Tests within Installation Qualification (IQ) may vary. IQ tests should verify that all the items listed in the functional specification have been delivered and that they are of the correct type. The FS may have stated that a differential pressure transducer 0-100 Pa is to be used with 1% accuracy. Has it?
The IQ test should check and verify that:
- All hardware installed on site is as stated—or better.
- All support systems are in place (user manuals, technical manuals, system diagrams, etc.).
- All instruments have been calibrated and the calibration is still valid.
- All software system discs (CDs) are available and have been properly filed.
- A “footprint” (system files, dates and sizes) of the software has been taken at this point.
A system must be able to be re-validated at a later date. IQ tests to ensure that all inputs/outputs of a data collection unit are operational and that must be conducted to ensure that all switches, lights, transducers, and such are functional. These tests can be regarded as operational tests; some companies include such tests in the Operational Qualification (OQ) test document. Once it has been documented that the system has been supplied as detailed within the FS, OQ can begin. The purpose of OQ is to verify that the system functions (operates) as stated within the FS. There must be a test to show that each of the items listed within the FS have been tested, but the tests should go further than this, especially with FMSs—or for that matter, with any other data collection system. There must be clear tests that show data is being collected correctly and that manipulations are being correctly applied, and that data is being stored correctly and can be retrieved correctly.