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 to
be 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 all
documents 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 be
available 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。

3.2 Document：The term 'document5 is used in the context of whatever means are used to make
information and or 'data' available to the user. It could be, for example; written on paper, held on
computer disk, video, audiotape or graphic posters. The type of information contained in
documents includes; policies, procedures, recipes, regulations, standards, codes, specifications etc.
文件：能让使用者获得信息或数据的文字即为术语的“文件”。

文件的形式可以多种多样，包括书面的文字、电脑中的电子文档、录像、录音、图片或海报等。

文件所传达的信息包括：方针政策、程序、图纸、规章制度、标准、编号以及规格说明书等
3.3 Document Control: Quality manual, procedures, working instructions, legal and other standards of
MMK are controlled by document controller; Program department is responsible for control of
technical documents from MMK and customers.
文件控制：质量手册，程序文件，作业指导书，法律法规及相关标准的控制由公司文控人员负责；
项目部负责控制本公司内部及来自客户的技术文件。

3.4 OEMS Representative：The Quality / Environmental Management System Representative: A
person who has been appointed by top management to establish, implement and maintain the
Quality / Environmental Management System of MMK, and report to top management on the
performance of the quality management system and any need for improvement.
质量/环境管理者代表：质量管理体系管理者代表和/或者环境管理体系管理者代表，由最高管理层指定的负责本公司质量管理体系和/或者环境管理体系所需的过程得到建立、实施和保持，并向最高管理者报告质量管理体系的业绩和任何改进的需求的管理人员；
3.5 External Documents：Documents issued to an area from another area outside.
外来文件：由公司外部的区域（如顾客、供应商、政府机构等）发放到公司内部供使用和参考的文件；
3.6 Technical documents: including compound recipe, drawing, engineering standards/specifications
which specify the characteristics or parameters of products or process. It can be from customers or
originated by MMK
技术文件：包括产品配方、图纸、工程标准或规范等用来规定产品特性或过程参数的文件资料，它可以是由本公司制定或者由顾客提供。

4.0 PROCEDURE 流程
4. 1 Preparing and authorizing /文件的编写和批准
4.1.1 Documents numbering is defined in u WD-QA-072 Numbering of Documents”. Document
controller will number for the documents.
文件的编号参见“WD-QA-004文件编码规则”，由公司文控人员统一编制.
4.1.2 Quality / Environmental Management System Manual prepared by QEMS Rep and authorized
by MMKG.M..
质量/环境手册由公司管理者代表编写，公司最高管理者批准；
4.1.3 Based on respective function, each department prepares related procedures. Dept manager
check the contents and QEMS Rep should approve those procedures.
程序文件按照职能分配，由各相关部门编写，各部门经理审核，管理者代表批准；
4.1.4 WD documents prepared by related supervisor or process owner and approved by relevant
managers.
工作指导书由各责任部门相关人员编写，部门经理批准；
4.1.5 Department managers should check all documents.
部门负责人应参与文件的编写和检查工作；
4.1.6 Management System documents should be approved by authorizing officer before issuing.
文件必须得到授权人员的批准；
4.2 Document initiation/文件的起草：
4.2.1 Based on respective function, document writer prepares the document and creates a draft.
根据职能分工，文件编写人，编写并提供草稿；
4.2.2 Documents shall be reviewed and approved by the document owner's supervisor or
department manager.
相关人员对文件的草稿进行审批，批准由文件持有人的上级主管或部门经理执行；
4.2.3 Approved document is sent to MMK Document controller..
得到审批后的文件，提交给MMK文控人员。

4.2.4 The document is distributed or notified to related area after document controller numbering the
document and filling it into documentation system. Technical documents are controlled by Program department.
文控人员为文件编号，将文件归档，并分发或通知到相关区域。

技术文件由项目部负责控制。

4.3 Document review and revision/文件评审/修订
4.3.1 Reason for review or revision/评审/修订原因
a) The documents shall be reviewed and re-approved as necessary, document review
report
should be kept
必要时应对文件进行评审和重新批准，保留文件评审报告
b) Document review/revision shall occur for any of the following reasons:
以下情况都应该及时进行文件评审/修订
- Periodic review as notified by the System Engineer.
体系工程师发出周期评审的通知
- Document no longer reflects the actual procedure that is used for a function.
文件不再适用于某项功能的实际操作流程
- An improvement in the method of conduct of a function has been identified.
过程方法进行了改善并得到确认
- A referenced document has been changed.
参考文件已修改
When receiving new or revised customer engineering standards/specifications
收到顾客新的或变更的工程规范时
All employees have authority to propose a document change when incorrect information is found or further information is needed. The document owner must approve this revision beforehand. In some departments when a change is deemed necessary an appropriateTN-QA-008 Documentation revise / Abolition of the application sheet ”is completed to initiate the change and review of the document. These forms must be signed off and filed when the review process is complete.
所有员工在使用过程中发现文件不适用或者有补充信息时，都可以对文件提出变更要求。

文件的修订必须得到文件持有人的批准。

如有变更，文件持有人提供“FN-QA-008文件修订废止清单”进行变更申请和文件修订。

当所有修订工作完成后，变更通知表必须得到签字批准并且归档保存。

4.3.2 Revision Process/修订流程
a) If a document is considered to need modification, the document owner request for
modification and amend it after authorization by relevant person mentioned in section 4.1.
文件需要修改时，由需求人(一般是文件持有人)提出申请，填写FN-QA-008文件修订废止清单，将修改后的文件经相关人员(同4.1)批准后，提交给管理者代表；
b) Updated document approved by original authorization staff or his deputy.
修改后的文件由原批准人(或其代理人)审批；
c) Document controller registers and updates it after approval.
公司文控人员确认足够的批准，归档并发行更新的文件；
d) Sequential revision numbering: Original documents shall be revision number 'O'. Revised
versions shall be incremented by T at each revision/review.
版本代号采用“1.0、2.0、3.0..."数字表示，变更后采用后一位的数字；
4.3.3 Review Process/评审流程
a) O n receiving notification of a document requiring review, the document owner should
be responsible for taking one of the following actions, and forwarding the result (in writing)
to the document controller (FN-QA-008 Documentation revise / Abolition of the application
sheet). This review should result in a revision of the document and notification change
reason in the front page.
接到文件评审要求的通知后，各文件持有人负责进行以下工作，并将评审结果以书面形式提
交给公司文控人员(FN-QA-008文件修订废止清单)。

文件评审后，在首页注明便变更后的
版本以及变更原因。

b) Once the document has had the appropriate action taken, the QEMS Representative is
notified. Document controller shall issue an updated document list to inform all departments.
文件评审完成后，应向管理者代表汇报，相关文件签字审核后，将文件归档，文件库更新后
将由公司文控人员发送更新文件清单通知各部门。

c) Technical department is responsible for the review of technical documents. Timely review of
all customer engineering standards/specifications and changes should base on customer-
required schedule, or be as soon as possible, and shall not exceed two working weeks.
项目部负责技术文件的评审工作。

对于顾客工程标准/规范以及其变更的及时评审应按照顾客
的时间安排或者尽快完成，评审时间应不超过两个工作周。

4.3.4 Obsolete Documents/文件报废
a) Original authorization staff or his deputy must approve obsolete documents.
文件的报废要经过原发行审批人的批准。

需要填写(FN-QA-008文件修订废止清单).
b) Document owners should ensure that the document controller is notified of any obsolete or
withdrawn documents so the document can be updated.
文件报废或撤销使用，文件持有人要必须通知公司文控人员，以便文件得到及时地更新。

c) Obsolete documents in Document are archived to the Archive Folder or destroyed.
报废文件在文件库中压缩保存或立即销毁。

d) The obsolete technical documents are controlled by technical department.
技术文件的报废由项目部控制。

4.4 Document reception and distribution/文件的收发
4.4.1 Document controller is responsible for document reception and distribution.
文件的收发由文控人员执行
4.4.2 Document controller should also request that new and updated department and external
documents are communicated to all relevant employees through those nominated on the
distribution list.
收到新的文件或更改后的文件后，文控人员必须及时进行登记和更新，进行管控，并按照文件
封面的发行/通知区域清单，通知相关人员。

4.4.3 Ensure that lasted versions of application documents are available at points of use. All
obsolete documents should be marked with “OBSOLETE “and removed to a place appointed
or destroyed.
文件保存最新版本，所有旧版本文件应标注“作废文件”，及时移至指定的文件夹中或销毁旧
版文件。

4.4.4 If a document need to be distributed to an outside unit (e.g. customer, supplier and sub-
contractor), it must be marked with "REFERENCE ONLY" as uncontrolled document. The
outside recipient should sign in the form Document distribution / recovery record sheet (FN-
QA-005).
文件需要发放到外部单位，例如客户、供应商、分包商等，应提供非受控版本，注明
"REFERENCE ONLY",并由客户代表在“FN-QA-005文件分发回收记录”上签收.
4.4.5 The technical documents reception and distribution are controlled by technical department.
技术文件的收发由项目部控制。

4.5 Documents index/文件索弓I
4.5.1 The “FN-QA-007 document master list n is kept by the document controller as a record of
current versions and as an approval to update document. External documents are available
its master list.
文控人员对现行版本的记录和变更文件在“FN-QA-007文件索引清单”上登记备案；其他一些
外来文件也应该通过其清单来进行管理。

4.5.2 Whenever a controlled document is created, revised or withdrawn the document controller
must be informed and “FN-QA-007 document master list" updated.
任何受控文件的建立、变更或者废除经批准后由文控人员“FN-QA-007文件索引清单”上及时
更新。

4.6 External Documents Control(Legal and standards) /外来文件管控(法律法规及标准)
4.6.1 Related department should review the external documents in two days. If internal documents
need be amended, all the modification should be done in three days.
外来文件在接收时应进行文件评审，使用部门在接收文件两个工作口内完成对文件的评审，如
果该外来文件引起公司内部文件的变动，则使用部门要在3个工作口内完成对内部文件的修
改，并得到发行。

4.6.2 External documents should be registered by document controller when reviewed. And fill in
TN-QA-006 Document alien registration sheeforTN-QA-020 Drawing&Technical standards
Issued/Recovery sheet”
评审后可以使用的外来文件应由使用部门交文控中心，由文控人员进行登记。

并填写“FN-QA- 006外来文件登记表”或“FN-QA-020图面发行回收管制表”
4.6.3 Customer documents are controlled according to technical documents. If required,
specifications and standards from customer should be transformed into internal documents
and issued to relevant position.
客户文件按照技术文件来管理。

如有必要，客户提供的技术规范及相关标准(含内部参考标准)，应转换为公司内部文件，发放到相关岗位使用。

4.6.4 Same as internal documents, all obsolete external documents should be returned and
archived.
外来文件的发文厂家需要收回文件时，应将作废的外来文件，归还厂家，其他部分同内部文件
控制的方式一样。

4.7 Identification of Controlled Documents /受控文件的识别
4.7.1 All controlled documents can be obtained from DCC
所有受控文件可以从DCC处获得。

4.7.2 Controlled latest documents can be searched via the settled path defined by MR or
somewhere where the controlled hard copies distributed. Controlled documents are
recognized by followings:
以下两种方式可获得有效的受控文件版本
a) The Hard copies and stamped with ,,CONTROLLED^^).
打印出来的硬拷贝文件，并盖有“CONTROLLED”印章，这些文件只能在指定的文件夹中查
阅。

b) Soft copies in electronic documentation system.
电脑服务器上文件库中的电子版本，这些可以通过登陆公司内部网络系统
4.7.4 Controlled documents CANNOT be taken out the office or location where they were, without
authorization.
没有主管的批准，使用者不得随意将受控文件带离存放的办公室或工作场所.
4.8 Confidentiality of Documents 文件的保密
4.8.1 The company manages to ensure the confidentiality of customer-contracted products and
projects under development, and related product information.
公司采用措施来确保顾客委托的正在开发的产品项目和有关产品信息的保密。

4.8.2 The action of keep documents and other information confidentiality may include: signing
confidentiality agreement, empowering for access the special doc, copy prevention, USB
transmission prevention.
保密措施可以包括：与相关员工签署保密协议、特殊文件的阅读权限设置、防拷贝设置、电脑
USB接口锁定等。

5.0 REFERENCE DOCUMENTS 参考文件
5.1 PD-S1-02 Record Control & Retention Procedure 记录控制和保存程序
5.2 WD-QA-004 Numbering of Documents 文件编码规则
6.0 REFERENCE FORMS 参考表单
6.1 FN-QA-005 Document distribution / recovery record sheet 文件分发回收记录
6.2 FN-QA-006 6.3 FN-QA-007 Document alien registration sheet 外来文件登记表Document master list文件索引清单
6.4 FN-QA-008 6.5 FN-QA-020 Documentation revise / Abolition of the application sheet 文件修订废止清单Drawing Technical standards Issued/Recovery sheet 图面发行回收管制表
7.0 FLOW CHART流程图
Reference / Remark 参考文件或表单Responsibility 责任部门
Internal Document control flow chart 内部文件控制流程图如下
FN-QA-005 Document distribution / recovery record sheet文件分发回收记录
FN-QA-007 Document master list文件索引清单
FN-QA-008 Documentation revise / Abolition of the application sheet文件修订废止清单
FN-QA-007 Document master list文件索引清单
Related dept
相关部门
Dept, manager / MR / GM 部门经理/管代/总经理
Related dept
相关部门
DCC
文管
Related dept/
相关部门
Related dept/
相关部门
External Document control flow chart 外部文件控制流程图如下
Reference / Remark
参考文件或表单
Responsibility
责任部门
Related dept
相关部门
Related dept
相关部门
FN-QA-005 Document
distribution / recovery record
sheet文件分发回收记录
FN-QA-007 Document master
list文件索引清单
FN-QA-008 Documentation
revise / Abolition of the application
sheet文件修订废止清单
FN-QA-007 Document master
list文件索引清单
Related dept
相关部门
DCC
文管
Related dept/
相关部门
Related dept/
相关部门。