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Applying Lean Sigma Into Validation


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Validation techniques from lean six sigma tools

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Applying Lean Sigma Into Validation

  1. 1. Applying Lean Sigma into Validation Thomas J Cornish PMP
  2. 2. Introduction / Agenda <ul><li>Six Sigma Basics </li></ul><ul><li>Six Sigma relationship to Lean Sigma </li></ul><ul><li>How to implement Lean Sigma </li></ul><ul><li>How to use Lean Sigma to supplement validation </li></ul><ul><li>Lean Sigma metrics </li></ul><ul><li>Case study </li></ul>
  3. 3. What is Six Sigma? Terminology <ul><li>SIPOC : A methodology to capture requirements. Supplier, Input, Process, Output, Customer </li></ul><ul><li>DMAIC : A five step process—Define, Measure, Analyze, Improve, Control </li></ul><ul><li>VOC : Voice of the Customer </li></ul><ul><li>Six Sigma : Variation with six sigma's, or three sigma's from center of normal curve, or within 99.73%. </li></ul><ul><li>Normal Curve : A bell shaped curve, where center of process is at 50% from each side. Random variation, Gaussian, symmetrical. </li></ul><ul><li>Expected variation : No undue influence, expected variation. </li></ul>
  4. 4. Benefits of Six Sigma and Lean Sigma—Business Gains <ul><li>Primary, obvious, apparent: </li></ul><ul><ul><li>Reduction of waste </li></ul></ul><ul><ul><li>Process efficiency </li></ul></ul><ul><ul><li>Lower costs </li></ul></ul><ul><ul><li>Customer satisfaction </li></ul></ul><ul><li>Secondary, not as obvious </li></ul><ul><ul><li>Improved organizational changes </li></ul></ul><ul><ul><li>Cultural change </li></ul></ul><ul><ul><li>Better utilization of tools </li></ul></ul><ul><ul><li>Better vendor management </li></ul></ul><ul><ul><li>Compliance </li></ul></ul>
  5. 5. Basic Statistics <ul><li>NORMAL DISTRIBUTION </li></ul><ul><li>Bell-shaped </li></ul><ul><li>Symmetric </li></ul><ul><li>Most powerful and most commonly used probability distribution </li></ul>Mean
  6. 6. Basic Statistics NORMAL DISTRIBUTION Approximately 99.7% of the data (or virtually all) are between +/- 3 standard deviations from the mean when data is normally distributed. Mean -1s +1s 99.7% -2s +2s -3s +3s
  7. 7. Process Capability LSL USL Poor Process Capability! Off Center, Spread Too Wide LSL USL Fair Process Capability! Off Center, Tight Spread LSL USL Fair Process Capability! Centered, Spread Too Wide LSL USL THE MISSION: Excellent Process Capability! Centered, Tight Spread Centering and Spread are critical components of Process Capability!
  8. 8. Process Capability Process Capability Statistics The formula: USL - X Cpk-upper = 3  Cpk-overall = X – LSL min {Cpk-up, Cpk-lo} Cpk-lower = 3  *Note: we are working with continuous data only when computing a Cpk
  9. 9. <ul><li>Need to enhance competency in Root Cause elimination </li></ul><ul><li>More disciplined & data driven approach to Root Cause elimination </li></ul><ul><li>Not just a toolset it connects process performance to business goals </li></ul><ul><li>Is more than deviation elimination it reduces process variability </li></ul><ul><li>Specific Facets of Six Sigma that are advantageous </li></ul><ul><ul><li>Will address both special AND common cause based issues </li></ul></ul><ul><ul><li>Compatible with one of our chosen metrics process capability </li></ul></ul><ul><ul><li>Offers comprehensive suite of both qualitative and quantitative tools </li></ul></ul><ul><li>Builds on the Continuous Improvement approach </li></ul><ul><li>Encourages the use of cross functional teams </li></ul>It is envisioned that the other process improvement techniques will be integrated with our use of the Six Sigma approach Why Six Sigma ? Control Define Improve Measure Analyze
  10. 10. Deviation and Six Sigma Methods <ul><li>Method 1 - KT, Taproot, etc. </li></ul><ul><ul><li>Resolve basic deviations </li></ul></ul><ul><ul><li>Timeline measured in days or weeks </li></ul></ul><ul><ul><li>Tools: Brainstorming, Fishbone Diagram, Pareto Charts, Histograms, KT </li></ul></ul><ul><ul><li>Special cause problems </li></ul></ul><ul><li>Method 2 – Continuous Improvement </li></ul><ul><ul><li>Eliminate deviations </li></ul></ul><ul><ul><li>Timeline measured in weeks to months </li></ul></ul><ul><ul><li>Tools: Method 1 + Scatter Diagrams, Control Charts, Capability, FMEA </li></ul></ul><ul><ul><li>Special and some common cause problems </li></ul></ul><ul><li>Method 3 – Six Sigma </li></ul><ul><ul><li>Eliminate variation </li></ul></ul><ul><ul><li>Timeline measured in 4-8 months </li></ul></ul><ul><ul><li>Tools: Method 2 + Measurement Systems Analysis, Statistical Roadmap, DoE </li></ul></ul><ul><ul><li>Complex problems – both special and common </li></ul></ul>
  11. 11. What is Lean Sigma? <ul><li>Lean Sigma is a customer-focused, enterprise change strategy to deliver increased capability, improved results, and desired culture change. </li></ul><ul><ul><li>Driven by business leaders and market requirements </li></ul></ul><ul><ul><li>Utilizes teamwork and tools to increase knowledge and improve performance </li></ul></ul><ul><ul><li>Integrates functional foundation and expertise </li></ul></ul>
  12. 12. Lean Sigma Customer focus Culture Values and Mindset Capability Lean Sigma
  13. 13. What is the difference between Lean Sigma and Six Sigma? <ul><li>Six Sigma is one of the tools used by Lean Sigma </li></ul><ul><li>Six Sigma concentrates on decreasing variability and randomness, Lean Sigma also concentrates on organizational culture and behavior </li></ul><ul><li>Lean sigma concentrates on using principles of process improvement and six sigma for operational improvement </li></ul><ul><li>Utilization of six sigma may not be applicable for all cases, as cost is high. Lean sigma can be used for operational improvements at a lower cost </li></ul>
  14. 14. What is the difference between Lean Sigma and Six Sigma? <ul><li>Lean Sigma centers around improving the current process by cutting waste, repetition, manual handling, efficiency, and FTE utilization optimization </li></ul><ul><li>Six Sigma centers around improving the quality and reducing the variations in quality by statistical measurements </li></ul><ul><li>Six Sigma is only a tool that helps identify what is wrong, not how to fix it. This is where Lean Sigma can help identify solutions </li></ul>
  15. 15. Process Terminology <ul><li>Kaizen : Japanese word for continuous improvement. Process to continuously improving any work process. </li></ul><ul><li>Poka Yoke : Japanese term meaning ‘mistake proofing’. Prevention, rather than detection. Process to identify flaws and errors. </li></ul><ul><li>5s : Sort, set in order, shine, standardize, sustain </li></ul><ul><li>Balanced scorecard : Measuring a defined set of parameters </li></ul><ul><li>Fishbone diagram : Identify root causes for analysis and resolution </li></ul>
  16. 16. Process Terminology <ul><li>CTQ : Critical to Quality. Identify what is of utmost importance to customer and the product. </li></ul><ul><li>QFD : Quality Function Deployment. Phases that specify design, specifications, delivery, and measurement. </li></ul>
  17. 17. Examples of where Lean Sigma can be used <ul><li>Large Pharma needs to harmonize processes for their SAP service. </li></ul><ul><li>Increasing production output on a production line </li></ul><ul><li>Reducing production overhead by reducing waste </li></ul><ul><li>A set of standards and tools need to be implemented across a new department specializing project management and governance. </li></ul><ul><li>Bottlenecks in a chocolate manufacturing process need to be minimized. </li></ul><ul><li>Several IT tools are bought, but the best way to implement is not known yet. </li></ul>
  18. 18. Applying Lean Sigma <ul><li>Most Lean Sigma projects fall under three categories: </li></ul><ul><ul><li>Taking advantage of low hanging fruit </li></ul></ul><ul><ul><li>Process improvement within operations </li></ul></ul><ul><ul><li>Long term change management within an organization </li></ul></ul><ul><li>For optimal results, the project should identify all three of the above. It’s not really possible to realize full benefits without having change management in place. </li></ul>
  19. 19. Applying Lean Sigma <ul><li>Biggest issue to overcome is getting the data. </li></ul><ul><ul><li>Most institutions do not have the data collection devices available or in place. </li></ul></ul><ul><ul><li>Cost is usually high for these solutions, whether in man-hours or computer based </li></ul></ul><ul><li>QO may have issues with a continuous open architecture interfaced to the process. </li></ul>
  20. 20. Where to begin? <ul><li>DMAIC – Define, Measure, Analyze, Improve, Control </li></ul><ul><li>Six Sigma Term but works well to help solve just about any problem </li></ul>
  21. 21. Define <ul><li>Define – Can include Charter, SIPOC, VOC, CTQ Tree, Kano, PI Grid, QFD </li></ul><ul><ul><li>Map the as-is process of flow </li></ul></ul><ul><ul><li>Gather the needs of the customer. This is the VOC. (Voice of the Customer). Use SIPOC if possible. Or other equally strong method for requirements. </li></ul></ul>
  22. 22. Measure <ul><li>Measure – Flow Charts/Maps, Time Value, Takt, Inventory, TOC, OEE </li></ul><ul><ul><li>From the requirements, map out the to-be process. What should the future process look like, based on what the needs are? </li></ul></ul>
  23. 23. Analyze <ul><li>Analyze – Pareto, Cause & Effect, Process Analysis, Equipment Analysis, DOE </li></ul><ul><ul><li>Perform the gap analysis. What will it take to get there? How long? How many resources? What will the budget be? This is the ACTION PLAN </li></ul></ul><ul><ul><li>From the to-be process, are there any areas of improvement? What areas can be consolidated? </li></ul></ul>
  24. 24. Improve <ul><li>Improve – Alternatives, Solutions, Kaizens, Pilot, FMEA </li></ul><ul><ul><li>Select a sponsor champion to drive the change </li></ul></ul><ul><ul><li>Select the tool to match the need </li></ul></ul><ul><ul><li>IMPLEMENT </li></ul></ul>
  25. 25. Control <ul><li>Control – Standard Work, Takt, Kanban/JIT, Visual Control, TPM, 5S </li></ul><ul><ul><li>These are a lot of the same things we did in the ‘Measure’ stage. We are trying to monitor and control the processes now. </li></ul></ul>
  26. 26. Where to use in Validation? <ul><li>Major components of validation: </li></ul><ul><ul><li>Documentation </li></ul></ul><ul><ul><li>Testing </li></ul></ul><ul><ul><li>Methodology </li></ul></ul><ul><ul><li>Records Retention </li></ul></ul><ul><ul><li>What parts of Lean Sigma can we use for these components of validation? </li></ul></ul>
  27. 27. Where to use in Validation? <ul><li>Major components of validation: </li></ul><ul><ul><li>FMEA (more Six Sigma than Lean) </li></ul></ul><ul><ul><li>RACI </li></ul></ul><ul><ul><li>Design for Six Sigma (can be adjusted for Lean) </li></ul></ul><ul><ul><li>DMAIC </li></ul></ul><ul><ul><li>VOC </li></ul></ul><ul><ul><li>CTQ </li></ul></ul><ul><ul><li>SIPOC </li></ul></ul>
  28. 28. Example of using Lean Sigma into Validation <ul><li>One can use CTQ (Critical to Quality) measurements into testing protocols. </li></ul><ul><li>CTQs (Critical to Quality) are the key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer. They align improvement or design efforts with customer requirements </li></ul><ul><li>CTQs represent the product or service characteristics that are defined by the customer (internal or external). They may include the upper and lower specification limits or any other factors related to the product or service. A CTQ usually must be interpreted from a qualitative customer statement to an actionable, quantitative business specification. </li></ul>
  29. 29. Example of using Lean Sigma into Validation <ul><li>For testing a design, you can use CTQ in the following way: </li></ul><ul><ul><li>Use a CTQ such as affinity diagrams or CTQ trees to gather what is most important for customer </li></ul></ul><ul><ul><li>Start with ‘what’. Define a ‘how’ for each ‘what’ </li></ul></ul><ul><ul><li>Dive deeper with each ‘what’ to develop a measurable quality or amount </li></ul></ul>
  30. 30. Example of using Lean Sigma into Validation <ul><li>So, for example: </li></ul><ul><ul><li>The customer believes the most important characteristics in the system are the ability to generate reports and gather accurate data. So, based on these two most important “what's”, dive deeper to ascertain the functionalities behind each of these. For each functionality, ask ‘how’ will this be done. Next, develop a measurable range that this needs to be done to appropriately satisfy the customer. Then, design for these as the most important needs, and test for these as the most important needs. </li></ul></ul><ul><li>In effect, you’ve concentrated your testing on the customers most important needs, making sure the voice of the customer is heard. </li></ul>
  31. 31. Critical Lean Sigma Metrics <ul><li>Time (speed) to complete process and deliver (start-finish) </li></ul><ul><li>Total Throughput (capacity) </li></ul><ul><li>On Time Delivery and Service </li></ul><ul><li>Lead Times and Cycle Times </li></ul><ul><li>VA/NVA Activities </li></ul><ul><li>Quality (Accuracy, Consistency, etc) </li></ul>
  32. 32. Critical Lean Sigma Metrics <ul><li>Inventory (Amount, Cash, Cost, Turns) </li></ul><ul><li>Financial (Cost, Cash Flow, Margins, ROI) </li></ul><ul><li>Productivity (Employee utilization; Output) </li></ul><ul><li>Waste (Reduction) </li></ul>
  33. 33. Questions <ul><li>Questions? </li></ul>
  34. 34. Reference Material <ul><li>Ishiwata, Junichi (1997), Productivity through Process Analysis </li></ul><ul><li>Axios Incorporated (2001), ABC Company Lean Sigma Executive Overview </li></ul><ul><li> </li></ul>
  35. 35. Case Study <ul><li>A small pharmaceutical research company needs to do its validation, but it’s cost constrained. They’ve hired you as the six sigma / lean sigma expert to work with their project lead to perform this validation as efficiently as possible and at lowest costs. </li></ul>
  36. 36. Case Study <ul><li>The project is to develop a records retention system for their R&D division. They will be using a large packaged solution. Assume the following: </li></ul><ul><ul><li>They have no methodology for packaged implementation </li></ul></ul><ul><ul><li>They have no written protocol templates </li></ul></ul><ul><ul><li>They have not involved the customers (research scientists), except as FYI </li></ul></ul><ul><ul><li>They do have SOPs </li></ul></ul><ul><ul><li>What would you advise the project lead to do so that he’d experience the lowest cost possible in his validation effort? </li></ul></ul>