。
2.0 SCOPE 范畴2.1 This procedure is applicable to quality management system (QMS) documentation such assystem manual, procedures & work instructions.本程序合用于质量管理体系（QMS）的系统文献，如体系手册，程序文献及作业指导书。
2.2 This procedure also covers the DCN & ECN generation and approval signatory for QMSdocumentation and product documentations.本程序还涉及质量管理体系文献和产品文献的文献变更告知（DCN）&工程变更告知（ECN）的生成和审批订立。
2.3 This procedure also covers control and handling of customer documents and otherregulatory requirements.本程序还涉及客户文献和其它法规规定的控制和解决。
2.4 This procedure also covers control and handling of supplier documents.本程序还涉及对供应商文献的控制和解决。
汽车行业程序文件中英文版-QP019程序
5.1实施条件:
5.1.1来料检验和试验发现不合格时，由品质部进货检验员填写“材料拒收报告（MRR）”经部门主管审批后由采购部转交相关供应商，要求供应商对不合格项目/内容进行原因分析并采取纠正措施，品质部和生产部于供应商下次进厂交货时对其进行效果验证和确认。
5.1.2在制品、半成品、成品之废品率或不合格率超出计划指标时，由品质部QC检验员填写“不合格报告”经品质部主管审批后交各相关生产部门稽核,分析原因并采取纠正与预防措施。
5.3.2.2质量异常经原因分析并拟定对策实施改善后，品质部门应确认对策之改善成效并书面反馈，若对策本身牵涉作业标准或规程之变更，则应修订相关作业标准或规程,按《文件与数据控制程序》执行。
5.3.3客户抱怨或退货之质量异常:
由品质部监督生产部门对客户报怨或不合格产品进行确认，将确认记录交品质主管审核后，由责任部门提交纠正措施报告。
5.1.5如出现可能无法按顾客要求交期100%按时出货时，则综合计划部应及时沟通市场与客服部与顾客协调，相关责任部门要进行原因分析并提出纠正措施。同时市场与客服部尽快以电话、传真或E-mail方式通知顾客，请求顾客同意延迟交期并在征得顾客书面同意后方可执行延期交付作业。
5.1.6每次顾客投诉或出货产品被顾客退货时，相关责任归属部门应向顾客解释原因，提交纠正措施，并由业务将措施内容提交客户。
5.2解决问题的方法:
5.2.1当发生不符合规范或要求的问题时，可使用QC七大方法来解决问题。
5.2.2当发生顾客投诉时，若顾客有要求，则应以顾客要求的方式来回复其抱怨。
5.3纠正措施:
5.3.1进料品质异常:
参考《检验与测试程序》和《供货商管理办法》。
5.3.2厂内途程品质异常:
Document Control文件控制程序(中英文)
1.1 PURPOSE 目的1.1 This procedure provides guidelines for minimum control requirements necessary for a document tobe controlled, to ensure the suitability, adequacy and effectiveness of *** Automotive Technologies Co., Ltd. management system documents.本程序是规定了****汽车科技有限公司对管理体系文件和资料的控制与管理，确保管理体系文件的适宜性、充分性和有效性。
1.2 SCOPE 范围2.1 This procedure applies to controlled documents identified as part of the Management System for alldocuments issued and controlled in MMK:本程序适用于MMK的管理体系有关的受控文件2.1.1 Quality manual, procedures, working instructions质量手册，程序文件，作业指导书；2.1.2 Technical documents (including internal and customer)；技术文件(包括内部的和从客户处获得的)；2.1.3 External documents: e.g. legal and other standards etc.外来文件：法律法规以及相关标准。
3.0 DEFINITIONS 定义3.1 Controlled Document：Any document essential to the functioning of a process that needs to beavailable in its latest form.受控文件：流程运作的基本文件，这些文件必须保持最新版本。
保密文件管理程序-中英文对照
CONFIDENTIALITY PROCEDURE 10 DECEMBER 2010SYNOPSISCONTENTSCONTENTS (3)1.PURPOSE 目的 (4)2.RESPONSIBILITYS 职责 (5)3.CONFIDENTIAL INFORMATION SCOPE (6)4.STORAGE，COPY, DISTRIBUTION, BORROW AND DISPOSAL (7)4.1Storage and Copy (7)4.2Distribution (7)4.3Disposal (8)APPENDIX 1– CONFIDENTIAL DOCUMENT DISTRIBUTION REGISTERAPPENDIX 2– CONFIDENTIAL DOCUMENT CHECKLIST1. PURPOSE 目的This procedure provides the necessary requirements and guidelines for controlling confidential documents to assure XX COMPANY personnel are aware of storage, copy, distribution, and disposal confidential documentation.本程序旨在提供了一些必要的要求和准则，用于控制保密级别的文件以确保XX公司员工明确保密文件的存储，复印，发布和销毁的程序。
2. RESPONSIBILITYS 职责XX Manager is responsible for the implementation of this procedure in order to protect the company and client intellectual property information.为了更好的对公司和业主的知识产权进行保护XX经理负责实施本程序。
ISO14001文件管理与控制程序(中英文版)
文件管理与控制程序Documents management and control procedure1.目的Purpose确保环境管理体系文件、适用的外来文件（有关的法律、法规、标准、相关方提供的文件或规范）使用的有效性。
To assure the2.适用范围 scope适用于对环境管理体系相关文件及适用的外来文件的控制。
It is apply to theenvironment management system relation documents and usable external documents’ control.3.职责Responsibility3.1 环工组：负责环境管理体系文件及适用的外来文件的归口管理；负责监控文件的执行。
The environment team: to manage and be in charge of environment management documents and external documents.3.2 各部门individual department：确保各相关场所均使用现行文件的有效版本。
To ensureThe relative workplace is using the current effective documents.4.工作程序Work procedure4.1文件控制范围包括：documents control’s scopea）环境管理手册；environment management manual;b）环境管理体系程序文件；environment management system procedure documents;c）环境管理体系作业指导文件；the work instruction documents for environment management system;d）环境记录表格；environment record form;e）外来文件。
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合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 Responsibility3.1 管理者代表负责手册(质量手册、 EHS 手册)及程叙文件的批准。
Management Representative is responsible for the approval of manuals (quality manual,EHS manual) and procedure files.3.2 质量部经理负责质量手册、 EHS 手册的审核，程叙文件的复核。
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；程叙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 documents and review thesupportive 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。
ISO程序文件中英文版04设计和开发控制程序
1. 目的：对产品设计开发全过程进行控制，确保设计和开发的新产品满足规定的要求。
Purpose：Control the whole process of product design and development to ensure that the design and development of new product meet the stated requirements.2. 适用范围：适用于产品设计和开发的全过程。
Applicable Scope：Apply to the whole process of product design and development.3. 职责Responsibility：3.1董事总经理负责设计开发项目的立项、设计输入及试产交接会的组织和批准工作。
The Director General shall be responsible for approving the establishment of design and development project, design input and organizing the meeting for hand-over of pre-production .3.2技术总监领导负责产品的设计开发全过程的组织协调及审批工作。
The C.T.O will organize and coordinate the overall process of design and development of product, take charge of audit and approval as well.3.3项目工程师负责统筹产品的设计开发、型式试验及组织设计开发过程中产品的装配测试工作。
The project engineer shall be in charge of coordinating the design and development and type-test of product, organize the work related to assembly and test during the process of design and development.3.4 生产技术部负责配合执行产品测试及试验工作，组织产品试产，组织生产装配工艺文件和检验文件的编制及审核工作。
ASME程序文件-设计控制规程(中英文)
The rules hereinafter are as appendix to the QC Manual for design control.1.Authority and Responsibility1.1 Design QC Engineer1.1.1 To be responsible for design control of Code Items and assuring that the designwork done by other design agent is also in accordance with the Code requirements.1.1.2 To arrange the review and acceptance to customer documentations includingdrawing and referenced documents.1.1.3 To be responsible for overall engineering design work.1.1.4 To designate design engineer to review the Customer’s technical requirementsand the design documents prepared by the customer or his designated agent. 1.1.5 To prepare the Document List (QC Manual Form 3-2).1.1.6 To verify the design calculation and the stress analysis satisfy the Coderequirements.1.2 Design Engineer1.2.1 To prepare/check up design documents including drawings, calculation sheet andspecifications.1.2.2 To review the Customer’s Specificat ion to verify that the specificationcontains requirements and data detailed enough to constitute an adequate basis for selecting materials, designing, fabricating, testing and inspecting the Code Items, and that the Specification complies with the requirements of the Code .If necessary, design engineer shall get customer’s the supplemental information for checking.1.2.3 To perform proof test and/or perform experimental stress analysis, if necessary.1.2.4 To revise the design documents in accordance with part 4 of this rule.1.2.5 Review the design documents provided by user & his designed agent.1.3 Document KeeperTo receive, distribute, keep and file the documentations.2 Design Process Control2.1 Design ProcessThe design process of Code Item is divided into two stages,preliminary design and construction drawing design. The review process of construction drawing shall be in accordance with the QC manual. The preliminary design shall refer to thebasic design prepared for bidding or quoting purpose. For the cause of management, the quoting drawing shall be prepared by design engineer and approved by design QC engineer.2.2 The Work of Two Stages2.2.1 In the preliminary design, a comparison of technique and economy shall be madeto indicate that the technology is advanced, the expense is reasonable, safety is ensured, and the design is in compliance with requirements of the Code.2.2.2 The construction drawing design documents shall conform to therequirements of the ASME Code and the Customer’s Specification.3 Design Documents Control3.1 The design documents include the Customer’s Specification, Designing Assignment(issued by SURF), Drawings, Calculation Sheet, and the MaterialRequisition,Purchase Specification,etc.3.2 The documents prepared by Technical Department shall be registered and numberedby the Document Keeper.3.3 The documents such as the Customer’s Specification shall be registered bythe Document Keeper, and issued to the concerned personnel by Design QC engineer.3.4 The assignee of any document shall be registered in the Document Issuance Book.The obsolete documents shall be handled in accordance QC Manual and be handled by Design QC Engineer.4 Revision of Design Documents4.1 Responsibility and Procedure4.1.1 If the design revision is needed to be done during the fabrication period, therevision work should be done by the original designer whenever possible.4.1.2 The drawings issued for manufacturing shall be replaced by the latest ones.4.2 Methods of Revision4.2.1 The size, letter or figure to be revised shall be marked out by a thin line.The part marked out shall be still clearly visible for showing the content before revision. Then, the new size, letter or figure shall bemarked.4.2.2 The revision mark shall be shown near the original position. The entire partof revision shall be enclosed by a cloudy circle. See the followings:4.2.3 The main cause and content of revision shall be filled in the revision block4.2.4 The part number in the drawing and the title block shall be allowed to skip,if the part has been canceled from the original drawing due to revision. The words “Part number xx was canceled” shall be filled up in the revision description column of the revision block.。
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对公司管理体系文件和外来文件进行控制，确保各相关场所使用的文件为满足标准、顾客及法律法规要求的有效版本。
To control all the company management systems documents and external origin documents and to ensure all the documents at relevant points of use are effective based on the standard, customer and regulatory requirements.合用于公司质量( ISO/TS 16949 ) 、环境( ISO 14001 ) 、安全( OHSAS 18001) 管理体系文件及外来文件的控制。
Be applicable to control all the company quality ( ISO/TS 16949 ) & environment ( ISO 14001 ) & safety ( OHSAS 18001) management systems documents and external origin documents.3.1 文件名Document name：文件封面及页眉里标题项下所显示的名称为文件名。
Document name is described on the document cover page and under the title of each page header.3.2 外来文件External Document国际、国家行业标准和非公司内部制定的文件和设计的图纸，包括合用的法律法规文本、顾客或者供应商提供的资料、质量标准、技术要求、顾客提供的图纸等。
Industrial standards of international and internal, and documents compiled and blueprint designed by external company. Including applicable laws & regulations, the material offered by customer and supplier,quality standard,technical requirements,blueprint provided by customers, etc.3.3 受控文件To be controlled document按照发放范围登记、分发或者独立存档管控，并能保证收回以防止失效作废文件的非预期使用的文件。
The documents which are registered, distributed or filed independently according to the distribution scope, and could be retrieved to avoid unintended use of obsolete documents.1 、标准要求Standard requirements：1.1,4.2.3,4.2.3.1,5.1,5.6.2.1,6.4.1,7.1.3,7.2.1,7.3.3.,7.4.1.12 、顾客的要求Customer requirements；3 、法律法规要求Statutory and regulatory requirements4 、管理体系要求(文件编写需求) Management system requirements(documentation requirements) 1 、经过审查、批准且受控的合格正式文件/资料(包括暂时试制文件/资料)；Official controlled and qualified documents or materials (incl. temporarytrial-manufacture documents or materials)after reviewed, verified and approved.2、《文件有效版本清单》“List of document effective versions”3 、《外来文件一览表》“List of external origin documents”4、《文件处置记录》“Record of document dispositio n”5、《文件评审记录》“Record of document review”6 、《文件发放/回收记录》“Record of document issuance / retrieval”7 、《文件更改申请、通知单》“Application and Notice of documentchange”8 、《外来文件评审表》“Review of external origin documents”项目Item监视方法和频次Monitoring method & frequency实际内审不合格项个数测量部门Department responsiblefor measurement内审不合格项Non-conformance audit外审不合格项Non-conformance audit fromfrominternalexternalActual number of non-conformancefrom internal audit每半年Semiannually实际外审不合格项个数Actual number of non-conformancefrom external audit每年AnnuallyCTO外审公司external audit corporation5.1 部门文控员Department document controller：体系文件编写员或者体系维护人员将作为文控员，负责本部门文件管理的实施、协调、联络等工作。
Document drafters or system maintenance persons will act as document controllers to beresponsible for the implementation, coordination and liaison of document management work for their own department.5.2 文件控制活动的职责规定Stipulation of responsibilities for document controlling activities：文件的编制、识别、评审、审核、批准、发放、更改、作废、回收、销毁、保留及其他管理职责一览表见附件1。
List of responsibilities for document compilation, identification, review, verification, approval, issuance, change, invalidation, retrieval, disposing, retention and other management aspects is attached in annex 1.6.1 文件策划Plan for document：6.1.1 文件的分类Document classification:公司管理体系所需要的文件由CTO-QA、CAO-HSE 部门共同组织公司各部门进行策划，形成文件编写计划。
管理体系文件组成：Company management systems documents shall be planned by each department which is organized by CTO-QA & CAO - HSE department, and document preparation plan should be made. The constitution of company management systems documents is:6.1.1.1 质量方针、质量目标、 HSE 方针、HSE 目标指标及方案、管理手册Quality policy, Quality objectives, HSE policy, HSE target, management manual6.1.1.2 程叙文件Procedure documents6.1.1.3 作业文件(包括外来文件) Work instructions (include external origin documents) 6.1.1.4 表单Forms6.1.2 文件受控管理Manage controlled documents6.1.2.1 公司管理体系文件分为受控和非受控两类文件，纸质版的受控文件发放，由各部门文控员在统一位置加盖“受控”印章，并注明发放号。
Company management systems documents include “to be controlled” and “not to be controlled” . The seal of “to be controlled” shall be used by department document controller before “to be controlled” documents are issued, and Issue No. shall be indicated meanwhile.6.1.2.2 电子版本的文件在DMS 电子文件系统管理。
E-Documents shall be managed by DMS system.6.1.3 文件编号Document numbering rules：6.1.3.1 CTO-QA 部门编制《文件编号规则》，实现对文件、记录的编号控制。
For general document, document numbering rules are defined in the relevant document 《Document numbering rules》.6.1.3.2 文件版次号由版本号与修订号组成，A-0 表示首版,每次换版,依序编B-0、C-0；每次修订分别用A-1 、A-2 、A-3 表示修订次数。
Document version no. consists of edition No. and revision no., version no. for the first edition will be A-0, each time when the edition changed, the version no. will be B-0, C-0 in sequence; each time when the revision no. changed, the version no. will be A-1, A-2, A-3 in sequence.6.1.3.3 文件的发放号为流水号，表示某部门发放某文件的序号。