Skip to main content
SpringerLink
Log in

Critical Success Factors for Operational Excellence in the Pharmaceutical Industry: Insights from a Qualitative Study

  • Conference paper
  • First Online:
Lean, Green and Sustainability (ELEC 2022)

Part of the book series: IFIP Advances in Information and Communication Technology ((IFIPAICT,volume 668))

Included in the following conference series:

  • 465 Accesses

Abstract

The paper aims to investigate the Critical Success Factors that exist for Operational Excellence methodology deployment in the Pharmaceutical industry. The research will seek to establish the levels of current Operational Excellence awareness and integration in the Pharmaceutical industry in terms of the deployment of Continuous Improvement methodology. The study involves the analysis of the pros, cons, strengths, weaknesses, and limitations of management commitment for the application to the deployment of Continuous Improvement methodologies in the Pharmaceutical industry. A qualitative methodology was utilised by interviewing a cohort of 28 Pharmaceutical manufacturing Operational Excellence and Continuous Improvement practitioners. The study found that while participants advocated and supported the requirement and importance of Operational Excellence, a key Critical Success Factor identified was senior management support in fostering Operational Excellence culture. A top challenge highlighted for Operational Excellence and Continuous Improvement success, particularly in regulated industries, was a regulatory compliance culture and regulatory bureaucracy. The paper provides a valuable resource for organisations to obtain insight into Critical Success Factors for Continuous Improvement and Operational Excellence and in particular, in a regulated Pharmaceutical manufacturing industry.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 79.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 99.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Dale, B.G.: Sustaining a process of continuous improvement: definition and key factors. TQM Mag. 8(2), 49–51 (1996)

    Article  Google Scholar 

  2. Zollo, M., Winter, S.G.: Deliberate learning and the evolution of dynamic capabilities. Organ. Sci. 13(3), 339–351 (2002)

    Article  Google Scholar 

  3. Friedli,T., Bellm, D.: OPEX: a definition. In: Friedli, T., Basu, P., Bellm, D., Werani, J. (eds.) Leading Pharmaceutical Operational Excellence. Springer, Berlin, pp. 7–26 (2013). https://doi.org/10.1007/978-3-642-35161-7_2

  4. Irish Pharmaceutical Healthcare Association (IPHA), Code of Practice for the Pharmaceutical Industry, V8.5 (2021)

    Google Scholar 

  5. McDermott, O., Antony, J., Sony, M., Daly, S.: Barriers and enablers for continuous improvement methodologies within the Irish pharmaceutical industry. Processes 10(1), 73 (2022)

    Article  Google Scholar 

  6. Bunn, G.P.: Good Manufacturing Practices for Pharmaceuticals. CRC Press, Boca Raton (2019)

    Book  Google Scholar 

  7. Barney, J.: Firm resources and sustained competitive advantage. J. Manag. 17(1), 99–120 (1991)

    Google Scholar 

  8. Wit, B.D.: Strategy: an international perspective (2017)

    Google Scholar 

  9. Friedli, T., Kohler, S., Buess, P., Eichs, P.: FDA quality metrics research. University of St. Gallen Report #1, 1 November 2018

    Google Scholar 

  10. Friedli, T., Kohler, S., Buess, P., Eichs, P.: FDA Quality Metrics Research, (2) (2018a)

    Google Scholar 

  11. Antony, J., Kumar, A., Banuelas, R.: World Class Applications of Six Sigma, 1st edn. Butterworth-Heinemann, Oxford Burlington MA (2006)

    Book  Google Scholar 

  12. Chatterjee, B.: Applying Lean Six Sigma in the Pharmaceutical Industry. Routledge, Milton Park (2016)

    Book  Google Scholar 

  13. Witcher, M.F.: Integrating development tools into the process validation lifecycle to achieve six sigma pharmaceutical quality. BioProcess. J. 17 (2018)

    Google Scholar 

  14. McDermott, O., Antony, J., Sony, M., Healy, T.: Critical failure factors for continuous improvement methodologies in the Irish MedTech industry. TQM J. 34(7), 18–38 (2022). https://doi.org/10.1108/TQM-10-2021-0289

    Article  Google Scholar 

  15. Mauri, F., Garetti, M., Gandelli, A.: A structured approach to process improvement in manufacturing systems. Prod. Plan. Control 21(7), 695–717 (2010)

    Article  Google Scholar 

  16. Brown, A., Eatock, J., Dixon, D., Meenan, B.J., Anderson, J.: Quality and continuous improvement in medical device manufacturing. TQM J. 20, 541–555 (2008)

    Article  Google Scholar 

  17. Moore, S.: Next generation medical device manufacture: a strategic assessment. J. Enterp. Excell1 (2016)

    Google Scholar 

  18. Hines, P., Butterworth, C.: The Essence of Excellence: Creating a Culture of Continuous Improvement, 1st edn. SA Partners, Caerphilly (2019)

    Google Scholar 

  19. Åhlström, P., et al.: Is lean a theory? Viewpoints and outlook. Int. J. Oper. Prod. Manag. (2021)

    Google Scholar 

  20. Willmott, P., Quirke, J., Brunskill, A.: TPM: A Foundation of Operational Excellence.1st ed. Caerphilly (2019)

    Google Scholar 

  21. Bajaj, V., Reffell, B.: Research Report 2019/2020: The Global State of Operational Excellence. An Exclusive Business Transformation and Operational Excellence World Sumit (BTOES): Critical Challenges and Future Trends, (2020)

    Google Scholar 

  22. Bernhard, G.: Lean manufacturing in a high containment environment. Innovations in Pharmaceutical Technology, pp. 74–76 (2010)

    Google Scholar 

  23. Falco, L.: Deploying standard work in the lab. American Pharmaceutical Review, pp. 1–9 (2015)

    Google Scholar 

  24. Antony, J., et al.: An empirical study into the reasons for failure of sustaining operational excellence initiatives in organizations. TQM J., January 2022. https://doi.org/10.1108/TQM-05-2022-0176.

  25. Chandrasekaran, A., Toussaint, J.: Creating a culture of continuous improvement. Harvard Bus. Rev. 5(24), 2–5 (2019)

    Google Scholar 

  26. Huang, S.-J., Wu, M.-S., Chen, L.-W.: Critical success factors in aligning IT and business objectives: a Delphi study. Total Qual. Manage. Bus. Excellence 24(9–10), 1219–1240 (2013)

    Article  Google Scholar 

  27. Shahin, M., Babar, M.A., Zhu, L.: Continuous integration, delivery and deployment: a systematic review on approaches, tools, challenges and practices. IEEE Access 5, 3909–3943 (2017)

    Article  Google Scholar 

  28. McDermott, O., Antony, J., Douglas, J.: Exploring the use of operational excellence methodologies in the era of COVID-19: perspectives from leading academics and practitioners. TQM J. 33(8), 1647–1665 (2021). https://doi.org/10.1108/TQM-01-2021-0016

    Article  Google Scholar 

  29. McDermott, O., Antony, J.: Lean six sigma as an enabler for healthcare operational excellence in COVID-19. In: Six Sigma for Healthcare & Leadership, Purdue University, Indiana, 26–27 June. https://docs.lib.purdue.edu/iclss/2021/hl/3.

  30. Mathiyazhagan, K., Gnanavelbabu, A., Agarwal, V.: A framework for implementing sustainable lean manufacturing in the electrical and electronics component manufacturing industry: an emerging economies country perspective. J. Cleaner Prod. 334, 130169 (2022)

    Article  Google Scholar 

  31. McGrane, V., McDermott, O., Trubetskaya, A., Rosa, A., Sony, M.: The effect of medical device regulations on deploying a lean six sigma project. Processes 10(11), 2303 (2022)

    Article  Google Scholar 

  32. Trubetskaya, A., Manto, D., McDermott, O.: A review of lean adoption in the Irish MedTech Industry. Processes 10(2), February 2022. Art. no. 2. https://doi.org/10.3390/pr10020391.

  33. Byrne, B., McDermott, O., Noonan, J.: Applying lean six sigma methodology to a pharmaceutical manufacturing facility: a case study. Processes 9(3), 550 (2021). https://doi.org/10.3390/pr9030550

    Article  Google Scholar 

  34. Forza, C.: Survey research in operations management: a process-based perspective. Int. J. Oper. Prod. Manag. (2002)

    Google Scholar 

  35. Charmaz, K., Belgrave, L.: Qualitative interviewing and grounded theory analysis. SAGE Handb. Interview Res. Complex. Craft 2, 347–365 (2012)

    Article  Google Scholar 

  36. Denzin, N.K., Lincoln, Y.S.: Introduction: the discipline and practice of qualitative research (2008)

    Google Scholar 

  37. Punch, K.F.: Introduction to Social Research: Quantitative and Qualitative Approaches. Sage, Newcastle upon Tyne (2013)

    Google Scholar 

  38. Kanyesigye, S.T., Uwamahoro, J., Kemeza, I.: Data collected to measure the impact of problem-based learning and document physics classroom practices among Ugandan secondary schools. Data Brief 44, 108534 (2022)

    Article  Google Scholar 

  39. Unkelos-Shpigel, N., Sherman, S., Hadar, I.: Finding the missing link to industry: LinkedIn professional groups as facilitators of empirical research. In: Presented at the 2015 IEEE/ACM 3rd International Workshop on Conducting Empirical Studies in Industry, pp. 43–46 (2015)

    Google Scholar 

  40. Polit, D.F., Beck, C.T.: Nursing Research: Generating and Assessing Evidence for Nursing Practice. Lippincott Williams & Wilkins, Philadelphia (2008)

    Google Scholar 

  41. Morrow, R., Rodriguez, A., King, N.: Colaizzi’s descriptive phenomenological method. Psychologist 28(8), 643–644 (2015)

    Google Scholar 

  42. McMullen, J.S.: Perspective taking and the heterogeneity of the entrepreneurial imagination. In: What is so Austrian about Austrian economics? Emerald Group Publishing Limited (2010)

    Google Scholar 

  43. Davis, M.H.: Measuring individual differences in empathy: evidence for a multidimensional approach. J. Pers. Soc. Psychol. 44(1), 113 (1983)

    Article  Google Scholar 

  44. Khan, S.N.: Qualitative research method-phenomenology. Asian Soc. Sci. 10(21), 298 (2014)

    Article  Google Scholar 

  45. Clarke, V., Braun, V.: Thematic analysis. J. Positive Psychol. 30(5), 385–399 (2016)

    Google Scholar 

  46. Muazu, M.H., Tasmin, R.: Operational excellence in manufacturing, service and the oil & gas: the sectorial definitional constructs and risk management implication. Traektoriâ Nauki= Path of Sci. 3(9) 3001–3008 (2017)

    Google Scholar 

  47. Raghunath, A., Jayathirtha, R.: Critical success factors for six sigma implementation by SMEs. Int. J. Sci. Eng. Res. 4(2), 1–7 (2013)

    Google Scholar 

  48. Edgeman, R.: Excellence models as complex management systems: an examination of the Shingo operational excellence model. Bus. Process Manag. J. 24(6), 1321–1338 (2018)

    Article  Google Scholar 

  49. Kelly, S., Hines, P.: Discreetly embedding the Shingo principles of enterprise excellence at Abbott diagnostics manufacturing facility in Longford Ireland. Total Q. Manage. Bus. Excellence 30(11–12), 1235–1256 (2019)

    Article  Google Scholar 

  50. Carvalho, M., Sá, J.C., Marques, P.A., Santos, G., Pereira, A.M.: Development of a conceptual model integrating management systems and the Shingo model towards operational excellence. Total Q. Manage. Bus. Excellence, 1–24 (2022)

    Google Scholar 

  51. Collins, J.C., Porras, J.I.: Building your company’s vision. Harvard Bus. Rev. 74(5), 65 (1996)

    Google Scholar 

  52. McDermott, O., Antony, J., Sony, M., Looby, E.: A critical evaluation and measurement of organisational readiness and adoption for continuous improvement within a medical device manufacturer, 1–11, May 2022. https://doi.org/10.1080/17509653.2022.2073917

Download references

Author information

Authors and Affiliations

  1. School of Engineering, University of Limerick, Limerick, Ireland

    Elizabeth O’Callaghan & Mark Southern

  2. College of Science and Engineering, University of Galway, Galway, Ireland

    Olivia McDermott

  3. School of Chemical Sciences, Bernal Institute, University of Limerick, Limerick, Ireland

    Elizabeth O’Callaghan, Gavin Walker & Mark Southern

Authors
  1. Elizabeth O’Callaghan
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Olivia McDermott
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Gavin Walker
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Mark Southern
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Elizabeth O’Callaghan .

Editor information

Editors and Affiliations

  1. University of Galway, Galway, Ireland

    Olivia McDermott

  2. LUM University "Giuseppe Degennaro", Casamassima, Italy

    Angelo Rosa

  3. Instituto Superior de Engenharia do Porto, Porto, Portugal

    José Carlos Sá

  4. University of Galway, Galway, Ireland

    Aidan Toner

Ethics declarations

The authors declare no conflict of interest.

Rights and permissions

Reprints and permissions

Copyright information

© 2023 IFIP International Federation for Information Processing

About this paper

Check for updates. Verify currency and authenticity via CrossMark

Cite this paper

O’Callaghan, E., McDermott, O., Walker, G., Southern, M. (2023). Critical Success Factors for Operational Excellence in the Pharmaceutical Industry: Insights from a Qualitative Study. In: McDermott, O., Rosa, A., Sá, J.C., Toner, A. (eds) Lean, Green and Sustainability. ELEC 2022. IFIP Advances in Information and Communication Technology, vol 668. Springer, Cham. https://doi.org/10.1007/978-3-031-25741-4_17

Download citation

  • DOI: https://doi.org/10.1007/978-3-031-25741-4_17

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-031-25740-7

  • Online ISBN: 978-3-031-25741-4

  • eBook Packages: Computer ScienceComputer Science (R0)

Publish with us

Policies and ethics

Societies and partnerships

Search

Navigation