Documentcontrolprocedure文件控制程序

1、文件化信息控制程序Document & Record Control Procedure文件编号：QAP-03文件版本：生效日期：2016-4-29诺而达超导技术（中山）有限公司Luvata Superconductors (Zhongshan) Limited审批页部门审核人签名文件名：文件控制程序编写：许名端评审：版本：VER批准:文件更改记录更改在舁 厅P原文件版本/更改内容更改原因更改人更改日期1文件编写根据ISO9001:2015体系进行编写许名端4/29/2016注：通常”文件更改记录”表位于各程序文件前面1.目的本程序按质量、环境和职业健康安全管理手册文件要求制定；本程序

2、针对质量/环境/职业健康安全体系有关的文件化信息（文件，资料，记录等）进行受控 确 保所有使用部门使用的文件和记录处在受控状态。PurposeThe procedure is formulated according to the requirement of <Quality, environment and occupational health and safety management manual.The procedure control over the documents and records related to the quality, Environment, O

3、HSASsystem to ensure that all the documents and records used by each department are current and valid.2.范围本程序适合于与质量环境职业健康安全管理体系有关的文件的控制和管理，包括：1）第一层次文件：质量、环境和职业健康安全手册，质量、环境和职业健康安全目标；2）第二层次文件：质量、环境和职业健康安全管理程序文件、总部文件；3）第三层次文件：操作规程、作业指导书、检验规程等；4)技术文件：产品工艺技术要求、技术图纸、企业标准等；5)行业产品标准和产品检验标准；6)客户提供或确认的技术/质量 /

4、商务文件 / 产品标准；7)适用的法律法规及其他要求文件。2. ScopeThe procedure is suitable for controlling and managing the documents and records what relatedto the quality, environment, OHSAS management system. Including:The first level files: Quality , environment and occupational health and safety management manualThe secon

5、d level files: The procedure of quality, environment and OHSAS , Headquarters files.The third level files: Work instruction, inspect instruction. Etc,Technical documents: Product technology requirement, technical drawing , QB,etc.Industry product standards and product inspection standardsApplicable

6、statutory and regulatory requirements3. 职责 Responsibility总职责质量部负责文件控制的管理工作，确保本文件的适宜性和有效执行。Total responsibilityQA Department is responsible for managing the document control, to ensure the document is current and valid.具体职责 Specific duties质量部负责质量、环境和职业健康安全管理体系第一、二、三层次有关文件、内部标准、法律法规和其他要求文件的控制与管理， 以及文件

7、控制的日常监督和管理工作，确保本文件的有效实施；质量部负责有关环保协议、 调查、 承诺书等有关环境和职业健康安全管理方面外来文件管理.技术部负责顾客提供的技术/ 质量文件和外来标准/ 文件的控制与管理；销售 / 市场助理负责商务合同文件的控制与管理。Specific duties1) QA DEPTis responsible for controlling and managing the first/second/third level document about QMS,EMS and OHSAS, controlling and manager the statutory and r

8、egulatory requirements files, to ensure the document is current and valid,2) QA DEPTis responsible for environment and OHSAS,such as environmental agreements, survey, etc.3) Technology DEPTis responsible for controlling and managing documents about technology, quality and standard.4) Sales or SO are

9、 responsible for controlling and managing business contract document and records.4. 定义 Define无5. 工作流程图 Work FlowPass or notApprora01 car files &r notChai r1£ = OliPeiodictttsctiveorrD'：备注：系统策划者指的是文件最初版本的审核部门。Comment: System leader is the department what edit the document first time6.工作程

10、序文件的分类及标识原装文件：在其页面以盖有原装文件章的绿色印迹予以标识。第一，二，件源于原装文件。受控文件：在其页面内以盖有受控文件章的红色印迹予以标识，或在中国区内部网上发布的文件。所有体系文件，包括技术文件、法律法规及其他要求文件在中国区内部均为受控文件。作废保留文件：在其页面内以盖有作废文件章的蓝色印迹予以标识，并长期保存。Documents classification and identification1） Original document: Chapter carries on the page with the original documents of the green

11、mark to be identified. The first, second and third level controlled documents are from the original document.2） Controlled document: Within its pages with stamped with "controlled documents" chapter red mark to be identified, or which are issued in the internal internet of China. The whole

12、 system document, including technology files, statutory and regulatory requirements are controlled documents3） Invalid keep document: Within its pages to bore a blue print of chapter "invalid document" logo, and long-term preservation文件架构及格式二级文件架构1 目的 ； 2 范围； 3 职责； 4 定义（无时填无）； 5 工作流程图； 6 工

13、作程序； 7 相关文件（无时填无）； 8 相关表格（无时填无）三级文件架构1 目的； 2 范围； 3 工作流程； 4 相关文件（无时填无） 5 相关表格（无时填无）document architectureThe first level document architecture1 Purpose; 2 Scope; 3 Responsibility; 4 Define （No content no fill）; 5 Work flow; 6 Work instruction; 7 Related documents （No content no fill）; 8 related form （

14、No content no fill）The third level documents architecture1 Purpose; 2 Scope; 3 Work instruction; 4 Related documents （No content no fill）; 5 related form （No content no fill）体系文件的编号指南System document number guide第一层次文件编号The first level document numberQEOM-XX （QEOM:质量、环境和职业健康安全管理文件；XX:用阿拉伯数字表示文件序号）QEO

15、M-XX （QEOM: Quality/Environment/EHS manage documents; XX: Use the Arabic numerals to stand documents number.）第二层次文件编号The second level document numberAAP-XX（AA:部门编码；P:程序文件；XX用阿拉伯数字表示文件序号），如QAP-01,代表质量部（QA）程序文件AAP-XX （AA: Department; P: procedure document; XX: Use the Arabic numerals to stand document

16、s number）. For example, QAP-01, it is stand for quality department procedure document.第三层次文件编号The third level documents numberAAI-XXX （AA:部门编码；I:作业文件/指导书；XXX用阿拉伯数字标示文件序号），如 QAI-001,代表质量部（QA）的作业文件。AAI-XXX （AA: Department; I: Working instruction; XXX: Use the Arabic numerals to stand documents number）

17、. For example, QAI-001, it is stand for quality department instructiondocument.企业标准编号Enterprise standard numberQB/主皆iLriStandJor the year of standard take effect)一亦p (SSf獭腺1胆um02晾业原材料/辅料标准03-其他标准(Stand for standard category: 01- Enterprise product standards; 02- Enterprise standards for raw表/aer囱超/l

18、auxifery书ater商)艮公司.for Luvata Superconductors (Zhongshan) Limited) her翻ocUmcompanyjsmberrd)其他文件垢号格式不限定，但要求能够惟一识别且能够便于检索The form of others documents number are not provision. But required that have only identifcation and can facilitate retrieval发件相关记录编号 Document relative record number 文件编号-RXX (R表表格；

19、XX:用阿拉伯数字标示表格序号)Document number-RXX (R: Form; XX: Use the Arabic numerals to stand form number)文件版本号Document versionVER 口 .YY用 01/02/03/04/05 表示该版本的修改次数(Indicate the number of changesto this version)用 A/B/C/D/E 表示版本号 (Stand for version)备注:当修改次数>5次后,需要升级版本.或一次，住进行大修改，需升级版本.Comment: When modified m

20、ore than 5 times, or a one-time large changes, that need to upgradethe version)文件的编写、审核和批准第一层文件由质量部编写，总经理审核并批准；程序文件由各部门编写，质量部经理审核，总经理批准.作业文件由各部门编写，各部门负责人审核，质量经理批准.Document preparation, review and approvalThe first layer documents are prepared by quality department, the general manager review and app

21、roval.The procedure documents are prepared by each department, and reviewed by quality manager, approval by the general manager,The working instruction are prepared by each department, and reviewed by each department manager, approval by quality manager.文件受控及发放Control and issue文件待审核并批准后，由质量部盖“原装文件”章

22、并扫描电子档，纸档由质量部保存。电子档存入公共盘。After review and approval, the document would be stamped < original documents> and scanned. Paper file would be saved by quality department, and electronic file would be saved in public disk文件审批部门提出文件发放范围及发放形式(电子档或纸档)纸制档发放质量部按照发放范围进行影印文件，在文件上盖“受控文件”章，并按要求进行分发，领用 人签收确认。

23、电子文件的发放由公司 IT 部门设置权限， 应确保除文件管理者外其他人只能读取电子版文件而不能做任何修改；当文件有更改时，电子版文件所在公共盘的文件应由 QA 工程师将其即时更新；电子文件在公共盘更新后， QA 工程师应将更新信息以邮件的形式在公司内部通知。The department which review the document want to put forward the scope of the documentand issue form (electronic file or paper file)The paper document issueThe quality dep

24、artment copy the document according to the issue scope, and stamped with < controlled documents >, and issue by requirement, and the received person sign for confirmation Electric document issueThe IT department want set pe rmissions and ensure that all the person only can read and can make an

25、y change but the document manager.When the original documents are changed, QA engineer should update the electric files as well.After update in the public disk, QA Engineer should notice others by email.文件回收电子文件的回收:在公共盘中取消电子版文件，并在原件中盖上“作废文件”后归档保存以供以后参考之用。书面文件的回收按台帐要求回收并登记失效文件；失效原件由文件管理员盖“失效文件”印章后，归档

26、保存供以后参考之用，其他失效文件上盖“失效文件章”后销毁以防止非预期使用。RecoveryElectric files recovery: Cancel the electronic files in public disk, and stamped with "invalid document", and save for reference.Paper files recoveryRecovery and register the failure files according to the accounting requirement.Failure document of original documents stamped with "invalid document", and saved for reference, other failure files stamped with “ invalid document” and destroy to prevent unintended use