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Merck's West Point Facility Embraces RCM

Merck's West Point Facility Embraces RCM



International Manufacturing Conference 2012

International Manufacturing Conference 2012
Merck Manufacturing Division
Life Cycle Engineering



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    Merck's West Point Facility Embraces RCM Merck's West Point Facility Embraces RCM Presentation Transcript

    • Merck’s West Point Facility Embraces RCMAAsset MManagement PProgramRRisk BBased AAsset MManagementChris Gould, Merck – West PointMike Rose, Merck – West Point
    • Merck - West Point Site2Merck - West Point is a 397 acre site that provides a diversified portfolio ofproducts including vaccines and sterile pharmaceutical products
    • The Journey• 2008/9 1st Reliability Engineer– 2010 FMEAs Initiated For “Critical Assets”– 2010 PDM Program Initiated– 2010 Reliability Group Established• 2011 RBAM Program Initiated• 2011 Program Procedures Developed– 2012 AMP Drafted– 2012 RBAM Evaluations Completed For Site– 2012 Risk Reduction Measures Identified» 2013 AMP Implemented» 2013 Actions Implemented To Reduce Risk» 2013 “Success” Metrics Developed / Used• FMEA: Failure Modes and Effects Analysis• PDM: Predictive Maintenance• RBAM: Risk Based Asset Management• AMP: Asset Management Program3
    • Physical Asset Portfolio of Merck Manufacturing DivisionExternalEXCELOptimize CostStructure &ProductivityEXTENDComplementaryBusinessesEXECUTEWorld ClassSupplier & Leadin NewTechnologyEXPANDServe 80% ofthe WorldConcept/Concept/DesignDesignProcureProcureInstall/Install/CommissionCommissionQualificationQualificationValidationValidationOperate/Operate/SustainSustainDeDe ––commissioncommissionVision 2020Target 2015Asset Management Program (AMP)Strategic Model4CorporateVision & Strategy. .Merck Manufacturing Division (MMD)Vision & Strategy
    • 55551) To create cost-effective management of asset utilization throughout the life cycle toensure asset:Reliability – Performs as designedAvailability – Runs as designed when scheduled to runMaintainability – Configured to allow least downtime and highest qualitymaintenance including safety and ergonomic considerationOperability – Can be operated to prevent maintenance failuresCompliance – Maintenance completed on prescribed frequency, meeting job planexpectations and following safe work practicesAMP Target Condition5
    • 2) Trend asset utilization and performance metrics to drive continuous improvement3) Asset risk is defined and appropriate control actions are taken to mitigate or eliminatethe risk considering maintenance programs, continuity and contingency.4) Establish criteria for asset life cycle and end of useful life – when an asset becomesobsolete based on cost of maintenance and validation cost.5) Ensure organizational design supports the asset management plan considering:Organization roles and responsibilityTalent ManagementTrainingLabor StrategyCultureStaffing Model – considering in-house/outsourcingChange Execution ManagementAMP Target Condition Continued
    • AMP Playbook Chapters1. Introduction to assetmanagement2. Compliance3. Reliability4. Work execution5. Planning and scheduling6. Asset life cycle7. Organization design8. System support9. Capital program10.SME11.Metric Mgmt philosophy12.Configuration Mgmt13.Communication14.Connection withexternal groupsDevelop detailed playbook or assessment
    • AMP Potential Benefits8Priority Business ImpactCompliance• Structured asset management plan provides greater stability:Reduce deviations, thereby ensuring GMP complianceVisible performance measures drives continuous improvementBetter colleague safety from reliable equipment and stable processesFocused loss elimination yielding greater product quality and customersatisfactionSupply• Improved asset healthBetter qualityMore and consistent fill ratesImproved customer experienceStrategy• Long-term benefit to be a preferred provider:Proactive strategyProcess-driven organizationTransparent governanceEngaged employeesKnowledge sharingProfit Plan• Business benefits may include:Less capital requirementLower energy costGreater utilization of installed capacityIncreased yieldGreater market share 8
    • 999RBAM Intent & Approach• RBAM Mission:– To always achieve a high level of assurance that Merck’s productsand commitments will not be impacted by equipment-related failures.• RBAM Intent:– Address continuity and contingency for mission critical assets.• Continuity: Ability to maintain normal asset function.• Contingency: Action(s) taken to retain asset function when continuity islost.Asset Management ProgramRisk Based Asset Management9
    • Program OverviewPrioritizeAssetsCore MaintenanceProgramsReactiveCorrectiveMaintenanceProactivePreventative &PredictiveMaintenance.TrendingMetrics & OversightPMsEvaluate Assets& Issue PMs/Job PlansCorrectFailures Determine CauseTrend Results of AssetPerformanceMaintenance programs including processes & training(e.g. valves, air handlers, lubrication, torquing)Metrics to assess program performanceMetrics reviewed by oversight team and program adjustedSummary Reports and CommunicationsPredictiveMaintenance1234310
    • Prioritize Assets1. Prioritize Assets (Per The Criteria) & Identify Known Issues2. Identify actions to Mitigate Risk[Focusing on the Critical Assets]For Each Action, Identify: Priority/Owner/Due Date3. Develop Focus Factory Risk ProfileImplementActionsFinalize & Track Actions•Portfolio•Capital PlanLOW (LOW (Risk ≤ 99))HIGH ( RiskHIGH ( Risk ≥ 130)MEDIUM (MEDIUM (100 ≤ Risk ≤ 129)CRITICALCRITICAL•HIGH RISK•Compliance = 5•Supply = 5•Profit Plan = 5Consider ContingencyConsider ContinuityQuarterlyUpdates4. Issue Focus Factory Quarterly Report11
    • 12Prioritization ToolFailureProbabilityComplianceSupplyStrategyProfitFailure Probability[% per lot / run]Compliance[Impact of a single failure]Supply[Impact of a single failure]StrategyProfit Plan[Impact of a single failure]MultiplicationFactorN/A 4 3 2 11 Insignificant None NoneNot listed on Capital Plan, LROP,Transformation, PortfolioNone2 ≤ LOW ≤LOW ≤LOW ≤LOW3 LOW < Failure Rate ≤ MEDIUM LOW< Impact ≤MEDIUM LOW< Impact ≤MEDIUMTo be listed on Capital Plan, LROP,Transformation, Portfolio.LOW< Impact ≤MEDIUM4 MEDIUM < Failure Rate ≤ HIGH MEDIUM< Impact ≤HIGH MEDIUM< Impact ≤HIGH MEDIUM< Impact ≤HIGH5 > HIGH > HIGH > HIGHListed on Capital Plan, LROP,Transformation, Portfolio> HIGHMin Max Symbol Description10 99 L Low100 129 M Medium130 250 H HighImpact AssessmentProbability of equipment having a failure based upon historical events. [NOTE: Failure = Inability to perform designed function]If asset fails, impact on GMP compliance, product quality, environmental compliance, personnel safetyIf asset fails, impact on the ability to meet supply requirements, considering product impact, discards and/or critical path production time lostAlignment with Capital Plan, Long Range Operating Plan, Transformation, PortfolioIf asset fails, impact to Profit Plan considering cost impact of a failure (e.g. discards or lost transfers) and savings benefits due to improvementsImpact ScoresRisk LevelFailure Probability x [Compliance x 4 + Supply x 3 + Strategy x 2 + Profit Plan x 1]Total Score Risk Level12
    • Prioritization ResultsFor illustrative purposes onlyCritical Assets Meet One of the Following:Risk Level = HIGH, orCompliance = 5, orSupply = 5, orProfit Plan = 5Numbers shown for illustration purposes onlyABCDEF13
    • % shown for illustration purposes onlyA B C D E F14Prioritization ResultsFor illustrative purposes only
    • Critical Asset CountFor illustrative purposes onlyNumbers shown for illustration purposes only15
    • Average Asset Risk Level (%)For illustrative purposes onlyNumbers shown for illustration purposes only16
    • Maintenance Strategy• What is an FMEA? (FFailure MModes and EEffects AAnalysis)– A team-based, structured way of assessing risk and reducing thechance of failures through development of actions to control the risk(e.g. PMs).• What is a SMR? (SSimplified MMaintenance RReview)– A team-based, structured way of developing a maintenance strategybased upon a review of vendor recommendations and failure history.• FMEA & SMR Process1. Gap analysis2. Maintenance Strategy3. PMs & Job Plans4. Replacement spare part identification5. Spare parts availability17
    • PDM - Vibration ProgramFor illustrative purposes onlyNumbers shown for illustration purposes onlyFocus FactoryTotal Machines Extreme Serious Moderate SlightSerious Repairs OverdueA 121 0 0 9 45 0B 125 0 2 14 24 1C 181 0 4 22 41 1D 8 0 1 2 0 2E 256 0 6 23 66 1F 167 0 3 18 59 0G 94 1 1 17 25 1952 1 17 105 260 63rd Qtr 2012 VIBRATION FAULTS ‐ Open Work Order Status18
    • PDM – ThermographyFor illustrative purposes onlyNumbers shown for illustration purposes onlyFocus FactoryTotal Machines Extreme Serious Moderate SlightSerious Repairs OverdueA 973 0 1 2 2 1B 1219 0 0 0 0 0C 1479 0 0 0 1 0D 8 0 0 0 0 0E 678 0 0 0 0 0F 475 0 0 0 0 0G 405 0 1 0 2 15237 0 2 2 5 23rd Qtr 2012 THERMOGRAPHY Failed Scan Open Work Order Status19
    • ReportingElectricalContinuity &ContingencyCapital andProjectStatusPredictiveMaintenanceMetrics RBAM StatusQuarterly Summary Report to Plant• Roll-Up of Plant• Summary of Each Focus FactoryQuarterly Report-Out to Each Focus Factory(Tailored to each Focus Factory)Both Written And Oral Quarterly Summaries Enhance Change Management20
    • Key TakeawayDeveloping an action-oriented asset-based prioritization process sets thefoundation to:1. Understand Asset Priorities2. Work on the “Right Stuff”3. Reduce Asset Risk4. Make Problems Visible5. Address Problems Continually
    • 22Questions?22Mike RoseAssociate Director - EngineeringMerck - West PointMichael_Rose@Merck.comwww.Merck.comChris GouldExecutive DirectorMerck - West PointChristopher_Gould@Merck.comwww.Merck.com