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  • Thursday, 9 June 2016

    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


    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.
    Follow Me on Twitter AjaySpectator & Computer Innovations

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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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