5 Principles of Lean Six Sigma

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Published Date:18-07-2017
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Principles of Lean Six Sigma and CAPA Eugenio Longo, PhD. Eugenio Longo, PhD. Industrial Advisor & Industrial Advisor & Visiting Professor for Universities Visiting Professor for Universities 1Agenda : Part 1  Lean Six Sigma Overview Lean and 6 Sigma integration Work shop + Quiz Take away: Closing 2Agenda : 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. 3Principles of Lean Six Sigma Overview of Lean Manufacturing and Six Sigma Methodologies A Lean Enterprise 4Introduction 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. 5Business Facts Every single organization is looking for one single outcome& 6Business Facts PROFIT 7Business 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 8Business Facts The most traditional definition of PROFIT&& .. 9Business Facts LET S MAKE MONEY BUT DO IT RIGHT 10How 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. 11History of Manufacturing History of Manufacturing Craft Craft Craft Made to customer spec Single piece mfg& each product unique Variable quality Little inventory High cost & made for the rich Mass Production Mass Production Mass Production § Interchangeable parts Whitney § Division of labor Taylor § Assembly lines Ford § Labor strife The  LeanEnterprise The  LeanEnterprise The  LeanEnterprise § High variety § Small batch sizes § PPM quality § Engaged workforce 12How we make PROFIT Recognize a need to change and be able to do PROFIT. Process Analysis is the foundation Process Analysis is the foundation toward achieving Process Excellence. toward achieving Process Excellence. 13We need to Change to make We need to Change to make We need to Change to make PROFIT? P PR ROF OFIIT T? ? 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 14Why 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 Failure to improve in all three areas means a loss of competitiveness in today s global marketplace. In other words, How we make PROFIT? 15Why Change ? Why Change ? Why Change ?  Lean Linking is & Forward Thinking 16Why Change ? Why Change ? Why Change ?  Lean Linking  Lean Linking is & is & Forward Thinking Forward Thinking Do not become the dinosaur Do not become the dinosaur of your industry of your industry 17Evolutionary vs. Revolutionary Evolutionary vs. Revolutionary Evolutionary vs. Revolutionary Change C Ch ha an ng ge e 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 18What can we expect with Lean W Wh ha at t c ca an n we we e ex xp pe ec ct t wi wit th h L Le ea an n Thinking? Thinking? Thinking? ( over 5 years) ( 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%+ 19Analyzing and Improving Analyzing and Improving Analyzing and Improving Processes P Pro roc ce es ss se es s What s in a Name . . . What s in a Name . . . What s in a Name . . . §Toyota Production System, J.I.T., Lean Manufacturing, Demand Flow Technology, Kaizen, is really Process Analysis A Lean Definition A Lean Definition A Lean Definition § 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. Overriding Principle Overriding Principle Overriding Principle § Identify and eliminate waste (MUDA). 20