MES (Manufacturing Execution System) is now on the agenda of most pharmaceutical and biotechnology companies, many with multiple sites spread over the globe. What differentiates this undertaking against the roll-out of other corporate wide systems? We ask the question what can be achieved by developing a “core” system and what cannot.
“The requirement to model in great detail the plant, material flow and work processes will dictate that the majority of the MES project team need to come from the site”
There are several fundamental reasons why MES implementations tend to require more attention and localisation at plant level compared with other comparable plant systems. These relate to maturity of the MES platforms that are available and some of the basic technical challenges that are unique to this kind of application. The business/process workflows between plants tend to be less standard than those for enterprise or lab practises. This is not to say much cannot be achieved by a core structure and there are many reasons why it is essential for the success of the overall program.
Although MES is established as a need and can be justified even in these leaner times, there are still relatively few fully deployed MES systems in operation achieving true paperless manufacturing for their plants. Basically, MES within the industry is still in its infancy compared to other systems. The vendors tend to be small to medium independent software companies or smaller divisions of global ERP or process automation corporations. The software itself is also less developed. It tends to be less functionally rich with a more fragmented review cycle and individual versions may have a limited user base. In addition, local specialist support is often not available from the vendor to address day-to-day technical issues at site level. As a consequence, clients need to take a more active role in the management of the software and the vendor including more intensive vendor audits and active involvement in the system development and upgrades.
The essential difference with MES compared to other systems is it has minute by minute interaction with manufacturing. Consequently there is a total reliance by manufacturing on the MES system once installed. It becomes the system of record for all manufacturing activities, replacing the paper batch record and open to inspection by regulatory authorities. On the other hand for enterprise systems it is possible to have corporation wide (global) workflows and operating procedures that only require limited localisation to deal with language and country issues. While in theory, using a standard design for manufacturing facilities is an option, the reality is that most pharmaceutical manufacturing sites are legacy brown field installations which have undergone incremental expansion over a period of years. Individual plants have a physical variability of manufacturing buildings and equipment and various interfaces with a variety of non-standard systems. For all of these reasons, it is essential to have control of configuration on site.
The critically of the data being recorded and its purpose, also have ramifications when considering the most appropriate IT infrastructure. At present, most sites favour the MES being fully supported by on-site infrastructure allowing local management and real-time responsiveness to system failures. There also tends to be little need for information interchange between manufacturing sites in the same corporation at MES level. A centralised approach means global or regional data centres with dual redundant cross country links. These links have delays in communication (latency) and it can also be very difficult to verify that two 'independent' links do not have a single point of failure. However, there is good reason to try to consider a centralised approach. These systems require a high degree of resilience and redundancy, making the infrastructure expensive for a site-based approach, especially when you factor in the costs of the housing, energy and management. Central data centres, both third party and in-house, are becoming more common place and have better performance, reliability and management procedures. As cross country and global communication links become more resilient and faster, in time, a centralised approach is likely to be the right one.
The requirement to model in great detail the plant, material flow and work processes will dictate that the majority of the MES project team need to come from the site. Core support is however essential. The core team will ensure best practice and standard project management procedures across sites. They need to control the phasing of the MES rollout programme in order to avoid resource and production constraints within the client and the vendor. They will ensure 'learnings' from site-to-site are transferred and must play a critical role in managing the vendor and the core system. The 'core' design should include the basic MES functionality together with the interfaces to the ERP, LIMS and other systems, as well as, developing a standard library of validation procedures and protocols. The development of in-house custom interfaces is very expensive, both initially and throughout the life cycle and should be avoided. The use of middleware to handle the interfacing may result in additional customisation and increased life cycle burden. It is likely, in a multi-site rollout that different sites may require their own customisations which are additional to the 'core' functionality. Having central management of the core requirements is essential to avoid systems diverging and becoming unmanageable. Core must seek to leverage the vendor capability and resources at all times, with central resources needing to co-ordinate requirements, upgrades and bug-fixes across sites. An objective for the core group should be to get these customisations incorporated in the standard for the next release. In this process, it can be helpful to involve other users through a user group.
As with every programme of projects, the roles played by corporate, site and vendor need to be carefully thought out. It is critical to manage your MES through a corporate core process because of the clear benefits of standard interfaces and procedures, standard project methodology and vendor management. However, due to the granularity of MES and the variability of manufacturing processes an increased level of site flexibility and resources must be allowed for. This puts some limits on what can be achieved with the core approach.