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Implementation of lean production systems in small and medium-sized pharmaceutical enterprises
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Procedia Manufacturing 21 (2018) 814–821 Procedia Manufacturing 00 (2017) 000–000 www.elsevier.com/locate/procedia
15th Global Conference on Sustainable Manufacturing 15th Global Conference on Sustainable Manufacturing
Implementation of lean production systems in small and mediumImplementation of lean production systems in small and mediumsized pharmaceutical enterprises Manufacturing Engineering Society International Conference 2017, MESIC 2017, 28-30 June sized pharmaceutical enterprises 2017, Vigo (Pontevedra), Spain Felix Sieckmannaa *, Hien Nguyen Ngocbb, René Helmaa, Holger Kohla,c Felix Sieckmann *, Hien Nguyen Ngoc , René Helm , Holger Kohla,c
Technische Universität Berlin, Pascalstraße 8-9, 10587 Germany Costing models for capacity optimization inBerlin, Industry 4.0: Trade-off Technische UniversitätUniversity, Berlin, Pascalstraße 10587 Berlin, Vietnamese-German Le lai, Binh8-9, Duong New City, Germany Vietnam University, Le lai, Binh Duong New City, Vietnam Fraunhofer InstituteVietnamese-German for Production Systems and Design Technology, Pascalstraße 8-9,efficiency 10587 Berlin, Germany between used capacity and operational a
ab b
c c
Fraunhofer Institute for Production Systems and Design Technology, Pascalstraße 8-9, 10587 Berlin, Germany
A. Santana , P. Afonso , A. Zanin , R. Wernke Abstract Abstract a University of Minho, 4800-058 Guimarães, Portugal In order to ensure a sustainable supply of the population89809-000 with affordable b Unochapecó, Chapecó,medicines, SC, Brazil it is necessary to organize pharmaceutical In order to processes ensure a sustainable the population with affordable medicines,Lean it isProduction necessary to organize pharmaceutical production efficiently insupply terms of costs, process quality, time and flexibility. Systems (LPS) have proved production processes in terms of costs, process quality, time and flexibility. Productionmodels Systems (LPS) have proved as an effective way to efficiently respond appropriately to these requirements. To date, the transferLean of established to the pharmaceutical as an effective way to respond to theseenterprises requirements. To date, the transfer of established models to the pharmaceutical industry and especially smallappropriately and medium-sized (SMEs) is difficult, because of special characteristics regarding industry and especially and medium-sized enterprises (SMEs) is difficult, of special characteristics regarding production processes andsmall regulatory requirements. At the same time, SMEs often lackbecause the necessary knowledge to develop suitable Abstract production processes regulatory the same SMEs lack the knowledge process to develop suitable LPS themselves. The and paper describesrequirements. Lean successAtfactors andtime, barriers andoften proposes an necessary LPS implementation taking into LPS themselves. Thefeatures paper describes factorsprocesses and barrierswill and be proposes an is LPS implementation process taking into account the unique of SMEs Lean in thesuccess pharmaceutical industry. Special attention to the consideration of humanUnder the concept of "Industry 4.0", production pushed togiven be increasingly interconnected, account the unique features of SMEs in the pharmaceutical industry. Special attention is given to the consideration of humanoriented factors and the appropriate selection of Lean methods, which are aligned with business goals. information based on a real time basis and, necessarily, much more efficient. In this context, capacity optimization oriented factors and the appropriate selection of Lean methods, which are aligned with business goals. goes beyond the traditional aim of capacity maximization, contributing also for organization’s profitability and value. © 2017 The Authors. Published by Elsevier B.V. Indeed, lean management and continuous improvement approaches suggest capacity optimization instead of © 2017 2018 The Published Elsevier B.V. © The Authors. Authors. Published by by B.V. committee of the 15th Global Conference on Sustainable Manufacturing. Peer-review under responsibility of Elsevier the scientific Peer-review underThe responsibility of the scientific committeeand of the 15th Global Conference on Sustainable Manufacturing maximization. study of capacity optimization is an important research topic that(GCSM). deserves Peer-review under responsibility of the scientific committee ofcosting the 15thmodels Global Conference on Sustainable Manufacturing. a
a,*
b
b
contributions from both holistic the practical and theoretical perspectives. This paper presents andenterprises discusses a mathematical Keywords: lean management, production systems, pharmaceutical production, small and medium-sized model forlean capacity management based on different costing production, models (ABC andmedium-sized TDABC). enterprises A generic model has been Keywords: management, holistic production systems, pharmaceutical small and developed and it was used to analyze idle capacity and to design strategies towards the maximization of organization’s value. The trade-off capacity maximization vs operational efficiency is highlighted and it is shown that capacity 1. Introduction 1. Introduction optimization might hide operational inefficiency. © 2017 The Authors. by Elsevier B.V. The inherent goalPublished of pharmaceutical enterprises is to produce and deliver affordable and safe medicines to extend Peer-review under responsibility of the scientific committee of produce the Manufacturing Engineering International Conference The inherent goal of pharmaceutical enterprises is to and the deliver affordable and safe medicines toecologic extend or enhance life. The sustainable supply of those medicines requires balancing ofSociety economic, social and 2017. or enhance life. The sustainable supply of those medicines requires the balancing of economic, social and ecologic issues [1]. For the pharmaceutical industry these issues include the improvement of resource efficiency of production issues [1]. For the pharmaceutical industry these issues include the improvement of resource efficiency of production Keywords: Cost Models; ABC; TDABC; Capacity Management; Idle Capacity; Operational Efficiency
1. Introduction
* Corresponding author. Tel.: +49 (0)30/314-24947; fax: +49 (0)30 / 314-22759. * E-mail Corresponding Tel.: +49 (0)30/314-24947; fax: +49 (0)30 / 314-22759. address:author. [email protected] The cost of idle capacity is a fundamental information for companies and their management of extreme importance E-mail address: [email protected]
in modern©production systems. In general, it isB.V. defined as unused capacity or production potential and can be measured 2351-9789 2017 The Authors. Published by Elsevier 2351-9789 2017responsibility The Authors. Published by Elsevier B.V.hours Peer-review of the scientific committee of the 15th Global Conference on Sustainable Manufacturing. in several©under ways: tons of production, available of manufacturing, etc. The management of the idle capacity Peer-review underTel.: responsibility the761; scientific committee the 15th Global Conference on Sustainable Manufacturing. * Paulo Afonso. +351 253of 510 fax: +351 253 604of741 E-mail address: [email protected]
2351-9789 © 2017 The Authors. Published by Elsevier B.V. Peer-review under responsibility of the scientific committee of the Manufacturing Engineering Society International Conference 2017. 2351-9789 © 2018 The Authors. Published by Elsevier B.V. Peer-review under responsibility of the scientific committee of the 15th Global Conference on Sustainable Manufacturing (GCSM). 10.1016/j.promfg.2018.02.188
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processes, reducing emissions of harmful substances into the environment and facilitating access to medicines for underserved populations [2]. A study published by the World Health Organization in 2011 concluded that even for an adult respiratory infection treated with generic drugs, the costs amount to over two days´ wages in over half the countries studied, while costs of one-day´s salary are generally considered affordable [2]. Since production costs account for up to 50% of these costs, improvements in the pharmaceutical production are an important lever [3]. Subsequently, pharmaceutical companies have to improve their service level, flexibility, costs and quality and at the same time satisfy demanding regulatory conditions and economic factors, such as research and development costs and post approval risks and returns. This is especially relevant for pharmaceutical SMEs that make up the majority of pharmaceutical enterprises. Out of 669 pharmaceutical companies registered in Germany in 2016, 17.3% had between 100 and 499 employees and 76.1% even less than 100 [4]. SMEs in general lack opportunities and resources to harness the economics of scale exploited by large companies and are therefore inherently vulnerable where they have to compete with them [6]. Within the scope of this paper, the focus is on companies that produce pharmaceutical drugs themselves. The first step of the pharmaceutical production process is the preparation of the active pharmaceutical ingredient (API), e.g. from chemical synthesis, bioprocessing or herbal/plant origin. Afterwards, during the formulation, the API and additional excipients are combined into a pharmaceutical product, most commonly in the form of tablets, capsules, pills, salves or liquids. Packaging represents the last step of the production process. To address these issues in a production environment, the application of the Lean philosophy can be an appropriate approach. Lean focuses on the elimination of waste while relying on the employees of a company for continuous process improvement. Lean Production Systems (LPS), as enterprise-specific methodical systems of rules for comprehensive and continuous designing of enterprise processes, have proven their ability to enhance operational efficiency and effectiveness in a production environment [7]. In contrast to other industries that adopted LPS relatively quickly and successfully, the pharmaceutical industry has been slow in deploying them. Regardless of business size, implementing a LPS whilst taking into account the enterprises strategies and while meeting all rules and requirements of the current Good Manufacturing Practices (cGMP) proves to be a challenge [8]. Because of those difficulties, several studies have been released to facilitate pharmaceutical enterprises to deploy LPS. Some of them focus on the compatibility of Lean concepts with cGMP environments [9] while other pinpoint general factors influencing on the success in medium-sized companies [10]. Approaches for the pharmaceutical production focusing on specific production processes like bio-manufacturing [11] as well as more holistic viewpoints regarding operational excellence [8] have been proposed but are lacking a practical step-by-step process. Therefore, the goal is to develop such an implementation process and adapting it to the conditions of pharmaceutical SMEs. 2. Literature review 2.1. Lean success factors and barriers The successful implementation of LPS can lead to shorter lead times, less rework, higher financial savings and less inventory, which in turn makes lean enterprises more responsive and flexible in dynamic markets [12]. However, not all LPS implementations have produced such results [13]. A high number of factors has to be considered, ranging from technological to cultural aspects. To give an overview of these factors a literature analysis of 27 research papers was conducted. Out of the selected papers fifteen describe a general background [14 – 28], seven focus on SMEs [6, 29 – 34] and five specifically address healthcare or process industries [9, 35 – 38]. Figure 1 shows a list of common Lean success factors and barriers respectively. In general, human-oriented “softer” factors predominate. The most important success factors revolve around leadership and aspects related to the qualification of employees. If these are not taken into account sufficiently, they act as barriers. Derived from the companies’ strategy, the implementation follows generally a top-down approach. Since the use of Lean methods and tools often necessitates a major change in the work environment, initial resistance of the employees is to be expected. To address this, it is necessary for management personnel to represent the implementation credibly and lead with good examples [17]. In order for the employees to apply Lean methods and tools, they must be appropriately qualified. Favorable approaches are practice-oriented qualification measures like learning factories and workshops directly at the workplace.
Sieckmann al. / Procedia Manufacturing 21 (2018) 814–821 Felix Felix Sieckmann et al. et / Procedia Manufacturing 00 (2017) 000–000
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3
Figure 1: Frequency of listed Lean success factors and barriers in the literature (n=27)
2.2. Critical implementation steps One significant reason behind the failure of Lean implementation is the lack of an effective implementation methodology and planning. Possible implementation processes have been described by different authors in a variety of industries. Although these processes show differences in regard to specific conditions (e.g. company size, industry or cultural background) they emphasize similarly on ten critical steps of a Lean implementation: understanding (S1), expert Lean-team (S2), enterprise evaluation (S3) training program (S4), communication and feedback system (S5), methods and tools (S6), improvement projects (S7), sustaining (S8), performance measurement system (S9) and documentation and standardization (S10). A detailed description of the ten steps is given in section 3. Table 1.Summary of literature review on critical steps of Lean implementation Source [7] VDI, 2012
Focus
S1
S2
S3
General
S4
Critical steps S5 S6 S7
S8
+
+
+
+
+
+
S9
S10
[11] Smart, 2013
Pharma
+
+
+
+
+
+
+
+
+
[12] Wilson, 2010
General
+
+
+
+
+
+
+
+
+
[13] Karim and Arif-Uz-Zaman 2013
General
+
+
+
+
[35] Friedli 2006
Pharma
+
[39] Valles-Chavez and Sanchez, 2011
General
[40] Sherif et al., 2013
General
+
[41] Jadhav et al., 2014
General
+
[42] Kumar et al., 2013
General
+
+
+
[43] Scholz, 2012
Pharma
[44] Nordin et al., 2012
General
+
SMEs Total
+ 7
[45] Dombrowski et al., 2010
+ 8
+ +
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ 6
+ 9
+
+
+ +
+
+
+
+
+
+
+
+
+
+ +
+
+
+
+
+
+
+ 9
+ 7
+ 9
+ 7
+ 10
10
As can be seen by Table 1, the implementation initiatives proposed by the different authors are not consistent in terms of implementation steps. For example, the model proposed by Wilson [12] does not show a communication and feedback system (S5), while it is included by Scholz [43] who in turn did not emphasize the importance of an expert
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Lean-team (S2). Smart [11] presents an approach which includes all mentioned critical steps but is missing a logical order. S1, S2 and S3 include mainly strategic activities for the preparation and planning of a Lean implementation. Afterwards, during S4 and S5, specific systems to prepare the introduction of the Lean topic into the whole organization are developed. The actual improvement activities take place in S6 and S7 and are secured by S8 in the long term. S9 and S10 are used for parallel, continuous monitoring of the other steps. 3. Implementation process for LPS The proposed implementation process for a LPS is structured in four phases: planning the initiative, development of support systems, execution of improvements and sustaining the system. The last three phases are complemented by parallel monitoring, controlling and documentation, which ensure continuity throughout the process (Figure 2). In the following the phases are described in more detail based on the previously identified critical steps.
Figure 2: Implementation process for LPS in pSME
3.1. Planning the initiative The implementation of a LPS is a strategic decision. Therefore, the top management needs to have a clear understanding regarding LPS (S1) as a prerequisite for the launch of the implementation activities [45]. While the LPS in its practical implementation is company-specific, the basic principles are transferable independently of the industry. Following the decision by the top management to start LPS related activities an expert Lean-team needs to be formed that implements the LPS into the operative work processes (S2) [35]. The Lean-team members will preferably come from different departments and hierarchy levels, so that all relevant areas of the company are represented. In the beginning external consultants can support the expert Lean-team with valuable experience and expert knowledge until employees of the company are sufficiently qualified. This is recommended especially for SMEs as smaller companies initially often lack the required knowledge to implement a LPS. To decide on the scope of the LPS implementation and which methods and tools need to be used, a systematic evaluation of the company is required (S3). Internal factors like products, processes, employees, facilities and resources as well as external factors like markets, competitors, suppliers and customers need to be assessed. Both internal and external factors should not only be evaluated from a purely economic perspective but also from a social and ecological standpoint. Based on the evaluated current situation, an intended future state is developed [12]. For this a vision and mission statement is defined. A sustainability related orientation should be anchored here [1], so that it can be further specified during the following formulation of strategic business goals. Subsequently specific goals for the LPS implementation can be derived. 3.2. Development of support systems An extensive training program conveys LPS knowledge and skills to all employees and specifically execution teams (S4). It is beneficial to follow the approach of cascade trainings, whereby managers and members of the expert Lean-team are trained first and are subsequently responsible for the training of the middle management. Afterwards
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5
the middle management is transferring the knowledge to their employees. Going through this “cascade” requires all management personnel to thoroughly understand the LPS. Furthermore, it promotes the cultural change that goes along with the implementation as the management can set a good example. [47] Supplementary to a training program, a communication and feedback system needs to be developed. Through this the information flow involving the implementation is managed through the entire organization (S5) [43]. Information regarding the goals of the implementation flows top-down from the leadership and expert Lean-team to the employees. At the same time feedback of the operational employees should flow back-up. The daily work in the operative processes gives employees the ability to point out previously overseen problems and propose improvement ideas. Besides internal information flows, the external communication is managed as well. Customers and suppliers need to be involved in major changes due to the LPS. The expert Lean-team not only establishes the system of communication and feedback, but also functions as a coordinator and catalyst for Lean discussions among participants. 3.3. Execution of improvements During the execution phase methods and tools for the LPS are chosen depending on the previously defined business goals (S6) (see Figure 3). As a first step different value streams are analysed using the method value stream mapping (VSM) [11]. This helps to work towards holistic improvements of the whole value stream and avoid insulated solutions. Value streams are selected mainly according to improvement potentials, which are preferably identified during the enterprise evaluation. Further selection criteria include similar routings, similar processing times, and customers with similar needs and demand rates [48]. Once a value stream is selected, the next step is to create a current-state map of the value stream and to collect relevant data. This is used to perform a waste analysis, focusing on overproduction, inventory, transport, waiting, motion, over processing, defects and unused employee potential. In the following, key performance indicators (KPIs) with specific targets are defined and suitable Lean methods and tools can be selected to develop a future state value stream.
Figure 3: Step-by-step approach for the selection of lean methods and tools
After having selected suitable Lean methods and tools they are implemented in a series of improvement projects (S7). The initial improvements are done in a pilot project that is used as a learning opportunity for the expert Leanteam and most importantly as a showcase of the positive impact of the LPS. For this a pilot project needs to be selected that makes it easy to visualize the improvement, like a known bottleneck, that affects multiple departments and/or processes. The management engagement needs to be high, so that changes can be made quickly. The size of the pilot project should not be too big, so that first improvements can be made in a short timeframe [40]. Following the implementation of the pilot project, adjustments regarding the approach are made, if needed and further improvement projects can be rolled out to other value streams.
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3.4. Sustaining the system Following the initial implementation project, a transition to continuous training and improvement activities that are supported by the companies’ employees need to be made, so that the LPS can perform as a long-term working system (S8) [9]. A recognition policy in form of monetary or non-monetary incentives can positively affect the motivation of employees. Especially non-monetary incentives, such as personal development incentives by training or workshop participation, are suitable in SMEs due to financial constraints and powerful in shaping an ongoing learning culture. 3.5. Monitoring, controlling and documentation Parallel to the development of support systems, the execution of improvements and in coordination with efforts to ensure the sustainability of the LPS, additional activities regarding monitoring, controlling and documentation are carried out. Performance targets of the LPS implementation are set and continuously measured by a defined series of KPIs (S9). The KPIs must be aligned with the strategic goals of the company and continuously discussed in a transparent format so that all participants are able to track the progress of the LPS implementation. If a deviation in the progress becomes apparent, corrective actions need to be taken. All completed LPS related activities are documented in a systematic way (e.g. in an electronic database) to serve as a knowledge base for future projects and continuous learning of the organization (S10) [18]. The visual publication and discussion of achieved results on dashboards helps to motivate employees and secure support of the management. 4. Influences of pharmaceutical production characteristics on the LPS implementation process Special characteristics of the pharmaceutical production have different effects on the described ten implementation steps. In some cases, like the training program (S4) as well as the communication and feedback system (S5), there are hardly any adjustments necessary in comparison to established practices in other industries. In contrast to this, the steps understanding (S1), expert Lean-team (S2), enterprise evaluation (S3), methods and tools (S6) and improvement projects (S7) require adaptations since they frequently come in contact with production processes. In the pharmaceutical production, a special role is often perceived as a result of the high regulatory requirements which prevent the use of LPS. Regarding the necessary understanding (S1) of LPS, it is therefore of importance to know how the LPS approach is integrated into a quality-oriented system like the cGMP, which is demanded and by regulatory agencies worldwide. In fact, the targets of LPS, waste reduction and value creation, are not only compatible with but provide supplements to those of the cGMP. The goal of the cGMP is to ensure a high product quality and safety. Therefore, only validated processes can be used, so that deviations regarding the outcome of production or testing processes are minimal. This fits very well with the LPS approach, where a high process quality is sought after to achieve minimal waste through defects and rework. [49] Regarding the composition of an expert Lean-team (S2), the enterprise evaluation (S3) and implementation of improvement projects (S7) the significance of quality management activities needs to be considered. Major parts of the pharmaceutical value creation process are taking place and/or are being influenced by the quality and regulatory related functions [11]. Therefore, these functions should be integrated into the LPS with equal importance as the production itself. Because of technological and regulatory characteristics LPS methods and tools (S6) need to be modified. The pursued objectives are strongly influenced by the process technology used. During the production of the active pharmaceutical ingredient, a chemical synthesis typically gets more benefits through the reduction of processing time, e.g. through the application of continuous production concepts. Molecules formed through bioprocessing benefit comparatively better through quality improvements, e.g. by keeping nutrients levels steady and avoiding deviations that reduce cell viability [11]. Compared to the production of automobiles, changeover processes in the pharmaceutical production take much longer. This is especially due to complex cleaning and testing processes. At this point, there are great potentials for organizational improvements before resource-intensive technical solutions have to be implemented. In order to avoid set-up and cleaning operations, the use of dedicated systems for specific products is a good option. Adjustments to plant layouts, as are customary in the context of Lean projects, often do not have a positive cost-benefit ratio in the pharmaceutical production. Pharmaceutical production equipment cannot be moved
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easily as it is integrated into the building structure and/or is operated in separate smaller rooms. The equipment is thus rather combined into “virtual cells”. A virtual cell then produces only one product group, which reduces the need for changeover and therefore the throughput time. The layout is not changed. Due to the long process times, the unchanged travel times can often be neglected [43]. To apply LPS in the pharmaceutical production some implementation steps can be transferred almost directly, while others have to be adapted. The underlying objectives and principles of LPS, such as a high process quality and short throughput times continue to apply. However, it is necessary to adapt the goals and application of some methods. If these points are taken into account, it is possible to obtain positive results by applying LPS in the pharmaceutical production. 5. Summary and Outlook Improving the efficiency of the pharmaceutical production through the use of LPS provides a way to advance the sustainable supply of the population with affordable medicines. Through a literature analysis, important success factors and barriers of a LPS implementation as well as critical implementation steps were identified. On this basis an integrated process for the implementation of LPS was developed, consisting of the four phases planning, development of support systems, execution and sustaining. These phases are complemented by parallel activities in monitoring, controlling and documentation. Special characteristics of this process, which are to be considered for the application in pharmaceutical SMEs, have been highlighted. A major obstacle to the implementation of LPS in the pharmaceutical industry is still the limited suitability of individual Lean methods and tools for process-related production processes. In view of this, further adjustments to individual methods and tools are necessary in order to be able to use them to their full extend in the pharmaceutical production. Acknowledgements This paper is based on work from the project “LeanProductionPharma” (IGF project 18890 N) in cooperation with the German Research Association of Pharmaceutical Manufacturers (FAH). The project was supported via the German Federation of Industrial Research Associations (AiF) within the program for promoting the Industrial Collective Research (IGF) of the German Ministry of Economic Affairs and Energy (BMWi), based on a resolution of the German Parliament. References [1] Leonard, T., Schneider, J. Integrated sustainability in the pharmaceutical industry. International journal for sustainable business. Vol. 11, No. 2 (2004) 119-28. [2] Langenwalter G. Life is Our Ultimate Customer: From Lean to Sustainability. Target Magazine. Vol. 22, No. 1 (2006) 5-15. [3] World Health Organization. The World Medicines Situation 2011. 3rd edition, WHO press, Geneva, 2011. [4] Gütter S.P. Lean Practices in Pharmaceutical Manufacturing – An empirical investigation. Difo-Druck, Bamberg, 2014. [5] German Pharmaceutical Association. Pharma-Data 2016, 46th revised edition, October 2016. available online: http://www.bpi.de/daten-undfakten/pharmadaten/ (last checked: 01.06.2017). [6] Achanga, P., Shehab, E., Roy, R., Nelder G. Critical success factors for Lean implementation within SMEs. Journal of Manufacturing Technology Management. Vol. 17, No. 4 (2006) 460-471. [7] The Association of German Engineers (VDI). Guideline 2870-1 – Lean Production Systems – Basic principles, introduction and review. Beuth, Berlin, 2012. [8] Friedli, T. (editor). The Pathway to Operational Excellence in the Pharmaceutical Industry. Overcoming the internal inertia. Editio Cantor Verlag, Aulendorf, 2010. [9] Bellm, D. Operational Excellence in the Pharmaceutical Industry – An Architecture for Emerging Markets. The University of St. Gallen, St. Gallen, 2015. [10] Schuh, G., Riesener, M., Arnoscht, J. Critical Success Factors in Medium-sized Pharmaceutical Enterprises. Proceedings of the 5th ISPIM Innovation Symposium, Seoul, Korea. 9-12 December 2012, 1-15. [11] Smart, N. J. Lean biomanufacturing. Crating value through innovative bioprocessing approaches. Woodhead Publishing, Philadelphia, 2013. [12] Wilson L. How to Implement Lean Manufacturing. McGraw-Hill, New York, 2010. [13] Karim, A., Arif-Uz-Zaman, K. A methodology for effective implementation of Lean strategies and its performance evaluation in manufacturing organizations. Business Process Management Journal. Vol. 19, No. 1 (2013) 169-196.
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The Benefits of Lean Manufacturing: What Lean Thinking has to offer the Process Industries. Chemical Engineering Research and Design. Vol. 83, No. 6 (2005) 662-673. [38] Zidel, T.G. A Lean toolbox: Using Lean principles and techniques in healthcare. Journal for Healthcare Quality. Vol. 28, No. 1 (2006) 1 – 7. [39] Valles-Chavez, A., Sanchez, J. Definition of the Guide for Implementation Lean. In: Coskun, A., Tamer, I. C., Serteser, M. editor. Six Sigma Projects and Personal Experiences. InTech, Rijeka, 2011. pp 24-44. [40] Sherif, M., Jantanee, D., Hassan S. A framework for lean manufacturing implementation. Production & Manufacturing Research. An Open Access Journal. Vol.1, No.1 (2013) 44-64. [41] Jadhav, J. R., Mantha, S.S., Rane, S.B. Development of framework for sustainable Lean implementation: an ISM approach. Journal of Industrial Engineering International. Vol. 10, No. 3 (2014) Article 72. [42] Kumar, N. Implementing Lean Manufacturing System: ISM Approach. Journal of Industrial Engineering and Management. Vol. 6, No. 4 (2013) 996-1007. [43] Scholz, M. Entwicklung eines ganzheitlichen Gestaltungsrahmens zur Lean Transformation in der pharmazeutischen Formulierung und Konfektionierung. Verlag Praxiswissen, Dortmund, 2012. [44] Nordin, N., Deros, B.M., Wahab, D.A., Rahman, M.N.A. A framework for organisational change management in lean manufacturing implementation. International Journal of Services and Operations Management. Vol. 12, No. 1 (2012) 101-117. [45] Dombrowski, U., Crespo, I., Zahn, T. Adaptive Configuration of a Lean Production System in Small and Medium-sized Enterprises. Production Engineering. Vol. 4, No. 4 (2010) 341-348. [47] Rafi, M. Evaluating training cascade: A methodology and case study. Educational Research and Reviews. Vol. 5, No. 2 (2010) 64-77. [48] Rother, M., Shook, J. Learning to see. Value-stream mapping to create value and eliminate muda. Lean Enterprise Institute, Cambridge, 1999. [49] Greene, A., O’Rourke, D. Lean manufacturing practice in a cGMP environment. Pharmaceutical Technology Europe, Vol. 18. No. 10 (2006) 33-40.
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Procedia Manufacturing 21 (2018) 814–821 Procedia Manufacturing 00 (2017) 000–000 www.elsevier.com/locate/procedia
15th Global Conference on Sustainable Manufacturing 15th Global Conference on Sustainable Manufacturing
Implementation of lean production systems in small and mediumImplementation of lean production systems in small and mediumsized pharmaceutical enterprises Manufacturing Engineering Society International Conference 2017, MESIC 2017, 28-30 June sized pharmaceutical enterprises 2017, Vigo (Pontevedra), Spain Felix Sieckmannaa *, Hien Nguyen Ngocbb, René Helmaa, Holger Kohla,c Felix Sieckmann *, Hien Nguyen Ngoc , René Helm , Holger Kohla,c
Technische Universität Berlin, Pascalstraße 8-9, 10587 Germany Costing models for capacity optimization inBerlin, Industry 4.0: Trade-off Technische UniversitätUniversity, Berlin, Pascalstraße 10587 Berlin, Vietnamese-German Le lai, Binh8-9, Duong New City, Germany Vietnam University, Le lai, Binh Duong New City, Vietnam Fraunhofer InstituteVietnamese-German for Production Systems and Design Technology, Pascalstraße 8-9,efficiency 10587 Berlin, Germany between used capacity and operational a
ab b
c c
Fraunhofer Institute for Production Systems and Design Technology, Pascalstraße 8-9, 10587 Berlin, Germany
A. Santana , P. Afonso , A. Zanin , R. Wernke Abstract Abstract a University of Minho, 4800-058 Guimarães, Portugal In order to ensure a sustainable supply of the population89809-000 with affordable b Unochapecó, Chapecó,medicines, SC, Brazil it is necessary to organize pharmaceutical In order to processes ensure a sustainable the population with affordable medicines,Lean it isProduction necessary to organize pharmaceutical production efficiently insupply terms of costs, process quality, time and flexibility. Systems (LPS) have proved production processes in terms of costs, process quality, time and flexibility. Productionmodels Systems (LPS) have proved as an effective way to efficiently respond appropriately to these requirements. To date, the transferLean of established to the pharmaceutical as an effective way to respond to theseenterprises requirements. To date, the transfer of established models to the pharmaceutical industry and especially smallappropriately and medium-sized (SMEs) is difficult, because of special characteristics regarding industry and especially and medium-sized enterprises (SMEs) is difficult, of special characteristics regarding production processes andsmall regulatory requirements. At the same time, SMEs often lackbecause the necessary knowledge to develop suitable Abstract production processes regulatory the same SMEs lack the knowledge process to develop suitable LPS themselves. The and paper describesrequirements. Lean successAtfactors andtime, barriers andoften proposes an necessary LPS implementation taking into LPS themselves. Thefeatures paper describes factorsprocesses and barrierswill and be proposes an is LPS implementation process taking into account the unique of SMEs Lean in thesuccess pharmaceutical industry. Special attention to the consideration of humanUnder the concept of "Industry 4.0", production pushed togiven be increasingly interconnected, account the unique features of SMEs in the pharmaceutical industry. Special attention is given to the consideration of humanoriented factors and the appropriate selection of Lean methods, which are aligned with business goals. information based on a real time basis and, necessarily, much more efficient. In this context, capacity optimization oriented factors and the appropriate selection of Lean methods, which are aligned with business goals. goes beyond the traditional aim of capacity maximization, contributing also for organization’s profitability and value. © 2017 The Authors. Published by Elsevier B.V. Indeed, lean management and continuous improvement approaches suggest capacity optimization instead of © 2017 2018 The Published Elsevier B.V. © The Authors. Authors. Published by by B.V. committee of the 15th Global Conference on Sustainable Manufacturing. Peer-review under responsibility of Elsevier the scientific Peer-review underThe responsibility of the scientific committeeand of the 15th Global Conference on Sustainable Manufacturing maximization. study of capacity optimization is an important research topic that(GCSM). deserves Peer-review under responsibility of the scientific committee ofcosting the 15thmodels Global Conference on Sustainable Manufacturing. a
a,*
b
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contributions from both holistic the practical and theoretical perspectives. This paper presents andenterprises discusses a mathematical Keywords: lean management, production systems, pharmaceutical production, small and medium-sized model forlean capacity management based on different costing production, models (ABC andmedium-sized TDABC). enterprises A generic model has been Keywords: management, holistic production systems, pharmaceutical small and developed and it was used to analyze idle capacity and to design strategies towards the maximization of organization’s value. The trade-off capacity maximization vs operational efficiency is highlighted and it is shown that capacity 1. Introduction 1. Introduction optimization might hide operational inefficiency. © 2017 The Authors. by Elsevier B.V. The inherent goalPublished of pharmaceutical enterprises is to produce and deliver affordable and safe medicines to extend Peer-review under responsibility of the scientific committee of produce the Manufacturing Engineering International Conference The inherent goal of pharmaceutical enterprises is to and the deliver affordable and safe medicines toecologic extend or enhance life. The sustainable supply of those medicines requires balancing ofSociety economic, social and 2017. or enhance life. The sustainable supply of those medicines requires the balancing of economic, social and ecologic issues [1]. For the pharmaceutical industry these issues include the improvement of resource efficiency of production issues [1]. For the pharmaceutical industry these issues include the improvement of resource efficiency of production Keywords: Cost Models; ABC; TDABC; Capacity Management; Idle Capacity; Operational Efficiency
1. Introduction
* Corresponding author. Tel.: +49 (0)30/314-24947; fax: +49 (0)30 / 314-22759. * E-mail Corresponding Tel.: +49 (0)30/314-24947; fax: +49 (0)30 / 314-22759. address:author. [email protected] The cost of idle capacity is a fundamental information for companies and their management of extreme importance E-mail address: [email protected]
in modern©production systems. In general, it isB.V. defined as unused capacity or production potential and can be measured 2351-9789 2017 The Authors. Published by Elsevier 2351-9789 2017responsibility The Authors. Published by Elsevier B.V.hours Peer-review of the scientific committee of the 15th Global Conference on Sustainable Manufacturing. in several©under ways: tons of production, available of manufacturing, etc. The management of the idle capacity Peer-review underTel.: responsibility the761; scientific committee the 15th Global Conference on Sustainable Manufacturing. * Paulo Afonso. +351 253of 510 fax: +351 253 604of741 E-mail address: [email protected]
2351-9789 © 2017 The Authors. Published by Elsevier B.V. Peer-review under responsibility of the scientific committee of the Manufacturing Engineering Society International Conference 2017. 2351-9789 © 2018 The Authors. Published by Elsevier B.V. Peer-review under responsibility of the scientific committee of the 15th Global Conference on Sustainable Manufacturing (GCSM). 10.1016/j.promfg.2018.02.188
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processes, reducing emissions of harmful substances into the environment and facilitating access to medicines for underserved populations [2]. A study published by the World Health Organization in 2011 concluded that even for an adult respiratory infection treated with generic drugs, the costs amount to over two days´ wages in over half the countries studied, while costs of one-day´s salary are generally considered affordable [2]. Since production costs account for up to 50% of these costs, improvements in the pharmaceutical production are an important lever [3]. Subsequently, pharmaceutical companies have to improve their service level, flexibility, costs and quality and at the same time satisfy demanding regulatory conditions and economic factors, such as research and development costs and post approval risks and returns. This is especially relevant for pharmaceutical SMEs that make up the majority of pharmaceutical enterprises. Out of 669 pharmaceutical companies registered in Germany in 2016, 17.3% had between 100 and 499 employees and 76.1% even less than 100 [4]. SMEs in general lack opportunities and resources to harness the economics of scale exploited by large companies and are therefore inherently vulnerable where they have to compete with them [6]. Within the scope of this paper, the focus is on companies that produce pharmaceutical drugs themselves. The first step of the pharmaceutical production process is the preparation of the active pharmaceutical ingredient (API), e.g. from chemical synthesis, bioprocessing or herbal/plant origin. Afterwards, during the formulation, the API and additional excipients are combined into a pharmaceutical product, most commonly in the form of tablets, capsules, pills, salves or liquids. Packaging represents the last step of the production process. To address these issues in a production environment, the application of the Lean philosophy can be an appropriate approach. Lean focuses on the elimination of waste while relying on the employees of a company for continuous process improvement. Lean Production Systems (LPS), as enterprise-specific methodical systems of rules for comprehensive and continuous designing of enterprise processes, have proven their ability to enhance operational efficiency and effectiveness in a production environment [7]. In contrast to other industries that adopted LPS relatively quickly and successfully, the pharmaceutical industry has been slow in deploying them. Regardless of business size, implementing a LPS whilst taking into account the enterprises strategies and while meeting all rules and requirements of the current Good Manufacturing Practices (cGMP) proves to be a challenge [8]. Because of those difficulties, several studies have been released to facilitate pharmaceutical enterprises to deploy LPS. Some of them focus on the compatibility of Lean concepts with cGMP environments [9] while other pinpoint general factors influencing on the success in medium-sized companies [10]. Approaches for the pharmaceutical production focusing on specific production processes like bio-manufacturing [11] as well as more holistic viewpoints regarding operational excellence [8] have been proposed but are lacking a practical step-by-step process. Therefore, the goal is to develop such an implementation process and adapting it to the conditions of pharmaceutical SMEs. 2. Literature review 2.1. Lean success factors and barriers The successful implementation of LPS can lead to shorter lead times, less rework, higher financial savings and less inventory, which in turn makes lean enterprises more responsive and flexible in dynamic markets [12]. However, not all LPS implementations have produced such results [13]. A high number of factors has to be considered, ranging from technological to cultural aspects. To give an overview of these factors a literature analysis of 27 research papers was conducted. Out of the selected papers fifteen describe a general background [14 – 28], seven focus on SMEs [6, 29 – 34] and five specifically address healthcare or process industries [9, 35 – 38]. Figure 1 shows a list of common Lean success factors and barriers respectively. In general, human-oriented “softer” factors predominate. The most important success factors revolve around leadership and aspects related to the qualification of employees. If these are not taken into account sufficiently, they act as barriers. Derived from the companies’ strategy, the implementation follows generally a top-down approach. Since the use of Lean methods and tools often necessitates a major change in the work environment, initial resistance of the employees is to be expected. To address this, it is necessary for management personnel to represent the implementation credibly and lead with good examples [17]. In order for the employees to apply Lean methods and tools, they must be appropriately qualified. Favorable approaches are practice-oriented qualification measures like learning factories and workshops directly at the workplace.
Sieckmann al. / Procedia Manufacturing 21 (2018) 814–821 Felix Felix Sieckmann et al. et / Procedia Manufacturing 00 (2017) 000–000
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3
Figure 1: Frequency of listed Lean success factors and barriers in the literature (n=27)
2.2. Critical implementation steps One significant reason behind the failure of Lean implementation is the lack of an effective implementation methodology and planning. Possible implementation processes have been described by different authors in a variety of industries. Although these processes show differences in regard to specific conditions (e.g. company size, industry or cultural background) they emphasize similarly on ten critical steps of a Lean implementation: understanding (S1), expert Lean-team (S2), enterprise evaluation (S3) training program (S4), communication and feedback system (S5), methods and tools (S6), improvement projects (S7), sustaining (S8), performance measurement system (S9) and documentation and standardization (S10). A detailed description of the ten steps is given in section 3. Table 1.Summary of literature review on critical steps of Lean implementation Source [7] VDI, 2012
Focus
S1
S2
S3
General
S4
Critical steps S5 S6 S7
S8
+
+
+
+
+
+
S9
S10
[11] Smart, 2013
Pharma
+
+
+
+
+
+
+
+
+
[12] Wilson, 2010
General
+
+
+
+
+
+
+
+
+
[13] Karim and Arif-Uz-Zaman 2013
General
+
+
+
+
[35] Friedli 2006
Pharma
+
[39] Valles-Chavez and Sanchez, 2011
General
[40] Sherif et al., 2013
General
+
[41] Jadhav et al., 2014
General
+
[42] Kumar et al., 2013
General
+
+
+
[43] Scholz, 2012
Pharma
[44] Nordin et al., 2012
General
+
SMEs Total
+ 7
[45] Dombrowski et al., 2010
+ 8
+ +
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ 6
+ 9
+
+
+ +
+
+
+
+
+
+
+
+
+
+ +
+
+
+
+
+
+
+ 9
+ 7
+ 9
+ 7
+ 10
10
As can be seen by Table 1, the implementation initiatives proposed by the different authors are not consistent in terms of implementation steps. For example, the model proposed by Wilson [12] does not show a communication and feedback system (S5), while it is included by Scholz [43] who in turn did not emphasize the importance of an expert
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Lean-team (S2). Smart [11] presents an approach which includes all mentioned critical steps but is missing a logical order. S1, S2 and S3 include mainly strategic activities for the preparation and planning of a Lean implementation. Afterwards, during S4 and S5, specific systems to prepare the introduction of the Lean topic into the whole organization are developed. The actual improvement activities take place in S6 and S7 and are secured by S8 in the long term. S9 and S10 are used for parallel, continuous monitoring of the other steps. 3. Implementation process for LPS The proposed implementation process for a LPS is structured in four phases: planning the initiative, development of support systems, execution of improvements and sustaining the system. The last three phases are complemented by parallel monitoring, controlling and documentation, which ensure continuity throughout the process (Figure 2). In the following the phases are described in more detail based on the previously identified critical steps.
Figure 2: Implementation process for LPS in pSME
3.1. Planning the initiative The implementation of a LPS is a strategic decision. Therefore, the top management needs to have a clear understanding regarding LPS (S1) as a prerequisite for the launch of the implementation activities [45]. While the LPS in its practical implementation is company-specific, the basic principles are transferable independently of the industry. Following the decision by the top management to start LPS related activities an expert Lean-team needs to be formed that implements the LPS into the operative work processes (S2) [35]. The Lean-team members will preferably come from different departments and hierarchy levels, so that all relevant areas of the company are represented. In the beginning external consultants can support the expert Lean-team with valuable experience and expert knowledge until employees of the company are sufficiently qualified. This is recommended especially for SMEs as smaller companies initially often lack the required knowledge to implement a LPS. To decide on the scope of the LPS implementation and which methods and tools need to be used, a systematic evaluation of the company is required (S3). Internal factors like products, processes, employees, facilities and resources as well as external factors like markets, competitors, suppliers and customers need to be assessed. Both internal and external factors should not only be evaluated from a purely economic perspective but also from a social and ecological standpoint. Based on the evaluated current situation, an intended future state is developed [12]. For this a vision and mission statement is defined. A sustainability related orientation should be anchored here [1], so that it can be further specified during the following formulation of strategic business goals. Subsequently specific goals for the LPS implementation can be derived. 3.2. Development of support systems An extensive training program conveys LPS knowledge and skills to all employees and specifically execution teams (S4). It is beneficial to follow the approach of cascade trainings, whereby managers and members of the expert Lean-team are trained first and are subsequently responsible for the training of the middle management. Afterwards
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5
the middle management is transferring the knowledge to their employees. Going through this “cascade” requires all management personnel to thoroughly understand the LPS. Furthermore, it promotes the cultural change that goes along with the implementation as the management can set a good example. [47] Supplementary to a training program, a communication and feedback system needs to be developed. Through this the information flow involving the implementation is managed through the entire organization (S5) [43]. Information regarding the goals of the implementation flows top-down from the leadership and expert Lean-team to the employees. At the same time feedback of the operational employees should flow back-up. The daily work in the operative processes gives employees the ability to point out previously overseen problems and propose improvement ideas. Besides internal information flows, the external communication is managed as well. Customers and suppliers need to be involved in major changes due to the LPS. The expert Lean-team not only establishes the system of communication and feedback, but also functions as a coordinator and catalyst for Lean discussions among participants. 3.3. Execution of improvements During the execution phase methods and tools for the LPS are chosen depending on the previously defined business goals (S6) (see Figure 3). As a first step different value streams are analysed using the method value stream mapping (VSM) [11]. This helps to work towards holistic improvements of the whole value stream and avoid insulated solutions. Value streams are selected mainly according to improvement potentials, which are preferably identified during the enterprise evaluation. Further selection criteria include similar routings, similar processing times, and customers with similar needs and demand rates [48]. Once a value stream is selected, the next step is to create a current-state map of the value stream and to collect relevant data. This is used to perform a waste analysis, focusing on overproduction, inventory, transport, waiting, motion, over processing, defects and unused employee potential. In the following, key performance indicators (KPIs) with specific targets are defined and suitable Lean methods and tools can be selected to develop a future state value stream.
Figure 3: Step-by-step approach for the selection of lean methods and tools
After having selected suitable Lean methods and tools they are implemented in a series of improvement projects (S7). The initial improvements are done in a pilot project that is used as a learning opportunity for the expert Leanteam and most importantly as a showcase of the positive impact of the LPS. For this a pilot project needs to be selected that makes it easy to visualize the improvement, like a known bottleneck, that affects multiple departments and/or processes. The management engagement needs to be high, so that changes can be made quickly. The size of the pilot project should not be too big, so that first improvements can be made in a short timeframe [40]. Following the implementation of the pilot project, adjustments regarding the approach are made, if needed and further improvement projects can be rolled out to other value streams.
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3.4. Sustaining the system Following the initial implementation project, a transition to continuous training and improvement activities that are supported by the companies’ employees need to be made, so that the LPS can perform as a long-term working system (S8) [9]. A recognition policy in form of monetary or non-monetary incentives can positively affect the motivation of employees. Especially non-monetary incentives, such as personal development incentives by training or workshop participation, are suitable in SMEs due to financial constraints and powerful in shaping an ongoing learning culture. 3.5. Monitoring, controlling and documentation Parallel to the development of support systems, the execution of improvements and in coordination with efforts to ensure the sustainability of the LPS, additional activities regarding monitoring, controlling and documentation are carried out. Performance targets of the LPS implementation are set and continuously measured by a defined series of KPIs (S9). The KPIs must be aligned with the strategic goals of the company and continuously discussed in a transparent format so that all participants are able to track the progress of the LPS implementation. If a deviation in the progress becomes apparent, corrective actions need to be taken. All completed LPS related activities are documented in a systematic way (e.g. in an electronic database) to serve as a knowledge base for future projects and continuous learning of the organization (S10) [18]. The visual publication and discussion of achieved results on dashboards helps to motivate employees and secure support of the management. 4. Influences of pharmaceutical production characteristics on the LPS implementation process Special characteristics of the pharmaceutical production have different effects on the described ten implementation steps. In some cases, like the training program (S4) as well as the communication and feedback system (S5), there are hardly any adjustments necessary in comparison to established practices in other industries. In contrast to this, the steps understanding (S1), expert Lean-team (S2), enterprise evaluation (S3), methods and tools (S6) and improvement projects (S7) require adaptations since they frequently come in contact with production processes. In the pharmaceutical production, a special role is often perceived as a result of the high regulatory requirements which prevent the use of LPS. Regarding the necessary understanding (S1) of LPS, it is therefore of importance to know how the LPS approach is integrated into a quality-oriented system like the cGMP, which is demanded and by regulatory agencies worldwide. In fact, the targets of LPS, waste reduction and value creation, are not only compatible with but provide supplements to those of the cGMP. The goal of the cGMP is to ensure a high product quality and safety. Therefore, only validated processes can be used, so that deviations regarding the outcome of production or testing processes are minimal. This fits very well with the LPS approach, where a high process quality is sought after to achieve minimal waste through defects and rework. [49] Regarding the composition of an expert Lean-team (S2), the enterprise evaluation (S3) and implementation of improvement projects (S7) the significance of quality management activities needs to be considered. Major parts of the pharmaceutical value creation process are taking place and/or are being influenced by the quality and regulatory related functions [11]. Therefore, these functions should be integrated into the LPS with equal importance as the production itself. Because of technological and regulatory characteristics LPS methods and tools (S6) need to be modified. The pursued objectives are strongly influenced by the process technology used. During the production of the active pharmaceutical ingredient, a chemical synthesis typically gets more benefits through the reduction of processing time, e.g. through the application of continuous production concepts. Molecules formed through bioprocessing benefit comparatively better through quality improvements, e.g. by keeping nutrients levels steady and avoiding deviations that reduce cell viability [11]. Compared to the production of automobiles, changeover processes in the pharmaceutical production take much longer. This is especially due to complex cleaning and testing processes. At this point, there are great potentials for organizational improvements before resource-intensive technical solutions have to be implemented. In order to avoid set-up and cleaning operations, the use of dedicated systems for specific products is a good option. Adjustments to plant layouts, as are customary in the context of Lean projects, often do not have a positive cost-benefit ratio in the pharmaceutical production. Pharmaceutical production equipment cannot be moved
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easily as it is integrated into the building structure and/or is operated in separate smaller rooms. The equipment is thus rather combined into “virtual cells”. A virtual cell then produces only one product group, which reduces the need for changeover and therefore the throughput time. The layout is not changed. Due to the long process times, the unchanged travel times can often be neglected [43]. To apply LPS in the pharmaceutical production some implementation steps can be transferred almost directly, while others have to be adapted. The underlying objectives and principles of LPS, such as a high process quality and short throughput times continue to apply. However, it is necessary to adapt the goals and application of some methods. If these points are taken into account, it is possible to obtain positive results by applying LPS in the pharmaceutical production. 5. Summary and Outlook Improving the efficiency of the pharmaceutical production through the use of LPS provides a way to advance the sustainable supply of the population with affordable medicines. Through a literature analysis, important success factors and barriers of a LPS implementation as well as critical implementation steps were identified. On this basis an integrated process for the implementation of LPS was developed, consisting of the four phases planning, development of support systems, execution and sustaining. These phases are complemented by parallel activities in monitoring, controlling and documentation. Special characteristics of this process, which are to be considered for the application in pharmaceutical SMEs, have been highlighted. A major obstacle to the implementation of LPS in the pharmaceutical industry is still the limited suitability of individual Lean methods and tools for process-related production processes. In view of this, further adjustments to individual methods and tools are necessary in order to be able to use them to their full extend in the pharmaceutical production. Acknowledgements This paper is based on work from the project “LeanProductionPharma” (IGF project 18890 N) in cooperation with the German Research Association of Pharmaceutical Manufacturers (FAH). The project was supported via the German Federation of Industrial Research Associations (AiF) within the program for promoting the Industrial Collective Research (IGF) of the German Ministry of Economic Affairs and Energy (BMWi), based on a resolution of the German Parliament. References [1] Leonard, T., Schneider, J. Integrated sustainability in the pharmaceutical industry. International journal for sustainable business. Vol. 11, No. 2 (2004) 119-28. [2] Langenwalter G. Life is Our Ultimate Customer: From Lean to Sustainability. Target Magazine. Vol. 22, No. 1 (2006) 5-15. [3] World Health Organization. The World Medicines Situation 2011. 3rd edition, WHO press, Geneva, 2011. [4] Gütter S.P. Lean Practices in Pharmaceutical Manufacturing – An empirical investigation. Difo-Druck, Bamberg, 2014. [5] German Pharmaceutical Association. Pharma-Data 2016, 46th revised edition, October 2016. available online: http://www.bpi.de/daten-undfakten/pharmadaten/ (last checked: 01.06.2017). [6] Achanga, P., Shehab, E., Roy, R., Nelder G. Critical success factors for Lean implementation within SMEs. Journal of Manufacturing Technology Management. Vol. 17, No. 4 (2006) 460-471. [7] The Association of German Engineers (VDI). Guideline 2870-1 – Lean Production Systems – Basic principles, introduction and review. Beuth, Berlin, 2012. [8] Friedli, T. (editor). The Pathway to Operational Excellence in the Pharmaceutical Industry. Overcoming the internal inertia. Editio Cantor Verlag, Aulendorf, 2010. [9] Bellm, D. Operational Excellence in the Pharmaceutical Industry – An Architecture for Emerging Markets. The University of St. Gallen, St. Gallen, 2015. [10] Schuh, G., Riesener, M., Arnoscht, J. Critical Success Factors in Medium-sized Pharmaceutical Enterprises. Proceedings of the 5th ISPIM Innovation Symposium, Seoul, Korea. 9-12 December 2012, 1-15. [11] Smart, N. J. Lean biomanufacturing. Crating value through innovative bioprocessing approaches. Woodhead Publishing, Philadelphia, 2013. [12] Wilson L. How to Implement Lean Manufacturing. McGraw-Hill, New York, 2010. [13] Karim, A., Arif-Uz-Zaman, K. A methodology for effective implementation of Lean strategies and its performance evaluation in manufacturing organizations. Business Process Management Journal. Vol. 19, No. 1 (2013) 169-196.
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