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A few years ago, the expectation was that big pharmaceutical companies would become R&D and sales and marketing organisations, with manufacturing being subcontracted. Given the failure in the yield of many R&D pipelines, it seems that many companies have lost faith in their ability to create new chemical entities and are now refocusing on improving their core manufacturing processes and looking towards new investments in growth markets.As a result of this altered focus within the pharmaceutical industry, there has been a rise in the numbers of investments in the areas of biopharmaceuticals, consumer healthcare, OTC medicines and generics, but generally manufacturing (that is efficient manufacturing) is becoming more important. This increasing importance is being particularly felt on packaging lines, where the need to reduce costs through efficiency savings and finding additional capacity is a constant goal, particularly because it has been necessary for many companies to consolidate their packaging facilities.
So the pressure is really on to improve processes and packaging efficiency and to generate additional profit margins. This is becoming a neverending challenge and the pharma industry’s daily mantra.
The cost to find and develop new drugs is increasingly difficult, and to stay competitive companies must drive throughput and reduce changeovers. Even if, for example, a Lean Six Sigma programme has already added an additional 15% output, where do you go from here?In the early stages of continuous improvement, it is usual to find that adopting good practices, such as Lean Manufacturing, Continuous Improvement and Lean Six Sigma, helps to deliver improvements, but the ‘easy gains’ soon start to disappear. Using manual processes to collect and process data only allows you to see what the eye and pen can record: identifying the ‘easy gains’. More detailed and accurate information is needed to keep the improvement programmes fuelled and targeted in the right direction.
It is also alarming to find that many of the improvements that are made initially are not sustained; when the focus of attention moves on, old habits started to creep back and the improvement is eroded. In fact, it has been suggested that at least 50% of improvement programmes are deemed to be failures over the longer term and up to 70% fail to achieve all of their intended benefits.1
To deliver their full potential, these continuous improvement programmes need support, cultural adoption and information (Figure 1).Overall Equipment Effectiveness (OEE) is a powerful plant Key Performance Indicator (KPI) and provides a metric that can be used by operations, production, engineering, maintenance, quality and continuous improvement teams. It consists of three components: availability (major downtimes), performance (line speeds and minor losses) and quality.
Created by Seiichi Nakajima at Nippon Denso in the late 1960s, OEE has become a key measure used in continuous improvement and lean manufacturing programmes.
OEE is expressed as a percentage, and shows the achievement to target of your best possible production output.
OEE (%) = Availability (%) x Performance (%) x Quality (%)
Single Minute Exchange of Dies (SMED), on the other hand, is a way of working and studying changeovers to minimise their effect on production time. It is one of the Lean manufacturing tools designed to reduce waste from the production process. SMED focuses on transferring online to offline operations so they can be done before the changeover starts; using simplified connectors and fastenings; minimising adjustments and trials; and working together. Real-time systems can monitor changeover conformance and provide operational staff alerts of when a changeover is due, allowing them to conduct the offline activities, ensure new materials are ready and be at the line ready to perform the changeover. Although the terms ‘Single Minute’ and ‘Dies’ may not seem to apply to all processes, using its methods will allow any changeover to be improved.