Corrective Action Problem Solving

1. Corrective ActionProblem Solving Carol Kurtz CJ Kurtz & Associates LLC CJ Kurtz & Associates LLC

2. Trainer: Carol Kurtz American Society for Quality (ASQ) • Certified Quality Engineer • Certified Quality Auditor • Certified Quality Manager • Certified Mechanical Inspector 20+ years of Quality & Manufacturing Experience CJ Kurtz & Associates LLC

3. Course Objectives • Understand 8D Corrective Action & Problem Process • Identify and Use Tools for Each 8D Process Step • Understand Vocabulary & Principles • Compare to Other Fact Based Problem Solving Methods CJ Kurtz & Associates LLC

4. Corrective Action • Action to eliminate the cause of a detected nonconformity. • Action to protect the customer from receiving or using nonconforming product. • Corrective action is taken to prevent recurrence. CJ Kurtz & Associates LLC

5. Problem Solving • Problem Solving: Typically involves a methodology of clarifying the description of the problem, analyzing causes, identifying alternatives, assessing each alternative, choosing one, implementing it, and evaluating whether the problem was solved or not. • 8D, PDCA, DMAIC (du-may-ic) CJ Kurtz & Associates LLC

6. Corrective Action Origins • The origins of the 8-D system actually goes back many years. • The US Government first ‘standardized’ the system in Mil-Std-1520 “Corrective Action and Disposition System for Nonconforming Material” • Mil-Std-1520 - First released: 1974 • Last Revision was C of 1986 • Cancelled in 1995 CJ Kurtz & Associates LLC

7. What is 8D? • 8D means Eight Disciplines • It is a methodology used for solving problems • 8D also refers to the form that is used to document the problem and resolution • Also called 8-D Report • Corrective Action Report • EW8D Report – East-West-8D CJ Kurtz & Associates LLC

8. Why 8D? • 8D is a structured approach to solving problems • Fact Based • Data Collection & Analysis • Tests progress and results • Verify & Validate • Documented • History – An information database • Anticipate future problems • Prevent recurrence CJ Kurtz & Associates LLC

9. 8D Corrective Action CJ Kurtz & Associates LLC

10. Six Sigma DMAIC CJ Kurtz & Associates LLC

11. Plan Do Check Act - PDCA CJ Kurtz & Associates LLC

12. Problem Symptom Concern Root Problem Failure Mode Effect Cause Special Cause Common Cause Root Cause Some Vocabulary CJ Kurtz & Associates LLC

13. Verification & Validation Verification and Validation are often not well understood. Verification and Validation work together as a sort of ‘before’ (Verification) and ‘after’ (Validation) proof. • Verification provides ‘insurance’ at a point in time that the action will do what it is intended to do without causing another problem. Predictive. • Validation provides measurable ‘evidence’ over time that the action worked properly. CJ Kurtz & Associates LLC

14. Verification & Validation CJ Kurtz & Associates LLC

15. Structure of a Problem • Determining the structure of a problem assists in the selection of the correct tools to use. • It may give clues to the nature of the root causes. CJ Kurtz & Associates LLC

16. Structure of a Problem CJ Kurtz & Associates LLC

17. Structure of a Problem (continued) CJ Kurtz & Associates LLC

18. Structure of a Problem (continued) Sometimes we experience positive changes that need to be investigated so that processes and products may be improved. CJ Kurtz & Associates LLC

19. Classifying Problems • Correctly categorizing and classifying a problem precedes any problem solving effort. • Ensures proper methods and tools are selected. • If not done, wasted time and effort may occur and wrong solutions may be implemented. CJ Kurtz & Associates LLC

20. Classifying Problems – Type I • Plant Floor Problems • Rapid response is needed • Usually have discernable root causes • Usually require less data collection and analysis • Usually can be solved by local experts • Usually gradual or sudden problem structures • Special causes • Specific problem requiring Problem Analysis • 8D methodology applies CJ Kurtz & Associates LLC

21. Classifying Problems – Type II • Technical Problems • Permanent corrective actions are needed • Usually have difficult to discern root causes • Usually require more data collection and analysis • Usually require some technical expertise to solve • May be any problem structure • Special Causes • Specific problem requiring Problem Analysis • 8D methodology applies CJ Kurtz & Associates LLC

22. Classifying Problems – Type III • Process Improvement • Major systemic fixes needed • Multiple causes and effects • May require data collection and analysis • May need “systems thinking” to solve • Usually requires process owner’s involvement • Common cause problem • Structures include startup and positive. Others may apply. • Broad problems requiring a Situation Analysis • Quality Improvement Projects, Continual Improvement Projects or other methodologies apply. CJ Kurtz & Associates LLC

23. Trend Chart Control Chart Pareto Chart Brainstorm Checksheet Histogram Nominal Group Technique Five Why’s Computer Aided Engineering APQP Situation Analysis Flowchart Failure Analysis Database Decision Analysis Action Plan Root Cause Analysis Cause & Effect Diagram Scatter Diagram Design of Experiments Poka Yoke Preventive Action Matrix Problem Solving Tools CJ Kurtz & Associates LLC

24. Problem Solving Tools CJ Kurtz & Associates LLC

25. Problem Solving Tools Quiz CJ Kurtz & Associates LLC

26. D0: Recognize the Symptoms • Detect the problem! • Nonconforming Product • Out of Control Conditions on Charts • Rework • Trend Charts • What others? CJ Kurtz & Associates LLC

27. D0: Recognize the Symptoms Supplier Here? In Transit Or Here? Or Here? Or Here? Company Receiving / Inventory Inventory / Shipping In-Process In Transit Or Here? Or Here? Or Here? Customer Or Here? CJ Kurtz & Associates LLC

28. D0: Recognize the Symptoms Trend Chart A line graph plotting data over time. • Use to observe behavior over time • Provides a baseline and visual examination of trends • No statistical analysis • Look for trends and patterns • Ask “Why?” • Good for operations/processes where data for control charts is not available CJ Kurtz & Associates LLC

29. D0: Recognize the Symptoms Trend Chart CJ Kurtz & Associates LLC

30. D0: Recognize the Symptoms • Nonconforming Product • Out of Control Conditions on Charts • Rework • Trend Charts • What others? CJ Kurtz & Associates LLC

31. D0: Recognize the Symptoms Control Chart A line graph of a quality characteristic that has been measured over time • Based on sample averages or individual samples • Includes statistically determined Control Limits. • Requires certain assumptions and interpretation CJ Kurtz & Associates LLC

32. Interpreting Control Charts Control Charts provide information as to whether a process is being influenced by Chance causes or Special causes. A process is said to be in Statistical Control when all Special causes of variation have been removed and only Common causes remain. This is evidenced on a Control Chart by the absence of points beyond theControl Limits and by the absence ofNon-Random Patterns or Trends within the Control Limits. A process in Statistical Control indicates that production is representative of the best the process can achieve with the materials, tools and equipment provided. Further process improvement can only be made by reducing variation due to Common causes, which generally means management taking action to improve the system. Upper Control Limit Average Lower Control Limit A. Most points are near the center line. B. A few points are near the control limit. C. No points (or only a ‘rare’ point) are beyond the Control Limits. CJ Kurtz & Associates LLC

33. Interpreting Control Charts When Special causes of variation are affecting a process and making it unstable and unreliable, the process is said to be Out Of Control. Special causes of variation can be identified and eliminated thus improving the capability of the process and quality of the product. Generally, Special causes can be eliminated by action from someone directly connected with the process. The following are some of the more commonOut of Controlpatterns: Change To Machine Made Tool Broke Tool Wear? Upper Control Limit Average Lower Control Limit CJ Kurtz & Associates LLC

34. Interpreting Control Charts Points Outside of Limits Upper Control Limit Average Lower Control Limit Trends A run of 7 intervals up or down is a sign of an out of control trend. CJ Kurtz & Associates LLC

35. Interpreting Control Charts Run of 7 ABOVE the Line A Run of 7 successive points above or below the center line is an out of controlcondition. Run of 7 BELOW the line CJ Kurtz & Associates LLC

36. Interpreting Control Charts Systematic Variables Predictable, Repeatable Patterns Cycles CJ Kurtz & Associates LLC

37. Interpreting Control Charts Freaks Sudden, Unpredictable Instability Large Fluctuations, Erratic Up and Down Movements CJ Kurtz & Associates LLC

38. Interpreting Control Charts Mixtures Unusual Number of Points Near Control Limits (Different Machines?) Sudden Shift in Level Typically Indicates a Change in the System or Process CJ Kurtz & Associates LLC

39. Interpreting Control Charts Stratification Constant, Small Fluctuations Near the Center of the Chart CJ Kurtz & Associates LLC

40. Control Chart Analysis Reaction There is a wide range of non-random patterns that require action. When the presence of a special cause is suspected, the following actions should be taken (subject to local instructions). 1. CHECK Check that all calculations and plots have been accurately completed, including those for control limits and means. When using variable charts, check that the pair (x bar, and R bar) are consistent. When satisfied that the data is accurate, act immediately. CJ Kurtz & Associates LLC

41. Control Chart Analysis Reaction 2. INVESTIGATE Investigate the process operation to determine the cause. Use tools such as: Brainstorming Cause and Effect Pareto Analysis Your investigation should cover issues such as: The method and tools for measurement The staff involved (to identify any training needs Time series, such as staff changes on particular days of the week Changes in material Machine wear and maintenance Mixed samples from different people or machines Incorrect data, mistakenly or otherwise Changes in the environment (humidity etc.) CJ Kurtz & Associates LLC

42. Control Chart Analysis Reaction 3.ACT Decide on appropriate action and implement it. Identify on the control chart The cause of the problem The action taken As far as possible,eliminate the possibility of the special cause happening again. CJ Kurtz & Associates LLC

43. Control Chart Analysis Reaction 4. CONTINUE MONITORING Plotting should continue against the existing limits The effects of the process intervention should become visible. If not, it should be investigated. Where control chart analysis highlights an improvement in performance, the effect should be researched in order that: Its operation can become integral to the process Its application can be applied to other processes where appropriate Control limits should be recalculated when out of control periods for which special causes have been found have been eliminated from the process. The control limits are recalculated excludingthe data plotted for the out of control period. A suitable sample size is also necessary. On completion of the recalculation, you will need to check that all plots lie within the new limits CJ Kurtz & Associates LLC

44. D0: Recognize the Symptoms Other Indicators • Customer Concerns & Issues • Warranty Data • Quality Reports • Product Quality Planning CJ Kurtz & Associates LLC

45. D1: Establish the Team • Establish a small group of people with the knowledge, time, authority and skill to solve the problem and implement corrective actions. The group selects a team leader. CJ Kurtz & Associates LLC

46. D1: Establish the TeamThe 8D Team Members • Cross Functional or Multi-Disciplinary • Process Owner • Technical Expert • Others involved in the containment, analysis, correction and prevention of the problem CJ Kurtz & Associates LLC

47. D1: Establish the TeamTeam Roles Several roles need to be established for the team. These roles are: Leader, Champion, Record Keeper (Recorder), Participants and (if needed) Facilitator. Leader Group member who ensures the group performs its duties and responsibilities. Spokesperson, calls meetings, establishes meeting time/duration and sets/directs agenda. Day-to-day authority, responsible for overall coordination and assists the team in setting goals and objectives. Participants Respect each others ideas. Keep an open mind. Be receptive to consensus decision making. Understand assignments and accept them willingly. Record Keeper Writes and publishes minutes. Champion Guide, direct, motivate, train, coach, advocate to upper management. CJ Kurtz & Associates LLC

48. D1: Establish the TeamProblem Solver Characteristics • Persistent • Intuitive (supported by mechanical aptitude) • Logic & discipline • Common sense • Ability to balance priorities • Ownership • Inquisitive and willing • Creative and open minded • Needs proof & facts CJ Kurtz & Associates LLC

49. D1: Establish the TeamEffective Team Characteristics • Leadership • Clearly define goals • Clearly defined responsibilities • Trust & Respect • Authority • Positive Atmosphere • Good two way communication • Effective action plan with timing CJ Kurtz & Associates LLC

50. D1: Establish the TeamManagement Responsibility • Provide time and resouces • Provide mentoring • Understand need for change • Recognize accomplishments & team process CJ Kurtz & Associates LLC