Each qualification step is substantiated by a documented confirmation of correctness of operation of equipment, utilities, clean rooms, etc.
At the Installation Qualification (IQ) step this documented confirmation concerns correctness of installation of equipment, utilities, clean rooms, etc.
This phase is aimed at checking correctness of installation of equipment and other systems, as well as compliance of its installation with the installation and maintenance documentation requirements.
Installation Qualification (IQ) includes:
- check that documentation is available (assembly drawings, specifications, operation and safety manuals, calibration/verification documents, list of components and spare parts, materials and products certificates, factory test protocols and reports, etc.);
- check completeness of equipment (measuring instruments, special tools and spare parts required for operation);
- check correctness of equipment installation for compliance with the design;
- check materials working surface in contact with the product for compliance with the specification;
- check measuring instruments for compliance with the technical requirements.
In case of complex or bulky equipment it is allowed to perform inspection/acceptance at the supplier's assembly site; however, it does not replace the Installation Qualification (IQ) phase that is completed at the production site.
In case of failure to comply with IQ criteria/requirements it is necessary to define a procedure for further corrective actions and their deadlines. Moreover, Installation Qualification (IQ) requires checking of all auxiliary elements needed for system operation, including, for example, maintenance and calibration programs, housekeeping and cleaning procedures.
Thus, Installation Qualification (IQ) confirms that the equipment, utilities, clean rooms, etc. have been installed in compliance with the design and requirements of regulatory and technical documentation.
Qualification results are reflected in the relevant protocols.
To assess and confirm the functionality of installed equipment, utilities, clean rooms, etc., the next qualification stage is performed, i.e. Operational Qualification (OQ)..
