Defining and implementing review by exception in an existing MES

The site’s problem

The building already used Opcenter for all its operations. Batch records were electronic. Yet a large team spent its time reading them line by line. As volumes grew, the site added reviewers, and release lead times kept getting longer.

The site wanted to move to review by exception across the whole building, and make it a pilot for the group. But quality assurance had a legitimate question: on what basis do you decide that an element of the record no longer needs to be read?

What we did

We started by building the answer to that question. For each MES element, we analysed where the data came from (manual entry, calculation, interface) and what would happen if it were wrong, for the process and for the patient. More than ten thousand elements were assessed. This assessment formed the basis of the discussion with quality assurance. It made it possible to say, element by element, what stayed under review and what left it.

We then translated these rules into the MES. The electronic records had to behave differently: flag deviations, keep passed results without having them read. We were responsible for these changes and their specifications. We also led user acceptance testing and wrote its protocol.

The scope was wide for a single building: equipment preparation and washing, media and solutions, cell and viral culture, purification, inactivation. More than thirty MES recipes for around forty items. Exchanges with SAP, the SCADA, the balances and local instruments (pH meters, filter testers, osmometers) were part of the work, as were master data configuration, qualification, procedures and key-user training.

Two Maelo consultants took part in the project. Releases to production took place during the planned production shutdowns.