An Adhoc qualification may also be automatically triggered upon completion of a maintenance activity. In such cases, the equipment will remain unavailable until the qualification result is “Pass”. This capability is extremely important following annual maintenance for instance, during which multiple components may be replaced and/or process recipes updated, etc.

Alternatively, rather than triggering a qualification following a maintenance activity, it would also be possible to incorporate the maintenance tasks directly within the qualification process itself with all the known functionalities (Checklist, Data Collection, BOM, Certification, Documents, etc.)

Assignment point is where Material assigned to the Qualification Procedure must be located. But what should be done if no qualification lot is available at that moment? Should we cancel the qualification until someone can create lots in the MES for this purpose? No! In these scenarios the system supports composing on the fly lots for this purpose. This allows users to dynamically generate the lots needed for the qualification without requiring preexisting master data setups. Another option is to select a lot under an experiment to be sent to the assignment Step at the end of the experiment

The “Run at Risk” option enables shop floor operations to process a predefined set of lots on equipment that is currently undergoing qualification. This functionality may be used only under exceptional circumstances, in which an authorized user or role with the required permission determines that specific lots may proceed under these conditions. Typical use cases include urgent lots or lots that are known in advance to present minimal risk and are expected to be automatically placed on hold at a subsequent process step, with an associated protocol assigned for further evaluation.

When selecting lots for qualification, the system can ensure that a minimum quantity of units from the lot is provided to ensure that the qualification process is operationally valid. This control guarantees that the qualification is based on a sufficiently representative number of units. Additionally, users can choose whether the quantity is captured using the lot’s primary or secondary unit of measure, providing greater operational flexibility.

It is possible, under very specific conditions, to bypass result capture within a verification step

Qualification is triggered after a complex maintenance Activity. During the qualification a Dummy lot must be created on the fly, and some productive lots will Run at Risk whilst the equipment is still under qualification

MODELING

EXECUTION

Final thoughts

Introduction