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Applying Quality and Project Management methodologies in biomedical research laboratories: a public research network’s case study

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Abstract

Quality principles and Project Management (PM) methodologies have long been ignored in non-regulated scientific research, even though they have been widely used in industrial and business applications, improving management and results and reducing costs. A groundbreaking project named Quality and Project Management OpenLab was implemented by a network of Italian National Research Council institutes, with the aim to realize and disseminate within the scientific community an innovative way to plan and organize research activity, inspired by Quality and PM principles and customized for needs and requisites of biomedical research laboratories. The results show better use of time and project consistency. Our experience of working side by side with Quality consultants clearly shows that the proper and accurate application of Quality and PM methodologies to intellectual and scientific production can facilitate and strengthen research, providing tools to make it faster and more efficient without imposing any undue constraints.

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Abbreviations

DoE:

Design of experiment

FMEA:

Failure mode and effect analysis

GLP:

Good laboratory practice

GMP:

Good manufacturing practice

ICH:

International Conference on Harmonization

ICT:

Information and Communication Technology

PDCA:

Plan–do–check–act

PM:

Project Management

QMS:

Quality Management System

qPMO:

Quality and Project Management

TQM:

Total Quality Management

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Acknowledgments

The authors wish to thank Giuseppe Martini for encouraging the formation of the qPMO network and his deep trust in Quality principles for biological research. Special thanks also go to Stella Zannini, for her comments and discussions. We also thank Loredana Riccobono, Alessandro Pensato, and Luca Caruana for technical support in QMS development, Sara Mancinelli and Valeria Zazzu for DoE application and validation, Romeo Prezioso for Web platform management, and Richard Burket for editing the manuscript. The present studies have been supported by the Italian Ministry of Economy and Finance (CNR-Project FaReBio Farmaci e Reti Biotecnologiche di Qualità) and from the FONDAZIONE CON IL SUD (Grant 2011-PDR-13) (to GLL). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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    Authors and Affiliations

    1. Institute of Biomedicine and Molecular Immunology “A. Monroy” (IBIM), Consiglio Nazionale delle Ricerche (CNR), 90146, Palermo, Italy

      Antonella Bongiovanni & Marta Di Carlo

    2. Institute of Molecular Biology and Pathology (IBPM), Consiglio Nazionale delle Ricerche (CNR), 00185, Rome, Italy

      Gianni Colotti

    3. Institute of Genetics and Biophysics “Adriano Buzzati-Traverso” (IGB), Consiglio Nazionale delle Ricerche (CNR), 80131, Naples, Italy

      Giovanna Lucia Liguori, Giuseppina Lacerra & Adriano Barra

    4. Institute of Experimental Endocrinology and Oncology “G. Salvatore” (IEOS), Consiglio Nazionale delle Ricerche (CNR), 80131, Naples, Italy

      Anna Mascia, Anna Maria Cirafici & Annamaria Kisslinger

    5. Institute of Biosciences and BioResources (IBBR), Consiglio Nazionale delle Ricerche (CNR), 80131, Naples, Italy

      Filomena Anna Digilio

    6. Valore Qualità, 27100, Pavia, Italy

      Antonella Lanati

    Authors
    1. Antonella Bongiovanni
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    2. Gianni Colotti
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    3. Giovanna Lucia Liguori
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    4. Marta Di Carlo
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    5. Filomena Anna Digilio
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    7. Anna Mascia
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    8. Anna Maria Cirafici
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    9. Adriano Barra
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    10. Antonella Lanati
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    11. Annamaria Kisslinger
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    Corresponding authors

    Correspondence to Antonella Lanati or Annamaria Kisslinger.

    Additional information

    Antonella Bongiovanni, Gianni Colotti and Giovanna Lucia Liguori have contributed equally to this work.

    AL and AK share senior coauthorship.

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    Bongiovanni, A., Colotti, G., Liguori, G.L. et al. Applying Quality and Project Management methodologies in biomedical research laboratories: a public research network’s case study. Accred Qual Assur 20, 203–213 (2015). https://doi.org/10.1007/s00769-015-1132-5

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