IQ,OQ Requirements for critical utilities viz water system, HVAC.

IQ Requirements:
1) Document and Drawings Verification
a)All general documentation reviewed for accuracy, identity, and permanent storage location.
B)Copy of Purchase order.
c)list of change parts, spare parts and lubricants used in the system.
d)list and attach all drawings(project drawings along with applicable manufacturer's drawings.
i)All electrical drawings
ii)All mechanical drawings.
iii)P&I Drawing.
Drawings must reflect as built conditions that include any field modifications of the design
e)All equipment manuals to provide information needed to operate the equipment or instrument.
f)Equipment warranty details.
g)Maintenance procedure,manual,preventive maintenance documents & schedule.
h)List of all equipments which contact the product including MOC & surface finishes.
i)List of all SOPs and SOPs.
2) Utilities
i)Power
a)Main power requirements
b)voltage :
c)Phase :
ii)Compressed Air
a)consumption
b)pressure
c)air quality
iii)Other utilities
3) Major components
a)component name
i)ID
ii)sr.no
iii)location
iv)manufacturer
v)model
vi)capacity
vii)MOC
viii)Dimensions
4) Instrumentation
List of all the instruments
a)critical

b)non critical
5)Software/Hardware
a)Details of operating systems
b)PLC programs
c)PLC hardware related to maintenance & operation
6) Training
Training details for operation, cleaning and maintenance, safety of equipments,system etc.
7) Instruments test equipments calibration
a) list of critical instruments with details
b) calibration certificates.
8) Structural testing
a) MOC
b) Pipe line drawing
c) Pipeline welding(welding,fusion)
9) Control,alarm and interlocks
10) Power failure SOP for restarting.
11) Environmental conditions
ii)
Check environmental requirements of the equipment.
i)
Obtain a copy of the manufacturer recommendations with regard to
iv)
temperature and humidity.
v)
Attach a copy of the manufacture recommendations.
vi)
Measure air temperature and relative humidity.
vii)
Review environmental data to determine if air temperature and relative humidity
meets manufacturer requirements.
ix)
Attach the calibration information of equipment used to monitor ambient air
environment.

OQ Requirements :
1) Training
2) Instrument/test equipment calibration
3) Controls,alarms,interlocks
4) Structuring testing
5) power failure verification

6) Environmental conditions(e.g for hvac )

i)
ii )
ii)
iv)
v)
vi)

Air velocity check.CFM verification. Air change testing

Hepa filter leak test
Humidity,temperature measurement
Pressure differential measurement
Air flow visualization check
Airborne particle counts

7) Functional operation
e.g 1) water quality check, water testing at every sampling point for chemical and
microbiological analysis.
2) The HVAC microbial & particulate matter analysis as per ISO requirements.