Equipment qualification is normally performed as part of an overall equipment and process validation program. An equipment qualification program will normally encompass the following:
- Establish that the process equipment has the capability of operating within required parameters.
- Demonstrate that controlling, monitoring, and/or measuring equipment and instrumentation are capable of operating within the parameters prescribed for the process equipment.
- Confirm that over repeated cycles (runs) representing the required operational range of the equipment, that the output or product consistently meets predetermined specifications for quality and function.
- Require the implementation of an ongoing monitoring, re-qualification and recertification of equipment.
Equipment needs to be “fit for purpose”, which will encompass user safety, ease of use, efficiency, environmental considerations (noise, fume emissions, etc..) in addition to the ability to consistently and reliability meet capability requirements in terms of output specifications.
Stages of Equipment Validation:
- User Requirements Specification (URS)
This document will define the expected capabilities of an item of equipment being ordered or built. The URS will normally be a non-technical document, with the focus on the ability of the equipment to provided pre-determined capabilities.
- Design qualification (DQ)
When planning and designing equipment it is necessary to ensure that the overall design and component parts selected will have adequate capacity to function for the intended purpose.
- Factory Acceptance Testing (FAT)
The factory acceptance test allows inspection and testing of an item of equipment before it leaves a supplier. The clear advantages are that any deficiencies are identified in the supplier manufacturing facility, also the potential for delay or disturbance due to unforeseen deficiencies arising during installation are reduced.
- Installation Qualification (IQ)
Will list all the identification information, the location where the equipment will reside, utility requirements such as electrical power, water, compressed air, etc.
- Operational Qualification (OQ)
Outlines the information required to provide evidence that all components of a system or of a piece of equipment operate as specified.
- Performance Qualification (PQ)
The performance qualification will be performed after both IQ and OQ have been completed, reviewed and approved. The PQ describes the procedures for demonstrating that a system or piece of equipment can consistently perform and meet required specification under routine operation.