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Principles ofLean Six Sigma
andCAPA
Eugenio Longo, PhD.Eugenio Longo, PhD.Industrial Advisor &Industrial Advisor &Visiting ProfessorVisiting Professor for Universitiesfor Universities
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Agenda :
Part 1 – Lean Six Sigma
OverviewLean and 6 Sigma integration
Work shop + QuizTake away:
Closing
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Agenda :Part 2 - CAPA
Objectives of courseMed Dev + Pharmaceuticals
Operations OverviewStatistics regarding CAPA issues: FDA 483, Warning
Letters + Consent Decree.What is an effective CAPA program important for your
businessCAPA regulation in detailCAPA inputsEffective approach
Problem SolvingTechnical WritingTracking and F/UOwnership – your way of making business.
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Principles of Lean Six Sigma
Overview of LeanManufacturing and Six Sigma
MethodologiesA
Lean Enterprise
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Introduction
Today’s manufacturing and businessenvironments are reaching a point thatcompetition for survival and market share isan obligation.
Tracking the global economy will show thatbeing good is not enough, therefore eachorganization really strive for excellence ifwant to stay in the market.
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Business Facts
Every single organization islooking for one singleoutcome…
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Business Facts
PROFIT
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Business Facts
PROFIT is not a single concept butcomes with many importantimplications:• P- Process excellence• R- Resources Management• O- Oriented to a Goal• F- Financially Strong• I- Innovative – to stay ahead of
competition• T- Timely deployment of strategies
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Business Facts
The most traditionaldefinition ofPROFIT……..
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Business Facts
$$$LET’S MAKE
MONEY$$$
BUT DO ITRIGHT
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How we make PROFIT
In order to be a leader, most companies arerealizing that traditional management,manufacturing processes, and other historicapproaches, are not enough.
More effective methods are needed:• Six Sigma• Lean Manufacturing
With origins in the Toyota ProductionSystem, is a way of living in the businessenvironment.
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History of ManufacturingHistory of Manufacturing
Made to customer specSingle piece mfg… each product uniqueVariable qualityLittle inventoryHigh cost … made for the rich
CraftCraftCraft
Interchangeable parts – Whitney Division of labor – Taylor Assembly lines – Ford Labor strife
Mass ProductionMass ProductionMass Production
High variety Small batch sizes PPM quality Engaged workforce
The “Lean” EnterpriseTheThe ““LeanLean”” EnterpriseEnterprise
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Recognize a need to change and beable to do PROFIT.
Process Analysis is the foundationProcess Analysis is the foundationtoward achieving Process Excellence.toward achieving Process Excellence.
How we make PROFIT
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We need to Change to makePROFIT?
We need to Change to makeWe need to Change to makePROFIT?PROFIT?
A need for change is usually characterized by:Quality is a “Q.A.” department responsibility
Large production lots
Large centralized stores
Customer dissatisfaction
Enormous part and process variation
Set-up measured in hours instead of minutes
Order entry times measured other than in minutes
Product margins eroded by increasing operating costs
Ever-increasing competitive pressures
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Why Change ?Why Change ?Why Change ?
Need for change is a STRATEGIC ISSUE whichany and every Manufacturer must address:
Quality - How to improve it
Cost - How to control it
On-time Delivery - How to ensure it
In other words, How we make PROFIT?
Failure to improve in all three areas means a lossof competitiveness in today’s global marketplace.
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Why Change ?Why Change ?Why Change ?
“Lean Linking”
is …
Forward Thinking !
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Why Change ?Why Change ?Why Change ?
““Lean LinkingLean Linking””
isis ……
Forward Thinking !Forward Thinking !
Do not become the dinosaurDo not become the dinosaurof your industryof your industry
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Evolutionary vs. RevolutionaryChange
Evolutionary vs. RevolutionaryEvolutionary vs. RevolutionaryChangeChange
Having a forward looking perspective on continuousimprovement is a requirement of the competitivemarketplace and is the first step in becoming world-class.
DO NOT set incremental improvement goals over previousperformance, rather -
Think of where we need to be:Continually declining costs
Zero defects
Minimal inventories
Fully satisfied customers
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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 reduced by 20% per year
Delivery Lead Times reduced by more than 75%
On Time Delivery improved to 99+%
Productivity (sales per employee) increases of
15-25% per year
Inventory (working capital) reductions of more than75%
Return on Assets improvement of 100%+
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Analyzing and ImprovingProcesses
Analyzing and ImprovingAnalyzing and ImprovingProcessesProcesses
An integrated approach to utilizing Capital, Materials, andHuman resources to produce just what is needed, when it isneeded. In the amount needed with minimum Materials,Equipment, Labor and Space.
A Lean DefinitionA Lean DefinitionA Lean Definition
Identify and eliminate waste(MUDA).
Overriding PrincipleOverriding PrincipleOverriding Principle
What’s in a Name . . .WhatWhat’’s in a Name . . .s in a Name . . . Toyota Production System, J.I.T., Lean Manufacturing,
Demand Flow Technology, Kaizen, is really Process Analysis !
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How we make PROFIT - TPS
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Building Blocks of The LeanBuilding Blocks of The LeanEnterpriseEnterprise
“Continuous Improvement”
TeamworkRewards / RecognitionTraining
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“Continuous Improvement”
ValueStreamMapping
TeamworkRewards / RecognitionTraining
Building Blocks of The LeanBuilding Blocks of The LeanEnterpriseEnterprise
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Quick Changeover
Standard Work Batch Reduction Layout
Mistake Proofing
5S SystemProjects Visual Management
POU
Cellular / FlowPull / Kanban TPM
“Continuous Improvement”
ValueStreamMapping
TeamworkRewards / RecognitionTraining
Building Blocks of The LeanBuilding Blocks of The LeanEnterpriseEnterprise
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How we do PROFIT – by anOperational Excellence
Mission Statement
How we do PROFITHow we do PROFIT –– by anby anOperational ExcellenceOperational Excellence
Mission StatementMission StatementDevelop the ability:
To recognize and identify waste
To have to courage to call it waste
To have the desire to eliminate it
Eliminate the waste
Truly understand that wasteRaises costs
Produces no corresponding benefit
Threatens all of our jobs
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To do PROFIT we can use the Lean SixSigma Strategy …To do PROFIT we can use the Lean SixTo do PROFIT we can use the Lean SixSigma StrategySigma Strategy ……
… for turning manufacturing and businessprocesses into competitive weapons.
Producing what is needed, when it isneeded, with a minimum amount of
materials, equipment, labor and space.
“Prime Directive” - to continually seek out andeliminate waste and wasteful practices.
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The Lean Six Sigma Strategy …The Lean Six Sigma StrategyThe Lean Six Sigma Strategy ……
… with 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 COSTS
With an overriding principle: Safety 1Safety 1stst !!to continually seek out and eliminate unsafe operatingconditions and practices in every aspect of ourBusiness.
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The Lean Enterprise is a Strategy …The Lean Enterprise is a StrategyThe Lean Enterprise is a Strategy ……
… with 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 COSTS
With 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 issues.
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With a well-planned implementation,overall expected RESULTS may include a …
(within 12 months)
35% to 50% reduction in lost time/safety-related incidents and accidents
15% to 30% decrease in scrap and rework
25% to 40% reduction in total cycle time
The Promise of Lean Six SigmaThe Promise of Lean Six SigmaThe Promise of Lean Six Sigma
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Lean Six Sigma – Benefits.
The Benefits Are There For The Taking
The Benefits Always Include Increased Market Share, Lowered Cost HigherProfits And Happier Customers (And Shareholders)
“Lean” Is The Only Answer Known That Provides These Benefits
“Lean” Never Fails If You (R-E-A-L-L-Y) Do It
Saying “Lean” Is Not Doing Lean
Every Successful Business That Competes In An Over-capacity Or Price-sensitive Market Is Doing “Lean” Whether They Know It Or Not
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Lean Six Sigma
Philosophy and Key Concepts• The 5 core principles of Lean• Define value-added and non-valued added
activity• Define the 7 most common types of waste• and their causes.• Review a systematic approach to discover
waste within a process.
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Learn the 5 Core Principles of Lean:1) Specify value in the eyes of the customer
2) Identify value stream and eliminate waste
3) Make value flow at pull of the customer
4) Involve & empower employees
5) Continuously improve in pursuit of perfection
Lean Six Sigma
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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 customer.
Non-Value Added ActivityThose activities that consume time or resources, but do not addvalue in the eyes of the customer.
Lean Six Sigma
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Value Added• Any activity or operation performed that helps transform a product or service
from its raw state into its finished form.• Completed right the first time.• Any activity customer is prepared to pay for. Activity required to ensure that
a product or service is delivered in conformance to specification.
Non-Value Added• Any activity that doesn’t help to transform a product or service into its final
form. 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 times
Lean Six Sigma - Definitions
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Lean Six Sigma - 7 most common wastes
Identify 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’s…”*7 common wastes of production (Shingo)
““Commonly referred to as the 7WCommonly referred to as the 7W’’ss…”…”*7 common wastes of production (Shingo)*7 common wastes of production (Shingo)
MUDA = nonMUDA = non--value added activityvalue added activity(waste)(waste)……
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Motion
Waiting time
Overproduction
Processing time
Defects
Inspection
Transportation
Problems/ CausesIncorrect layoutsLack of proximity of machinesOff-line resources
Waiting workers, machines, materialsLong set-ups and lead times
Large batches, raw material stocksHigh WIP, finished goods stocksMaking for the sake of itIgnoring customer demands
Long cycle times- process, itselfReduced efficiency- over processingHigh overall lead times
Long delays for rectificationCostly reworkDissatisfied customers
Approvals of approvalsHigh number of verification stepsReliance- Mass inspection techniques
Unnecessary movementExtra handling
Types of Waste(7W’s)Value
Added
Non- Value Added,but necessary
Waste
Focus onreduction
Peop
lePr
oces
sPr
oduc
t
The Causes of Waste in most ProcessesThe Causes of Waste in most Processes
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Product LeadProduct Lead--TimeTimeRaw
MaterialsFinishedGoods
Value AddedTime
Non- ValueAdded Time
TIME
Lean Six Sigma
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Product LeadProduct Lead--TimeTime
95% Non95% Non-- Value AddedValue Added
Lean Six Sigma
Historically,Historically,improvement effortsimprovement efforts
have been focused here.have been focused here.
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Product LeadProduct Lead--TimeTime
Whereas,Whereas, ““Process AnalysisProcess Analysis”” activitiesactivitiesshouldshould
Focus hereFocus here -- the Elimination of Wastethe Elimination of Waste(MUDA)(MUDA)
95% Non95% Non-- Value AddedValue Added
Lean Six Sigma
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Identifying WasteIdentifying WasteWaste can take many forms; some causes of
the most common forms of waste include:
lack of adherence unnecessary approvals or signatures reviews of reviews multiple hand-offs transportation long setup time correction, and over-production
Lean Six Sigma
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Identifying WasteIdentifying WasteOther causes of waste may include:
poor maintenance lack of training poor supervisory skills ineffective production planning/ scheduling lack of workplace organization Supplier quality/ reliability
In most cases, inventory is wasteful; moreimportantly, inventory hides all sorts ofproblems in the company
Lean Six Sigma
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Learn to Recognize the Types ofWaste
From Taiichi Ohno, Architect of the Toyota Production System
PEOPLE
TYPESOF
WASTE
Processing
Motion
Waiting
FixingDefects
Making TooMuch
MovingThings
Inventory
QUANTITY
QUALITY
Overproduction / Making To MuchTies up capital, diverts production fromcustomer requirements, loss of inventories
Transporting / Moving ThingsUnnecessarily increases production time,extra WIP
Unnecessary Stock / InventoryTies up capital, risk of changes
WaitingDecreases productivity, wastes personnelresources
Unnecessary MotionIncreases production time, unnecessaryoperator motion
ProcessingPoorly designed / incapable processes
DefectsScrap, rework, returns
Lead time reduction is achieved by identifying and eliminating waste
43Inventory Hides ProblemsInventory Hides Problems
LongSet-upTime
Poor5-S
QualityProblemsLine
Imbalance
Down-Time
Vendor Delivery Problems
PoorScheduling
PoorCommunication Absenteeism
PoorProcess
Capability
Raw Material Finished Goods
Your CompanyYour Company
Lean Six Sigma
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Process Analysis to the RescueProcess Analysis to the Rescue… we have only begun to deal with issues involvedin trying to tie everything together for a whole-system approach. Some of the problems thatcontinue to confound us are the following:
The way manufacturing works with Sales makesscheduling and running the plants difficult. We compound the above problem by the way we order from
suppliers.
Labor and management still don’t trust each other.
The way we measure performance doesn’t provide information usefulto running a plant and often encourages wrong decisions.
Lean Six Sigma
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Look at the “3 Real Things” in every operation …
• Material Flow(or Business Steps i.e. transactional processes)
• Information Flow (data)
• Work-in-process (could be both…)
Lean Six Sigma – How to Discover Waste
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Lean Six Sigma – How to Discover Waste
Ask what?What is the operation doing?
Ask why?Why is the operation necessary?Ask why at least 5 times to lead you to the root cause
Everything that is not work is wasteOnce you know the function, you can identify as wasteanything that does not execute that function
Draft an improvement plan…Ask how?
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Be on the look-out for these3 Major contributors …
• Overburden/ Overdoing
• Unevenness
• Process methods
Lean Six Sigma – How to Discover Waste
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Be on the look-out for these3 Major contributors …
• Overburden/ Overdoing (muri)
- waste caused by how work and tasks are designed
• Unevenness (mura)- waste caused by poor quality (process unpredictability)
• Process methods (muda)- waste caused by “DOT WIMP”
Lean Six Sigma – How to Discover Waste
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Lean Six Sigma - What actions must we take?
We must …• decrease cycle times• reduce travel distances• standardize our processes• reduce scrap, rework and waste• improve all of our business processes• reduce the variation in our schedules• provide a constant, steady supply of• parts to production, assembly, and test
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Lean Six Sigma - What actions must we take?We must …
• design products to match a stable,• standard production process• gain Market share
- and -• increase our competitiveness !
• NowNow –– how do we get there ??how do we get there ??
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Lean Six Sigma
Utilize the processUtilize the process ““DMAICDMAIC”” ……(Define, Measure, Analyze, Improve and Control)(Define, Measure, Analyze, Improve and Control)
• Understand the Problem• Form the Team• Understand the Process• Gather Process Data• Analyze the Process• Identify possible Corrective Actions• Screen/ Experiment to select best action• Implement Action• Verify Action• Sustain Improvement
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The Lean Six Sigma is a StrategyThe Lean Six Sigma is a Strategy ……… for turning manufacturing and business
processes into competitive weapons.
Producing what is needed, when it isProducing what is needed, when it isneeded, with a minimum amount ofneeded, with a minimum amount of
materials, equipment, labor and space.materials, equipment, labor and space.
“Prime Directive” - to continually seek out andeliminate waste and wasteful practices.
Lean Six Sigma
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SIX SIGMA
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Six SigmaSix Sigma is the term applied to the
application of the DMAICmethodology.
It is a structured, disciplined, rigorousapproach to process improvement.
The five steps link to each other into alogical sequence, creating an infiniteloop for process improvement.
The goal of the method is to achieve3.4 defects per million parts (oropportunities of doing it wrong), mostcommonly known as 6 Sigma.
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Six Sigma
Implementation of Six Sigma requirescommitment of the organization andteam leaders.
Is quite common to see, Yellow Belts,Green Belts, Black Belts and too oftenthe …Soft Belts….
Being the last ones the ones obstructingthe implementation.
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Six Sigma
If the organization you work for has a SixSigma Program in place, notnecessarily guarantee the success ofthe organization. It depends on goodteams, good steering committee andchampions as well as managementsupport.
In any Six Sigma program, keeping theright people engaged towards successis the key.
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Six Sigma – DEFINE Stage:
The objective in this area is to create aclear statement, a Team Charter, thatdepicts the success story to be created.
Shows a high level description of theprocesses being improved and theexpected achievements.
Show how your customers will beimpacted
The most critical stage to catch thesupport from your organization.
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Six Sigma – MEASURE Stage:The whole objective here is to gather data
and information that will help you in pinpointing the real causes of the problembeing resolved.
Here you will know your current situationand the expectation on how much canbe improved.
Information here, helps to refine yourdefine stage if needed.
Set up the basis for the next stage:
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Six Sigma – ANALYZE Stage:
The objective here is to get the data anduse statistical tools to identify the rootcause(s), create a hypothesis (orseveral ones) and prove them out.
The ones that prove to be the realcauses, are the ones needed to beaddressed on the next stage.
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Six Sigma – IMPROVE Stage:
The target id to implement actions tocorrect the problems identified on theprevious stage.
These actions need to be tested andmeasured to verify that are effective.
The effective methods set the basis forthe next stage.
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Six Sigma – CONTROL Stage:
The target in here is to turn the solutions found into arentable change in the processes.
These changes are to monitor the performance,maintain the benefits from the solution implementedand set the ground for new improvementopportunities as the new data being collected feedsthe DMAIC cycle for another project.
In the regulated industry, theses changes mightrequire, new procedures (SOP) and Validations toensure compliance to ISO and FDA regulations asapplicable.
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Six Sigma – Summary
Each single stage relies on the previous one fora comprehensive effect.
Cutting corners is prohibited in Six Sigma.All data generated and used must be kept in an
organized fashion, might be helpful when theDMAIC cycle gets you to a problem wherethat particular information was alreadygathered.
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Six Sigma – Tool BoxTOOL NAME D M A I C TOOL NAME D M A I CAffinity Diagram X X Frequency Plots X X X XBrainstorming X X FMEA (Failure Mode & Effect Analysis) XBusiness Case X Gage R & R XCause-and- Effect Diagrams X Hypotesis Tests XCharter X t-testConsensus X paired t-testControl Charts X X X X ANOVA
Continuous data Chi SquareIndividuals Kano Model XX-Bar, R Planning Tools XEWMA Gantt Charts
Discrete data Planning Gridp,np Pareto Charts X X Xc,u Prioritization Matrix X X
Critical to Quality Tree X Process Capability X XData Collection Forms X X X X Process Sigma X X
Check Sheet Quality Control Process Chart XPfrequency Plot Check Sheet Regression XConfirmation Check Sheet Rolled Throughput Yield XConcentration Diagram Sampling X X X X
Data Collection Plan X X X X Scatter Plots XDesign of Experiment X X SIPOC (Suppliers, Inputs,Process,Outputs,Customers) X
Full Factorial Stakeholder Analysis X XReduced Fractions Standardization XScreening Designs Stratification X X X XPlacket-Burnham Designs Stratified Frequency Plots XMore than Two Levels Time Series Plots (Run Charts) X
Flow Diagrams X X X X X VOC (Voice of the customer) X
CYCLE STAGE CYCLE STAGE
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Six Sigma -Summary
After each stage is completed,demand a meeting a with thepeople that must know, theprogress is your best selling tool tokeep getting the support.
Don’t be shy – your champion isthere to assist you, the Black Beltis there to help you; no one is anexpert on all the statistical tools,so ask for help before assumingincorrectly.
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Lean Six SigmaSix Sigma alone is not Lean
Manufacturing, is just one tool,that combined with statistics cangive you solutions.
Using the DMAIC cycle and usingother Lean Manufacturing toolsinstead of Statistics can alsoproduce results.
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TYPE OFWASTE
WASTEREDUCTIONAPPROACH
METHOD DESIREDRESULT
Standard Work
WorkplaceOrganization
Kaizen
WorkplaceManagement
Just-in-time
ErrorProofing
Processing
Motion
Waiting
WhatYouNeed,WhenYou
NeedIt
HighlyEfficient,
SafeWorkAreasWithHigh
Output
GoodQuality
Inventory
MovingThings
Making TooMuch
FixingDefects
Leveling
Kanban
Quick Setup
PreventiveMaintenance
Detection
Warning
Prediction
Prevention
CATEGORYOF WASTE
PEOPLE
QUANTITY
QUALITY
FOCUSPOINTS
Work BalanceWIPLocation/AmountKanban LocationKanban TypesLot SizesChangeover AnalysisPM Analysis
LayoutLabelingTools/PartsArrangementWork InstructionsEfficiencyTakt TimeSkills TrainingShift MeetingsCell/Area TeamsVisual Displays
Appropriate AutomatedAssistance
Fixture ModificationsSuccessive ChecksLimit SwitchesCheck SheetsPhotocells, Templates,
Etc.Cross Training
PRINCIPALWORKSHEETS
Standard WorkSheet (SWS)
Time ObservationForm (TOF)
Standard WorkCombination
Sheet (SWCS)Work Load
Balancing Sheet(WLBS)
Kaizen TargetSheet (KTS)
Kaizen ActionSheet (KAS)
SWSSWCSWLBSKanbansTable of
ProductionCapacity ByProcess (TPCP)
PM SchedulingSheet (PMSS)
SWCS
Error ProofingAction Sheet(EPAS)
Error Proofing “ToDo” List (EPL)
Skill VersatilityVisual DisplayJidoka
Autonomation
20 Keys
Kaizen - oneeffectivemethod amongmany thatengages PEOPLEand “recruits”the other tools
Lean Six Sigma- Approaches and Techniques
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KAIZEN
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Kaizen = Continuous Improvement
“Kai” = Small, Continuous Change“Zen” = Ongoing Change For The
BetterStructured, Focused, Coached,
Mandated & Required Activity ToCompel Every Employee ToParticipate In Improving The QualityAnd Efficiency Of Their Day-to-dayMicro-processes
Not A “Suggestion Box” Program
Building Blocks of Lean ProductionJust-in-timeStandard operationsMistake-proof processingPull production & single pieceflowCellular manufacturingVisual workplace
Kaizen is the “transport vehicle”to import these building blocksof lean production
These concepts are equally applicable to the factory floor and within the office
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• Reject the current situation
• Keep an open mind to change
• Maintain a positive attitude
• Make problems visible; make theworkplace visual
• Never leave in silentdisagreement
• Practice mutual respect everyday
• One person, one voice - noposition or rank
There’s no such thing as a dumbquestion
Take action over excuses andmake actual improvements now
Get on base rather than go for thelong ball (small progress vs. all)
Use your head rather than yourmoney
Destroy myths of fixed production
It’s a never ending task
HAVE FUN and JUST DO IT!
Lean Six Sigma – Guides for Kaizen
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VALUEVALUESTREAMSTREAMMAPPINGMAPPING
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Origins in Toyota, circa1955 – The way of doing business…
Also called “Material and Information Flow Mapping”
Used by Toyota Motors to show both current and ideal statesas part of the lean implementation process
Discussed in “Lean Thinking”Further developed anddocumented by the LeanEnterprise Institute ofBrookline, Mass.“Learning to See”
19961998
Lean Six Sigma – Short History
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Total Value Stream
SUPPLIERS YOUR PLANT OR BUSINESS CUSTOMER TO END USER
All the actions, both value added and non-value added, currentlyrequired to bring a product from raw materials to the customer.All the actions, both value added and non-value added, currentlyrequired to bring a product from raw materials to the customer.
Lean Six Sigma – What is Value Stream?
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A value stream is all the actions (both value added and non-valueadded) currently required to bring a product (or transaction) though themain flows essential for every product/ service: from raw material/(customer need), through all the required steps, then – back to thearms of the customer.
Taking a value stream perspective means working on thebig picture, not just individual processes, and improvingthe whole, not just optimizing the parts.
TOTAL VALUE STREAM
SUPPLY
PARTNERS YOUR PLANT OF COMPANY CUSTOMER TO END USER
Lean Six Sigma – Value Stream Perspective
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WIP 870
QTIME72H
MELT903M
INSPCHEM
HoldFurnace
Cast903
INSPPROFILE
WIP 696QTIME
P/T 6N
LOT 75K
P/T 8HWIP 8 COILS
120K
P/T 3 HR15KWIP
STORE STAGE BREAKDOWN911
REC STAGE
LEAD 2231.1
VA 210.17%SCRAP
WIP746KQTIME8 1OK
LOT 1 COILTIME .1WIP 15K
WIP108K8HRQ/T8
DOWNTIME 15%
DOWNTIME 15.5%
8 6 8 3
OperationalOperational exampleexample
Map major process stepsI.D. Value (green/ yellow) / Non-value (red)Capture all times, quantitiesPrioritize areas to improve
X SHIPPED PER DAY
850K
1.870 WIP BEING WORKED
4.276 WIP BEING STORED
Lean Six Sigma – Value Stream Map
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Customer
MACHINING
C/T=1568 mC/O=50 min.
2 SHIFTSOPER. 48
Daily
FIFO
Prod’n Cont.
Supplier OrdersOrders
IRREGULAR
ASSEMBLY
C/T=936 mC/O=0 min.1 SHIFT
OPER. 24
TEST
C/T=60 mC/O=30 min.1 SHIFTS
OPER. 5
FINISH
C/T=210 mC/O=0 min.
1 SHIFTSOPER. 6
DISPATCH
C/T=30 mC/O=0 min.
1 SHIFTSOPER. 2
FIFOFIFO
OXOX
1 DAY
2 DAYS 2 DAYS
900 MINS 900 MINS 240 MINS 150 MINS 120 MINS
1568 MINS 936 MINS 60 MINS 210 MINS 30 MINS
4 WEEKSOUT
12 WEEK FORECAST
< 1/2 DAY <2 ENGINES <2 ENGINES
PITCH = 60MINUTES
LT<3 1/2 DAYS
MANUFACTURING LEADTIME = 3 1/2 DAYSCUSTOMER LEADTIME = 2 WEEKS
Big PictureBig Picture exampleexampleLean Six Sigma – Value Stream Map
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• To understand the current situation - The“big picture” point of view (To use as a tool to
improve the whole vs. optimizing the parts…)
• Exposes sources of waste - not just the waste
• Shows linkage between information flow andmaterial flow
• Forms the blueprint to identify areas ofimprovement
Lean Six Sigma – Why do Value Stream Mapping?
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• It helps visualize more than just the single-process level, i.e.assembly, welding, etc., in production. You can see the wholeflow.
• It helps to see more than waste. Mapping helps to see the sourcesof waste in your value stream.
• It provides a common language for talking about manufacturing(and transactional) processes.
• It makes decisions about the flow apparent, so you can discussthem. Otherwise, many details and decisions in your area justhappen by default.
• By adding data, it ties together lean concepts and six sigmatechniques, which helps you avoid “pet projects”.
Lean Six Sigma – Why do Value Stream Map do for us?
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It forms the basis of an implementation plan. Byhelping you design how the whole door-to-door flowshould operate - a missing piece in so many leanefforts - value stream maps become a blueprint forimprovement. Imagine trying to build a housewithout a blueprint!
• It shows the linkage between the information flowand the material flow. No other tool does this.
Lean Six Sigma – Value Stream Map is an Essential Tool
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It enhances the quantitative tools and layoutdiagrams that produce a tally of non-value addedsteps, lead time, distance traveled, the amount ofinventory, and so on.
• Value stream mapping is a qualitative tool by whichyou describe in detail how your facility shouldoperate in order to create flow. Numbers are goodfor creating a sense of urgency or as before/ aftermeasures. Value stream mapping is good fordescribing what you are actually going to do toaffect those numbers.
Lean Six Sigma – Value Stream Map is an Essential Tool
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SteelRecd
PartsStocked
Componentsmachined
Plate Steelburned
StructuralSteel Sawed
Steelstocked Weld Shop Paint Shop
Elect/Mech PartsRecd
Blasting BoothSand Bast
Mech parts toMech Assembly
Staging
Partsstocked
Inspection
MechAssembly
Elect parts toElect Assembly
Staging
ElectAssembly
InspectionRun TestCratingShippingWarehouseShip toCustomer
Steel Fabrication Process (Current State)Can you identify areas for improvement?
Lean Six Sigma – Process Map Analysis
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SteelRecd
Componentsmachined
Plate Steelburned
StructuralSteel Sawed
Weld Shop Paint Shop
Elect/Mech PartsRecd
Blasting BoothSand Bast
All parts toAssemblyStaging
Inspection
Mech/ElectAssembly
Inspection &Run Test
Ship toCustomer
Steel Fabrication Process (Future State)
Shipping &Crating
Lean Six Sigma – Process Map Analysis
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5 S
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The Benefits of ImplementingThe Benefits of Implementing ““5S5S””
5S provides a basis for being a world-class competitorand the foundation for a disciplined approach to theworkplace.
Safer working conditions A cleaner and more organized work area Reduction in non-value added time Effective work practices Efficient work processes
Facilitating a change: Safer, Better, Faster !Facilitating a change: Safer, Better, Faster !
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And The 5And The 5--SS’’s ares are……
Seiri – (Separate) or SortSeiton – (Straighten) Store, or Put-in
PlaceSeiso – (Clean) or ShineSeiketsu – (Standardize)Shitsuke – (Discipline) or Sustain
+ Safety !+ Safety !
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Sometimes called 5S + 1 orSometimes called 5S + 1 or ““6S6S””
Safety 1Safety 1stst !! (in everything we do!)Seiri – (Separate) or Sort
Seiton – (Straighten) Store, or Put-in Place
Seiso – (Clean) or Shine
Seiketsu – (Standardize)
Shitsuke – (Discipline) or Sustain
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Lean Six Sigma - Other Lean Tools
• Root Cause Analysis and CorrectiveAction (RCCA) – 5 Why Technique
• Spaghetti Charts• Pareto Analysis• Visual Displays• Visual Controls• Total Predictive Maintenance• SMED – Single Minute Exchange of Dies.
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Lean Six Sigma
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LEAN SIX SIGMA
REFERENCES:• The Lean Enterprise – http://www.freeleansite.com/• Six Sigma Green Belt and Champion Training– BD Training• The Kaufman Consulting Group, LLC (KCG) – BD Training• Six Sigma –Pocket Guide, Rath & Strong’s (ISBN: 0-9705079-0-9)