Al-Jaber International Company

Procedure
Design Review
1. Revision History
Revision Description of
DATE Initiated By Completed By
No# Changes

2. Distribution List
Sr. No/
Designation Issue Date Distributed by

QA Manager / Management
01 Management Representative
Representative

CEO Management Representative

02

03 Chairman Management Representative

Others as per distribution List

Revision Document
Document Issue Revision Original Document Document
Issue Reviewed
Number Number Number Issue Date Prepared By Approved By
Date by
Department
CEO / MR Chairman
Head
AJB-DESGN-01 1.0 00

Copyright
This document contains confidential information. It may be copied in full or in parts only by Al-Jaber
International Company and only for the purpose of Al-Jaber International Company related activities.
Disclosure of any information contained within this procedure to any person (s) outside the employee of Al-
Jaber International Company without written permission of the Top Management is strictly prohibited.
 Al-Jaber International Company

Table of Contents

1 PURPOSE ............................................................................................................................................... 3
2 SCOPE .................................................................................................................................................... 3
3 GENERAL .............................................................................................................................................. 3
4 RESPONSILTIES ................................................................................................................................... 4
5 DEFINATIONS ........................................................................................................................................ 5
6 REFERENCE …………………………………………………………………………………………………..6
7 PROCEDURE ...................................................................................................................................... 7
8 RECORDS ............................................................................................................................................ 10
 Al-Jaber International Company
1.0 PURPOSE

The purpose of this procedure is to provide guidelines for performing a design review for
direct impact and indirect impact utilities, process equipment or systems and to
adequately control and document changes implemented during the design phase to
ensure that process requirements are met.

2.0 SCOPE

This procedure applies only to new and/or equipment and systems being modified and
determined to be “direct impact” or “indirect impact.

3.0 GENERAL

3.1 A design review compares the design of equipment and systems with the applicable
user and process requirements. These are primarily based on the current User
Requirements specification. processing requirements, product specifications, license
commitments, manufacturing records and applicable SOPs. The design review is
intended to ensure and record that the system’s design meets the user’s requirements.

3.2 Design reviews shall be performed for all new/modified direct impact and indirect impact
utilities, process equipment or systems.

3.3 The Design Review Record (DRR) shall be completed before placing equipment on order
or before approving drawings (or other submittals) on complex systems.

3.4 The approved Design Review Record on file for each system shall also be revised if
changes that alter the design review results are made to the system prior to completion
of validation. The Design Review Record revision may occur with accumulated
changes, so long as it is complete prior to commissioning.

3.5 If desired, a Design Review document may be generated, instead of using the single-
page DRR form attached. However, at a minimum, the content of the DRR form, and
the intent of the design review shall be included.

3.6 Change Control Management during design:

3.6.1 The Design Review team members must review all implemented changes to
the design of new/modified direct or indirect impact systems.

3.6.2 The Project Engineer/Manager or User will lead the Change Control effort.

3.6.3 The following questions must be addressed:

3.6.3.1 What is the change? Rationale/Justification

3.6.3.2 Which documents/drawings will be affected?
3.6.3.3 What impact will the change have?
3.6.4 Only approved documents can have changes
 Al-Jaber International Company
3.6.4.1 Specifications/Drawings
3.6.4.2 Design Drawings and other documents in-process of development
are not covered under the change control

4.0 RESPONSIBILITIES

4.1 The Engineering Project Leader, Project Engineer or Manager shall initiate the design
review activity and change control forms generated during the design of any new or
modified direct or indirect impact utilities, process equipment or system. If the
Engineering/Plant Services departments are not involved in the project, the User/Owning
department Project Leader, or designee, shall initiate the design review or change
control activities.

4.2 Design Review:

4.2.1 The Engineering/User department shall complete the “process requirements”

and “acceptance” sections of each Design Review Record. The User/Owning
department is responsible to identify any discrepancies as noted below.

4.2.2 The User/Owning department Manager (or designated alternate) is responsible

for reviewing and approving all Design Review documentation for
completeness, accuracy and acceptance, including approval of justifications for
discrepancies.

4.2.3 The Quality Assurance Department shall review the finalized design reviews for
completeness, accuracy, and User acceptance, including approval of
justifications for deviations.

4.2.4 The Validation Department is responsible for issuing Design Review Record
numbers and maintaining the completed records.

4.3 Change Control:

4.3.1 The project engineer or manager is responsible for coordinating the activities
related to the completion of the Change Control form (Attached) including:

4.3.1.1 Evaluation of Impact.

4.3.1.2 Approval by the User

4.3.1.3 Implementation of the change and verification of the change

implementation.

4.3.2 The design review team members will review the implementation of the pre-
approved changes during the design review meetings.
 Al-Jaber International Company

5.0 DEFINITIONS

Cross-reference Table - An item-by-item correlation between higher-level requirements

and the lower-level specification/engineering documents (i.e., FS, DS, submittals,
drawings, etc.). This document may be a table that lists each requirement’s item
number and then lists the section numbers of the lower level document that addresses
it.

Change Control - the implementation of, and adherence to, a formal process that documents
any change to a (specified/qualified/validated/approved) piece of equipment, system, process or
document that can affect the identity, strength, quality.
 Al-Jaber International Company
6.0 REFERENCES

6.1 AJB-IMS-PR-01, Validation and Lifecycle Document Numbering System

6.2 Attachment I, Design Review Record

6.3 Attachment II, Design Review Discrepancy Report

7.0 PROCEDURE

7.1 The Engineering Project Leader (or designee) initiates the Design Review Record
(Attachment I) for each new system.
.

7.2 The User/Owning department representative (or designee) enters the User or Process
Requirements for the equipment or system.

7.2.1 If a User Requirements document has been generated, enter the document
number..

7.2.3 Sign and date the bottom of the Process Requirements field.

7.3 The Engineering Project Lead (or designee) completes the Design Specifications
section.

7.3.1 List the Design Specification documents that satisfy the Process Requirements
listed.

7.3.2 Sign and date the bottom of the Design Specifications field.

7.3.3 Submit the DRR form, along with a copy of the design documents, to the
User/Owning department.

7.4 The User/Owning department representative (or designee) completes the

Acceptance/Comments section.

7.4.1 Review the functional, design and other specification documents against the
User/Process requirements.

7.4.2 If a cross-reference table is included in the design documents, this should be

verified at this time. A traceability matrix (or similar listing) should be created at
this time.
 Al-Jaber International Company

7.4.3 If the Design Specifications completely complies with the User/Process

Requirement, enter a single “Yes” in the Acceptance/Comments column.

7.4.4 If there are items in the User/Process Requirements that are not satisfied by
the design, enter a single “No”, and initiate a Design Review Discrepancy
Report (as detailed below) and note its requirement number in the
Acceptance/Comments field.

7.4.5 Once the Acceptance/Comments field is complete, and the numbers of all
Discrepancies Reports are listed, the User/Owner representative signs the
Design Review completed by line.
7.5 Design Review Discrepancy Reports (Attachment II)
7.5.1 For each item from Attachment I where the Design Specifications do not meet
the User/Process Requirements, initiate a separate Design Review
Discrepancy Report.
7.5.2 Number each Discrepancy Report with a non-reoccurring, consecutive,
discrepancy report number (i.e., “01”, “02”, etc.).
7.5.3 Record the Design Review Record number on each Discrepancy Report.
7.5.4 Enter a brief description of the discrepancy. Reference the item number or
section numbers of the applicable User/Process and Design documents. The
user/owner representative then signs and dates the form.
7.5.5 The User/Owner representative and the responsible Engineer then coordinate
to determine if corrective action is required, or if the discrepancy is acceptable
as-is. The determination is recorded on the Discrepancy Report (check box).
7.5.6 Record either the Justification, or the Corrective Action Plan on the
Discrepancy Report.
7.5.7 If the corrective action requires a change to the user requirement document, a
justification and impact statement must also be included. All
requirements/specification documents must be revised and kept current.
7.5.8 Both the User/Owner and Engineering representatives sign and approve the
decision
 Al-Jaber International Company
7.5.9 Once the Justification and/or Corrective action is complete, both the
User/Owner and Engineering representatives verify that the discrepancy has
been sufficiently resolved, justified and completed.
7.5.10 The completed discrepancy report is attached to the Design Review Record
and submitted to QA for review/approval.
7.6 Special Cases
7.6.1 Complex or multi-vendor systems that are assembled on site (i.e. DI water
system), may require that the design documents for various sub-components
be reviewed independently as they become available.
Review of the sub-components may be recorded via “Approved By” signatures
from the User/Owner, Engineering and QA representatives directly on the
design documents, or other appropriate means.
After all sub-components have been reviewed, all design documents (for the
entire system) will be compiled by Engineering. Engineering will then initiate
the Design Review Record form (Attachment I) which will encompass the entire
system.

7.7 Design Review Record Completion

7.7.1 The User/Owning department representative verifies that the Design Review
Record is complete and all discrepancies are addressed, resolved and are
acceptable.

7.7.2 The User/Owning department Manager reviews and approves the Design
Review Record package (Review Record and Discrepancy Reports).

7.7.3 The Project Manager (Engineering) reviews and approves the Design Review
Record package.

7.7.4 The QA representative reviews and approves the Design Review Record
package.

7.8 Design Review Record Storage

7.8.1 The Validation Department will maintain all Design Review Record packages
for the life of the equipment,

7.9 Change Control Management during design:

7.9.1 The Project Engineer/Manager (PE/M) or User will initiate the Change Control
Management process by describing the change and the rationale for it on the
Change Control form. The form will include the following sections:

7.9.1.1 Description of Change

7.9.1.2 Documents Affected
7.9.1.3 Reason/Rationale for Change
7.9.1.4 Impact of Change
7.9.1.5 Approvals
7.9.1.6 Implementation Verification
 Al-Jaber International Company
7.9.2 Once approved, the PE/M will implement the change to the affected
documents/drawings and document the implementation/verification on the
form.
7.9.3 The Project Engineer/Leader/Manager will discuss the changes implemented
during the Design Review meetings and document the discussion on the DDR.
This will serve as the verification approval of the change implementation.
 Al-Jaber International Company
ATTACHMENT I
DESIGN REVIEW RECORD

QA Tracking #: Design Review Record #:

Equipment ID #; Equipment Name:

User/Owner Dept.: Equipment Location:

ACCEPTANCE / COMMENTS /
PROCESS
DESIGN SPECIFICATIONS DISCREPANCY REPORT
REQUIREMENTS
LISTING

Functional Specification #:
URS#:

Other: Design Specification #:

Mfr's Specification Data Sheet #:

P&ID #:

Submittal (Name and #):

Affected Utilities to ensure adequacy (WFI, electrical, drains, etc.).

Document with calculations, justifications, etc. (Name & #):

Other (Specify)

Entered by / Date: Entered by / Date:

Design Review completed by: Date:

User / Owner Manager Approval / Date:

Project Manager (Engineering) Approval / Date:

QA Technical Approval / Date:

EHS Approval / Date:

 Al-Jaber International Company
ATTACHMENT II
DESIGN REVIEW DISCREPANCY REPORT

Design Review Record No.: Discrepancy No.: of

Discrepancy Description:

User-Owner Signature / Date:

Corrective Action Required (describe) Acceptable As-Is (Justify)

Justification / Corrective Action / Impact:

User-Owner Signature / Date: Project Lead (Engineer) / Date:

The Discrepancy has been sufficiently resolved, justified and/or action plan completed.

Comments:

User-Owner Signature / Date: Project Lead (Engineer) / Date:

QA Technical / Date:
 Al-Jaber International Company
ATTACHMENT
III
CHANGE CONTROL FORM – DESIGN
CHANGES

Change Control Form No.: Date Initiated

System/Equipment Affected: Documents

Affected:

Change Description:

Justification:

Impact:

User-Owner Signature / Date: Project Lead (Engineer) / Date:

The Change was implemented and verified as proposed.

Comments:

User-Owner Signature / Date: Project Lead (Engineer) / Date:

REVISION HISTORY

EFFECTIVE
REV. NO. CR. NO. SUMMARY OF CHANGES
DATE
Draft New document.