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Quality Methods for the Scientific Research

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Quality Management in Scientific Research
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Abstract

This chapter is devoted to illustrating some methods and techniques for specific topics, starting from an overview of the project management discipline and related tools, to plan, execute, control, document and close a project. The failure mode and effect analysis (FMEA) is then illustrated to provide the reader with a method of risk assessment and error prevention for a process. The design of experiment (DoE), a statistical method for planning experimental activities, can give the researcher a means to optimally plan experiments, extract more information from data, strengthen the analysis of results and at the same time reduce the resources required. Two methods borrowed from industry, which are very promising but still at the beginning of their exploitation in scientific research, are then illustrated: lean management and six sigma. For each method, examples of application to scientific research are provided.

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Notes

  1. 1.

    See Chap. 4, Sect. 4.5.2.2.

  2. 2.

    Automotive Industry Action Group: AIAG.org.

  3. 3.

    Project & Quality Manager at Blast Research, and Working Group Coordinator at Associazione Farmaceutici Industria.

  4. 4.

    AFI (Associazione Farmaceutici Industria—Scientific Society) is a cultural, professional and scientific association of graduates in scientific disciplines, drawn from many specialties within daily pharmaceutical practice such as manufacturing, quality control, quality assurance, research and development, engineering, regulatory affairs, marketing, general management and academia ( http://www.afiscientifica.it/all/AFI INGLESE.PDF last accessed Aug.4th 2017).

  5. 5.

    For the difference between technical and biological replicates, see [10].

  6. 6.

    See [11] for further details.

  7. 7.

    The normal probability plot is generated from the coefficients of the regression model that for the general factorial design is substituted by an evaluation of means of levels.

  8. 8.

    See [12] for further details.

  9. 9.

    Professor of Pharmaceutical Technology, University of Piemonte Orientale, Italy.

  10. 10.

    For example, see [9].

  11. 11.

    See EP2457088 patent for more details.

  12. 12.

    Professor of Pharmaceutical Technology, University of Piemonte Orientale, Italy.

  13. 13.

    As an example, the application of Lean Thinking in the Washington State Government offices, see [13].

  14. 14.

    This is one of the most specific concepts of Lean: Customer requirements drive the production pace, which is optimised to respond as quickly as possible to customer requests, instead of producing on estimates and storing it in warehouse awaiting for customer’s order.

  15. 15.

    A workplace with reduced production capacity, which slows down the production flow, is called bottleneck.

  16. 16.

    T. Barnhart refers to experimental results reported by T. Amabile in [17].

References

  1. A Guide to the Project Management Body of Knowledge (PMBOK® Guide). Project Management Institute (PMI). 2017.

    Google Scholar 

  2. ISO 21500:2012 guidance on project management.

    Google Scholar 

  3. IEC 60812:2006. Analysis techniques for system reliability—procedure for failure mode and effects analysis (FMEA).

    Google Scholar 

  4. AIAG. Potential failure mode and effects analysis (FMEA). 2008.

    Google Scholar 

  5. SAE J1739 potential failure mode and effects analysis in design (Design FMEA), Potential failure mode and effects analysis in manufacturing and assembly processes (Process FMEA). 2009.

    Google Scholar 

  6. Lanati A, et al. A design of experiment approach to optimize an image analysis protocol for drug screening. In: Zazzu V, Ferraro MB, Guarracino MR, editors. Mathematical models in biology. Heidelberg: Springer; 2015. p. 65–84.

    Chapter  Google Scholar 

  7. Mancinelli S, et al. Applying design of experiments methodology to PEI toxicity assay on neural progenitor cells. In: Zazzu V, Ferraro MB, Guarracino MR, editors. Mathematical models in biology. Heidelberg: Springer; 2015. p. 45–63.

    Chapter  Google Scholar 

  8. Antony J. Design of experiments for engineers and scientists. Amsterdam: Elsevier Science & Technology Books; 2003.

    Google Scholar 

  9. Montgomery D. Design and analysis of experiments. 8th ed. New York: Wiley; 2012.

    Google Scholar 

  10. Wang H. [Bio-Glossary]. Biological replicates vs technical replicates. 2012. https://honglangwang.wordpress.com/2012/04/24/%E3%80%90bio-glossary%E3%80%91biological-replicates-vs-technical-replicates/. Accessed 15 Sep 2017.

  11. Anderson MJ, Whitcomb PJ. DOE simplified: practical tools for effective experimentation. 3rd ed. Boca Raton: CRC Press; 2015.

    Book  Google Scholar 

  12. FDA. Guidance for industry. 2012. https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm313087.htm. Accessed 31 Oct 2017.

  13. Washington State: lean in Washington. 2013. http://www.results.wa.gov/what-we-do/lean-washington. Accessed 15 Sep 2017.

  14. Schweikhart SA, Dembe AE. The applicability of lean and six sigma techniques to clinical and translational research. J Investing Med. 2009;57(7):748–55. https://doi.org/10.2310/JIM.0b013e3181b91b3a.

    Article  Google Scholar 

  15. Womack JP, Jones DT, Roos D. The machine that changed the world. New York: Free Press; 1990.

    Google Scholar 

  16. Barnhart T. Creating a lean R&D system. Boca Raton: CRC Press; 2013.

    Google Scholar 

  17. Amabile T. The progress principle: using small wins to ignite joy, engagement and creativity at work. Brighton: Harvard Business Review Press; 2011.

    Google Scholar 

  18. Siemens Healthcare: pursuing perfection through continuous improvement—an introduction to lean healthcare principles. 2015. https://static.healthcare.siemens.com/siemens_hwem-hwem_ssxa_websites-context-root/wcm/idc/groups/public/@global/@lab/@corelab/documents/download/mda1/ntgz/~edisp/a91dx-cai-151464-gc1-4a00_final-02556006.pdf. Accessed 15 Sep 2017.

  19. Reynolds T. Leaning toward lean? 2010. http://www.labmanager.com/lab-design-and-furnishings/2010/07/leaning-toward-lean-#.WbueR8hJbIU. Accessed 15 Sep 2017.

  20. iSixSIgma: six sigma costs and savings—the financial benefits of implementing six sigma at your company can be significant. 2008. https://www.isixsigma.com/implementation/financial-analysis/six-sigma-costs-and-savings/. Accessed 15 Sep 2017.

  21. Carleysmith SW, Dufton AM, Altria KD. Implementing lean sigma in pharmaceutical research and development: a review by practitioners. R&D Manag. 2009;39(1):95–106.

    Article  Google Scholar 

  22. Hollensead SC, Lockwood WB, Elin RJ. Errors in pathology and laboratory medicine: consequences and prevention. J Surg Oncol. 2004;88:161–18.

    Article  PubMed  Google Scholar 

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Lanati, A. (2018). Quality Methods for the Scientific Research. In: Quality Management in Scientific Research. Springer, Cham. https://doi.org/10.1007/978-3-319-76750-5_6

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