BookAntonella Lanati.
Summary: In recent years, the attention of the scientific and social community has not solely been on producing new findings, but increasingly also on the related issues of the reliability, safety, and efficacy of the discoveries made, as well as the efficient and effective use of resources. The adoption of management models and tools can help scientists to improve their research, ensuring valuable, robust and dependable outcomes. Quality disciplines have been widely used for decades in industrial and business fields, building a knowledge base that can be translated and exploited, much to the advantage of scientific research. However, quality references in scientific research are still extremely rare and largely limited to an international guideline and a few sector-specific standards. Despite WHO and EU Commission campaigns, there are still precious few practical texts that offer researchers guidance on quality principles and provide simple tools and methodologies for their daily work. The book, starting from the problem of the reproducibility of scientific results and the substantial contribution that the Quality approach can make to research (Chapter 1), introduces the reader to key principles and basic concepts of Quality and illustrates both general and research-specific quality standards, paving the way for further discussion (Chapter 2). In turn, Chapter 3 presents detailed applications of Quality principles in various aspects of research, from study and ethics to materials and equipment management. Chapters 4 and 5, respectively, are devoted to Quality tools and Quality methodologies, as well as soft skills, all of which are valuable to scientific experimentation and study management. The concepts and practical tools discussed are extensively illustrated with examples from actual applications in scientific research.
Contents:
Intro; Foreword; Contents; Abbreviations;
1: Introduction; 1.1 Acknowledgements; 1.2 Permissions; References;
2: How Quality Can Improve Reproducibility; 2.1 The Unknown of Reproducibility; 2.1.1 Irreproducibility and Retractions; 2.1.2 The Economics of Poor Reproducibility; 2.1.3 Reasons and Solutions; 2.2 What Is Quality; 2.3 Quality for Research; 2.4 Research Integrity; References;
3: Principles, References and Standards; 3.1 Quality Basics; 3.2 Total Quality Management; 3.2.1 The Process Approach; 3.2.2 Principles; 3.2.3 PDCA Cycle; 3.2.4 The Requirements. 3.3 Quality Certification and Accreditation3.4 Quality Standards for Certification in Scientific Research; 3.4.1 ISO 9000; 3.4.2 Good Laboratory Practice; 3.4.3 ISO/IEC 17025; 3.4.4 Other References; References;
4: Quality and Basic Biomedical Research; 4.1 What Is Basic Biomedical Research; 4.2 Conscious Management; 4.3 Quality Throughout the Research Project; 4.3.1 Management of Study Contents and Controls; 4.3.1.1 Initial Requirements; 4.3.1.2 Controls and Metrics; 4.3.1.3 Documentation; 4.3.1.4 Training; 4.3.1.5 Communication; 4.3.1.6 Procurement. 4.3.2 Management of the Research Project4.3.2.1 Planning; 4.3.2.2 Executing and Measuring; 4.3.2.3 Exploiting; 4.3.2.4 The Importance of Planned Controls (Shannon Eaker); 4.4 International References and Models; 4.4.1 WHO-TDR Handbook on Quality Practices in Basic Biomedical Research; 4.4.2 Joint Code of Practice for Research: JCoPR (UK); 4.4.3 Research Quality Association Handbook and Guidelines; 4.4.4 Other Examples; 4.5 Quality Management in Basic Biomedical Research; 4.5.1 Organisation; 4.5.1.1 Quality Policy and Objectives; 4.5.1.2 Organisational Chart and Job Description. 4.5.2 Quality System4.5.2.1 Quality Assurance and Quality Control; 4.5.2.2 Research Reviews; 4.5.3 Personnel; 4.5.3.1 Responsibility; 4.5.3.2 Competence, Skills and Motivation; 4.5.4 Physical Resources; 4.5.4.1 Economics; 4.5.4.2 Facilities; 4.5.4.3 Equipment; 4.5.4.4 Products for the Research; 4.5.4.5 Computer Systems; 4.5.5 Validation; 4.5.5.1 Protocols and Assay Validation; 4.5.5.2 Result Validation; 4.5.6 Documentation; 4.5.6.1 Prescriptive Documents; 4.5.6.2 Descriptive Documents; 4.5.6.3 Study Report; 4.5.7 Storage and Archiving; 4.5.7.1 Data Archiving. 4.5.7.2 Sample Storage4.5.8 Health and Safety; 4.5.9 Publishing Practices; 4.5.10 Ethics; 4.6 Examples of Application; 4.6.1 Managing Research Resources in a Large Institute: The San Raffaele Experience (Daniele Zacchetti); 4.6.2 A QMS for a Life Sciences Research Laboratory and Its Related Management Software (the qPMO WP3 Team); 4.6.3 GLP as a Reference for Non-regulated Research (the MoBiLab Team); References;
5: Quality Tools for the Scientific Research; 5.1 Tools for Project and Process Quality; 5.2 7 Basic Tools of TQM; 5.2.1 Pareto Chart.