“Using Lean Six Sigma To Improve a Risk …

1 Using lean Six Sigma To Improve a Risk management process ASQ Temecula; June 17, 2010 Niles, ASQ Fellow, MSQA, CSSMBB, CSSBB, CQE ; do we narrow in on something meaningful? what we mean by LSS and RM process lean (L), Six Sigma (SS), LSS, DFSS Risk the scope of our project Efficacy, efficiency, accuracy, consistency Evolutionary vs. a project Typical steps, tasks, and reports Learned + / -23 Nominal Group Techniques (NGT)Affinity Diagram for PizzaProduct CategoryService CategoryCost CategoryFeatures CategoryPost-it NotesExtra valueDelivered Hot45 min max waitFriendly DriversLower priceMore toppingsDeals availableQuick ordering> Crust TypesProper change$0 Fee Delivery3 Affinity Diagrams, Multi-voting, Tree diagrams, Mind mapping, Un-inhibited group discuss, Caf /town hall mtgs, Unusual settings, etc.

2 NGT Brainstorming Sticky Notes4 Rate 1 low to 10 dislike/pain for Six dislike/pain for Risk your RM experience level (relative to?) as a Quality Professional1=52=93=14=103 minutesTGNWhat do we mean by lean Six Sigma ?Collections of best known methods: Models, methods, and toolsProcess ImprovementVisibilityValueVelocityProjec tManagementChangeManagementVariationMana gementThe 3V s and the 3M s5 What do we mean by Risk management Project ? Definition:A formal program used to assess, avoid/mitigate, and control all reasonable forms of business / safety risks Contains elements listed above in some way, plus teams, measurements (subjective), action triggers / specifications Lifespan oriented: making, using, maintaining, & obsolescing Prioritized cost to benefit efforts (RPN based) Typically concerned with safety & of RM Application The project can cover concept (market), customer needs, design, intermediate use ( labs, Drs.)

3 , nurse), end user, mfg. process , equip., services, suppliers, project risks , etc. IVD Example from ISO14971: #III ICH / FDA guidance from 2006 ISPE GAMP5 Computerized systemsKim s DRAFTG rand RISKM odel The Acronym RISK can help us remember Missing: SAE AS9100 AIAG PPAPRisk Factor IdentificationHazard Assess / AnalysisRisk EvaluationRisk Control Option AnalysisRisk Measures ImplementResidual Risk EvaluationRisk / Benefit AnalysisEval of risks From ControlsComplete Risk ControlOverall Risk AcceptabilityVerification Testing / DOES tatistics - OtherRisk management ReportOn-going Data GatheringRisk Reviews / MonitoringIEC 60812 (Systems Reliability)xxxxxxxISO13485>> 14971 Risk ManagementxxxxxxxxxxxxxISPE Gamp 5; Computerized SystemsxxxxxxICH Q9 Basic RM Facilitation: FlowChartsxBasic RM Facilitation: Mode Effects Analysis (FMEA)xxxxxxxxFME& Criticality Analysis (FMECA)xxxxxxxxFault Tree Analysis (FTA) Critical Control Points (HACCP)xxxxHazard Operability Analysis (HAZOP)xPreliminary Hazard Analysis (PHA)xRisk ranking and filteringxSupporting statistical toolsxHIPPALoss PreventionLoss ReductionRisk MitigationClaims ManagementUnsure of focus for each functional areaRisk FinancingRegulatory Accredidation ComplianceOperations (Risk management Dept.

4 BioethicsSSubstantiate(Verify)KKnow(Repo rt)(Plan)RIRealizeInstigate(Assess)Tools KN Model: 4 Ways to ImproveAny ProcessConsistencyEfficiencyEffectivenes sLean Six Sigma (LSS)Evolutionary Change11 Design For lean Six Sigma (DFLSS); Revolutionary ChangeAccuracyDiscuss each area relative to a target & a RM projectList muda, mura, muri; 17 signature storyPolitical bias > program failDelta customer centered RM storyQPFMEA criteria bias storyWhat is the scope of the project?NGT Brainstorming-Multi-vote likelihood (3 votes)12 What is a more reasonable improvement project? RM program efficiency(cost / benefit)? RM program efficiency(cost / benefit)? team accuracy(criteria or process )? team accuracy(criteria or process )? team consistently(following procedures)?

5 Team consistently(following procedures)? program effectiveness(end result) program effectiveness(end result) 2 minutesTGNS imulated Case StudyBasic pick gate reviews and celebratory closing meetingSpaghetti MapRun ChartsValue Stream MapC&E CascadeCpKDesign Space OptimizationDOE Reports HereAir Academy DARPA 2006 Three C s to Inspire CreativityComparisonConsequenceConflictC omponent of DFSSS omeone somewhere has already solved your problem-Dr. Ellen Domb20 Facilitate Risk Based Decision MakingCorrective ActionContainment Direction ClarityOperational ImpactPreventive ActionIdentify RisksPromote DialogTighten Sample PlansRegulatory ComplianceUmbrella Risk ManagementD/P/FMEAFlow Charts & process MapsMitigate Collective RisksJustify DecisionsBusiness EfficiencyReduce Sample PlansAvoid ConflictBecomes a DashboardCollection of KnowledgeIdentify StrengthsControl Plan Purpose / UseFile: FTA_ControlPlan_v1_KN_061510 June 15, 2010 KN x 1209 Risk Jan 2010 230 comps: 40 life sci.

6 23% lg. Little s/w useQuality Progress Poll May 2010 Risk Control Measures ISO14971 suggests forming of a list of risk control measures Also see the annex solutions Reliasoft software contains a related databaseHazards per management depends upon people Focus on having fun Minimizing the pain (no long meetings) Pre-prioritize ( by area risks ) Maximizing the value-add usingNGT To pre-prioritize & to select criteria Inspire creativity using the 3C s a control plan centricprogram Many complimentary tools ( FTA, process maps with threats, FMEA) all the components using risks ummary of Tips and Tricks