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Principles of lean_six_sigma_2012

This document provides an overview and agenda for principles of Lean Six Sigma and CAPA. It discusses Lean Six Sigma strategies for improving quality, eliminating waste, reducing lead time and costs. The document defines value-added vs. non-value added activities and the seven most common types of waste. It explains how identifying and reducing waste can help reduce lead times and costs. The expected results of Lean Six Sigma implementation may include reductions in safety incidents, scrap, cycle times within 12 months. The document emphasizes analyzing processes to identify the three major contributors to waste: overburden/overdoing, unevenness and process methods.

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1 Principles of Lean Six Sigma and CAPA Eugenio Longo, PhD.Eugenio Longo, PhD. Industrial Advisor &Industrial Advisor & Visiting ProfessorVisiting Professor for Universitiesfor Universities
2 Agenda : Part 1 – Lean Six Sigma Overview Lean and 6 Sigma integration Work shop + Quiz Take away: Closing
3 Agenda : Part 2 - CAPA Objectives of course Med Dev + Pharmaceuticals Operations Overview Statistics regarding CAPA issues: FDA 483, Warning Letters + Consent Decree. What is an effective CAPA program important for your business CAPA regulation in detail CAPA inputs Effective approach Problem Solving Technical Writing Tracking and F/U Ownership – your way of making business.
4 Principles of Lean Six Sigma Overview of Lean Manufacturing and Six Sigma Methodologies A Lean Enterprise
5 Introduction Today’s manufacturing and business environments are reaching a point that competition for survival and market share is an obligation. Tracking the global economy will show that being good is not enough, therefore each organization really strive for excellence if want to stay in the market.
6 Business Facts Every single organization is looking for one single outcome…
7 Business Facts PROFIT
8 Business Facts PROFIT is not a single concept but comes with many important implications: • 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
9 Business Facts The most traditional definition of PROFIT……..
10 Business Facts $$$ LET’S MAKE MONEY $$$ BUT DO IT RIGHT
11 How we make PROFIT In order to be a leader, most companies are realizing that traditional management, manufacturing processes, and other historic approaches, are not enough. More effective methods are needed: • Six Sigma • Lean Manufacturing With origins in the Toyota Production System, is a way of living in the business environment.
12 History of ManufacturingHistory of Manufacturing Made to customer spec Single piece mfg… each product unique Variable quality Little inventory High 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
13 Recognize a need to change and be able to do PROFIT. Process Analysis is the foundationProcess Analysis is the foundation toward achieving Process Excellence.toward achieving Process Excellence. How we make PROFIT
14 We need to Change to make PROFIT? We need to Change to makeWe need to Change to make PROFIT?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
15 Why Change ?Why Change ?Why Change ? Need for change is a STRATEGIC ISSUE which any 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 loss of competitiveness in today’s global marketplace.
16 Why Change ?Why Change ?Why Change ? “Lean Linking” is … Forward Thinking !
17 Why Change ?Why Change ?Why Change ? ““Lean LinkingLean Linking”” isis …… Forward Thinking !Forward Thinking ! Do not become the dinosaurDo not become the dinosaur of your industryof your industry
18 Evolutionary vs. Revolutionary Change Evolutionary vs. RevolutionaryEvolutionary vs. Revolutionary ChangeChange Having a forward looking perspective on continuous improvement is a requirement of the competitive marketplace and is the first step in becoming world- class. DO NOT set incremental improvement goals over previous performance, rather - Think of where we need to be: Continually declining costs Zero defects Minimal inventories Fully satisfied customers
19 What can we expect with Lean Thinking? (over 5 years) What can we expect with LeanWhat can we expect with Lean Thinking?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 than 75% Return on Assets improvement of 100%+
20 Analyzing and Improving Processes Analyzing and ImprovingAnalyzing and Improving ProcessesProcesses  An integrated approach to utilizing Capital, Materials, and Human resources to produce just what is needed, when it is needed. 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 !
21 How we make PROFIT - TPS
22 Building Blocks of The LeanBuilding Blocks of The Lean EnterpriseEnterprise “Continuous Improvement” TeamworkRewards / RecognitionTraining
23 “Continuous Improvement” Value Stream Mapping TeamworkRewards / RecognitionTraining Building Blocks of The LeanBuilding Blocks of The Lean EnterpriseEnterprise
24 Quick Changeover Standard Work Batch Reduction Layout Mistake Proofing 5S SystemProjects Visual Management POU Cellular / FlowPull / Kanban TPM “Continuous Improvement” Value Stream Mapping TeamworkRewards / RecognitionTraining Building Blocks of The LeanBuilding Blocks of The Lean EnterpriseEnterprise
25 How we do PROFIT – by an Operational Excellence Mission Statement How we do PROFITHow we do PROFIT –– by anby an Operational ExcellenceOperational Excellence Mission StatementMission Statement Develop 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 waste Raises costs Produces no corresponding benefit Threatens all of our jobs
26 To do PROFIT we can use the Lean Six Sigma Strategy … To do PROFIT we can use the Lean SixTo do PROFIT we can use the Lean Six Sigma StrategySigma Strategy …… … for turning manufacturing and business processes into competitive weapons. Producing what is needed, when it is needed, with a minimum amount of materials, equipment, labor and space. “Prime Directive” - to continually seek out and eliminate waste and wasteful practices.
27 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 operating conditions and practices in every aspect of our Business.
28 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 and practices in every aspect of our Business and every process within our Operations and to constantly, and consistently, enhance Health/Welfare, Safety and Environmental concerns and issues.
29 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
30 Lean Six Sigma – Benefits. The Benefits Are There For The Taking The Benefits Always Include Increased Market Share, Lowered Cost Higher Profits 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
31 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.
32 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
33 Customer perceives valueCustomer perceives value Value Added Activity An activity that changes the size, shape, fit, form, or function of material or information (for the first time) to satisfy the customer. Non-Value Added Activity Those activities that consume time or resources, but do not add value in the eyes of the customer. Lean Six Sigma
34 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
35 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)……
36 Motion Waiting time Overproduction Processing time Defects Inspection Transportation Problems/ Causes Incorrect layouts Lack of proximity of machines Off-line resources Waiting workers, machines, materials Long set-ups and lead times Large batches, raw material stocks High WIP, finished goods stocks Making for the sake of it Ignoring customer demands Long cycle times- process, itself Reduced efficiency- over processing High overall lead times Long delays for rectification Costly rework Dissatisfied customers Approvals of approvals High number of verification steps Reliance- Mass inspection techniques Unnecessary movement Extra handling Types of Waste (7W’s) Value Added Non- Value Added, but necessary Waste Focus on reduction PeopleProcessProduct The Causes of Waste in most ProcessesThe Causes of Waste in most Processes
37 Product LeadProduct Lead--TimeTime Raw Materials Finished Goods Value Added Time Non- Value Added Time TIME Lean Six Sigma
38 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.
39 Product LeadProduct Lead--TimeTime Whereas,Whereas, ““Process AnalysisProcess Analysis”” activitiesactivities shouldshould Focus hereFocus here -- the Elimination of Wastethe Elimination of Waste (MUDA)(MUDA) 95% Non95% Non-- Value AddedValue Added Lean Six Sigma
40 Identifying WasteIdentifying Waste Waste 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
41 Identifying WasteIdentifying Waste Other 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; more importantly, inventory hides all sorts of problems in the company Lean Six Sigma
42 Learn to Recognize the Types of Waste From Taiichi Ohno, Architect of the Toyota Production System PEOPLE TYPES OF WASTE Processing Motion Waiting Fixing Defects Making Too Much Moving Things Inventory QUANTITY QUALITY Overproduction / Making To Much Ties up capital, diverts production from customer requirements, loss of inventories Transporting / Moving Things Unnecessarily increases production time, extra WIP Unnecessary Stock / Inventory Ties up capital, risk of changes Waiting Decreases productivity, wastes personnel resources Unnecessary Motion Increases production time, unnecessary operator motion Processing Poorly designed / incapable processes Defects Scrap, rework, returns Lead time reduction is achieved by identifying and eliminating waste
43 Inventory Hides ProblemsInventory Hides Problems Long Set-up Time Poor 5-S Quality ProblemsLine Imbalance Down- Time Vendor Delivery Problems Poor Scheduling Poor Communication Absenteeism Poor Process Capability Raw Material Finished Goods Your CompanyYour Company Lean Six Sigma
44 Process Analysis to the RescueProcess Analysis to the Rescue … we have only begun to deal with issues involved in trying to tie everything together for a whole- system approach. Some of the problems that continue to confound us are the following: The way manufacturing works with Sales makes scheduling 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 useful to running a plant and often encourages wrong decisions. Lean Six Sigma
45 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
46 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 waste Once you know the function, you can identify as waste anything that does not execute that function Draft an improvement plan… Ask how?
47 Be on the look-out for these 3 Major contributors … • Overburden/ Overdoing • Unevenness • Process methods Lean Six Sigma – How to Discover Waste
48 Be on the look-out for these 3 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
49 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
50 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 ??
51 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
52 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 is needed, 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 and eliminate waste and wasteful practices. Lean Six Sigma
53 SIX SIGMA
54 Six Sigma Six Sigma is the term applied to the application of the DMAIC methodology. It is a structured, disciplined, rigorous approach to process improvement. The five steps link to each other into a logical sequence, creating an infinite loop for process improvement. The goal of the method is to achieve 3.4 defects per million parts (or opportunities of doing it wrong), most commonly known as 6 Sigma.
55 Six Sigma Implementation of Six Sigma requires commitment of the organization and team leaders. Is quite common to see, Yellow Belts, Green Belts, Black Belts and too often the …Soft Belts…. Being the last ones the ones obstructing the implementation.
56 Six Sigma If the organization you work for has a Six Sigma Program in place, not necessarily guarantee the success of the organization. It depends on good teams, good steering committee and champions as well as management support. In any Six Sigma program, keeping the right people engaged towards success is the key.
57 Six Sigma – DEFINE Stage: The objective in this area is to create a clear statement, a Team Charter, that depicts the success story to be created. Shows a high level description of the processes being improved and the expected achievements. Show how your customers will be impacted The most critical stage to catch the support from your organization.
58 Six Sigma – MEASURE Stage: The whole objective here is to gather data and information that will help you in pin pointing the real causes of the problem being resolved. Here you will know your current situation and the expectation on how much can be improved. Information here, helps to refine your define stage if needed. Set up the basis for the next stage:
59 Six Sigma – ANALYZE Stage: The objective here is to get the data and use statistical tools to identify the root cause(s), create a hypothesis (or several ones) and prove them out. The ones that prove to be the real causes, are the ones needed to be addressed on the next stage.
60 Six Sigma – IMPROVE Stage: The target id to implement actions to correct the problems identified on the previous stage. These actions need to be tested and measured to verify that are effective. The effective methods set the basis for the next stage.
61 Six Sigma – CONTROL Stage: The target in here is to turn the solutions found into a rentable change in the processes. These changes are to monitor the performance, maintain the benefits from the solution implemented and set the ground for new improvement opportunities as the new data being collected feeds the DMAIC cycle for another project. In the regulated industry, theses changes might require, new procedures (SOP) and Validations to ensure compliance to ISO and FDA regulations as applicable.
62 Six Sigma – Summary Each single stage relies on the previous one for a 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 the DMAIC cycle gets you to a problem where that particular information was already gathered.
63 Six Sigma – Tool Box TOOL NAME D M A I C TOOL NAME D M A I C Affinity Diagram X X Frequency Plots X X X X Brainstorming X X FMEA (Failure Mode & Effect Analysis) X Business Case X Gage R & R X Cause-and- Effect Diagrams X Hypotesis Tests X Charter X t-test Consensus X paired t-test Control Charts X X X X ANOVA Continuous data Chi Square Individuals Kano Model X X-Bar, R Planning Tools X EWMA Gantt Charts Discrete data Planning Grid p,np Pareto Charts X X X c,u Prioritization Matrix X X Critical to Quality Tree X Process Capability X X Data Collection Forms X X X X Process Sigma X X Check Sheet Quality Control Process Chart X Pfrequency Plot Check Sheet Regression X Confirmation Check Sheet Rolled Throughput Yield X Concentration Diagram Sampling X X X X Data Collection Plan X X X X Scatter Plots X Design of Experiment X X SIPOC (Suppliers, Inputs,Process,Outputs,Customers) X Full Factorial Stakeholder Analysis X X Reduced Fractions Standardization X Screening Designs Stratification X X X X Placket-Burnham Designs Stratified Frequency Plots X More 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
64 Six Sigma -Summary After each stage is completed, demand a meeting a with the people that must know, the progress is your best selling tool to keep getting the support. Don’t be shy – your champion is there to assist you, the Black Belt is there to help you; no one is an expert on all the statistical tools, so ask for help before assuming incorrectly.
65 Lean Six Sigma Six Sigma alone is not Lean Manufacturing, is just one tool, that combined with statistics can give you solutions. Using the DMAIC cycle and using other Lean Manufacturing tools instead of Statistics can also produce results.
66 TYPE OF WASTE WASTE REDUCTION APPROACH METHOD DESIRED RESULT Standard Work Workplace Organization Kaizen Workplace Management Just-in-time Error Proofing Processing Motion Waiting What You Need, When You Need It Highly Efficient, Safe Work Areas With High Output Good Quality Inventory Moving Things Making Too Much Fixing Defects Leveling Kanban Quick Setup Preventive Maintenance Detection Warning Prediction Prevention CATEGORY OF WASTE PEOPLE QUANTITY QUALITY FOCUS POINTS Work Balance WIP Location/Amount Kanban Location Kanban Types Lot Sizes Changeover Analysis PM Analysis Layout Labeling Tools/Parts Arrangement Work Instructions Efficiency Takt Time Skills Training Shift Meetings Cell/Area Teams Visual Displays Appropriate Automated Assistance Fixture Modifications Successive Checks Limit Switches Check Sheets Photocells, Templates, Etc. Cross Training PRINCIPAL WORKSHEETS Standard Work Sheet (SWS) Time Observation Form (TOF) Standard Work Combination Sheet (SWCS) Work Load Balancing Sheet (WLBS) Kaizen Target Sheet (KTS) Kaizen Action Sheet (KAS) SWS SWCS WLBS Kanbans Table of Production Capacity By Process (TPCP) PM Scheduling Sheet (PMSS) SWCS Error Proofing Action Sheet (EPAS) Error Proofing “To Do” List (EPL) Skill Versatility Visual Display Jidoka Autonomation 20 Keys Kaizen - one effective method among many that engages PEOPLE and “recruits” the other tools Lean Six Sigma- Approaches and Techniques
67 K A I Z E N
68 Kaizen = Continuous Improvement “Kai” = Small, Continuous Change “Zen” = Ongoing Change For The Better Structured, Focused, Coached, Mandated & Required Activity To Compel Every Employee To Participate In Improving The Quality And Efficiency Of Their Day-to-day Micro-processes Not A “Suggestion Box” Program Building Blocks of Lean Production Just-in-time Standard operations Mistake-proof processing Pull production & single piece flow Cellular manufacturing Visual workplace Kaizen is the “transport vehicle” to import these building blocks of lean production These concepts are equally applicable to the factory floor and within the office
69 • Reject the current situation • Keep an open mind to change • Maintain a positive attitude • Make problems visible; make the workplace visual • Never leave in silent disagreement • Practice mutual respect every day • One person, one voice - no position or rank  There’s no such thing as a dumb question  Take action over excuses and make actual improvements now  Get on base rather than go for the long ball (small progress vs. all)  Use your head rather than your money  Destroy myths of fixed production  It’s a never ending task  HAVE FUN and JUST DO IT! Lean Six Sigma – Guides for Kaizen
70 VALUEVALUE STREAMSTREAM MAPPINGMAPPING
71 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 states as part of the lean implementation process Discussed in “Lean Thinking” Further developed and documented by the Lean Enterprise Institute of Brookline, Mass. “Learning to See” 1996 1998 Lean Six Sigma – Short History
72 Total Value Stream SUPPLIERS YOUR PLANT OR BUSINESS CUSTOMER TO END USER All the actions, both value added and non-value added, currently required to bring a product from raw materials to the customer. All the actions, both value added and non-value added, currently required to bring a product from raw materials to the customer. Lean Six Sigma – What is Value Stream?
73 A value stream is all the actions (both value added and non-value added) currently required to bring a product (or transaction) though the main flows essential for every product/ service: from raw material/ (customer need), through all the required steps, then – back to the arms of the customer. Taking a value stream perspective means working on the big picture, not just individual processes, and improving the 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
74 WIP 870 QTIME 72H MELT 903M INSP CHEM Hold Furnace Cast 903 INSP PROFILE WIP 696 QTIME P/T 6N LOT 75K P/T 8H WIP 8 COILS 120K P/T 3 HR 15K WIP STORE STAGE BREAKDOWN 911 REC STAGE LEAD 2231.1 VA 210.17% SCRAP WIP 746K QTIME 8 1OK LOT 1 COIL TIME .1 WIP 15K WIP 108K 8HR Q/T 8 DOWNTIME 15% DOWNTIME 15.5% 8 6 8 3 OperationalOperational exampleexample Map major process steps I.D. Value (green/ yellow) / Non-value (red) Capture all times, quantities Prioritize areas to improve X SHIPPED PER DAY 850K 1.870 WIP BEING WORKED 4.276 WIP BEING STORED Lean Six Sigma – Value Stream Map
75 Customer MACHINING C/T=1568 m C/O=50 min. 2 SHIFTS OPER. 48 Daily FIFO Prod’n Cont. Supplier OrdersOrders IRREGULAR ASSEMBLY C/T=936 m C/O=0 min. 1 SHIFT OPER. 24 TEST C/T=60 m C/O=30 min. 1 SHIFTS OPER. 5 FINISH C/T=210 m C/O=0 min. 1 SHIFTS OPER. 6 DISPATCH C/T=30 m C/O=0 min. 1 SHIFTS OPER. 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 WEEKS OUT 12 WEEK FORECAST < 1/2 DAY <2 ENGINES <2 ENGINES PITCH = 60 MINUTES LT<3 1/2 DAYS MANUFACTURING LEADTIME = 3 1/2 DAYS CUSTOMER LEADTIME = 2 WEEKS Big PictureBig Picture exampleexample Lean Six Sigma – Value Stream Map
76 • 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 and material flow • Forms the blueprint to identify areas of improvement Lean Six Sigma – Why do Value Stream Mapping?
77 • It helps visualize more than just the single-process level, i.e. assembly, welding, etc., in production. You can see the whole flow. • It helps to see more than waste. Mapping helps to see the sources of 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 discuss them. Otherwise, many details and decisions in your area just happen by default. • By adding data, it ties together lean concepts and six sigma techniques, which helps you avoid “pet projects”. Lean Six Sigma – Why do Value Stream Map do for us?
78 It forms the basis of an implementation plan. By helping you design how the whole door-to-door flow should operate - a missing piece in so many lean efforts - value stream maps become a blueprint for improvement. Imagine trying to build a house without a blueprint! • It shows the linkage between the information flow and the material flow. No other tool does this. Lean Six Sigma – Value Stream Map is an Essential Tool
79 It enhances the quantitative tools and layout diagrams that produce a tally of non-value added steps, lead time, distance traveled, the amount of inventory, and so on. • Value stream mapping is a qualitative tool by which you describe in detail how your facility should operate in order to create flow. Numbers are good for creating a sense of urgency or as before/ after measures. Value stream mapping is good for describing what you are actually going to do to affect those numbers. Lean Six Sigma – Value Stream Map is an Essential Tool
80 Steel Recd Parts Stocked Components machined Plate Steel burned Structural Steel Sawed Steel stocked Weld Shop Paint Shop Elect/Mech Parts Recd Blasting Booth Sand Bast Mech parts to Mech Assembly Staging Parts stocked Inspection Mech Assembly Elect parts to Elect Assembly Staging Elect Assembly InspectionRun TestCratingShippingWarehouse Ship to Customer Steel Fabrication Process (Current State) Can you identify areas for improvement? Lean Six Sigma – Process Map Analysis
81 Steel Recd Components machined Plate Steel burned Structural Steel Sawed Weld Shop Paint Shop Elect/Mech Parts Recd Blasting Booth Sand Bast All parts to Assembly Staging Inspection Mech/Elect Assembly Inspection & Run Test Ship to Customer Steel Fabrication Process (Future State) Shipping & Crating Lean Six Sigma – Process Map Analysis
82 5 S
83 The Benefits of ImplementingThe Benefits of Implementing ““5S5S”” 5S provides a basis for being a world-class competitor and the foundation for a disciplined approach to the workplace.  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 !
84 And The 5And The 5--SS’’s ares are…… Seiri – (Separate) or Sort Seiton – (Straighten) Store, or Put-in Place Seiso – (Clean) or Shine Seiketsu – (Standardize) Shitsuke – (Discipline) or Sustain + Safety !+ Safety !
85 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
86 Lean Six Sigma - Other Lean Tools • Root Cause Analysis and Corrective Action (RCCA) – 5 Why Technique • Spaghetti Charts • Pareto Analysis • Visual Displays • Visual Controls • Total Predictive Maintenance • SMED – Single Minute Exchange of Dies.
87 Lean Six Sigma
88 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)

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In this document
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Introduction to Lean Six Sigma principles and CAPA by Eugenio Longo, PhD.

Agenda for parts 1 and 2: Lean Six Sigma overview and CAPA objectives including workshop.

Presentation of CAPA objectives, statistics, regulations, technical writing, problem-solving strategies.

Introduction to Lean Enterprise principles and methodologies related to Lean and Six Sigma.

In competitive markets, organizations must strive for excellence beyond being merely good.

The central theme of profit in business, emphasizing process excellence, resource management, and strategic goals.

Highlighting the necessity for change towards advanced methods like Lean Manufacturing and Six Sigma to maintain profit. Indicators of business change needed for profitability involving quality, cost, and delivery improvements.

Differentiating between evolutionary and revolutionary changes necessary for competitive advantage.

Predicted improvements over 5 years including defect reduction and productivity increases.

A definition of Lean focusing on waste elimination and optimal utilization of resources.

Building blocks of the Lean enterprise include continuous improvement, teamwork, and mistake-proofing.

Capabilities required for recognizing and eliminating waste to achieve operational excellence.

Four main goals of Lean Six Sigma are quality improvement, waste elimination, lead time reduction, and cost reduction.

Anticipated results within 12 months of Lean Six Sigma implementation including significant reductions in waste.

Lean Six Sigma benefits include increased market share and customer satisfaction through efficiency improvements.

Five core principles of Lean and definitions of value-added versus non-value added activities.

Common types of waste in manufacturing processes and their consequences, emphasizing the need for waste identification.

Investigating causes of waste from process inefficiencies and the relationship between departments affecting operations.

Methods and techniques to identify waste within processes based on operational questions.

Specific actions needed to align operations with Lean Six Sigma principles to gain competitiveness.

Overview of the DMAIC method as a structured approach to process improvement within Lean Six Sigma.

Defining Six Sigma, focusing on the DMAIC methodology, its application, and the organizational commitment needed.

Detailed breakdown of Six Sigma stages: Define, Measure, Analyze, Improve, Control, and their importance.

Key tools and techniques utilized during Six Sigma processes for effective problem-solving and improvement.

Differentiation between Lean Manufacturing and Six Sigma, emphasizing Lean as a foundational component.

Introduction to Kaizen as a philosophy of continuous improvement and its role in Lean production.

Principles and mindset necessary for successful Kaizen sessions to foster workplace improvements.

Introduction to value stream mapping as a tool for visualizing processes to identify waste and improve flow.

Real examples of value stream mapping used in steel fabrication and its role in revealing areas for process improvement.

Explaining the benefits of the 5S method for workplace organization and safety.

Other tools aligned with Lean methodologies to enhance operational efficiency and effectiveness.

Principles of lean_six_sigma_2012

  • 1.
    1 Principles of Lean SixSigma and CAPA Eugenio Longo, PhD.Eugenio Longo, PhD. Industrial Advisor &Industrial Advisor & Visiting ProfessorVisiting Professor for Universitiesfor Universities
  • 2.
    2 Agenda : Part 1– Lean Six Sigma Overview Lean and 6 Sigma integration Work shop + Quiz Take away: Closing
  • 3.
    3 Agenda : Part 2- CAPA Objectives of course Med Dev + Pharmaceuticals Operations Overview Statistics regarding CAPA issues: FDA 483, Warning Letters + Consent Decree. What is an effective CAPA program important for your business CAPA regulation in detail CAPA inputs Effective approach Problem Solving Technical Writing Tracking and F/U Ownership – your way of making business.
  • 4.
    4 Principles of LeanSix Sigma Overview of Lean Manufacturing and Six Sigma Methodologies A Lean Enterprise
  • 5.
    5 Introduction Today’s manufacturing andbusiness environments are reaching a point that competition for survival and market share is an obligation. Tracking the global economy will show that being good is not enough, therefore each organization really strive for excellence if want to stay in the market.
  • 6.
    6 Business Facts Every singleorganization is looking for one single outcome…
  • 7.
  • 8.
    8 Business Facts PROFIT isnot a single concept but comes with many important implications: • 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
  • 9.
    9 Business Facts The mosttraditional definition of PROFIT……..
  • 10.
  • 11.
    11 How we makePROFIT In order to be a leader, most companies are realizing that traditional management, manufacturing processes, and other historic approaches, are not enough. More effective methods are needed: • Six Sigma • Lean Manufacturing With origins in the Toyota Production System, is a way of living in the business environment.
  • 12.
    12 History of ManufacturingHistoryof Manufacturing Made to customer spec Single piece mfg… each product unique Variable quality Little inventory High 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
  • 13.
    13 Recognize a needto change and be able to do PROFIT. Process Analysis is the foundationProcess Analysis is the foundation toward achieving Process Excellence.toward achieving Process Excellence. How we make PROFIT
  • 14.
    14 We need toChange to make PROFIT? We need to Change to makeWe need to Change to make PROFIT?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
  • 15.
    15 Why Change ?WhyChange ?Why Change ? Need for change is a STRATEGIC ISSUE which any 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 loss of competitiveness in today’s global marketplace.
  • 16.
    16 Why Change ?WhyChange ?Why Change ? “Lean Linking” is … Forward Thinking !
  • 17.
    17 Why Change ?WhyChange ?Why Change ? ““Lean LinkingLean Linking”” isis …… Forward Thinking !Forward Thinking ! Do not become the dinosaurDo not become the dinosaur of your industryof your industry
  • 18.
    18 Evolutionary vs. Revolutionary Change Evolutionaryvs. RevolutionaryEvolutionary vs. Revolutionary ChangeChange Having a forward looking perspective on continuous improvement is a requirement of the competitive marketplace and is the first step in becoming world- class. DO NOT set incremental improvement goals over previous performance, rather - Think of where we need to be: Continually declining costs Zero defects Minimal inventories Fully satisfied customers
  • 19.
    19 What can weexpect with Lean Thinking? (over 5 years) What can we expect with LeanWhat can we expect with Lean Thinking?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 than 75% Return on Assets improvement of 100%+
  • 20.
    20 Analyzing and Improving Processes Analyzingand ImprovingAnalyzing and Improving ProcessesProcesses  An integrated approach to utilizing Capital, Materials, and Human resources to produce just what is needed, when it is needed. 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 !
  • 21.
    21 How we makePROFIT - TPS
  • 22.
    22 Building Blocks ofThe LeanBuilding Blocks of The Lean EnterpriseEnterprise “Continuous Improvement” TeamworkRewards / RecognitionTraining
  • 23.
    23 “Continuous Improvement” Value Stream Mapping TeamworkRewards /RecognitionTraining Building Blocks of The LeanBuilding Blocks of The Lean EnterpriseEnterprise
  • 24.
    24 Quick Changeover Standard WorkBatch Reduction Layout Mistake Proofing 5S SystemProjects Visual Management POU Cellular / FlowPull / Kanban TPM “Continuous Improvement” Value Stream Mapping TeamworkRewards / RecognitionTraining Building Blocks of The LeanBuilding Blocks of The Lean EnterpriseEnterprise
  • 25.
    25 How we doPROFIT – by an Operational Excellence Mission Statement How we do PROFITHow we do PROFIT –– by anby an Operational ExcellenceOperational Excellence Mission StatementMission Statement Develop 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 waste Raises costs Produces no corresponding benefit Threatens all of our jobs
  • 26.
    26 To do PROFITwe can use the Lean Six Sigma Strategy … To do PROFIT we can use the Lean SixTo do PROFIT we can use the Lean Six Sigma StrategySigma Strategy …… … for turning manufacturing and business processes into competitive weapons. Producing what is needed, when it is needed, with a minimum amount of materials, equipment, labor and space. “Prime Directive” - to continually seek out and eliminate waste and wasteful practices.
  • 27.
    27 The Lean SixSigma 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 operating conditions and practices in every aspect of our Business.
  • 28.
    28 The Lean Enterpriseis 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 and practices in every aspect of our Business and every process within our Operations and to constantly, and consistently, enhance Health/Welfare, Safety and Environmental concerns and issues.
  • 29.
    29 With a well-plannedimplementation, 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
  • 30.
    30 Lean Six Sigma– Benefits. The Benefits Are There For The Taking The Benefits Always Include Increased Market Share, Lowered Cost Higher Profits 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
  • 31.
    31 Lean Six Sigma Philosophyand 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.
  • 32.
    32 Learn the 5Core 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
  • 33.
    33 Customer perceives valueCustomerperceives value Value Added Activity An activity that changes the size, shape, fit, form, or function of material or information (for the first time) to satisfy the customer. Non-Value Added Activity Those activities that consume time or resources, but do not add value in the eyes of the customer. Lean Six Sigma
  • 34.
    34 Value Added • Anyactivity 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
  • 35.
    35 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)……
  • 36.
    36 Motion Waiting time Overproduction Processing time Defects Inspection Transportation Problems/Causes Incorrect layouts Lack of proximity of machines Off-line resources Waiting workers, machines, materials Long set-ups and lead times Large batches, raw material stocks High WIP, finished goods stocks Making for the sake of it Ignoring customer demands Long cycle times- process, itself Reduced efficiency- over processing High overall lead times Long delays for rectification Costly rework Dissatisfied customers Approvals of approvals High number of verification steps Reliance- Mass inspection techniques Unnecessary movement Extra handling Types of Waste (7W’s) Value Added Non- Value Added, but necessary Waste Focus on reduction PeopleProcessProduct The Causes of Waste in most ProcessesThe Causes of Waste in most Processes
  • 37.
    37 Product LeadProduct Lead--TimeTime Raw Materials Finished Goods ValueAdded Time Non- Value Added Time TIME Lean Six Sigma
  • 38.
    38 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.
  • 39.
    39 Product LeadProduct Lead--TimeTime Whereas,Whereas,““Process AnalysisProcess Analysis”” activitiesactivities shouldshould Focus hereFocus here -- the Elimination of Wastethe Elimination of Waste (MUDA)(MUDA) 95% Non95% Non-- Value AddedValue Added Lean Six Sigma
  • 40.
    40 Identifying WasteIdentifying Waste Wastecan 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
  • 41.
    41 Identifying WasteIdentifying Waste Othercauses 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; more importantly, inventory hides all sorts of problems in the company Lean Six Sigma
  • 42.
    42 Learn to Recognizethe Types of Waste From Taiichi Ohno, Architect of the Toyota Production System PEOPLE TYPES OF WASTE Processing Motion Waiting Fixing Defects Making Too Much Moving Things Inventory QUANTITY QUALITY Overproduction / Making To Much Ties up capital, diverts production from customer requirements, loss of inventories Transporting / Moving Things Unnecessarily increases production time, extra WIP Unnecessary Stock / Inventory Ties up capital, risk of changes Waiting Decreases productivity, wastes personnel resources Unnecessary Motion Increases production time, unnecessary operator motion Processing Poorly designed / incapable processes Defects Scrap, rework, returns Lead time reduction is achieved by identifying and eliminating waste
  • 43.
    43 Inventory Hides ProblemsInventoryHides Problems Long Set-up Time Poor 5-S Quality ProblemsLine Imbalance Down- Time Vendor Delivery Problems Poor Scheduling Poor Communication Absenteeism Poor Process Capability Raw Material Finished Goods Your CompanyYour Company Lean Six Sigma
  • 44.
    44 Process Analysis tothe RescueProcess Analysis to the Rescue … we have only begun to deal with issues involved in trying to tie everything together for a whole- system approach. Some of the problems that continue to confound us are the following: The way manufacturing works with Sales makes scheduling 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 useful to running a plant and often encourages wrong decisions. Lean Six Sigma
  • 45.
    45 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
  • 46.
    46 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 waste Once you know the function, you can identify as waste anything that does not execute that function Draft an improvement plan… Ask how?
  • 47.
    47 Be on thelook-out for these 3 Major contributors … • Overburden/ Overdoing • Unevenness • Process methods Lean Six Sigma – How to Discover Waste
  • 48.
    48 Be on thelook-out for these 3 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
  • 49.
    49 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
  • 50.
    50 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 ??
  • 51.
    51 Lean Six Sigma Utilizethe 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
  • 52.
    52 The Lean SixSigma 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 is needed, 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 and eliminate waste and wasteful practices. Lean Six Sigma
  • 53.
  • 54.
    54 Six Sigma Six Sigmais the term applied to the application of the DMAIC methodology. It is a structured, disciplined, rigorous approach to process improvement. The five steps link to each other into a logical sequence, creating an infinite loop for process improvement. The goal of the method is to achieve 3.4 defects per million parts (or opportunities of doing it wrong), most commonly known as 6 Sigma.
  • 55.
    55 Six Sigma Implementation ofSix Sigma requires commitment of the organization and team leaders. Is quite common to see, Yellow Belts, Green Belts, Black Belts and too often the …Soft Belts…. Being the last ones the ones obstructing the implementation.
  • 56.
    56 Six Sigma If theorganization you work for has a Six Sigma Program in place, not necessarily guarantee the success of the organization. It depends on good teams, good steering committee and champions as well as management support. In any Six Sigma program, keeping the right people engaged towards success is the key.
  • 57.
    57 Six Sigma –DEFINE Stage: The objective in this area is to create a clear statement, a Team Charter, that depicts the success story to be created. Shows a high level description of the processes being improved and the expected achievements. Show how your customers will be impacted The most critical stage to catch the support from your organization.
  • 58.
    58 Six Sigma –MEASURE Stage: The whole objective here is to gather data and information that will help you in pin pointing the real causes of the problem being resolved. Here you will know your current situation and the expectation on how much can be improved. Information here, helps to refine your define stage if needed. Set up the basis for the next stage:
  • 59.
    59 Six Sigma –ANALYZE Stage: The objective here is to get the data and use statistical tools to identify the root cause(s), create a hypothesis (or several ones) and prove them out. The ones that prove to be the real causes, are the ones needed to be addressed on the next stage.
  • 60.
    60 Six Sigma –IMPROVE Stage: The target id to implement actions to correct the problems identified on the previous stage. These actions need to be tested and measured to verify that are effective. The effective methods set the basis for the next stage.
  • 61.
    61 Six Sigma –CONTROL Stage: The target in here is to turn the solutions found into a rentable change in the processes. These changes are to monitor the performance, maintain the benefits from the solution implemented and set the ground for new improvement opportunities as the new data being collected feeds the DMAIC cycle for another project. In the regulated industry, theses changes might require, new procedures (SOP) and Validations to ensure compliance to ISO and FDA regulations as applicable.
  • 62.
    62 Six Sigma –Summary Each single stage relies on the previous one for a 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 the DMAIC cycle gets you to a problem where that particular information was already gathered.
  • 63.
    63 Six Sigma –Tool Box TOOL NAME D M A I C TOOL NAME D M A I C Affinity Diagram X X Frequency Plots X X X X Brainstorming X X FMEA (Failure Mode & Effect Analysis) X Business Case X Gage R & R X Cause-and- Effect Diagrams X Hypotesis Tests X Charter X t-test Consensus X paired t-test Control Charts X X X X ANOVA Continuous data Chi Square Individuals Kano Model X X-Bar, R Planning Tools X EWMA Gantt Charts Discrete data Planning Grid p,np Pareto Charts X X X c,u Prioritization Matrix X X Critical to Quality Tree X Process Capability X X Data Collection Forms X X X X Process Sigma X X Check Sheet Quality Control Process Chart X Pfrequency Plot Check Sheet Regression X Confirmation Check Sheet Rolled Throughput Yield X Concentration Diagram Sampling X X X X Data Collection Plan X X X X Scatter Plots X Design of Experiment X X SIPOC (Suppliers, Inputs,Process,Outputs,Customers) X Full Factorial Stakeholder Analysis X X Reduced Fractions Standardization X Screening Designs Stratification X X X X Placket-Burnham Designs Stratified Frequency Plots X More 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
  • 64.
    64 Six Sigma -Summary Aftereach stage is completed, demand a meeting a with the people that must know, the progress is your best selling tool to keep getting the support. Don’t be shy – your champion is there to assist you, the Black Belt is there to help you; no one is an expert on all the statistical tools, so ask for help before assuming incorrectly.
  • 65.
    65 Lean Six Sigma SixSigma alone is not Lean Manufacturing, is just one tool, that combined with statistics can give you solutions. Using the DMAIC cycle and using other Lean Manufacturing tools instead of Statistics can also produce results.
  • 66.
    66 TYPE OF WASTE WASTE REDUCTION APPROACH METHOD DESIRED RESULT StandardWork Workplace Organization Kaizen Workplace Management Just-in-time Error Proofing Processing Motion Waiting What You Need, When You Need It Highly Efficient, Safe Work Areas With High Output Good Quality Inventory Moving Things Making Too Much Fixing Defects Leveling Kanban Quick Setup Preventive Maintenance Detection Warning Prediction Prevention CATEGORY OF WASTE PEOPLE QUANTITY QUALITY FOCUS POINTS Work Balance WIP Location/Amount Kanban Location Kanban Types Lot Sizes Changeover Analysis PM Analysis Layout Labeling Tools/Parts Arrangement Work Instructions Efficiency Takt Time Skills Training Shift Meetings Cell/Area Teams Visual Displays Appropriate Automated Assistance Fixture Modifications Successive Checks Limit Switches Check Sheets Photocells, Templates, Etc. Cross Training PRINCIPAL WORKSHEETS Standard Work Sheet (SWS) Time Observation Form (TOF) Standard Work Combination Sheet (SWCS) Work Load Balancing Sheet (WLBS) Kaizen Target Sheet (KTS) Kaizen Action Sheet (KAS) SWS SWCS WLBS Kanbans Table of Production Capacity By Process (TPCP) PM Scheduling Sheet (PMSS) SWCS Error Proofing Action Sheet (EPAS) Error Proofing “To Do” List (EPL) Skill Versatility Visual Display Jidoka Autonomation 20 Keys Kaizen - one effective method among many that engages PEOPLE and “recruits” the other tools Lean Six Sigma- Approaches and Techniques
  • 67.
  • 68.
    68 Kaizen = ContinuousImprovement “Kai” = Small, Continuous Change “Zen” = Ongoing Change For The Better Structured, Focused, Coached, Mandated & Required Activity To Compel Every Employee To Participate In Improving The Quality And Efficiency Of Their Day-to-day Micro-processes Not A “Suggestion Box” Program Building Blocks of Lean Production Just-in-time Standard operations Mistake-proof processing Pull production & single piece flow Cellular manufacturing Visual workplace Kaizen is the “transport vehicle” to import these building blocks of lean production These concepts are equally applicable to the factory floor and within the office
  • 69.
    69 • Reject thecurrent situation • Keep an open mind to change • Maintain a positive attitude • Make problems visible; make the workplace visual • Never leave in silent disagreement • Practice mutual respect every day • One person, one voice - no position or rank  There’s no such thing as a dumb question  Take action over excuses and make actual improvements now  Get on base rather than go for the long ball (small progress vs. all)  Use your head rather than your money  Destroy myths of fixed production  It’s a never ending task  HAVE FUN and JUST DO IT! Lean Six Sigma – Guides for Kaizen
  • 70.
  • 71.
    71 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 states as part of the lean implementation process Discussed in “Lean Thinking” Further developed and documented by the Lean Enterprise Institute of Brookline, Mass. “Learning to See” 1996 1998 Lean Six Sigma – Short History
  • 72.
    72 Total Value Stream SUPPLIERSYOUR PLANT OR BUSINESS CUSTOMER TO END USER All the actions, both value added and non-value added, currently required to bring a product from raw materials to the customer. All the actions, both value added and non-value added, currently required to bring a product from raw materials to the customer. Lean Six Sigma – What is Value Stream?
  • 73.
    73 A value streamis all the actions (both value added and non-value added) currently required to bring a product (or transaction) though the main flows essential for every product/ service: from raw material/ (customer need), through all the required steps, then – back to the arms of the customer. Taking a value stream perspective means working on the big picture, not just individual processes, and improving the 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
  • 74.
    74 WIP 870 QTIME 72H MELT 903M INSP CHEM Hold Furnace Cast 903 INSP PROFILE WIP 696 QTIME P/T6N LOT 75K P/T 8H WIP 8 COILS 120K P/T 3 HR 15K WIP STORE STAGE BREAKDOWN 911 REC STAGE LEAD 2231.1 VA 210.17% SCRAP WIP 746K QTIME 8 1OK LOT 1 COIL TIME .1 WIP 15K WIP 108K 8HR Q/T 8 DOWNTIME 15% DOWNTIME 15.5% 8 6 8 3 OperationalOperational exampleexample Map major process steps I.D. Value (green/ yellow) / Non-value (red) Capture all times, quantities Prioritize areas to improve X SHIPPED PER DAY 850K 1.870 WIP BEING WORKED 4.276 WIP BEING STORED Lean Six Sigma – Value Stream Map
  • 75.
    75 Customer MACHINING C/T=1568 m C/O=50 min. 2SHIFTS OPER. 48 Daily FIFO Prod’n Cont. Supplier OrdersOrders IRREGULAR ASSEMBLY C/T=936 m C/O=0 min. 1 SHIFT OPER. 24 TEST C/T=60 m C/O=30 min. 1 SHIFTS OPER. 5 FINISH C/T=210 m C/O=0 min. 1 SHIFTS OPER. 6 DISPATCH C/T=30 m C/O=0 min. 1 SHIFTS OPER. 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 WEEKS OUT 12 WEEK FORECAST < 1/2 DAY <2 ENGINES <2 ENGINES PITCH = 60 MINUTES LT<3 1/2 DAYS MANUFACTURING LEADTIME = 3 1/2 DAYS CUSTOMER LEADTIME = 2 WEEKS Big PictureBig Picture exampleexample Lean Six Sigma – Value Stream Map
  • 76.
    76 • To understandthe 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 and material flow • Forms the blueprint to identify areas of improvement Lean Six Sigma – Why do Value Stream Mapping?
  • 77.
    77 • It helpsvisualize more than just the single-process level, i.e. assembly, welding, etc., in production. You can see the whole flow. • It helps to see more than waste. Mapping helps to see the sources of 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 discuss them. Otherwise, many details and decisions in your area just happen by default. • By adding data, it ties together lean concepts and six sigma techniques, which helps you avoid “pet projects”. Lean Six Sigma – Why do Value Stream Map do for us?
  • 78.
    78 It forms thebasis of an implementation plan. By helping you design how the whole door-to-door flow should operate - a missing piece in so many lean efforts - value stream maps become a blueprint for improvement. Imagine trying to build a house without a blueprint! • It shows the linkage between the information flow and the material flow. No other tool does this. Lean Six Sigma – Value Stream Map is an Essential Tool
  • 79.
    79 It enhances thequantitative tools and layout diagrams that produce a tally of non-value added steps, lead time, distance traveled, the amount of inventory, and so on. • Value stream mapping is a qualitative tool by which you describe in detail how your facility should operate in order to create flow. Numbers are good for creating a sense of urgency or as before/ after measures. Value stream mapping is good for describing what you are actually going to do to affect those numbers. Lean Six Sigma – Value Stream Map is an Essential Tool
  • 80.
    80 Steel Recd Parts Stocked Components machined Plate Steel burned Structural Steel Sawed Steel stocked WeldShop Paint Shop Elect/Mech Parts Recd Blasting Booth Sand Bast Mech parts to Mech Assembly Staging Parts stocked Inspection Mech Assembly Elect parts to Elect Assembly Staging Elect Assembly InspectionRun TestCratingShippingWarehouse Ship to Customer Steel Fabrication Process (Current State) Can you identify areas for improvement? Lean Six Sigma – Process Map Analysis
  • 81.
    81 Steel Recd Components machined Plate Steel burned Structural Steel Sawed WeldShop Paint Shop Elect/Mech Parts Recd Blasting Booth Sand Bast All parts to Assembly Staging Inspection Mech/Elect Assembly Inspection & Run Test Ship to Customer Steel Fabrication Process (Future State) Shipping & Crating Lean Six Sigma – Process Map Analysis
  • 82.
  • 83.
    83 The Benefits ofImplementingThe Benefits of Implementing ““5S5S”” 5S provides a basis for being a world-class competitor and the foundation for a disciplined approach to the workplace.  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 !
  • 84.
    84 And The 5AndThe 5--SS’’s ares are…… Seiri – (Separate) or Sort Seiton – (Straighten) Store, or Put-in Place Seiso – (Clean) or Shine Seiketsu – (Standardize) Shitsuke – (Discipline) or Sustain + Safety !+ Safety !
  • 85.
    85 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
  • 86.
    86 Lean Six Sigma- Other Lean Tools • Root Cause Analysis and Corrective Action (RCCA) – 5 Why Technique • Spaghetti Charts • Pareto Analysis • Visual Displays • Visual Controls • Total Predictive Maintenance • SMED – Single Minute Exchange of Dies.
  • 87.
  • 88.
    88 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)