Key Elements for Effective Root Cause Analysis & Problem Solving

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Key Elements for Effective Root Cause Analysis & Problem Solving. Presented by: Cathy Fisher Quality Improvement Strategies. What we will discuss. What are problems How problems are communicated: CREI statement Types of problems and problem solving methods Process View of problems - PowerPoint PPT Presentation

Transcript of Key Elements for Effective Root Cause Analysis & Problem Solving

  • Key Elements for Effective Root Cause Analysis & Problem SolvingPresented by:Cathy FisherQuality Improvement Strategies

  • What we will discuss. . .What are problemsHow problems are communicated: CREI statementTypes of problems and problem solving methodsProcess View of problemsIsolating problems to their process of origin; establishing context for Root Cause AnalysisLevels of Root Cause investigationData collection/analysis tools to apply at each level of Root Cause investigationConfirming root causes before applying solutionsThree possible solutions to each root causeGetting the most out of Root Cause Analysis investigations

  • Visual Definition of ProblemGap 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 systemA problem can only be considered to be valid if what should be is specified

  • Where do gaps arise?Customer complaintNonconforming output of a processOut of control processManagement systems not being followedSafety incidentsEnvironmental releasesGoals not being achievedCan be actual, potential or generated

  • Communication of Problems

  • CREI Problem StatementA tool for communicating the gap:Concern: what is wrong; statement of nonconformityRequirement: what should be; documented requirement or reference toEvidence: 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

  • ConcernWhat 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)

  • RequirementWhat should beMust be defined and validCan be found in procedures, policies, drawings, specifications, etc.#1 reason problems are not effectively solved is that Requirement is not clearly known or definedReference where Requirement can be foundState as defined in Requirement document

  • EvidenceDemonstrates requirement is not being fulfilledData initially gathered associated with problemObjective evidence collected while auditing process or systemMust be verifiableCan be tangible, a statement of admission or observed

  • ImpactHow 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 impactAlso consider cost impactIn the case of auditing findings: typically, auditors do not cite Impact as this could be viewed as subjectiveImpact should be determined by auditee upon their review of the audit finding

  • Utilizing CREI FormatIncorporate these fields on problem solving and nonconformance report formats to prompt complete recording of information re: problemsMay require some investigation to identify necessary information for completing CREI statement, especially location and actual statement of RequirementCritical success factor to effective problem solving is consistent and complete communication of problem condition

  • Problem Categoriesand Problem Solving Approaches

  • Types of ProblemsSimple, cause known; Just do it issuesComplex, cause unknown; need to dig deeper issuesSometimes the financial impact of a problem dictates how it will be classified

  • Just Do It IssuesTypically isolated, sporadic incidentsAre easily fixed; apparent cause tends to be knownOften recognized during process planning and reflected in PFMEAAddressed through troubleshooting, (diagnosis and remedy) and reaction plans on control plans, (control of nonconformity)Can be fixed by process owner; addressed at process levelOccurrence should be monitored ongoing for cost and impact

  • Troubleshooting

    Company Name

    Recognize problem condition

    Communicate problem condition to process owner

    Diagnose problem condition

    Decide on appropriate action

    Implement remedy

    Observe results of remedy

    Record condition and remedy

    Periodically review records of conditions for trends

  • Dig Deeper IssuesSometimes referred to as ChronicLong-term and/or complex issuesCause is not readily apparent, unknownRequire in-depth investigation to identify root causeAddressed through root cause analysis, disciplined problem solving and improvement processSource of problem typically unknownCross-functional participation needed to solveEffective resolution requires both process and system solution considerationRequire management intervention via resource commitmentWhen available data re: problem is limited, may be handled as Just do it based on impact and/or risk

  • Steps in Disciplined Problem Solving1. Establish Team2. Operational Problem Definition3. Containment & Interim Actions, (if needed)4. Root Cause Analysis, (process & system)5. Plan & Implement Solutions6. Results of Solutions7. Verification, (including independent)8. Closure & Congratulate the Team

  • Problem Type ConsiderationsJust Do ItReflects product or process controls established when planning the processManagement decision to live with such conditions based on acceptable level of riskShould be routinely evaluated for cost and impactCan only be eliminated by applying disciplined problem solving to understand true root cause in order to improve process Dig DeeperUnanticipated conditions which occurMay also be anticipated issues for which actual level of risk is now determined to be unacceptableRequire concentrated investigation to understand source of problem and process factors leading to problem condition to allow appropriate solutions

  • 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 outputFire-fighting is dangerous as these actions tend not to be specifically focused to a particular causeThe resulting impact of fire-fighting is typically not known ahead of timeTherefore, chaos is introduced into the processA very high-risk approach to problem solving!

  • Problem Type Considerations

  • Prioritize ProblemsMost 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 resourcesManagement is responsible for establishing the priority

  • Process View of Problems

  • The Secret to Solving ProblemsThe 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

  • Components of Process

  • What are the Process Factors?Processes are mainly influenced by:ManMaterialMachineMethodsMother Nature, (environment)Other factors which influence processes include:MeasurementManagement System, (policies including SOPs, targets, operational decisions)MoneyOther?

  • Process ViewSystem Processes = Policies, Objectives & Practices (how an organization does business)Planning Processes apply System to fulfill customer requirementsProducing Processes to accomplish PlansProducts/Services = output of producing Processes

  • Main Functions of Problem SolvingDefine Gap between what is and what should beIdentify process of origin from which gap is originatingStudy the process of origin to determine which process factor(s) are causing the gapAnalyze the relationship between process causal factors and system factors to identify root cause

  • Getting to the Process of OriginWhere 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.

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  • Is/Is Not AnalysisAlso known as Stratification AnalysisProvides 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

  • Use Data to determineWhat is the problem? define the problem condition such that anyone could recognize it; basis for data collection about the problemWhere 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 problemsHow big is the problem? how much output is affected?Narrows the problem focus to isolate the problem to its process of originData is collected to demonstrate answers to these questions

  • Is/Is Not Analysis Workshee