1. 1 Assessment: Audits

2. Assessment: Audits - Module 9 2 Learning Objectives At the end of this activity, you will be able to: Develop a process to prepare your laboratory staff for an external audit. Plan and manage an internal audit. Discuss how to use results from a laboratory audit. Advocate for the importance of taking corrective actions.

3. Assessment: Audits - Module 9 3 Problem Scenario You are the quality manager in your laboratory and you want to organize an internal audit. What steps will you take?

4. Assessment: Audits - Module 9 4 The Quality Management System OrganizationPersonnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety

5. Assessment: Audits - Module 9 5 Assessment—Audit systematic examination of some part (or all) of the quality management system conformance with requirements

6. Assessment: Audits - Module 9 6 What is an assessment? Someone is asking: What is being done? How does this comply with written policies and procedures?

7. Assessment: Audits - Module 9 7 Why perform an assessment? learn “where we are” in terms of quality management measure gaps need information for:  planning and implementation  monitoring  continuous improvement

8. Assessment: Audits - Module 9 8 Outside group or agency Internal audit External audit Quality Laboratory

9. Assessment: Audits - Module 9 9 Path of Workflow THE PATIENT Test selectionSample Collection Sample Transport Laboratory Analysis Examination Phase Report CreationReport Transport Preexamination Phase Result Interpretation Postexamination Phase

10. Assessment: Audits - Module 9 10 Auditing 1. Gather information about:  process, operating procedures  staff, equipment, test methods  environment, handling of samples  quality control verification activities  recording and reporting practices

11. Assessment: Audits - Module 9 11 2. compare findings with documented quality management system 3. identify breakdown in system or departure from procedures 4. do something with audit results Auditing

12. Assessment: Audits - Module 9 12 Health authoritie s Accreditation body Public health program Funding program External Auditors Laboratory

13. Assessment: Audits - Module 9 13 Organize Schedule with staff External Audit Preparation Gather information and records Plan

14. Assessment: Audits - Module 9 14 External Audit Report and Plan of Action Identify gaps Record results and actions Write report Plan corrective actions Develop timeline Assign responsibility Laboratory understands recommendations Auditor’s closing summary and report

15. Assessment: Audits - Module 9 15 Flexible Costs less Internal Audit  required by ISO standards  conducted on a regular basis  conducted when problems identified Look at your own processes

16. Assessment: Audits - Module 9 16 Value of Internal Audits prepare for external audit increase awareness opportunity for improvements preventive and corrective actions opportunity for continuing education meeting quality standards

17. Assessment: Audits - Module 9 17 Internal Audits: ISO Requirements  must have an audit program  must document procedures  auditors independent of activity  results documented and reported to management for review  prompt follow-up action

18. Assessment: Audits - Module 9 18 Virology O&P Urines Int. Audit Bacteriology Quality Laboratory Internal Audits Do not audit your own work Consultant, another laboratory

19. Assessment: Audits - Module 9 19 Assign responsibility Internal Audit Program Schedule regular audits Prepare documents checklists forms

20. Assessment: Audits - Module 9 20 Laboratory Director determines the internal auditing policy assigns responsibility for the internal audit program – Quality Manager internal audit outcomes supports corrective action measures

21. Assessment: Audits - Module 9 21 Quality Manager Responsibility establish and maintain an internal audit system coordinate the audit process manage corrective actions develop schedule internal audit outcomes report to staff select & train auditors report to management

22. Assessment: Audits - Module 9 22 Conducting an Internal Audit  develop plan  write checklists  opening meeting  collect and analyze information  record results  conduct closing meeting  report

23. Assessment: Audits - Module 9 23 Establishing an Audit Schedule conduct regularly more frequent audits for problems or areas needing improvement over time audits should look at all of the quality system essentials

24. Assessment: Audits - Module 9 24 Documents checklists develop forms for documenting corrective actions and reports

25. Assessment: Audits - Module 9 25 Important Skills for Auditors Attention to detail TrainedDiplomatic Technical/ Quality management expertise Communicate effectively

26. Assessment: Audits - Module 9 26 Audit Audits Should Lead to Actions Identify OFI Identify OFI Take Action

27. Assessment: Audits - Module 9 27 Corrective and Remedial Actions These actions are the steps taken to improve a process or to correct a problem Who is responsible? Quality Manager

28. Assessment: Audits - Module 9 28 Taking corrective action using problem-solving team:  investigate root causes  develop appropriate corrective action implement corrective action examine effectiveness record all actions and findings monitor

29. Assessment: Audits - Module 9 29 Opportunity for Improvement Form

30. Assessment: Audits - Module 9 30 Continuous monitoring is the key element to success in the Quality System

31. Assessment: Audits - Module 9 31 Quality Improvement Plan Corrective Action Plan Monitoring & Evaluation customer satisfaction quality control proficiency testing audits Continuous Quality Improvement

32. Assessment: Audits - Module 9 32 “It isn’t what you find… it’s what you do about what you find.” Philip Crosby

33. Assessment: Audits - Module 9 33 Summary Assessment is important in monitoring the effectiveness of the laboratory quality management system. Both external and internal audits yield useful information. An outcome of assessment is finding root causes of problems and taking corrective actions.

34. Assessment: Audits - Module 9 34 Key Messages All laboratories should establish an internal audit program. Conducted on a regular basis, it will provide information for continual improvement. Problems become opportunities for improvement.

35. Assessment: Audits - Module 9 35 Questions? Comments? Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety