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Ref.

No: ESCL-SOP-011

EGBA SPLIT-CLAMPS LIMITED

Rev. No: 00
Issue Date:12th Nov, 2012

Design and Development


Procedure

Page 1 of 7

DESIGN AND DEVELOPMENT


PROCEDURE

APPROVAL AND REVISION STATUS


Rev. No.

Issue Date

Revision

00

12/11/2012

Identification
First Issue

Prepared by

Reviewed

Approved by

Production
Manager

by
QHSE
Manager

Managing
Director

EGBA SPLIT-CLAMPS LIMITED

Ref. No: ESCL-SOP-011

Design and Development


Procedure

Rev. No: 00
Issue Date:12th Nov, 2012
Page 2 of 7

CHANGE (S)/AMENDMENT (S)

The change(s)/amendment(s) noted below have been made and approved by the
Managing Director for issue.
Change/Amendment No.

Date

Page

Description of Change/Amendment

EGBA SPLIT-CLAMPS LIMITED

Design and Development


Procedure
1.0

Ref. No: ESCL-SOP-011


Rev. No: 00
Issue Date:12th Nov, 2012
Page 3 of 7

PURPOSE
The purpose of this procedure is to define the activities or processes involved in the
design and development stages of Egba Split-Clamps in order to ensure that quality is
built into the product right from the design stage.

2.0

SCOPE
This procedure is applicable to design and development Egba Split-Clamps.

3.0

REFERENCES
ESCL Quality Manual (ESCL-QM-001)
NIS ISO 9001: 2008, Quality Management Systems Requirements.
NIS ISO 9000: 2005, Quality Management Systems - Fundamentals and Vocabulary
ESCL-SOP-013, Outsourcing Procedure
Form 125, Job Card
Form 129, Disciplinary Check
Form 130, Inter-Disciplinary Check

4.0

TERMS AND DEFINITIONS


The following terms and definition and the ones given in ESCL Quality Manual and
NIS ISO 9000: 2005 apply.

4.1

ESCL: Egba Split-Clamps Limited;

4.2

ISO: International Organization for Standardization;

4.3

NIS: Nigerian Industrial Standard;

4.4

Design and Development: Set of processes that transform requirements into specified
characteristics or into the specification of a product, process, or system.

4.5

Characteristics: Distinguishing features.

4.6

Design Package: This refers to detailed plan for a product including applicable
Standards, drawings, data, specifications, calculations, procedures, checklists, any
other. Such documentation includes but is not limited to design plans, input
elements, output elements, evidence of review/verification and evidence of
validation.

4.7

Design Originator: This refers to the person that originated the design package.

EGBA SPLIT-CLAMPS LIMITED

Design and Development


Procedure
4.8

Ref. No: ESCL-SOP-011


Rev. No: 00
Issue Date:12th Nov, 2012
Page 4 of 7

Process: Set of inter-relating or interacting design activities, which transforms


design inputs into outputs.

4.9

Product: Result of a design process.

4.10

Review: Activity undertaken to determine the suitability, adequacy and effectiveness


of design activity to achieve established objectives.

4.11

Validation: Confirmation, through the provision of objective evidence, that the


requirement for a specified intended use or application have been fulfilled. (Testing
the reality of a design product).

4.12

Verification: Confirmation and provision of objective evidence that specified


requirements have been achieved.

5.0

Responsibilities and Authority

5.1

Production Manager: Overall responsibility for design and development including the
overall production and integrity of all engineering design calculations and drawings.
Supervises all engineering design calculations and drawings and carries out relevant
disciplinary and interdisciplinary checks to ensure conformance to specified
requirements.

5.2

Design Engineer: Prepare all design calculations, sketches and reports to satisfy
project requirement in accordance with the specified standards and codes of
practice. This activity is presently outsourced (see the Outsourcing Procedure, Ref
No. ESCL-SOP-013).

5.3

QA/QC Department/QC Inspector: Ensures that work execution follows plan (e.g.
through inspection, test, audit).

6.0

PROCEDURE

6.1

General

6.1.1 The under listed modalities are strictly adhered to by ESCL in order to ensure that all
engineering design documents and drawings are verified prior to their issue.

Design verification must be completed entirely prior to issue for construction;

Design verification is also performed on changes made on the overall design;

EGBA SPLIT-CLAMPS LIMITED

Design and Development


Procedure

Ref. No: ESCL-SOP-011


Rev. No: 00
Issue Date:12th Nov, 2012
Page 5 of 7

6.1.2 Design and development review, verification and validation have distinct purposes.
They can be conducted and recorded separately or in any combination, as suitable for
any project/product.
6.1.3 Where design and development process is outsourced in a project/product, ESCL
maintains control over the process by ensuring that each design package prepared is
appropriately verified and approved before use.
6.2

Design Input

6.2.1 Prior to the commencement of the design project, the Design Engineer develops plans
for each design development activity.
6.2.2 The design input consists as applicable of all clients specifications, equipment spec
sheet, design briefs, referenced codes/standards, drawings and approved procedures
which are to be adapted to the project/product.
6.2.4 The design input information is reviewed by a qualified personnel equipped with
adequate resources. This is to ensure that design activities are carried out in a correct
manner and also to provide consistent basis for design verification and change
evaluation.
6.3

Design Output

6.3.1 The design output is documented and expressed in terms that can be verified and
validated against design input requirements. Design output includes the following as
appropriate:

Materials Specification;

Welding WPS;

Test Procedures;

Design Calculations;

Drawings.

6.3.2 The design output

Meet the design input requirements;

EGBA SPLIT-CLAMPS LIMITED

Design and Development


Procedure

Ref. No: ESCL-SOP-011


Rev. No: 00
Issue Date:12th Nov, 2012
Page 6 of 7

Contain or make references to acceptance criteria;

Identify those characteristics of the design that are crucial to the safe and proper
functioning of the product e.g. operating, storage, handling, maintenance and
disposal requirements.

6.4

Discipline Checks (DC)

6.4.1 The purpose of the discipline check (DC) is to achieve an independent check of the
performed work by the Originator (Design Engineer). The Disciplined Check (DC) is
applicable to all design input information i.e. specifications, data sheets, calculations,
drawings, reports, bill of material and purchase order data.
6.4.2 It is the responsibility of the Production Manager or his designee to perform the
Disciplined Check (DC). This involves check on every page in the document
concerned.
6.4.3 Changes to design documents resulting from the check are notified to the Originator as
appropriate.
6.5

Inter Discipline Checks (IDC)

6.5.1 The aim of the IDC is to ensure that documents produced by one discipline are
compatible with related documents produced by other disciplines and also to verify that
the input information incorporated in the document are correct.
6.5.2 The IDC, relates to all types of documents produced, i.e. specifications, procedures,
drawings and data.
6.5.3 The Production Manager is responsible for deciding which documents are subjected
to IDC and by whom they must be checked.
6.6

Design Review

6.6.1 At appropriate stages of design, formal documents reviews of the design result is
conducted. This is to ensure that the design output i.e. documents and drawings are
correct and meet the requirements for their intended use.

6.6.2 Participants of the design reviews include representatives of all functions concerned
with the design stage under review.

EGBA SPLIT-CLAMPS LIMITED

Design and Development


Procedure

Ref. No: ESCL-SOP-011


Rev. No: 00
Issue Date:12th Nov, 2012
Page 7 of 7

6.6.3 It is the responsibility of the Production Manager to decide at which stage and which
document is reviewed.
6.6.4 The outcome of the design review points out the short comings and discrepancies in
the design to ensure:

All contributory factors have been considered;

The design meets the project/product requirements;

All design paths have been explored;

Availability of adequate supporting documentation to define the design.

6.6.5 All design reviews records are maintained e.g. discipline checks (DC), inter-discipline
checks (IDC), Check list showing what guidelines was used e.g. API Specification.
6.7

Design Verification
At appropriate stages of design, design verification is performed to ensure that the
design stage output meets the design stage input requirements. Records of design
verification are maintained. This includes discipline checks (DC), inter-discipline
checks (IDC), Check list showing what guidelines was used e.g. API Specification.

6.8

Design Validation

6.8.1 The aim of design validation is to ensure that product conforms to defined user needs
and/or requirements. Design validation follows successful design verification.
6.8.2 Validation is performed under certain defined operating conditions. Also validation can
be performed on the final product e.g. NDE(Pressure Testing).
6.9

Design Changes
All design changes and modifications are identified, documented, reviewed and
approved as appropriate.

7.0

RECORDS

7.1

Design and development plan

7.2

Design Input

7.3

Design Output

7.4

Design review, verification and validation record

7.5

Record of design changes

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