Installation Qualification (IQ)

Good Day dear viewers.....!!
On the way of Documentation, today i've desired to post on Installation Qualification document, which is something which comes next to Design Qualification, Simply called as IQ.

And Before going on into full flow, you need to know the basics like what is Installation Qualification, and why it is useful, now i'll complete this demo in simple lines.

What is IQ and what is its purpose ?

The Installation Qualification Protocol verifies the proper installation and configuration of a System. This can include ensuring that necessary installations have been loaded, equipment has been installed, the necessary procedures have been approved, or the appropriate personnel have been trained. The requirements to properly install the system were defined in the Design Specification. Installation Qualification must be performed before completing the Operational Qualification or Performance Qualification.

 So, Now i'll simply tell you what are the major steps in this Qualification protocol below.

Step by Step Procedure :

1. Identification of Major Components / Accessories,

2. Installation Check / Review,

3. Inspection Check / Review,

4. Identification, Classification, Verification of Process Control Instruments,

5. Identification & Verification of MOC,

6. Identification & Verification of Supporting Utilities,

7. Identification & Verification of Supporting Documents,

8. Deviation & Corrective Action Report,

9. Conclusion,

10. Installation Qualification Approval.


Now, i'll explain you briefly about each above point,

Identification of Major Accessories/Components :

This Column includes the follwing.

Reactor main body

Jacket with insulation cladding

Nozzles as per drawing

Agitator assembly

Mechanical seal

Baffles

Dip Pipe

Thermo well

Electric motor

Gear box

Supporting lugs

Pressure gauges

Rota meter

Vacuum gauge

Temperature indicator &RTD Sensor

Primary heat exchanger

Secondary heat exchanger

Safety Relief Valve

Rupture disc

Thermal relief  valve

2. Installation Check/Review :

This column would include a checklist something like,

Verify that the “as built’ drawings are complete and represent the design concept

Verify that major components are securely fixed.

Verify that there is no observable physical damage

Verify that there is sufficient       space provided for Operation & maintenance

Verify that all piping and electrical connections have been done

Required electric connections are tight, weather proof and earthed.

Units installed  and secure in place

All access parts are examined and cleared of any debris

Verify that the equipment is installed and leveled properly on the floor.

3. Inspection Check/Review :

This is just to verify all the measurements and capacities of the components installed were upto the URS or not. Like nozzles sizes, MOC, and their senstivities, and whether they were working or not as per protocol......!


4. Identification, Classification, Verification of Process Control Equipments  :

This includes Guages, Controllers, Indicators, Sensors, 

(1). Critical (C) – The instruments whose performance will directly affect the quality attributes of the processed material.

(2). Monitor (M) – The instruments whose performance failure would not affect product quality and which are used for process control.

5. Identification & Inspection of MOC :


Below is the regular list that will be given in this column,

Components	Material of Construction
Main body	SS316
Primary  heat   exchanger	SS316
Secondary  heat   exchanger	SS316
Mechanical seal	Carbon & TC
Agitator	SS316
Safety Relief valve	CS
Rupture disc	SS316
Supporting lugs	MS
Jacket	MS
Thermal Relief Valve	CS
Insulation Cladding	MS Cladding

6. Identification and Verification of Supporting Utilities :

This column we need to mention our observation against the supporting utilities, whether they were correctly installed or not,

Utility	Specification
Power	Required
Steam	Required
RT water	Required
Chilled water	Required
Brine	Required
Air	Required
Nitrogen	Required
Vacuum	Required
Hot water	Required

7. Identification and Verification of Documents  :

This documents list will include the following,
                                                                                    Yes/No                 Sign                       Date

GENERAL
URS
Purchase Orders
As built drawing
CALIBRATION CERTIFICATES
Instruments Calibration certificate
MOC CERTIFICATES
Material specification & Certificates

8. Deviation and Corrective Action Report  :

Simply this column includes 3 lines,

• Description of Deviation observed and Date,
• Person responsible for Corrective action and date signed,
• Corrective Actions taken and Date Signed.

9. Conclusion & Approval :

Finally the document to be given a conclusion and it should approved by respective department heads........ That's it.......Cheers !!!

If still any doubts are there, please feel free to contact me, we will be there to solve your queries,

This is best of my knowledge, and if anything is missing then comment below.......!!!

** Note: Please Don't copy these from here,
About The Author

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Hi! I am Ajay Kumar Kalva, Currently serving as the CEO of this site, a tech geek by passion, and a chemical process engineer by profession, i'm interested in writing articles regarding technology, hacking and pharma technology.
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