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1、Key Elements for Effective Root Cause Analysis&Problem Solving,Presented 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 p
2、rocess 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 Caus
3、e Analysis investigations,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 systemA problem can only be considered to be valid if“what should be”is specified,Where do“g
4、aps”arise?,Customer complaintNonconforming output of a processOut of control processManagement systems not being followedSafety incidentsEnvironmental“releases”Goals not being achievedCan be actual,potential or generated,Communication of Problems,CREI Problem Statement,A tool for communicating the g
5、ap: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/o
6、r cost standpoint,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),Requirement,What should beMust be defined and validCan be found in procedures,polici
7、es,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,Evidence,Demonstrates requirement is not being fulfilledData initially gathered associated
8、with problemObjective evidence collected while auditing process or systemMust be verifiableCan be tangible,a statement of admission or observed,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 severit
9、y 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 Format,Incorporate these fields on
10、 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“Requirement”Critical success factor to effective proble
11、m solving is consistent and complete communication of problem condition,Problem Categoriesand Problem Solving Approaches,Types of Problems,Simple,cause known;“Just do it”issuesComplex,cause unknown;need to dig deeper issuesSometimes the financial impact of a problem dictates how it will be classifie
12、d,“Just Do It”Issues,Typically 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
13、 by process owner;addressed at process levelOccurrence should be monitored ongoing for cost and impact,Troubleshooting,“Dig Deeper”Issues,Sometimes referred to as ChronicLong-term and/or complex issuesCause is not readily apparent,unknownRequire in-depth investigation to identify root causeAddressed
14、 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 ava
15、ilable data re:problem is limited,may be handled as“Just do it”based on impact and/or risk,Steps in Disciplined Problem Solving,1.Establish Team2.Operational Problem Definition3.Containment&Interim Actions,(if needed)4.Root Cause Analysis,(process&system)5.Plan&Implement Solutions6.Results of Soluti
16、ons7.Verification,(including independent)8.Closure&Congratulate the Team,Problem Type Considerations,Just 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
17、 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 concentrate
18、d 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 outputFir
19、e-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,Prioriti
20、ze 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 porti
21、on 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 Problems,The source of every problem is a process:typically the gap is found in the output of
22、the processThe cause of every problem is one or more process factors not behaving as they shouldUnderstanding the relationship between process factors and process outputs is important to effective problem solvingData about the process and the problem is required to gain enough understanding to effec
23、tively solve any problemThe 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 processe
24、s include:MeasurementManagement System,(policies including SOPs,targets,operational decisions)MoneyOther?,Process View,System Processes=Policies,Objectives&Practices(how an organization does business),Planning Processes apply System to fulfill customer requirements,Producing Processes to accomplish
25、Plans,Products/Services=output of producing Processes,Main Functions of Problem Solving,Define Gap between“what is”and“what should be”Identify process of origin from which gap is originatingStudy the process of origin to determine which process factor(s)are causing the gapAnalyze the relationship be
26、tween process causal factors and system factors to identify root cause,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 ob
27、served;this is the process of origin!Use a process flow diagram to make this investigation visual.,Is/Is Not Analysis,Also 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
28、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 determine,What is the problem?define the problem condition such that anyone could recognize it;basis for
29、 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
30、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 t
31、hese questions,Applying Is/Is Not Analysis,Clarify aspect what question needs to be answered to obtain a better understanding of the problemIdentify what data to collect that would assist in answering the questionDetermine where that data can be obtainedDecide how to go about collecting the data;wha
32、t tools/methods to applyGo collect the dataReview and analyze the data to draw a conclusion re:questions being posedThis is an important step in Root Cause Analysis as the results of this investigation provide a context for the root cause investigationBy conducting Is/Is Not Analysis,it is also poss
33、ible to determine if further investigation can take place at this time,Components of Problems Operational Definition,Basis for root cause investigationMore detailed version of CREI statement based on what was learned from Is/Is NotIndicate process from which problem originated/generatedIndicate dire
34、ction of problem related to requirementDefine extent of problemPossibly isolates problem to a certain timeframeInclude refined information re:impact Problem statement must be clear,concise and understandable by anyone,A Root Cause is.,A process factor which directly defines the reason for the proble
35、m when it is present and is having an influence on the process and its output.,4 Levels of Root Cause,Dig!How Deep?,Management decides on depth of root cause investigation through the establishment of SMART goals for each problem solving effort.,Problem Solving Goals,Define problems boundaries/depth
36、 of solutionsIdentify right people to solve problemEstablish measures of end resultsDevelop plan of how to accomplish the goalTie problem solving goals to organizational objectives/targetsProvided to team by Management,Effective Problem Solving is based on SMART Goals:SpecificMeasurableAgreed upon b
37、y team as attainableRelevant to organization and results-orientedTiming defined,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 futureA structured investigation tha
38、t aims to identify the true cause of a problem,and the actions necessary to eliminate it.,Process Cause vs.System Cause,Process CauseWhat factor of the process of origin is triggering the undesirable outputWhat other processes and their factors are causing the trigger?Relates product output,(symptom
39、),to process parameters,(causes),System CauseAddresses how the management system allowed the process to become out of controlRelates process factor causes to“weaknesses”in management systems policies/practices,Root Cause Analysis Levels,Control Barrier Analysis(Defect/Detection Root Cause),How did t
40、he 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
41、controls?Assists in identifying appropriate interim actions as well as identifying the defect/detection root cause,Control Barrier Analysis Worksheet,Results of Control Barrier Analysis,May recognize missing controls or controls not working as plannedInterim actions represent solutions to addressing
42、 these concerns but should not be accepted as the permanent solutionWhen the results of this analysis uncover additional problems,refer these to the team champion for direction on addressingTeams main focus at this point is to implement some type of control to protect downstream processes from conti
43、nuing to experience the problemSolutions based on this level of“root cause investigation”mainly are reactive in nature;they only improve our ability to detect the problem condition but dont typically do anything about addressing the root cause!,Direct Process Cause,Relates one or more factors of the
44、 affected process,(process of origin),not“behaving”as required to obtain the desired output result at that processUse Cause&Effect diagram,(fishbone technique)Direct process causes,(trigger causes),are the starting point for identifying root causeSome action may be required to address the direct pro
45、cess/trigger cause but actions should not be taken until actual root cause is known,Cause&Effect Diagram,Apply to problems process of originGap is head of fishMajor cause categories 5MsPotential causes brainstormed are process factors existing at the problems process of originDefine potential causes
46、 specificallyWhen confirmed,these will be known as direct process/trigger causes,Fishbone Diagram,Fishbone Process,Involve personnel from process of origin in brainstorming of potential causes at the process of origin triggering the problemDevelop a sketch/list of the process factors,(man,material,m
47、achines,methods,mother nature),related to the process of originAfter brainstorming,review each identified cause to establish:If the cause is actually a factor at the process of originIf the cause makes sense based on the operational definition of the problemPrioritize remaining causes as to their po
48、ssible contribution to the problem conditionDevelop hypothesis test to evaluate each potential cause at the process of origin,Direct Process Root Cause Investigation Plan&Results,Process of Origin:,Problem Understanding Tools(especially useful in identifying system causes),Task Analysis reviews proc
49、ess in detail;helpful for operator dependent processChange Analysis identifies differences;extension of Is/Is Not analysis;expands on application of timelineBoth these tools must be applied with a location context,(process of origin),Task Analysis Worksheet,Change Analysis Worksheet,Actual Root Caus
50、e,Explains why trigger cause/condition exists at the process of origin of the problemTypically found in previous“planning”processesMany problems have multiple causesUsually only one over-riding cause that when addressed,can significantly reduce the problems impact on the organizationVery complex pro
