Different users, different needs
These definitions have to be sufficiently formal and robust to meet the needs of the different users and representations encountered at the various levels of the manufacturing hierarchy – Product Lifecycle Management (PLM), Enterprise Resource Planning (ERP), Manufacturing Execution System (MES) and control system. And the information may reside in or be required by any or all of a host of different individual systems. Personnel information – who is authorized to perform a particular action, who is qualified, who is available and who is at the right location, all of which may have both security and legal implications – may be held in or derived from HR, security, accounting, control, RFI tracking, GPS/Cell phone tracking or just plain paper.
The fact that less than 50 out of the IET’s 150,000 members deemed the subject important enough to give up a day probably tells us as much about U.K. manufacturing as we need to know. It also tends to confirm Brandl’s own estimate that only between 10% and 20% of manufacturing companies use IT effectively in their manufacturing operations. Given that he also reckons that those who do are seeing productivity advantages of between 30% and 40% and, perhaps even more significantly, are seeing their productivity improve at twice the rate of their competitors, it’s not difficult to predict what is going to happen to those who don’t.
Confirmation that such figures are indeed realizable came from presentations from Martin Beckford of Unilever and Marian Brennan from Wyeth Medica Ireland. Beckford has led a major refurbishment project at Unilever’s Marmite plant at Burton on Trent, U.K., where a €26-million investment program has included an investigation of the potential benefits of an MES implementation at the site. “That investment has made us more aware of where the gaps are,” said Beckford. Those gaps include the degree to which the plant runs sub-optimally due to lack of a material processing schedule; the variability in operating procedures which are based on experience of a process which, even after 100 years, is not fully understood; the proportion of operator and supervisor time that is taken up in manual data collection and monitoring; the limited value of the resultant product ion performance information which is compiled retrospectively and, hence, too late to be used for performance improvement purposes; and the constraints placed upon TPM (Total Productive Maintenance) programs by difficulties in collecting and analyzing loss information. These issues are now being addressed through an MES program developed in conjunction with Siemens and Deloitte and based on a simple approach in which the scope and goals of the project have been clearly defined in order to develop a business case in which functionality is linked directly to clearly quantified benefits.
Cost of compliance
Arguably the most significant benefits realizable in the pharmaceutical industry derive from reducing the cost of compliance with the regulatory environment. Based on experience at its other plants, the predicted results of the MES project at Wyeth Medica Ireland include a 99% reduction in batch record-related deviations and resultant investigations; a 50% to 75% reduction in batch review resources through the adoption of a “Review by Exception” methodology; a 15% reduction in processing cycle time for the total MES solution; and a 50% reduction in batch record review time. Wyeth’s MES strategy is based on a globally developed, integrated suite of applications built around a core solution which is common to all of the company’s sites.
That solution is based on a set of common standard business requirements, business processes and data structures and has been developed by a cross-functional team with input from all of the company’s operating units. Within this framework the approach is to target those areas yielding the fastest and highest ROI as part of a phased deployment involving integration both upwards with ERP and LIMs and downwards with the plant floor. Key components of the approach are the weigh/dispense, electronic batch record and data historian systems, which will allow the virtual elimination of conventional manual record keeping and hence of its inherent associated human errors.
Under the new regime, a total of 86% of the 2.5m batch record entries made each year will now be automated or captured within the eMBR environment, resulting in a 91% reduction in the number of batch record pages generated each year. At the same time, the review by exception approach to batch review, whereby all exceptions to the standard validated process are presented to the reviewer in a single consolidated list for batch release, with all other relevant data logged to the historian for audit purposes, makes realistic Wyerth’s objective of a one minute release time.
“MES is not yet at the point where ERP was 10 years ago”, said Deloitte’s Lawrence Hutter in the final presentation of the day, but it soon will be, given the opportunities created by rapidly rising commodity and energy prices and environmental pressures. “The environment thing is huge,” he assured anyone who might be in any doubt. With 38% of respondents to a recent survey reporting that they had problems obtaining a view into their manufacturing operations, he believes that many companies are already aware that they need to eliminate the disconnect between the enterprise and the plant floor and provide the CIO with visibility down into the manufacturing layer. On the other hand, he acknowledged, establishing and presenting a business case for MES may, in many cases, have to start with convincing the CEOs of some of our largest enterprises that they are indeed involved in manufacturing.
More on events organized by the IET’s Control & Automation network from http://www2.theiet.org/oncomms/pn/controlauto/