Document control procedure 文件控制程序

程序文件/Procedure

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

文件名：文件控制程序版本：VER 编写：许名端

批准：

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。

Purpose

The procedure is formulated according to the requirement of .

The procedure control over the documents and records related to the quality, Environment, OHSAS system 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/商务文件/产品标准；

7)适用的法律法规及其他要求文件。

2. Scope

The procedure is suitable for controlling and managing the documents and records what related to the quality, environment, OHSAS management system. Including:

The first level files: Quality , environment and occupational health and safety management manual

The second 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 standards

Applicable statutory and regulatory requirements

3. 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 responsibility

QA 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 duties

1) QA DEPT is responsible for controlling and managing the first/second/third level document about QMS,EMS and OHSAS, controlling and manager the statutory and regulatory requirements files, to ensure the document is current and valid,

2) QA DEPT is responsible for environment and OHSAS, such as environmental agreements, survey, etc.

3) Technology DEPT is responsible for controlling and managing documents about technology, quality and standard.

4) Sales or SO are responsible for controlling and managing business contract document and records.

4. 定义Define

无

5. 工作流程图Work Flow

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 time.

6. 工作程序

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。第一，二，三层次受控文

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 identification

1) Original document: Chapter carries on the page with the original documents of the green 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 system document, including technology files, statutory and regulatory requirements are controlled documents

3) 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 architecture

The first level document architecture

1 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 (No content no fill)

The third level documents architecture

1 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 number

QEOM-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）

QEOM-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 number

AAP-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 documents 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 number

AAI-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). For example, QAI-001, it is stand for quality department instruction

document.

企业标准编号 Enterprise standard number QB/

文件版本号 Document version VER

备注:the 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 approval

The first layer documents are prepared by quality department, the general manager review and approval.

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。

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 document and issue form (electronic file or paper file)

The paper document issue

The quality department 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 issue

The IT department want set pe rmissions and ensure that all the person only can read and can’t make any 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。

Recovery

Electric files recovery: Cancel the electronic files in public disk, and stamped with "invalid document", and save for reference.

Paper files recovery

Recovery and register the failure files according to the accounting requirement.

Failure document of original documents stamped with "invalid document", and saved for reference, othe r failure files stamped with “invalid document” and destroy to prevent unintended use.

文件更改

当文件不适用时需要更改，由申请部门进行更改，并按要求进行审核并批准。

审批并批准后由质量部安排受控，并回收旧文件，发放更新的文件。

documents change

When the document is not suitable want to be changed, the application charges to change, and reviewed and approved according requirement.

After reviewing and approving, QA department arrange control, and recall the older files, issue the new file.

定期评审

针对两年之内均无修改的文件，需要重新评审其有效性，如有效则直接升级版本继续使用，不适用则由责任部门进行修改再评审。

Periodic review

If the document is not modification in two years, it needs to review its effectiveness again. If it

is suitable, the document can direct upgrade version to continue to use. If not, it want to be change and review.

7. 相关文件Related documents

无

8. 相关表格Related Form

无

9. 备注Remark