EQUIPMENT QUALIFICATION



EQUIPMENT QUALIFICATION : 
The action of proving that any equipment or process work correctly and consistently and  produces the expected result. Qualification is part of, but not limited to a validation process, i.e. Installation Qualification (IQ), Operation Qualification(OQ) and Performance Qualification (PQ).
The act of planning, carrying out and recording the results of tests on equipment to confirm its capabilities and to demonstrate that it will perform consistently as intended use and against predefined specification
1.design qualification
2.installation qualification
3.operational qualification
4.performance qualification
Design Qualification : Documented verification that equipment, instrument, facility and system are of suitable design against the URS and all key aspects of design meet user requirements.
Installation Qualification (IQ):The documented verification that all components of the equipment and associated utilities are properly installed or modified in accordance with the approved design and manufacturer’s recommendations.
Operational Qualification : Operational qualification consists of verification and documentation, of the parameters of the subjected equipment. The documented verification that the equipment, instrument, facility and system as installed or modified, perform as intended throughout the installed operating range.
Performance Qualification :Performance Qualification is designed to prove the process, can consistently produce a product that meets the stated requirements and specifications. It is a documented verification that the equipment, instrument, facility and system as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.


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