Document Confidential Level: 1

Engineering Change Procedure

工程变更程序

ENP-00060

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Document Confidential Level: 1

Revision History
Revision Author Description of Change Date Issued
Create global document for change control, Replaces
E N P - 0 0 0 0 0 1 , F I B - Q P - 0 7 a n d E N P - 0
01 Vicky Carl individual facilities 2010-2-25
为变更管理创建了全球适用的文件，替换各区的ENP-
000001, FIB-QP-07 和 ENP-00045

02 Vicky Carl Add validation 2011-11-30

Add PCN link Requirements. Update responsibilities.

03 Vicky Carl 2013-02-05
Add IPQA audit at implementation

04 Vicky Carl Add time to complete per Ericsson audit finding 2013-02-13

Clarify use of MCO for mass changes. (DNV audit

05 Vicky Carl 2013-11-07
finding in Taiwan)

06 Becky Xu Change to SP standard system document template 2014-07-22

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Engineering Change
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TABLE OF CONTENT

1. Objective/目的......................................................................................................................4
2. Scope/适用范围....................................................................................................................4
3. Definition/定义......................................................................................................................4
4. Responsibility/职责.............................................................................................................4
5. Work Process/工作程序......................................................................................................6
6. Related Documents and Records/相关文件和记录....................................................13
7. Flow Charts/流程图...........................................................................................................13

1. Objective/目的

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The purpose of this document is to define the process for creating, approving and
i m p l e m e n t i n g c
documentation。
该文件定义了索尔思光电产品文档建立，审批和执行各方面变更的流程。

2. Scope/适用范围

This document applies to all documentation relating to the design, manufacture,

test and inspection of Source Photonics products.
该文件适用于索尔思光电产品设计，制造，测试和检测相关的所有文件。

3. Definition/定义

ECN Engineering Change Notice 工程变更通知

LCO Lifecycle Change Order 生命周期变更指令
MCO Manufacturer Change Order 制造商变更指令
PCN Product Change Notice 产品变更通知

4. Responsibility/职责

Each approver is responsible for reviewing changes when assigned and carrying
out any tasks required to implement the changes

审批人负责对更改的地方进行检查并完成更改所要求的所有工作。

4.1 Originator is responsible for generating ECN with sufficient detail to enable others
to approve, selecting correct workflow criteria and attaching required validation
data.

发起人负责创建ECN，提供详细信息以便其他审核人进行审核，选择正确的
workflow,并上传必须的确认信息。

4.2 Change Analyst is responsible for checking that the above requirements are met.

Change Analyst检查是否符合上述要求。

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4.3 Material Control is responsible for setting effectivity dates, determining disposition
and carrying out any purges, etc required by the ECN．

物控负责生效日期的设定，明确物料的处置，并按ECN中的要求进行清除等操作。

4.4 Planning is responsible for determining impact on W

implementing changes in WIP and any updates required to Oracle system such
as yield.

计划确定对WIP和计划WIP产生的影响，在WIP中执行变更和Oracle系统所要求的更
新，例如通过率等。

4.5 PD Manager and XDL are responsible for verifying that the change is technically
correct.

PD主管和XDL负责验证变更是否符合技术方面的可行性。

4.6 QE is responsible for determining impact on quality of product and co-ordinating

implementation tasks.

QE负责确定变更对产品质量的影响和协调实施任务。

4.7 SQE is responsible for determining any supplier issues that need to be addressed
and checking if parts have been properly qualified.

SQE负责处理供应商一切事宜，并负责检查产品是否达标。

4.8 S o u r c i n g i s r e s p o n s i b l e f o r c h e c k i n g i t e m s a g a i n s t k e y
ensuring suppliers of parts are in active status.

采购负责检查主要部件清单对应的item，并确保零部件的供应商为active状态。

4.9 NPIE is responsible for determining and carrying out any test changes that may
be required by the ECN.

NPIE确定并实施ECN所需的测试变更。

4.10 PE is responsible for any changes in manufacturing process required by the ECN.

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PE负责ECN中所需的生产流程变更。

4.11 PLM i s responsi bl e for determi ni ng customer i mpact

needed.

PLM确定对客户产生的影响，以及PCN的创建。

4.12 Document Control is responsible for final release of ECN and

documents as needed.

文控负责所有ECN的最终审核及文件的分发。

5. Work Process/工作程序
All Changes to documents and parts are managed through the Agile PDM System.
Upon release all changes that affect parts and BOMS are automatically transferred into
the Oracle ERP System via SCMnet software.
对文件和器件的所有变更通过Agile PDM系统进行管理，发布后，所有对部件和BOM有
影响的更改就通过SCMnet软件自动转到Oracle ERP系统。
5.1 Change Classifications变更类型
There are multiple change types in Agile. Each serves a specific function.
Agile系统中有多种变更类型，每一种都有专门的功能。
5.2 Change Approvals变更审批
Approval routings are managed in Agile via workflows. Workflows are determined
b a s e d o n S o u r c e P h o t o n i c s i n t e r n a l r e q u i r e m e
requirements.
审批程序通过Agile系统中的工作流程进行管理，工作流程是以索尔思光电的内部要求
ISO 和 TL9000要求为基础确定的。
C h a n g e s t o w o r k f l o w s c a n b e m a d e o n l y b y G l
Management or local DCC (Document Control) Manager.

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工作流程只能由Global Product Information Management或local DCC manager进行

更改。
Minor changes such as change in personnel are made with the approval o
appropriate manager. Major changes such as adding or removing a functional approval
group are made only with the approval of management team.
像人事变更之类的小改动在得到相关主管的批准后就可以进行，但诸如添加或删除职
能审批小组这样的大改动须得到管理层批准后才能进行。
For specified reviewers of LCOs, see LCM-000001.
对于LCO评审人的指定，见LCM-000001。
For specified reviewers of other changes, see ENP-00063.
对于其它变更评审人的指定，见ENP-00063。
Below is the current workflow for production ECNS.
以下是目前production ECN的工作流程。

Change Analyst
Pending (PMG,Product Data Materials/Planning
Information Group)

CCB(Quality,PE,NPIE,Supply
PLM Released
Chain,Reliability)

Implemented (QE.IPQA)

5.3 ECN Process time/ECN流程时间

For standard ECNs the time from submission to release should be no longer than
10 days.
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标准ECN从创建到发行不能超过10天。

For emergency ECNs the time from submission to release should be no longer than
2 days.

紧急ECN从创建到发行不能超过2天。

Exceptions to standard processing time are acceptable only if t

pending customer approval.

如果有待客户审核的PCN可不按此标准流程时间执行。

Each reviewer must approve or reject ECNs within 2 days.

ECN的审核人应该在2天内通过或退回ECN。

5.4 Customer Notification/Approval客户通知/审批

If it is determined by PLM (Product Line Management) that customer notification

and/or approval is required on an ECN or if design chan
commitments, PLM will send a PCN (Product Change Notice) to customer(s).

如果PLM确定ECN需要通知客户或由客户审批，或是设计上的更改会影响合同约定，
PLM要将PCN（产品更改通知）发给客户。

Changes that require customer approval will not be released until such approval is
obtained.

需要客户审批的变更须得到客户的批准后才能发行。

There are required fields on ECNs that must be completed by PLM. The fields are
“PCN Required” and “PCN Number”. PLM shall not approve EC
approval (if required) is received.

ECN的“PCN Required” 和 “PCN Number”栏位必须由PLM完成。收到客户的批准

后PLM才能审批这些ECN。

5.5 Traceability of Changes变更的可追溯性

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When changes are incorporated into products, the revision levels are updated by
the Agile system and transferred into the ERP system.

更改投入生产后，版本等级通过Agile系统更新并转入ERP系统。

When Manufacturing Orders are released to build product, the curre

level appears on the printed MO. This revision level is programmed into final product,
enabling traceability of changes to the part.

生产订单公布并投入生产后，当前版本级别会出现在打印的生产订单上，此版本级别
会编入最终产品，从而体现出器件更改的可追溯性。

For lower level parts and assemblies, the rev level will be marked on the parts by
the vendors when practicable

低级别的部件和组件，可行时由卖方将版本级别标在部件上。

5.6 Validation of Changes 变更验证

Ma j or ch an g e s to d e sig n , man u fa ctu ri ng pro ce ss o r t est sp ecs re qu i re va li d at

testing. Test results must be attached to ECNs prior to submission.

针对设计，制造工艺或测试标准的较大变更都要进行验证测试，并在提交ECN之前将
测试结果附在ECN的附件中。

5.7 Implementation Validation 实施验证

After ECNs are released, they move to implementation status. QE reviews E

requirements for implementation. Working with other teams, they ensure all tasks ar
performed, including scrapping of material, etc.

ECN发行后转到实施状态。QE对ECN的实行要求进行审核，并与其他团队一起确保
所有任务项完成，包括物料的作废等。

QE notifies IPQA of ECN implementation. IPQA audits ECN imple

production and notes the results of the audit on the ECN.

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ECN转为实施状态后，由QE通知IPQA，由IPQA对ECN在生产中的实行情况进行审
核，并将审核结果备注在ECN中。

QE determines what activities are required to implement the ECN and

those activities are carried out. QE then signs the ECN and
comments section what activities were performed and
performed. No ECN should be signed in implementation stage without comments. If no
implementation activities are required this should be stated.

QE确定ECN实行的必要活动，并保证所有活动按要求进行。QE审核ECN时，必须在
注 释 一 栏 里 填 上 所 有 执 行 的 活 动 和 实 行 的 日 期 。 没 有 注 释 的 E C N一 律 不 予 通 过
implementation(实施)阶段的审核，如果没有要求实施活动，应该做相应说明。

IPQA audits the ECN implementation in production. IPQA MU

comments section exactly what they checked and the results of the check. If an ECN is
not implemented correctly, IPQA shall report results to QE for implementation follow-up.
After follow-up is complete IPQA shall re-audit and sign the ECN.

IPQA审核ECN在生产中的实行情况。IPQA必须在注释一栏里填上所检查的内容和检
查结果。如果ECN没有正确实行，IPQA应将情况汇报给QE跟进。待跟进完成，IPQA再次
审核ECN。

5.8 Deviations偏差

Deviations are short term changes to standard process. They

requirements defined in ENP-00059. Deviations to production products have the same
approval requirements as production ECNS. If needed custom
obtained prior to implementing deviations.

偏差是对标准程序的短期更改，要符合ENP-00059中的要求。生产产品的偏差的审批
要求和ECN的审批要求一样。必要时，执行前要先得到客户的批准。

5.9 Emergency Changes紧急变更

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Emergency Changes are defined as ECNs that must be processed in an extremely

short amount of time, usually due to production impact.

紧急变更的定义是要在极短时间内处理的ECN，通常是由于生产的影响。

Details of Emergency Change Procedure may be found in ENP-00037 and ENP-

00064.

紧急变更程序详细内容，请参考ENP-00037和ENP-00064。

Emergency process may be used to implement certain changes

approval and formal release.

在完成批准，正式发行之前，可照紧急处理程序实施变更。

5.10 Mass Changes/批量变更

From time to time it is determined by management that mass changes need to be

made to many part n umb ers. The se chang es a re ge nerally done w ith MCO and on
DCC management is permitted to create these changes。

公司管理层会针对大批的P/N做批量变更。大批量变更可通过MCO完成，但只有
DCC管理层有权限创建此类变更。

6. Related Documents and Records/相关文件和记录

6.1 Quality Manual/质量手册 SP-IMS
6.2 Deviation/偏差 ENP-00059
6.3 Updating Test Tables /测试表格的更新 ENP-00037
6.4 Label Creation and Release /标签的创建和发行 ENP-00053
6.5 Change Approval Matrix /变更审批矩阵 ENP-00063
6.6 Emergency Engineering Change Procedure /紧急工程变更 ENP-00064
6.7 TL 9000 Quality Management System Requirements Handbook/
质量管理体系要求手册

7. Flow Charts/流程图
NA/无

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