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uality

Q. uality. Tutorial for Transfusion Medicine Residents. Understanding Quality, Tools to Support the Pursuit of Quality, Importance of a Quality Culture. Role of Q&RA Division in all the above. What is a. ?. Quality Management System. What is. ?. Quality. Q. Quality ?.

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uality

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  1. Q uality Tutorial for Transfusion Medicine Residents

  2. Understanding Quality, Tools to Support the Pursuit of Quality, Importance of a Quality Culture. Role of Q&RA Division in all the above.

  3. What is a . . . ? Quality Management System

  4. What is . . . ? Quality

  5. Q Quality ? How do we, should we, define quality in laymen’s terms?

  6. Q The Goal . . . Doing the right things right the first time. Doing it better and better.

  7. If Quality is the Goal . . . Q: How do we get there?

  8. GoalToolEnvironment QQMS A Learning Organization

  9. GoalToolEnvironment QQMSA Learning Organization

  10. Documenting a QMS . . . Need to document the QMS so that can effectively and efficiently communicate to, and train, the organization. Two approaches to documenting a QMS: • Document-Centric • Process-Centric

  11. Document-Centric In a word . . . Procedures - Procedures - Procedures Disadvantages: • large number of very detailed procedures at work instruction level but very difficult to see the big picture of how the overall system works, and as such very hard to manage; • documents take on a life of their own such that people believe that the documents are the QMS rather than the implementation of what is written in the documents.

  12. Process-Centric In a word . . . Pictures Advantages: • gives a graphical view of system & processes; • easier to understand overall system, constituent processes & interrelationships (connectivity); • level of detail can be tailored to intended audience / user (hierarchical structure with drill downs / cascades).

  13. The Missing Link . . . Quality Manual Organization System Management Procedures Managers Work Instructions (SOPs, COPs, DOPs) Operators Forms Records QMS Documentation Hierarchy

  14. How? An enterprise model is an enterprise process-map that provides a high-level systems view of the processes and process interdependencies that comprise the enterprise. In other words . . . the QMS.

  15. D R A F T

  16. GoalToolEnvironment QQMSA Learning Organization

  17. GoalToolEnvironment QQMSA Learning Organization An environment where people thrive on continuous learning and improvement.

  18. Not because we have to . . .

  19. Because we want to.

  20. Quality Expectations Regulators • Federal • Provincial • International

  21. Canadian Blood Servicesas of February 2007

  22. Mandate Leadership Quality management system and quality culture

  23. Mandate Oversight Compliance to regulations and standards

  24. Mandate Support Continuous improvement of processesand services

  25. Organizational Structure Q&RAas of 2006-07-26 Vice-President Dr. Christian Choquet Exec. Admin. Assistant Sylvie Beaudet Quality System Support Ken McTaggart QualityAssurance Tom Poirier Regulatory Affairs &Quality Audits Dr. Tom Walker

  26. Roles & Responsibilities Quality System Support • Process Improvement • CAPA • Change Control • Deviation Management • Document Management • Quality Training • Validation

  27. Roles & Responsibilities Quality Assurance • QA oversight • Internal audits • Release of supplies • Document control • Change control • Non-conformance • GMP training • Validation review • QC testing • Project quality

  28. Roles & Responsibilities Regulatory Affairs & Quality Audits • Regulations & standards • Licensing • Reporting • Liaison for Regulatory Inspections • Corporate Audits • Supplier Audits

  29. CBS’s Quality Journey It’s About You • Let’s Do the Right Thing Right the First Time! and • Let’s work together to find ways of Doing it Better and Better!

  30. CBS’s Quality Journey Lifestyle… Everyone-Everywhere-Everytime

  31. Q uestions ? . . . and on behalf of Q&RA,Thank You.

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