Planning an MES project to guarantee manufacturing operational experience

A leading laboratory specialized in its domain

This laboratory, present in 50 countries and historical leader in its specialized domain, has a significant number of production processes to transform animal or vegetal strains into finished products in several of its French sites, in particular.

Our client launched a modernization of its industrial information system (IS) with the goal to support the whole of the production processes and guarantee operational excellence in a much regulated context. The MES (Manufacturing Execution System) is an essential component of a future IS in the implementation of an Electronic Batch Record (EBR).

Integrate the future MES solution in the production processes

Our client asked SPC to help in the planning phase and also in making choices, where the challenges were initially to confirm that there was the possibility of an MES approach including the implementation of Electronic Batch Record (EBR) and then to define an MES system integrated in a complex production environment.

The challenge could not be addressed without bringing significant complementary business expertise to the IT dimension of the project.

This complementary expertise in the SPC teams enabled the production management principles to be questioned and reviewed, notably those linked to the dividing up of production orders, the process equipment integration conditions to be measured relative to the Electronic Batch Record (EBR) approach and, of course, modeling the production recipes (Master Batch Recipes) to standardize and ultimately decrease the integration costs of the future MES project.

Business Competence and Expert Solutions

Our planning and supervision approach emphasized the business challenges and the data flow which was useful for each user category, from the operator to the head pharmacist. Based on our work methodology, this approach was also guided in the present case by « Data integrity » concerns as well as by those which addressed the construction of an IS « Connected Plant », a prerequisite in the digitalization plan of Industry 4.0.
Both our knowledge of the pharmaceutical industry processes, as well as much feedback from previous implementation of MOM functionalities via the MES software packages, enabled us to efficiently pilot this study and deliver the key documents for the final decision to launch such a project. This included the choice of MES solution and the detailed organization of its launch all within a short period: URS (User Requirement Specifications), modeling the future MBR’s for all sectors, definition of the interactions with other systems (ERP, process equipment, EDMS, and LIMS, etc.)

Complete decision file and detailed project organization

This study, covering all the production sectors, resulted in:

• Functional and applied data flow charts for the IS target with MES in a key position
• A model of the Master Batch Recipes made for each sector using a standardized approach guaranteeing the optimization of the implementation costs of the MES-EBR project
• A feasibility study on the connections of the different process equipment
• A detailed document evaluating all the MES solutions likely to address the client’s needs
• A well-defined implementation procedure including the setting up of a Core Model which was first tested on a pilot sector then deployed on the other sectors.

The comprehensiveness of the study results gave our client the ability to organize their project in the best possible way, notably by:

• Dimensioning the project team in a meaningful way (in particular, the business actors)
• Giving a firm commitment to the chosen company integrating the MES solution for a carefully-planned project over a clearly-defined zone.