MESA Tutorial Practical Applications of the ISA 95 Applications of the ISA 95 standard Dennis Brandl MESAKNOWS ... • ANSI‐ISA 95.02 ed2 “Enterprise ‐Control System Integration

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  • PracticalApplicationsoftheISA95standard

    DennisBrandl

    MESAKNOWSBR&LConsulting

    SUSTAINABILITY&ECOEFFICIENCY LEANMETRICS&PERFORMANCEMANAGEMENTINFORMATIONINTEGRATION SAFETY ASSETPERFORMANCEMANAGEMENT B2MMLQUALITY&COMPLIANCE PRODUCTLIFECYCLEMANAGEMENT AUTOMATION

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  • DennisBrandl DennisBrandlhasbeenanactivememberofISAsSP88

    BatchControlSystemcommitteesince1990,aU.S.yexpertinbatchcontroltoIEC,editoroftheISA95EnterpriseControlSystemIntegrationstandard,andconveneroftheIECSC65EJWG5workinggroup.

    He has been involved in automation system design andHehasbeeninvolvedinautomationsystemdesignandimplementationforthepast30yearsincludingApolloandSpaceShuttletestsystemsforRockwellSpaceDivision,aswellasworkwithShellOil,TexasInstruments, Siemens, Square D, Sequencia,Instruments,Siemens,SquareD,Sequencia,Telemecanique,Modicon,Pfizer,Lilly,Merck,GSK,Genentech,P&G,DOW,andotherprocessindustrycompanies.

    Dennis has a B S in Physics an M S in Measurement DennishasaB.S.inPhysics,anM.S.inMeasurementandControlfromCarnegieMellonUniversity,andanM.S.inComputerSciencefromCaliforniaStateUniversity.

    ThepowerofknowingwhatMESAKNOWSCopyright2012,MESAInternational

  • Agenda

    IntroductiontoISA95&MES AdvantagesoftheISA95standard Most important models of ISA95 MostimportantmodelsofISA95 PracticalapplicabilityoftheISA95modelsfor

    d lt t d iendusers,consultantsandengineers Practicalexamplesanddescriptionsoftypicalapplicationstructures

    Questionsandanswers

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  • WhatisISA95 USAANSIstandarddevelopedbyanISACommitteeofvolunteerexperts

    ANSI/ISA95.01ed2Enterprise ControlSystemIntegrationPart1:ModelsandTerminology

    ANSIISA95.02ed2Enterprise ControlSystemIntegrationP t 2 Obj t d Att ib t Part2:ObjectsandAttributes

    ANSI/ISA95.03ed2Enterprise ControlSystemIntegrationPart3:ModelsofManufacturingOperations

    ANSI/ISA 95.04 ed1 Enterprise Control System Integration ANSI/ISA95.04ed1 Enterprise ControlSystemIntegrationPart4:Objectsandattributesformanufacturingoperationsmanagementintegration

    ANSI/ISA95.05ed3Enterprise ControlSystemIntegrationBusiness to Manufacturing TransactionsBusinesstoManufacturingTransactions

    AlsoavailableasIEC/ISO62264standards

    ThepowerofknowingwhatMESAKNOWSCopyright2012,MESAInternational

  • ABitOfHistory PriortoISA95

    MES was not a well defined area slow growth in deploymentsMESwasnotawelldefinedarea,slowgrowthindeployments MESwassometimeviewedasasolutioninsearchofaproblem Hardtointegratewithbusinesslevelsystemsandshopfloorcontrol Very,very,veryindustryspecificy, y, y y p Nocommondefinitionsorterminology

    AfterISA95 RedefinedMESasMOM(ManufacturingOperationManagement) MOMactivitiesarewelldefined Standarddefinitionsandterminology,commonrequirements Wellunderstoodandsupportedbusinessleveltoshipfloorcontrol

    i t tiintegration Morecrossindustrysolutionsbecomingavailable Significantcompetitionandadvancesinsolutions Rapid growth in deployments

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    Rapidgrowthindeployments

  • ExampleBenefitsfromMES/MOM*

    BenefitCategory RangeofBenefits ReductionRange

    i l (SO ) $ 00 000 $3 illi 0% 80%DocumentReviewApproval(SOPs) $100,000 $3Million 10% 80%

    BatchRecordPreparation&Handling $11,000 $1.3Million 40% 80%

    BatchRecordReview $115,000 $1.0Million 40% 80%

    DataEntry&Calculations $20,000 $4.6Million 40% 90%

    Deviations $6,000 $1.3Million 25% 60%

    Logbook Handling $7,000 $105,000 25% 80%LogbookHandling $7,000 $105,000 25% 80%

    MaterialLosses Valueofpreventablediscards 30% 60%

    Testing Preventabledeviationstesting 30% 50%

    InventoryCarryingCosts ReducedInventoryCarrying

    Throughput $valueofadditionalbatches

    RANGEOFTOTALANNUALBENEFITS $450,000 >$10Million

    ThepowerofknowingwhatMESAKNOWSCopyright2012,MESAInternational

    * CBINet Conference,INDUSTRYBESTPRACTICESFORMESARCHITECTURE,August2009,KeyConsiderationsforMESProjectPlanningandExecution,Michalle AdkinsandPaulBrandenburg(Lilly)

  • TheAdvantagesoftheISA95Standard

    CommonterminologyanddefinitionoffunctionsSimplifies writing requirements for end users Simplifieswritingrequirementsforendusers

    Simplifiedvendorunderstandingofenduserrequirements IntegrationofERPwithMES/MOMsystems

    i j k & % f l PriortoISA95,projectstook12years&90%successful

    DefinitionofMES/MOMsystems PriortoISA95,specificationtookyearstoreachagreement AfterISA95,typicalspecificationscompletein

  • MostImportantISA95Models

    MESAKNOWSSUSTAINABILITY&ECOEFFICIENCY LEANMETRICS&PERFORMANCEMANAGEMENTINFORMATIONINTEGRATION SAFETY ASSETPERFORMANCEMANAGEMENT B2MMLQUALITY&COMPLIANCE PRODUCTLIFECYCLEMANAGEMENT AUTOMATION

    MESAKNOWS

    Doyouknow MESA?

  • LevelsandFunctionsLevel4

    BusinessPlanning& Logistics

    4 - Establishing the basic plant schedule -production, material use, delivery, and shipping. Determining inventory levels. &Logistics

    Plant Production Scheduling,Operational Management, etc

    g y

    Time FrameMonths, weeks, days, shifts

    Level3

    ManufacturingOperationsManagement

    3 - Work flow / recipe control to produce the desired end products. Maintaining records and optimizing the production process.

    Level 2

    Dispatching Production, Detailed ProductionScheduling, Reliability Assurance, ...

    Time FrameShifts, hours, minutes, seconds

    Level1

    Level2

    ManufacturingControlBasicControl,SupervisoryControl,

    ProcessSensing,ProcessManipulation, 1 - Sensing the production process, manipulating the production process

    2 - Monitoring, supervisory control and automated control of the production process

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    the production process

    Level0 0 - The physical production processProductionProcess

  • ISA95DomainDefinitions Providesamethodtoanswerthequestion;

    Whatisinlogisticsand

    whatisinoperations?p

    Wh t i i L l 4 L l 1 2 3? WhatisinLevel4orLevel123?

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  • CriteriaforLevel3,2,1 ActivitiestobeincludedinLevel 3,2,or1aredirectlyinvolvedin

    manufacturing and includes information about personnel,manufacturingandincludesinformationaboutpersonnel,equipment,ormaterialandmeetsanyofthefollowingconditions. Theactivityiscriticaltoplantsafety. Theactivityiscriticaltoplantreliability. Theactivityiscriticaltoplantefficiency.

    NOTE:Absoluteplantefficienciesmaybedependentuponfactorsthatareoutsidethecontrolofafacility(MRPschedules,productmixes,etc.).

    Theactivityiscriticaltoproductquality.Th ti it i iti l t i t i i l t li Theactivityiscriticaltomaintainingregulatorycompliance.

    EXAMPLE:Maintainingregional,governmentandotheragencycompliancerelatedtoproductsandproduction. NOTE:Thisincludessuchfactorsassafety,environmentalandcGMP (currentgoodmanufacturingpractices)compliance.

    NOTE:Thereareothercriteriasuchascompanypolicyandorganizationalstructure,orthenatureoftheoperationsthatcouldexpand the scope of manufacturing operations managementexpandthescopeofmanufacturingoperationsmanagement.

    NOTE:Suchactivitiesaspersonnelmanagementofsalariesandjobtitlesmaybeimportantforrunningamanufacturingbusiness,buttheyarenotconsideredpartofmanufacturingoperationsmanagement.

    ThepowerofknowingwhatMESAKNOWSCopyright2012,MESAInternational

  • LevelOverlapwithSystemsLevel4 4 - Establishing the basic plant schedule -

    production, material use, delivery, and shipping. Determining inventory levels.

    BusinessPlanning&LogisticsBusiness Logistics

    S t (ERP)

    Level 3

    Time FrameMonths, weeks, days, shifts

    Plant Production Scheduling,Operational Management, etcSystems (ERP)

    Level33 - Work flow / recipe control to produce the

    desired end products. Maintaining records and optimizing the production process.

    Time Frame

    ManufacturingOperationsManagement

    Dispatching Production, Detailed Production

    Manufacturing OperationsManagement Systems

    Level2 2 - Monitoring, supervisory control and automated

    Time FrameShifts, hours, minutes, secondsScheduling, Reliability Assurance, ...(MES, Batch, LIMS, AM, )

    Control Systems(PLC, DCS, OCS, )

    Level1 1 - Sensing the production process, manipulating the production process

    g p ycontrol of the production processManufacturingControl

    BasicControl,SupervisoryControl,ProcessSensing,ProcessManipulation,

    Intelligent devices(Vision, Flow,

    ThepowerofknowingwhatMESAKNOWSCopyright2012,MESAInternational

    Level0 0 - The physical production processProductionProcessBatch, Discrete, Continuous

  • ISA95FormalModels

    Interfacestobusinesssystems(ERP,MDM,PLM)throughXMLd WBF B2MML S d d ( bf )andWBFB2MMLStandard(www.wbf.org)

    StandardmodelforMOMtasksandactivities

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  • ProcessSegments

    DefinestheBusinessView ofproduction

    (3Segments)PharmaceuticalManufacturingExample

    RawMaterials

    FinishedP d t

    MakeActiveIngredient

    MakePills

    PackageDoses

    Materials Products

    Inventory trackedfor Acti e Ingredient

    Inventory trackedfor Pills

    Inventory trackedfor Pill Packs

    g

    for Active Ingredient for Pills for Pill Packs

    Know throughput,resources and time to

    Know throughput,resources and time to

    Know throughput,resources and time to

    ThepowerofknowingwhatMESAKNOWSCopyright2012,MESAInternational

    make Active Ingredient make Pills make Pill Packs

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