Lean readiness – The case of the European pharmaceutical manufacturing industry

Purpose The purpose of this paper is to assess the quality practices of European pharmaceutical manufacturers to determine the level of readiness of this industrial sector to implement and/or sustain lean manufacturing (LM). Design/methodology/approach An assessment framework developed by Al‐Najem et al. (2013) was adapted to evaluate how ready European pharmaceutical manufacturers are to implement and/or sustain lean manufacturing. Therefore, the lean readiness (LR) level of these organisations was assessed through six quality practices related to LM. These included: processes; planning and control; human resources; top management and leadership; customer relations; and supplier relations. One research question and three hypotheses were formulated and tested using a combination of descriptive statistics and non-parametric Mann-Whitney tests. Data was collected through a survey questionnaire distributed to 310 European pharmaceutical manufacturers and responded by 37 of these organisations. Findings Overa...

[1]  John N. Pearson,et al.  Jit Manufacturing: a Survey of Implementations in Small and Large U.S. Manufacturers , 1999 .

[2]  Manoj Kumar Tiwari,et al.  Implementing the Lean Sigma framework in an Indian SME: a case study , 2006 .

[3]  M. Tawfik Mady,et al.  Quality management practices: An empirical investigation of associated constructs in two Kuwaiti industries , 2009 .

[4]  H. Magd.  An investigation of ISO 9000 adoption in Saudi Arabia , 2006 .

[5]  S. Helper.  How much has realliy changed between U.S. automakers and their suppliers , 1991 .

[6]  Jeffrey K. Liker,et al.  The Toyota way fieldbook : a practical guide for implementing Toyota's 4Ps , 2004 .

[7]  Charles R. Standridge,et al.  A simulation-enhanced lean design process , 2009 .

[8]  D. Keeling,et al.  Improving quality in pharma manufacturing , 2007 .

[9]  G. Anand,et al.  Development of a framework for lean manufacturing systems , 2009 .

[10]  A. Ghobadian,et al.  TQM and organization size , 1997 .

[11]  S. W. Carleysmith,et al.  Implementing Lean Sigma in Pharmaceutical Research and Development: A Review by Practitioners , 2009 .

[12]  Kimberly P. Ellis,et al.  Development and application of a worker assignment model to evaluate a lean manufacturing cell , 2009 .

[13]  Hendrik Van Landeghem,et al.  CHALLENGES AND SUCCESS FACTORS FOR IMPLEMENTATION OF LEAN MANUFACTURING IN EUROPEAN SMES , 2011 .

[14]  Suraj Choudhary,et al.  Assessing the application of Kaizen principles in Indian small-scale industry , 2015 .

[15]  Sanjay Bhasin,et al.  Performance of Lean in large organisations , 2012 .

[16]  N. Williams,et al.  ISO 9000 as a route to TQM in small to medium‐sized enterprises: snake or ladder? , 1997 .

[17]  K. Kirytopoulos,et al.  Supplier selection in pharmaceutical industry , 2008 .

[18]  Sherif Mostafa,et al.  A framework for lean manufacturing implementation , 2013 .

[19]  Tomás Bonavía,et al.  An empirical study of lean production in the ceramic tile industry in Spain , 2006 .

[20]  Jeffrey K. Liker,et al.  The Toyota way : 14 management principles from the world's greatest manufacturer , 2004 .

[21]  Dirk Van Goubergen,et al.  Application of lean practices in small and medium-sized food enterprises , 2014 .

[22]  Baba Md Deros,et al.  A survey on lean manufacturing implementation in Malaysian automotive industry , 2010 .

[23]  Thomas Friedli,et al.  Leading Pharmaceutical Operational Excellence , 2013 .

[24]  Jiju Antony,et al.  Assessing the status of six sigma implementation in the Indian industry: Results from an exploratory empirical study , 2009 .

[25]  Maneesh Kumar,et al.  Comparing the quality management practices in UK SMEs , 2008, Ind. Manag. Data Syst..

[26]  Taiichi Ohno,et al.  The Barriers to SMEs ’ Implementation of Lean Production and Countermeasures — — Based on SMEs in Wenzhou , 2014 .

[27]  Dirk Van Goubergen,et al.  Operational performance and critical success factors of lean manufacturing in European food processing SMEs , 2013 .

[28]  V. Gupta,et al.  A strategic and operational approach to assess the lean performance in radial tyre manufacturing in India , 2013 .

[29]  Daniel T. Jones,et al.  The machine that changed the world : based on the Massachusetts Institute of Technology 5-million dollar 5-year study on the future of the automobile , 1990 .

[30]  Isabel Maria Bodas Freitas.  THE DIFFUSION OF ISO 9000 AND ISO 14001 CERTIFICATION, CROSS SECTORAL EVIDENCE FROM EIGHT OECD COUNTRIES , 2009 .

[31]  G. Anand,et al.  Performance measurement system for lean manufacturing: a perspective from SMEs , 2008 .

[32]  Katarina Pavlović,et al.  LEAN AND SIX SIGMA CONCEPTS APPLICATION IN PHARMACEUTICAL INDUSTRY , 2011 .

[33]  Rose A.M.N.,et al.  LEAN MANUFACTURING BEST PRACTICES IN SMES , 2011 .

[34]  Maneesh Kumar,et al.  Six sigma in service organisations: Benefits, challenges and difficulties, common myths, empirical observations and success factors , 2007 .

[35]  Yen-Chun Jim Wu,et al.  LEAN MANUFACTURING: A PERSPECTIVE OF LEAN SUPPLIERS , 2003 .

[36]  Thomas Y. Choi,et al.  Building deep supplier relationships , 2004 .

[37]  S. R. Devadasan,et al.  Lean Six Sigma through ISO 9001 standard-based quality management system: an investigation for research , 2011 .

[38]  Roberto Panizzolo,et al.  Applying the lessons learned from 27 lean manufacturers.: The relevance of relationships management , 1998 .

[39]  Jose Arturo Garza-Reyes,et al.  Exploring the application of quality improvement programmes and ISO standards in the Indian marble mining sector , 2014 .

[40]  Carmen Escanciano,et al.  Influence of ISO 9000 certification on the progress of Spanish industry towards TQM , 2001 .

[41]  Katerina Gotzamani,et al.  An empirical study of the ISO 9000 standards’ contribution towards total quality management , 2001 .

[42]  Bengt Klefsjö,et al.  The machine that changed the world , 2008 .

[43]  Damian George,et al.  Improvement of manufacturing operations at a pharmaceutical company , 2011 .

[44]  Janet Houser.  Comprar Nursing Research. Reading, Using, And Creating Evidence | Janet Houser | 9781449631734 | Jones & Bartlett Publishers , 2011 .

[45]  Jose Arturo Garza-Reyes,et al.  The development of a lean park homes production process using process flow and simulation methods , 2012 .

[46]  Thomas Friedli,et al.  Analysis of the Implementation of Total Productive Maintenance, Total Quality Management, and Just-In-Time in Pharmaceutical Manufacturing , 2010, Journal of Pharmaceutical Innovation.

[47]  Jose Arturo Garza-Reyes,et al.  The impact of lean methods and tools on the operational performance of manufacturing organisations , 2014 .

[48]  R. Andersson,et al.  Similarities and differences between TQM, six sigma and lean , 2006 .

[49]  Peter Hasle,et al.  Lean and the working environment: a review of the literature , 2012 .

[50]  Mohamad Al-Najem,et al.  Lean readiness level within Kuwaiti manufacturing industries , 2013 .

[51]  N. Belavendram,et al.  The adoption of ISO 9000 and total quality management in Malaysia , 1996 .

[52]  P. Baker.  Aligning Distribution Center Operations to Supply Chain Strategy , 2004 .

[53]  Maria Elena Nenni,et al.  Improvement of Manufacturing Operations through a Lean Management Approach: A Case Study in the Pharmaceutical Industry , 2014 .

[54]  Rajkumar Roy,et al.  LEAN MANUFACTURING FOR SMES: ENABLING RAPID RESPONSE TO DEMAND CHANGES , 2005 .

[55]  R. Schroeder,et al.  Relationships between implementation of TQM, JIT, and TPM and manufacturing performance , 2001 .

[56]  Sanjiv Kumar Jain,et al.  Impacts of Kaizen in a small-scale industry of India: a case study , 2014 .

[57]  Janet Houser,et al.  Nursing Research: Reading, Using, and Creating Evidence , 2007 .

[58]  Hongyi Sun,et al.  Total quality management, ISO 9000 certification and performance improvement , 2000 .

[59]  Organisation for Economic Cooperation and Development,et al.  Organisation for economic cooperation and development , 1998 .

[60]  Dimitra Dodou,et al.  Five-Point Likert Items: t test versus Mann-Whitney-Wilcoxon , 2010 .

[61]  K. Langfield-Smith,et al.  Developing Co-operative Buyer–Supplier Relationships: A Case Study of Toyota , 1998 .

[62]  Federica Brunetta,et al.  Innovative Business Models in the Pharmaceutical Industry: A Case on Exploiting Value Networks to Stay Competitive , 2014 .

[63]  Su Mi Dahlgaard-Park,et al.  Lean Production, Six Sigma Quality, TQM and Company Culture , 2006 .

[64]  Pius Achanga,et al.  Critical success factors for lean implementation within SMEs , 2006 .

[65]  Toni L. Doolen,et al.  A review of lean assessment in organizations: An exploratory study of lean practices by electronics manufacturers , 2005 .

[66]  Sanjay Bhasin,et al.  Lean viewed as a philosophy , 2006 .

[67]  Peter T. Ward,et al.  Lean manufacturing: context, practice bundles, and performance , 2003 .

[68]  Susan K. Land,et al.  Applying Lean Six Sigma , 2008 .

[69]  Jose Arturo Garza-Reyes,et al.  Measuring lean readiness through the understanding of quality practices in the Turkish automotive suppliers industry , 2015 .

[70]  Giorgia Dal Pont,et al.  Complementarity and lean manufacturing bundles: an empirical analysis , 2011 .

[71]  Nilay Shah,et al.  Pharmaceutical supply chains: key issues and strategies for optimisation , 2004, Comput. Chem. Eng..

[72]  W. Andrew Taylor,et al.  Senior executives and ISO 9000 , 1995 .

[73]  C. Robson,et al.  Real World Research: A Resource for Social Scientists and Practitioner-Researchers , 1993 .

[74]  A. Sequeira,et al.  The Relationship between TQM Practices and Business Excellence in Small and Medium Sized Manufacturing Enterprises of North Karnataka Region , 2012 .

[75]  Geoffrey A. Lancaster,et al.  Research methods in management : a concise introduction to research in management and business consultancy , 2005 .

[76]  M. Sadiq Sohail,et al.  TQM practices and organizational performances of SMEs in Malaysia: Some empirical observations , 2003 .

[77]  Christer Karlsson,et al.  Change processes towards lean production , 1995 .

[78]  Rodolfo de Castro,et al.  Extent of the use of Lean concepts proposed for a value stream mapping application , 2009 .