QMS-03 Rev 1 Procedure For Design Control

AMIGOS Ltd.
, Quality Management System Ref: QMS-03

Dong Xuyen Industrial Park. Procedure Rev: 1
Ward 10, Procedure For Issue: 0
Vung Tau City. Design/Engineering Control Date: 25th February 2006
S.R. Vietnam Page 1 of 22
PROCEDURE FOR
DESIGN/ENGINEERING CONTROL
Prepared By CAS Date 25.2.04 Signature

Reviewed By Tuan Date 25.2.04 Signature
Approved By BJA Date 28.2.04 Signature
Issue Date 25.02.06 Effective Date 26.02.06
AMIGOS Ltd., Quality Management System Ref: QMS-03
AMENDMENT CONTROL SHEET

Rev Date Section Description By Approved
A Aug ‘01 All Issued for review & comments CAS N/a
B Feb ‘04 All Comments incorporated, for review CAS N/a
0 Feb '04 All Issued CAS N/a
1 Feb '06 6 Minor Wording changes section 6 CAS N/a

CONTENTS
Document Revision History
1. Purpose
2. Scope
3. Definitions
4. Related Documents
5. Responsibilities
6. Procedure
6.1 Design & Development Planning

6.2 Organizational & Technical Interfaces
6.3 Design Input
6.4 Design Output
6.5 Design Review
6.6 Design Verification
6.7 Design Validation
6.8 Design Software
6.9 Design Changes
6.10 Issue to Client for Approval
7. Appendix
Appendix 1 Typical Example of Design & Engineering Work Flow

Appendix 2 Typical Example of Organizational & Technical Interfaces
Appendix 3 Sample of Technical Query
Appendix 4 Engineering Document Status List

Appendix 5 Sample of Revision Status/Summary of Changes
Form 1 Contract Document Check

Form 2 Engineering Scope of Work Check
Form 3A Design Input Check List (Platform)
Form 4A Technical Interface Check List (Project Operations)
Form 5A Design Review Check List (Report)
Form 5B Design Review Check List (Specifications)
Form 5C Design Review Check List (Drawings)
Form 6 Design Verification Check List
Form 7 Design Validation Checklist
1. PURPOSE
The purpose of this procedure is to outline the design/engineering work

sequence and procedure to control and verify the design of products in order to
meet the Client’s specified requirements.
2. SCOPE
This procedure shall be applicable to all design/engineering works undertaken

by AMIGOS Co. Ltd.
3. DEFINITIONS
Design Review shall mean the formal documented, comprehensive and

systematic examination of a design, to evaluate its capability
to fulfill the requirements for quality, to identify problems, if
any and to propose the development of solutions.
Design Verification shall mean the confirmation by examination that the

accuracy and adequacy of design outputs has fulfilled the
specified design requirements.
Design Validation shall mean the confirmation by examination and provision of

objective evidence that the design has fulfilled the particular
requirements under defined conditions for a specified
intended purpose. This is normally performed after design
verification for new concept design.
4. RELATED DOCUMENTS
AMG-QM-01 Quality Manual
QMS-04 Control of Quality Records Procedure

QMS-04A Project Document Control Procedure
QMS-02 Contract Review Procedure
5. RESPONSIBILITIES
5.1 The engineering department comprises of the Technical Manager and a

group of engineers as required from the following disciplines :
 Structural
 Piping
 Mechanical/Equipment
 Electrical
 Instrumental
Each discipline group shall be supervised by a Senior Engineer.

The engineering team is supported by Third Party Agencies as required.
5.2 The Technical Manager shall be responsible :
 for the assignment and staffing of project discipline engineering groups.

 supervision of preparation of all design engineering documents
including specifications, drawings, data sheets and material
requisitions.
 maintenance of communication to ensure timely information distribution
to project services, procurement, fabrication and installation functional
groups.
 overall quality control of discipline engineering work, review and
approval of all technical documents prior to submittal to Client for
review and/or approval. This shall include Liaison with third parties
engaged to conduct Design Verification and Design Validation as
required by Contract.
5.3 The Senior Engineer reports to the Technical Manager for the supervision
and effective utilization of the engineered staff engaged in the various
disciplines. His responsibilities include :
 initiation of the development and preparation of design data, drawings,

engineering specifications for materials and equipment, and
preparation of technical input for Material Requisition.
 planning, supervising and directing activities of the engineering
discipline staffing in the preparation of engineering documents to meet
the established budget and time schedules.
5.4 The Discipline Draughting Engineer reports to the Senior Engineer and
shall have the assigned responsibility for the design/draughting of
offshore and onshore products. This includes review of the basic design
package supplied by the Client, finalizing the product design criteria in
consultation with the Senior Engineer and performing the necessary
calculation and analysis, including detailed design drawings where
applicable.
5.5 The terminology of the above positions may varies from client to client
depending on project requirements. E.g. :
- Design Manager or Engineering Manager is equivalent to Design &
Engineering Manager or Technical Manager.
- Chief Design Engineer is equivalent to Senior Discipline Engineer.
6. PROCEDURE
The design & develoment review, verification and validation are performed at
the various stages of design/engineering phases to ensure that the
design/engineering outputs are in compliance with the design/engineering basis
and Client’s requirements. A typical example of design & engineering work flow
is illustrated in Appendix 1.
6.1 Design & Development Planning
6.1.1 The Technical Manager shall ensure all design & development
documents to be prepared have been identified and assigned to
responsible engineers, and when required by contractual
requirements, are approved by the Client.
6.1.2 Form 1 Contract Document Check shall be used to ensure that the
Contract Document is adequately documented.
6.1.3 Form 2 Engineering Scope of Work Check shall be used to identify

the required engineering scope of work.
6.1.4 The Technical Manager shall ensure that the assigned personnel
for design & development work shall have the necessary training
and/or qualification and adequate resources to perform the
assigned task satisfactorily.
6.1.5 The Technical Manager shall ensure that design & development
activities which are not performed by the internal design and
development team, are subcontracted to qualified approved design
& development subcontractors.
6.1.6 The Technical Manager shall ensure that the design and
development plans are updated as the design evolves.
6.2 Organizational & Technical Interface
6.2.1 The organizational & technical interfaces between different

functions affecting design shall be identified during a new contract
start-up including, where appropriate, coordination between
engineering subcontractors activities. (see Appendix 2).
6.2.2 The Technical Manager shall be responsible for ensuring that

design & development work performed by design & development
subcontractors is systematically coordinated in order to produce
good and reliable design which shall be in compliance with this
procedure.
6.2.3 The Design & Engineering Manager shall interface with the related
functional groups, different disciplines groups, fabrication shop,
technical specialist and engineering subcontractors as required.
Form 4A, 4B & 4C Technical Interface Check list for Project

Operation, Fabrication shop and Design & development
Subcontractor shall be used as required. The Client shall be
consulted on design & development input requirements to
establish the basis of design & development.
6.2.4 All necessary information for effective design and development

planning are documented and communicated to the different
functions through minutes of meetings, correspondence (fax, mail,
telephone, email) from time to time and reviewed regularly to
facilitate the proper design process.
6.2.5 Examples of design data and information which are transmitted for
coordination through the design interface may include :
(1) Design plan/schedule

(2) Design criteria & procedures
(2) Design drawings and calculations
(3) Design specifications
(4) Design change
(5) Survey reports (where applicable)
6.3 Design & development Input
6.3.1 Upon receipt of a new contract, the Project Manager and/or the
Technical Manager shall :
 ascertain whether compliance can be attained;

 review the design & development input requirements including
statutory and regulatory requirements regularly for adequacy;
 ensure that Client supplied documentation is clearly defined and
the requirements are adequately documented;
 ensure that design & development input takes into consideration
the results of contract review activities which are in accordance
with QMS-02
The engineering documents shall be prepared systematically and

in compliance with the agreed basis of design & development
6.3.2 The Technical Manager shall be responsible for allocating design

& development responsibility to suitably qualified discipline
engineers, for their origination, checking and interface control.
6.3.3 Any incomplete, ambiguous or conflicting requirements shall be

resolved with those responsible for drawing up these requirements
by correspondence through a combination of phone, fax or mail.
A sample of technical query (Appendix 3) is attached herein for

reference. This shall be used in the absence of Client’s specified
format.
Where required, a clarification meeting coordinated by the Project

Manager may be held and all issues discussed and resolution shall
be recorded in the minutes of meeting. Such records shall serve as
objective evidences for clarification and shall be maintained in
accordance with QMS-15.
6.4 Design & Development Output
6.4.1 The design & development outputs shall be documented in the

appropriate specifications in terms of calculations, supporting
analyses and drawings and shall ensure that design output
 meets the design & development input requirements;

 contains or makes reference to acceptance criteria;
 conforms to statutory requirements;
 identify characteristics that are crucial to the safe and proper
functioning of the facilities.
6.4.2 Design & development output documents including design

calculations, drawings, procedures, data sheets, etc. shall be
reviewed and approved by the assigned authority to ensure
accuracy and adequacy of each element of design & development
output in respect to Client’s requirements or statutory or regulatory
requirements.
6.4.3 Calculations
Design & development calculations shall be prepared by the

discipline engineer assigned using relevant design criteria and
applicable codes and standards. Cover sheets for the calculations
shall be completed with relevant information, indexed and logged.
6.4.4 Drawings
All drawings shall be checked for its accuracy and compatibility in

relation to other engineering disciplines.
The drawings to be issued for construction shall be approved by

the Technical Manager and/or the Senior Engineer where
references can be made for clarification when necessary.
6.4.5 Specifications and Data Sheets
Specifications and data sheets for material requisition covering

equipment and materials for design & development shall be
reviewed and modified when necessary. These shall be recorded
and updated on the Engineering Document Status List (Appendix
4) and maintained by the responsible Senior Engineer or the
Technical Manager.
6.4.6 Procedures
Design & development procedures shall be developed by the

relevant discipline engineer or assigned personnel by the Technical
Manager in accordance with Client’s specifications and
requirements, taking into consideration the applicable codes and
standards, statutory and regulatory requirements.
6.5 Design Review
6.5.1 At appropriate stages of design & development, formal

documented reviews of the design & development results shall be
planned and conducted. Participants at each design &
development review shall include representatives of all functions

concerned with the design & development stage being reviewed,
as well as other specialist personnel, as required.
6.5.2 Design & development Review shall be performed by the Senior

Engineer or the Technical Manager and reviewed by the Design &
Engineering Manager using Form 5A Design Review Checklist
(Report), Form 5B Design Review Checklist (Specification) and
Form 5C Design Review Checklist (Drawings) accordingly.
Records of such reviews shall be maintained in accordance with
QMS-15.
6.5.3 Design & development procedures and specifications shall be

reviewed by the Senior Engineer and approved by the Technical
Manager.
6.5.4 Design & development calculations, analysis, data sheets and

drawings shall be reviewed and verified by the responsible Senior
Engineer and approved by the Technical Manager.
6.5.5 When required by contractual requirements, the design &

development documents shall be submitted to the Client for
approval.
6.6 Design & development Verification
6.6.1 Design & development verification shall be carried out by one of

the following methods :
 Client Verification.
 Consulting Engineering Company Verifies
 request internationally approved third party certifying authority to
verify design methods, calculations, etc.
Form 6 Design Verification Checklist shall be used to ensure that

design verification has been performed.
6.7 Design & development Validation shall be the responsibility of the client,
consulting Engineering Company or Certifying Authority.
6.7.1 Design & development validation shall be performed on the final

stage or at the earlier stages where applicable after successful
completion of design & development verification, to ensure that the
design & development is fit for its intended purpose and function.
Form 7 Design Validation Checklist may be used to ensure that

design validation has been performed or third party forms used.
Note that for supporting engineering, item 6.7.1 shall be sufficient

to validate that the design & development is fit for its intended
purpose.
(Supporting engineering denotes technical studies to ensure the
reliability of construction methods used.)
6.7.2 Where necessary, design & development validation may be

performed by third parties under defined operating conditions and if
there are different intended uses, multiple validations may be
performed. For repeated design & development, validation may not
be required.
6.7.3 Validation of design & development for fitness for purpose and
function shall be deemed acceptable once the client approves the
relevant drawings and specifications.
6.8 Design Software
6.8.1 Use of Design Software
The Technical Manager may permit the use of special design

software for carrying out the calculations by computer.
6.8.2 Updating Design Software
The Technical Manager shall ensure that any Design Software

used for calculation is updated as required to incorporate
applicable Rules/Codes/Standards/issues/revisions.
6.9 Design & Development Changes
6.9.1 Design & development change can occur as a result of internal

request or external request.
(1) Internal request for design & development change by design

& development discipline groups and other related functional
groups shall be documented by internal correspondence.
(2) External request for design & development change by

Client, third party certifying bodies as required, design &
development subcontractors, etc. shall be documented in
the correspondence (e.g. fax, mail, etc.) and forwarded to
the appropriate department manager and the Senior
Engineer.
6.9.2 The Senior Engineer shall review the design & development
change with the Technical Manager and the appropriate functional
groups, taking into consideration the scope of work, cost impact,
project milestones and overall performance.
6.9.3 If the design & development change is acceptable, the work on

design & development change shall proceed The requesting party
shall be informed of the rejection of request. Should a Client
request have impact on the cost, schedule scope or performance,
the Client shall be informed via the Project Manager of the impact
and Client approval on the variations shall be required before the
change is implemented.
6.9.4 Any change/modification made to the calculations, drawings,

specifications and data sheets shall be recorded in accordance
with Project Document Control Procedure (QMS-04A) and updated
by the Senior Engineer/ Technical Manager in the Engineering
Document Status List. (Appendix 4). Such change/modification
shall be incorporated into the design after the approval by the
Client.
Changes in design & development drawings, specifications,

technical data sheets should be identified by a triangle and
reflected in the Revision Status/Summary of Changes (Appendix
5).
6.9.5 Design & development documents including design calculations,

analysis, drawings, procedures, data sheets, etc. shall be recorded
in the Engineering Document Status List. This list shall serve as a
Master List in ensuring that the design & development documents
are of the latest revision.
6.9.6 The Engineering Document Status List shall be maintained and

distributed by the Senior Engineer/Technical Manager to the
Project Management Team and the affected parties, as and when
there is an update.
6.10 Issue to Client for Approval
The Technical Manager shall ensure that the design &

development outputs meet the design & development input
requirements before the submission of the design & development
outputs to the Client for approval and subsequent submission (if
required) to the relevant regulatory and statutory authorities for

approval for construction.
7. APPENDIX
Appendix 1 Typical Example of Design & Engineering Work Flow

Appendix 2 Typical Example of Organizational & Technical Interfaces
Appendix 3 Sample of Technical Query
Appendix 4 Engineering Document Status List
Appendix 5 Sample of Revision Status/Summary of Changes
Form 1 Contract Document Check

Form 2 Engineering Scope of Work Check
Form 3A Design Input Check List
Form 4A Technical Interface Check List (Project Operations)
Form 5A Design Review Check List (Report)
Form 5B Design Review Check List (Specifications)
Form 5C Design Review Check List (Drawings)
Form 6 Design Verification Check List
Form 7 Design Validation Checklist
7. APPENDIX 1
TYPICAL EXAMPLE OF DESIGN & ENGINEERING WORK FLOW
Client’s Requirements
& Specifications
Resolve any incomplete,

ambiguous or conflicting Design Development & Organizational &
requirement Planning Technical Interface
Design Input Design Input Review
Design
Basis/Procedure
Design & Engineering

Activities
Design Output
Design Review Design Change
DesignVerification
1. Third Party
Verification
2. Client Verification
Design validation
Approved?
APPENDIX 2 Issue for Client approval

As required
TYPICAL EXAMPLE OF ORGANIZATIONAL AND TECHNICAL INTERFACE
FUNCTIONAL
FUNCTIONALGROUPS
GROUPS
Project
ProjectOperations
Operations
Bidding
Bidding&&Marketing
Marketing
Purchasing
Purchasing
Research
Research&&Development
Development
Business
BusinessDevelopment
Development

Project Specification Requirements
Requirements Client’s Specifications
Design &
Technical DESIGN
DESIGN&&ENGINEERING
ENGINEERING Engineering
Requirements DEPARTMENT
DEPARTMENT Inputs
Sttructure DESIGN
Sttructure DESIGN&&
TECHNICAL
TECHNICAL Piping
Piping ENGINEERING
ENGINEERING
SPECIALIST
SPECIALIST Mechanical/Equipment
Mechanical/Equipment SUBCONTRACTORS
SUBCONTRACTORS
Electrical
Electrical
Technical Instrumental
Instrumental Design &
Reports Engineering
Outputs

Outputs Fabrication
Fabrication Requirements
Requirements
FABRICATION
FABRICATIONSHOP
SHOP
APPENDIX 3
SAMPLE OF TECHNICAL QUERY
TQ/XXX
AMIGOS Ltd. TECHNICAL QUERY
DONG XUYEN INDUSTRIAL PARK
WARD 10, Project : _________________________________
VUNG TAU CITY.
S.R. VIETNAM
Bid No. : _________________________________
PHONE 84.64.610580 FAX 84.64.610579
To Date
Attn Page of Rev.
C.C. Fax
Subject
Ref.
TECHNICALQUERY & RECOMMENDED SOLUTION/CLARIFICATION
Originator : Date :
ANSWER/RESPONSE
Originator : Date :
Approved by Signature : Date :

Client :
APPENDIX 5
SAMPLE OF REVISION STATUS/SUMMARY OF CHANGES
DESIGN BASIS AND PROCEDURE FOR PIPING

DOCUMENT NO AMG-ENG-XXXXRev0 SHEET 1
REVISION STATUS / SUMMARY OF CHANGES
REVISION REVISED PAGES / REVISION DESCRIPTION REASON FOR

CHAPTERS REVISION
A Issue for review
0 Table of contents Issued for Client

Introduction Review/Approval

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AMIGOS Ltd.

, Quality Management System Ref: QMS-03

Prepared By CAS Date 25.2.04 Signature

AMENDMENT CONTROL SHEET

B Feb ‘04 All Comments incorporated, for review CAS N/a

0 Feb '04 All Issued CAS N/a

1 Feb '06 6 Minor Wording changes section 6 CAS N/a

Document Revision History

6.1 Design & Development Planning

Appendix 1 Typical Example of Design & Engineering Work Flow

Appendix 4 Engineering Document Status List

Form 1 Contract Document Check

The purpose of this procedure is to outline the design/engineering work

This procedure shall be applicable to all design/engineering works undertaken

Design Review shall mean the formal documented, comprehensive and

Design Verification shall mean the confirmation by examination that the

Design Validation shall mean the confirmation by examination and provision of

AMG-QM-01 Quality Manual

QMS-04 Control of Quality Records Procedure

QMS-04A Project Document Control Procedure

QMS-02 Contract Review Procedure

5.1 The engineering department comprises of the Technical Manager and a

Each discipline group shall be supervised by a Senior Engineer.

5.2 The Technical Manager shall be responsible :

 for the assignment and staffing of project discipline engineering groups.

 initiation of the development and preparation of design data, drawings,

6.1 Design & Development Planning

6.1.3 Form 2 Engineering Scope of Work Check shall be used to identify

6.2 Organizational & Technical Interface

6.2.1 The organizational & technical interfaces between different

6.2.2 The Technical Manager shall be responsible for ensuring that

Form 4A, 4B & 4C Technical Interface Check list for Project

6.2.4 All necessary information for effective design and development

(1) Design plan/schedule

6.3 Design & development Input

 ascertain whether compliance can be attained;

The engineering documents shall be prepared systematically and

6.3.2 The Technical Manager shall be responsible for allocating design

6.3.3 Any incomplete, ambiguous or conflicting requirements shall be

A sample of technical query (Appendix 3) is attached herein for

Where required, a clarification meeting coordinated by the Project

6.4 Design & Development Output

6.4.1 The design & development outputs shall be documented in the

 meets the design & development input requirements;

6.4.2 Design & development output documents including design

Design & development calculations shall be prepared by the

All drawings shall be checked for its accuracy and compatibility in

The drawings to be issued for construction shall be approved by

6.4.5 Specifications and Data Sheets

Specifications and data sheets for material requisition covering

Design & development procedures shall be developed by the

6.5 Design Review

6.5.1 At appropriate stages of design & development, formal

development review shall include representatives of all functions

6.5.2 Design & development Review shall be performed by the Senior

6.5.3 Design & development procedures and specifications shall be

6.5.4 Design & development calculations, analysis, data sheets and

6.5.5 When required by contractual requirements, the design &

6.6 Design & development Verification