The document discusses concepts and methods for continuous improvement, including root cause analysis. It defines quality as meeting or exceeding customer expectations. Organizations can meet expectations through transformation to continually meet or exceed customer needs. Continuous improvement involves measurement, analysis, and addressing nonconformities and potential issues. Root cause analysis identifies the underlying causes of problems in order to develop effective solutions and prevent recurrence. It should focus on action and condition causes rather than symptoms.

1. Continuous Improvement Eliminate the Nonconformities Using RCA June 10 1 Tarek Elneil

2. What is Quality? Dictionary definition: degree of excellence superiority in kind <merchandise of quality> Technical definition: To meet or exceed customer expectation June 10 2 Tarek Elneil

3. Organizational Changes That Meet Customer Expectation Organization transformation from current state, to future state Constantly meet or exceed customer expectations Superior product or service Faster delivery Lower price June 10 3 Tarek Elneil

4. Continuous Improvement Cycle June 10 4 Tarek Elneil

5. Continuous Improvement Establishing adequate processes for measurement, analysis and improvement within the QMS as related to correction and/or corrective action for nonconformities or preventive action for potential nonconformities of systems, processes or products June 10 5 Tarek Elneil

6. Measurement System Is an essential part of continuous improvement system If you can’t measure it, you can’t improve it Measure the vital few Scorecard, dashboard metrics Financial measures Performance measures Process cycle time Effectiveness of new product development June 10 6 Tarek Elneil

7. CI Approach Active Strategic planning Validation FMEA Preventive action Reactive Corrective action Root cause analysis June 10 7 Tarek Elneil

8. CAPA the Reactive Approach The concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action. Preventive action is taken to prevent occurrence Corrective action is taken to prevent recurrence June 10 8 Tarek Elneil

9. Preventive Action Action to eliminate the cause of a potential nonconformity or other undesirable situation There can be more than one cause for nonconformity June 10 9 Tarek Elneil

10. Corrective Action Corrective Action: Action to eliminate the cause of a detected nonconformity or other undesirable situation There can be more than one cause for nonconformity Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence Correction Action: Action to eliminate a detected nonconformity A correction can be made in conjunction with corrective action Corrections can be, for example, rework or re-grade, fix June 10 10 Tarek Elneil

11. Manufacturing Process & Continuous Improvement June 10 11 Tarek Elneil

12. Process Components The Six M’s Man: Human error, technician, training. Machine: Equipment, instruments, tools, calibration. Material: Raw material, buffers, liquid, components. Method: SOP, work instructions, test, assay, TDS. Measurement: Liter, mol, vial to vial, % difference. Mother Nature: Environment, temperature, pressure. June 10 12 Tarek Elneil

13. Customer-Supplier Chain External Customers External Supplier Internal Customer Internal Supplier

14. Process Product Y LCL UCL Reject Accept Reject June 10 14 Tarek Elneil

15. Process and Sub-processes X1,1 X1,2 X1,3 X1,4 X2,1 X2,2 X2,3 X2,4 X3,1 X3,2 X3,3 X3,4 X4,1 X4,2 X4,3 X4,4 Y LCL UCL Y1 Y2 YN Y4 Y3 P4 P3 P2 P1 P= Process X = Drivers (input) Y = Product (output) June 10 15 Tarek Elneil

16. Sub-process Unit Y INPUT OUTPUT PROCESS Material SUPPLIER CUSTOMER X1 Man X2 Machine X3 Measurement X4 X5 Method X6 Environment June 10 16 Tarek Elneil

17. The cost of defects when they are: CUSTOMER DETECTED INTERNALLY DETECTED PREVENTED 100X 10X 1X The 1 – 10- 100 Rule

18. Cause and Effect Deeply in love I fell.. Deeply in love I was... when my eyes eyed your eyes...your eyes were the cause. Part 1:The Effectis what we see or experience with our senses Part 2 :The CauseThe reason why a particular element of a design or process resulted in a failure mode. June 10 18 Tarek Elneil

19. Symptoms and Causes Symptoms = Effects: are the signs or results of a failure but not the root cause Causes levels: First level causes: the direct lead to a problem High level causes: the highest level cause is called the root cause June 10 19 Tarek Elneil

20. Examples Sep 12, 2008 Metrolinkaccident 25 fatality and 135 injuries Symptom: Metrolink train collided head-on with Union Pacific freight at combined speed of 83 mph First level cause: Metrolinkengineer ran through red stop light and into a path of a Union Pacific freight train because he was text messaging. High level cause: Metrolink founders made a decision two decades ago to agree to share tracks with two giant freight lines, and refused to install an automatic breaking system June 10 20 Tarek Elneil

21. Cause and Effect Principals June 10 21 Tarek Elneil

22. 1. Causes and Effects are the Same Thing. Leaky Valve Injury Primary Effect Cause Caused By Caused By Caused By Effect Cause Wet Surface Cause Effect Fall June 10 22 Tarek Elneil

23. 2. Causes and Effects are Continuum Primary Effect Leaky Valve Injury Caused By Caused By Caused By Caused By Wet Surface Fall June 10 23 Tarek Elneil

24. 3. Each Effect has at Least Two Causes Action Cause Effect Condition Cause June 10 24 Tarek Elneil

25. 4. Effect & Causes Exists at the Same Point in Time and Space Action Cause Condition Cause Effect Space Oxygen Past -10 0 10 Future Present Time June 10 25 Tarek Elneil

26. Action & Condition Relations Any effect is the result of conditions interacting with an action Action Cause Condition Cause Match Strike Ignition Source Flammable Material Oxygen June 10 26 Tarek Elneil

27. Y LCL UCL Problem Investigation June 10 Tarek Elneil 27

28. When to Use RCA Problem that exceeded the established threshold Repeated occurrence One time occurrence that have high risk Within your span of control June 10 28 Tarek Elneil

29. Repeated Occurrence Pareto 80/20 Rule 100% 80% 600% Costs 40% 20% 0% Problems A B C D E F G H June 10 29 Tarek Elneil

30. One Time Threshold Start No Freq No No No Stop No No Safety Cost Revenue Envy. Yes Yes Yes Yes Yes Share Yes No CAPA Result Acceptable? Assemble Team Perform RCA Implement CA’s Control Phase June 10 30 Tarek Elneil

31. Root Cause Analysis Methodology Define the problem Analyze the problem root causes Identify effective solutions Implement the best solutions June 10 31 Tarek Elneil

32. Definition Tools Pareto chart Is, is not Flowchart June 10 32 Tarek Elneil

33. Why Problem Definition is Important? It focus everybody on the same problem It establish the value of the problem It communicate the problem impact on the organization Problem statements it focus on facts only Qualitative Quantitative June 10 33 Tarek Elneil

34. Problem Definition’s Elements Define the process input (X) and desired output (Y) qualitatively and quantitatively What: Primary effect (noun verb) When: Relative time of the primary effect Where: Relative location in system, facility, or component Significance: Why you are working on this problem? June 10 34 Tarek Elneil

35. Problem Definition: What The problem would be defined according to which of its aspects has the biggest impact on the organization Example: Customer loss Down time Backlog June 10 35 Tarek Elneil

36. Problem Definition: When Include both chronological time and relative time Example: Feb 20, 2009 At 2:30 PM First day back to work While preparing to leave for the day After the completion of step xx” June 10 36 Tarek Elneil

37. Problem Definition: Where Start with the broad area description and step down in details until you have described exactly where the problem has occurred Example : Camarillo facility Warehouse Cold storage Shelf #12 June 10 37 Tarek Elneil

38. Problem Significance Actual vs. potential impact: In examining the problem significance we look at both actual and potential impact. Example Customer complaint of a bad kit might worth $1000, but potential losing a $50,000 contract. June 10 38 Tarek Elneil

40. Potential loss of $1500 worth of raw materials

41. Twice this month

42. 2 weeks delay in customer order June 10 39 Tarek Elneil

43. What’s Not Problem Definition Who: diverts attention from the problem, and if it is important it will be discovered during the investigation. If it is necessary to mention who then mention the title (Analyst, Security, Manager, Technician, …etc) Why: this is what the investigation is all about June 10 40 Tarek Elneil

44. Look for Causes in Action & Condition Focus on causes Ask “what condition (input) had to be in place for the action to cause the effect (output)?” For each conditional cause must have an action cause Action cause can have more than one condition June 10 41 Tarek Elneil

45. Analysis Action causes are momentary, they act as the catalyst for the casual relationship Conditions causes exist over time. Condition provide the best opportunities for solutions June 10 42 Tarek Elneil

46. Problem Analysis Tools 5 Why’s? Fish Bone Diagram Brainstorming Contradiction Matrix June 10 43 Tarek Elneil

47. Ask “Why” Action Cause Action Cause Condition Cause Evidence ? Evidence Evidence Evidence Evidence Evidence Action Cause Condition Cause Condition Cause Why ? Why ? Why? Primary Effect June 10 44 Tarek Elneil

48. Stop Cause and effect charts can potentially extend infinitely into the past. Use stop at the end of the cause chain if there is no value in pursuing causes further Injury Leaking Valve Fall Wet Floor Stop June 10 45 Tarek Elneil

49. Start Solution(s) for this causes Solution(s) for this causes June 10 46 Tarek Elneil

50. Solution Significance The magnitude of the problem determines the amount of effort to direct toward a solution. Weight the cost of the problem and efforts verses the cost and efforts of the solution If the problem is very costly and the solution or the group of solutions cost less, then it is worth implementing June 10 47 Tarek Elneil

51. Solution Selection Establish Solution Criteria Prevent recurrence Comply with requirements Be within control Does not create other problems Meet organizational goals and objectives Develop solution matrix Challenge all solution ideas in the list against criteria for viable solutions June 10 48 Tarek Elneil

52. Solution Matrix June 10 49 Tarek Elneil

53. The Most Effective Solutions There is more control over conditional than actions causes There should be far more conditions than actions in the chart, thus creating far more solution opportunities Solutions for conditional causes are usually more reliable than solutions for action causes Implement and control the solution(s) June 10 50 Tarek Elneil

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