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EGBA SPLIT CLAMPS LIMITED

Ref. No: ESCL-SOP-011

Design and Development


Procedure

Rev. No: 01
Issue Date: 6th May, 2013
Page 1 of 6

DESIGN AND DEVELOPMENT


PROCEDURE

APPROVAL AND REVISION STATUS


Rev. No.

Issue Date

Revision

01

06/05/2013

Identification
First Revision

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: 01
Issue Date: 6th May, 2013
Page 2 of 6

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

1.0

EGBA SPLIT CLAMPS LIMITED

Ref. No: ESCL-SOP-011

Design and Development


Procedure

Rev. No: 01
Issue Date: 6th May, 2013
Page 3 of 6

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 130, Design Review/Verification

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
drawings, specifications, work instruction, any other. Such documentation includes
but is not limited to evidence of review/verification and evidence of validation.

4.7

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

4.8

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

EGBA SPLIT CLAMPS LIMITED

Ref. No: ESCL-SOP-011

Design and Development


Procedure

Rev. No: 01
Issue Date: 6th May, 2013
Page 4 of 6

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.
Prepare all engineering design calculations, sketches, drawings and carries out
relevant checks to ensure conformance to specified requirements.

5.2

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

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;

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.
6.2

Design Input

6.2.1 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.

EGBA SPLIT CLAMPS LIMITED

Ref. No: ESCL-SOP-011

Design and Development


Procedure

Rev. No: 01
Issue Date: 6th May, 2013
Page 5 of 6

6.2.2 The design input information is reviewed by the Production Manager. 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;

Drawings.

6.3.2 The design output

Meet the design input requirements;

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

Design Review

6.4.1 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.
6.4.2 It is the responsibility of the Production Manager to decide at which stage and which
document is reviewed.
6.4.3 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.

EGBA SPLIT CLAMPS LIMITED

Ref. No: ESCL-SOP-011

Design and Development


Procedure

Rev. No: 01
Issue Date: 6th May, 2013
Page 6 of 6

.
6.5

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.

6.6

Design Validation

6.6.1 The aim of design validation is to ensure that product conforms to defined user needs
and/or requirements. Design validation follows successful design verification.
6.6.2 Validation is performed under certain defined operating conditions. Also validation can
be performed on the final product e.g. NDE(Pressure Testing).
6.7

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

7.0

RECORDS

7.1

Design Drawings/sketches

7.2

Design Input

7.3

Design Output

7.4

Design review, verification and validation record

7.5

Record of design changes