The presentation "Lean Qualification: The smart approach to qualification and validation of hardware in cleanrooms" offers an insight into the efficient planning and implementation of qualification processes for hardware in cleanrooms. The focus will be on the lean approach in order to make the qualification process both lean and effective.
The presentation begins with a comprehensive explanation and definition of terms in order to create a clear understanding of the central topics. Basic terms in the area of qualification and validation of hardware in cleanrooms are explained. System classification to determine the depth of qualification is another central point of the presentation. Participants will gain an insight into the classification process according to ISPE and learn how this can be used to determine the required qualification depth. This aspect forms the basis for a customized and targeted qualification strategy.
A practical case study highlights the qualification of a human-machine interface (HMI) in a cleanroom. Using real-life examples, participants will learn how the theoretical concepts are applied in practice. This provides a realistic insight into the challenges and solutions for the qualification of specific hardware. In this example, the potential of supplier know-how will be included in the qualification process and how specific tasks can be outsourced to them. Close cooperation with suppliers can make a decisive contribution to the efficiency and quality of qualification.
In summary, the presentation "Lean Qualification: The smart approach to qualification and validation of hardware in the cleanroom" offers not only theoretical knowledge, but also practical insights and innovative approaches. Participants will receive specific recommendations for optimizing their qualification processes in order to ensure efficient yet high-quality validation of hardware in the cleanroom.