Solution Identification and Verification of Effectiveness

1. Solution Identification and Verification of Effectiveness ASQ PALMETTO SECTION JUNE 9, 2009

2. 3 possible solutions for each root cause Solution selection methodology Change management as it relates to solution implementation 3 levels of verification Evaluation of solution effectiveness Team verification Independent verification Measuring solution effectiveness Verification tools Focus of this presentation

3. In our previous presentations. . . • CREI statement for communicating problems • Isolating problems to their process of origin and related tools, (process flow, timeline, Is/Is Not analysis) • Four levels of root cause investigation and related tools, (control barrier analysis, fishbone, 5 why, system cause analysis)

4. Visual Definition of Problem • Gap between current condition, (what is), and the desired performance level, (what must be, should be or could be) • This gap can exist in a process, product or service • The gap can be actual, potential or “generated”

5. How is Problem Stated? • Concern – what is; what was observed, detected, etc.; what is the nonconforming condition • Requirement – what should be; refer to defined requirement/specification in detail • Evidence – what was observed that indicates there is a gap between what is and what should be; the more detailed the data, the easier problem definition will be, (when, where, how many, etc.) • (Impact) – initial estimation of how the problem may affect the organization; used in establishing the priority/need for disciplined problem solving; best stated financially

6. Correction is action to eliminate nonconformity Typically action is applied only at location where nonconformance was identified Is not designed to prevent the nonconformance from re-appearing elsewhere Corrective action is action to eliminate the cause of a detected nonconformity By applying appropriate corrective action, recurrence of the nonconformance is typically prevented Correction vs. Corrective Action

7. Problem Type Considerations

8. Main Functions of Problem Solving • Define Gap between “what is” and “what should be” • Identify process of origin from which gap is originating • Study the process of origin to determine which process factor(s) are causing the gap • Analyze the relationship between process causal factors and system factors to identify all levels of root causes

9. Process View Products/Services = output of producing Processes Producing Processes to accomplish Plans Planning Processes apply System to fulfill customer requirements System Processes = Policies, Objectives & Practices (how an organization does business)

10. The Secret to Solving Problems • The source of every problem is a process: typically the gap is found in the output of the process • The cause of every problem is one or more process factors not behaving as they should • Understanding the relationship between process factors and process outputs is important to effective problem solving • Data about the process and the problem is required to gain enough understanding to effectively solve any problem • The result of any problem solving effort is increased knowledge about processes and their outputs

11. Describe Problem • Symptoms are only starting point in problem definition • What is (actual) – What should be = Problem • Use quality and investigation tools: process flow, timeline, interview • Is/Is not analysis (splitting the dictionary) Output: • Operational definition – precise explanation of problem specifying the process of origin to study for root cause

12. Failure Modes & Effects Analysis(FMEA) – Problem Solving Clues

13. Process mapping process flow End point of flow reflects where problem was found Flow extends back to process where problem feature is initially created or changed Process of origin of the problem will be somewhere within these process flow boundaries Begin when the problem was found Data may help identify when problem originated With traceability data, may be able to recognize time-related pattern of problem Both of these tools will also help with containment and application of interim action Process Flow & Timeline

14. Is/Is Not Analysis • Also known as Stratification Analysis • Provides further detail about the problem so process of origin can be identified and a complete operational definition of the problem can be formulated. • Used at this stage as well as in applying interim/containment actions and implementing/verifying permanent actions. • “Splitting the dictionary” or “20 questions to the answer” demonstrates this idea of problem convergence

15. Components of Operational Definition of Problem • Basis for root cause investigation • Indicate process from which problem originated/generated • Indicate direction of problem related to requirement • Define extent of problem • Possibly isolates problem to a certain timeframe • Include refined information re: impact • Problem statement must be clear, concise and understandable by anyone

16. 4 Levels of Root Cause Defect/Detection Cause = Product level Process Root Cause = at Process of Origin Actual Root Cause = previous process factor contributing to Process Root Cause, (planning) System Root Cause = management system policy/practice contributing to Actual Root Cause

17. Root Cause Analysis Levels

18. How did the problem escape the process and/or organization? Was the problem anticipated in advance? Were controls defined to recognize and contain the problem? At which process are the planned controls applied? Were the planned controls in place? Were the planned controls working? What is the capability of these controls? Assists in identifying appropriate interim actions as well as identifying the defect/detection root cause Control Barrier Analysis(Defect/Detection Root Cause)

19. Process Cause at Process of Origin • Relates one or more factors of the affected process, (process of origin), not “behaving” as required to obtain the desired output result at that process • Use Cause & Effect diagram, (fishbone technique) • Direct process causes, (trigger causes), are the starting point for identifying root cause • Some action may be required to address the direct process/trigger cause but actions should not be taken until actual root cause is known

20. Actual Root Cause • Explains why condition exists at the process of origin of the problem • Typically found in previous “planning” processes • Use 5 why analysis and hypothesis testing • Usually only one over-riding cause that when addressed, can significantly reduce the problems impact on the organization • Very complex problems may have interacting causes but these are typically viewed as isolated problems that only repeat infrequently, (often managed as Just Do It), until resources allow necessary time to discover interaction through data collection, analysis and experimentation

21. System Causes • What in the system allowed this problem/cause to occur • Identifies why the process root cause occurred based on current management policies/practices • Often not readily measurable • Data obtained through interview • By identifying system causes, systemic improvement can be made in order to prevent recurrence of problem in other similar processes • Typically addressed once process root cause of problem is known

22. Inputs: Confirmed process root causes Confirmed system root causes SMART goals Solution criteria Methods: Brainstorming solutions Decision-making process Planning Outputs: Solutions for process of origin, (if appropriate) Solutions addressing process root cause Solutions addressing system root cause Error/mistake-proofing Solutions implementation plans Contingency plans Action plans Plan/Implement Solutions

24. 3 Possible Solutions • Eliminate root cause – preventive control; often referred to as error-proofing; eliminates causal factor leading to problem condition • Control root cause – process detective control; implement actions to monitor cause condition so action can be taken on process factor before problem occurs • “Do nothing”/Live with it – reactive control; continue monitoring for problem condition; defect detection solution; may be required when root cause can’t be eliminated or controlled economically or technically; this solution may include accepting interim action as permanent solution

25. Problem Solutions • There are always at least 3 possible solutions related to each level of cause • Therefore, at least 12 possible solutions could be identified for a problem investigation if all levels of cause are investigated! • Management provides solution selection criteria as basis for evaluating possible solutions

26. Process Solutions • Address process root cause • Impact control or elimination of process factor(s) identified to be root cause • Consider error-proofing, (elimination of cause), or mistake-proofing, (control of cause)

27. Error-proofing Product or process features designed such that a potential failure mode and/or its cause can not occur Eliminate the possibility for the failure mode and/or cause to occur Also includes self-correcting cause detection mechanisms, (e.g. regulators) E.g. polymer bonding of teeth Mistake-proofing Detection mechanisms designed into the process to identify the cause of a potential failure mode prevent manufacture of nonconforming product Also referred to as poka-yoke Installed at the process where defect could occur Mechanisms which detect incorrect cause conditions and alert the operator to these conditions so remedial action may be taken E.g. automatic shut-off on iron Error-Proofing vs. Mistake-Proofing

28. System Solutions • Address system root cause • Create new policy • Change existing policy • Monitor application of current policy • Apply process solution to other similar processes which could experience the same problem

31. Solution Selection • Allow brainstorming of possible solutions at all levels of confirmed causes and the 3 possible categories of solutions • Then apply solution selection criteria provided by management to evaluate each possible solution as well as refine the brainstormed ideas • Have data available re: actual costs associated with problem, (initial impact, revised impact based on data collection/analysis, anticipated future impact if no action is taken)

34. Actions to eliminate and control causes require change Also solutions that continue to monitor for problem condition Change management tools should be applied when implementing solutions Change Management Tools FMEA Risk assessment Resource planning Contingency planning Training Evaluation Verification Implementing Solutions

35. Apply Quality Planning Process to Implement Solutions • Determine if selected solutions will resolve problem • Test selected solutions prior to full-scale implementation • Use decision analysis tools - consensus, criteria rating, etc. • Evaluate adverse affects caused by solution; use FMEA • Consider solution’s impact on other processes • Develop contingency plans & countermeasures • Prepare action plan to manage verification activities • Verify that customer is satisfied with solution

36. Implement Permanent Solutions • Permanent actions should answer “why did this problem occur?” • Eliminates concern without creating other problems • Establish an action plan • Define on-going process controls • Statistical plan to measure effectiveness of corrective actions • Identify contingency actions • Controls for monitoring long-term effectiveness • Document changes • Provide training re: changes

37. Inputs: Solutions implementation plans SMART goals Methods: Trials of solutions Monitoring/data collection of implemented solutions Outputs: Data for evaluation of solutions effectiveness Other opportunities Evaluation of Results

38. Key Questions to Ask • Is objective data available to prove that actions taken work? • Has enough time elapsed to prove the Issue is truly fixed? • Since solutions were implemented, has the Issue been seen again? • What efforts have been made to track and report recurrence of the Issue? • Is sufficient evidence available in a presentable format to prove solutions are working? • Has the team looked for proof that the fix is working as planned?

39. Evaluate Solutions • Establish measures associated with problem cause to determine if implemented solution is effective • This step is data collection of solution results to support verification of effectiveness • Data collection may be done by problem solving team or process owners • Monitor application of contingency actions • Time needed for evaluation is dependent on problem process of origin’s business cycle, (how often that process occurs and generates data to support evaluation)

40. Inputs: Data from evaluation of implemented solutions SMART goals Methods: Problem solving team verification Independent verification Outputs: Objective evidence reflecting solutions effectiveness in fulfilling SMART goals for problem solving effort Evidence of continual improvement Other opportunities Verification

41. Verifying Solutions • Verification plan defined • Confirm effectiveness of solution in eliminating or controlling root cause • Statistical basis • Data collected to support verification • Interim actions should not be removed until permanent solution is verified • Verification plan should contain action, statistical confidence and results

43. Independent Verification • Possibly performed by internal auditor or someone not directly involved in problem solving effort • Review of problem solving effort and results • Checklist of questions prepared based on results • Problem solving team members and others affected interviewed • Data collected to support answers to questions • Results of team problem verification reviewed • Related indicators reviewed • Conclusion re: implementation and effectiveness of problem solving effort

44. How Verification Audits are Performed • Auditor reviews problem solving information prepared by problem solving team • Auditor prepares checklist of questions based on problem solving information, (fix it actions, how root cause was identified, actions taken to address cause, how results of actions were evaluated, etc.) • Auditor performs audit to identify evidence which supports that each step of problem solving process has been completed and that implemented actions have eliminated/controlled the causes to prevent recurrence of the problem • Auditor also reviews information collected demonstrating results of implemented actions and data reflecting whether the problem has recurred

45. Results of Verification • Record results of verification audit; formal audit report not required when only reporting results of verification audit • If results of verification audit demonstrate that problem solving is not complete or not effective, communicate this to manager of area and Management Representative; the problem solving effort can not be closed until specified actions have been taken and data exists to demonstrate that problem solution was effective in preventing recurrence of the problem • Verification audits should also be performed for preventive and improvement actions; same process except no “fix it” actions would be required

46. Inputs: Team plan SMART goals Results of Verification Records of problem solving effort Methods: Evaluation Presentation Celebration Outputs: Problem solving report Listing of additional opportunities identified Lessons learned Problem Closure

47. Problem Closure & Congratulate Team • Acknowledge significance and value of problem solution • Recognize team’s collective efforts in solving the problem as well as individual contributions • Document what was learned in solving the problem; lessons learned not only about the problem which was solved but also about the problem solving process • Consider investigating other potential causes as preventive actions • Write case study reports

48. Importance of Documenting Problem Solving Effort • Provides explanation of pathway used in solving problem • Captures the data collected and analyzed • Clearly states decisions made and solutions implemented • Sufficient information should exist for understanding the problem solving effort and its results; “tells the story” • May refer to other documents which support results of problem solving effort

49. A Key Outcome of Every Problem Solving/Root Cause Investigation. . . Expansion of Knowledge

50. An Anonymous Quote “Within each problem lies a disguised opportunity. . . But it is the art of unmasking the disguise that distinguishes between the two.”