Twin goals of improved efficiency and compliance are driving more life sciences companies to implement manufacturing execution systems (MES). MES software bridges the gap between traditional plant floor automation systems and business applications such as Enterprise Resource Planning (ERP). It provides a digital link that eliminates the errors and information latency of manual, paper-based interfaces, providing a real-time picture of what is happening on the plant floor.
However, MES installations are challenging, and a flawed implementation strategy will prevent MES from achieving its full potential return on investment (ROI). It is especially important to look carefully at underlying work processes to determine where the inefficiencies lie, or you will merely transfer these inefficiencies from a paper to an electronic medium. Thus, MES implementation is actually an opportunity to examine processes and how they can be improved. This article will summarize some best practices that can help optimize MES implementation for pharmaceutical manufacturing.
The first point to consider is cost. MES implementation can cost a plant anywhere from $1-10 million, depending on the facility’s size and scope. But most of this figure will pay for implementation resources and activities such as configuration, documentation and validation, rather than software or hardware. Thus it is vital that any implementation strategy be well thought-out.
Since the system will affect many different departments in a drug manufacturing plant, a multifunctional approach is essential for any MES implementation. Success also requires that people working at the facility understand the manufacturing process, as well as the issues that currently impede efficiency or compliance.
|Avoid paper on glass. Don’t map existing paper processes, blindly, into the MES. View the implementation as a way to optimize work processes, to avoid carrying over inefficiencies. Photo courtesy of ProsCon, Ltd.
Once problems have been identified, one can match them with available MES functionalities. Most MES systems are modular, with each module focusing on a given function, such as finite scheduling, dispensing, Electronic Batch Records (EBR), equipment management, performance monitoring or recipe management. Modules include interfaces to ERP, document management, laboratory information and plant-floor automation systems.
Plant Makeup and Issues Should Guide Implementation
Issues at the facility will determine which functional modules to focus on first. For example, a facility that manufactures high volumes of products using straightforward processes would want to focus on EBR first, since it could reduce the number of deviations and incorrect entries and shorten batch review and approval times through review by exception. In contrast, a complex multi-product plant would likely realize greater productivity gains by focusing on finite scheduling or equipment management modules.
Once an MES project has been initiated, it is critical to match the facility’s requirements to the software’s functional capabilities. Many of the current MES systems allow very sophisticated configuration using standard, off-the-shelf software.
Since customization inevitably increases the risk of something going wrong, standard software features should be used as much as possible in the MES configuration. In general, customization should be used only when there is an extremely convincing business case for it, since it will take up software development and validation time, and can lead to problems later on, when it’s time to upgrade to a more recent version of the software.
Avoid Paper on Glass
Consider why you want the customization in the first place. Are you merely trying to duplicate the current paper-based process in an electronic environment? The software functionality may meet the same goals, yet use a very different approach.
Furthermore, when moving from a paper-based manufacturing system to an electronic one, it is critical not to map, blindly, from one medium to the other. There may be inherent inefficiencies in the process that will show up, whether you use a paper or an electronic system. Thus, an MES implementation offers an opportunity for process improvement and optimization.
If the MES implementation is part of a global corporate rollout, many of the functional requirements will be identical for a number of plants. In such cases, adopting one core solution will result in benefits of scale. This is particularly true for validation documentation. The core functionality can be documented and validated for all sites by a corporate team, so that individual sites are only responsible for their own local configurations.
Taking this approach can drastically reduce the time, cost and resources required for validation. Not only will the benefits be related to the MES functionality of the particular package used, but it is also highly likely that the interfaces to other systems (e.g. ERP systems) will be the same across sites. Furthermore, if any customizations are required, they can be bundled into a core package, enabling greater control to be maintained and allowing more leverage for the client to obtain vendor support for these through system upgrades.
Interfaces to external systems can be perceived as high-risk, due to the variety of applications and technologies that exist. However, this challenge must be addressed if the installation is to provide the desired flow of data between plant floor and business. While vendors may have some standard interfaces—to leading ERP vendors, for example — some interfaces will inevitably need development or customization.