文件管理程序

更新时间:2023-06-29 04:42:08 阅读：评论：0

Document management procedure

那一刻我感动了文件管理程序

1.Purpo 目的：

The purpo of this document is to ensure management system operates efficiently and under control, and every department has latest version of document.

为确保本公司管理体系有效运作和受控，各部门均能持有最新版的受控文件.

2.Scope范围：

This procedure applies to all levels of controlled documents and external documents.

适用于本公司管理体系中各级文件以及外来文件。

3.Definition 定义：

Management system documents are of 4 levels: Manual; Procedures, Criterion, and Check

list

管理体系中文件分四级:手册；程序文件；工作指导书、规范或标准；表单

3.1 Manual手册:

Level 1 doc, a comprehensive description of the system, which include policy and target.

第一级文件，对体系进行综合描述，包括方针、目标。

3.2Procedure程序:

Level 2 doc, explains how to work and how to complete the policy and target in Manual.

第二级文件，详述如何进行工作及完成手册中所规定的政策及目标。

3.3Work instruction or Criterion:工作指导书、规范或标准:

Level 3 doc, important basis or guide documents for management procedure execution.

第三级文件，为支持各项管理程序于执行阶段时重要的依据或指导之文件、标准。

3.4Check list and Record表单及记录 :

Level 4 doc, test and verify management system’s efficiency from constantly recording all the procedures.

第四级文件，为验证管理体系有效运作，而对各个事项持续不断加以记录。

3.5External documents外来文件:

Include customer drawing, international/national criterion, relevant laws and regulations, industrial standards, customer/supplier technical documents, and etc.

指客户图面、国际、国家标准、相关法律法规、行业标准、客户或供应商提供的技术文件等。

3.6Controlled document : DCC relead document发挥.停工报告范本

受控文件：由DCC发行的文件属受控文件

3.7 Draft documents: onsite rework instruction shall be issued as draft rework instruction ect.), marked with expire date, and its validity period should be no longer than 1 month.

临时文件：现场需要临时使用的受控文件，如返工作业指导书等，临时文件上需注明失效日期，临时文件有效期不超过1个月。

3.8In this document DCC stands for document control center

文控中心,本文件中均以DCC表示

4Responsibility 权责：

4.1 DCC is responsible for managing all the company’s documents

DCC负责公司所有管理体系文件的管理工作。

4.2 Each department is responsible for managing their own documents.

其他部门负责各自体系文件的管理工作。

Each department is responsible for managing their own documents.

5Procedure流程：

输入（Input）	流程（Procedure）	输出（Output）	权责（Owner）	逝青春相关说明（Explanation）
Standard demands 标准化需求 Law/regulation relevant standards/customer drawing 法律法规/相关标准/客户图纸 Engineering change, standard demands 工程变更、标准化需求	NG NG OK . NG	[document/form application] ［文件/表单申请表］ Approved document 审批后的文件 [Attendance record] [培训签到表] Controlled document受控文件 [Document master list]［文件总览表］[Document Issue / Recall Records]［文件发放回收记录表］ [External Files(Specification)Review Report] [Drawing Identification Report] [外来文件评审表] [判图记录] ［文件总览表］[Document Issue / Recall Records]［文件发放回收记录表］ Controlled document受控文件 [Document/Form Revision And Approval]［文件表单修改和批准表］[ECN Application] ［工程变更通知及申请］ Approved document 审批后的文件 [Attendance record] [培训签到表] Controlled document受控文件[Document master]［文件总览表］[Document Issue/Recall Records]［文件发放回收记录表］ Document management文件管理	Demand document需求部门微信横屏 Department manager/manager reprentative/GM/project manager 我的梦想医生部门经理/管代/总经理/项目负责人 DCC DCC and Document Controller DCC及各部门文件管理人 Duty Departmen 各职能部门 Team 项目小组 DCC DCC and Document Controller DCC及各部门文件管理人 Document change initiator文件变更发起人 Department manager/manager reprentative/GM/project manager 部门经理/管代/总经理/项目负责人 DCC DCC and Document Controller DCC及各部门文件管理人	Document shall comply with< Criterion For Document No. Version, Format And Writing > 文件编写时需符合<文件编号、版次、格式及书写规范>, Document issued bad on 6.1 文件审批依此文件6.1执行 Document issued bad on 6.3 文件发行依本文6.3执行 Document using keeping and maintaining issued bad on 6.8 文件使用保管维护6.8执行 External documents should be reviewed for its feasibility, but no more than 2 weeks, and review the result feedback to the customer, in two weeks 外来的客户图纸发行前需得到项目组的评审（评审时间不可超过两周）并在2周内将评审结果反馈给客户 Document issued bad on 6.3 文件发行依本文6.3执行 Document using keeping and maintaining issued bad on 6.7 文件使用保管维护6.7执行 Demanding departments put forward the changing application for revid document.需求部门提出修改好的文件及提出变更申请。 Each department reviews whether the modification complies to requirements of system .各职能部门评审相应的修改是否符合系统及实际操作的要求。 Document issued bad on 6.3 文件发行依本文6.3执行 Document using keeping and maintaining issued bad on 6.7 文件使用保管维护依6.7执行

6Content内容：

6.1 Document preparation and approval

文件的编写与审批

(Level 2 documents of the management reprentative shall be drafted by quality manager, checked by management reprentative and approved by general manager)

(管理者代表的二阶文件由副总经理审核，总经理批准。)

If the approver ask for leave or be on a business trip，the document can’t be approved in time . it should be completed by the agent

当文件审批人由于请假或出差等原因不能及时完成文件审批时，则由该责任人的代理人完成文件的审批工作。

Doc Category 文件类别	Prepared by制定	Reviewed by/sign 审核/会签	Approved by批准
Quality/EHS/HSF Policy 质量/EHS /HSF方针 Quality/EHS/HSF objective 质量/EHS /HSF目标 Quality /EHS manual 质量/EHS手册	Management reprentative管理代表 EHS Engineering EHS工程师	/	General Manager 总经理
QP/EP程序文件	Related Department 相关部门	Head of department 相关部门主管/经理	Management reprentative 管理代表
WI三级文件	Related Department 相关单位	Head of department 相关单位主管	PM / Manager 项目经理/部门经理
External document 外来文件	Document is reviewed by project team，its distribution is determined by receiving department, then issued by DCC. 由项目组评审，接收部门确认需要分发部门，DCC发行
Form表单	QP and WI shall be checked and approved together. 随附QP与WI文件被审核，批准。

6.2Preparation of document: Document shall be prepared according to <Criterion for document No., version, format, and writing>. After approval, shall be submitted to DCC together.

文件制定: 文件制作需符合 <文件编号、版次、格式及书写规范>，经批准后交于DCC。苏联为啥解体

6.3Distribution/ Return

分发/回收作业

6.3.1 When DCC receive approved document, DCC shall confirm document No. and version, and issue then form and keep document in the Public drive \\192.168.19.11\ST-Quality\DCC or in the ERP and update in [Document master list]. Document can only be revid by DCC and be read-only by other departments. IT should back up the P drove document on periodically, in ca of the lost.

DCC收到签核完成之文件后，确认文件编号、版本版次符合性，确认合格后将文件发行，并存档，地址存于公共盘：\\192.168.19.11\ST-Quality\DCC，或ERP中，同时更新到［

文件总览表］中，该地址文件只有DCC中心可以修改，其他部门人员权限为只读。公共盘DCC文件定期由IT备份一份，以防资料丢失。

6.3. 2 The following documents shall be issued in paper, others in e-document.

下表文件需要发行纸文档，其他文件一律发行电子档。具体见下表：

Category文件类别	Name 文件名称	Receiving Department 接收部门/单位	Issue methods 发行方式
O	External Document 外来文件	Operation Center / Quality Dept./ Development Center 运营中心/ 质量部/ 开发中心	Paper 发行纸档
WI	＜Molding Data Sheet＞＜注塑标准工艺＞	Operation Center 运营中心	Paper 发行纸档
WI	＜Molding Production Operator Work Instruction ＞＜注塑生产作业员操作指导书＞	Operation Center 运营中心	Paper 客家习俗发行纸档
WI	＜GP12 Work Instruction＞＜GP12作业指导书＞	Operation Center 运营中心	Paper 发行纸档
WI	＜Inspection Instruction＞＜检验指导书＞	Operation Center / Quality Dept. 运营中心/ 质量部	Paper 发行纸档
WI	＜Packing Specification＞＜包装规范＞	Operation Center 运营中心	Paper 发行纸档
WI	<Fixture Drawing For Internal Inspection > ＜内部检治具图纸＞	Quality Dept. 质量部	Paper 发行纸档
WI	Criterion and regulation documents for work site 现场使用相关操作规范或规章制度类文件	Operation Center / Quality Dept./ Development Center 运营中心/ 质量部/ 开发中心	Paper 发行纸档

6.3.3 DCC is responsible for distributing documents to related department and is required to keep a record of issuance/ return of a hard copy into [Document issuance/return record form]. Recipient reprenting the receiving department has to sign the [Document issue return record form] and recycling the old document. If a soft copy is distributed, DCC shall inform related department by E-mail.

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输入（Input）	流程（Procedure）	输出（Output）	权责（Owner）	逝青春相关说明（Explanation）
Standard demands 标准化需求 Law/regulation relevant standards/customer drawing 法律法规/相关标准/客户图纸 Engineering change, standard demands 工程变更、标准化需求	NG NG OK . NG	[document/form application] ［文件/表单申请表］ Approved document 审批后的文件 [Attendance record] [培训签到表] Controlled document受控文件 [Document master list]［文件总览表］[Document Issue / Recall Records]［文件发放回收记录表］ [External Files(Specification)Review Report] [Drawing Identification Report] [外来文件评审表] [判图记录] ［文件总览表］[Document Issue / Recall Records]［文件发放回收记录表］ Controlled document受控文件 [Document/Form Revision And Approval]［文件表单修改和批准表］[ECN Application] ［工程变更通知及申请］ Approved document 审批后的文件 [Attendance record] [培训签到表] Controlled document受控文件[Document master]［文件总览表］[Document Issue/Recall Records]［文件发放回收记录表］ Document management文件管理	Demand document需求部门微信横屏 Department manager/manager reprentative/GM/project manager 我的梦想医生部门经理/管代/总经理/项目负责人 DCC DCC and Document Controller DCC及各部门文件管理人 Duty Departmen 各职能部门 Team 项目小组 DCC DCC and Document Controller DCC及各部门文件管理人 Document change initiator文件变更发起人 Department manager/manager reprentative/GM/project manager 部门经理/管代/总经理/项目负责人 DCC DCC and Document Controller DCC及各部门文件管理人	Document shall comply with< Criterion For Document No. Version, Format And Writing > 文件编写时需符合<文件编号、版次、格式及书写规范>, Document issued bad on 6.1 文件审批依此文件6.1执行 Document issued bad on 6.3 文件发行依本文6.3执行 Document using keeping and maintaining issued bad on 6.8 文件使用保管维护6.8执行 External documents should be reviewed for its feasibility, but no more than 2 weeks, and review the result feedback to the customer, in two weeks 外来的客户图纸发行前需得到项目组的评审（评审时间不可超过两周）并在2周内将评审结果反馈给客户 Document issued bad on 6.3 文件发行依本文6.3执行 Document using keeping and maintaining issued bad on 6.7 文件使用保管维护6.7执行 Demanding departments put forward the changing application for revid document.需求部门提出修改好的文件及提出变更申请。 Each department reviews whether the modification complies to requirements of system .各职能部门评审相应的修改是否符合系统及实际操作的要求。 Document issued bad on 6.3 文件发行依本文6.3执行 Document using keeping and maintaining issued bad on 6.7 文件使用保管维护依6.7执行