There are three commonly used types of validation protocols for systems and equipment:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
IQ protocols should be designed to:
- Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and the location where the equipment will be installed.
- Record the system instrument and valve information, including the manufacturer, model number, materials of construction, and calibration information (if applicable).
- Verify the required utilities for the equipment, such as electrical, process gases, and/or steam.
- Verify documentation specific to the equipment, such as P&IDs, operation and maintenance manuals, purchase orders, component specifications, lubricants, equipment safety features, and the required spare parts.
OQ protocols should be designed to:
- Demonstrate and document that the equipment operates within predetermined limits when used under defined operating procedures.
- Test and record the operation of equipment security systems, sequence of operations, all modes of operation to meet user requirements, equipment alarms and interlocks, and any other specific requirements of the equipment.
- Document the verification of any applicable equipment parameters, sensors, switches, control devices, logic circuits, gauges, and any preventative maintenance requirements.
PQ protocols should be designed to:
- Verify that the equipment, previously verified to be installed and operational per user requirements, is able to consistently perform in accordance with the predetermined acceptance criteria.
- Verify and document the equipment can operate consistently and repeatedly under normal, less than optimal, and worst case conditions.
- Verify the alarm and interlock functionality under operational conditions.
In some cases, the IQ and OQ protocols can be combined together into what is commonly referred to as an Installation and Operational Qualification (IOQ) protocol.
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