The learning factory

Among the top 15 pharmaceutical companies in Europe in terms of turnover, German companies occupy a top position. With almost 900 companies and 110,000 employees, the pharmaceutical industry is one of the oldest and most important sectors in Germany [1]. The formerly stable environment of this has changed considerably in recent years. For example, the expiration of patent rights for important drugs has led to declining sales and profits for pharmaceutical companies [2]. In turn, ever higher investments in research and development are necessary to keep the number of active ingredient approvals constant. To counter these trends, pharmaceutical companies have begun to focus on internal structural changes, complexity reduction, and cost cutting [3]. In this context, the concept of lean management has gained acceptance across industries. The concept of "lean" aims at streamlining production processes by reducing waste [4]. The design of such lean processes requires employees who are qualified to perceive problems in their own work environment as well as to continuously improve processes, but these are hardly available. By setting up and operating a learning factory, this need for qualification can be secured in the long term. Within a learning factory, theoretically learned knowledge is applied within the framework of a realistic, participative and experience-oriented simulation and thus leads to the development of competencies.

Technical qualification

The specific methods and procedures of lean management cannot be assigned to just one specialist discipline. Therefore, the construction and operation of a learning factory requires several disciplines. In the pharmaceutical industry, for example, process reliability is the basis for customer confidence in the product and thus quality is non-negotiable. One of the essential processes for ensuring quality is, for example, standardization, which can be assigned to the specialist discipline of quality management. Due to the high degree of automation in the process industry, the output and capacity utilization of the plants are cost-determining factors in addition to quality. The utilization of the plants depends on the technical availability and thus on the problem-solving ability of the maintenance staff and the line workers. This task and the creation and continuous tracking of key performance indicators (KPI) in the production area falls within the specialist discipline of production management. Ultimately, what counts for the customer is not only the required quality, but also delivery in the right quantity and on time. This means that the third discipline, logistics, is called upon to convey the relevant requirements and methods in the learning factory. The pharmaceutical industry aims to follow the flow principle at the interface of production and logistics and to take into account learning contents of layout design and, in the future, the "pulling" control of batches with just-in-time (JIT) and just-in-sequence (JIS) mechanisms and inter-company supply chain management [5].

While teaching modules that build on each other, such as problem-solving process, 5S and standards in a learning factory, can be easily presented in the technical qualification, performance management with its overall company understanding of causes and cost-related effects presents an overarching challenge. The associated team dialogues based on case-related information boards (performance boards) are aimed at changing behaviour. Mental changes in attitude towards the company as well as identification with goals and role expectations are to be triggered in all training phases.

In summary, it can be stated that an efficient pharmaceutical company is characterized by adequate and sustainable customer satisfaction (logistics), prices in line with the market (production management and process safety), predictably high product quality (quality) and innovative strength [6]. Thus, the addressed technical disciplines and the socio-technical dimension with the guidance for a change of mentality are challenged to design the training concept of the learning factory in an interdisciplinary way (Figure 1). Together with a practical partner from the process industry, the TU Berlin, represented by the departments of logistics, quality science as well as assembly technology and factory operation, and the Fraunhofer IPK have developed a concept together and brought it to implementation. Through the interdisciplinary cooperation of the various project partners, a holistic concept was developed that takes into account different approaches, ways of thinking and methods of various disciplines.

The learning factory

Previous learning factories focus on simulations and business games in the automotive and mechanical engineering industries [7] and are therefore only suitable for the pharmaceutical industry to a limited extent, as the production characteristics differ significantly. The concept of a learning factory developed by the project partners includes pharmaceutical-specific simulations and business games that have been differentiated according to different target groups. In addition to teaching methods, employees are to be sensitized to "lean" in order to bring about a change in mentality that is consistent with the overriding corporate goals, such as customer proximity and economic efficiency.

In order to make the best possible use of the advantages of the learning factory as a learning environment for the trainings, the concept of the trainings is fundamentally based on the alternation between observation, theory and practice. For each of the seven teaching modules (Figure 2), an observation of everyday processes or situations in the learning factory that are worthy of improvement takes place, which are represented by extras. This is followed by the teaching of the corresponding theoretical principles, which serve as a basis for optimising the situation observed in the learning factory. This is followed by the direct practical application of the learned contents in the production-related environment of the learning factory in order to consolidate the acquired knowledge through the active participation and self-awareness of the participants. Accordingly, a training course was developed that takes into account the concept of observation, theory and practice. The training materials were prepared by the respective project partners according to their expertise. In the conception of the practical exercises, scenarios were developed on which the learning contents could be presented in a practice-oriented manner. The practical experiences of the employees were incorporated into the creation of the scenarios in order to emphasise the company-specificity and the reference to the real workplace.

Realistic production scenery

The developed learning factory realistically reproduces a complete tablet production (solid production) in which extras act as workers and work strictly according to good manufacturing practice rules. This enables the participants to reflect on their own actions from an external perspective. In addition, the participants' intrinsic desire for change is stimulated. This entire tablet production was realized on approx. 400 m². For this purpose, a no longer used

Previous learning factories are only suitable for the pharmaceutical industry to a limited extent.

The production area, which was already in use, was completely renovated and redesigned to be multifunctional without destroying the production character of the area. The resulting learning factory is divided into three main areas, consisting of the entrance area, seminar room and the core of the learning factory, the production area. The production area contains all the equipment and machines required for the production of tablets as well as the necessary input materials, which are used for simulation. These simulations include team dialogues on various conflict situations in everyday life, which are practiced by the participants in role plays in order to further increase the subsequent acceptance of the need for lean management in the company.

The concept of the learning factory provides for the teaching of seven teaching modules. Since "Lean" has many methods and procedures, learning objectives for different target groups were defined in advance and synchronized with the corporate objectives of the practice partner. The three identified groups have a different focus regarding the learning objectives: Production employees

The transfer of what has been learned to one's own area of work now takes place more efficiently.

should primarily learn to "act lean", while for the foremen "design lean" and for the management "steer lean" are in the foreground.

The training concept was first implemented in a pretest with the practice partner's lean and operational excellence experts and adapted according to their feedback. This further increased the maturity of the concept. In addition, it turned out to be advantageous that the trainings are conducted by one trainer from the practice partner and one from the TU Berlin and Fraunhofer IPK, respectively. On the one hand, this constellation ensures pharmaceutical specificity and, on the other hand, a company-independent influence in the trainings. The first trainings showed that especially the vertical and horizontal heterogeneity of the participants (participants from different functions and locations; participants on different operational levels) leads to the desired company-internal exchange.

Conclusion and outlook

Implementing the concept of the learning factory specifically for the pharmaceutical industry has proven to be very useful. In particular, the production employees showed that the transfer of what they learned to their own work area takes place more efficiently. This resulted from the high level of interaction between trainers and participants as well as the strong activation in the practical exercises. The positive feedback of the participants to the trainings reflects this impression. The participants particularly praised the practical, interactive teaching of the methods and procedures of Lean Management. From the point of view of the participants, the expansion of the learning factory to include the teaching modules Single Minute Exchange of Die (SMED) and Total Productive Maintenance (TPM) is desirable for the future in order to promote holistic improvement in the company.

For the TU Berlin and Fraunhofer IPK, the joint use of the learning factory provides opportunities to train students and industry partners in lean management, to write joint publications, and to assign theses and internships. Since the winter semester 14/15, the TU Berlin has already been conducting the two courses "Logistics System Planning" and "Experience Production Management" in the learning factory. In the future, the establishment of a pharma-oriented master's degree as well as cooperation in research projects through the participation of the practice partner are conceivable.