Document Title

Engineering Change Control Procedure

3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 1 of 12

Revision History
Rev No DCN # Changes Effective Date Approved

01 Initial Release 08/06/04

02 0007 Footer changed 10/08/04 J. Rao

03 0080 Modification of flow chart 01/11/05 J. Rao

04 0724 Revised flow chart, detail change category 08/03/09 N. Guo

05 0821 Clarify change category 02/05/10 Y. Chen

06 0891 Clarify the flow, responsibility, and requirements. 08/31/10 Y. Chen

07 1003 Simplified the flow chart, emphasize section 6.2 06/29/11 A. Qin

08 1164 Yearly Review, Added three requires for ECN 05/15/13 A. Qin
initial

09 1172 Specify Customer Specification Review and 07/12/13 A. Qin

Release Process in section 6.2

10 1177 Modification of CRB Member Responsibility 10/11/13 A. Qin

Engineering Change Control Procedure

Process Owner: Nancy Guo Date: 10/09/2013

Department Manager: Alex Qin Date: 10/10/2013

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 2 of 12

1.0 Purpose

This procedure defines the process flow to ensure that all engineering changes are properly
reviewed, verified and validated, as appropriate, and approved before implementation.

2.0 Scope

This procedure applies to all Optoplex products, materials, test software and associated

manufacturing processes.

3.0 Authorities and Responsibilities

• Divisional • Initiates the request of engineering change(s)

Engineering • Provide the required information for engineering change(s)
• Perform test to verify and validate proposed change
• To ensure product integrity and manufacturability
• Conducts initial assessment on the impact of the proposed change to
production process, product quality/reliability, inventory and supplier
status.

• Responsible • Reviews the request of engineering change(s)

Manager • Review the required information for engineering change(s)
• Review the plan and results of validation test(s)
• Reviews the initial assessment conducted by divisional engineer.

• CRB • Reviews the proposed ECN,

• Reviews and verifies the plan and results of validation test(s)
• Reviews and verifies the change classification.

• Document • Assigns an ECN number.

Control • Manages ECN process, make pre-view on change proposal, and
coordinate approval status
• Chairs the CRB review meeting, present ECN information and maintain
accountability of process owner.
• Documents records upon ECN closure.

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 3 of 12

• Sales/ • Clarifies the request of PCN for the changes.

Marketing • Join the CRB to review the request of ECN.
• Notify customer about PCN and obtains approval when necessary.
• In charge of Customer Specification pre-review process

• Process • Performs necessary test to verify and validate any changes associated
Engineer with the manufacturing process
• Review; approves and implements the ECN.
• Makes associated changes with ECN such as BOM, W/I. Travel card, etc.
• Records/Maintains the traceability info associated with the change

• Quality • Conducts qualification and reliability assessment test when necessary.

Assurance • Determines the required departments to involve the ECN process
• Approves the ECN if the results are satisfactory.
• Makes changes associated with ECN such as inspection standard, etc.

• Cooperates with Production Plan on the disposition of materials.

• Production & • Notifies supplier of change or adjusts the PO if necessary.
Material • Works with Accounting if there is a cost concern on changes.
Control • Works with ECN Owner for the impact of the change as it affects the
Planning production plan, inventories, WIP and disposition of materials.
• Provides the effective date for material/assembly changes
• Manufacturing • Verifies the necessity of the change
/Production • Ensures that manufacturing is prepared for the change in the process
• Implements the changes on ECN effective date

• Contract • Report the inventory information disposition plan

Manufacturing • Verifies the necessity of the change for CM
• Implements the changes in CM on ECN effective date

• R&D • Review and approve the ECN that product in design and develop phase
Engineering include technical documents
• In charge of NPI product document transfer from Engineering to
Production based on approved ECN.
• Support production for ECN change in production phase

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 4 of 12

4.0 Definitions and Acronyms

DCC Document Control Center

ECN Engineering Change Notice

CRB Change Review Board

CRB Member: Sales , R&D Engineering (Mechanical and Electrical), Process
Engineering, Manufacturing, Optics Department Production and Material
control Planning, Contract manufacturing , QA and Cost Accounting

PCN Product Change Notice

Effective Date Date when the proposed change(s) start to be implemented

ECN can be effective starting from a particular lot or serial number if a clear
cut-off date is not practical

ECN Owner The person who responsible to implement the ECN.

Deviation Any practice that is deviated from the current documented work instruction
and process control.

NPI New Product Introduction

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 5 of 12

5.0 Flow Chart of Procedure

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 6 of 12

6.0 General Requirements

6.1 Product and Process Change Classifications
Change
Definitions Examples
Classification

• Any minor change to a process, material,

method, or product design that does not
1. Non-critical material and material
represent a fundamental change to the
process technique, material components, supplier change
or product functionality.
2. Cosmetic change without
Level 1 • No impact to product’s performance and
appearance change
form, fit, and function.
3. Correct typo or clarify step in W/I
• These changes typically require no formal
qualification and customer notification 4. Part number description change

• Any change to a process, material, 1. Design platform change

method, process architecture, or product
design that might impact device 2. Non critical Internai dimension change
performance but not to form, fit and 3. Critical material and material supplier
function.
change
• These changes represent a more
Level 2 fundamental change and typically require 4. Work instructions step change
a formal qualification and customer 5. Visual appearance change including
notification based on agreements and
contracts. weight, size, shape, general structure,
• Customer approval may be required. color, surface finish
6. Manufacturing site change

1. Correct safety or fire hazard related

concerns
2. Change affect functional parameters
• Fundamental changes to process
technique, material components or set
product design that might impact form, fit, 3. Major firmware change
and/or function of a product.
4. Changes impact reliability
• As for product termination, a 12-months
notification will be provided to customer. 5. New material and/or material supplier
Level 3
approved

• These changes need formal qualification 6. Changes affect external dimensions,

and customer approval based on standard associated tolerances and interface
agreements and contracts.
parameter
7. Critical manufacturing equipment or
methodology change
8. Discontinuation of product

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 7 of 12

6.2 Customer Specification Pre-review / Release Process

6.2.1 Sales and Marketing shall be in charge of the customer specification pre-review for both
new product and existing product modification. Engineer and Production shall be involved
in the review.

6.2.2 Follow the instruction on Customer Specification Review Sheet (Form S001) and assign an
engineer who will be responsible for the preparation of all related documents update and
the submission of the ECN for releasing the specification through ECN approval process.

6.2.3 Refer to PRD-DC-001 Revision Control Procedure for the revision assignment.

6.3 Initiate the Request of Engineering Change

Based on company business needs such as process enhancement, yield improvement, cost
reduction, regulation requirement and upgrade safety issue, an engineering change proposal will be
initiated.

The responsible engineer shall fill out the ECN form in the early stage of the change proposal.
The information required includes the following items. (Not limited)

1. Type of Change

2. Product affected

3. Reason(s) for change(s)

4. Change Category and PCN request verification

5. Description of Reason For ECN

6. Description of Change

7. Final Product Impacted

8. Total Cost For ECN Changes (Estimate)

9. ECN Implemented Owner

10. ECN Effective Date (Proposal)

11. Validation Test Requirement and report

12. PCN Requirement

13. Disposition Plan for all change parts

6.4 Make Preliminary Decision on the Change Levels

Beside the changes that assigned from customer, the ECN change initiator shall make preliminary
review on the PCN requests based on the classification of the levels on section 6.1.

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 8 of 12

If it is in a concern on the level classification, the initiator shall consult with the members of CRB in
advance.

The change level and the requested qualification plan will impact the implementation of the ECN.

Sufficient lead time should be identified and prepared for the test samples preparation, test times

and other activities that will impact the ECN implementations.

6.5 Make Early Pre-notification to the Production Planners

If there is a ECN request (Not belong to initial relapse) to overcome the current claims and make

further improvement, the change initiator shall keep closely communication with Production

Planner for the inventory control and P/O release issues to prevent over-stocked for the changed

parts.

6.6 Provide Sufficient Info on the Contents on the ECN Forms

[Change Reasons]

Each of the items on the ECN form shall be filled out with clear information. The change reasons

shall be clearly identified and explained that will help the technical accumulations and traceability
for the teams.

No blurred wording such as “quality improvement” or “dimensions change” is allowed.

[Disposition Plans]

The disposition plan shall apply to the raw material, WIP, finish goods products, parts in supplier

site, parts in transportation, parts/devices in Contract Manufacturing and open P/O. The disposition

plan includes:

1. Use as it (Running changes). Used up the parts of current revision and then switch to the parts

of new revision.

2. Scrap the parts with current revision.

3. Re-work on the parts of current revisions. The work instruction of re-work shall be prepared by

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 9 of 12

Engineering. If the re-work or adjustments are performed on the Production, the instruction

shall be prepared.

4. Due to purchasing lead time, Open P/O should be cancelled or take other disposition plan

such as re-work by supplier, etc for immediacy change.

[Change Documents]

The change documents such like specification, drawing, BOM, Work Instruction and Traveler
should provide with ECN package.

The changed documents and directly reported BOM must be listed in ECN as well. All supporting
data documents have to include in ECN package if this change required the validation test.

[Evaluation and Validation Test(s) of the Change]

Based on the proposed change, the responsible engineer shall set up the test plan and perform the

evaluation and validation assessment. All of the results shall be recorded and collected.

6.7 Perform the Preview by Department Manager

The change packages shall be reviewed and approved by department manager before sending to
DCC.

6.8 Submit/collect All Required Information to DCC

The ECN responsible engineer shall update the information on the ECN form and provide all
required information to DCC.

The ECN package with originator signature, department manager approved signature and related
documentations will be forwarded to DCC.

6.9 Check the completeness and Assign ECN # by DCC

DCC shall conduct the checking on ECN for completeness, the following areas shall be checked:

1. Manager approval is required.

2. Provide related data in softcopy and hardcopy.

3. Check all marked areas on necessary requirement. PCN, Validation test reports provided (if

required).

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 10 of 12

4. Ensure the revision is correct. Any drawing change or replacement for existing product,

reported BOM has to be updated.

An ECN number is assigned by DCC and forward the ECN to CRB members and/or appropriate

department managers.

6.10 Conduct the Review on the ECN by CRB

The ECN package shall be forwarded to CRB for preliminary review.

CRB members shall review and confirm the request of Product Change Notification associated
with the changes.

If there is no necessary for the PCN, the CRB meeting shall make the review on the contents such
as:

1. The draft disposition plan shall be checked by CRB. Any Scrap, Re-work and Cancel P/O for
material, WIP and Finish goods should add up the cost.
2. For those changes that need the evaluation and validation, CRB meeting will confirm the
contents of the test data submitted.
3. CRB members shall review and evaluate ECN to determine whether the changes are valid and
whether the proposed action achieves the expected improvement. .
3. Accounting or upper level manager might involve approval for an ECN with high cost impact.

If the change proposal had been accepted after review from CRB , the further action on the ECN
shall be conducted. Please skip to the section # 6.14.

If the ECN is held by CRB for further info, DCC shall notify the assigned engineer to modify or
provide supporting documents and information.

If the ECN is rejected from CRB, DCC shall write the reasons; scan softcopy of ECN; file
hardcopy, notify originator and requester the cancellation of the ECN.

6.11 Sent the PCN to Customer for Approval

If the change level meets the request of notification to customer, the PCN form shall be prepared
and sent to customer via Sales/Marketing. The details please refer to Product Change Notification
Procedure QP 72004.

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 11 of 12

6.12 Receive the Feedback from Customer about the PCN

Once customer had agreed the PCN, the ECN will be forward to CRB for final approval.

If the PCN was rejected from customer, depend on the detail of the feedbacks, the following
actions shall be taken;

1. The proposed engineering change will be cancelled.

2. Add more supporting information to meet the comment from customer.

3. Modify the change proposal.

6.13 Release the ECN and Filing the ECN Related Documents

DCC shall formal release the ECN once it gets the final approval by CRB.

DCC shall handle and file the ECN related documents, those activities such as updating BOM, WI,
verify revision on drawing, update Master log, data stored to DCC system, and ensure the soft file
located at suitable folders, file hardcopy of ECN.

6.14 Implement the ECN on Related Activities and Associated Document Changes

Individual department is responsible to implement changes in affected areas by effective date

as notice to customer, material disposition plan, and production schedule, record the
traceability information, and notice PCN implementation date or lot number.

The changes on the associated documents that had been impacted from the ECN such as
inspection standard from the other departments or contract manufacturer shall be completed at
timely basis.

6.15 Conduct the Deviation on the Urgent Changes

For urgent or temporarily engineering changes, there is no sufficient lead-time to complete the
ECN cycle, a deviation process shall be conducted.

The responsible engineer shall fill out the deviation request form in order to get approval for
implementing any deviation practice in Production or Contractor Manufacturer.

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 Document Title
Engineering Change Control Procedure
3390 Gateway Boulevard Document No: QP 73003 Revision Number 10
Fremont, CA 94538
USA Effective Date 10/11/13 Page Number Page 12 of 12

For traceability, the deviation form shall be attached to the traveler of the device that applies to the
change.

The effective spans of deviation have the following decisions:

1. The period of time. In general is 30 calendar days.

2. The number of lots. In general are three consecutive lots.

3. The total quantity. Specified by Optoplex for case to case bases.

4. Others, specified after team meeting

If the change is a permanent, the formal ECN process shall be initiated within 30 calendars

(In general conditions).

6.16 Monitor the Close of ECN Implementations

All parties responsible for ECN implementation must provide actual implementation date of the
ECN on their portion of the responsibility.

The respective department shall be the implementation coordinator to check all implementation
status before formal closing of ECN.

The definition of the formal close of ECN is all of the activities related to specified ECN are
implemented and changed products are shipped to customers.

7.0 Reference Documents

QM 001 Quality Manual

QP 72004 Product Change Notification Procedure

QP 75101 Process Control Procedure

QP 73002 Reliability Program Procedure

QP 42303 Document Control Procedure

Form E001 Engineering Change Notice (ECN)

Form P119 Deviation Request Notice

Form S001 Customer Specification Review Sheet

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