The manufacturing execution system (MES) has been around for more than 30 years in one form or another. However, the implementation of an MES has always been considered a complex task. It is typically the intense requirements in terms of time, capital and manpower that make managers reluctant to commit to the implementation of an MES.
According to NNIT's life sciences surveys, some 30 percent of pharmaceutical companies have not yet implemented an MES. Yet the same surveys confirmed its importance as the system for managing manufacturing operations.
MES is the platform for collecting and managing all relevant production data in real time – from ERP, LIMS, process control systems, machines and equipment, operators, and many other sources. It is the MES that ties all these different elements of production information together. And no expert would deny the fact that the pharma factory of the future is digital.
So, why do so many pharma companies struggle with the implementation of MES?
Here are four of the most common reasons:
1: MES Projects are complex
There is no denying that MES projects are complex and expensive, and they generate huge organizational change while often taking more than a year to complete. In particular, manufacturing sites that have been operational for many years tend to consider MES projects to be unpredictable.
Finding the right MES solution and a vendor that is a good fit for your organization requires careful consideration and market insights. And once the MES is selected, it is time for the execution phase of the implementation project. This is by far the most extensive part of the process, both in terms of time and strain on organizational resources
2: MES Projects are expensive
An MES is a substantial investment, with a total price tag of several million USD, depending on the scale and complexity of your production. Faced with the prospect of implementing an MES (or upgrading an existing one), it’s understandable that some operations managers would rather spend the budget and resources on new equipment or machines – like fully automated packaging lines – where the benefits are more immediately apparent.
3: MES Projects generate a huge organizational change
Implementing an MES requires the involvement of key staff, such as production specialists and process area experts, and can disrupt production for significant time. MES requires major changes of critical business processes. If the long-term benefits, based on clearly identified business drivers, are not visible and universally understood and accepted, there is a significant risk of friction within the organization and that will most likely result in unnecessary discussions and project delays.
4: MES Projects take too much time
Once the operational requirements have been identified, the most suitable solution needs to be selected (or developed), implemented, configured, installed, tested, and validated. Sounds simple. However, in the case of implementing an MES at an operational manufacturing site, years of experience and thousands of projects have proven that it is often anything but. Based on actual data, the standard implementation time for an MES ranges from 18-24 months. In order to accelerate MES projects, the execution time of all phases of an MES project must be decreased.
"So, what to do?" we asked our SME for Manufacturing Execution Systems, Carsten Holm Pedersen.
Here is what he answered: