MEDICAL DEVICE DESIGN FOR SIX SIGMA

Transcription

1 MEDICAL DEVICE DESIGN FOR SIX SIGMA A Road Map for Safety and Effectiveness BASEM S. EL-HAIK KHALID S. MEKKI WILEY- INTERSCIENCE A JOHN WILEY & SONS, INC., PUBLICATION

2 CONTENTS Foreword Preface xvii xix 1 Medical Device Design Quality Introduction, The Essence of Quality, Quality Operating System and the Device Life Cycle, Stage 1: Idea Creation, Stage 2: Voice of the Customer and Business, Stage 3: Concept Development, Stage 4: Preliminary Design, Stage 5: Design Optimization, Stage 6: Verification and Validation, Stage 7: Launch Readiness, Stage 8: Mass Production, Stage 9: Consumption, Stage 10: Disposal or Phaseout, Evolution of Quality, Statistical Analysis and Control, Root-Cause Analysis, Total Quality Management, Design Quality, Process Simplification, Six Sigma and Design for Six Sigma, 15

3 viii CONTENTS 1.5 Business Excellence: A Value Proposition, Business Operation Model, Structure of the Medical Device Quality Function, Quality and Cost, Quality and Time to Market, Summary, 23 2 Design for Six Sigma and Medical Device Regulation Introduction, Global Perspective on Medical Device Regulations, Medical Device Classification, Medical Device Safety, Medical Device Quality Management Systems Requirements, Medical Device Regulation Throughout the Product Development Life Cycle, Design and Development Plan, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes, Design History File, QSIT Design Control Inspectional Objectives, Summary, 52 3 Basic Statistics Introduction, Common Probability Distributions, Methods of Input and Output Analysis, Descriptive Statistics, Measures of Central Tendency, Measures of Dispersion, Inferential Statistics, Parameter Estimation, Hypothesis Testing, Experimental Design, Normal Distribution and Normality Assumption, Violating the Normality Assumption, Summary, 72

4 4 The Six Sigma Process Introduction, Six Sigma Fundamentals, Process Modeling, Process Mapping, Value Stream Mapping, Business Process Management, Measurement Systems Analysis, Process Capability and Six Sigma Process Performance, Motorola's Six Sigma Quality, Overview of Six Sigma Improvement, Phase 1: Define, Phase 2: Measure, Phase 3: Analyze, Phase 4: Improve, Phase 5: Control, Six Sigma Gose Upstream: Design for Six Sigma, Summary, 86 Appendix 4A: Cause-and-Effect Tools, 87 5 Medical Device Design for Six Sigma Introduction, Value of Designing for Six Sigma, Medical Device DFSS Fundamentals, The ICOV Process in Design, The ICOV Process in Product Development, Summary, Medical Device DFSS Deployment Introduction, Medical Device DFSS Deployment Fundamentals, Predeployment Phase, Predeployment Considerations, Deployment Phase, Training, Project Financials, Postdeployment Phase, DFSS Sustainability Factors, Black Belts and the DFSS Team: Cultural Change, Summary, Medical Device DFSS Project Road Map Introduction, Medical Device DFSS Team, 139 ix

5 X CONTENTS 7.3 Medical Device DFSS Road Map, Phase 1: Identify Requirements, Phase 2: Characterize Design, Phase 3: Optimize Requirements, Phase 4: Verify/Validate the Design, Software DFSS ICOV Process, Summary, Quality Function Deployment Introduction, History of QFD, QFD Fundamentals, QFD Methodology, HQQ Evaluation, HQQ 1: The Customer's House, Kano Model, HQQ 2: Translation House, HQQ 3: Design House, HQQ 4: Process House, Application: Auto 3D, Summary, DFSS Axiomatic Design Method Introduction, Axiomatic Method Fundamentals, Introduction to Axiom 1, Introduction to Axiom 2, Axiomatic Design Theorems and Corollaries, Application: Medication Mixing Machine, Application: Axiomatic Design Applied to Design Controls, Summary, 196 Appendix 9A: Matrix Review, DFSS Innovation for Medical Devices Introduction, History of the Theory of Inventive Problem Solving, TRIZ Fundamentals, Overview, Analytical Tools, Knowledge-Based Tools, TRIZ Problem-Solving Process, Ideal Final Result, 210

6 CONTENTS Itself Method, Ideality Checklist, Ideality Equation, Building Sufficient Functions, Eliminating Harmful Functions, Inventive Principles, Detection and Measurement Concepts, TRIZ Root Cause Analysis, Evolution trends in Technological Systems, TRIZ Functional Analysis and Analogy, Application: Using Triads to Predict and Conceive Next-Generation Products, Summary, 234 Appendix 10A: Contradiction Matrix, DFSS Risk Management Process Introduction, Planning for Risk Management Activities in Design and Development, Risk Assessment Techniques, Preliminary Hazard Analysis, Hazard and Operability Study, Failure Mode and Effects Analysis, Fault Tree Analysis, Risk Evaluation, Risk Control, Postproduction Control, Summary, 250 Appendix HA: Robust Design Failure Mode and Effects Analysis, A.1 Parameter Diagram, A.2 Robust Design FMEA Elements, Medical Device Design for X Introduction, Design for Reliability, Design for Packaging, Design for Manufacture and Design for Assembly, DFMA Approach, DFMA in the ICOV DFSS Process, DFMA Best Practices, Example, Design for Maintainability, Design for Serviceability, 282

7 XII CONTENTS DFS Guidelines, Application: Pressure Recorder PCB Replacement, Summary, DFSS Transfer Function and Scorecards Introduction, Design Mapping, Functional Mapping, Process Mapping, Design Mapping Steps, Design Scorecards and the Transfer Function, DFSS Scorecard Development, Transfer Function Life Cycle, Transfer Function Mathematics, Transfer Function and Optimization, Monte Carlo Simulation, Summary, Fundamentals of Experimental Design Introduction, Classical Design of Experiments, Study Definition, Factorial Experiment, Mathematical Transfer Function, Interaction Between Factors, Analysis of Variance, k Füll Factorial Designs, Design Layout, Data Analysis, DOE Application, The 2 3 Design, The 2 3 Design with Center Points, Fractional Factorial Designs, The 2" Design, Half-Fractional 2 k Design, Design Resolution, One-Fourth Fractional 2 k Design, Other Factorial Designs, Three-Level Factorial Design, Box-Behnken Designs, Summary, 350 Appendix 14A, A.1 Diagnostic Plots of Residuais, A.2 Pareto Chart of Effects, 351

8 CONTENTS xiii 14A.3 Square and Cube Plots, A.4 Interaction Plots, Robust Parameter Design for Medical Devices Introduction, Robust Design Fundamentals, Robust Design and DFSS, Robust Design Concepts, Concept 1: Output Classification, Concept 2: Quality Loss Function, Concept 3: Signal, Noise, and Control Factors, Concept 4: Signal-to-Noise Ratios, Concept 5: Orthogonal Arrays, Concept 6: Parameter Design Analysis, Application: Dynamic Formulation, Summary, Medical Device Tolerance Design Introduction, Tolerance Design and DFSS, Application: Imprecise Measurements, Worst-Case Tolerance, Application: Internal Pressures in Disposable Tubing, Statistical Tolerances, Relationship of Tolerance to Process Capabilities, Linear Statistical Tolerance, Nonlinear Statistical Tolerance, Taguchi's Loss Function and Safety Tolerance Design, Nominal-the-Best Tolerance Design, Smaller-the-Better Tolerance Design, Larger-the-Better Tolerance Design, High- vs. Low-Level Requirements' Tolerance Relationships, Tolerance Allocation for Multiple Parameters, Taguchi's Tolerance Design Experiment, Application: Tolerance Design, Summary, Medical Device DFSS Verifikation and Validation Introduction, Design Verification Process, Building a Verification Prototype, 416

9 xiv CONTENTS Prototype Testing, Confidence Interval of Small-Sample Veriflcation, Production Process Validation, Device Veriflcation Analysis, Software Validation, Design Validation, Summary, DFSS Design Transfer Introduction, Design Transfer Planning, Process Control Plan, Statistical Process Control, Choosing the Control Chart, Interpreting the Control Chart, Taking Action, Process Capability, Advanced Product Quality Planning, APQP Procedure, Product Part Approval Process, Device Master Record, Document for Intended Employees, Adequate Information, Preparation and Signatures, Summary, Design Change Control, Design Review, and Design History File Introduction, Design Change Control Process, Pre- and Postdesign Transfer CCP, Design Review, Design History File, Summary, Medical Device DFSS Case Study Introduction, DFSS Identify Phase, DFSS Characterize Phase, DFSS Optimize Phase, DOE Optimization Analysis, DOE Optimization Conclusions, DOE Confirmation Run, 479

10 CONTENTS xv 20.5 DFSS Verify/Validate Phase, Summary, 487 Glossary: DFSS Terminology 488 Appendix: Statistical Tables 497 References 510 Index 523