文件变更通知(DCN)生成作业指导书-中英文对照

TITLE : WORK INSTRUCTION FOR DOCUMENT CHANGE NOTICE (DCN) GENERATION 文件变更通知（DCN）生成作业指导书

Document No.: DC30002 Rev. No. : A00 Page 1 of 9

Revision History

REV DCN # INITIATED

BY

EFFECTIVE

DATE

(MM/DD/YY)

DESCRIPTION

A00 D141603 William

Magramo

04/18/14 Initial Release

APPROVED BY Motoaki Wakui AUTHORIZED BY SK Lam

CONFIDENTIAL

PROPERTY OF ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITED

This document, and the information it contains, are the property of Zhong shan Sunming Optical Technologies Limited and are protected by law. Both must be held in strict confidence at all times. No license expressed or implied, under any patent, copyright or other intellectual property right is granted or implied by the provision or possession of this document. No part of this document may be reproduced, transmitted, transcribed, stored in a retrieval system, translated into any language or computer language, in any form or by any means,

whatsoever, without the prior written consent of

Zhongshan Sunming Optical Technologies Limited.

?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITED

ALL RIGHTS RESERVED

1.0 SCOPE范围

1.1 This work instruction is used in generating Document Change Notice (DCN) applicable to

quality management system (QMS) documentation such as system quality manual,

corporate procedures and working instructions..

本作业指导书适用于质量管理体系（QMS）的系统文件，如系统手册，程序文件和作业指导书

的文件变更通知（DCN）的生成。

1.2 This work instruction can also be used during the initial release, revision and obsolescence

of a QMS documents.

本作业指导书也适用于质量管理体系（QMS）文件的初次发行，修订和废止。

2.0 ASSOCIATED DOCUMENTS 相关文件

2.1 DC20001 - Document Control Procedure文件管控程序

2.2 DC30001 – Work Instruction for Document Numbering 文件编号作业指导书

3.0 SAFETY REQUIREMENTS安全要求

3.1 Not applicable.不适用

4.0 GENERAL REQUIREMENTS 一般要求

4.1 An overview of the Document Change Notice (DCN) & Temporary Document Change Notice

(TDCN) generation flow can be found in Attachment 1 and 2.

文件变更通知（DCN）及临时文件变更通知（TDCN）作业流程的概述见附件1和2。

4.2 Initiator to fill up a DCN form. Specimen of a DCN form is in Attachment 3.

发起人填写文件变更通知（DCN）表格。文件变更通知（DCN）样本参见附件3。

4.2.1 Refer to Table 1 below for guidance on important details needed in filling up a DCN /

TDCN form for Quality Management System Documentation.

质量管理体系文件的文件变更通知（DCN）及临时文件变更通知（TDCN）表格内需要填

写的重要的细节，参阅以下表格1。

Table 1

4.3 For manual entry and signature, use black or blue pen only. Pencil is not allowed.

填写和签名，只可使用黑色或蓝色笔。不允许使用铅笔。

4.4 In case of urgent need, the initiator shall route the DCN / TDCN for approval.

在紧急需求的情况下，发行人应安排文件变更通知/ 临时文件变更通知的批准。

4.5 DCC shall proofread the content upon receiving the DCN / TDCN. Any discrepancy noted

shall be returned to initiator for correction.

文件控制中心在收到文件变更通知/ 临时文件变更通知后会核对相关内容，若有任何差异应退还并指出以便更正。

4.6 An ordinary DCN / TDCN shall be routed by DCC for approval within 5 working days. DCC

shall inform the initiator for any delay or inquiry regarding the change.

一般的文件变更通知/ 临时文件变更通知应在5个工作日内取得文控中心的批准。若有任何拖延或有关变更的质询，文件控制中心应告知发起人。

4.7 DCC shall provide DCN number and print hard copies of the approved documents once the

approval process is complete and will make it available for staff reading in the DCC room.

一旦批准程序完成，文控中心须提供文件变更通知的编号并打印这些已批准的文件共SUNMING职员在文件控制中心处查看。

4.8 Effectivity of TDCN expires in 3 months. To extend will require initiator to issue another

TDCN otherwise initiator may consider issuing a DCN.

临时文件变更通知有效期为3个月。另外若因其他问题发行人认为有必要延长此临时文件变更则需要启动另一个临时文件变更，否则发行（永久）文件变更通知。

(Attachment 1)

附件1

Document Change Notice (DCN) Generation Flow

文件变更通知作业流程

(Attachment 2)

附件2

Temporary Document Change Notice (TDCN) Generation Flow

临时文件变更通知生成流程

(Attachment 3)

附件3

Document Change Notice (DCN) Form

文件变更通知表

(Attachment 4)

附件4

Major and Minor Category 主要和次要类别

(Attachment 5)

附件5

Temporary Document Change Notice (TDCN) Expiry Notification For m 临时文件变更通知（TDCN) 到期通知表