The Installation Qualification (IQ) is the third document needed in the process of bringing a stability chamber online. The IQ is more than a turn on turn off test. It is the verification in detail of the requirements listed in the DQ. In the IQ, the requirements of the DQ are tested at a more detailed level to document the equipment as it is installed correctly. In Figure 1 the result of each test is documented by the person executing the protocol. The entering of the values seen is a better documentation process then checking a Pass/Fail box. As noted the sections are broken down to the individual requirement with a step for each test. In the step it identifies what the requirement is, the process to test and a written entry, with a signature and date. Each page is then reviewed and signed by a second person.
In the IQ, each section of the chamber needs to be tested to verify the Design requirements of the IQ.
The testing needs to document the connection to utilities with entries to record pressures and voltages. For the electrical system, it should notate the panel and circuit the unit is attached to. There should also be a documentation that the voltage and amperage is within specifications to operate the chamber. For water, a documentation of the feed line attachment and pressure verification needs to be identified. For steam if the unit is attached to in house steam, the documentation of the line connection and pressure reading. For a unit with a built in steam generator, the documentation of the boiler operation and the serial number needs to be tested.
In the DQ the size of the unit was identified and in the IQ this requirement needs to be verified. Any requirement in the DQ for special requirements for the cabinet enclosure such as locks on doors or controller access panels, tie downs or other additions needs to be documented as installed and functional.
In the purchasing of a unit, an operational range of temperature and RH should have been documented. This is not the intended operation temperature, it is the minimum and maximum temperatures the chamber may be required to be operated at some time in its lifecycle. Each minimum and maximum set point needs to be tested and recorded. A separate line entry should be included for the intended operating temperature/RH. If a chamber has an additional parameter other than Temperature/RH, the operational controls of that function needs to be tested. In a light chamber the documentation of the pre heaters, timers and lights functional operation all need to be included in the IQ
Each component of the chamber should be documented and if it has a serial number have its serial number recorded in the IQ. The recording of serial numbers of components is a critical part in the defense of a chambers maintenance history. The detail of the IQ should include the verification of fuses installed.
If a chamber has a built in redundant system, each system needs to have its components tested. If there is an auto switching function this should be tested also to ensure it performs as designed.
Review and Approval
As with all protocols the IQ needs to be preapproved before execution. During the execution a second person should be reviewing the work to make sure that the data collected is correct and accurate. Any step that fails needs to be corrected and retested before the completion of the IQ. The failure needs to be documented in an exception page in the final protocol to explain the failure.
Once completed the same group needs to approve the completed work.