TERAPUTICS SDN. BHD.

STANDARD OPERATING PROCEDURE

SUBJECT
PROCEDURE FOR
PREPARING INSTALLATION
QUALIFICATION
SOP No : MNT / SOP / 0068
Revision No : 02
Superseded : 01
Issued Date : 12 th April 2014

Review Date : 12
th
April 2016
Page 1 of3




Prepared by

Reviewed by

Approved by

Department
Maintenance
Executive
Maintenance
Manager
Quality Assurance
Manager
Name

Signature



Date





1.0 OBJECTIVE

1.1 This SOP outlines the procedure to be followed in the Installation Qualification of
new process equipment.

2.0 SCOPE

2.1 Applicable to all major process equipment.


3.0 REFERENCE

3.1 Not Applicable

4.0 DISTRIBUTION LIST

4.1 QA Department
4.2 Maintenance Department


5.0 FORMAT

5.1 Not Applicable

6.0 RESPONSIBILITY

6.1 It is the responsibility of the Maintenance Manager to ensure that Installation
Qualification are perform on all new process equipment as outlined in this SOP.
TERAPUTICS SDN. BHD.
STANDARD OPERATING PROCEDURE
SUBJECT
PROCEDURE FOR
PREPARING INSTALLATION
QUALIFICATION
SOP No : MNT / SOP / 0068
Revision No : 02
Superseded : 01
Issued Date : 12 th April 2014

Review Date : 12
th
April 2016
Page 2 of3




Prepared by

Reviewed by

Approved by

Department
Maintenance
Executive
Maintenance
Manager
Quality Assurance
Manager
Name

Signature



Date





6.2 It is the responsibility of QA Manager to ensure the procedure is followed
accordingly.

7.0 PROCEDURE

7.1 Upon receipt of process equipment check for the following:
7.1.1 Equipment name and identification.
7.1.2 Any documentation enclosed e.g. operation manual, certificates.
7.1.3 Packing list.
7.1.4 Installation requirements.
7.1.5 Utilities requirements.
7.1.6 Equipment specifications.
7.1.7 Calibration requirements.
7.1.8 Consumables and spare parts.
7.1.9 Other requirements.

7.2 Installation:
7.2.1 Identify asset number and room number.
7.2.2 Check suitability of location and utilities available.
7.2.3 Install the equipment as recommended in the Installation Manual, if
available. If manual is not available, installation shall be perform after
critically observing and assessing the equipment or after consultation with
the supplier.
7.2.4 Prepare TPM file and service report.
7.2.5 Report deviation from Installation Manual, if any.

7.3 Check operation / function :
TERAPUTICS SDN. BHD.
STANDARD OPERATING PROCEDURE
SUBJECT
PROCEDURE FOR
PREPARING INSTALLATION
QUALIFICATION
SOP No : MNT / SOP / 0068
Revision No : 02
Superseded : 01
Issued Date : 12 th April 2014

Review Date : 12
th
April 2016
Page 3 of3




Prepared by

Reviewed by

Approved by

Department
Maintenance
Executive
Maintenance
Manager
Quality Assurance
Manager
Name

Signature



Date





7.3.1 Upon successful installation of the equipment, perform test run as
specified in the Operation Manual. If manual is not available, check the
operation and function of equipment after critically observing and
assessing the equipment of its intended use or after consultation with the
supplier.
7.3.2 Check that each part function as it was intended.
7.3.3 Report any non-conformance.
7.3.4 Proceed with Operation Qualification.



8.0 CHANGE HISTORY


Revision No. Date Revised Reason for Changing
New 14
th
April 2010 NEW
Cross reference ENG/SOP/0017
01 12
th
April 2012 Revised expire SOP
02 12
th
April 2014 Revised expire SOP




9.0 END OF DOCUMENT