Principles of Lean Six Sigma - UPRM

1 1 Principles ofLean Six SigmaandCAPAE ugenio Longo, Longo, Advisor &Industrial Advisor &Visiting ProfessorVisiting Professorfor Universitiesfor Universities2 Agenda :Part 1 Lean Six SigmaOverviewLean and 6 Sigma integrationWork shop + QuizTake away:Closing3 Agenda :Part 2-CAPAO bjectives of courseMed Dev + PharmaceuticalsOperations OverviewStatistics regarding CAPA issues: FDA 483, WarningLetters + Consent is an effective CAPA program important for yourbusinessCAPA regulation in detailCAPA inputsEffective approachProblem SolvingTechnical WritingTracking and F/UOwnership your way of making of Lean Six SigmaOverview of LeanManufacturing and Six SigmaMethodologiesALean Enterprise5 IntroductionToday s manufacturing and businessenvironments are reaching a point thatcompetition for survival and market share isan the global economy will show thatbeing good is not enough, therefore eachorganization really strive for excellence ifwant to stay in the FactsEvery single organization islooking for one FactsPROFIT8 Business FactsPROFIT is not a single concept butcomes with many importantimplications.

2 P-Process excellence R-Resources Management O-Oriented to a Goal F-Financially Strong I-Innovative to stay ahead ofcompetition T-Timely deployment of strategies9 Business FactsThe most traditionaldefinition Facts$$$LET S MAKEMONEY$$$BUT DO ITRIGHT11 How we make PROFITIn order to be a leader, most companies arerealizing that traditional management,manufacturing processes, and other historicapproaches, are not effective methods are needed: Six Sigma Lean ManufacturingWith origins in the Toyota ProductionSystem, is a way of living in the of ManufacturingHistory of ManufacturingMade to customer specSingle piece product uniqueVariable qualityLittle inventoryHigh for the richCraftCraftCraft Interchangeable parts Whitney Division of labor Taylor Assembly lines Ford Labor strifeMass ProductionMass ProductionMass Production High variety Small batch sizes PPM quality Engaged workforceThe Lean EnterpriseTheThe LeanLean EnterpriseEnterprise13 Recognize a need to change and beable to Analysis is the foundationProcess Analysis is the foundationtoward achieving Process achieving Process we make PROFIT14We need to Change to makePROFIT?

3 We need to Change to makeWe need to Change to makePROFIT?PROFIT?Aneed for changeis usually characterized by:Quality is a department responsibilityLarge production lotsLarge centralized storesCustomer dissatisfactionEnormous part and process variationSet-up measured in hours instead of minutesOrder entry times measured other than in minutesProduct margins eroded by increasing operating costsEver-increasing competitive pressures15 Why Change ?Why Change ?Why Change ?Need for changeis a STRATEGIC ISSUE whichany and every Manufacturer must address:Quality-How to improve itCost-How to control itOn-time Delivery-How to ensure itIn other words, How we make PROFIT?Failure to improve inallthree areas means a lossof competitiveness in today s global Change ?Why Change ?Why Change ?

4 Lean Linking Thinking !17 Why Change ?Why Change ?Why Change ? Lean LinkingLean Linking Thinking !Forward Thinking !Do not become the dinosaurDo not become the dinosaurof your industryof your industry18 Evolutionary vs. RevolutionaryChangeEvolutionary vs. RevolutionaryEvolutionary vs. RevolutionaryChangeChangeHaving a forward looking perspective on continuousimprovement is a requirement of the competitivemarketplace and is the first step in becoming NOT set incremental improvement goals over previousperformance, rather-Think of wherewe need to be:Continually declining costsZero defectsMinimal inventoriesFully satisfied customers19 What can we expect with LeanThinking?(over 5 years)What can we expect with LeanWhat can we expect with LeanThinking?Thinking?(over 5 years)(over 5 years)Defects reducedby 20% per yearDelivery Lead Times reducedby more than 75%On Time Delivery improvedto 99+%Productivity(sales per employee)increasesof15-25% per yearInventory(working capital)reductionsof more than75%Return on Assets improvementof 100%+20 Analyzing and ImprovingProcessesAnalyzing and ImprovingAnalyzing and ImprovingProcessesProcesses An integrated approach to utilizing Capital, Materials, andHuman resources to produce just what is needed, when it isneeded.

5 In the amount needed withminimumMaterials,Equipment, Labor and Lean DefinitionA Lean DefinitionA Lean Definition Identify and eliminate waste(MUDA).Overriding PrincipleOverriding PrincipleOverriding PrincipleWhat s in a Name ..WhatWhat s in a Name ..s in a Name .. Toyota Production System, , Lean Manufacturing,Demand Flow Technology, Kaizen, is really ProcessAnalysis !21 How we make PROFIT-TPS22 Building Blocks of The LeanBuilding Blocks of The LeanEnterpriseEnterprise Continuous Improvement TeamworkRewards / RecognitionTraining23 Continuous Improvement ValueStreamMappingTeamworkRewards / RecognitionTrainingBuilding Blocks of The LeanBuilding Blocks of The LeanEnterpriseEnterprise24 Quick ChangeoverStandard WorkBatch ReductionLayoutMistake Proofing5S SystemProjectsVisual ManagementPOUC ellular / FlowPull / KanbanTPM Continuous Improvement ValueStreamMappingTeamworkRewards / RecognitionTrainingBuilding Blocks of The LeanBuilding Blocks of The LeanEnterpriseEnterprise25 How we do PROFIT by anOperational ExcellenceMission StatementHow we do PROFITHow we do PROFIT by anby anOperational ExcellenceOperational ExcellenceMission

6 StatementMission StatementDevelop the ability:To recognize and identify wasteTo have to courage to call it wasteTo have the desire to eliminate itEliminate the wasteTruly understand that wasteRaises costsProduces no corresponding benefitThreatens all of our jobs26To do PROFIT we can use the Lean SixSigma do PROFIT we can use the Lean SixTo do PROFIT we can use the Lean SixSigma StrategySigma turning manufacturingandbusinessprocesses into competitive what is needed, when it isneeded, with a minimum amount ofmaterials, equipment, labor and space. Prime Directive -to continually seek out andeliminate waste and wasteful Lean Six Sigma Lean Six Sigma StrategyThe Lean Six Sigma these 4 Main Goals:#1) IMPROVE QUALITY#1) IMPROVE QUALITY#1) IMPROVE QUALITY#2) ELIMINATE WASTE#2) ELIMINATE WASTE#2) ELIMINATE WASTE#3) REDUCE LEAD TIME#3) REDUCE LEAD TIME#3) REDUCE LEAD TIME#4) REDUCE TOTAL COSTS#4) REDUCE TOTAL COSTS#4) REDUCE TOTAL COSTSWith an overriding principle:Safety 1 Safety 1stst!

7 !to continually seek out and eliminate unsafe operatingconditions and practices in every aspect of Lean Enterprise is a Lean Enterprise is a StrategyThe Lean Enterprise is a these 4 Main Goals:#1) IMPROVE QUALITY#1) IMPROVE QUALITY#2) ELIMINATE WASTE#2) ELIMINATE WASTE#3) REDUCE LEAD TIME#3) REDUCE LEAD TIME#4) REDUCE TOTAL COSTS#4) REDUCE TOTAL COSTSWith an overriding principle: to continually seek out and eliminate unsafe operating conditions andpractices in every aspect of our Business and every process within ourOperations and to constantly, and consistently, enhance Health/Welfare,Safety and Environmental concerns and a well-planned implementation,overallexpectedRESULTSmay include (within 12 months)35% to 50%reduction in lost time/safety-related incidents and accidents15% to 30%decrease in scrap and rework25% to 40%reduction intotal cycle timeThe Promise of Lean Six SigmaThe Promise of Lean Six SigmaThe Promise of Lean Six Sigma30 Lean Six Sigma Benefits Are There For The TakingThe BenefitsAlwaysInclude Increased Market Share, Lowered Cost HigherProfits And Happier Customers (And Shareholders)

8 Lean Is The Only Answer Known That Provides These Benefits Lean Never Fails If You (R-E-A-L-L-Y) Do ItSaying Lean Is Not Doing LeanEvery Successful Business That Competes In An Over-capacity Or Price-sensitive Market Is Doing Lean Whether They Know It Or Not31 Lean Six SigmaPhilosophy and Key Concepts The 5 core Principles of Lean Define value-added and non-valued addedactivity Define the 7 most common types of waste and their causes. Review a systematic approach to discoverwaste within a the 5 Core Principles of Lean:1)Specify value in the eyes of the customer2) Identify value stream and eliminate waste3) Make value flow at pull of the customer4) Involve & empower employees5) Continuously improve in pursuit of perfectionLean Six Sigma33 Customer perceives valueCustomer perceives valueValue Added ActivityAn activity that changes the size,shape, fit, form, or function of materialor information (for the first time)to satisfy the Added ActivityThose activities that consume time or resources, but do not addvalue in the eyes of the Six Sigma34 Value Added Any activity or operation performed that helps transform a product or servicefrom its raw state into its finished form.

9 Completed right the first time. Any activity customer is prepared to pay for. Activity requiredto ensure thata product or service is delivered in conformance to Added Any activity that doesn t help to transform a product or service into its finalform. Activity not performed right. Activity customer not willing to pay for. This includes: Unnecessary process steps Movement of inventory, paperwork, etc. Re-work, corrections, etc. Storage between operations, batching inventory Wait times, delay times, idle timesLean Six Sigma -Definitions35 Lean Six Sigma -7 most common wastesIdentify and reduce: Defects (repair, rework, scrap) Overproduction (inventory) Transportation (conveyance) Waiting (queue time) Inspection (reliance on mass inspection/ verification) Motion (parts, paper, people) Process, itself (over-processing, long cycles) Commonly referred to as the 7W *7 common wastes of production (Shingo) Commonly referred to as the 7 WCommonly referred to as the 7W.

10 *7 common wastes of production (Shingo)*7 common wastes of production (Shingo)MUDA = nonMUDA = non--value added activityvalue added activity(waste)(waste)..36 MotionWaiting timeOverproductionProcessing timeDefectsInspectionTransportationProbl ems/ CausesIncorrect layoutsLack of proximity of machinesOff-line resourcesWaiting workers, machines, materialsLong set-ups and lead timesLarge batches, raw material stocksHigh WIP, finished goods stocksMaking for the sake of itIgnoring customer demandsLong cycle times-process, itselfReduced efficiency-over processingHigh overall lead timesLong delays for rectificationCostly reworkDissatisfied customersApprovals of approvalsHigh number of verification stepsReliance-Mass inspection techniquesUnnecessary movementExtra handlingTypes of Waste(7W s)