1. Q uality Tutorial for Transfusion Medicine Residents

2. 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. 3 ? What is a... Quality Management System

4. 4 ? What is... Quality

5. 5

6. 6 Q How do we, should we, define quality in laymen’s terms? Quality ?

7. 7 Q Doing the right things right the first time. Doing it better and better. The Goal...

8. 8 If Quality is the Goal... Q: How do we get there?

9. 9 Q QMS A Learning Organization Goal Tool Environment

10. 10 QMS Q QMS A Learning Organization Tool Goal Tool Environment

11. 11 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

12. 12 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.

13. 13 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).

14. 14 Records QMS Documentation Hierarchy Forms Work Instructions (SOPs, COPs, DOPs) System Management Procedures Quality Manual Operators Managers Organization The Missing Link...

15. 15 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.

16. D R A F T

17. 17 A Learning Organization Q QMS A Learning Organization Environment Goal Tool Environment

18. 18 An environment where people thrive on continuous learning and improvement. A Learning Organization Q QMS A Learning Organization Environment Goal Tool Environment

19. 19 Not because we have to...

20. 20 Because we want to.

21. 21 Quality Expectations Regulators  Federal  Provincial  International

22. 22 Canadian Blood Services as of February 2007

23. 23 Mandate Quality management system and quality culture Leadership

24. 24 Mandate Compliance to regulations and standards Oversight

25. 25 Mandate Continuous improvement of processes and services Support

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

27. 27 Roles & Responsibilities  Process Improvement  CAPA  Change Control  Deviation Management  Document Management  Quality Training  Validation Quality System Support

28. 28 Roles & Responsibilities  QA oversight  Internal audits  Release of supplies  Document control  Change control  Non-conformance  GMP training Quality Assurance  Validation review  QC testing  Project quality

29. 29 Roles & Responsibilities  Regulations & standards  Licensing  Reporting  Liaison for Regulatory Inspections  Corporate Audits  Supplier Audits Regulatory Affairs & Quality Audits

30. 30 CBS’s Quality Journey  Let’s Do the Right Thing Right the First Time! and  Let’s work together to find ways of Doing it Better and Better! It’s About You

31. 31 CBS’s Quality Journey Lifestyle… Everyone- Everywhere- Every time

32. 32 Q uestions ?... and on behalf of Q&RA, Thank You.