Quality A. Realist s View. Lyle Unrau ART ASC (Hon) Team Lead Transfusion Medicine and Cellular Children s & Women s Health Centre of BC

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1 Quality A Realist s View Lyle Unrau ART ASC (Hon) Team Lead Transfusion Medicine and Cellular Children s & Women s Health Centre of BC 1

2 Disclaimer The opinions expressed in this talk are those currently held by the author and do not necessarily reflect those of his place of employment (past, present or future) or those of his friends or members of his immediate family. 2

3 Background 3

4 Quality Essentials 1 Organization 2 Customer Focus 3 Facilities & Safety 4 Personnel 5 Purchasing & Inventory 6 Equipment 7 Process Management 8 Documents & Records 9 Information Management 10 Noncomforming Event Management 11 Assessment 12 Continual Improvement 4

5 Steps to Quality Comply with the standards (Regulations) Say what you are going to do (in writing) Do what you said you would do 5

6 Quality Management as demonstrated in half a glass of wine. 6

7 Quality Written plan is the glass 7

8 Quality Written plan is the glass Wine is what you do 8

9 Quality Written plan is the glass Wine is what you do Quality is measured by how close you come to what you said you would do. 9

10 Definitions 10

11 Definitions Optimist Says the glass is half full 11

12 Definitions Optimist Says the glass is half full Pessimist Says the glass is half empty 12

13 Definitions Realist Says I will need more wine soon. 13

14 If the Optimist is right and the glass is being filled Get on board and help 14

15 If the Pessimist is right and the glass is being emptied Determine What is causing the loss and whether it can be stopped. Determine how to fill 15

16 Quality Essentials 1 Organization 2 Customer Focus 3 Facilities & Safety 4 Personnel 5 Purchasing & Inventory 6 Equipment 7 Process Management 8 Documents & Records 9 Information Management 10 Noncomforming Event Management 11 Assessment 12 Continual Improvement 16

17 Organization 17

18 2015 DAP ORG2.1.1 Responsibilities, authorities and interrelationships are defined, documented and communicated within the laboratory. This includes the appointment of personnel responsible for each laboratory function and the appointment of alternates for key managerial and technical personnel. ORG2.12 There is a documented and dated organizational chart with clear lines of accountability, responsibility, interrelationship and authority 18

19 CSA Z The facility shall have documented policies and procedures that describe its organizational structure, staffing requirements and the qualifications of all personnel. These policies and procedures shall include clearly defined lines of authority and shall specify individual responsibilities Areas of responsibilities and lines of authority shall be identified in an organizational chart or other form. The names, qualifications and job descriptions of each personnel members shall be documented. 19

20 Staffing DAP ORG Laboratory directors ensure that there are appropriate numbers of personnel with the required education, training and competence to provide laboratory services that meet the need and requirements of users. CSA There shall be sufficient number of qualified personnel who have documented education, training and experience for the duties and responsibilities assigned. 20

21 Organization Conclusions 21

22 Organization Conclusions Senior management will never sort this out to my satisfaction 22

23 Organization Conclusions Senior management will never sort this out to my satisfaction No matter how confusing my reporting structure is, it is essential that those who report to me know their reporting structure 23

24 Organization Conclusions Senior management will never sort this out to my satisfaction No matter how confusing my reporting structure is, it is essential that those who report to me know their reporting structure My staff must have what they need to do their job 24

25 Documents (and Records) 25

26 CSA Z The facility shall establish and maintain written policies to ensure the safety, quality and efficacy of blood components and the safety of donors, recipients and facility personnel The facility s operating procedures shall be reviewed by it senior management. This may be delegated to another qualified individual within the facility. Senior management shall ensure that all facility personnel are aware of, and follow, its operating procedures 26

27 CSA Z Operating procedures shall include: a) The name of the facility b) The title and purpose of the operating procedure c) The unique identification number for the document, which shall include an indication of the revision number (if applicable) d) The date the operating procedure was implemented and date(s) revised e) The signature of the authorizing person(s) and the date of authorization f) The page number (given in relation to the total number of pages) g) A clear outline of the steps to be followed in the operating procedure and h) Clearly defined responsibilities for actions that require checking, review, or approval. 27

28 DAP 2015 QMS2.1.1 The laboratory controls documents required by the QMS and ensures that unintended use of any obsolete document is prevented. QMS2.1.2 There are defined authorities, procedures and processes for the maintenance and review of documents. QMS2.16 Only current, authorized versions of applicable documents are available at points of use. 28

29 DAP 2015 QM2.2 All documents contain standardized elements Title Unique identifier on each page Version information Page number to total number of pages Authority for issue 29

30 Documents Method of informing staff what they are supposed to do. They are: Controlled Authorized Followed 30

31 Documents While they contain standard elements there is no mention of format. 31

32 Process Management Telling staff what they are supposed to do and how they are supposed to do it. Proof that we can consistently get desired results. 32

33 Subsets of Process Management 33

34 Subsets of Process Management Personnel How do you hire, train, discipline staff How does staff call in sick, apply for leave etc. 34

35 Subsets of Process Management Purchasing & Inventory How are supplies etc ordered, How much do you have on hand Includes blood products 35

36 Subsets of Process Management Facilities & Safety How do you keep staff, patients and visitors safe 36

37 Subsets of Process Management Information Management How is information stored and made available Hard to differentiate from Records 37

38 Subsets of Process Management Equipment How is equipment operated and maintained How it is obtained covered under Purchasing 38

39 How do you know you are doing well? 39

40 How do you know you are doing well? Nonconforming Event Management What can you learn when something goes wrong? What can you learn when something almost goes wrong? Are there trends? 40

41 How do you know you are doing well? Assessments Internal & External How do others view what you are doing? Impartial look at your operation Commit to addressing anything found 41

42 How do you know you are doing well? Customer Focus What do your customers think/want? Surveys or more informal Transfusion Committee Commit to addressing anything found 42

43 Where do you go from here? Continual Improvement What we need to strive for. Integral to everything we do 43

44 Conclusions 44

45 Conclusion Document control is key: nimble 45

46 Conclusion Document control is key: nimble Be an optimist whenever you can 46

47 Conclusion Document control is key: nimble Be an optimist whenever you can Never say you will do more than the standard demands 47

48 Conclusion Document control is key: nimble Be an optimist whenever you can Never say you will do more than the standard demands Do what you are doing well 48

49 Conclusion Document control is key: uncomplicated Be an optimist whenever you can Never say you will do more than the standard demands Do what you are doing well Concentrate on what is important to your lab 49

50 Questions? 50