1. ORGANIZATION

2. 2 Problem scenario  Develop an organizational chart for your laboratory showing lines of authority from the head of the organization to all laboratory staff.  Design each line’s responsibility for quality.

3. 3 The Quality System Process Control (Quality Control & Specimen Management) Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service Facilities & Safety Organization Personnel Equipment Documents & Records

4. 4 Learning Objectives At the end of this session, you will be able to:  Describe organizational elements needed for quality system management  Discuss management roles and responsibilities in a quality system  Understand the process for designing, implementing, maintaining, and improving the laboratory quality system  Explain the purpose of a quality manual

5. 5 Essential: 1. management committed to quality system and, 2. an organizational structure designed to assure quality goals

6. 1. Leadership, managerial roles

7. 7 Leadership  Exercising responsible authority, while providing motivation and vision  Influencing and encouraging staff to good performance

8. 8 Management Responsibilities  Design, implement, maintain and continuously improve the quality management system  Document and communicate policies, processes, programs, procedures, and instructions to all relevant personnel  Provide a quality manual describing the quality management system

9. 9 Management Commitment  Seek support from upper management  Identify appropriate management level  Must involve those making financial decisions  Communicate commitment of laboratory managers to staff

10. 2. Organizational structure

11. 11 Organizational Structure  Establish a working structure that ensures efficiency and high quality at all points in the laboratory workflow  Designate responsibilities, define roles of all staff, develop organizational chart  Designate a quality manager  Allocate sufficient resources to assure that personnel and infrastructure needs are met

12. 12 Example – organizational chart

13. 13 Quality Manager  Quality manager vital to quality system implementation, required under ISO 15189  Delegated responsibility and authority to oversee compliance  Reports directly to the decision-making level of laboratory management

14. 14 Quality Manager Responsibilities Monitor all aspects of the quality system Regularly review records, quality control and other data, EQA performance Conduct audits to assess compliance with quality policies and procedures Investigate deficiencies Assure that decision makers are informed Coordinate on-site inspections of monitoring or accrediting agencies

15. 3. Planning

16. 16 Planning for Quality System Approaches to developing a quality system vary with local situation Many factors influence starting point Plan includes all quality elements May implement in stepwise process

17. 17 Planning: General rules  Don’t go too fast, don’t demoralize staff  Do not neglect communication  Analyze the situation, present the conclusions  Be transparent  Manage priorities, deal with biggest problems  Work on realistic, measurable objectives  Move forward step by step  Do not work on factors over which you have little influence

18. 18 Conduct Gap Analysis Determine the gaps in your current quality practices, using quality systems checklist Develop a task list using identified gaps Prioritize filling these gaps by –  Considering quick fixes first  Determining what would have the greatest positive impact

19. 19 Reminder and general direction: Factors influencing quality  Areas usually needing corrective action:  Test ordering  Specimen management  Training level of technical staff  Reagent and equipment management  Insufficiency of control procedures  Analytical process  Interpretation of raw results  Transcription and transmission of the results  Interpretation and use of the results

20. 20 Quality System Plan  Written quality system plan should include:  What should be done  Who will be responsible  Timeline  What resources are needed  Benchmarks  Must be available to all staff

21. 4. Implementation

22. 22 Implementation Commit to completion Estimate time needed based upon available resources Prepare for implementation in stages Stagger start dates Determine resource requirements Developing a Gantt chart can be useful

23. 23 IDTask Name 1 Quality System Implementation 2 Quality system planning 3 Training 4 5 6 Prepare Quality Manual 7 Schedule audits 8 9 10 Implementation Update Quality Manual JunJul AugSepOctJanFebMayJulSepOct 20032004 Gantt Chart Document Procedures Approval of Quality Manual

24. 24 Consider Resource Requirements  Financial requirements / budget  Personnel needs  Additional staff  Skills, training needed  Facilities, equipment, supplies, computers

25. 25 Implementation Exercise  Post-it exercise  Purpose – How to organize what needs to be done and determine sequence that will lead to successful implementation  List the 5 major steps,  one post-it at a time, n°1, n°2, etc

26. 26 Implementation Exercise  Group exercise – development of sample plan for lab X  Include GANTT chart exercise

27. 5. Monitoring – maintenance and improvement

28. 28 Monitoring Compliance  Assign responsibility, usually quality manager  Develop indicators using quality policy  Systems for monitoring  Conduct audits or periodic reviews  Internal and external  Management review

29. 29 Developing a Quality Manual  Essential organizational step  Management responsibility

30. 30 WHAT IS A QUALITY MANUAL? A document describing the quality management system of an organization

31. 31 Quality Manual  Communicates information  Serves as a framework or roadmap for meeting quality system requirements  Demonstrates managements commitment to quality

32. 32 Maintaining the Quality Manual Approval process Method of communication to all employees Process for updating  frequency  responsibility  documentation

33. 33 From Intent to Action  Assure commitment from top management  Develop quality system plan  Assign responsibility for implementation  Allocate resources  Develop and distribute a quality manual  Implement quality system  Monitor compliance with quality system requirements

34. 34 Successful implementation requires: planning, management commitment understanding the purpose of seeking quality understanding organization’s aims having staff involved at all levels looking for ways to continually improve setting realistic time frames

35. 35 Remember  Quality is not a science, it’s a way of thinking  Do what you wrote, write what you did  If you are willing to spend some time today, you will gain:  Quality results  Time  Professional, personal satisfaction  Peer recognition

36. 36 Who Is Responsible for Quality?  Laboratory leaders and management must commit to meeting quality needs  Laboratory personnel must follow all quality assurance procedures and adhere to requirements and standards EVERYONE!

37. 37 Develop an organizational chart for your laboratory showing lines of authority from the head of the organization to all laboratory staff. Design each line’s responsibility for quality. Problem scenario