This blog explains how equipment qualification can be modeled and controlled within CM MES V11.3 for validated manufacturing environments. In such contexts, equipment, related recipes, and service configurations must be requalified at defined intervals or unexpectedly to ensure continued compliance and operational reliability. Understanding how CM MES manages qualifications is essential for maintaining equipment readiness, preventing unqualified processing, and safeguarding overall production integrity
Introduction
Equipment and their associated recipes and/or capabilities may require periodic or unscheduled requalification. This process differs from standard maintenance because it involves assigning, running, and validating a special type of lot, commonly known as a “dummy lot.”
In summary, an Equipment Qualification can be viewed as a Maintenance Activity Order (MAO) in which, during or upon completion of the maintenance activity, a “Dummy” lot must be processed to confirm that the equipment is properly qualified, much like a Send-Ahead-Run.
The equipment, along with its recipes and capabilities, may require requalification under the following conditions:
- After processing a defined number of units
- On a time-based schedule
- After final installation and before being released for production use
- Following engineering activities that may have resulted in recipe changes
- After relocation within the facility
- After unplanned downtime events
- Etc.
How does it work in CM MES V11.3
The figure below provides an overview of how this functionality operates within the CM MES
Assignment Point: The Flow Path where Material assigned to the Qualification Procedure must be located. Material Type must also be defined
Execution Point: The Flow Path where Material assigned to the Qualification Procedure is processed in the equipment for which one of its items is being qualified (Equipment and/or sub-equipment and/or Equipment Recipe and/or Equipment Service). It is also necessary to define when the Qualification Item becomes unavailable for standard production operations
Verification Point: It consists of one or more Verification Flow Path in which a “Pass” or “Fail” result is recorded, along with the method used to capture that result
If all Verification Points pass, the qualification is approved and the equipment and/or equipment-recipe and/or equipment-service is/are released for production.
If a Verification Point fails, equipment or recipe adjustments may be required, and after that a new dummy lot must be run to repeat the qualification
⚙️DEMO
Annual qualification of Wire Bonding equipment and of a designated critical process recipe, with 3 verification Steps
MODELING
EXECUTION
Final thoughts
Equipment Qualification in MES ensures that all equipment, capabilities or recipes remain reliable, compliant, and ready for production. By structuring how qualification lots are assigned, executed, and verified, CM MES V11.3 helps maintain consistent equipment performance and reduces operational risk. It’s a simple but essential safeguard for any validated manufacturing environment.
Author
Hi! My name is José Romeu Bogas Gonçalves. 😉
Skills: MES Consultant | System Testing | System Modeling | User Training | Content CreatingI’ve been with Critical Manufacturing since 2018, starting out as an MES Consultant. In 2025 I stepped into the Advocate & Architecture team. My role sits at the intersection of technology, communication, and strategy. Making sure solutions are technically sound and that everyone understands how to use or build them.
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