Saturday, 9 March 2013

Installation Qualification (IQ) | Equipment and Instrument

Installation Qualification

Design Qualification Operational Qualification Performance Qualificaation
Installation Qualification (IQ) is done during validation or qualification of any instrument or equipment. So let us discuss what is installation qualification? It is the documented evidence or the collection of all activities necessary to establish that an instrument is delivered as designed and specified, is properly installed in the selected environment, and that this environment is suitable for the environment.

The responsibility for installation qualification  lies with the user but all the activities should be supported and are carried out by the vendor.  As an example, before the instrument arrives, the vendor should provide the user with environmental specifications so that using this information the user can prepare the installation site accordingly.

Now the verification that received equipment, services, piping and the instrumentation are installed as depicted on engineering drawings, the installation in a suitable environment occurred in accordance with the supplier's procedure, and all installation specification are met.

Following are the tasks which are performed for Installation Qualification :

  • Preparing the laboratory facility according to the environmental specification provided by vendor.
  • Record and control the environmental conditions, such as  temperature and humidity if critical.
  • Comparing the equipment received with the purchase order, including accessories and spare parts.
  • Check if any  damage done to an equipment.
  • Verify the instrument conforms with physical as well as construction requirements, as specified by the user.
  • Check all the documentation for completeness which includes operating manuals, maintenance instructions  standard operating procedures for testing, safety and validation certificates.
  • Check Install hardware which includes instrument, fittings and tubing for fluid connections, columns in GC or HPLC, power cables, data flow and instrument control cables.
  • During installation qualification switch on the instrument to check and ensure that all the modules are power up and perform an electronic self-test.
  • List SOPs and equipment manuals.
  • Record the firmware revision.
  • Prepare an installation report.
  • Enter the instrument data into an inventory data base.
  • Prepare and review and sign formal IQ documentation.
Testing for Installation Qualification:

Installation should verify that the instrument hardware and software are properly installed. It does not verify that the instrument conforms to the functional and performance specification.

For individual modules, testing is limited to perform and document the instruments self diagnostics when it is switched on.

For system comprised of multiple modules, correct connection between the modules should be verified. For a modular analytical system, this can be easily achieved by running a test sample and comparing the output with a reference plot.

All the three qualification and validation terms IQ, OQ and PQ are very important during calibration to maintain the quality of the products.


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