Key Elements for Effective Root Cause Analysis & Problem Solving

1. Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies

2. What we will discuss. . . • What are problems • How problems are communicated: CREI statement • Types of problems and problem solving methods • Process View of problems • Isolating problems to their process of origin; establishing context for Root Cause Analysis • Levels of Root Cause investigation • Data collection/analysis tools to apply at each level of Root Cause investigation • Confirming root causes before applying solutions • Three possible solutions to each root cause • Getting the most out of Root Cause Analysis investigations

3. 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 system • A problem can only be considered to be valid if “what should be” is specified

4. Where do “gaps” arise? • Customer complaint • Nonconforming output of a process • Out of control process • Management systems not being followed • Safety incidents • Environmental “releases” • Goals not being achieved • Can be actual, potential or generated

5. Communication of Problems

6. CREI Problem Statement A tool for communicating the gap: • Concern: what is wrong; statement of nonconformity • Requirement: what should be; documented requirement or reference to • Evidence: data demonstrating that something is wrong; objective evidence observed that supports statement of nonconformity • (Impact): how significant is the problem from a performance and/or cost standpoint

7. Concern • What is wrong? • What is different than what should be? • May be recognized as a symptom, (effect), or as a failure condition, (failure mode) • Define in terms of requirement, (language of organization)

8. Requirement • What should be • Must be defined and valid • Can be found in procedures, policies, drawings, specifications, etc. • #1 reason problems are not effectively solved is that Requirement is not clearly known or defined • Reference where Requirement can be found • State as defined in Requirement document

9. Evidence • Demonstrates requirement is not being fulfilled • Data initially gathered associated with problem • Objective evidence collected while auditing process or system • Must be verifiable • Can be tangible, a statement of admission or observed

10. Impact • How big is the problem? • How much does it cost? • Is the customer affected? • Is it affecting fulfillment of organizational goals? • Refer to effect and severity ranking on FMEA for performance impact • Also consider cost impact • In the case of auditing findings: typically, auditors do not cite Impact as this could be viewed as subjective • Impact should be determined by auditee upon their review of the audit finding

11. Utilizing CREI Format • Incorporate these fields on problem solving and nonconformance report formats to prompt complete recording of information re: problems • May require some investigation to identify necessary information for completing CREI statement, especially location and actual statement of “Requirement” • Critical success factor to effective problem solving is consistent and complete communication of problem condition

12. Problem Categoriesand Problem Solving Approaches

13. Types of Problems • Simple, cause known; “Just do it” issues • Complex, cause unknown; need to dig deeper issues • Sometimes the financial impact of a problem dictates how it will be classified

14. “Just Do It” Issues • Typically isolated, sporadic incidents • Are easily fixed; apparent cause tends to be known • Often recognized during process planning and reflected in PFMEA • Addressed through troubleshooting, (diagnosis and remedy) and reaction plans on control plans, (control of nonconformity) • Can be fixed by process owner; addressed at process level • Occurrence should be monitored ongoing for cost and impact

15. Troubleshooting

16. “Dig Deeper” Issues • Sometimes referred to as Chronic • Long-term and/or complex issues • Cause is not readily apparent, unknown • Require in-depth investigation to identify root cause • Addressed through root cause analysis, disciplined problem solving and improvement process • Source of problem typically unknown • Cross-functional participation needed to solve • Effective resolution requires both process and system solution consideration • Require management intervention via resource commitment • When available data re: problem is limited, may be handled as “Just do it” based on impact and/or risk

17. Steps in Disciplined Problem Solving 1. Establish Team 2. Operational Problem Definition 3. Containment & Interim Actions, (if needed) 4. Root Cause Analysis, (process & system) 5. Plan & Implement Solutions 6. Results of Solutions 7. Verification, (including independent) 8. Closure & Congratulate the Team

18. Just Do It Reflects product or process controls established when planning the process Management decision to “live with” such conditions based on acceptable level of risk Should be routinely evaluated for cost and impact Can only be eliminated by applying disciplined problem solving to understand true root cause in order to improve process Dig Deeper Unanticipated conditions which occur May also be anticipated issues for which actual level of risk is now determined to be unacceptable Require concentrated investigation to understand source of problem and process factors leading to problem condition to allow appropriate solutions Problem Type Considerations

19. A Note about Fire-fighting! • Fire-fighting is essentially un-prescribed actions taken on a process without understanding the relation of causal factors and process output • Fire-fighting is dangerous as these actions tend not to be specifically focused to a particular cause • The resulting impact of fire-fighting is typically not known ahead of time • Therefore, chaos is introduced into the process • A very high-risk approach to problem solving!

20. Problem Type Considerations

21. Prioritize Problems • Most organizations should only be actively working on 3-5 disciplined problem solving efforts, (Dig Deeper issues), at a time to balance the use of resources and get the most effective solutions; (no one person should be working on more than 2 Dig Deeper teams at any given time) • Impact portion of CREI statement facilitates prioritization of problems for allocation of problem solving resources • Management is responsible for establishing the priority

22. Process View of Problems

23. 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

24. Evaluation (plan, gages, etc.) Environment (space, layout, etc.) Input (Materials) Process steps (Methods) Actual Output (Desired outcome: targets, goals, specs) Equipment (selection, Maintenance, etc.) People (training, skills) Management Policies & Practices Components of Process

25. Processes are mainly influenced by: Man Material Machine Methods Mother Nature, (environment) Other factors which influence processes include: Measurement Management System, (policies including SOPs, targets, operational decisions) Money Other? What are the Process Factors?

26. 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)

27. 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 root cause

28. Getting to the Process of Origin • Where was the problem found? • Where is the first process the problem condition could occur? • Go to these and any processes in between to collect data recognizing where the problem is actually first observed; this is the process of origin! • Use a process flow diagram to make this investigation visual.

30. Is/Is Not Analysis • Also known as Stratification Analysis • Provides further detail about the problem so 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

31. Use Data to determine • What is the problem? – define the problem condition such that anyone could recognize it; basis for data collection about the problem • Where is the problem occurring? – which processes, customers; also, where on the output is the problem condition observed? • Who knows about the problem? – who initially identified the problem? Who else has seen this problem? Who is involved in the process steps reflected in the process flow? • When did the problem begin? – timeline associated with when the problem was seen; can be applied even for ongoing problems • How big is the problem? – how much output is affected? • Narrows the problem focus to isolate the problem to its process of origin • Data is collected to demonstrate answers to these questions

33. Applying Is/Is Not Analysis • Clarify aspect – what question needs to be answered to obtain a better understanding of the problem • Identify what data to collect that would assist in answering the question • Determine where that data can be obtained • Decide how to go about collecting the data; what tools/methods to apply • Go collect the data • Review and analyze the data to draw a conclusion re: questions being posed • This is an important step in Root Cause Analysis as the results of this investigation provide a context for the root cause investigation • By conducting Is/Is Not Analysis, it is also possible to determine if further investigation can take place at this time

34. Components of Problem’s Operational Definition • Basis for root cause investigation • More detailed version of CREI statement based on what was learned from Is/Is Not • 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

35. A Root Cause is. . . A process factor which directly defines the reason for the problem when it is present and is having an influence on the process and its output.

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

37. Dig! How Deep? • Management decides on depth of root cause investigation through the establishment of SMART goals for each problem solving effort.

38. Define problem’s boundaries/depth of solutions Identify right people to solve problem Establish measures of end results Develop plan of how to accomplish the goal Tie problem solving goals to organizational objectives/targets Provided to team by Management Effective Problem Solving is based on SMART Goals: Specific Measurable Agreedupon by team as attainable Relevantto organization and results-oriented Timingdefined Problem Solving Goals

39. Root Cause Analysis • Systematic investigation of a process to identify the root cause of the gap, and take corrective action to eliminate the gap and keep it from occurring again in the future • A structured investigation that aims to identify the true cause of a problem, and the actions necessary to eliminate it.

40. Process Cause What factor of the process of origin is triggering the undesirable output What other processes and their factors are causing the trigger? Relates product output, (symptom), to process parameters, (causes) System Cause Addresses how the management system allowed the process to become out of control Relates process factor causes to “weaknesses” in management systems policies/practices Process Cause vs. System Cause

43. Root Cause Analysis Levels

44. 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)

45. Control Barrier Analysis Worksheet

46. Results of Control Barrier Analysis • May recognize missing controls or controls not working as planned • Interim actions represent solutions to addressing these concerns but should not be accepted as the permanent solution • When the results of this analysis uncover additional problems, refer these to the team champion for direction on addressing • Team’s main focus at this point is to implement some type of control to protect downstream processes from continuing to experience the problem • Solutions based on this level of “root cause investigation” mainly are reactive in nature; they only improve our ability to detect the problem condition but don’t typically do anything about addressing the root cause!

47. Direct Process Cause • 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

48. Cause & Effect Diagram • Apply to problem’s process of origin • Gap is head of fish • Major cause categories – 5M’s • Potential causes brainstormed are process factors existing at the problem’s process of origin • Define potential causes specifically • When confirmed, these will be known as direct process/trigger causes

49. Fishbone Diagram

50. Fishbone Process • Involve personnel from process of origin in brainstorming of potential causes at the process of origin triggering the problem • Develop a sketch/list of the process factors, (man, material, machines, methods, mother nature), related to the process of origin • After brainstorming, review each identified cause to establish: • If the cause is actually a factor at the process of origin • If the cause makes sense based on the operational definition of the problem • Prioritize remaining causes as to their possible contribution to the problem condition • Develop hypothesis test to evaluate each potential cause at the process of origin