Matthias Goetzfried’s research while affiliated with Freudenberg Sealing Technologies and other places

Managing complexity induced by product variety represents a major challenge for every industrial company in this world. In the Pharmaceutical Industry the regulatory requirements make the situation even more challenging. Companies are especially concerned with the assessment of variety-induced complexity at production plants and its impact on operational performance. This chapter describes how Pfizer examined the connection between Complexity and Operational Excellence on the plant level and the potential for using the model for identification of operational improvements on the plant, as well as the broader manufacturing network level. The chapter follows a methodical combination of qualitative and quantitative approaches and presents a complexity index consisting of 20 indicators. Taking the index as a basis, the relationship between complexity and operational plant performance is investigated. Finally, two clusters, built on plant performance level and ability to transfer high external complexity into low internal complexity, are compared in detail. In the concluding part, the benefit for Pfizer from taking this perspective and approach on plant performance and on OPEX is described.

Kurzfassung Die Leistungsfähigkeit von Exzellenzinitiativen in der Produktion schwankt nicht nur zwischen Unternehmen, sondern ist auch industrieabhängig. Ein Vergleich zweier Studien – die eine ist industrieübergreifend, die andere auf die Pharmaindustrie fokussiert – zeigt jedoch: Es sind weniger Branchenspezifika, sondern vielmehr die konsequente Umsetzung grundsätzlicher Methoden, die die Leistungsunterschiede begründen. Lernen von den Besten – auch außerhalb der eigenen Industrie – scheint mitunter lohnenswert.

Turning manufacturing into a competitive advantage - Looking beyond industry borders. The performance of manufacturing excellence initiatives does not only differ between companies, but also between industries. However, a comparison of two scientific studies, one with cross-industrial scope, the other concentrating on pharmaceutical companies, reveals: Performance differences do not primarily originate from industry specific practices but rather from very general methods and holistic approaches. Thus, learning from the best -even beyond industry borders - can be beneficial.

In the pharmaceutical industry, systems for improving operational effectiveness and efficiency are becoming more and more popular. In this paper, developments in the industry's improvements in operational effectiveness and efficiency have been analyzed. A holistic model is presented which builds the basis for the presented study results. The study includes data gathered from pharmaceutical production sites in surveys in 2004 and 2009. The analysis is divided according to the four sub-systems: Total Productive Maintenance, Total Quality Management, Just-in-Time, and the Management System. For each sub-system, key performance indicators and associated elements (practices and instruments) from 2004 to 2009 are investigated. The data indicates that the industry did make continuous steps towards "Excellence in Operations" between 2004 and 2009. Pharmaceutical companies took control over their former low asset utilization and managed to improve the efficiency of their quality systems; however, they are still far away from having any kind of "continuous flow", smooth production scheduling or make-to-order manufacturing. It can be said that most of the companies are still working on the effectiveness side rather than focusing on the efficiency side.

In today's pharmaceutical industry, only a few executives see manufacturing as a competitive advantage. As a result of the increasing cost pressures affecting the entire industry, many have resorted to global low-cost sources for the production of goods, while at the same time reducing their own production capacities. Although such 'quick win' strategies may make sense in the short term, they may ultimately have a negative impact on the competitiveness of pharmaceutical companies. Outsourcing decisions are usually based on a simple comparison between manufacturing costs at the company's own location and manufacturing costs abroad. Apart from the issues that will be discussed below, the separation of manufacturing from R&D has long-term consequences for the research and development process. Manufacturing input is essential for high quality product development and vice versa. There is a need for a constant dialogue between the manufacturing site and researchers, who focus mainly on developing a laboratory process and are not so much concerned with scale-up.

Lange galt die Aufmerksamkeit pharmazeutischer Unternehmen fast ausschliesslich der Markt- und Forschungsseite. Während andere produzierdende Sektoren vermehrt den Druck globalen Wettbewerbs, volatiler Märkte und sinkender Margen spürten, waren viele forschende Pharmaunternehmen dank sprudelnder Produktpipelines und patentgeschützter de-facto-Monopole weniger stark dem ständigen Verbesserungsdruck freier Märkte ausgesetzt. Doch spätestens seit der sinkenden F&E-Produktivität Ende der Neunziger und dem nun mit 2010 massiv auslaufenden Patentschutz langjähriger Blockbuster forcieren forschende Pharmaunternehmen ihre Initiativen zur Effektivitäts- und Effizienzsteigerung.