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SUBJECT PROCEDURE FOR PREPARING INSTALLATION QUALIFICATION SOP No : MNT / SOP / 0068 Revision No : 02 Superseded : 01 Issued Date : 12 th April 2014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PROCEDURE SUBJECT PROCEDURE FOR PREPARING INSTALLATION QUALIFICATION SOP No : MNT / SOP / 0068 Revision No : 02 Superseded : 01 Issued Date : 12 th April 2014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