OPERATION QUALIFICATION

Equipment Name AIR HANDLING UNIT

Protocol Number OQ/CP/028/01
Facility
UNIT-I
Block C

Equipment Number
Effective Date
Module
I

AHU-1A
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

Form No: APL/QA/F011-00/06-2001

OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/01
Facility
UNIT-I
Block C

01.0

PROTOCOL APPROVAL

01.1

Protocol Prepared by

Equipment Number
Effective Date
Module
I

AHU-1A
18.08.2001
Page No
2 of 16

Preparation of this qualification plan is the responsibility of Validation Coordinator of the

Task Force II
NAME
Mr. R. Sridhar Reddy

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

Form No: APL/QA/F011-00/06-2001

DESIGNATION
Asst. ManagerMaintenance
Sr. Manager
Works
HeadQuality Assurance &
Regulatory Affairs

SIGNATURE

DATE

OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/01
Facility
UNIT-I
Block C

02.0

Equipment Number
Effective Date
Module
I

AHU-1A
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-1A) located in Block C Module I.

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.

Onsite calibration of the critical process control instruments, already identified in

the Installation Qualification

Identification and verification of the Key functions.

Simulation of a cycle similar to a routine operation cycle.

Verification of the relevant SOPs (such as operation, Cleaning, Sanitisation,

Preventive Maintenance etc).

Identification of the Training needs

Deviation Handling, if any

Form No: APL/QA/F011-00/06-2001

OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/01
Facility
UNIT-I
Block C

04.0

Equipment Number
Effective Date
Module
I

AHU-1A
18.08.2001
Page No
4 of 16

EXECUTION TEAM

Name
Mr. Vijay Gornale
Mr. A. Kameswara Rao
Mr. N. Sridhar Reddy

Form No: APL/QA/F011-00/06-2001

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/028/01
Facility
UNIT-I
Block C

05.0

Equipment Number
Effective Date
Module
I

AHU-1A
18.08.2001
Page No
5 of 16

CRITICAL INSTRUMENTS CALIBRATION

The class C instruments identified for calibration during Installation Qualification

Protocol Reference No: IQ/CP/028/01 to be calibrated and the observations and or
results to be recorded in a separate data sheet or reference of the data sheet to be
provided.
INSTRUMENT / INDICATOR/
SENSORS
Digital Temperature Indicator
Digital Relative Humidity
Indicator
Digital Differential Pressure
Indicator

Form No: APL/QA/F011-00/06-2001

CATEGORY

CALIBRATION

REMARKS

OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/01
Facility
UNIT-I
Block C

6.0

Equipment Number
Effective Date
Module
I

AHU-1A
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

Equipment / System Start-up & Shut-down

To check and establish the standard sequence to be followed to Start-up and Shut
down the subjected equipment/ system in Auto/ Manual/ Emergency mode to
avoid any damage to the product, equipment and personnel.

6.2

Safety /security checks

To check and ensure that the safety /security functions (such as program logging,
process control, personnel safety systems etc) for protection of the product,
process and personnel are working as expected.

Form No: APL/QA/F011-00/06-2001

OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/01
Facility
UNIT-I
Block C

Equipment Number
Effective Date
Module
I

AHU-1A
18.08.2001
Page No
7 of 16

EQUIPMENT /SYSTEM START-UP & SHUT-DOWN

Data Sheet # 06.1
Equipment / component Name: CONTROL PANEL
Tag/Identification No:
Action
Switch ON the Main
control panel
Switch ON the feeder
for AHU1A
Press Green indicator
Button
Open chilled water return
valve
Open chilled water supply
valve
Switch ON the chilled
water 3 way motorized
valve
Open Hot water return
valve
Open Hot water supply
valve
Press
Red
Indicator
Button.
Switch OFF the feeder
for AHU-1A.
Close chilled water return
valve
Close
chilled
water
supply valve

Form No: APL/QA/F011-00/06-2001

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/028/01
Facility
UNIT-I
Block C

Equipment Number
Effective Date
Module
I

Action

Acceptance Criteria

Switch OFF the chilled

water 3 way motorized
valve
Close Hot water return
valve
Close Hot water supply
valve
Switch OFF the main
control panel

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-1A
18.08.2001
Page No
8 of 16

Actual Observation /
Result

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/028/01
Facility
UNIT-I
Block C

Equipment Number
Effective Date
Module
I

AHU-1A
18.08.2001
Page No
9 of 16

SAFETY /SECURITY CHECKS

Data Sheet # 06.2
Equipment / component Name: CONTROL PANEL
Tag/Identification No:
Action

Acceptance Criteria

Switch ON Main Panel

Switch ON the feeder
for AHU1A
Press Green indicator
Button
Over Load Tripping

Actual Observation /
Result

Signature /
Date

R, Y and B Indicators
will glow.
Red light will glow

Light will glow and

Motor will start
When the system is
overloaded it gets
tripped off.
Press
Red
Indicator Light will glow and
Motor will stop.
Button.
Switch OFF the feeder
Red light will not glow
for AHU-1A.

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/028/01
Facility
UNIT-I
Block C

07.0

Equipment Number
Effective Date
Module
I

AHU-1A
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 AHU1A
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-1A.
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.

Form No: APL/QA/F011-00/06-2001

OBSERVATION /RESULTS
TRIAL-1
TRIAL-2
TRIAL-3

OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/01
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
I

AHU-1A
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/028/01
Facility
UNIT-I
Block C

08.0

Equipment Number
Effective Date
Module
I

AHU-1A
18.08.2001
Page No 12 of 16

VERIFICATION OF STANDARD OPERATING PROCEDURE

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

OPERATION OF AHU-1(A & B).

CLEANING OF AIR HANDLING
UNIT FILTERS
CALIBRATION OF PRESSURE
GAUGES.
CALIBRATION OF TEMPERATURE
GAUGES.
CALIBRATION OF DIGITAL
TEMPERATURE INDICATORS.
CALIBRATION OF HUMIDITY
INDICATORS.
CALIBRATION OF DIFFERENTIAL
PRESSURE INDICATORS.
PREVENTIVE MAINTENANCE OF
AHU-1(A & B).

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)

Most current revision in use

Operating personnel has understood
the
contents of SOP and had been trained
SOP provides adequate direction and control to
ensure uniform equipment operation.
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/028/01
Facility
UNIT-I
Block C

Equipment Number
Effective Date
Module
I

AHU-1A
18.08.2001
Page No 13 of 16

09.0 DEFICIENCY AND CORRECTIVE ACTION REPORT

09.1

Description of deficiency and date observed

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------09.2

Person responsible for corrective action and date assigned

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------09.3

Corrective actions taken and date conducted

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------SIGNATURES
Conducted By:

Date:

Approved By:

Date:

Form No: APL/QA/F011-00/06-2001

OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/01
Facility
UNIT-I
Block C

Equipment Number
Effective Date
Module
I

10.0

SUMMARY AND EVALUATION OF RESULTS

10.1

SUMMARY

AHU-1A
18.08.2001
Page No 14 of 16

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------10.2

ANALYSIS / EVALUATION DATA

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Form No: APL/QA/F011-00/06-2001

OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/01
Facility
UNIT-I
Block C
11.0

Equipment Number
Effective Date
Module
I

AHU-1A
18.08.2001
Page No 15 of 16

REPORT APPROVAL

CHECKED BY VALIDATION CO-ORDINATOR

The Signature of checked by indicates that the qualification protocol was executed and all
tests cases and discrepancies were properly documented.

Mr. R.SRIDHAR REDDY

_____________________
Name

___________________
Signature

________________
Date

Approval of this qualification is the responsibility of Validation Core Committee

MAINTENANCE
The signature of Maintenance indicates that the results have been reviewed and is in
agreement with those results and their conclusions

Mr. S. BAJI SAIDA

_____________________
Name

___________________
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

Dr. A.R.M RAO

_____________________
Name

___________________
Signature

Now the equipment is READY FOR PERFORMANCE

Form No: APL/QA/F011-00/06-2001

________________
Date

OPERATION QUALIFICATION
Equipment Name AIR HANDLING UNIT
Protocol Number OQ/CP/028/01
Facility
UNIT-I
Block C

Equipment Number
Effective Date
Module
I

12.0 APPENDIX
ABBREVIATIONS
AHU
B
EG
IQ
OQ
QA
R
RA
SOP
Sr
Y

Form No: APL/QA/F011-00/06-2001

Air Handling Unit

Blue
Engineering
Installation Qualification
Operation Qualification
Quality Assurance
Red
Regulatory Affairs
Standard Operating Procedure
Senior
Yellow

AHU-1A
18.08.2001
Page No 16 of 16