LS QA Manual

http://www.lscns.com

QUALITY MANUALQUALITY MANUAL

Head Office : Floor Nos. 12 and 17, LS Tower, 1026-6, Hogye-dong,

Dongan-gu, Anyang-si, Gyeonggi-do, 431-080, Korea

.Tel : 82-2-2189-9114, Fax:82-2-2189-9119

Anyang Plant : 555 Hogae-Dong, Dongan-Gu, Anyang-Si, Gyeonggi-Do

431-831, Korea

.Tel : 82-31-428-4162, Fax : 82-31-428-4033

Gumi Plant : 190 Gongdan-Dong, Gumi-Si, Gyeongbuk 730-708, Korea

.Tel : 82-54-469-7340, Fax : 82-54-469-7150

Indong Plant : 643 Jinpyeong-Dong, Gumi-Si, Gyeongbuk 730-735, Korea`

Donghae Plant: 1377 Songjeong-dong, Donghae-Si, Gangwon 240-806,Korea

Unauthorized efflux or distribution of this Manual is strictly prohibited.

Document No. : QM-901

Revision No. : 22

Last Revision Date : March 15, 2012

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LS Cable Ltd. user license only, These documents are property of LS Cable Ltd.

1.0 Table of Contents1.0 Table of Contents

Section 1.0 Table of Contents ----- 1

1.1 Quality Manual Confirmation ----- 2

1.2 Quality Manual Revision History ----- 3

1.3 Scope of Application ----- 4

Section 2.0 Terms and Definitions ----- 5

2.1 Organization Chart ----- 6

Section 3.0 Quality Policy ----- 7

Section 4.0 Quality Management System ----- 8

Section 5.0 Management Responsibility ----- 14

LS Cable & SystemLS Cable & System Quality ManualQuality Manual

Section: 1.0 Table of Contents1.0 Table of Contents Date: 03/15/2012

Page: 1/1 Revision: 22

Page: 1

Section 5.0 Management Responsibility ----- 14

Section 6.0 Resource Management ----- 20

Section 7.0 Product Realization

7.1 Planning of Product Realization ----- 22

7.2 Customer-related Processes ----- 24

7.3 Design and Development ----- 27

7.4 Purchasing ----- 31

7.5 Production and Service Provision ----- 33

7.6 Control of Monitoring and Measuring

Devices ----- 36

Section 8.0 Measurement, Analysis and Improvement

8.1 General ----- 38

8.2 Monitoring and Measurement ----- 39

8.3 Control of Non-conforming Product ----- 45

8.4 Analysis of Data ----- 47

8.5 Improvement ----- 48

Section 9.0 Others

9.1 Procedures by ISO 9001 Requirement ----- 51

9.2 List of Quality Records ----- 53

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1.1 Quality Manual Confirmation1.1 Quality Manual Confirmation

Following the overall revision of the quality manual based on ISO 9001:2008, the

latest revision No. ‘18’ shall be applied to each requirement item below.

Section Title Page Revision Date

1.0

1.1

1.2

1.3

2.0

2.1

3.0

4.0

5.0

Table of Contents

Quality Manual Confirmation

Quality Manual Revision History

Scope of Application

Terms and Definitions

Organization Chart

Quality Policy

Quality Management System

Management Responsibility

1

2

3

4

5

6

7

8-13

14-19

Quality ManualQuality Manual

Section: 1.1 Quality Manual Confirmation1.1 Quality Manual Confirmation

Page: 1/1

Date: 03/15/2012

Revision: 22

LS Cable & SystemLS Cable & System

Page: 2

5.0

6.0

7.1

7.2

7.3

7.4

7.5

7.6

8.1

8.2

8.3

8.4

8.5

9.1

9.2

Management Responsibility

Resource Management

Planning of Product Realization

Customer-related Processes

Design and Development

Purchasing

Production and Service Provision

Control of Monitoring and Measuring Devices

General (Measurement, Analysis and Improvement)

Monitoring and Measurement

Control of Non-conforming Product

Analysis of Data

Improvement

Procedures by ISO 9001 Requirement

List of Quality Records

21 03/15/2012

14-19

20-21

22-23

24-26

27-30

31-32

33-35

36-37

38

39-44

45-46

47

48-50

51-52

53-54

The contents above have been duly confirmed.

March 15, 2012

Quality Management Representative

Manager of Quality Management office

Seung-jae, Choi

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1.2 Quality Manual Revision History1.2 Quality Manual Revision History

Revision Date Description

Enacted

1

2

3

4

5

6

7

8

9

10

Feb,1985

Oct,1986

Nov,1989

Feb,1993

May,1993

Jun,1993

Jan,1994

Jul,1994

Feb,1995

Jun,1995

Aug,1995

Enacted in English for use in overseas biddings.

Reflected organizational changes.

Revised in Korean and English for domestic use.

Overall revision to adopt ISO 9001 quality system.

Reflected the advices from the preliminary audit

by ISO 9001.

Reflected the advices from the initial audit by ISO 9001.

Reflected the organizational changes and

supplemented deficiency.

Reflected the advices from the periodical audit by ISO 9001.

Reflected the revision of ISO 9001(1994), organizational

changes, and the feedback from customers.

Reflected the results of ISO 9001 periodical audit and

the feedback from customers.

Reflected the results of ISO 9001 periodical audit.


Section: 1.2 Quality Manual Revision History1.2 Quality Manual Revision History

Page: 1/1

Date: 03/15/2012

Revision: 22


Page: 3

10

11

12

13

14

15

16

17

18

19

20

21

22

Aug,1995

Feb,1996

Jul,1996

Feb,1998

Sep,1998

Jun, 2001

Sep, 2002

Oct, 2003

Mar, 2005

July, 2008

Mar, 2009

April, 2011

Mar, 2012

Reflected the results of ISO 9001 periodical audit.

Changed the English expressions of the quality policy.

Added facility part to the organization chart and


Reflected organization changes and and


Revised following the establishment of

a corporate-wide integrated quality system.

Overall revision following the new ISO 9001:2000.

Revised the quality policy and the quality manual scope, etc.

Reflected the head office address changes

and reorganization details, etc.

Reflected the name of a company changes

LG Cable Ltd. to LS Cable Ltd

LS Cable splits into LS Corp., LS Cable Ltd. & LS Mtron Ltd.

Reflected the CEO and Organization changed .

Overall revision following the new ISO 9001:2008.

Revised numbering way of the procedures

Reflected the name of a company changes

LS Cable Ltd. to LS Cable & System Ltd

Reflected the feedback from customers.

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1.3 Scope of Application1.3 Scope of Application

This quality manual shall be the base for the implementation of LS Cable & System’s

quality management, and no subordinate Procedures documents shall supersede

this manual.

This manual is composed to satisfy the requirements of ISO 9001:2008,

which is to adopt ISO 9001 quality system, and the product family to be covered by

this manual shall include:

- Design and manufacture: Copper telecommunication cable, Power cable, Power

cable accessories, Control cables, Nuclear power plant cables, Rubber

floorings, Vibration absorbent rubbers, Connectors for electronics

equipment, Overhead AL conductor, OPGW (Optical fiber composite

ground wires), Anisotropic conductive films for display material, Appliance


Section: 1.3 Scope of Application1.3 Scope of Application

Page: 1/1

Date: 03/15/2012

Revision: 22


Page: 4

ground wires), Anisotropic conductive films for display material, Appliance

wiring materials, Busduct systems, Aluminum extruded products for

industrial applications

- Manufacture (excluding design): Magnet wire, Bare conductor, Communication

cable(LAN), Copper rods, Aluminum products for curtain walls.

Control of customer-supplied product and Control of special process, parts of ISO

requirements, are excluded from this quality management system.

Each individual department, however, may prepare and apply a separate quality

manual to meet customers’ special needs.

Currently, Quality Plans (ASME NQA, etc.) and Quality Manuals are separately

Implemented for TS/TL 9000-certified product family, electricity system, machinery

business division and for special customers.

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2.0 Terms and Definitions2.0 Terms and Definitions

The terms described below and others shall abide by ISO 9000:2008 / KS A 9000:2001

standards.

●Organization : A group of people and facilities with an arrangement of responsibilities,

authorities and relationships.

●Requirement : The need or expectation stated explicitly, or the need or expectation

implied generally or required obligatory

●Nonconformity : Non-fulfillment of a requirement

●Quality : The degree to which a set of inherent characteristics fulfils requirements

●Quality policy : Overall intentions and direction of an organization related to quality

as formally expressed by top management

●Quality management : Coordinated activities related to quality to direct and control

an organization

●Quality planning : Part of quality management focused on the setup of quality objectives


Section: 2.0 Definition of Terms.0 Definition of Terms

Page: 1/1

Date: 03/15/2012

Revision: 22


Page: 5

and specification of necessary operational processes and related

resources to fulfill the quality objectives

●Quality control : Part of quality management, focused on the fulfillment of quality

requirements

●Quality assurance : Part of quality management, focused on the provision of confidence

that quality requirements will be fulfilled

●Quality improvement : Part of quality management, focused on the improvement of

the ability to fulfill quality requirements

●Corrective action : Action taken to eliminate the cause of a detected nonconformity

or other undesirable situation

●Preventive action : Action to eliminate the cause of potential nonconformity or other

undesirable potential situation

●Quality manual : Document specifying the quality management system of an organization

●Quality plan : Document specifying which procedures and associated resources shall

be applied to a specific project , product , process or contract, and by whom

and when those shall be applied

●(Quality) Record : Document stating results achieved or providing evidence of activities

performed

●Audit : A systematic, independent process for obtaining audit evidence and evaluating

it objectively to determine the extent to which the agreed criteria are fulfilled.

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2.1 Organization Chart2.1 Organization Chart


Section: 2.1 Organization Chart.1 Organization Chart

Page: 1/1

Manager ofQuality Management Office

(Quality ManagementRepresentative)

Corporate-wideManagement

Review Meeting

Business Place/Division-wideManagement

Review Meeting

Chief Executive Officer(CEO)

Date: 03/15/2012

Revision: 22


Page: 6

1.This organization chart is prepared based on the quality management

functions, and the names and scale of them may be changed to reflect

the characteristics of each business place/division.

Business place and business division may have similar functions.

2.The scope of ISO 9001 certification shall include business areas

and common areas.

Executive Directors ofBusiness Place

Managers of Business Division(Directors)

Manager o

f Sta

ndard

Managem

ent D

ept.

Manager o

f Pers

onnel/E

ducatio

n D

ept.

Manager o

f Purc

hasin

g D

ept.

Manager o

f M

easurin

g E

quip

ment C

ontro

l Dept.

Manager o

f Fin

ancia

l Supportin

g D

ept.

Manager o

f Sale

s D

ept.

Manager o

f Pro

ductio

n C

ontro

l Dept.

Manager o

f D

esig

n &

Develo

pm

ent D

ept.

Manager o

f Pro

ductio

n D

ept.

Manager o

f QA/C

S D

ept.

Manager o

f pro

duct C

ontro

l Dept.

Manager o

f Busin

ess P

lannin

g D

ept.

Manager o

f Facilitie

s M

ain

tenance D

ept.

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3.0 Quality Policy3.0 Quality Policy

All executives and employees of LS Cable & System shall understand

the quality policy and fulfill the materialized quality objectives.


Section: 3.0 Quality Policy.0 Quality Policy

Page: 1/1

LS Cable & System, to provide the products and services that best meet

the needs and expectations of customers, shall establish Quality Policy

as follows:

Quality PolicyQuality Policy

Recognizing customers as the foundation of our existence,

we shall make our utmost efforts to commit ourselves to be

a reliable partner and to realize our customers’ satisfaction as

well as to comply with the law by delivering safe products and

services that meet their expectations and needs just in time.

Date: 03/15/2012

Revision: 22


The details of quality objectives are described in Section 5.

For efficient implementation of the quality policy, the quality control department

manager, as a quality management representative, shall have organizational

freedom independent of cost and delivery time, and shall have the responsibilities

and authorities to maintain and improve the quality system.

This emblem represents LS Cable & System’s

quality policy, and may be

used in various documents for internal

and external use.

John (Jong-Ho) Son

President & CEO

Seung-Jae, Choi

Quality Management Representative,

Manager of Quality Management Officer

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4.0 Quality Management System4.0 Quality Management System

1. Objective and scopeThis section describes the quality management system to ensure that the

customer’s needs and the requirements of ISO 9001 are satisfied in each and

every phase of the management activities, product realization, resource

procurement, and measurement/analysis/improvement, which shall enable

efficient operation of quality management system and provide relevant evidences.

2. Responsibilities and authorities1) The manager of quality management department shall:

- Establish a quality management system and enhance its effectiveness,

- Manage the enactment/revision of quality manual,

- Manage the latest version of quality manual,

- Manage the valid version of standards of business places (Anyang, Gumi,

Indong): Computer information systems for regulation,

- Manage quality record.

2) The manager of standard management department shall


Section: 4.0 Quality Management System.0 Quality Management System

Page: 1/6

Date: 03/15/2012

Revision: 22


Page: 8

2) The manager of standard management department shall

- Manage the valid version of company regulations which is a part of the

standards

: Computer information systems for regulation,

- Manage the valid version of standards of a business place (Head office)

: Computer information systems for regulation.

3) The managers of business divisions shall

- Implement the latest version of quality manual,

- Prepare and maintain standards,

- Maintain quality record.

4) The managers of production-related divisions may refer to/utilize the

quality plan or others to:

- Understand and apply the processes necessary for the quality management

system,

- Determine the sequence and correlation of processes,

- Determine the standard and method for the efficient operation and

management of processes,

- Ensure the availability of the information and resources to support the

operation and monitoring of processes,

- Monitor, measure and analyze processes,

- Implement the actions for the continued improvement of the planned

result (objective) of a process.

The processes, however, shall be managed in compliance with ISO 9001.

Subcontracting processes shall be monitored and managed by the quality

management system.

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Page: 2/6

3. Quality management matrix

SalesDesign &

DevelopmentPurchsing

Production

ControlProduction

Facilities

Maintenance

Measuring

Equipment

Control

General

Support

Standard

Management

Incoming

InspectionQA QM

General 4.1 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ●

General requirments 4.2.1 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ●

Quality manual 4.2.2 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ●

Document management 4.2.3 ● ● ● ● ● ● ● ● ● ● ● ●

Records management 4.2.4 ● ● ● ● ● ● ● ● ● ● ● ●

Management's commitment 5.1 - - - - - - - - - - ○ ●

Focus on customers 5.2 ○ ○ - - ○ - - - - - ● ●

Quality policy 5.3 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ●

Quality objective 5.4.1 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ●

Planning of QM system 5.4.2 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ●

Responsibilities and authorities 5.5.1 ○ ○ ○ ○ ○ ○ ○ ● ○ ○ ○ ●

QM representative 5.5.2 - - - - - - - - - - - ●

Internal communication 5.5.3 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ●

Management review 5.6 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ●

Quality

Managem

ent

Syste

mM

anagem

ent Responsib

ility

● Auditee/Dept. to be audited ○ Related Dept.ISO 9001:2000

RequirementsReq.

No.

Date: 03/15/2012

Revision: 22


Page: 9

Supply of resource 6.1 - - - - - - - ● - - - -

Personnerl assignment 6.2.1 - ● ● - - - - ● - ● ● ●

Training, recognition, capability 6.2.2 ● ● ● ● ● ● ● ● ● ● ● ●

Infrastructure 6.3 - - - - ● ● - ● - - - -

Work environment 6.4 - - - - ● - ○ - - ○ ○ -

Planning of product realization 7.1 ○ ○ ○ ○ ● ○ ○ ○ ○ ○ ● ○Determination of product-related

requirement7.2.1 ○ ● ○ - - - - - - - ○ -

Review of product-related requirements 7.2.2 ● ○ - ○ - - - - - - ○ -

Communication with customers 7.2.3 ● - - - - - - - - - ○ -

Design and development 7.3 ○ ● ○ - - - - - - - ○ -

Purchasing 7.4 - - ● ○ - - - - - ○ ○ -

Production and service provision 7.5.1 - - ○ ○ ● ● - - - - ○ -

Identification and traceability 7.5.3 - - ○ - ● - - - - ○ ○ -

Preservation of products 7.5.5 - ○ ○ ● ○ - - - - - - -Control of monitoring and measuring

devices7.6 - - - - ○ - ● - - - - -

General 8.1 ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ● ●

Customer satisfaction 8.2.1 ○ - - ○ ○ - - - - - ● ○

Internal audit 8.2.2 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ●

Monitoring & measuring of process 8.2.3 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ●

Monitoring & measuring of product 8.2.4 - - - - ● - - - - ● ● -

Control of nonconforming product 8.3 - - ○ - ● - - - - ● ● -

Analysis of data 8.4 - - - - ○ - - - - ● ● ●

Continued improvement 8.5.1 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ●

Corrective action 8.5.2 ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ● ●

Preventive action 8.5.3 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ●

Measure

ment, A

naly

sis

, Im

pro

vem

ent

Resourc

eM

anagem

ent

Pro

duct Realization

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Page: 3/6

※ Note (Fig.1): Quality management system based on process

Customer

InputRequirements

Continued Improvement of Quality Management System

Customer

Satisfaction측정,분석및개선

Measurement,

Analysis,

Improvement

측정,분석및개선

Management

Responsibility

측정,분석및개선Resource

Management

제품ProductOutput제품실현

Product

Realization

Date: 03/15/2012

Revision: 22


Page:10

External

customers

External

customers

Input A

Input B

Process A

Process B

Resource A

Resource B

Output A

Output B

Input CProcess C

Resource C

P

DC

A

Feedback

※ Note (Fig.2): Example of process network

Output C

Management by Process

Legend: Value-adding activities Information flow

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Page: 4/6

4. Document structure of quality management system

2) Quality manual: The supreme document that provides

the company’ QM system including a

quality policy.

3) (Quality) Procedures: As the document that specifies the

quality activities of individual business

place/division and is not subject to the

quality manual, it is divided into

regulation, directives and guidelines. 4) (Quality) Instruction: The standard that specifies quality

planning methods, finished goods, semi-finished goods,

materials, machinery & equipment, measuring equipment,

tools, fixtures and furniture, and work methods.

Quality

Manual

Procedures

Quality Record

Instruction

5) Quality record :The records resulting from quality system

activities.

1) Definitions: The names of quality system documents shall

be applied respectively in accordance with the

management standard of the business place.

Date: 03/15/2012

Revision: 22


Page:11

5. Objects of documentationThe objects to be documented shall be as follows:

- Quality policy and quality objectives

- Quality manual

- Documented procedures that ISO 9001 requires

- The documents that the company organizations require for efficient planning,

implementation and management of processes

- Quality records that ISO 9001 requires.

Here, the ‘documented procedures’ shall include the establishment, implementation

and maintenance of the documented procedures.

6. Management of quality manual1) Review and revision

- The manager of the quality management department shall review the

suitability of and revise the quality manual when customers and/or

certification authorities require or when a relevant domestic and/or foreign

regulation/standard is amended.

- The revised part shall be distinguished by drawing underlines or bar lines.

- The reason of each revision shall be stated in Section: 1.2.

2) Management of the latest version

Quality management department shall immediately retrieve the old version or

have the relevant department discard it so that the latest valid version may be used.

activities.

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3) Identification and management of a valid version

After the approval of the enactment/revision by an appropriate approver,



Page: 5/6

7. Document management

1) Documents

- Documents shall include the standards of the company, drawings and the

technical materials for external use.

- Quality record is a special type of document and shall be managed according to the

provisions in Paragraph 7 of this section.

2) The approver of enactment & revision of standards shall be as follows.

Classification Approver Managing Dept.

Company

Business

Place/

Division

Regulation Representative director Standard Management Dep’t

Guidelines Executive director Standard Managementl Dep’t

Directives Executive director QM office

Guidelines Manager of a preparing Dept. QM office

Instruction Manager of a preparing Dept. QM office

Date: 03/15/2012

Revision: 22


Page:12

After the approval of the enactment/revision by an appropriate approver,

documents shall be registered with the ‘Standard Management Dept.’ and

the management department shall, to make the new version distinguished, manage

them in the way like distributing the latest document or publishing it through an

information system to enable real-time search.

4) Process for managing documents and data

- Standard management department shall publicize a document and preserve

an original version according to the corresponding # Procedures document.

- The manager of design & development department shall perform their duty according

to the corresponding # Procedures document.

- The managers of relevant departments shall perform their duty according

to the corresponding # Procedures document to manage the documents and data

originated from outside.

5) Management of document amendment

- The revision of a document shall be reviewed by an originating department,

and shall be approved by a relevant approver.

- A revised part of a document shall be distinguished by underlines or bar lines.

- The revised version shall be distributed to the related departments

and the old version shall be retrieved or discarded.

6) Use of document

- A document shall be managed to be easily readable and available.

- The document obtained from outside shall be distinguished and recognized when it is

distributed.

- When no-more-valid documents are preserved for reference, they shall be

managed so as to be easily distinguished.

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8. Management of quality record

1) Objects of quality record

They shall include the quality records required by ISO 9001, which are described in

Section 9.2 List of quality records in this quality manual.

2) Preservation period of quality record

It shall be determined by the ‘Document classification system and preservation period

table (Filing system)’ of the company.

3) Management of quality record

- A category number shall be given to all quality records according to the ‘Document

Classification System’.

- All records shall be filed not only to protect, identify, search, store them but also to

easily recognize their preservation period and disposition status. In addition, the

archives shall be protected from inundation, fire, theft, insects and humidity.

- Other detailed jobs shall be performed according to the corresponding # Procedures

document.



Page: 6/6

Date: 03/15/2012

Revision: 22


document.

Page:13

9. Related procedures documents

1) Regulation for the management of company standards

2) Directives/Guidelines for the management of

quality record

3) Directives for the management of drawings

4) Directives for Spec., Design books and drawings, etc.

5) Directives for Technology Information sharing ststem

LSC-GM-00040

LSC-QM-XXXXX

LSC-ED-XXXXX

LSC-ED-XXXXX

LSC-RD-XXXXX

LSC-ED-XXXXX

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5.0 Management Responsibility5.0 Management Responsibility

1. Objective and scopeThis section describes the responsibilities, authorities, management’s commitment,

customer-oriented management, quality objectives, quality management system planning,

communication, and management review to ensure the implementation of quality

management system; its continued suitability, adequacy and effectiveness; the availability

of resources; and the communication in compliance with the quality policy.

2. Responsibilities and authorities1) Top management shall:

- Determine the total volume of resources,

- Approve the quality policy and the quality objectives of individual business division,

- Internally communicate the requirements of customers as well as statutory and

regulatory,

- Appoint a quality management representative and grant his/her responsibilities and

authorities,

- Approve a quality manual,

- Preside over a corporate-wide management review meeting (and also verify

the effectiveness of QMS).


Section: 5.0 Management Responsibility.0 Management Responsibility

Page: 1/6

Date: 03/15/2012

Revision: 22


Page:14

the effectiveness of QMS).

2) Executive directors of business place/division shall:

- Determine the resources of a business place/division,

- Approve the quality policy of a business place/division and the quality objectives of

a department,

- Approve quality procedures,

- Preside over a quality review meeting (and also verify the effectiveness of QMS).

3) The manager of quality management dept. (quality management representative) shall:

- Establish, implement and maintain QMS processes,

- Report the performance of QMS and the need for its improvement to top management,

- Have all organizations to well understand the requirements of customers.

The detailed method to fulfill the items above shall include:

·Preparation of a work allotment chart of the department,

·Enactment and revision of a quality manual, and management of the latest version

thereof,

·Maintenance and improvement of related Procedures documents,

.Collect and analyze monthly quality reports and perform management review on that,

·Role as a secretary of the management review meeting of a company/business place,

·Planning and fulfillment of internal quality audit; corrective actions for nonconformity;

review of validity,

·Management of qualifications of internal auditors,

·Planning and fulfillment of the training plan for the staff of the department,

·Maintenance of related quality records,

·Role as a contact point for customers and certification authority, if necessary.

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4) The manager of standard management department shall:

- Prepare a work allotment chart of the department,

- Use the latest version of quality manual,

- Maintain and improve relevant Procedures documents,

- Manage the valid versions of company regulations and head office standards,

- Plan and fulfill the training plan for the staff of the department.

5) The manager of purchasing department shall:



- Maintain and improve relevant procedures documents,

- Ensure that the purchased goods shall conform to the requirements of the organization,

- Order, purchase, store and release goods,

- Manage a material warehouse (where goods shall be managed separately by

category: Accepted, Rejected, Waiting for inspection),

- Handle abnormal materials and inform the supply partner of the fact,

- Evaluate and select suppliers and perform the related follow-up actions,

- Analyze the supplier’s data,

- Plan and fulfill the training plan for the staff of the department,



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- Maintain related quality records.

6) The manager of incoming inspection department shall:




- Maintain and manage the qualification of incoming inspectors,

- Prepare and implement incoming inspection specifications,

- Identify, inspect, and test the materials requiring an incoming inspection,

- Manage materials according to results of incoming inspection (where goods shall be

managed separately by category: Accepted, Rejected),

- Issue the NCR (Non-conformance report) for non-conforming materials,

- Request non-conformance corrective action (related supplier) and determine

the method of dispose the non-conforming materials,

- Analyze the supplier’s the quality data,

- Maintain related quality records,

- Plan and fulfill the training plan for the staff of the department.

7) The manager of education and training department shall:




- Identify the works affecting quality, and select and allocate the personnel thereof,

- Plan and fulfill the training plan and evaluate its effectiveness,


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8) The manager of facilities maintenance department shall:




- Identify the facilities to maintain and maintain the facilities and monitoring equipment,



9) The manager of measuring equipment control department shall:




- Identify and determine the monitoring & measuring equipment,

- Establish and fulfill the plan to inspect and correct measuring equipment,



10) The manager of sales department shall:





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- Maintain and improve relevant procedures,

- Identify and review the requirements of customers, statutory and regulatory,

- Perform follow-up actions based on the result of contract review,

- Communicate with customers regarding customer’s complaints and others,



11) The manager of production control shall:




- Present feedback on the contract review request, such as the production

capacity and the appropriateness of the delivery time,

- Establish a demand plan for materials and provide it to a purchasing department,

- Plan and adjust production schedules,

- Plan and fulfill the training plan for the staff of the department


12) The manager of product control and the partners of product control shall:




- Manage the packing, marking, storage, preservation and delivery of products,



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13) The manager of design & development department shall:- Prepare a work allotment chart of the department,- Use the latest version of quality manual,- Maintain and improve relevant Procedures documents,- Enact, revise, implement the specifications for materials, products, design, designdocuments, packing, etc.,

- Manage the planning, input, output, review, verification, validity and change of design & development,

- Perform technical review of the customer’s requirements, and the nonconformity ofmaterials and work in process,

- Manage internal and external drawings and data,- Manage the qualifications of designers,- Plan and fulfill the training plan for the staff of the department,- Maintain related quality records.

14) The manager of production department shall:- Prepare a work allotment chart of the department,- Use the latest version of quality manual,- Maintain and improve relevant Procedures documents,- Handle and perform a routine check-up of facilities, and monitoring/measuringdevices,

- Manage the establishment, revision, disposition of quality plan, work standards, and facility operation standard/work instruction,

- Perform interim/self-inspection and ask for the inspection of finished goods,



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- Perform interim/self-inspection and ask for the inspection of finished goods,- Monitor and measure processes (including process capacity and productcharacteristics),

- Issue the NCR (Non-conformance report) for process and perform a due action according to the decision on non-conforming products handling,

- Manage the lots traceability of products and materials, - Plan and fulfill the training plan for the staff of the department,- Maintain related quality records.

15) The manager of QA/CS department shall:- Prepare a work allotment chart of the department,- Use the latest version of quality manual,- Maintain and improve relevant Procedures documents,- Establish quality policy of the department and have the role as a secretary of the management review meeting,

- Identify product requirements and establish quality objective, - Prepare the specifications of inspection and plan/implement the inspection/test,- Analyze, manage and periodically monitor inspection data, - Collect and analyze monthly quality reports and perform management review on that, - Educate inspectors and manage their qualifications, - Issue the NCR for non-conforming finished products,- Decide the disposition of non-conforming products and re-verify the results ofcorrective actions,

- Establish, fulfill and report internal quality audit plan, - Issue a written request of the corrective action for nonconformity and complete the matter (including the check-up of its validity),

- Establish the identification & trace system of materials and products,- Receive and handle the dissatisfaction from customers,- Survey the reaction and the degree of satisfaction of customers,- Plan and fulfill the training plan for the staff of the department,- Maintain related quality records.

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5. Quality policy

4. Customer-oriented management Top management shall ensure that customer requirements are determined and fulfilled to

achieve the objective to enhance customer satisfaction.

The detailed implementation method shall be provided in Section 7.2 (Customer-related

processes) and Section 8.2 (Monitoring and measuring) of this quality manual.

3. Management’s commitmentTop management shall present the will to develop and implement the quality

management; to maintain the effectiveness thereof; and to continuously improve it through

the followings:

- Communication of the importance of fulfilling customer, statutory and regulatory

requirements

through the organization

- Ensuring the establishment of quality policy and quality plan

- Holding a corporate-wide management review meeting

- Ensuring the availability of resources

These may be confirmed through the presentation of related documents or interview with

the top management.



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6. Quality objectives and quality management system planning1) Planning of quality objectives

Top management shall ensure that the quality objectives are established by each

level of the organization according to related functions through the followings:

- Draw-up of consensus on the quality objectives of individual business division

- Draw-up of consensus on the quality objectives of individual department of

a business division

- The objectives of department manager and strategy agreement, etc.

These shall be prepared in the first quarter of each year.

The related materials thereof shall be filed and maintained so as to be easily available.

The quality objectives shall be directly related to the fulfillment of quality policy

and be measurable.

The grounds of quality objectives shall be individual objectives and/or strategy

agreement, and the monitoring/measuring records for the objectives shall be

monthly quality reports or management review records.

2) Planning of quality management system

Top management shall plan and fulfill the quality management system so as to

satisfy Section 4: Quality management system of this quality manual, and shall

ensure the completeness of the amendment when it is planned and implemented.

5. Quality policyQuality policy shall be provided in Section 3 of this quality manual.

Top management shall review the adequacy of the quality policy once or more a year

and amend it, if necessary.

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8. Management review1) General

- Top management shall hold corporate-wide management review meeting once or

more a year to ensure the suitability, adequacy and effectiveness of the

Quality Management System (QMS).

- Executive director of individual business place/division shall hold management review

meeting of the business place/division once or more a year for the same purpose

stated above.

- The topics of the management review meeting shall include quality policy, quality

objectives,the evaluation of the opportunity to improve QMS and the need for revision

thereof.

7. Internal communicationTop management shall ensure that the effectiveness of the quality management system

is adequately communicated within the organization through the followings.

- Meeting minutes or materials of corporate-wide quality management review meeting

- Minutes or materials of various meetings

- E-mail records or internal publications



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9. Related procedures documents1) Quality planning & Management Review Procedure' LSC-QM-00204

2) Directives/Guidelines for the management of quality record LSC-QM-XXXXX

thereof.

- The record of management review, as a quality record, shall be maintained

according to the # Procedures document.

2) Input for review

The input for review shall be as follows:

- Audit results

- Customer feedback

- Performance of processes and the conformity of a product

- Preventive actions and the status of corrective actions

- Follow-up actions for the result of a previous management review

- Planned amendment that may affect quality management system (e.g. external

environment, statutory and regulatory restriction)

- Other proposals for improvement, etc.

3) Output of review

The output of management review shall be as follows:

- Improvement of the effectiveness of the quality management system and its

processes

- Improvement of product in regard to customer requirements

- The necessity for resources

- Others including the implementation strategy for the organization and customers, etc.

Quality planning & Management Review Procedure'

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6.0 Resource Management6.0 Resource Management

1. Objective and scopeThis section shall be applied to the procurement of resources, human

resources, infrastructure and work environment, the purpose of which is to implement

and maintain the QMS of the company and to achieve the product conformity.

2. Responsibilities and authorities1) Each department manager shall:

- Prepare a work allotment chart of the department. (Follow the related # Procedure

document)

2) The manager of quality management department shall:

- Maintain and manage the qualifications of internal auditors (Follow the related

# Procedures document)

3) The manager of design & development department shall:

- Maintain and manage the qualifications of designers (design verifiers) (Follow the

related # Procedures document)



Section: 6.0 Resource Management.0 Resource Management

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- Maintain and manage the qualifications of inspectors for incoming inspection (Follow

the related # Procedures document)

5) The manager of quality assurance department shall:

- Maintain and manage the qualifications of inspectors (Follow the related # Procedure

document)

3. Procurement of resourceThe company and organization shall procure resources for the following purpose.

Here, the resources shall include human resources, material resources and financial

resources.

- Implementation and maintenance of the QMS and the continued improvement thereof

- Enhancement of customer satisfaction

4. Human resource

1) General

The standard of the qualifications - such as schooling, training, skill and career

– shall be established for the personnel who affect the product quality such as

those who perform internal quality audit, design & development and inspection

(incoming, product, etc.), and an appropriate qualifications shall be granted to them

and duly managed.

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2) As for the competence, awareness and training of the personnel, the followings shall be

fulfilled.

- Determine the competence requirements of the personnel who will perform the works

that affect product quality.

- Provide the training opportunity or others to satisfy the competence requirements.

- Identify the effectiveness of training or other actions.

- Recognize how well the organization members understand the importance and

correlation of their activities and the degree to which they contribute to the

achievement of the quality objectives.

- Maintain quality records (e.g. schooling, training, skill and careers).

Quality record shall include training plan, experience, careers, qualification-related

records, education certificates, records on the effectiveness of training, and job

capability, which shall be maintained according to # Procedures document.

5. InfrastructureThe company and organization shall determine, secure and maintain the infrastructure

required to achieve the conformity to product requirements, and shall:

- Manage buildings, offices, warehouses, and other facilities

- Perform the planning and preventive maintenance of the equipment for process (e.g.


Section: 6.0 Resource Management.0 Resource Management

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- Perform the planning and preventive maintenance of the equipment for process (e.g.

facilities, equipment, tools, and software) : according to the related # Procedure

document.

- Manage support services. (e.g. transportation equipment, communication, intranet, etc.)

A management department to perform these works shall be appointed.

6. Work environmentEach department manager shall determine the work environment necessary to achieve

product conformity, and which shall include the followings:

- Resting/meeting space

- Safety gears and safety rules

- Layout, etc.

7. Related procedures document

1) Regulation for human resource recruitment, etc. LSC-HR-XXXXX

2) Regulation for quality audit LSC-QM-00205

3) Guidelines for qualifications of design verifiers and designer LSC-HR-XXXXX

4) Guidelines for qualifications of inspectors LSC-QM-XXXXX

5) Directive for the management of facilities and machinery LSC-PM-XXXXX

6) Directive for training and education, Directive for OJT LSC-HR-XXXXX


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7.1 Planning of Product Realization7.1 Planning of Product Realization

1. Objective and scope

This section shall be applied to the planning of product realization to satisfy

the product requirements of customers.

2. Responsibilities and authorities


- Identify product requirements and establish quality objectives,

- Establish the product inspection & test plan including the criteria for acceptance and

rejection.

2) The manager of production department shall:

- Fulfill/use quality plan and QC process chart.

- Use # Quality specifications, etc.


Section: 7.1 Planning of Product Realization.1 Planning of Product Realization

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- Use # Quality specifications, etc.

3. Processes1) The manager of quality assurance department shall establish quality objectives for

each product within the first quarter of each year through objective consensus

meeting, etc.

2) The managers of production and related department shall plan and develop the

necessary processes for product realization.

The planning shall be consistent with the process requirements of the company’s

QMS and shall be fulfilled referring to the followings.

- Quality objectives and product requirements

- The needs for establishment/documentation of processes, and the needs for resource

procurement

- The methods of verification, validation, monitoring, inspection and testing related to

product requirements; and the criteria for product judgment.

- The records necessary for presenting the evidence of the conformity of finished goods

and of the realization processes, which shall be maintained according to the related

# Procedures document.

3) Quality record may vary depending upon the characteristics of business division/

department/product, which shall include QC process chart, production process

chart, work flow chart, etc.

4) The manager of production department shall utilize a quality plan for the relevant

products, and also prepare and utilize # Quality specifications

(work standard, design specifications, design books, etc.).

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4. Related procedures documents1) Quality specifications of each division

2) Directives/Guidelines for development work LSC-HR-XXXXX

Guidelines for quality assurance of new products LSC-HR-XXXXX

3) Directives/Guidelines for the control plan LSC-PP-XXXXX



Section: 7.1 Planning of Product Realization.1 Planning of Product Realization

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7.2 Customer7.2 Customer--related Processesrelated Processes

1. Objective and scopeThis section shall be applied to the customer-related processes in order to satisfy

customer requirements through the clear identification of customer requirements to

determine if the capability of the company and organization conforms to them.

2. Responsibilities and authorities1) The manager of sales department shall:

- Identify the customer, statutory and regulatory requirements,

- Review contracts and perform the follow-up actions thereof,

- Communicate with customers about customer dissatisfaction, etc.


- Fulfill the technical review of customer requirements (including the determination of

product requirements).

3) The manager of production control department shall:

- Review the suitability of the production capacity and delivery time.


Section: 7.2 Customer.2 Customer--related Processesrelated Processes

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3. Review and determination of product-related requirements1) The manager of sales department shall receive customer requirements and determine

the necessity for technical review, and ask a design & development department of the

review, if necessary.

Here, the customer requirements shall be identified and determined in regard to the

followings:

- The requirements specified by a customer (including the post-delivery actions)

- Other requirements necessary for the use of the product, even though they are not

specified by customers

- Statutory and regulatory requirements related to the product

- Additional requirements determined by the organization

However, for the existing products traded repeatedly, the manager

may identify only the additional requirements, while all the customer requirements

above shall be reviewed and determined for a new product.

2) When a sales department asks for technical review, the manager of design &

development department shall perform the review to check if the customer

requirements can be satisfied.

The result of the review shall be reported to the manager of sales, and the reporting

shall be done through phone or other media (e.g. E-mail, Fax, document).

The manager of sales department shall maintain the result of the review as a quality

record according to the related # Procedures document.

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3) The manager of sales department shall ask the manager of production control of the

delivery time review to check the suitability of supply capacity.

The manager of production control department shall inform the manager of sales

department of the review result.

The result of the review shall be reported to the manager of sales, and the method of

which shall be through phone or other media (e.g. E-mail, Fax, document).

The manager of sales department shall maintain the review result as a quality record

according to the related # Procedures document.

4) The manager of sales department shall identify the customer requirements before

agreeing on a contract if a customer does not present the requirements in a written

document.

5) When product requirements are changed, the manager of a relevant department

shall amend the corresponding documents and understand the changed requirements.

To do this, the changes, as a quality record, shall be managed in the form of records or

a changed contract document according to the related # Procedures document.

6) The manager of sales department shall ensure the followings before concluding a

contract with a customer.

- Determination of product requirements



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- Determination of product requirements

- Adjustment of the difference between the contents of a final contract and those of a

previous contract or requirements.

- Securing of the capability to fulfill customer requirements.

Page:25

4. Report of order reception 1) After concluding a contract, the manager of sales department shall issue a shipping

request and send it to the production control department and related departments.

2) The contents of a shipping request shall include a serial No., customer name, delivery

time, quantity, specifications, etc.

5. Establishment of production plan1) The manager of production control department shall establish a production

schedule that reflects the delivery time of a shipping request.

2) If there is a need to change the production schedule or if something unexpected

happens, the manager of production control department shall immediately report

the fact to a sales department, and the method of which shall be through phone or

other media.

The records on the agreement of a delivery time adjustment shall be maintained as a

quality record according to the related # Procedures document.

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6. Method of communication with customers1) The manager of sales department shall determine an efficient way to communicate

with customers in regard to the followings, and which shall be specified in a related


- Product information

- How to handle the questions, contracts and orders including changes.

- Customer feedback including customer complaints.

2) The examples of the method to communicate with customers are as follows:

- Holding a regular meeting with customers, visit of site, exchange of documents, etc.


7. Survey of customer satisfactionThe manager of quality assurance department shall perform the survey of customer

satisfaction according to Section 8.2 of this manual.



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8. Related procedures documents 1) Directives for the handling of customer dissatisfaction LSC-QM-00047

2) Directives for contract review work LSC-SD-XXXXX

3) Directives for customer satisfaction LSC-QM-XXXXX

4) Directives/Guidelines for quality record management LSC-QM-XXXXX

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7.3 Design and Development7.3 Design and Development

1. Objective and scopeThis section shall be applied to the planning of design & development, input, output,

review, verification, validity check and change management of products, in order to

efficiently satisfy the needs and expectations of customers and increase the value of

products.

2. Responsibilities and authorities1) The manager of design & development department shall:

- Establish, revise and implement the specifications of products, materials, design and

design drawings,

- Fulfill the planning of design & development, inputs, outputs, review, verification,

validity check and change management of products,

- Fulfill the technical review of the nonconformity of materials and work-in-process,

- Manage internal and external drawings/data.


- Support audit and evaluation activities for design & development verification, etc.

3. Process of design and development


Section: 7.3 Design and Development.3 Design and Development

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3. Process of design and developmentThe manager of design & development department in business division shall perform

his/her duties according to the related # Procedures document, and shall maintain

the quality record thereof according to the related # Procedures document.

4. Planning of design and development1) Business division shall establish an annual plan of design & development and

prepare/fulfill a detailed development plan for each project or item. A detailed

development plan shall include the followings:

- Phases and timeline of design & development process

- Activities for review, verification and validity check for each phase of design &

development process

- Determine the roles (responsibilities and authorities) of those who participate in the

design & development activities.

2) The manager of design & development department shall evaluate the qualifications of

design verifiers according to the related # Procedures document, and shall maintain the

quality record thereof according to the related # Procedures document.

3) For efficient communication and more clear definition of responsibilities & authorities,

the manager of design & development department shall identify and manage the

relations to other organization/department. To do this, he/she may:

- Check the departments that will participate in a design & development review meeting

and demonstration.

- Check the departments where a related document will be distributed and shared.

- Check the support departments that will support the inspection/evaluation work for

internal/external verification, etc.

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4) The manager of design & development department shall update and maintain

a detailed development plan so as to check the latest status of the progress.

5. Inputs for design and development1) The manager of design & development department shall input the product requirements

including the followings:

- Functions and performance requirements of a product

- Statutory and regulatory restriction requirements to be applied

- The information derived from a previous similar design, if possible.

- Other requirements that are essential for design and development

2) The manager of design & development department shall review the inputs for design to

ensure that the requirements are complete, clear and non-contradictory to other

requirements.

3) The input records for design & development, such as a detailed development plan,

shall be maintained as a quality record according to the related # Procedures document.



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6. Outputs of design and development1) The form of outputs of design and development shall include LS Spec. (product design

documents for customer) or other documents, and the other examples shall be

the data comparing the inputs and outputs of a process, the specifications for

materials, test, purchasing and products.

2) The outputs of design and development shall be presented in the form that can

be verified against their inputs, and shall be approved before distribution.

3) The outputs of design and development shall necessarily:

- Satisfy the input requirements for design & development,

- Provide appropriate information necessary for purchasing, production and

service provision.

- Include or make reference to the product acceptance criteria,

- Identify the product characteristics that are essential for safe, proper and right use

of the product.

7. Review of design and development1) At appropriate stages of design & development, the manager of design & development

department shall:

- Evaluate the result of design and development that meets the product

requirements,

- Identify problems and present proper actions for them.

2) The personnel who have the capability required by the # Procedures document of

the relevant business division shall participate in the design and development stages.

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3) For the topics of the design and development review, the followings may be quoted or

referred to:

- The suitability of the input for design and development

- The progress of the design and development

- Verification, validity check and the possibility of achieving the objectives of design and

development

- Evaluation of the potential risks and defects in the use of a product

- Life cycle data on the product performance

- Management of changes in design and development

- Identification and correction of problems

- The opportunity of improvement in design and development

- The potential impact of product on environment.

4) The records of such design & development review shall be maintained as a quality

record according to the related # Procedures document.

8. Verification of design and development 1) The manager of design & development department shall verify the followings to ensure

that the outputs of design and development meet their input requirements.

2) The stages of design and development shall be specified in and implemented



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2) The stages of design and development shall be specified in and implemented

according to the # Procedures document of the relevant business division and here,

the followings may be quoted/referred to.

- Comparing the input requirements with the outputs of processes

- Verification through alternative calculations

- Performing verification/certification tests

- Performing simulation and test operation

3) The records of design & development verification and the actions thereof shall be

maintained as a quality record according to the related # Procedures document.

9. Validation of design and development1) The manager of design & development department shall perform product validation

according to a planned method, to check if the product resulting from the design and

development meets the requirements that are specified or intended.

2) The validation shall be completed before the delivery or implementation/mass-

production of the product, and the process of which shall be specified in and conducted

according to the related # Process document.

3) For the validation of design and development, the followings may be quoted/referred to.

- A presentation for evaluation before mass-production or internal/external

certification and approval tests

- Validation of the engineering design before starting construction, installation or

application of it

- Validation of the software output before installation or use of it

4) The records of design & development validation and the follow-up actions thereof

shall be maintained as a quality record according to the related # Procedures

document.

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10. Management of the changes in design and development1) The manager of design & development department shall identify the changes

in design and development and fulfill follow-up actions thereof.

2) The manager of design & development department shall, if necessary, review, verify

and validate the outputs of design and development, and which shall be duly

approved before fulfilling them.

The objects of the review shall include the impacts of the changes of constituent parts

and the products that have been already delivered.

3) The records of the changes and the follow-up actions thereof shall be maintained as a

quality record according to the related # Procedures document.

11. Management of the design documents, etc.1) The manager of design & development department shall maintain the results of

the design and development, Specifications and design documents and according to

the related # Procedures document.

2) The manager of design & development department shall manage the internal/external

drawings, etc. which are applied to design and development activities according to the

related # Procedures document.


Section: 7.3 Design and development.3 Design and development

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Page:30

12. Related procedures documents1) Directives/Guidelines for development work, LSC-RD-XXXXX

Guidelines for quality assurance of new products LSC-RD-XXXXX

2) Directives for the management of drawings

3) Directives/Guidelines for the management of Specifications LSC-ED-XXXXX

and drawing documents

4) Guidelines for qualifications of design verifiers and designer LSC-RD-XXXXX

5) Directives for the management of mold LSC-PP-XXXXX


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7.4 Purchasing7.4 Purchasing

1. Objective and scopeThis section shall be applied to the purchasing process, purchasing information, and the

verification of the purchased goods, so that the purchased goods that affect

quality shall satisfy specified requirements.

2. Responsibilities and authorities1) The manager of purchasing department shall:

- Ensure that the purchased goods satisfy the requirements of the organization,

- Order, purchase, store and release the goods to purchase,

- Manage a material warehouse (where goods shall be managed separately by

category: Accepted, Rejected, Waiting for inspection)

- Handle abnormal materials and inform the supply partner of the fact.

- Evaluate and select suppliers and perform related follow-up actions.



Section: 7.4 Purchasing.4 Purchasing

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Page:31


- Prepare and operate a standard for incoming inspection,

- Manage the qualifications of incoming inspectors,

- Identify, inspect and test the materials which require incoming inspection,

- Manage materials according to results of incoming inspection (where goods

shall be managed separately by category: Accepted, Rejected),

- Determine the method of dispose the non-conforming materials,


- Prepare and manage the specifications of raw materials.

4) The manager of production control shall:

- Establish a plan for materials provision and report the information to the purchasing

department,

- Inform the purchasing department of a changed production plan, if any.

3. Purchasing process1) The manager of purchasing department shall specify the purchasing process in the

related # Procedures document and fulfill it, thus to ensure the suitability of products.

2) The manager of purchasing department shall specify the method and the degree of

managing purchased goods and suppliers in the related # Procedures document in

various ways depending on their impact on the following implementation process or

the final product.

3) The manager of purchasing department shall evaluate and select partners based on

their supply capacities according to the related # Procedures document.

Here, all the records on the evaluation, re-evaluation and selection of the partners shall

be maintained according to the related # Procedures document as a quality record.

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4. Purchasing information1) The managers of production control department and all the departments

using materials shall establish a demand plan and check their inventories and then

report the necessary quantity to a purchasing department in a written form or through

computer system.

The report on the necessary quantity shall include item name, specification, quantity,

use and delivery time of it, etc.

For the details of purchase request, the related # Procedures document shall be

followed.

2) The manager of design & development department shall prepare a material

specification – a purchasing standard – for the materials that affect quality,

and report it to the purchasing department.

A material specification shall basically include item name, its specification, class,

items & method of test, packing, prints, quoted standard, etc.

3) The manager of purchasing department shall clearly state the followings and others

when preparing a purchasing document, if applicable.

- The requirements on product, procedure, process, facilities and equipment

- The requirements on the qualifications of related personnel


Section: 7.4 Purchasing.4 Purchasing

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- The requirements on the qualifications of related personnel

- The requirements of QMS

4) The manager of purchasing department shall ensure the suitability of requirements of

the purchasing document before communicating with a supplier.

5. Verification of purchased goods1) The manager of incoming inspection department shall perform the incoming inspection

according to the related # Procedures document. The qualifications of the incoming

inspectors shall be managed according to the related # Procedures document.

2) The manager of incoming inspection department shall determine how to handle the

abnormal materials resulting from the incoming inspection, and inform the supply

partner of the fact.

3) If a customer or the manager of incoming inspection department verify purchasing

goods at supplier’s site, the purchasing information which includes the method of

verification and shipment shall be reported to a supplier.

6. Related procedures documents1) Guidelines for purchasing work LSC-MM-00001

2) Guidelines for outside order management of products LSC-MM-XXXXX

3) Guidelines for material ordering work LSC-MM-00002

4) Guidelines for evaluation of logistic partners LSC-MM-00015

5) Guidelines for evaluation and management of partners LSC-MM-00014

6) Guidelines for incoming inspection LSC-QM-00215

7) Guidelines for the management of inspectors’ qualifications LSC-QM-00217


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7.5 Production and Service Provision7.5 Production and Service Provision

1. Objective and scopeThis section, with the purpose to satisfy customer requirements and manage the product

realization process to provide interested parties with benefits, shall be applied to the

management of production and service provision, validation, identification and traceability

of processes, and the preservation of product.

2. Responsibilities and authorities1) The manager of production department shall:

- Prepare and implement # Quality standards including work standard work sheets,

- Preserve and maintain facilities and monitoring equipment,

- Manage the lots traceability of products and materials, if applicable.


- Prepare and register # Quality standards (of packing materials and printing methods).

3) The manager of QA department shall:


Section: 7.5 Production and Service Provision.5 Production and Service Provision

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- Establish the identification & trace system of materials and products.

4) The manager of purchasing department shall:

- Manage the incoming and outgoing of materials.

5) The manager of product control department and the partner for product

control shall:

- Manage the packing, marking, preservation and delivery of products,

- Manage the shipment of products.

6) The manager of facilities maintenance department shall:

- Maintain facilities and monitoring equipment.

3. Management of production and service provision1) The manager of production control department shall, before starting production,

identify the name, specification, and delivery time of the required product and establish

a production plan for the planned periods according to the related # Procedures

document.

The job instructions shall be issued and the workers, standard work sheets and

necessary facilities shall be designated according to the production plan.

2) The manager of production department shall secure proper 4M (operators, facilities,

materials, standards) and environment, and perform production activities.

The manager of production department shall proceed with the production according

to the method specified in a # Quality standards (quality plan, standard work sheets,

job instructions, etc.) for the corresponding process.

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3) Operators shall fulfill their duties in compliance with standard work sheets, etc.4) In operating and managing the facilities and monitoring equipment which are input

into production, the managers of production and facilities maintenance departmentsshall follow the related # Procedures document.

5) An operator shall perform interim/self-inspection of the inspection items that arespecified in standard work sheets.

6) The manager of product control department or the partner of product control shall perform the release and delivery of product and post-delivery activities accordingto the related # Procedures documents.



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4. Validation of processes for production and service provision1) The organization shall validate any processes for production and service provision

where the resulting output cannot be verified by subsequent monitoring ormeasurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

2) Validation shall demonstrate the ability of these processes to achieve planned results.3) The organization shall establish arrangements for these processes including,

as applicable- defined criteria for review and approval of the processes,- approval of equipment and qualification of personnel,

Page:34

5. Product identification and traceabilityIdentification and traceability shall be applied to customer requirements or contracts, andshall be implemented according to the # Procedures document prepared by the relevantbusiness division.1) The manager of quality assurance department of a business division shall establish

a system for the identification and traceability of materials and products, and therelated managers of departments (e.g. the departments of purchasing and production,and product related departments) shall be responsible for the operation of the system. - Materials, semi-finished goods and finished goods shall be identified through the way that can trace each stage.

- The status of the stored materials shall be identified in due manner. (e.g. stickers, notice boards, stamping, etc.)

- The status of semi-finished goods and finished goods shall be identified by tags orrecords.

2) The managers of relevant departments shall establish the log management principle, and the followings may be referred to for it. - Lots shall be formed in a certain size for materials, semi-finished goods and finishedgoods.

- The formed lots shall be identified by giving them process codes and recording themin daily work sheets and tags

This records shall be maintained according to the related # Procedures document as aquality record.

- approval of equipment and qualification of personnel,- use of specific methods and procedures,- requirements for records- revalidation.

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6. Preservation of productsThe manager of a relevant department shall define the procedures for identification,

handling, packing, storage and protection of materials or products in the related

# Procedures document and implement it, in order to prevent the damage or loss of them.

1) The manager of a relevant department shall use transportation means that can protect

materials or product from damages while moving them, and their drivers shall have

due qualifications.

2) The manager of design & development department shall prepare the # Quality

standard for the packing materials and its printing methods, and register it with

a standard management department.

The manager of product control department shall perform the packing and printing

work according to the relevant # Quality standard.

3) The manager of a relevant department shall store the materials or products which

require special treatment to prevent damage or quality deterioration in an appropriate



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3) The manager of a relevant department shall, if necessary, specify and fulfill the method

of separate storage of lots based on the inspection result so that their status can be

identified.

Page:35

require special treatment to prevent damage or quality deterioration in an appropriate

place.

4) The manager of a relevant department shall release or ship the stored materials or

products in FIFO (First-in, First-out), and check their status before using or shipping

them if they are long-term supplies.

The storage and release of materials shall be performed according to the related


5) The manager of product control department shall classify and store the preserved

goods according to the related # Procedures document. Here, the preserved goods

shall include constituent parts.

7. Related procedures documents1) Quality standards in Devisions

2) Directives for production control LSC-PD-XXXXX

3) Directives for production work LSC-PP-XXXXX

4) Directives for process control work LSC-SD-XXXXX

5) Directives/Guidelines for the management & trace of lots LSC-PP-XXXXX


7) Directives for handling, storage and shipment of products LSC-PD-XXXXX

8) Guidelines for the incoming and outgoing of materials LSC-PD-XXXXX

9) Directive for the management of facilities and machinery LSC-PM-XXXXX

10) Directive for the management of 4M changes and LSC-PP-XXXXX

process changes

11) Directives/Guidelines for quality record management LSC-QM-XXXXX

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7.6 Control of Monitoring and Measuring Devices7.6 Control of Monitoring and Measuring Devices

1. Objective and scopeThis section shall be applied to the control of monitoring and measuring

devices to ensure the conformance of products to the determined product

requirements.

2. Responsibilities and authorities1) The manager of measuring equipment shall:

- Identify and determine the equipment for measurement (monitoring and measuring

devices),

- Establish and implement the inspection/calibration plan for measuring devices.


- Handle, check and maintain the equipment for measurement (monitoring and

measuring devices).


Section: 7.6 Control of Monitoring.6 Control of Monitoring

and Measuring Devicesand Measuring DevicesPage: 1/2

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Revision: 22


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3. Establishment of process for monitoring and measuring activitiesThe manager of measuring equipment control department shall specify the monitoring

and measuring activities that conform to the requirements in the related # Procedure

document and perform it.

4. The measuring equipment to be managed1) The scope of the equipment to be managed shall include the equipment for

inspection, measuring and testing, and the monitoring equipment attached to facilities

2) The manager of measuring equipment department shall provide a unique number to

each equipment to be managed and maintain a equipment register, etc.

5. Plan for calibration and check-up period1) The manager of measuring equipment control department shall establish a plan for

calibration and check-up period for the equipment that monitors and measures product

quality.

2) The calibration and check-up period of the relevant equipment shall be determined

in consideration of its use condition and environment, and the plan shall be periodically

updated.

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6. Inspection and calibration1) The manager of measuring equipment control department shall inspect and calibrate

the measuring equipment according to the specified period or before starting using

them, based on the measurement standard that satisfies internal/domestic standards.

If there is no such standard, a separate # Procedures document for calibration shall

be prepared and the inspection and calibration activities shall be performed upon

it, and the records of which shall be maintained according to the related # Procedure

document as a quality record.

2) The result of calibration shall be recorded in a calibration performance book and

maintained in a measuring equipment room along with equipment history cards.

After the completion of calibration, a ‘certificate of calibration’ shall be attached to the

accepted equipment. If a direct attachment is difficult, it shall be presented in an

appropriate manner that the equipment have been duly calibrated.

The records on the result of inspection and calibration shall be maintained according

to the related # Procedures document as a quality record.

3) When using the hardware (Jig, mold, etc.) or software for inspection and testing, the

manager of the department that uses them shall periodically check their conformity to

the specified requirements and status before using them.


Section: 7.6 Control of Monitoring.6 Control of Monitoring

and Measuring Devicesand Measuring DevicesPage: 2/2

Date: 03/15/2012

Revision: 22


Page:37

the specified requirements and status before using them.

7. Management of equipmentThe manager of measuring equipment control department shall safeguard measuring

equipment from adjustments that would invalidate the calibration setting.

The reference instruments that are used for inspection and calibration based on the

calibration Procedures document shall be stored and managed in the measuring

equipment room where standard criteria are maintained.

8. Retroactive actions for abnormal equipment1) When a man being responsible for the management of measuring equipment finds the

defect of the equipment in use or under calibration process shall immediately inform

the fact to the using departments and take appropriate action for the rejected

equipment according to the related # Procedures document.

2) The using departments shall retroactively validate the previous data measured by the

rejected equipment and take appropriate action.


1) Directives for the management of measuring equipment LSC-PP-00029

2) Directives for the management of test room LSC-QM-XXXXX


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8.1 General (Measurement, Analysis, Improvement)8.1 General (Measurement, Analysis, Improvement)

This section describes the procedures for planning and implementing the processes

of monitoring, measurement and continued improvement.

Quality assurance, quality management and other related divisions shall plan and

implement the processes that are required for the followings:

1) Verification of product conformity through inspection and testing, etc.

2) Ensuring of the suitability of quality management system

3) Continued improvement of the effectiveness of quality management system

The processes shall include and follow the stages:

Monitoring → Measurement →Analysis →Improvement.

To do this, each relevant department manager shall determine applicable

method and frequency including statistical techniques.


Section: 8.1 General (Measurement, Analysis, .1 General (Measurement, Analysis,

Improvement)Improvement)Page: 1/1

Date: 03/15/2012

Revision: 22


Page:38

method and frequency including statistical techniques.

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8.2 Monitoring and Measurement8.2 Monitoring and Measurement

1. Objective and scopeThis section shall be applied to customer satisfaction, internal quality audit, processes,

and monitoring & measuring activities in regard to product.

2. Responsibilities and authorities

1) The manager of quality management department shall:

- Establish, implement and report annual plan of internal quality audit,

- Manage the qualifications of quality auditors,

- Issue and conclude the request of corrective action for nonconformance,

- Collect and analyze monthly quality reports, and perform the management review

thereof.

2) The manager of QA/CS department shall:


Section: 8.2 Monitoring and Measurement.2 Monitoring and Measurement

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2) The manager of QA/CS department shall:

- Survey customer reaction and satisfaction,

- Establish, implement and report internal quality audit plan,

- Issue and conclude the request of corrective action for nonconformance,

- Collect and analyze monthly quality reports, and perform the management review

thereof.

- Establish inspection/testing plan,

- Manage the qualifications of inspectors,

- Inspect finished goods (or work-in-process).


- Inspect the work-in-process,

- Request for the inspection of finished goods.

4) The managers of the departments fulfilling corrective actions shall:

- Fulfill the corrective actions for the issued nonconformance

(Identify the causes and establish a plan to prevent recurrence)


- Fulfill incoming inspection,

- Maintain and manage the qualification of incoming inspectors.

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3. Monitoring of customer satisfactionThe manager of QA/CS department shall survey customer reaction and

satisfaction for the customer requirements, which is one of the way measuring the

performance of quality management system, according to the related # Procedure

document as follows:

1) The manager of QA/CS department shall establish and fulfill an annual

plan to survey not only the complaints received from customers but also the customer

satisfaction, and a plan for periodical tour survey of quality, etc., and shall report

the results to the general manager of his/her business division.

2) In surveying the customer reaction and satisfaction, the followings shall be considered.

- When a new product is released or it is the first trade

- When potential customer complaints are expected

- When it is required to immediately check the effectiveness of the actions against

customer dissatisfaction

- When a fatal customer complaint occurs or the same complaint occurs repeatedly

3) Monitoring of customer satisfaction may be fulfilled through interview, consulting or

questionnaires, and the results shall be collected using paper or electric document.



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4. Internal quality auditInternal quality audit shall be conducted in order to identify the suitability of the customer

requirements including product requirements and the quality management system of the

company, and to check if the quality management system is effectively implemented and

maintained, and which shall be performed according to the related # Procedures

document.

The records on the planning and conducting of internal quality audit, ensuring of audit

independence, and the results thereof shall be maintained as a quality record, according

to the related # Procedures document.

1) Audit plan

- The manager of quality management (quality assurance) department shall establish

an annual internal quality audit plan which includes:

·Summary of the previous audit result

·Purpose

·Scope

·Organization of audit team

·Audit schedule

·Applicable ISO requirements / Audit check list / Quality procedures documents

- Audit plan shall be duly approved and maintained as a quality records, according

to the related # Procedures document.

2) Organization of audit team

- The manager of quality management/quality assurance department shall organize

an audit team, according to the related # Procedures document.

- An auditor shall not audit his/her own job, and therefore the independence of audit

shall be guaranteed in audit planning/establishment stage.

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- An audit team shall consist of a senior auditor and auditors, and auditors shall be

appointed according to the related # Procedures document.

- The records on the qualifications of the auditors shall be maintained as a quality

record, according to the related # Procedures document.

3) Conducting of audit

- When an audit plan is completed, the manager of quality management/quality

assurance department shall report the audit plan to related departments so that they

may prepare for it.

- The base of nonconformance found during audit, such as a related quality procedure

document, shall be clearly stated.

In addition, the nonconformance shall be explained in the manner that the manager of

the audited department may identify the reason and find the direction for appropriate

actions for it.

- When there occur important matters between an auditor and an auditee, the auditor

shall immediately report the matter to a quality management representative, thus to

take a proper action.

(For example, interference with audit activities, change of audit schedule by the



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(For example, interference with audit activities, change of audit schedule by the

department to be audited, audit delay, etc.)

4) Reporting of audit result

- The manager of quality management/quality assurance department shall report the

result of an internal quality audit, which shall includes:

·Audit scope

·Type of audit

·Period of audit

·Auditors

·Auditee and the audited department

·Summary of an audit result (which shall state the effectiveness of quality

management system.)

·Findings of nonconformance

- Audit result shall be feed-back to the relevant department manager.

- Audit report shall be duly approved, and shall be maintained as a quality record,


5) Corrective actions for nonconformance

- The manager of quality management/quality assurance department shall issue a

letter requesting corrective actions for the nonconformance found during audit to a

relevant department, and the letter shall include:

·Issue No.

·Date of issue

·Receiving department

·Corrective actions required

·Reason for nonconformance

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·Plan to prevent recurrence

·Expected date of completion

·Confirmation of the result of the actions taken and conclusion, etc.

- The relevant department shall identify the cause of nonconformance and establish

a plan to prevent recurrence and report the result to the requesting department

within a due date.

- If the corrective action cannot be completed within a due date, the requested

department shall report a plan that clearly states a completion schedule.

- The department requesting corrective actions may request additional actions from

the requested department again, if the actions taken are not sufficient.

- The letter requesting corrective action shall be duly approved, and shall be

maintained as a quality record, according to the related # Procedures document.

6) Confirmation of the result of the actions taken and conclusion

- The department requesting corrective actions shall validate the result of a

corrective action.

- After the result of a corrective action is duly validated, the requesting

department shall conclude the matter by signing the letter requesting corrective

action.



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5. Monitoring and measuring of processQuality management process shall include customer-related matters, product

realization (design, purchasing, production and measurement), internal audit and

improvement process, etc., and shall be implemented according to the followings:

1) Setup of management objective

- Quality assurance department shall set up and monitor the performance of last year,

objective of this year and monthly performance specially for product quality.

2) Collection of process management items and data

- Each business division shall collect the date that will be recorded in a monthly quality

report.

3) Arrangement and analysis of data

- Quality management/quality assurance department shall collect and analyze monthly

quality reports, and the result of which shall be reported in a management review

meeting.

4) Corrective action for nonconformance

- Depending on the result of management review, quality management/quality

assurance department shall, if necessary, take corrective actions and preventive

actions for the process whose performance does not reach the objective.

5) Components of monthly quality report

- Quality management/quality assurance department shall manage the components of

a monthly quality report including the followings:

·The overall status of customer dissatisfaction (or that by region)

·The status of customer dissatisfaction by business division

action.

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6. Monitoring and measuring of productTo verify the product requirements, the characteristics of a product shall be monitoredand measured as follows, according to the related # Procedures document. 1) General

- Inspector/tester shall have the authority independent of cost and delivery time. - In case of a contract item, the manager of quality assurance department shallprepare an inspection & test plan and have it approved by a relevant customer.

·List of customer complaints for the year

·The overall status of a product quality (or that by region)

·Detailed product quality of each business division

·Analysis of quality trend, etc.

6) Other applicable items except for monthly quality report.

- For the items of internal quality audit, Paragraph 4 of Section 8.2 in this manual shall

be referred to.

- For the items of improvement process, Section 8.5 of this manual shall be referred to.

- Other items shall be determined autonomously by an individual business division and

shall be shared through management review meeting of the division.

(e.g. Rate of meeting delivery time, Index of process capacity, Rate of rework, # of

repairs, cost of disposition, etc.)



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prepare an inspection & test plan and have it approved by a relevant customer. - Inspector/tester who has the qualifications specified in the related # Proceduredocument shall be selected and the records thereof shall be maintained as a qualityrecord, according to the related # Procedures document.

- If a critical quality problem occurs during inspection/testing, the manager of qualityassurance department shall have the authority to stop the relevant work by usingthe NCR (Non-Conformance Report)

- Product release and service delivery shall not proceed until the planned arrangements (Section 7.1 Planning of product realization) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable,by the customer.

- Non-conforming product shall be handled according to Section 8.3 of thismanual.

- The records on inspection/testing shall include the judgment result: Accepted or Rejected, and shall be maintained as a quality record, according to the related #Procedures document.

2) Inspection & test plan- The manager of quality assurance department shall establish an inspection & test plan based on customer requirements, LS Spec., quality plan and quality proceduredocument, and which shall include inspection items, applied standards and judgmentcriteria, etc.

- The method of inspection/test and sampling plan shall follow relevant standards.3) Setup of hold point

- In case of a contract item, the manager of quality assurance department shall set holdpoints in an inspection/test plan or quality plan and have them approved by a relevantcustomer.

- At the hold points designated by a customer, the relevant process shall not becontinued arbitrarily without the permission or consent of relevant personnel.

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4) Incoming inspection

- Incoming inspector shall test and identify the materials whose quality needs to be

checked, according to the related # Procedures document.

- The materials requiring inspection shall be managed not to be input into

production process before being checked. In a situation where the materials

must be input before checking, however, proper action shall be taken to trace and

identify the relevant products.

- Inspection result shall be maintained as a quality record, according to the related


5) Inspection of work-in-process

- Inspection of work-in-process shall be fulfilled by the inspector or the worker of

a production department to whom the inspection duties are delegated, according to

the relevant procedure.

- The manager of production department shall, if necessary, use proper monitoring

devices such as spark tester, eddy current tester, diameter analyzer, concentricity

tester, etc. in the production line to ensure that the production process is fulfilled in

accordance with a specified standard.



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7. Related procedures documents1) Regulation/Guidelines for handling customer dissatisfaction LSC-QM-00047

2) Directives/Guidelines for quality audit LSC-QM-00205

3) Directives/Guidelines for internal audit LSC-QM-XXXXX

4) Regulation for inspection LSC-QM-XXXXX

5) Guidelines for qualifications of inspectors LSC-QM-00217



Page:44

accordance with a specified standard.



6) Inspection of finished goods

- The manager of production department shall be responsible for the inspection of

finished goods.

- The manager of quality assurance department shall verify the product conformity to

a relevant requirement.

- The manager of quality assurance department shall transfer only the accepted

finished goods to a product control department.



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8.3 Control of Non8.3 Control of Non--conforming Productconforming Product

1. Objective and scopeThis section shall be applied to the management of non-conforming product, to prevent

the improper use of non-conforming product (materials and products).

2. Responsibilities and authorities1) The manager of incoming inspection department shall:

- Issue the NCR (Non-conformance report) for non-conforming materials,

- Determine the method to dispose the non-conforming product (material).


- Issue the NCR for non-conforming products,

- Determine the method to dispose the non-conforming product,

- Periodically analyze NCRs and report the result to management review meeting,

- Re-verify the conformity after the correction (repair, rework) of non-conforming

product,

- Take proper action if non-conforming products are found after they are delivered to


Section: 8.3 Control of Non.3 Control of Non--conforming Productconforming Product

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- Take proper action if non-conforming products are found after they are delivered to

customers.


- Issue the NCR for process,

- Dispose non-conforming product as determined.

3. Procedures The managers of incoming inspection department and quality assurance department

shall prepare and implement the # Procedures document to manage the following

non-conforming products.

1) Identification and marking of non-conforming product

- When non-conforming products are found, inspector/tester shall distinguish

non-conforming products from conforming products in a proper way, and

issue/send the NCR to a responsible department.

- The responsible department shall store the non-conforming products separately, and

prevent them from being conveyed to the next process until the final decision on how

to handle them is made.

If the separate storage of non-conforming products is difficult, they shall be separated

in a proper way such as using notice board, rope, etc.

2) Evaluation of non-conforming product

- The manager of incoming inspection department determines the concession or

the return by referring opinions of related departments (design & development,

production, quality assurance, etc.), if it is necessary,

- The manager of the department being responsible for the non-conforming products

shall examine the reason of nonconformity and ask the manager of quality

assurance department to determine how to dispose them.

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- The manager of quality assurance department shall determine a method for the

disposition of non-conforming product – one of the following methods: concession,

repair, rework, scrap, return - by considering the examined cause and the opinions

of related departments.

3) Disposition of non-conforming product

- The manager of a relevant department shall dispose the non-conforming products

through one of the following methods, based on the final decision thereof.

·Concession: Inspector/tester shall convey the relevant products to the next

process after removing the ‘tag of rejection’, etc. attached to the products.

·Repair or rework: The manager of a relevant department shall fulfill repair or rework

according to the related procedure and then ask for inspection.

Inspector/tester shall re-test them through the same method as the initially applied

one.

·Selection: Inspector/tester shall perform total inspection of the selected lot through

the same method as the initially applied one.

·Return: The manager of materials purchasing department shall return the materials

which are determined to be returned to the relevant partner.


Section: 8.3 Control of Non.3 Control of Non--conforming Productconforming Product

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Page:46

which are determined to be returned to the relevant partner.

·Scrap: The manager of a relevant department shall immediately scrap the

non-conforming products which are determined to be scraped.

- The manager of quality assurance or incoming inspection department shall confirm

the result of disposition of non-conforming products and conclude the NCR.

4) Customer confirmation and post-delivery actions

- In case of a contract item, the manager of quality assurance department shall have

the decision on the disposition of the non-conforming products approved by a

customer and then dispose them.

- The manager of quality assurance department shall take a proper action for

the impact of the nonconformity, if nonconformity is found after the delivery of

the relevant products or the start of using them.

5) Management review of product nonconformity and the management of quality record

- The manager of quality assurance department shall periodically analyze NCRs and

report the result to the management review meeting of the business division, and

shall ensure that proper correction, corrective action and preventive action shall be

decided and fulfilled through management review.

- NCRs (of incoming inspection, inspection of work-in-process, and inspection of

finished goods) shall be maintained as a quality record, according to the related


4. Related Procedures documents1) Directives for disposition of non-conforming product LSC-QM-XXXXX

2) Directives for disposition of non-conforming material LSC-QM-00216

3) Regulation/Guidelines for handling customer dissatisfaction LSC-QM-00047

4) Directives/Guidelines for management of quality record LSC-QM-XXXXX

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8.4 Data Analysis8.4 Data Analysis

2. Responsibilities and authorities1) The manager of quality management department shall:

- Fulfill the collection, analysis and management review of monthly quality reports,

- Operate the computer system for the management of returned goods.


- Fulfill the collection, analysis and management review of monthly quality reports,

- Survey customer reaction and satisfaction.


- Analyze the supplier’s quality data

4) The manager of material purchasing department shall:

1. Objective and scopeThis section shall be applied to the analysis of data, in order to evaluate suitability,

effectiveness and continued improvement of the quality management system.


Section: 8.4 Data Analysis.4 Data Analysis

Page: 1/1

Date: 03/15/2012

Revision: 22


Page:47

4) The manager of material purchasing department shall:

- Analyze the supplier’s data

3. Data analysis1) The manager of quality assurance department shall analyze the data including results

of monitoring customer satisfaction in Section 8.2, Paragraph 3 of this manual to

provide the information on customer satisfaction.

2) The manager of quality management/quality assurance department shall analyze

relevant data including the results of monitoring and measuring of process in

Section 8.2, Paragraph 5 of this manual to verify the conformity to product

requirements.

3) The manager of quality management/quality assurance department shall analyze

relevant data through monthly quality reports or internal quality audit, etc. to identify the

opportunity of preventive action and the trend of process and product.

4) The manager of incoming inspection department shall analyzes the quality data of

suppliers such as the data on incoming inspection to provide the quality information

about suppliers.

5) The manager of material purchasing department shall analyzes the data of suppliers

such as the data on the appointed data of delivery, a unit cost, etc. to provide the

information about suppliers.

4. The media for providing the result of data analysisThe result of data analysis performed for each functional department may be provided

through electronic media (e.g.electronic program), document or bulletin board, etc.

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8.5 Improvement8.5 Improvement

1.Objective and scopeThis section shall be applied to the continued improvement of the effectiveness of quality

management system, corrective action to prevent the recurrence of nonconformity, and

the preventive action to eliminate the cause of potential nonconformity.

2. Responsibility and authorities1) The manager of quality management/quality assurance department shall:

- Request the corrective actions of nonconformity,

- Analyze the objects which need the corrective action for potential nonconformity,

- Identify the effectiveness of the result of actions,

- Perform a management review of quality management system once or more a year.


- Request non-conformance corrective action (related supplier),

- Verify the effectiveness for the result of corrective action.

3) The managers of the departments which take actions shall:


Section: 8.5 Improvement.5 Improvement

Page: 1/3

Date: 03/15/2012

Revision: 22


Page:48

3) The managers of the departments which take actions shall:

- Analyze the cause of nonconformity and establish a plan to prevent recurrence,

- Fulfill the corrective action for nonconformity,

- Fulfill the preventive action for the potential nonconformity.

3. Identification of problemsIdentification of the major quality problems that requires corrective/preventive action shall

be fulfilled by referring/reviewing the followings:

- Nonconformities found during incoming inspection and product inspection

- Nonconformities found during check-up of process

- Result of trend analysis by using data

- The dissatisfaction or claims of customers

- Nonconformities found during internal/external quality audit.

4. Continued improvement

1) To improve the effectiveness of quality management system continuously, the

manager of quality management/quality assurance department shall use a part or all

of the following methods:

- Review of quality policy and quality objective

- Corrective and preventive actions resulting from audit result and data analysis

- Comprehensive management review.

2) The main group that fulfills continued improvement activities shall be the organization

for improvement (SKILL, SIX SIGMA, other TFTs), small group activity on site and

proposal system, etc.

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3) To fulfill the continued improvement activity, the followings may be referred to as an

example.

*Select Theme → Select Task → Develop Reform Program →Complete

*Define Problem →Measure → Analyze → Improve → Manage

*Select Improvement theme→ Survey Site → Analyze Cause →

Prepare/Implement Solution → Identify Effectiveness → Complete Recurrence

Prevention Plan

5. Corrective actionThe manager of quality management/quality assurance department shall proceed

with the corrective action for nonconformities, according to the related # Procedures

document.

The result of the completed corrective action shall be maintained as a quality record,


Corrective actions shall include the followings:

- Review of nonconformity (including customer complaint)

- Determination of the cause of nonconformity

- Evaluation of the necessity for the actions to prevent the recurrence of nonconformity

- Determination and fulfillment of the necessary actions

- Maintenance of the result of the taken actions as a quality record



Page: 2/3

Date: 03/15/2012

Revision: 22


Page:49


- Review of the corrective action that has been taken

1) Corrective action for nonconformity of material’s quality

- The manager of incoming inspection department shall issue a request letter for

corrective action to a relevant supplier (partner) in regard to the NCR (Non-

conformance report) of non-conforming materials if their quality needs to be improved.

- The manager of incoming inspection department shall confirm that the corrective

actions of the partner have been effectively performed and then conclude the matter.

2) Corrective action for nonconformity of product’s quality

- The manager of production department shall issue the NCR for the non-conforming

work-in-process, and establish and fulfill a necessary quality improvement plan.

The manager of quality assurance department shall validate a process NCR and then

conclude the matter.

- The manager of quality assurance department shall issue an NCR for the

non-conforming finished goods, and request a relevant department of corrective

action if the quality needs to be improved.

The manager of a relevant department shall establish and fulfill an improvement plan

in accordance with the request of quality improvement, and then report the result to

the manager of quality assurance department.

The manager of a relevant department shall check if the relevant department has

implemented the improvement plan, and conclude the NCR of the finished goods

when the actions are effective.

3) Corrective action for customer dissatisfaction

- If a proper action is necessary to prevent recurrence of the complaints received

from customer, the manager of QA/CS department shall send the news of customer

complaints to relevant departments and request a counterplan to prevent recurrence.

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- The manager of QA/CS department shall verify the effectiveness of the

analyzed cause and counterplan presented by a responsible department, and

then conclude the matter if they are effective and acceptable.

4) Corrective action for the nonconformity in the operation of quality management system

- The manager of quality management/quality assurance department shall issue a letter

requesting corrective action for the nonconformity of quality management system

found by internal quality audit and/or external certification authority to the manager

of a relevant department.

- The manager of the relevant department shall fill in the request letter with the cause

of nonconformity, improvement plan and the result of fulfillment, and then send the

letter back to the requesting department .

- The manager of quality management/quality assurance department shall verify the

effectiveness of the improvement plan, and then conclude the matter.

6. Preventive actionThe manager of quality management/quality assurance department shall proceed with

the preventive action for the potential nonconformity, according to the



Page: 3/3

Date: 03/15/2012

Revision: 22


Page:50

the preventive action for the potential nonconformity, according to the

related # Procedure document.

The result of the completed preventive action shall be maintained as a quality record,


Preventive actions shall include the followings:

- Determination of the type and cause of potential nonconformities

- Evaluation of the necessity for the actions to prevent the occurrence of nonconformity

- Determination and fulfillment of the necessary actions


- Review of the preventive action that has been taken

1) The manager of quality management/quality assurance department shall fulfill the

analysis of NCRs and data trend, customer complaints, and comprehensive review of

the result of auditing quality management system, and then report the result to

management review meeting once or more a year, thus to have preventive actions

taken.

2) The manager of quality management/quality assurance department shall make sure

that the effectiveness of the taken actions is officially reviewed in the next

management review meeting.

3) The methods that can be used to fulfill preventive actions are as follows:

- Application of statistical techniques

- Operation of troubleshooting TFTs

- Improvement of quality management system, etc.

7. Related procedures documents1) Directives for corrective & preventive action LSC-QM-XXXXX

2) Directives/Guidelines for management of quality record LSC-QM-XXXXX

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9.1 Procedures by ISO 9001 Requirement9.1 Procedures by ISO 9001 Requirement

ISO 9001

Requirements

Related QMS Procedures documents

Document/# of Standard

Document/Name of Standard

Prepared

By (Dept.)

4.0 Quality Management

System

QM-901LSC-QM-00040

LSC-ED-XXXXX

LSC-QM-XXXXX

.Quality manual

.Regulation for management of company standards.Directives for management of Spec., design document, and drawings.Directives/Guidelines for management of quality record

.QM

.Standardmanagement.Design &development

.QM

5.0 Management

Responsibility

LSC-QM-00204

LSC-QM-XXXXX

.Quality planning & management review procedure‘.Directives/Guidelines for management of quality record

.QM

.QM

LSC-HR-00031 .Guidelines for management .Personnel &


Section: 9.1 Procedures by ISO 9001 Requirement.1 Procedures by ISO 9001 Requirement

Page: 1/2

Date: 03/15/2012

Revision: 22

Section


Page:51

6.0 Resource ManagementLSC-HR-00031

LSC-HR-XXXXX

LSC-QM-00205LSC-HR-XXXXX

LSC-QM-XXXXX

LSC-PM-XXXXX

LSC-QM-XXXXX

.Guidelines for management of work allotment and work allotment table.Regulation for human resourcerecruitment, etc. .Regulation for quality audit.Guidelines for qualifications of design verifiers.Guidelines for qualifications of inspectors.Directives for management of facilities and machinery.Directives/Guidelines for management of quality record

.Personnel &education

.Personnel &education.QM.Design &development.QA

.Facilitiesmaintenance.QM

7.1 Planning of

Product Realization LSC-QM-XXXXX

.# Quality specifications

.Directives/Guidelines for management of quality record

.Each Dept.

.QM

7.2 Customer-related

Processes

LSC-SD-XXXXX

LSC-QM-XXXXX

.Directives for contract review work.Directives/Guidelines for management of quality record

.Sales

.QM

7.3 Design and

Development

LSC-RD-XXXXX

LSC-RD-XXXXX

LSC-RD-XXXXX

LSC-ED-XXXXX

LSC-ED-XXXXX

LSC-QM-XXXXX

.Directives/Guidelines for development work,.Guidelines for quality assurance of new products.Guidelines for qualifications of design verifiers.Directives/Guidelines for management of Specifications.Directives for management of drawings.Directives/Guidelines for management of quality record

.Design &development

.Design &development.Design &

development .Design &

development .QM

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7.4 PurchasingLSC-MM-00015

LSC-MM-00014

LSC-MM-00002LSC-QM-00215

LSC-QM-00217

LSC-QM-XXXXX

.Regulation for management of goods.Guidelines for evaluation and management of partners.Guidelines for material ordering.Guidelines for incoming inspection.Guidelines for management of inspectors’ qualifications.Directives/Guidelines for management of quality record

.Purchasing

.Purchasing

.Purchasing

.Incoming inspection.QA, Incominginspection.QM

7.5 Production and

Service Provision

LSC-PD-XXXXXLSC-PP-XXXXX

LSC-PM-XXXXX

LSC-PP-XXXXX

LSC-QM-XXXXX

LSC-MM-XXXXX

.Directives for production control

.Directives for production work

.#Quality specifications

.Directive for management of facilities and machinery.Directives/Guidelines for management & trace of lots.Guidelines for incoming inspection.Guidelines for the incoming and outgoing of materials

.Production Control

.Production Control

.Each Dept.

.Facilitiesmaintenance.QA

.Incominginspection.Purchasing


Section: 9.1 Procedures by ISO 9001 Requirement.1 Procedures by ISO 9001 Requirement

Page: 2/2

Date: 03/15/2012

Revision: 22

SectionISO 9001

Requirements

Related QMS Procedures documents

Document/# of Standard

Document/Name of Standard

Prepared

By (Dept.)


Page:52

LSC-PD-XXXXX

LSC-QM-XXXXX

outgoing of materials.Directives for handling, storage and shipment of products.Directives/Guidelines for management of quality record

.Each Dept.

.QM

7.6 Control of Monitoring

& Measuring Devices

LSC-PP-XXXXX

LSC-QM-XXXXX

LSC-QM-XXXXX

LSC-QM-XXXXX

.Directives for calibration and inspection.Procedure for calibration by

equipment.Directives for the management of measuring equipment.Directives/Guidelines for management of quality record

.Measuringequipment control



.QM

8.2 Monitoring and

Measurement

LSC-QM-00047

LSC-QM-00205

LSC-QM-XXXXXLSC-QM-00217

LSC-QM-00215

LSC-QM-XXXXX

.Regulation/Guidelines for handling customer dissatisfaction.Directives/Guidelines for quality audit.Directives for inspection.Guidelines for qualifications of inspectors.Guidelines for incoming inspection.Directives/Guidelines for management of quality record

.QM

.QM

.QA

.QA

.Incominginspection.QM

8.3 Control of

Non-conforming Product

LSC-QM-XXXXX

LSC-QM-00216

LSC-QM-XXXXX

.Directives for disposition of non-conforming product.Directives for disposition of non-conforming material.Directives/Guidelines for management of quality record

.QA

.Incominginspection.QM

8.5 ImprovementLSC-QM-XXXXX

LSC-QM-XXXXX

.Directives for corrective & preventive action.Directives/Guidelines for management of quality record

.QM,QA

.QM

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9.2 List of Quality Records 9.2 List of Quality Records

SectionISO 9001

Requirements Quality Records Managed By

5.0 ManagementResponsibility

- Management review data of the company, business place/division

.QM, QA

6.0 Resource Management - Records on qualifications of verifiers(auditor, inspector, designer):Schooling, training, careers, etc.

- Training plan and performance for

department members

.QM, QA,Incominginspection,Design &development

.Each Dept.

7.1 Planning of Product Realization

- Quality plan/QC process diagram/production process diagram/work flow chart

Production

7.2 Customer-related

Processes

- Contracts- Records on order sheet/quotation/changeof contract

- Reports on technical review- Report on delivery time review

SalesSales

SalesSales


Section: 9.2 List of Quality Records.2 List of Quality Records

Page: 1/2

Date: 03/15/2012

Revision: 22


Page:53

- Report on delivery time review Sales

7.3 Design and

Development

- Records on the evaluation of designer’s qualifications

- Inputs for design such as development plan

- Records on design review

- Records on design review and relatedactions

- Records on validation of design and relatedactions

- Records on design change and relatedactions

.Design &development.Design &development.Design &development.Design &development.Design &development.Design &development

7.4 Purchasing Records on selection, evaluation, re-evaluation of partners

Purchasing

7.5 Production and

Service Provision

- Records on lot trace (daily work sheets, etc.)

production, etc.

7.6 Control of Monitoring

& Measuring Devices

- Records on calibration/correction of monitoring/measuring devices


8.2 Monitoring and

Measurement

- Plan for internal quality audit- Records on qualifications of auditor- Report on internal quality audit- Letters requesting the correction ofnonconformity

- Records on incoming inspections- Records on inspection of work-in-process(daily work sheets, etc.)

- Records on inspection of finished goods

.QM,QA

.QM,QA

.QM,QA

.QM, Incominginspection, QA .QA.production

.QA

# Reflected the business differences of the divisions, the preservation term of quality records complies with

requirement of procedures and directives/guidelines for management of quality record.

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8.3 Management of

Non-conforming Product

- Non-conforming reports (of material, process, finished product inspection)

.Incominginspection, production.QA

8.5 Improvement - Records on corrective actions·Letters requesting the correction of QMS nonconformity·NCRs for materials

·NCRs for processes ·NCRs for finished goods·Newsletter on customer complaints, reporton the result of taken actions·Other improvement activities- Records on preventive actions·Application of statistical

.QM,QA

.Incominginspection.production.QA.QA

.Each Dept.

.Each Dept.


Section: 9.2 List of Quality Records.2 List of Quality Records

Page: 2/2

Date: 03/15/2012

Revision: 22

SectionISO 9001

Requirements Quality Records Managed By


Page:54

·Application of statisticaltechniques

·Activities of troubling shooting TFTs·Other activities for improvement

.Each Dept.

.Each Dept.

.Each Dept.

# Reflected the business differences of the divisions, the preservation term of quality records complies with

requirement of procedures and directives/guidelines for management of quality record.

10.15.18.95 / 2013.03.28 13:07 / 20100189
