CCC CRCC 认证产品变更控制程序 中英文版.doc

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认证产品变更控制程序 authentication product change control procedure1 目的 purpose为了满足ccc、crcc产品认证质量保证能力和相关的法律、法规要求，确保申请认证的产品与认证标准的符合性和与型式试验样机的一致性，特制定本程序。in order to meet ccc, crcc product certificate quality assurance capability and related law, regulation requirements, ensure the conformity and consistency of the authentication product with certificate standard and type test sample, specially formulated the procedure. 2 适用范围 application scope 本程序适用于动车组和高速车辆、重型铁路车辆、地铁轻轨的风挡、公交客车折棚和航空登机桥前端折棚等强制性认证产品和铁路客车重要零部件（a类）生产条件的审核认证，自愿性认证和“四防”（防燃、防裂、防脱、防松）要求的产品可以参考执行。the procedure is applied to the audit certificate of production condition for crh train, high speed train, heavy railway, light railway metro gangway, bus bellows and air bridge front bellow etc. mandatory authentication product and important parts (a class) of railway passenger car. voluntary certificate and product with “four prevents” (burning resistance, cracking resistance, fall-off resistance, loosen-preventive”) can reference to it. 3 规范性引用文件 normative documents下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件，其随后所有的修改单（不包括勘误的内容）或修订版均不适用于本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件，其最新版本适用于本标准。 the clauses in the following documents will become the clauses of the standard via the quote of the standard. all the quoted documents with date, all the future change form(corrected contents excluded) or the revised editions are not applicable to the standard. while, encourage the parties who has had agreement acc. to standard to study whether can use the latest version of these documents. all quoted documents which not notes the data, the latest version is applicable to the standard. iso9001：2008 质量管理体系要求 iso9001:2008 quality management system requirement 铁路客车零部件生产资质管理办法railway passenger car parts production qualification management measures产品认证工厂质量保证能力要求product certificate factory quality assurance capacity requirementcrcc产品认证实施规则implementation rules of crcc product certificate4 术语和定义 terms and definitionsccc：中国强制性产品认证的标志 china compulsory product certificate markcrcc：中国铁路产品强制性认证的标志 china railway product compulsory certificate mark5 部门职责 responsibility of dept5.1 管理部是归口管理部门负责：management dept is the centralized administration dept a) 认证产品变更申请、联络；be responsible for authentication product change application, contact;5.2 质量和技术部负责 quality dept and technical dept are responsible for：a) 定期收集、更新与认证产品相关的标准和法律法规要求；collect and update the standard,statutory and regulatory requirements related with the certificated product regularly;b) 组织制定认证产品的企业标准并到上级政府主管部门备案。organzise to make enterprise standard of certificated product and record in the high level government department. 5.3 项目部负责 project dept is responsible for：a) 接收合同订单，识别顾客提出的产品认证要求；receive contract order, identify customer proposed product certificate requirement;5.4 技术部负责 technical dept is responsible for：a) 编制关键零部件清单；prepare key parts list;b) 提出关键零部件变更申请；propose key parts change application;c) 提出产品结构设计变更申请；propose product structure design change applicationd) 提供认证产品变更的图纸、技术文件和设计验证、设计确认资料。provide drawing, technical document, design validation, design confirmation document of certificated product change 5.5 工艺部负责 process dept is responsible for：a) 确定认证产品的加工工艺和关键工序；confirm certificated product processing technic and key processes;b) 确定认证产品的主要生产设备、工艺装备和检验仪器、试验设备；confirm the certifcated product main production equipment, process equipment and inspection instruments, test equipment;c) 提供认证产品生产所需的各种工艺文件和工装设计、工装验证资料；provide the necessary various process document and tooling design, tooling validation document for the production of certificated product;d) 对特殊过程进行设备认可、人员鉴定和工艺评定；implement equipment approval, personal appraisal and process evaluation for special process.e) 认证产品的工艺纪律检查。process discipline inspection of certificated product.5.6 各部门负责 various dept are responsible for：a) 提出变更申请；proposes change application5.7 工艺部质量部负责 process quality is responsible for ：认证产品必备的测量设备的管理和维护保养。 necessary measurement equipment manageemnt and maintainance of certificated product.5.8 质量部负责 qm dept is responsible for：a) 变更产品的质量检验；quality inspection of the changed product.6 程序要求 procedure requirements6.1 认证产品的变更 change of certificated product6.1.1 质量和技术部定期收集与认证产品相关的法律法规要求，并及时传递给相关部门quality and technical dept collect and update the standard,statutory and regulatory requirements related with the certificated product regularly, and pass to the related departments in time. a) 当认证产品的执行标准和产品认证实施规则出现修订时，与认证产品相关的设计文件、工艺文件、质量计划、检验文件等都需要作相应的修改；when the executive standard of the certificated product or product certificate implementation rules revised, the related design documents, process documents, quality manual, inspection document of certification product have to have corresponding revision; b) 当认证产品的范围目录出现变更并与本公司的产品相关，或公司的生产经营范围发生变化后出现与认证资质要求相关的产品，管理部需要及时按本程序的要求进行产品认证申请和管理控制。when the scope of authentication product have changes and its related with the company product, or after the scope of the company production and business changed, the product which is related with the certificate qualification requirement, the management dept has to implement prouduct certificate application and management control acc.to the procedure documents in time.6.1.2 公司的获证产品需要变更关键零部件（或元器件或材料）、产品结构设计、认证依据、组织机构、关键生产场所、必备生产或检测设备时，管理部应在批量生产前提出认证变更申请并经认证中心确认。when the key parts( or components or material), product structure design, certificate bases, organization, key production location, necessary production or test equipment of the product which have certificate needed to be changed, the management dept has to propose certificate change applicateion and get confirmation from the certificate center before mass production.6.1.3 公司申请人或名称、注册及生产地址名称、产品名称或型号（结构未变）、质量管理体系发生变更时，管理部应在变更的一个季度内向认证中心提出认证变更申请与备案。when the company applicant or name, name of register and production location, product name or specification( structure not changed), quality managemetn system changed, management deptment has to propose certificate change application and registration to the certification center within a season. 6.2 关键原材料的变更 key raw material change6.2.1 在crcc认证申报时，由技术部设计师按认证实施规则的要求，编制关键零部件控制清单，明确关键零部件的供应商、材质。during the declaration of crcc certificate, the designer of technical dept will acc. tocertificate implementation rulesrequirement to create key parts control listand clarify the supplier and material of the key parts.6.2.2 当关键零部件的供应商、材质、型号规格等需发生任何的变化时，由申请变更的部门向研发部提出变更申请。研发部按本程序的要求，对变更内容进行评审后报管理部。when theres any change to the suppliers, material and specification of key parts, the department which applied changes to propose change application to r&d dept. r&d dept will acc. to the procedure requirement to report to management dept after review of the changed contents.6.2.3 管理部收集相应的变更材料，包括变更前后的对比说明、变更供应商的资质材料、变更原材料的出厂报告、ccc/crcc证书等，在批量生产前填写变更申请表向认证中心提出认证变更，并经认证中心确认。management dept collect the corresponding change document, include the contrast statement of change(before and after), qualification document of the changed supplier, the deliery report of changed raw material, ccc/crcc certificate etc. fill in the change application form and propose certificate change to the certifidate center and get confirmation by the center before mass production.6.2.4 管理部在接收到认证中心批准同意变更后，通知研发部实施变更。未得到认证中心的批复的关键原材料变更一律不允许实施。the management dept informs the r&d dept to implement change after getting the change approval from the certificate center. 6.3 产品结构设计变更 product structure design change6.3.1 当产品结构需进行变更时，技术部按变更控制程序执行变更，并向管理部提出变更申请，提供设计变更的评审、验证、确认等相关资料。when the product struture need to be changed, technical dept will implement change acc.tochange control procedure, and propose the change application to the management dept, provide related documents of review, validation , confirmation of design change. 6.3.2 管理部在批量生产前填写变更申请表向认证中心提出认证变更申请并经认证中心确认。before mass production , the management dept fills in change application form, propose change application and get approval from the certification center.6.4 组织机构、关键生产场所、必备生产或检测设备的变更 organization, key production location, necessary production or test equipment change6.4.1 当组织机构变更时，管理部按认证实施规则要求，在批量生产前填写变更申请表，并提交差异描述、质量手册等相关资料，向认证中心提出变更申请，并经认证中心确认。when the organization change, the management dept will be acc. to certificate implementation rules requirement to fill in the change application formbefore the mass production. provide the difference description, quality manual etc. documents. propose the change application to the certification center and get the confirmation. 6.4.2 当关键生产场所变更时，制造部向管理部提出变更申请，管理部按认证实施规则要求，在批量生产前填写变更申请表，并提交认证证书原件、工商证明、营业执照复印件等相关资料，向认证中心提出变更申请，并经认证中心确认。when the key production location change, the manufacturing dept have to propose the application to the management dept, the management dept will be acc. to certifi