Root Cause Analysis

1. ERROR MANAGEMENT RCA, 5WHYs & CAPAs CAP Accredited ISO 15189 Accredited Prepared By Bilal Al-kadri Feb, 2009

3. Understand the 5 whys method to determine root cause

4. Plan and implement actions

5. Verify effectiveness of actions implemented

8. CAs = Corrective Actions

9. PAs = Preventive Actions

10. RCA = Root Cause Analysis

11. QA = Quality Assurance

13. Report the error

14. Take immediate action to contain the error

15. Investigate the error

16. Find the likely cause of the error.

17. Take CAs to correct the error

20. If it is NOT documented it is NOT done

21. Documentation is to be complete and legible.

24. Avoid words such as, I, He, She, poorly, inadequately, haphazardly, carelessness and complacency.

28. Remove XY & segregate from other thermometers.

29. No documented procedure addressing AB requirement.

30. Write a procedure addressing AB requirement.

31. Inadequate instructions in a procedure.

34. Contributing causes also called Intermediate causes are those that may not have sufficient power to result in the event taking place.

36. Promotes additional research

37. Enhances problem solving skills

38. Does not assume there is one right answer

39. Avoids predetermined answers

40. Stimulates discussion

42. Five Why’s Preparation Corrective Action(s) Problem Root Cause Follow up Preventive Action(s)

44. Design of Experiments

45. Is / Is not Analysis

46. Cause & Effect Diagram.

50. It is Okay to write it down even if it seems too obvious for you. (It may not seem that obvious to other persons that will read the document).

54. Method

55. Materials

56. Manning

57. Machines

59. Five Why’s –Benefits Flexibility. It works well alone and when combined with other Quality Improvement & Troubleshooting techniques. Engaging. By its very nature, it fosters and produces teamwork and teaming within and without the organization. Inexpensive. It is a guided, team focused exercise. There are no additional costs.

60. Five Why’s One final point to ponder: After root cause has been determined, move on to the corrective actions, preventive actions. You may follow up to verify the effectiveness of CAs and PAs as necessary. Close out OERs

61. Exercise, Duration 20min An error has occurred in your area(or outside); Use OER form to report the error. Hints: _ Describe the error; _ State your immediate action; _ Investigate, Use the 5Whys to find the root cause; _ Write down CAPAs;

62. Summary Errors are ways to improve. Errors in medical labs are systematic and/or human Identify the problem clearly and keep in mind why it happened? And why not detected? Report errors upon occurrence Use the 5whys efficiently & don’t jump into conclusions Knowing the Root cause = Implementing correct CAPAs

63. Contacts Bilal Al-kadri iso15189.consultant@gmail.com