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MANDATAIRE DESIGNE PAR LE MAITRE D’OUVRAGE : COMPAGNIE DE L’ENGINEERING DE

L’ELECTRICITE ET DU GAZ «CEEG.SPA»


DIRECTION DE L'ENGINEERING DES MOYENS DE PRODUCTION
IMMEUBLE 700 BUREAUX RN N° 38 GUE DE CONSTANTINE KOUBA ALGER
TEL: 021 83 84 00 - FAX: 021 83 90 17

CENTRALE ELECTRIQUE EN CYCLE COMBINE


JIJEL
1 398,290 MW Aux conditions site
Number of Contract : Distribution Status : Owner’s Numbering :
N°2014/04/KD.M Pour Approbation JJL-CQ-580-302_EN
N°08/SPE/2014
Space reserved for stamps (Review and validation of the document – if necessary) :

History of revision :

00 PA Pour Approbation S.H.KIM S.H.YUN S.H.DO S.H.KIM H.S.KANG 09-08-14

Rev. St. Description of revision Originator Verifier Verifier Controler Approver Date
Title :
QUALITY ASSURANCE PROGRAM / MANUAL, QUALITY
CONTROL PROCEDURES FOR THE WORKSHOP AS WELL AS
FOR THE SITE FOR H2 PLANT
Project no Issuer Teamcenter’s Issuer Numbering of Contractor

BEDZ1402 B.K.PARK J.H.PARK JJL-CQ-580-302_EN


Supplier’s Name and Logo Supplier’s Numbering

JJL-CQ-580-302_EN
Doc. Type Confidential Class Derived from Scale Format Sheet Out of Follows
page
DGG 2 1:1 A4 1 1 36

Hyundai Engineering Co, Ltd / Hyundai Engineering & DESIGNATED REPRESENTATIVE : CEEG/KDM
Construction CO, Ltd / Daewoo International Corporation
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1. Table of Contents & Revision History


1.1 Table of Contents
Revision Revision
Chapter Title
N. Date
January
I Table of Contents & Revision History 1 2, 2012
April
2 Quality and Environmental Control Management Policy 2 4, 2013
January
3 List of Procedure and Company overview 1 2, 2012
Quality and Environmental Management Manual
January
4 4.1 General Requirement 1 2, 2012
4.2 Document Requirement
Management Responsibility
5.1 Management Commitment
5.2 Customer Focused Management
January
5 5.3 Quality Policy 1 2, 2012
5.4 Quality System Planning
5.5 Responsibility, Authority and Communication
5.6 Management Review
Resource Management
6.1 Provision of Resources
January
6 6.2 Human Resource 1 2, 2012
6.3 Infrastructure
6.4 Working Environment
Realization of Product
7.1 Planning of Product Realization
7.2 Customer related Processes
April 4, 2
7 7.3 Design and Development 2 013
7.4 Purchase
7.5 Product and Service Provision
7.6 Monitoring and Monitoring Equipment
Measurement, Analysis and Improvement
8.1 General Information
8.2 Monitoring and Measuring January
8 1
8.3 Management of Nonconformity 2, 2012

8.4 Data Analysis


8.5 Improvement
Environment Plan
9.1 General Condition
9.2 Environmental Policy January
9 1
9.3 Environment Framework 2, 2012

9.4 Regulation and Requirement


9.5 Environmental Objective and Details
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9.6 Environmental Management Program


Environment Performance and Management
10.1 Structure and Responsibility
10.2 Training, Awareness and Qualification
January
10 10.3 Communication 1
2, 2012
10.4 Control of Document
10.5 Management Control
10.6 Emergency and Countermeasure
Environment Monitoring and Corrective Action
11.1 Monitoring and Measuring
January
11 11.2 Corrective Action and Prevention for Nonconformity 1
2, 2012
11.3 Internal Evaluation
11.4 Management Review
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2. Quality and Environmental Control Management Policy

Policy and objective of Quality

1. Competence by Quality Management and Product Supply

2. Continual Improvement Activities for Customer's Satisfaction

ASPE Inc. implements best production and service to satisfy customers by continual improvement and
quality assurance. We develop the company gaining credibility from customers.

We’re committed to establishing and performing quality management system in accordance with ISO
9001:2008/ ISO 13485:2003 and have a responsilibity to assure the promises with customers.

Management representative maintains the independency, monitors and implements activities throughout
the organization and has the authority to audit.

Sale team does customer survey to improve the quality of product and satisfy the customer
QC team does strict quality control and improves the quality of product and satisfy the customer.
R/D team improves the satisfaction of customers reflecting customer’s demands to quality improvement of
manufacturing process.
Provision team purchase and supply the material resource to improve the customers’ satisfaction
Production team manages the process and improves the quality of product and the customers’ satisfaction
(addition in April 4, 2013)

ASPE Inc.
President & CEO H.S Lee
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Policy and objective of Environment

1. Diminution of Air pollution and Energy save

2. Environmental regulation practice and Continual improvement

ASPE Inc., reduce the environmental impact and effectively manage the environmental policy to achieve
our environmental objectives.

We’re committed to establishing and understanding the policy in accordance with ISO 14001:2004, and
implementing promises with customers.

Our environmental objectives are to understand environmental issues and to practice environmental
improvement in order to protect the nature.

Management representative maintains the independency, check, carry forward and monitor environmental
activities.

ASPE Inc.
President & CEO H.S Lee
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3. List of Procedure and Company overview


3.1 List of procedure
Working Manual Quality Management Procedure Responsible d
No. Standard
Chapter Document title Document No. Document Title epartment
Document control
QP-401 Management
procedure
Quality/Environment
Quality Manage Quality Manag QP-402 Management
4 4 records procedure
ment System ement System
QP-403 Vigilance system Marketing &
procedure Sales
Objective control
QP-501 Management
procedure
Management Re Management Quality Management
5 5 QP-502 Management
sponsibility Responsibility procedure
QP-503 Communication Management
QP-601 Education & Training Management
Human resource
QP-602 Management
management
Employment and wor
QP-603 Management
Resource Mana Resource Man king
6 6 Equipment
gement agement QP-604 Manufacture
management
QP-605 Tool management Manufacture
Production and
QP-606 Manufacture
inspection equipment
Marketing &
QP-701 Contract review
Sales
QP-702 Design management Engineering
Purchase
QP-703 Purchase
management
Customer property
QP-704 Manufacture
management
Resource and produc
QP-705 Manufacture
tion management
Process of
QP-706 Manufacture
production
QP-707 Process validation Manufacture
Realization of Pr Realization of Identification &
7 7 QP-708 Manufacture
oduct Product Traceability
Customer complaint Marketing &
QP-709
management Sales
Customer complaint
QP-710 R&D
management
Planning of product
QP-711 R&D
realization
QP-712 Packing & labelling Manufacture
Drawing
QP-713 Engineering
management
Outsourcing
QP-714 Manufacture
management
QP-715 Change point R&D
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management
Customer satisfactio Marketing & S
QP-801
n management ales
QP-802 Internal audit Q.C
Measurement &
QP-803 Q.C
monitoring
Measurement, a Measurement, Nonconformity
8 nalysis and impr 8 analysis and i QP-804 Q.C
management
ovement mprovement Data analysis and
QP-805 Q.C
application
Corrective action &
QP-806 Q.C
prevention
Continual
QP-807 Q.C
improvement

Working Manual Quality Management Procedure


Responsible depart
No. Standard Document Document
chapter Document title ment
title No.
Evaluation and regist
EP-401 ration of R&D
Environmental effect
4.1 Planning 9 Planning Management of Envir
EP-402 R&D
onmental regulation
Environmental mana
EP-403 R&D
gement program
EP-404 Emergency policy Manufacture
Environmental hazar
Implementa Execution
EP-405 dous material Manufacture
4.2 tion & Man 10 & Manag
management
agement ement
Energy & Resource
EP-406 Manufacture
management
Review & C Review &
Environment monitori
4.3 orrective ac 11 Corrective EP-407 Manufacture
ng & measurement
tion action
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3.2 Company overview

Company name: ASPE Inc.


President & CEO Heung Seob Lee
Established in August 2000
Office Address
1501 SungjiStarwith, 954-6, Gwanyang-dong, Dongan-gu, Anyang, Gyeonggi-do, South Korea
Telephone +82 (0)31 319 6845
Fax +82 (0)31 319 6848
Headquarter & Factory
10-5, Cheomdansaneop 7-ro, Deasowon-myeon, Chungju, Chungcheongbuk, South Korea
Homepage www.aspe.kr
Business N2 Generation, O2 Generation, Methane Purification

3.3 Company history

August 2000 O2 N2 Gas Engineering Co., Ltd.


September 2001 Company name changed for Korea Gas Line Co., Ltd.
October 2001 Nation’s first N2 generator for tire injection
November 2002 Patent registration on Oxygen supplying Equipment (Patent No. 0364584)
December 2003 ISO 9001 certified and registered
March 2004 ISO 13485 & 9001 certified and registered by TUV for medical oxygen
generator
May 2004 ANYOXY registered (Trademark No. 10583581)
November 2004 Patent registration on Top-manifold of oxygen generation equipment
(Patent No. 0368179)
June 2007 Research and development task force registered (Certificate No. 20075642)
October 2007 INNO BIZ certified (Certificate No. 7061-3555), Venture company certified
(Certificate No. 2007010347)
October 2011 Company name changed for ASPE Inc. Office moved to Anyang
June 2012 Factory moved to Chungju for expansion
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4. Quality and Environmental Management Manual

4.0 Scope
This scope includes all activities affecting on qualities of engineering, development,
manufacturing and service of N2 generator, H2 generator, purification and air dryer. They are
applicable on requirement and conditions related to any documentation, system structure,
maintenance of system and its continual improvement.

4.1 General Requirement

1) Following are rules and criteria for requirement;


(1) Medical Appliance Act
(2) ISO 9001(2008), ISO 14001(2004) – Requirements
(3) ISO 13485(2003-7-15) Medical devices – Quality management system requirement for reg
ulatory purpose
(4) To Document, establish, execute and maintain the quality management system in order to
continually improve its effectiveness in accordance with MEDDEV 2.12-1 Rev.4 Guidelines
on a medical device vigilance system shall follow;
a) Processes needed for the quality management system are identified and applied
throughout the organization
b) Determining the order and the interaction among processes
c) Determining the criteria and the method needed to ensure the effectiveness for
operating and maintaining the processes
d) Ensuring the necessary information and the availability of resource for operating and
monitoring the processes
e) Monitoring, measuring and analyzing the processes
f) Executing the policies to reach the objective planned and improving continually the
processes

2) Exclusions
According to ISO 9001:2008, ISO 13485:2003, below are excluded;
(1) Clean Class and contamination control
(2) Requirement specified of Pasterized medical appliances
(3) Deleted 4 April 2013
(4) Medical appliances for transplantation and their requirements(7.5.3.2.2)

3) When processes are outsourced, they are recognized and distinguished in the quality
management system. System of processes mentioned above are included management
activity, provision of resource, realization of product and measurement.
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4.2 Document requirement

1) General Requirement
The company documentation is executed by following steps;

1st Step Quality Environmental Manual


2nd Step Quality Procedure
3rd Step Quality Policy & Documentation

(1) Quality Environmental Manual


It includes of basic policy and requirement in accordance with Medical Appliance Act, ISO
9001:2008, ISO 14001:2004 and ISO 13485:2003.

(2) Quality Procedure


It explains the procedure and methods and maintains the responsibility of each
organization of company.

(3) Quality Policy


It describes concrete contents enough to perform the detailed activities and needs
documents below;

① DMF(Device Master File) – Manufacture and assurance of each model and Refer to QP
-706

② Inspection standards

③ QC Process and Work Operation sheet

④ Drawing

⑤ Etc(International and national standards)

2) Working manual
The company establishes and maintains the manual including;
(1) Application range of Quality Management System
(2) Procedure and its reference to establish the Quality Management System
(3) Order of process and interaction to establish the Quality Management System

3) Control of document
Documents needed for Quality management system shall be controlled by Document control
procedure (QP-401) and Records issued during Quality management execution shall be
controlled by Article 4.3 in the procedure. Document control shall include following;
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(1) approving documents for adequacy prior to issue


(2) reviewing and update as necessary and re-approved documents
(3) ensuring that changes and the current revision status of documents are identified
(4) ensuring that relevant versions of applicable documents are available at points of use
(5) ensuring that documents remain legible and readily identifiable
(6) ensuring that documents ( ex. official note, drawing, purchaser order, and technical spec.
etc.) of external origin are identified and their distribution controlled
(7) preventing the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose
(8) keeping 1 copy of original document being disuse. The document shall be preserved 15
years from the moment de shipping of product concerned.

4.3 Control of quality records


1) Quality records are established and maintained to provide to evidence of conformity to
requirements and the effective operation of the quality management system. Records shall
be visible, readily identifiable and retrievable. They shall be controlled for the identification,
storage, protection, retrieval, retention time and disposition of records in accordance with
Quality/Environment records procedure (QP-402).
2) Records required by applicable industry product standards shall be retained for more than 15
years
3) Records of quantity of production and event shall be maintained.
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4.4 Interconnection within Processes

Objective
ee

Quality R/D Manufactur


Control e
Customer’s
demand
Customer
(person of interest) Measuring &
Monitoring

Regulatory
Customer’s
requiremen
Satisfaction
t

Effectiveness measurement Continual


Result measurement Improvement

4.5 Related document


1) Document control procedure (QP-401)
2) Quality/Environment records procedure (QP-402)
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Attachment 1. Quality Management Process Map

Quality
management
system

Documentation

Management
responsibility
Quality Policy
Customer focused Management
review
Quality
objective

Customer’ Resource Customer’s


Continual
s demand management Satisfaction
Improvemen
t
Resource
provision

Product Development
realization Oursourced
- PLC
- Software
Purchase - Power suppl
y
Process for - Etc.
customer
Manufacture

Measuremen
t, analysis & Quality
Receiving
improvement Assurance
& shipping
Product

- Monitoring custom - Data analysis


ers’ satisfaction - Evaluation

Quality - Process monitoring - Nonconforme produc


Improvement
Assurance - Product monitoring t management
- Corrective action & p
revention
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5. Management Responsibility

5.0 Scope
It emphasizes responsibility and role of management and establishes organization, job
distribution, objectives of quality, performance and management review.

5.1 Management commitment


President shall perform evidence of its commitment to the development and implementation of
the quality management system and continually improving its effectiveness by
1) Communicating to the organization the importance of meeting customer as well as statutory a
nd regulatory requirements

2) Establishing the quality policy

3) Ensuring that quality s are established

4) Reviewing management

5) Ensuring the availability of resources

5.2 Customer focused management


President shall ensure the customers’ demands are determined and fulfill them according to the
quality of customers’ demands

5.3 Quality Policy


President shall ensure that the quality policy are following
1) Appropriate to the purpose of organization
2) Committing to comply with requirements and continually improve the effectiveness of the quali
ty management system
3) Providing a framework for establishing and reviewing quality and effectiveness
4) Communicating and understanding within organization of company
5) Reviewing the continuous suitability
6) Complying with national regulations, directives and requirements for quality management syst
em

5.4 Quality System Planning


1) Quality objective
President shall ensure that the quality objective including requirements of manufacture are
established according to the function and grade of organization. The objective of quality
management shall be measured and consistent. Detailed procedure shall follow Objective
control procedure (QP-501).

2) Planning of quality management system


President shall ensure that;
(1) Planning of quality management system is established in order to meet the quality objective
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(2) Wholeness of system is retained even if the quality management system is planned to be c
hanged or its changement is executed.

5.5 Responsibility, authority and communication

1) Responsibility and authority


Responsibility and authority of company are indicated in Attachment I. President is
responsible to educate employees in order to ensure the communication of responsibility and
recommendation in the organization.

2) Quality assurance department manager


The QA manager, irrelevant to other responsibility, has the responsibility and the authority
including,
(1) Assuring to establish, maintain and implement the Quality management process
(2) Reporting and reviewing the results to President
(3) Promoting awareness of customers’ requirements throught the organization
(4) Coordinating communication with external parties concerning the Quality management sy
stem

3) Internal communication
President has the responsibility for the communication process and the effectiveness of
Quality management system to ensure proper communication between the management and
the organization throughout periodical meeting.

5.6 Management Review

1) General
President review the Quality management system to assure the suitability, effectiveness and
satisfaction of system. The purposes of reviews include the quality policy and the quality
objectives. Opportunities for improvements and necessities for change are also evaluated.
Reviews of results are documented and maintained in accordance with Quality Management
review procedure (QP-502).

2) Review input
The management reviews input shall include;
(1) Results of review
(2) Feedback for customer
(3) Results of process and suitability of product
(4) Prevention policy and its status
(5) Follow-up from previous management review
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(6) Changes affecting the Quality management system


(7) Recommendations for improvements
(8) Attention o persons of interest
(9) Conducting the quality policy and objectives and achievement
(10) Considering the possibility of change of policy, objective, detail and management system r
egarding environmental condition from internal review, will for continuous improvement
(11) New or renewed legal requirements

3) Review output
The management reviews output shall include;
(1) Effectiveness and its improvement of Quality management system and process
(2) Improvements of product from customers’ requirement
(3) Necessity of resource

5.7 Related document


1) Objective control procedure(QP-501)
2) Quality management procedure(QP-502)
3) Communication procedure(QP-503)
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Attachment 1. Organization

1. President
1) Delegating the responsibility and the authority to Management director
2) Having responsibility to review the Quality management
3) Establishing and approving the Quality policy and
4) Approving the Quality manual and procedure
5) Supplying the resource for Quality management

2. Management Director
1) Conducting the responsibility and the authority concerning Quality management system assistin
g President
2) Reporting the status of Quality management activities to President for maintenance of document
ation and review of Quality management as well as basic document for improvement.
3) Approving the prevention policy, reviewing and correcting the internal quality auditing plan
4) Reviewing the communication with certification institution and authority
5) Reviewing V/S operation
6) Approving the corrective actions for nonconformance and the prevention policy
7) Reviewing the manual and procedure of Quality management

3. Quality Control

1) Furnishing and making use of product standard, manual and procedure of Quality control
2) Checking and verifying the operation if it is suitable in accordance with documents of 3.1)
3) Making a decision if the product will be released or not
4) Deviation approval
5) Having a responsibility to write a inspection procedure and inspect for import/export
6) Having a responsibility to identify inspection status
7) Establishing measurements and analyzing reasons for non conformance
8) Managing and maintaining the documents of preventions and corrective actions
9) Reviewing and managing according to statistic method
10) Measurement and observation list
11) Having responsibility on measurement and inspection devices
12) Drawing up and implanting regulations for nonconformance prevention
13) Figuring out and recording quality problems
14) Conducting the internal audit and analyzing trends

4. Engineering
1) Developing and Design
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2) Reviewing and verifying the design and examine the validity


3) Supporting the production/construction drawing
4) Writing the operation specification

5. Management
1) Planning and conducting education throughout the organization
2) Disseminating and managing company regulation
3) Managing documents and human resource
4) Writing management reports
5) Managing the budget and company performance
6) Finance
7) Accounting
8) Licensing

6. Marketing and Sales


1) Sales, order-receiving and management
2) Quotation and tender
3) Managing and reviewing contracts
4) Communication with customers
5) Service management
6) Conducting customer satisfaction survey and reporting the results of survey

7. Purchase
1) Managing subcontractors
2) Planning and reviewing resource provision
3) Ordering and managing outsourcing production
4) Ordering and approving resource

8. Manufacture
1) Managing manpower and cost
2) Managing manufacturing facilities
3) Managing process on site
4) Managing observation devices
5) Managing environmental condition
6) Safety control
7) Cost analysis and reviewing validity
8) Managing process
9) Reviewing the capacity of production in case of customers’ requirement
10) Product identification and traceability
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11) Managing resource


12) Manufacturing regarding to planning
13) Managing manufacturing equipment
14) Responsibility to educate manufacturing workers about Quality management and its process
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6. Ressource Management
6.0 Scope
This chapter determines the condition of required resource for Quality management system.

6.1 Provision of resources


President determines and secures the supply required resource for below;
1) Execution, maintenance and continuous improvement for efficiency of Quality management
2) Increasing the customers’ satisfactions fulfilling the requirement

6.2 Human resource


1) Personnel assigned for tasks on Quality of product and environment are qualified for appropria
te education, training, experience and skill.
2) Competence, awareness and training
President provides below;
(1) Determining the competence of personnel for tasks on Quality of product and manageme
nt
(2) Training and other actions for meet the needs
(3) Evaluating the effectiveness of actions taken
(4) Making that the personnel is aware of the relevance and importance of its his/her action h
ow their actions contribute the objectives of Quality management
(5) Maintaining the records of education, training, skills and experience

6.3 Infrastructure
Company shall determine, provide and maintain the infrastructure for validity of requirements
of contractor
1) Building, workplace and related utilities
2) Process equipment(hardware and software): ref. Process of Production Procedure(QP-702)
3) Support service(transport, communication etc.)

6.4 Working environment


President determines and manage necessary working environment for requirement. The
working environment is cleaned and checked up.

6.5 Related document


1) Education and training procedure (QP-601)
2) Process of production procedure (QP-706)
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7. Realization of Product
7.0 Scope
This chapter is applicable on product realization planning, customers’ requirement review,
purchasing, manufacturing, service, and monitoring and measuring device.

7.1 Planning of product realization


The company shall plan and develop the process for product realization. This planning is
relevant to requirements of other process of Quality management.
1) Requirement and objective of Quality management on product

2) Necessity of documentation and establishment of process, and of provision of resource specifi


c
3) Verification, validity checking, motoring, inspection and examination specific for product and st
andards of product indications
4) Planification necessary for acquiring evidences that product and result from realization proces
s

7.2 Customer related process


1) Determination of requirements related to product
Responsible on contract shall determine below;
(1) Requirement from customer including manufacturing and after sending activities
(2) Requirement for utilization defined or intended even if it is not mentioned
(3) Regulatory and legal requirement on product
(4) Additional regulation decided by organization

2) Review of requirements related to the product


The company reviews the requirement related to the product. It shall undergo before
organization promise de supply the product to the customer and ensure below;
(1) Product requirements are defined
(2) Contract or order requirements differing from those previously expressed are resolved
(3) The company has an ability to meet the defined requirements

Relative manager maintain records of the results of the review and actions arising from the
contract review. If the customer express his demand by telephone, manager of marketing &
sales team records it and verifies before accepting. When the demand is changed, relative
manager shall ensure that related documents are amended and relevant personnel are made
aware of modifications

3) Communication
The company shall determine and implant efficient communication system with customers on
issue related to purchase, order, specification, visit, approved document and claim.
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7.3 Design and Development


1) Design and Development Planning
(1) Engineering manager plans and controls the design and the development of the product.
(2) Manager shall determine below;
a) Design and development stages
b) Review, verification, and validation regarding to each stage of design and development
c) Responsibilities and authorities for design and development

(3) Engineering manager manages interfaces to ensure between different groups involved in
design and development to ensure effective communication and clear assignment of
responsibility.
(4) Planning output shall be updated as the design and development progress.

2) Output of Design and Development

(1) Technical manager determine the input of the design and development of the product and
maintain the record include following

a) Function and performance requirement

b) Applicable regulatory requirement

c) Applicable and derived from previous similar project information

d) Other essential requirement for design and development


(2) Review the sufficiency of these output requirements
(3) Requirements shall not be ambiguous but be complete.

3) Output of design and development


(1) Technical manager provide outputs of design and development in a form that enables veri
fication against the design and development input and approve prior to release.
(2) Outputs of design and development are below;
a) Satisfying requirements for design and development inputs
b) Providing appropriate information for purchase, production and service
c) Containing and referring the product acceptance criteria
d) Determine the specification for safe and appropriate product use

4) Design and development review


(1) Systematic review on design and development at related stage in accordance with planne
d arrangement shall be executed for below;
a) Evaluating the ability of results of design and development to meet requirements
b) Suggesting necessary actions and identifying problem
(2) Personnel concerning design and development in reviewing stage participating the review
(3) Records of review result and necessary action shall be documented
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5) Design and development verification


(1) Technical manager performs design and development verification to ensure that the desig
n and development outputs have met the design and development input requirements
(2) Results of verification and any necessary action shall be documented

6) Design and development validation


(1) Verify the validation of design and development shall be performed in accordance with pla
nned requirements for ensuring to satisfy requirements on defined application and purpos
e.
(2) Validation shall be completed before implementation or release of product
(3) Results and any necessary action shall be documented.

7) Management for design and development change


(1) Design and development changes shall be understood and theirs records shall be docum
ented
(2) Changes shall be reviewed, verified and validated and approved before implementation
(3) Review of design and development change shall include the evaluation of the effect of ch
anges on parts and products already released.
(4) Results and any necessary actions on changes shall be documented

7.4 Purchase

1) Process of purchase
Purchase manager ensure that purchased item satisfies quality requirement. The type and
extent of control applied to the supplier and the purchased product shall be dependent upon
the effect of the purchased product on subsequent product realization or the final product.
Relevant manager evaluate and select according to the ability to supply product. Selection,
evaluation and re-evaluation criteria are established. Results and any necessary actions after
evaluation shall be documented.

2) Purchase information
Purchase manager describes the product to be purchased in the purchasing information
including below;
(1) Requirements for approval of product, procedure, process and equipment
(2) Requirements for qualification of personnel
(3) Requirements for Quality management
Purchase manager reviews the adequacy of specified purchase requirements prior to issuing
the purchase order.

3) Purchase verification
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Purchase manager ensure that purchased product meets requirement of customer and
establish and implement any necessary verification actions. When verified on site, manager
shall indicate the verification plan and release method on the purchase order.

7.5 Product and service provision


1) Manufacturing manager shall plan and carry out the provision of the service and product under
management condition including below;
(1) Using information defined product character
(2) Supplying required instruction
(3) Using appropriate device
(4) Using calibrated monitoring device
(5) Checking and monitoring
(6) Executing release, delivery and after activities

2) Validation of process for production and service


Company verifies the validity on the process for production and service when the output could
not be verified by monitoring. It proves the ability to approach the planned objective after
product utilization or service release. The company determines the process including;
(1) Standards on process review and approval
(2) Approval of equipment qualification of personnel
(3) Use of specific methods and procedure
(4) Requirement for records
(5) Revalidation

3) Identification and traceability


The company identifies and controls the product and the status of product concerning
monitoring and measuring requirement throughout product realization. When the traceability is
required, the company manages and controls the identification of product.

4) Customer property
(1) The company identifies, verifies protects and safeguards customer property for use or inc
orporation into the product.
(2) Customer property includes the intellectual property.

5) Property preservation
The company preserves the conformity of product during internal processing and delivery to
the intended destination. The preservation includes identification, handling, packaging,
storage, and protection.

7.6 Monitoring and measuring equipment


(1) Procedure
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a) Determining the monitoring and measurement to be undertaken and the monitoring an


d measuring devices needed to provide evidence of conformity of product to determine
d requirements.

b) Establishing the process concerning monitoring and requirements of monitoring and m


easuring devices

c) In order to secure the valid results, measuring devices are qualified in accordance with

① Being calibrated or verified at specified intervals, or prior to use, against meas


urement standards traceable to international or national measurement standar
ds; where no such standards exist, the basis used for calibration or verificatio
n shall be recorded
② Adjusted or readjusted as necessary
③ Identified to enable the calibration status
④ Safeguarded from adjustments that would invalidate the measurement result

⑤ Protected from damage and deterioration during handling, maintenance and s


torage

d) When the equipment is found not to conform to requirements, the previous measuring
results shall be reevaluated and assessed.
e) Results of calibration and verification shall be maintained.

7.7 Related document


1) Contract review procedure (QP-701)
2) Design management procedure(QP-702)
3) Purchase management procedure(QP-703)
4) Customer property management procedure(QP-704)
5) Resource and production procedure(QP-705)
6) Process of production management procedure(QP-706)
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8. Measurement, Analysis and Improvement


8.0 Scope
This chapter is applicable on monitoring, measuring, analyzing and improving processes in
order to evaluate the validity and suitability.

8.1 General
The purpose is to verify the validity of Quality management, to ensure the conformity and to
improve continually the effectiveness using applicable and appropriate method.

8.2 Monitoring and measuring


Relevant manager plans and implement the process of monitoring, measuring, analysis and
continual improvement for below;
(1) Demonstrating the conformity of the product
(2) Assuring the conformity of the Quality management system
(3) Improving continual the effectiveness of the system

1) Customer satisfaction
The company monitors information related to customer recognition if the organization
satisfies the customer requirements as a measuring method for Quality management. And it
determined methods to acquire ad apply information including below;

2) Internal audit
The company verifies, evaluates the conformity and the validity, implements and maintains
the Quality management by conducting internal audit.

(1) Procedure
The company shall carry out internal audit periodically to determine that below;
a) Arrangements of planned Quality management system meet standards ISO 14001-20
04/ISO 9001-2008 and requirements
b) The management are effectively implemented and maintained
c) When management agent an audit program shall be planned, taking into consideratio
n the status, identify response time for addressing detected nonconformities and imp
ortance of the processes and areas to be audited as well as the results of previous au
dits
d) The criteria, scope, frequency and method are defined
e) The objectivity and the impartiality of selection of auditors and audits shall be secured.

f) Auditors shall not audit their own work.


g) Plan, performance and independency, reporting the result and responsibility and requ
irement for documentation related auditing are defined.
h) Relevant manager shall be responsible for performing the corrective action on the def
iciencies found by the audit.
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i) Follow up activities shall include verifying actions and reporting the verification results.

3) Monitoring and measuring process


Relevant manager monitors and measures the process to ensure ability of process. If it is not
suitably in the result where the process output is planned, the manager performs necessary
corrective actions to ensure the conformity.

4) Monitoring and measuring product


The company measures the character of product to verify that requirements are met. Quality
assurance manager approves, it excludes the case which the customer approves and before
the monitor ring and measurement are completed, the product (including raw material) is not
output with succeeding process.

8.3 Manage of nonconformity


The company shall ensure that product which does not conform to product requirements is
identified and controlled in accordance with the control of nonconforming product procedure to
prevent its unintended use or delivery
1) The company identifies and manages the nonconformity to customers’ requirement to preve
nt the unintended use or delivery of product.

2) Responsibility and authority to manage the nonconformity are documented in accordance wit
h procedure.

3) The process of acceptance of nonconforming product shall follow by one or more;


(1) Eliminating the nonconformity
(2) Authorizing use or release under concession by authority or customer
(3) Precluding its original intended use or application

4) Records of customers’ notification and nature of nonconformities and any subsequent action
s taken, including concessions obtained, shall be maintained.

5) When nonconforming product is corrected, it shall be subject to being reevaluated.

6) The nonconformity is found out when the product is delivered or in use, the necessary action
for nonconforming or potential effects shall be executed.

8.4 Analysis of Data


1) Procedure
The company shall determine, collect and analysis appropriate to demonstrate the suitability
and effectiveness of the quality management system and to evaluate where continual
improvement of the effectiveness of the quality management system can be made.

The company analyze the data related to;


(1) Customers’ satisfaction
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(2) Conformity of product requirements


(3) Characteristics and trends of process and product
(4) Suppliers

8.5 Improvement
The purpose is continually improving the effectiveness of the quality management system
through the use of the quality policy, quality objectives, audit results, analysis of data, corrective
and preventive actions and management review.

1) Improvement process

(1) Continual improvement


Quality performance is determined by analyzing information about customer satisfaction,
records of product and process nonconformity, results of internal audits and other data
relevant.

(2) Corrective action


a) The company shall execute the corrective action to eliminate the cause of nonconfor
mities.
b) They shall be appropriate to the effects of the nonconformities encountered.
c) They shall be established to define requirements below;

① determining the causes of nonconformities and potential nonconformities

② evaluation the need for action to ensure that nonconformities do not recur

③ determining and implementing action needed

④ records of the results of actions taken, and

⑤ reviewing corrective action taken

8.6 Related document


1) Customer complaint management procedure (QP-710)
2) Customer satisfaction procedure (QP-801)
3) Internal audit procedure (QP-802)
4) Nonconformity management procedure (QP-804)
5) Data analysis and application procedure (QP-805)
6) Corrective action and prevention procedure (QP-806)
7) Continual improvement procedure (QP-807)
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9. Environment Plan
9.0 Scope
This chapter is applicable on regulation and requirement, objective, detail, and environmental
management program related to Environmental management system.

9.1 General condition


1) The company established and maintain the environmental management system in accordan
ce with ISO 14001-2004

2) The company shall conduct appropriate actions for continual improvement and environmenta
l assessment.

9.2 Environmental policy


1) Environmental policy shall follow in paragraph 5.3

2) The policy is suitable for the nature and the impact of activities, products and services on the
nature.

3) Environmental policy shall include below;


(1) Continual improvement and pollution prevention
(2) Environmental regulation and code, and requirement established by organization
(3) System to set up and review environmental objective and its detail

4) Environmental policy shall be informed to the employee in the organization chart

5) The policy shall be available and usable to everyone

6) It is periodically reviewed and applied by changed condition and information

9.3 Environmental framework


1) The company follows the environmental assessment and registration procedure to determine
the important impact or potentiality to the Environment and figure out organization activities,
product, service important impact or potentiality.

2) The company ensures that important environmental effect and related effect shall be reviewe
d.

3) Information concerning environment shall be updated and maintained latest version

4) Assessment for environmental effect analysis


(1) Environmental effect when normal condition, abnormal condition and emergency
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(2) Environmental activities for past, now and future


(3) Direct and indirect environmental effect
(4) Person of interest
(5) General environmental effect
Air pollution, water pollution, waste management, soil pollution, noise & vibration,
hazardous material, effect on local community, raw and natural material management,
and other local environmental problem

9.4 Regulation and requirement


1) Subject of application of regulation
(1) Prevention of air pollution
(2) Prevention of water pollution
(3) Noise and vibration prevention
(4) Waste management
(5) Wastewater, excrement and livestock wastewater management
(6) Resource save and recycle promotion

2) Regulation on environment shall be reviewed and managed by relevant manager of Manage


ment team

3) Environmental regulation and policy shall be managed by document and information manage
ment procedure and maintained as latest version.

4) Check direct enable regulation and other requirements and follow environmental regulation
management procedure for details

9.5 Environmental objective and details


1) Environmental objectives and details are relevant to Quality management procedure and con
tain the will of pollution prevention

2) Environmental objectives and details are specific and enable to be performed including quan
tification, digitization, and continual improvement

3) Consideration for environmental objective implementation and review


(1) High risky and relatively high productive issue
(2) High productive environmental civil appeals and accidents
(3) Restriction limitation indicated by regulation and policy
(4) Solvable by technique
(5) Budget needed available by Company
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4) Environmental objectives and details follows Environmental management program procedur


e

9.6 Environmental management program


1) To achieve environmental objectives and details, Environmental management program inclu
des below;
(1) Appointing the responsible to achieve objectives and details
(2) Implementation of method and plan

2) New development and modified actions, products and services shall be reflected to Environ
mental management or to special policy.

3) Management details follow Environmental management procedure

9.7 Control of documents


Control of documents related to environmental planning follows the Documentation control of
Quality management procedure.

9.8 Related document


1) Environmental effect evaluation and registration procedure

2) Environmental regulation management procedure

3) Environmental management program procedure


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10. Environment Performance and Management


10.0 Scope
This chapter describes performance, organization, responsibility, training, awareness,
qualification, communication, documentation control, documentation management,
management, emergency preparation and countermeasure in accordance with Environmental
management system.

10.1 Structure and responsibility


1) Relevant manager conduct the meeting for important environmental accident to set up coun
termeasure.

2) Management team has a responsibility to perform and manager environmental relative issu
es
(1) Setting and performing environmental education plan through organization
(2) Reporting important environmental accident/ civil appeal information
(3) Collecting internal/external environmental information and case publicizing
(4) Corrective actions and preventions of Environment related
(5) Internal/external communication management and maintenance
(6) Responsibility of documentation control

3) Management establishes emergency plan and implements periodically training and reportin
g through relevant manager to CEO.

10.2 Training, awareness, and qualification


1) Education and training are necessary to make personnel performing works affecting import
ant effect to Environment and potentially important understand the necessity of Environmen
tal management activities and capacity for performing.

2) Relative employees such as environmental manager and inspector of internal environment


shall be educated and qualified regarding to appropriate education, training and profession
al experience.

3) Awareness education shall include by function and grade;


(1) Importance of complying with procedure and policy of Environment and Environmental
management system
(2) Environmental effect and result of improvement after conducting
(3) Responsibility and role to assure the Environment system(emergency plan and reaction
requirement included)
(4) Problem estimated when broke from regulated working procedure

4) Details about training, awareness and qualification shall comply with Education procedure.
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10.3 Communication
1) Relevant manager shall correspond with external persons of interest on related information
and requirement concerning Environment information and shall document if necessary.

2) Manager of Quality and Environment maintains records of decisions after reviewing require
ments and environmental information from persons of interest. These records are consider
ed for environmental effect evaluation and re-registration.

3) Communication details shall comply with Environmental communication procedure.

10.4 Control of documents


1) To efficiently conduct the Environmental management system, it is important that writing, re
viewing, approval, divulgation, revision, maintenance of documents to assure that all docu
ments are controlled and written by adequate method comply with document and resource
management procedure

2) Documents shall be furnished in the area of directly related department

3) Documents are regularly reviewed and revised if necessary. Authorized person shall appro
ve the appropriacy and identify obsolete documents from documents preserved as legal or
preservative purpose to prevent to be misemployed or discarded from all publisher and us
er

4) Latest version of documents to conduct essential task for effective Environmental manage
ment shall be furnished

5) Details of documents control shall comply with Document and resource management proce
dure.

10.5 Management control


1) Relevant manager of management shall verify Environmental activities and managements
according to Environmental policy, objective, and details.

2) Contract review
Relevant manager of Marketing & Sales team shall make the bidding documents and
Environmental requirements released from customer reflected on contract in accordance
with Contract review management procedure.

3) Relationship with subcontractor


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Any important Environmental contents shall be reflected on the purchase order and the
contract and deliver to contractor

4) Documentation
Policy and procedure on Environmental effects and activities shall be documented and
stipulated to control Environmental policy, objectives and details

10.6 Emergency and countermeasure


1) Management team shall implement the appropriate countermeasure for unpredictable disas
ter or accidental incident such as fire, explosion, collapse, leak, wind and flood and notice r
equirement to minimize or prevent consequent environmental effect.

2) Emergency plans shall include minimum;


(1) Emergency organization and responsibility
(2) Principal employees list
(3) Institution and authority concerning Emergency state
(4) Measures for emergency state by case

3) Relevant manager shall review and revise measures and countermeasure process against
emergency if necessary

4) Details of emergency plan and reaction shall comply with Emergency management proced
ure

10.7 Control of documents


Documents of Environmental performance and management shall comply with
Quality/Environment management procedure

10.8 Related document


1) Education and training procedure
2) Contract review procedure
3) Environmental communication procedure
4) Emergency procedure
5) Environmental hazardous material management procedure
6) Energy and resource management procedure
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11. Environment Monitoring and Corrective Action


11.0 Scope
This chapter determines monitoring, measurement, nonconformity, corrective activities,
prevention, record, environmental audit, management review as inspections and corrective
actions for Environmental management system.

11.1 Monitoring and measurement

1) Relevant manager implement and maintain written procedure to monitor and measure activi
ties and principal characters which give important impacts to Environment

2) Procedure shall include information traceable to conformity, administrative management, re


sult on Environmental objective and detail

3) Monitoring and measuring devices shall be calibrated and managed by Device calibration p
rocedure and the results shall be maintained.

4) Compliance of Environmental regulation and policy shall be periodically evaluated

5) Details on measurement and examination shall comply with Environmental inspection and
measurement management procedure

11.2 Corrective action and prevention for nonconformity


1) Corrective action and prevention measurement shall be conducted in order to prevent the r
ecurrence of nonconformity from inspection and measurement

2) Responsibility and authority to implement and perform corrective actions and prevention m
easurement to minimize impact to Environment because of nonconformity

3) Corrective action and prevention measurement to eliminate the reason of already issued or
potential nonconformity shall be appropriate to scale of problem and environmental effect.

4) Every change of written procedure by Corrective action and prevention measurement shall
be performed and recorded

5) Details of nonconformity, corrective action and prevention measurement shall comply with
Corrective and prevention measurement management procedure. Nonconformity elements
shall follow Nonconformity management procedure.

11.3 Internal audit(Environment)


1) Environmental audit which verifies the suitability and validity of Environmental management
system identifies that Environmental management activities comply with Environmental ma
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nagement plans as well as standards and requirements. And the results shall be reported t
o President. Detail follows paragraph 8.2.2 and internal audit procedure.

2) Possibility to conduct and suitability of Environmental management program and detailed pl


an for Environmental audit shall be verified.

11.4 Management review


President review Management review reports to check if Environmental management system
has continually improved and the suitability and validity maintain. Environmental policy,
objective and management system will be changed by result and changed condition and
continual improvement. Details follow Management review procedure.

11.5 Control of documents


Records of Environmental inspection and measurement shall be controlled by
Quality/Environmental management procedure

11.6 Related document


1) Equipment management procedure
2) Corrective actions and prevention procedure
3) Internal audit procedure
4) Education and training procedure
5) Environmental monitoring and measurement management procedure
ATTACHMENT

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