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Qualification refers to the process of establishing documented evidence that an equipment or system is fit for use and set for their intended use, establishing confidence that the equipment can consistently operate within determined limits and established tolerances. It is a documented process of assuring that a specific facility, system or equipment are able to achieve an acceptable criteria already predetermined to confirm that such an equipment is fit for purpose. 

Qualification focuses on equipment, systems, facilities and other tangibles. During the stage of process qualification, the process design is confirmed as being capable of reproducible commercial manufacturing. 

The four qualification stages help determine if the process being tested is capable of operating in its specific environment. These stages are:

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  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)


  • Design Qualification (DQ)

Design qualification is used to assess the design parameters to ensure that they are able to measure the elements that they have been designed for such as temperature range, size, capacity and power needs, ease of use and, of course, manufacturer warranty and support. 

Design qualification helps to access and evaluate the quality and suitability of raw materials for manufacturing, ensuring that the construction materials are free from any hazard and, not reactive with the materials or product or absorb any substance in the product or material. At this stage user requirements are considered when deciding on the specific design of a system or equipment.

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  • Installation Qualification (IQ)

This stage considers specific information surrounding the equipment placement and receipt at its site where it is to be operated. The testing details focuses on the condition of the equipment, such as electrical specifications (voltage, current etc.) and to determine if the equipment is installed in accordance with an installation plan and installation qualification procedure. It is at this stage that requirements for calibration, maintenance and cleaning are developed. This stage should include identification and verification of all system elements, parts, services, controls, gauges and other components. Measuring, control and indicating devices should be calibrated against traceable appropriate national or international standards.

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  • Operational Qualification (OQ)

This qualification testing element should focus on testing specific manufacturer claims including determining if the equipment functions according to the temperature specified by the manufacturer, if the operating parameters meets their prescribed specifications and others. This stage verifies that the supplied equipment functions consistently within determined tolerances over the defined operating parameters. In this stage, critical variables such as upper and lower operating limits and circumstances can be tested.


  • Performance Qualification (PQ)

In this stage, we look to see if the equipment being tested is performing consistently and verify that the equipment actually performs according to design specifications and user defined requirements in a reliable and reproducible manner under normal production conditions.

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Conclusion

The four stages of equipment qualification have quality as the primary theme. That means that the equipment is qualified by standards that will not have a negative impact on the material it is to be used on.



About the Author

Olanrewaju, Adebayo Bamidele is a Lead Auditor of ISO 9001, FSSC 22000 / ISO 22000, 14001 & 45001 Management Systems, Certified Six Sigma Master Black Belt (CSSMBB), process engineer, and quality management professional with strong working experience and proven skills in manufacturing excellence, ISO management systems implementation, lean / digital manufacturing, and project management. 

Adebayo is a Corporate Member of American Institute of Chemical Engineers (AIChE), Associate Member, the Institution of Chemical Engineers (IChemE), Corporate Member, Nigerian Society of Engineers (NSE), Corporate Member, Nigerian Society of Chemical Engineers (NSChE), Associate Member, Nigerian Institute of Management (NIM), and Associate Member, Institute of Strategic Management of Nigeria (ISMN).

He is an author of over 15 books and has published over 45 online courses on various e-learning platforms including UdemyAlison, Learnformula & Study Plex.

You can reach him, here.

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