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The Enormous Initial Mistake   Why?  The Ultimate Curse   A Metamorphosis is Possible   The Enormous Initial Mistake    The Origins of Six Sigma  Genesis  Understanding and Reducing Variation  Understanding the Sigma Level   Gaining Greatest Leverage   Some Structural Elements of Six Sigma  Conclusion     Evolution   In the Beginning…   The Advent of Mass Production   Illustrating Variation     Revolution   Is This Understanding Important?  Stabilize First  …Then Improve the Process   The First Principle   Deming Polishes the Diamond  Deming’s First Opportunity  Deming’s Second Opportunity   The Deming Approach   Limits to Knowledge     Paradox  How Do You Know?  Improving the Analysis  Detecting Instability Using Control Charts  Chemical Example from the Pharmaceutical Industry   Biological Example from the Pharmaceutical Industry  Compliance Example from the Pharmaceutical Industry   The Attributes or Binary Mindset     Action and Reaction  The Nelson Funnel (or Pen Dropping) Experiment   Results of the Exercise   Service Elements of the Pharmaceutical Industry     Close Enough; … Or On Target?     Make More…Faster!   The Dice Experiment  Little’s Law  Quality Control Considerations  Six Sigma and First Pass Yield   Pharmaceutical Case Study ? Increasing Output    Case Studies   Biological Case Study ? Fermentation   Parenterals Operation Case Study   Safety Case Study  Improved Control of Potency  Deviations in a Pharmaceutical Plant    The Camera Always Lies  In God We Trust…   How Exact is Exact?   Giving Data Meaning   Service Industries     Keeping It Simple   Time ? The First Imperative  Pattern and Shape   The DTLF Approach     Why Use Control Charts?   Why Use Control Charts?   Types of Data  Control Charts Advantages  Developing Control Limits    Average and Range Control Charts   Constructing an Average and Range Control Chart   How the Formulae Work   Why the Chart Works   Sub-Group Integrity  Serial Sampling ? Loss of Sub-Group Integrity and Over-Control     Origins and Theory   Developing Control Limits  Making the Control Chart   Control Limits Vary with Sub-Group Size   Specifications and Control Limits  Why Use Averages?  Interpreting the Charts  The Final Word  Appendix A Origins of the Formulae     Charts for Individuals   Constructing the Charts   Interpreting Individual Point and Moving Range Charts   Summary  Stratification  Pattern and Shape   Periodicity     Practical Considerations  What Do the Statistics Mean?  Rational Sub-Groups   The Blessing of Chaos   Stabilizing a Process  Causal Relationships  Process Control  Eliminate Waste   What to Measure and Plot  Appendix A Example Operational Directive     Improving Laboratories  Production Lines are the Laboratory’s Customers  Types of Methods   Variability Estimates  Understanding Capability   Accuracy vs. Precision   Use of Validation Data to Determine Laboratory Precision  Reducing Variability ? More Is Not Always Better  Appendix A Implementing a Laboratory Variability Reduction Project  Appendix B Implementing a Blind Control Study    Beyond Compliance  We Have Met the Enemy, and He is Us     Appendix 1  Factors for Estimating s from R? and s?  Appendix 2  Factors for x? and R Control Charts  Appendix 3  Factors for x? and s Control Charts

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