The arguments for moving to an MES platform are compelling. In reports provided by the MES Association (MESA), a consortium of hardware and software vendors, companies claim that 50% to 80% of their paper batch records contain errors, putting added pressure upon quality assurance personnel, production planners and supervisors. In some cases, it can take reviewers several weeks before records are processed and the errors caught. This presents more problems as the trail of batch tracking grows cold and many errors may not be explained due to the elapsed time since processing.
If implemented properly, an MES system can enable near-paperless batch processing, allow for integrated electronic signatures, and help with developing and maintaining bills of materials and equipment, and dispensing raw or in-process materials.
By integrating plant floor IT and ERP, MES allows operators to key in current batch data at any point within a manufacturing process so that the data are available, in real time, to all areas of production, planning and supervision. An MES eliminates various manual data entries, manual calculations, manual checks and the opportunity to miss a step. For example, operators no longer have to check their calculations; the system will do the calculations for them via formulas entered into the master recipe by an author. This eliminates errors, which in turn helps reduce cycle time.
Manufacturing operators no longer need to read a scale weight and write down the weight. The system automatically retrieves the weight from the scale and places it in the electronic batch record. This also eliminates errors and will then automatically compare this weight to the weight obtained in the dispensing operation while informing the operator if there is a discrepancy.
This process streamlines the product release by reducing the number of after-the-fact checks that are needed. Each manufacturing area performs these after-the-fact checks in accordance with its own policies. Some facilities have associates check calculations and other entries after each manufacturing operation. Other areas have associates check at the end of the entire manufacturing process. An MES network offers savings opportunities in both of these areas.
At its core, MES tracks work-in-process through detailed product routing and tracking, labor reporting, resource and rework management, production measurement and data collection. Since data are transferred in real time, batch evaluations and updates can occur almost immediately and be sent to relevant departments for example, quality control, document management and plant-floor dispatching.
Finding the real-dollar impact
However, an MES platform is not a small budget item. Implementation costs range from an average of $1 million to $6 million, and annual support and licensing fees can run into the tens of thousands. Given the costs involved, most pharmaceutical manufacturers are content to stick with more limited Manufacturing and Resources Planning (MRP) systems. Corporate management typically requires substantive data to convince them that investing in an MES system will add to the corporate bottom line.
An economic analysis of the Return on Investment (ROI) and the costs and benefits of installing an MES system is imperative, both for pharmaceutical manufacturers who are evaluating the software, and for those who have already implemented it, to gauge its impact on their ongoing operations. And this research must determine the real-dollar impact that the platform has on the key performance indicators (KPIs) at any pharmaceutical manufacturing facility:
- cycle time
- cost of goods manufactured
- direct and indirect labor hours required for batch processing
- deviations per batch.
Functionality and finance
Data are available on the benefits of MES systems. Software providers, both independently and through MESA, sell their products based on the probability of what an MES network might do for a given manufacturing company . Much of what is available focuses on functionality, not finances, to justify the use of an MES.
The push to zero errors is cited as a major driver for implementing MES for pharmaceutical manufacturing operations. Vendors typically promise that MES will reduce manufacturing costs, improve compliance with Good Manufacturing Practices (GMPs), and reduce process deviations and inventory levels (Box).
To gain objective data, any pharmaceutical manufacturing team that is evaluating the use of MES should examine initial implementation costs, the feasibility of using an MES network within its environment, and the technical support staffing and network maintenance costs involved. These factors are beyond the scope of this article, which, instead, will suggest a way to survey staff.
Setting up a survey
In order to determine the KPIs, all production planners and quality reviewers at the site should be surveyed twice during each of two three-month intervals, to cover two full quarters of production and six months worth of fiscal data. Primary production planners would be asked to monitor KPIs on a weekly basis, using a production database with information from the MRP system to look at trending and monitor KPIs.