Академический Документы
Профессиональный Документы
Культура Документы
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No
1 of 16
TABLE OF CONTENTS
01.0 PROTOCOL APPROVAL..............................................................................................2
02.0 OBJECTIVE...................................................................................................................3
03.0 SCOPE..........................................................................................................................3
04.0 EXECUTION TEAM......................................................................................................4
05.0 CRITICAL INSTRUMENTS CALIBRATION..................................................................5
6.0KEY FUNCTIONS ...........................................................................................................6
Operated by ........................................................................................................................11
08.0 VERIFICATION OF STANDARD OPERATING PROCEDURE..................................12
09.0 DEFICIENCY AND CORRECTIVE ACTION REPORT............................................13
10.0 SUMMARY AND EVALUATION OF RESULTS .........................................................14
11.0 REPORT APPROVAL.................................................................................................15
Mr. R.SRIDHAR REDDY.....................................................................................................15
Approval of this qualification is the responsibility of Validation Core Committee...............15
MAINTENANCE..................................................................................................................15
Mr. S. BAJI SAIDA........................................................................................................15
Mr. V.RAMULU............................................................................................................15
QUALITY ASSURANCE......................................................................................................15
Dr. A.R.M RAO..............................................................................................................15
12.0 APPENDIX................................................................................................................16
B
16
16
16
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
01.0
PROTOCOL APPROVAL
01.1
Protocol Prepared by
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No
2 of 16
TITLE
Deputy Manager-
SIGNATURE
DATE
Validation
01.2
Protocol checked by
Checking of this qualification plan is the responsibility of Validation Task Force Leader
NAME
Dr. A. Dikshit
01.3
TITLE
SIGNATURE
DATE
Manager- QA & RA
Protocol Approved by
Pre approval of this qualification plan is the responsibility of the Validation Core
Committee
NAME
Mr. S. Baji Saida
Mr. V. Ramulu
Dr. A. R. M Rao
DESIGNATION
Asst. ManagerMaintenance
Sr. Manager
Works
HeadQuality Assurance &
Regulatory Affairs
SIGNATURE
DATE
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
02.0
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No
3 of 16
OBJECTIVE
The objective of this protocol is to provide written procedure and or guidelines and
respective acceptance criteria for the Operation Qualification of Air Handling Unit
(AHU-1B) located in Block C Module II.
03.0
SCOPE
The scope of this protocol is to follow the procedure and or guidelines for the
Operational Qualification of the subjected equipment within the following boundaries
and order.
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
04.0
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No
4 of 16
EXECUTION TEAM
Name
Mr. Vijay Gornale
Mr. A. Kameswara Rao
Mr. N. Sridhar Reddy
Responsibility
Designation
To provide Engineering Asst. Manager
support for execution.
Engineering
To
provide
protocols/ Sr. Assistant datasheets and to review
Q.A
the executed protocols.
To
provide
adequate Sr. Executive manpower and supervise
Production
the execution activities.
Signatures
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
05.0
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No
5 of 16
CATEGORY
CALIBRATION
REMARKS
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
6.0
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No
6 of 16
KEY FUNCTIONS
The key functions will be classified in the specific headings. Each function test shall be
recorded in a separate test data sheet specifying each test function, action, expected
output/result, actual output/result, remarks.
6.1
6.2
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No
7 of 16
Acceptance Criteria
R, Y and B Indicators
will glow.
Red light will glow.
Green Light will glow
and motor will start.
Chilled water return
valve will be open.
Chilled water supply to
coils will start
Power supply to
motorized valves will
start.
Hot water return valve
will be open.
Hot water supply to
coils will start
Red Light will glow and
motor will stop.
Red light will not glow
Chilled water return
valve will be close.
Chilled water supply to
coils will stop.
Actual Observation /
Result
Signature /
Date
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
Equipment Number
Effective Date
Module
II
Action
Acceptance Criteria
Power supply to
motorized valves will
stop.
Hot water return valve
will be stop.
Hot water supply to
coils will stop
R ,Y and B Indicators
will not glow
AHU-1B
18.08.2001
Page No
8 of 16
Actual Observation /
Result
Signature /
Date
Comments:
Reviewed by
Name
Signature
Date
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No
9 of 16
Acceptance Criteria
Actual Observation /
Result
Signature /
Date
R, Y and B Indicators
will glow.
Red light will glow
Comments:
Reviewed by
Name
Signature
Date
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
07.0
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No 10 of 16
SIMULATION CYCLE
PROCESS
PARAMETERS
Switch ON the Main
control panel
SET LIMIT
R, Y and B
Indicators will
glow.
Switch ON the feeder Red light will
for AHU1B
glow.
Press Green indicator
Green Light will
Button
glow and Motor
will start.
Open chilled water
Chilled water
return valve
return valve will
be open.
Open chilled water
Chilled water
supply valve
supply to coils
will start.
Switch ON the Power supply to
chilled water 3 way motorized valves
motorized valve
will start.
Open Hot water return Hot water return
valve
valve will be
open.
Open Hot water supply Hot water supply
valve
to coils will start.
Press Red Indicator
Red Light will
Button.
glow and motor
will stop.
Switch OFF the
Red light will not
feeder for AHU-1B.
glow.
Close chilled water
Chilled water
return valve
return valve will
be close.
Close chilled water
Chilled water
supply valve
supply to coils
will stop.
OBSERVATION /RESULTS
TRIAL-1
TRIAL-2
TRIAL-3
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
PROCESS
PARAMETERS
Switch OFF the
chilled water 3 way
motorized valve
Close Hot water return
valve
SET LIMIT
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No 11 of 16
OBSERVATION /RESULTS
TRIAL-1
TRIAL-2
TRIAL-3
Power supply to
motorized valves
will stop.
Hot water return
valve will be
stop.
Close Hot water supply Hot water supply
valve
to coils will stop
Switch OFF the main R ,Y and B
control panel
Indicators will not
glow
Operated by
Signature & Date
Comments:
Reviewed by
Name
Form No: APL/QA/F011-00/06-2001
Signature
Date
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
08.0
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No 12 of 16
After checking all possible test functions minimum three process simulation cycles will be
carried out to demonstrate, that the equipment/system as an integrated system is capable
of achieving the desired results when operated as per the set parameters.
PROCESS
Operation
Cleaning
SOP No
SUBJECT
EG/C/027-00
EG/C/025-00
EG/C/004-00
EG/C/022-00
Calibration
EG/C/002-00
EG/C/046-00
EG/C/047-00
Preventive
maintenance
EG/C/028-00
OBSERVATION
TESTING
DATE
OPERATOR
NAME
OBSERVATION YES / NO
(IF NO STATE IN COMMENTS)
Name
Form No: APL/QA/F011-00/06-2001
Signature
Date
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No 13 of 16
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------09.2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------09.3
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------SIGNATURES
Conducted By:
Date:
Approved By:
Date:
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
Equipment Number
Effective Date
Module
II
10.0
10.1
SUMMARY
AHU-1B
18.08.2001
Page No 14 of 16
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------10.2
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
11.0
Equipment Number
Effective Date
Module
II
AHU-1B
18.08.2001
Page No 15 of 16
REPORT APPROVAL
___________________
Signature
________________
Date
___________________
Signature
________________
Date
MANUFACTURING
The signature of Manufacturing indicates that the results have been reviewed and is in
agreement with those results and conclusions
Mr. V.RAMULU
_____________________
Name
___________________
Signature
________________
Date
QUALITY ASSURANCE
The signature of Quality Assurance indicates that qualification, documentation and reports
have been reviewed and they meet the requirements specified
___________________
Signature
________________
Date
OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/02
Facility
UNIT-I
Block C
Equipment Number
Effective Date
Module
II
12.0 APPENDIX
ABBREVIATIONS
AHU
B
EG
IQ
OQ
QA
R
RA
SOP
Sr
Y
AHU-1B
18.08.2001
Page No 16 of 16