Performance Qualification is the final step in equipment qualification. It is much like Operational Qualification, as it tests the operational requirements of the equipment, but in this case, the equipment will contain a load or process medium.
In other words, it is the testing of equipment while being subject to “real-world” conditions – conditions which the equipment would be subject to during batch production.
This phase is hugely important as it combines the workings, forces and energy of the individual components of the equipment into one harmonious system. By doing so, faults such as the examples below (as well as many more) can be discovered in this phase of qualification:
- Excessive Vibration/Noise – This may be caused by a combination of 2 or more individual vibrating components.
- Excessive Heat – This may be caused by a build-up of heat due to a driving belt.
- Process Media Backflow – This may be caused by incorrect sizing of pipework (a factor which is only highlighted in this case).
- Pressure Differentials – This may be caused by the use of a valve (toggle open/closed) or other equipment, as well as Process Media Backflow, as mentioned above.
- Combination of Individual Faults – Problems in the system can also arise due to a combination of these faults.
The working environment around the system can also be affected by the equipment in use. Excessive heat, for example, can cause a dramatic increase in room temperature depending on what process is being carried out.
The spike in room temperature may be uncomfortable for personnel to work in and could possibly be unsafe if personnel are exposed to the high temperatures for an extended period of time. Equally, excessive vibration/noise can not only cause damage to the equipment, but could also be a safety hazard to personnel in the area.
In any case, steps must be taken to deal with such problems, whether it be increased air conditioning to combat excessive heat or fitting noise dampening features to the system to reduce vibration/noise, or by simply cordoning off the area while the equipment is in use.