CORBEL Quality Management Webinar Slides

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Quality Management enables organisations to deliver value by fulfilling the needs and expectations of relevant interested parties. Research infrastructures are user and service oriented organisations, hence quality management systems can help them to identify quality objectives and to identify the processes and resources required to meet them. Many of the relatively new European-level research infrastructures in the area of biomedical, social and environmental sciences, but also in other research disciplines, are organised as distributed research infrastructures. This brings about specific requirements and challenges when it comes to implementing quality management systems. This webinar will address some of these specific requirements and challenges. It will be a great introduction for people interested in attending the CORBEL Quality Management Exchange of Experience Workshop which will take place on June 18-19, 2018 in Freising, Germany, organised by the INFRAFRONTIER GmbH. Alternatively, the webinar is a stand-alone introduction to quality management with an emphasis on distributed Research Infrastructures. CORBEL (http://www.corbel-project.eu) is an initiative of eleven new biological and medical research infrastructures (BMS RIs), which together will create a platform for harmonised user access to biological and medical technologies, biological samples and data services required by cutting-edge biomedical research. CORBEL will boost the efficiency, productivity and impact of European biomedical research. This webinar took place on 22nd May 2018 and is part of the CORBEL webinar series. A recording of the webinar is available through the CORBEL website: http://www.corbel-project.eu/webinars/quality-management-in-distributed-research-infrastructures.html For previous and upcoming CORBEL webinars see: http://www.corbel-project.eu/webinars
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  • 1. Quality Management in distributed Research Infrastructures Presenters: Dr Michael Raess (INFRAFRONTIER) Host:Vera Matser (EMBL-EBI) 24/05/2018footer 1 CORBEL Webinar Series http://www.corbel-project.eu/webinars
  • 2. 24/05/2018footer 2 This webinar is being recorded
  • 3. AUDIENCE Q&A SESSION 24/05/2018footer 3 Please write your questions in the questions window of the GoToWebinar application
  • 4. BACKGROUND 4 Since 2015, thirteen ESFRI Research Infrastructures from the field of BioMedical Science (BMS RI) joined their scientific capabilities and services to transform the understanding of biological mechanisms and accelerate its translation into medical care. • biobanking & biomolecular resources • curated databases • marine model organisms • systems biology • translational research • functional genomics • screening & medicinal chemistry • microorganisms • clinical trials • structural biology • biological/medical imaging• plant phenotyping • highly pathogenic microorganisms
  • 5. CORBEL MISSION 5 Modern biological and biomedical research involves complex projects and a variety of different technologies. Some of the most important discoveries are made at the interface between different disciplines. CORBEL will harmonise access and services for complex research projects involving more than one RI that offer: • biological and medical technologies • biological samples and • data services
  • 6. TODAY’S PRESENTERS 24/05/2018footer 6 Dr. Michael Raess, biologist and research manager.After his PhD and a postdoc position in the field of behavioral physiology at Max-Planck he changed in 2008 to the Helmholtz Zentrum München as lead project manager for the INFRAFRONTIER Preparatory Phase and head of the INFRAFRONTIER Project Office. INFRAFRONTIER is the European Research Infrastructure for the development, phenotyping, archiving, and distribution of model mammalian genomes. In 2010 he received a MSc degree in „ScienceCommunications and Marketing“ of theTechnical University in Berlin. Since 2014 he is Head of General Management of the INFRAFRONTIER GmbH, the management and coordination unit of the INFRAFRONTIER Research Infrastructure. Michael Raess is leading theWP5 - Common access solutions in the CORBEL project and is chairing the CORBEL Quality Management Expert Network.
  • 7. www.infrafrontier.eu Quality management in distributed research infrastructures Michael Raess, 22 May 2018
  • 8. www.infrafrontier.eu • Some basic quality management concepts • Implementation of a QMS in a distributed research infrastructure  Example of the INFRAFRONTIER Research Infrastructure • Specific aspects of QM in a distributed research infrastructure • CORBEL activities for QM capacity building Webinar contents
  • 9. www.infrafrontier.eu • Deliver value through fulfilling the needs and expectations of customers and other relevant interested parties (includes regulatory compliance) • Determined by the ability to satisfy customers and the impact on relevant interested parties • Not only the intended function and performance of products and services, but also their perceived value and benefit Quality
  • 10. www.infrafrontier.eu • Business philosophy that champions the idea that the long- term success of a company comes from customer satisfaction • Quality management is the act of overseeing all activities and tasks needed to maintain a desired level of excellence. • This includes the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. Quality Management
  • 11. www.infrafrontier.eu Quality Management Requirements of Customers, Market Organisation Employees, Knowledge, Finance, Infrastructure Financial Output Customer Satisfaction and Advantage Business Approach QM Approach
  • 12. www.infrafrontier.eu • Quality: Compliance to agreed requirements and specifications, subjective, delivers value • Quality Assurance: Ensuring compliance (of products/services), part of Quality Management • Quality Management: Management tool, covers all relevant business processes in order to reach the quality goals Some terminology
  • 13. www.infrafrontier.eu • Comprises activities by which the organisation identifies its quality objectives and determines the processes and resources required • Manages interacting processes and resources to provide value • Enables top management to optimise the use of resources • Provides means to identify actions to address consequences and to ensure continual improvement Quality Management System
  • 14. www.infrafrontier.eu INFRAFRONTIER is the Europen Research Infrastructure for the generation, phenotyping, archiving and distribution of mammalian models
  • 15. www.infrafrontier.euwww.infrafrontier.eu Why mouse? Current Biology Studying human diseases using mice Mouse model for c-KIT associated piebaldism
  • 16. www.infrafrontier.eu INFRAFRONTIER Resources and Services www.infrafrontier.eu Archiving / Distribution Systemic Phenotyping Model Development EMMA Repository Mouse Clinics Trans- genics Training & Consulting Axenic Services NKI Cancer Models Distributed research infrastructure – one face to the customer
  • 17. Archive Size 3rd largest mouse repository world-wide Annual Requests World-wide user community of INFRAFRONTIER
  • 18. www.infrafrontier.eu International Mouse Phenotyping Consortium • First comprehensive catalogue of mammalian gene function • An engine for discovering the genetic basis for disease • Open access to data and resources • Access to positive and negative results INFRAFRONTIERPartners
  • 19. www.infrafrontier.eu • Increased efficiency and reliability by coordination and standardisation of procedures and resources, transparent processes, preservation of knowledge • Increased trust in INFRAFRONTIER by partners, users, agencies, and authorities • Increased visibility: Approved QMS as “label of excellence” for the research infrastructure  Sustainability! Why QM in INFRAFRONTIER?
  • 20. www.infrafrontier.eu • Analyse the organisational context • Define scope, choose a fitting QM approach • Define the quality strategy / policy • Identify and describe the relevant processes • Define the quality goals • Plan – Do – Check – Act • Improve! Implementing a QMS
  • 21. www.infrafrontier.eu • Determine organisation‘s purpose including its vision, mission, policies and objectives • Identify factors which influence the organization‘s purpose, objectives and sustainability • Consider internal factors like values, culture, knowledge and performance of the organization as well as external factors such as legal, competitive, social and economic environment Context of an organisation
  • 22. www.infrafrontier.eu Distributed research infrastructures • Hubs and nodes • provide different kinds of services • may provide services to different interested parties • may have different requirements in terms of QM • Nodes may have further developed QMS than hubs • Different nodes may have different QMS in place • Different levels of regulatory frameworks
  • 23. www.infrafrontier.eu
  • 24. www.infrafrontier.eu Quality Management in distributed RIs Requirements of Customers, Market Organisation Employees, Knowledge, Finance, Infrastructure Financial Output Customer Satisfaction and Advantage Business Approach QM Approach
  • 25. www.infrafrontier.eu • National and international regulations; e.g. GxP (Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice) • International standards DIN EN ISO; e.g. 9000f (management systems), 17025 (laboratories), 13485 (medicinal devices) • Total Quality Management Concepts ; e.g. EFQM Excellence Model (European Foundation of Quality Management) • Others: Six Sigma, etc ... Quality Management – Common Approaches
  • 26. www.infrafrontier.eu GMP: Good Manufacturing Practice • for medicinal products for human (and veterinary) use. • Legal framework (EU): Commission Directive 2003/94/EC. Detailed guidance: European GMP Guidelines (Eudralex Volume 4 "The rules governing medicinal products in the European Union"). Inspections to verify compliance by national authorities as coordinated by EMA. GCP: Good Clinical Practice • Ethical and scientific quality standard for conduction of clinical trials • Legal framework (EU): ´Clinical Trial Directive´ 2001/20/EC (to be replaced by EU No 536/2014), GCP Directive 2005/28/EC. Guideline for good clinical practice: ICH E6(R2) - EMA/CHMP/ICH/135/1995 GLP: Good Laboratory Practice • for non-clinical health and environmental safety studies (e.g. non-clinical safety, toxicological and pharmacological studies) • Legal framework (EU): Directive 2004/9/EC, Directive 2004/10/EC QxP
  • 27. www.infrafrontier.eu International standard Focused on consistent delivery of products / services that meet requirements of customers and relevant interested parties. Aims to enhance customer satisfaction. ISO EN 9001
  • 28. www.infrafrontier.eu • European Model. • Focused on an overall quality approach (TQM), a journey to excellence. All stakeholders are taken into account. • Covers all business processes. EFQM Excellence Model
  • 29. www.infrafrontier.eu Strategy development
  • 30. www.infrafrontier.eu Strategy development & Quality management Quality Policy PDCA Relevant processes Quality goals
  • 31. www.infrafrontier.eu Strategy development & Quality management Quality Policy PDCA Relevant processes Quality goals
  • 32. www.infrafrontier.eu Quality Policy
  • 33. www.infrafrontier.eu Process Approach Management Processes Core / Realization Processes Support Processes ContextofOrganization ContinualImprovement InterestedParties-Satisfaction InterestedParties-Requirements
  • 34. www.infrafrontier.eu Process Approach Main Questions: Who are your customers / to whom do you provide services? Partners? Biomedical Research Community? Others? What do they expect from you / what are their requirements? => Core processes Identification of Core/Realization Processes, i.e. customer related processes Process Approach
  • 35. www.infrafrontier.eu Process Approach
  • 36. www.infrafrontier.eu Turtle model Process definition Input OutputProcess With what? With whom? How?  Requirements   Requirements  Results? • Training • Knowledge • Abilities • Performance indicators • Equipment • Installations • Instructions • Procedures • Methods
  • 37. www.infrafrontier.eu Quality Goals Quality Policy Quality Goal Performance figure Target value Clear Achievable Measureble
  • 38. www.infrafrontier.eu • Analyse the organisational context • Define scope, choose a fitting QM approach • Define the quality strategy / policy • Identify and describe the relevant processes • Define the quality goals • Plan – Do – Check – Act • Improve! Implementing a QMS
  • 39. www.infrafrontier.eu PDCA cycle Continuous improvement
  • 40. www.infrafrontier.eu QM in distributed research infrastructures • Hubs and nodes • provide different kinds of services • may provide services to different interested parties • may have different requirements in terms of QM • Nodes may have further developed QMS than hubs • Different nodes may have different QMS in place • Different levels of regulatory frameworks
  • 41. www.infrafrontier.eu QM Expert Network in CORBEL
  • 42. www.infrafrontier.eu QM Expert Network in CORBEL
  • 43. www.infrafrontier.eu • Continuous development of community standards and references is a core activity of the BMS RIs • BMS RIs endorse the methodologies and underlying mindset of quality management • BMS RIs offer a wide portfolio of resources and services  no one-size-fits-all solution for quality management • BMS RIs share a core set of QM principles: BMS QM Framework
  • 44. www.infrafrontier.eu 1. Standardisation is the basis for reproducible and traceable results in science  important role in cataloguing, developing, improving and widely disseminating community standards 2. Application of quality management methodology  highest-quality services and data  highest- quality science 3. Open access to research data is an important quality measure 4. Independent assessment by a competent authority is the gold standard for quality assurance 5. Use internationally recognised standards and best practices where applicable. Actively engage in the development of internationally recognised standards where appropriate 6. Pooling best-practice examples and guidelines in a shared resource 7. Importance of training of quality management methodology for research infrastructures and their users 8. Importance to create awareness and appraisal for quality management  clearly communicating how QM contributes to improving the biomedical research outputs BMS QM Framework – Core principles
  • 45. www.infrafrontier.eu • 18-19 June in Freising, near the Munich Airport • Topics: • Quality management in distributed research infrastructures • Quality management and data and service management • Opportunities for QM staff visits / staff exchanges • Deep-drilling parallel sessions: 1. International standards development 2. Updating to ISO EN 9001:2015 3. Self-assessment versus external assessment Registration open! CORBEL QM Exchange of Experience Workshop
  • 46. www.infrafrontier.eu CORBEL QM Exchange of Experience Workshop
  • 47. www.infrafrontier.eu • Information on the CORBEL Quality Management Exchange of Experience Workshop on 18-19 June 2018: https://www.infrafrontier.eu/infrafrontier-research- infrastructure/public-relations/corbel-quality-management- exchange-experience • A framework for quality management in the biomedical research infrastructures (BMS RIs): https://zenodo.org/record/834333 Links
  • 48. Questions? Quality Management in distributed Research Infrastructures Presenter: Dr Michael Raess (INFRAFRONTIER) 24/05/2018footer 34 Please write your questions in the questions window of the GoToWebinar application
  • 49. NEXT WEBINAR footer 52 Title: Status Update on the Code of Conduct for Health Research Initiative Speaker: MichaelaTh. Mayrhofer (BBMRI-ERIC) Date:Tue 5th June, 2018 Time: 15:30 CET Registration and details http://www.corbel-project.eu/webinars
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