Six Sigma - Overview

Presented by: Ryan M. Ismail, M.Eng, MBATherapeutic Area Program ManagerMerck Research Labs

*What is Six Sigma?A structured, methodical approach to process / product improvement and design robustness

All decisions are based on facts and data

A powerful Tool Box is used to identify and eliminate waste through the reduction of underlying process variability

It is applicable in both Manufacturing and Transactional (Business) processes

It is implemented through highly trained, motivated individuals called Black Belts and Green Belts from all functions

Six Elements of Six SigmaGenuine focus on the customerThe Voice of the Customer (VOC) is the foundation of the methodologyData- and fact-driven managementUse data to prove that solutions work and gains are sustainedProcess focusImproving processes ensures competitive advantage delivering real value to customersFrom The Six Sigma Way, by Pande, et al

Proactive managementSet/track goals, establish priorities, reward fire preventionBoundaryless collaborationCustomer-centric; processes transcend departmental silosDrive for perfection, tolerate failureNew ideas/approaches involve risk; overcome fear of mistakesSix Elements of Six Sigma

Determine customer need to be satisfiedIdentify the business process that fulfills the needStudy the process, identify variation driversOptimize the processEnsure that customer need is met and fix is sustainedThe Six Sigma Approach

What is the Definition of

Six Sigma?

*Area Under Normal Curve68% OF DATA FALL WITHIN 1 STANDARD DEVIATION OF THE MEAN

*Area Under Normal Curve95% OF DATA FALL WITHIN 2 STANDARD DEVIATIONS OF THE MEAN

*Area Under Normal Curve99.7% OF DATA FALL WITHIN 3 STANDARD DEVIATIONS OF THE MEAN

*LSL3 Sigma ProcessPROCESS 6 sLSLUSLPERFORMANCE 6 sCp = 1.001 s

*6 Sigma ProcessLSL Cp = 2.00PROCESS 6 sLSLUSLPERFORMANCE 12 sCp = 2.00

*Process CapabilityLCLUCLyUSLLSL6s12sProcess TolerancesPerformance (VOC) TolerancesLatitudeThe Tools Develop Latitude in Process Capability

*Major Sources of VariabilityInsufficientProcess CapabilitySkillsandBehaviorsPoor DesignMeasurement SystemUnstable Partsand Material

Average Average DeliveryDelivery CycleCycleCustomers Expectations: 8 Day Order to Delivery Cycle2017 152 305 1012 5416 Day8 DayExisting Process After ConventionalDelivery Cycle Process Improvement(days)Cycle (days)2 5 8 12 17Customer Want DateDays Late(+9)Days Early (-6)15 Day SpanWe are pleased with our 50% cycle improvement however, our customers didnt feel a thing!Averages vs. Variation

*Effectiveness (customers view): meeting customer requirements and creating delight Customers feel VARIATION, not averages Win by preventing fires, not fighting themEfficiency (management view): providing streamlined processes, minimizing internal costsCustomer & Management Views

*Sigma or the Standard Deviation of the process distribution allows us to determine and communicate the capability of the process. The Sigma Level of a an in-control process is simply the number of standard deviations of the process distribution that consume 1/2 the allowed tolerance band if the process were centered around the target value.

The term SIX SIGMA

What is a Six Sigma

Project?

*"All improvement takes place project by project and in no other way."Dr. Joseph M. JuranSIX SIGMA PROJECTS

*The overall goal of the Six Sigma Initiative is to significantly improve customer perceived value and companys profitability. Projects that fit that criteria are legitimate projects. Six Sigma projects should be linked to the highest levels of strategy and be in direct support of specific WW business and core process objectives.

Six Sigma projects should be definable and manageable in scope with high probability of completion in four to six months, or less.

A Six Sigma project should offer a significant opportunity for reduction in Cost of Poor Quality (COPQ), in addition to improving such things as customer satisfaction, capacity, and top-line growth.

What Is a Six Sigma Project?

*What Is a Six Sigma Project? There are five phases of Six Sigma methodology:

Define (D)Measure (M)Analyze (A)Improve (I)Control (C)

Together it is called DMAIC

*The Six Sigma RoadmapA Structured Approach:

DMAIC

*What Is a Six Sigma Model?Taken together, they are referred to as the DMAIC process of quality improvement. The Six-Sigma methodology is based on simple yet powerful model,y=f(x)

where y represents the key process outputsx represents key process inputs that strongly effect the outputfunction, f represents the relationship between the inputs and outputs.

*Six Sigma Toolbox

*Purpose: To accurately describe the problem, define project success, and to commit the resources necessary to solve the problem.

Deliverables:Problem statementMission statement and project scopeProject teamApproved COPQProject plan and timelinePhase 1: DEFINE

*Problem StatementMission StatementProject TeamInitial COPQSix Sigma Toolbox Define

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*Project Assignment / SelectionDefinition of Six Sigma Projects

Definable and manageable

High probability of completion in less than six months

Significant opportunity for reduction in Cost of Poor Quality (COPQ)

Improve customer satisfaction, capacity, and top-line growth

*Prepare a Problem / Mission Statement

Define the scope of your project in the Problem / mission statement

Example: Effective Problem StatementOur companys procedure for shipping replacement parts takes ten days longer on average than our major competitors take.

This statement is:Specific: It names a particular process and states the problem.Observable: Evidence of the problem can be obtained from internal reports and customer feedback.Measurable: Shipping time is measured in days.Manageable: The problem is limited to one type of shipping procedure.

*Cost Of Poor Quality (COPQ)Theory of:Tip of an Iceberg

A few costs are easy to see like the part above the waterline

Many more costs are hidden below the water.

*Define COPQCOPQ are the costs that would disappear if every task was always performed without deficiency (Source: Juran Institute Inc.)

COPQ are the cost of failures including costs of insuring quality in manufacturing, delivering, and servicing of the products.

The three major COPQ categories:Appraisal / Inspection CostInternal Failure CostsExternal Failure Costs

*Purpose: To characterize the process as it currently exists and to focus the project by narrowing the range of potential causes. To evaluate current measurement systems and ensure measurement capability. Define and develop a data collection strategy.Deliverables:Process MapCause and Effect DiagramCE-Matrix of prioritized KPIVsProcess FMEAData collection planMeasurement system analyses (MSA)Baseline measurement dataProcess CapabilityList of Theories to testFirst draft of preliminary control planPhase 2: MEASURE

*Process MappingCause and Effect DiagramCause and Effect MatrixProcess FMEAList of Theories to TestMSAData Collection PlanBaseline DataSix Sigma Toolbox - Measure

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*Data Collection PlanPurpose: Generate data to learn aboutThe ProcessThe Measurement System (Note: The measurement system must be suitable for the task at hand)

Steps: Develop forms/spreadsheets necessary to collect the data.Record the process inputs Measure and record the output (i.e; frequency or days)Present the data (graphically) and analyze the output (Why is there so much variation?)

*Define and MeasureMeasurement Systems Analysis (MSA)

Understanding how much variability comes from your gage or measuring device.

Reducing the variation, if possible, so that variation observed is from the process.

*Measurement SystemExamples

Weights Check (weight)Part tolerance (distance)UV measurement (absorbance)Analytical tests (concentration)Torque testing (force)Visual inspection (labels, color, etc.)Functional performance (activity, days, etc.)Others? ____________________

*Where does Total System Variation Occur?System Variation

*Measurement System AttributesA measurement system

Should be Accurate

Should be Precise

And should be Stable

*ACCURACYBias is the difference between the observed average measurement value and the actual or true value. Bias is a measure of lack of accuracy.It is typically the most common and easiest problem to fix.Bad Accuracy, Good PrecisionTRUE VALUE

* Accurate but not PreciseTRUE VALUEPRECISIONPRECISION is the ability to replicate measurements time after time. LACK OF PRECISION implies VARIABILITY.

All measurement systems should be repeatable, both within and between evaluators.

*STABILITYAll instruments need to be periodically re-calibrated because ACCURACY DETERIORATES over time.A lack of stability implies a creeping bias over time. Need to run a standard on a regular basis to ensure there is no degradation or bias in the measurements.

*Purpose: Through data analysis, narrowing down the trivial many process variables (X's) to the significant few Key Process Input Variables (KPIVs / Vital X's).

Deliverables:List of Key Process Input Variables (KPIVs)Updated Preliminary Control PlanUpdated list of Theories to Test

Phase 3: ANALYZE

*Passive Data Collection:Run ChartsPareto ChartsHistograms and DotchartsBox plotsDefect Concentration PlotsScatterplots and Marginal Plots

Active Experimentation (DOE):Factorial DesignsFactor Pareto Charts Main Effects ChartsInteraction Charts

Six Sigma Toolbox - Analyze

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*Not all inputs are important.Only a few will drive the processDEFINE & MEASURE

ANALYZE

IMPROVE

CONTROLY = f ( X1, X5, X9 )Y, X1, .., X15CharacterizationOptimizationYsXsUnimportant XsremovedProcess Dynamics UnpredictableImportant Xs (KPIVs)discovered and controlled

*How to determine the KPIVsFrom the Batch History RecordFrom Machine logsHistoric dataFrom lab experimentsFrom modification of business process or manufacturing conditions

*Analyze PhaseFinding KPIVs through

Passive Data Acquisition

*Passive Data Analysis

*Analyze PhaseFinding KPIVs through

Active Data AcquisitionOne Factor at a timeDesign of ExperimentFractional Factorial Design

*Active Data Acquisition

*Purpose: To optimize the process by determining the relationship between the Key Process Input Variables (KPIV's) and the Key Process Output Variables (KPOV's).

Deliverables:Determine the f in Y=f(X)Updated preliminary control plan

Phase 4: IMPROVE

*Active Experimentation (DOE): Response Surface DesignsMethod of Steepest AscentOptimization

Six Sigma Toolbox - Improve

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*Purpose: To maintain the gains through control of the Key Process Input Variables (KPIV's) and error detection-correction methods.Deliverables:Error Proofing / Poka-YokeSafety Issues / OSHA5S / TPM / Updated PMValidation (IQ, OQ, PQ)Updated FMEAUpdated Process Map (Improved Process)TrainingControl PlanSPCProject Impact & Summary (e.g. updated COPQ and documented process improvement)Phase 5: CONTROL

*Mistake Proofing 5s / TPM / PMValidation (IQ, OQ, PQ)Updated FMEAUpdated Process MapControl PlanSOP and TrainingStatistical Process ControlProject ImpactDocumented Savings

Six Sigma Toolbox - Control

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*Improve and ControlPoka-yoke

A Poka-Yoke device is mechanism that either prevents a mistake from occurring or makes a mistake obvious at a glance

Mistake-Proofing is the Anglican translation of this principle

Several basic principles are consistently used in Poka-Yoke efforts

*Poka-yoke Device CategoriesPreventionEngineer the process or product so that it is impossible to make the mistake in the first place.3 1/2 floppy disk example.Prevention devices eliminate the need to detect or correct a mistake

DetectionA detection device cues the operator when a mistake has been made. This enables a quick fix.Your car has some of these: door ajar, beeps when key in ignition and door open, seat belt not fastened.Clutch in, or in park before it will start are examples of prevention devices.

*Poka-yoke Device

Simple and cheap

Part of the process

Placed close to where the mistakes occurGood Poka-yoke Device Characteristics:

*Example of Mistake ProofingFueling area of car has three mistake-proofing devices:

1. Filling pipe insert keeps larger, leaded-fuel nozzle from being inserted 2. Gas cap tether does not allow the motorist to drive off without the cap 3. Gas cap is fitted with ratchet to signal proper tightness and prevent over-tightening. Every Day Examples used from John Grout. Go to his website at mistakeproofing.com for more examples.

*Example of Mistake ProofingThe window in the envelope is not only a labor saving device. It prevents the contents of an envelope intended for one person being inserted in an envelope address to another. Every Day Examples used from John Grout. Go to his website at mistakeproofing.com for more examples.

*Hungry Jack syrup has a small window near the bottom of the container that changes from black to clear when heated revealing the word HOT. This signals that the syrup is warm and ready to serve.Examples of Mistake Proofing

*Total Productive MaintenanceTPM is a process focused, team-based effort that will build quality into manufacturing or service process steps and by doing so will improve the overall effectiveness.

TPM . . .Focuses on entire life cycleCoordinates all processes in a departmentInvolves all associatesIs implemented through teamsMaximizes equipment/process effectiveness

*Statistical Process Control (SPC)

*Six Sigma Quality CostsThe Benefits of higher quality are obvious. However, many believe it costs a lot to achieve this.

With Six Sigma, it can actually cost less. Six Sigma looks at attacking all the hidden components contributing to the Cost of Quality.

(General Electric Company)

*Any Questions, Please??

*Project Management Humor

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