Gary Dechant Laboratory Quality Systems

1. Root Cause Analysis Gary Dechant Laboratory Quality Systems

2. What is it • Why do you do it • When do you do it • How do you do it

3. What is Root Cause Analysis? Root Cause Analysis is a systematic and structured approach to get to the true root causes of our process problems.

4. Root Cause Analysis Root Cause Analysis is used to eliminate problems so that they do not occur again.

5. Root Cause Analysis is not used to correct a non-conformance. Fixing a non-conformance is important but eliminating the problem is of far greater benefit.

6. Repairing, reworking, correcting, modifying, retraining and redesigning are temporary solutions to fix the symptom and not designed to eliminate the problem

7. Why Do Root Cause Analysis Root Cause Analysis is done in response to problems that cause losses. Whether they are injuries, interruptions, client dissatisfaction, errors, quality failures. Root Cause Analysis is done in response to RISK

8. RISK Is the combination of frequency What is the likelihood of something happening And the consequence How great are the ramifications

9. Root Cause Analysis is used for Catastrophic Failures Recurring Failures or Complaints Accident Investigations Equipment Failures Excessive Down-time and Delays Repeated Rework or Reprocessing

10. When a failure occurs the initial goal will almost always be to get production back on line. But the ultimate goal is to make sure the problem does not occur again

11. Plan for Success Get Management Buy In Commit the necessary time Minimize interruptions

12. Pick an appropriate team DOES THE TEAM Have the authority to make changes Have the expertise to evaluate Have a leader

13. Set a Plan Have a Place Set the Ground Rules Have the Resources Set a Schedule

14. Be focused Be open-minded Be patient And above all be relentless .

15. Define the Problem This might be from An incident Trend analysis Audit findings Pareto analysis or A directive from management

16. Consensus is the Key All problems are in their perception And All perceptions will be different For different people The team must agree on what the failure was And Where the failure actually occurred

17. Root Cause Analysis Tools Cause And Effect Diagrams Fault Tree Analysis Interrelationship Diagrams Current Reality Trees Five Why Sequence

18. Cause And Effect Diagrams (CED) • Informally called the fishbone diagram • Easy to use • Works best when the problem is well defined • Tends to be difficult to determine the true root cause • Can get very complicated

20. Fault Tree Analysis (FTA) • Similar to Cause and effect diagrams • Used for reliability and safety analysis • Uses Boolean logic and flow charts (and/or paths) • Includes risk assessment • Qualitative and quantitative analysis

21. Fault Tree Analysis Example

22. Interrelationship Diagrams (ID) • Used to identify and classify relationships • Non-linear approach • Arrows show direction of cause to effect • Relationships are numerically weighted • Root cause determined by numeric value

24. Current Reality Trees (CRT) • Allows for interrelationships and interdependence of causes • Starts with effect, works downward with if-then logic • Complex and rigorous logic • Time consuming • Generally well defined root cause

26. Five Why Sequence • Most commonly used for simpler problems • Easily implemented with small group • Minimal time • Linear cause and effect • Gives single root cause

27. Solutions All problems will have multiple solutions The key is picking the best one

28. Key Considerations • Be practical • Cost - balance diminishing returns • Probability of implementation - buy in • Ownership in solution • Time and commitment • Complexity

29. Corrective Action Plan • Is it a long term fix • Is it comprehensive • Is it only used by select management • Will staff take ownership • Does it really address the root cause • Can it be monitored and measured

30. Human Error Almost all failures in a Service orientated organization Can be traced to human execution errors But Human execution errors are seldom the cause of the Failure

31. Human Based Problems If it’s frequent or systematic Find out why Employee Doesn’t Care Doesn’t believe they can do it right Punished for doing it right Rewarded for doing it wrong

32. The Human Factor Punishment is generally the first choice Is generally the least effective Fixes symptoms not root causes

33. Punishment Indicators • Discharge or release • Re-assignment • Counseling • Re-training • Procedure review • Re-testing • Additional reviews and checks

34. If the “best” solution includes a punishment indicator It will probably not fix the root cause

35. Solution analysis • Negative impacts of corrective action • Available resources • Time constraints • Funding • Personnel

36. Final Report • Key to the completion is management • Buy-in • Commitment • Support How you report your conclusions can define the success of your evaluation

37. Implementing Corrective Actions • Define the process or steps • Set measurable objectives • Set time lines • Assign responsibilities • Test effectiveness – get feedback • Document effects

38. Successfully closing corrective actions Implement the changes. Document the changes. Update SOPs if needed. Train all appropriate staff. Verify implementation and it’s effectiveness. Re-verify and Monitor – add to internal audits. Closing Corrective Actions

39. In Closing • Define the risk • Pick a team • Make a plan • Define the problem • Find the cause • Pick and evaluate a solution • Report to management • Implement the corrective action • Close the CA and follow-up

40. Final Thought Not all problems are worth solving Sometimes you just monitor and fix the Failures as they occur

41. Questions

42. Gary Dechant Laboratory Quality Systems gldechant@aol.com 970-434-4875