Medical Device Design for Six Sigma

1 - MEDICAL DEVICE DESIGN FOR SIX SIGMA [Seite 3]
1.1 - Contents [Seite 9]
1.2 - Foreword [Seite 19]
1.3 - Preface [Seite 21]
1.4 - 1 Medical Device Design Quality [Seite 31]
1.4.1 - 1.1 Introduction [Seite 31]
1.4.2 - 1.2 The Essence of Quality [Seite 32]
1.4.3 - 1.3 Quality Operating System and the Device Life Cycle [Seite 35]
1.4.3.1 - 1.3.1 Stage 1: Idea Creation [Seite 36]
1.4.3.2 - 1.3.2 Stage 2: Voice of the Customer and Business [Seite 37]
1.4.3.3 - 1.3.3 Stage 3: Concept Development [Seite 38]
1.4.3.4 - 1.3.4 Stage 4: Preliminary Design [Seite 39]
1.4.3.5 - 1.3.5 Stage 5: Design Optimization [Seite 39]
1.4.3.6 - 1.3.6 Stage 6: Verification and Validation [Seite 39]
1.4.3.7 - 1.3.7 Stage 7: Launch Readiness [Seite 40]
1.4.3.8 - 1.3.8 Stage 8: Mass Production [Seite 40]
1.4.3.9 - 1.3.9 Stage 9: Consumption [Seite 41]
1.4.3.10 - 1.3.10 Stage 10: Disposal or Phaseout [Seite 41]
1.4.4 - 1.4 Evolution of Quality [Seite 41]
1.4.4.1 - 1.4.1 Statistical Analysis and Control [Seite 42]
1.4.4.2 - 1.4.2 Root-Cause Analysis [Seite 43]
1.4.4.3 - 1.4.3 Total Quality Management [Seite 43]
1.4.4.4 - 1.4.4 Design Quality [Seite 44]
1.4.4.5 - 1.4.5 Process Simplification [Seite 45]
1.4.4.6 - 1.4.6 Six Sigma and Design for Six Sigma [Seite 45]
1.4.5 - 1.5 Business Excellence: A Value Proposition [Seite 47]
1.4.5.1 - 1.5.1 Business Operation Model [Seite 47]
1.4.5.2 - 1.5.2 Structure of the Medical Device Quality Function [Seite 48]
1.4.5.3 - 1.5.3 Quality and Cost [Seite 52]
1.4.5.4 - 1.5.4 Quality and Time to Market [Seite 53]
1.4.6 - 1.6 Summary [Seite 53]
1.5 - 2 Design for Six Sigma and Medical Device Regulation [Seite 55]
1.5.1 - 2.1 Introduction [Seite 55]
1.5.2 - 2.2 Global Perspective on Medical Device Regulations [Seite 55]
1.5.3 - 2.3 Medical Device Classification [Seite 58]
1.5.4 - 2.4 Medical Device Safety [Seite 59]
1.5.5 - 2.5 Medical Device Quality Management Systems Requirements [Seite 61]
1.5.6 - 2.6 Medical Device Regulation Throughout the Product Development Life Cycle [Seite 64]
1.5.6.1 - 2.6.1 Design and Development Plan [Seite 66]
1.5.6.2 - 2.6.2 Design Input [Seite 72]
1.5.6.3 - 2.6.3 Design Output [Seite 74]
1.5.6.4 - 2.6.4 Design Review [Seite 76]
1.5.6.5 - 2.6.5 Design Verification and Validation [Seite 77]
1.5.6.6 - 2.6.6 Design Transfer [Seite 79]
1.5.6.7 - 2.6.7 Design Changes [Seite 80]
1.5.6.8 - 2.6.8 Design History File [Seite 80]
1.5.6.9 - 2.6.9 QSIT Design Control Inspectional Objectives [Seite 81]
1.5.7 - 2.7 Summary [Seite 82]
1.6 - 3 Basic Statistics [Seite 83]
1.6.1 - 3.1 Introduction [Seite 83]
1.6.2 - 3.2 Common Probability Distributions [Seite 83]
1.6.3 - 3.3 Methods of Input and Output Analysis [Seite 86]
1.6.4 - 3.4 Descriptive Statistics [Seite 88]
1.6.4.1 - 3.4.1 Measures of Central Tendency [Seite 89]
1.6.4.2 - 3.4.2 Measures of Dispersion [Seite 91]
1.6.5 - 3.5 Inferential Statistics [Seite 93]
1.6.5.1 - 3.5.1 Parameter Estimation [Seite 93]
1.6.5.2 - 3.5.2 Hypothesis Testing [Seite 95]
1.6.5.3 - 3.5.3 Experimental Design [Seite 99]
1.6.6 - 3.6 Normal Distribution and Normality Assumption [Seite 100]
1.6.6.1 - 3.6.1 Violating the Normality Assumption [Seite 102]
1.6.7 - 3.7 Summary [Seite 102]
1.7 - 4 The Six Sigma Process [Seite 103]
1.7.1 - 4.1 Introduction [Seite 103]
1.7.2 - 4.2 Six Sigma Fundamentals [Seite 103]
1.7.3 - 4.3 Process Modeling [Seite 104]
1.7.3.1 - 4.3.1 Process Mapping [Seite 104]
1.7.3.2 - 4.3.2 Value Stream Mapping [Seite 105]
1.7.4 - 4.4 Business Process Management [Seite 106]
1.7.5 - 4.5 Measurement Systems Analysis [Seite 107]
1.7.6 - 4.6 Process Capability and Six Sigma Process Performance [Seite 108]
1.7.6.1 - 4.6.1 Motorola's Six Sigma Quality [Seite 112]
1.7.7 - 4.7 Overview of Six Sigma Improvement [Seite 114]
1.7.7.1 - 4.7.1 Phase 1: Define [Seite 114]
1.7.7.2 - 4.7.2 Phase 2: Measure [Seite 114]
1.7.7.3 - 4.7.3 Phase 3: Analyze [Seite 115]
1.7.7.4 - 4.7.4 Phase 4: Improve [Seite 115]
1.7.7.5 - 4.7.5 Phase 5: Control [Seite 115]
1.7.8 - 4.8 Six Sigma Gose Upstream: Design for Six Sigma [Seite 116]
1.7.9 - 4.9 Summary [Seite 116]
1.7.10 - Appendix 4A: Cause-and-Effect Tools [Seite 117]
1.8 - 5 Medical Device Design for Six Sigma [Seite 119]
1.8.1 - 5.1 Introduction [Seite 119]
1.8.2 - 5.2 Value of Designing for Six Sigma [Seite 121]
1.8.3 - 5.3 Medical Device DFSS Fundamentals [Seite 124]
1.8.4 - 5.4 The ICOV Process in Design [Seite 126]
1.8.5 - 5.5 The ICOV Process in Product Development [Seite 128]
1.8.6 - 5.6 Summary [Seite 130]
1.9 - 6 Medical Device DFSS Deployment [Seite 131]
1.9.1 - 6.1 Introduction [Seite 131]
1.9.2 - 6.2 Medical Device DFSS Deployment Fundamentals [Seite 132]
1.9.3 - 6.3 Predeployment Phase [Seite 133]
1.9.3.1 - 6.3.1 Predeployment Considerations [Seite 135]
1.9.4 - 6.4 Deployment Phase [Seite 155]
1.9.4.1 - 6.4.1 Training [Seite 156]
1.9.4.2 - 6.4.2 Project Financials [Seite 157]
1.9.5 - 6.5 Postdeployment Phase [Seite 158]
1.9.6 - 6.6 DFSS Sustainability Factors [Seite 159]
1.9.7 - 6.7 Black Belts and the DFSS Team: Cultural Change [Seite 162]
1.9.8 - 6.8 Summary [Seite 165]
1.10 - 7 Medical Device DFSS Project Road Map [Seite 167]
1.10.1 - 7.1 Introduction [Seite 167]
1.10.2 - 7.2 Medical Device DFSS Team [Seite 169]
1.10.3 - 7.3 Medical Device DFSS Road Map [Seite 173]
1.10.3.1 - 7.3.1 Phase 1: Identify Requirements [Seite 174]
1.10.3.2 - 7.3.2 Phase 2: Characterize Design [Seite 178]
1.10.3.3 - 7.3.3 Phase 3: Optimize Requirements [Seite 181]
1.10.3.4 - 7.3.4 Phase 4: Verify/Validate the Design [Seite 182]
1.10.4 - 7.4 Software DFSS ICOV Process [Seite 184]
1.10.5 - 7.5 Summary [Seite 187]
1.11 - 8 Quality Function Deployment [Seite 189]
1.11.1 - 8.1 Introduction [Seite 189]
1.11.2 - 8.2 History of QFD [Seite 190]
1.11.3 - 8.3 QFD Fundamentals [Seite 191]
1.11.4 - 8.4 QFD Methodology [Seite 191]
1.11.5 - 8.5 HQQ Evaluation [Seite 194]
1.11.6 - 8.6 HQQ 1: The Customer's House [Seite 195]
1.11.6.1 - 8.6.1 Kano Model [Seite 197]
1.11.7 - 8.7 HQQ 2: Translation House [Seite 200]
1.11.8 - 8.8 HQQ 3: Design House [Seite 201]
1.11.9 - 8.9 HQQ 4: Process House [Seite 201]
1.11.10 - 8.10 Application: Auto 3D [Seite 202]
1.11.11 - 8.11 Summary [Seite 205]
1.12 - 9 DFSS Axiomatic Design Method [Seite 207]
1.12.1 - 9.1 Introduction [Seite 207]
1.12.2 - 9.2 Axiomatic Method Fundamentals [Seite 209]
1.12.3 - 9.3 Introduction to Axiom 1 [Seite 213]
1.12.4 - 9.4 Introduction to Axiom 2 [Seite 215]
1.12.5 - 9.5 Axiomatic Design Theorems and Corollaries [Seite 219]
1.12.6 - 9.6 Application: Medication Mixing Machine [Seite 222]
1.12.7 - 9.7 Application: Axiomatic Design Applied to Design Controls [Seite 223]
1.12.8 - 9.8 Summary [Seite 226]
1.12.9 - Appendix 9A: Matrix Review [Seite 226]
1.13 - 10 DFSS Innovation for Medical Devices [Seite 228]
1.13.1 - 10.1 Introduction [Seite 228]
1.13.2 - 10.2 History of the Theory of Inventive Problem Solving [Seite 228]
1.13.3 - 10.3 TRIZ Fundamentals [Seite 230]
1.13.3.1 - 10.3.1 Overview [Seite 230]
1.13.3.2 - 10.3.2 Analytical Tools [Seite 234]
1.13.3.3 - 10.3.3 Knowledge-Based Tools [Seite 234]
1.13.4 - 10.4 TRIZ Problem-Solving Process [Seite 239]
1.13.5 - 10.5 Ideal Final Result [Seite 240]
1.13.5.1 - 10.5.1 Itself Method [Seite 240]
1.13.5.2 - 10.5.2 Ideality Checklist [Seite 241]
1.13.5.3 - 10.5.3 Ideality Equation [Seite 241]
1.13.6 - 10.6 Building Sufficient Functions [Seite 242]
1.13.7 - 10.7 Eliminating Harmful Functions [Seite 242]
1.13.8 - 10.8 Inventive Principles [Seite 243]
1.13.9 - 10.9 Detection and Measurement Concepts [Seite 249]
1.13.10 - 10.10 TRIZ Root Cause Analysis [Seite 250]
1.13.11 - 10.11 Evolution trends in Technological Systems [Seite 251]
1.13.12 - 10.12 TRIZ Functional Analysis and Analogy [Seite 254]
1.13.13 - 10.13 Application: Using Triads to Predict and Conceive Next-Generation Products [Seite 255]
1.13.14 - 10.14 Summary [Seite 264]
1.13.15 - Appendix 10A: Contradiction Matrix [Seite 264]
1.14 - 11 DFSS Risk Management Process [Seite 270]
1.14.1 - 11.1 Introduction [Seite 270]
1.14.2 - 11.2 Planning for Risk Management Activities in Design and Development [Seite 271]
1.14.3 - 11.3 Risk Assessment Techniques [Seite 274]
1.14.3.1 - 11.3.1 Preliminary Hazard Analysis [Seite 275]
1.14.3.2 - 11.3.2 Hazard and Operability Study [Seite 275]
1.14.3.3 - 11.3.3 Failure Mode and Effects Analysis [Seite 275]
1.14.3.4 - 11.3.4 Fault Tree Analysis [Seite 276]
1.14.4 - 11.4 Risk Evaluation [Seite 278]
1.14.5 - 11.5 Risk Control [Seite 280]
1.14.6 - 11.6 Postproduction Control [Seite 280]
1.14.7 - 11.7 Summary [Seite 280]
1.14.8 - Appendix 11A: Robust Design Failure Mode and Effects Analysis [Seite 281]
1.14.8.1 - 11A.1 Parameter Diagram [Seite 282]
1.14.8.2 - 11A.2 Robust Design FMEA Elements [Seite 283]
1.15 - 12 Medical Device Design for X [Seite 289]
1.15.1 - 12.1 Introduction [Seite 289]
1.15.2 - 12.2 Design for Reliability [Seite 292]
1.15.3 - 12.3 Design for Packaging [Seite 295]
1.15.4 - 12.4 Design for Manufacture and Design for Assembly [Seite 299]
1.15.4.1 - 12.4.1 DFMA Approach [Seite 299]
1.15.4.2 - 12.4.2 DFMA in the ICOV DFSS Process [Seite 301]
1.15.4.3 - 12.4.3 DFMA Best Practices [Seite 304]
1.15.4.4 - 12.4.4 Example [Seite 310]
1.15.5 - 12.5 Design for Maintainability [Seite 311]
1.15.6 - 12.6 Design for Serviceability [Seite 312]
1.15.6.1 - 12.6.1 DFS Guidelines [Seite 312]
1.15.6.2 - 12.6.2 Application: Pressure Recorder PCB Replacement [Seite 315]
1.15.7 - 12.7 Summary [Seite 320]
1.16 - 13 DFSS Transfer Function and Scorecards [Seite 321]
1.16.1 - 13.1 Introduction [Seite 321]
1.16.2 - 13.2 Design Mapping [Seite 322]
1.16.2.1 - 13.2.1 Functional Mapping [Seite 323]
1.16.2.2 - 13.2.2 Process Mapping [Seite 324]
1.16.2.3 - 13.2.3 Design Mapping Steps [Seite 327]
1.16.3 - 13.3 Design Scorecards and the Transfer Function [Seite 327]
1.16.3.1 - 13.3.1 DFSS Scorecard Development [Seite 329]
1.16.3.2 - 13.3.2 Transfer Function Life Cycle [Seite 329]
1.16.4 - 13.4 Transfer Function Mathematics [Seite 332]
1.16.5 - 13.5 Transfer Function and Optimization [Seite 336]
1.16.6 - 13.6 Monte Carlo Simulation [Seite 338]
1.16.7 - 13.7 Summary [Seite 339]
1.17 - 14 Fundamentals of Experimental Design [Seite 341]
1.17.1 - 14.1 Introduction [Seite 341]
1.17.2 - 14.2 Classical Design of Experiments [Seite 344]
1.17.2.1 - 14.2.1 Study Definition [Seite 344]
1.17.3 - 14.3 Factorial Experiment [Seite 354]
1.17.3.1 - 14.3.1 Mathematical Transfer Function [Seite 355]
1.17.3.2 - 14.3.2 Interaction Between Factors [Seite 355]
1.17.4 - 14.4 Analysis of Variance [Seite 357]
1.17.5 - 14.5 2(k) Full Factorial Designs [Seite 362]
1.17.5.1 - 14.5.1 Design Layout [Seite 363]
1.17.5.2 - 14.5.2 Data Analysis [Seite 364]
1.17.5.3 - 14.5.3 DOE Application [Seite 364]
1.17.5.4 - 14.5.4 The 2(3) Design [Seite 371]
1.17.5.5 - 14.5.5 The 2(3) Design with Center Points [Seite 372]
1.17.6 - 14.6 Fractional Factorial Designs [Seite 373]
1.17.6.1 - 14.6.1 The 2(3-1) Design [Seite 374]
1.17.6.2 - 14.6.2 Half-Fractional 2(k) Design [Seite 375]
1.17.6.3 - 14.6.3 Design Resolution [Seite 376]
1.17.6.4 - 14.6.4 One-Fourth Fractional 2(k) Design [Seite 377]
1.17.7 - 14.7 Other Factorial Designs [Seite 379]
1.17.7.1 - 14.7.1 Three-Level Factorial Design [Seite 379]
1.17.7.2 - 14.7.2 Box-Behnken Designs [Seite 380]
1.17.8 - 14.8 Summary [Seite 380]
1.17.9 - Appendix 14A [Seite 381]
1.17.9.1 - 14A.1 Diagnostic Plots of Residuals [Seite 381]
1.17.9.2 - 14A.2 Pareto Chart of Effects [Seite 381]
1.17.9.3 - 14A.3 Square and Cube Plots [Seite 381]
1.17.9.4 - 14A.4 Interaction Plots [Seite 382]
1.18 - 15 Robust Parameter Design for Medical Devices [Seite 383]
1.18.1 - 15.1 Introduction [Seite 383]
1.18.2 - 15.2 Robust Design Fundamentals [Seite 384]
1.18.2.1 - 15.2.1 Robust Design and DFSS [Seite 385]
1.18.3 - 15.3 Robust Design Concepts [Seite 387]
1.18.3.1 - 15.3.1 Concept 1: Output Classification [Seite 387]
1.18.3.2 - 15.3.2 Concept 2: Quality Loss Function [Seite 388]
1.18.3.3 - 15.3.3 Concept 3: Signal, Noise, and Control Factors [Seite 391]
1.18.3.4 - 15.3.4 Concept 4: Signal-to-Noise Ratios [Seite 392]
1.18.3.5 - 15.3.5 Concept 5: Orthogonal Arrays [Seite 393]
1.18.3.6 - 15.3.6 Concept 6: Parameter Design Analysis [Seite 395]
1.18.4 - 15.4 Application: Dynamic Formulation [Seite 398]
1.18.5 - 15.5 Summary [Seite 406]
1.19 - 16 Medical Device Tolerance Design [Seite 407]
1.19.1 - 16.1 Introduction [Seite 407]
1.19.2 - 16.2 Tolerance Design and DFSS [Seite 408]
1.19.2.1 - 16.2.1 Application: Imprecise Measurements [Seite 410]
1.19.3 - 16.3 Worst-Case Tolerance [Seite 412]
1.19.3.1 - 16.3.1 Application: Internal Pressures in Disposable Tubing [Seite 413]
1.19.4 - 16.4 Statistical Tolerances [Seite 418]
1.19.4.1 - 16.4.1 Relationship of Tolerance to Process Capabilities [Seite 419]
1.19.4.2 - 16.4.2 Linear Statistical Tolerance [Seite 419]
1.19.4.3 - 16.4.3 Nonlinear Statistical Tolerance [Seite 421]
1.19.5 - 16.5 Taguchi's Loss Function and Safety Tolerance Design [Seite 424]
1.19.5.1 - 16.5.1 Nominal-the-Best Tolerance Design [Seite 424]
1.19.5.2 - 16.5.2 Smaller-the-Better Tolerance Design [Seite 426]
1.19.5.3 - 16.5.3 Larger-the-Better Tolerance Design [Seite 427]
1.19.6 - 16.6 High- vs. Low-Level Requirements' Tolerance Relationships [Seite 428]
1.19.6.1 - 16.6.1 Tolerance Allocation for Multiple Parameters [Seite 429]
1.19.7 - 16.7 Taguchi's Tolerance Design Experiment [Seite 430]
1.19.7.1 - 16.7.1 Application: Tolerance Design [Seite 432]
1.19.8 - 16.8 Summary [Seite 434]
1.20 - 17 Medical Device DFSS Verification and Validation [Seite 435]
1.20.1 - 17.1 Introduction [Seite 435]
1.20.2 - 17.2 Design Verification Process [Seite 438]
1.20.2.1 - 17.2.1 Building a Verification Prototype [Seite 446]
1.20.2.2 - 17.2.2 Prototype Testing [Seite 447]
1.20.2.3 - 17.2.3 Confidence Interval of Small-Sample Verification [Seite 448]
1.20.3 - 17.3 Production Process Validation [Seite 449]
1.20.3.1 - 17.3.1 Device Verification Analysis [Seite 457]
1.20.4 - 17.4 Software Validation [Seite 458]
1.20.5 - 17.5 Design Validation [Seite 459]
1.20.6 - 17.6 Summary [Seite 460]
1.21 - 18 DFSS Design Transfer [Seite 461]
1.21.1 - 18.1 Introduction [Seite 461]
1.21.2 - 18.2 Design Transfer Planning [Seite 462]
1.21.3 - 18.3 Process Control Plan [Seite 463]
1.21.4 - 18.4 Statistical Process Control [Seite 464]
1.21.4.1 - 18.4.1 Choosing the Control Chart [Seite 465]
1.21.4.2 - 18.4.2 Interpreting the Control Chart [Seite 467]
1.21.4.3 - 18.4.3 Taking Action [Seite 468]
1.21.5 - 18.5 Process Capability [Seite 468]
1.21.6 - 18.6 Advanced Product Quality Planning [Seite 469]
1.21.6.1 - 18.6.1 APQP Procedure [Seite 470]
1.21.6.2 - 18.6.2 Product Part Approval Process [Seite 474]
1.21.7 - 18.7 Device Master Record [Seite 476]
1.21.7.1 - 18.7.1 Document for Intended Employees [Seite 479]
1.21.7.2 - 18.7.2 Adequate Information [Seite 481]
1.21.7.3 - 18.7.3 Preparation and Signatures [Seite 482]
1.21.8 - 18.8 Summary [Seite 483]
1.22 - 19 Design Change Control, Design Review, and Design History File [Seite 484]
1.22.1 - 19.1 Introduction [Seite 484]
1.22.2 - 19.2 Design Change Control Process [Seite 485]
1.22.2.1 - 19.2.1 Pre- and Postdesign Transfer CCP [Seite 485]
1.22.3 - 19.3 Design Review [Seite 487]
1.22.4 - 19.4 Design History File [Seite 489]
1.22.5 - 19.5 Summary [Seite 490]
1.23 - 20 Medical Device DFSS Case Study [Seite 492]
1.23.1 - 20.1 Introduction [Seite 492]
1.23.2 - 20.2 DFSS Identify Phase [Seite 492]
1.23.3 - 20.3 DFSS Characterize Phase [Seite 497]
1.23.4 - 20.4 DFSS Optimize Phase [Seite 500]
1.23.4.1 - 20.4.1 DOE Optimization Analysis [Seite 506]
1.23.4.2 - 20.4.2 DOE Optimization Conclusions [Seite 506]
1.23.4.3 - 20.4.3 DOE Confirmation Run [Seite 509]
1.23.5 - 20.5 DFSS Verify/Validate Phase [Seite 510]
1.23.6 - 20.6 Summary [Seite 517]
1.24 - Glossary: DFSS Terminology [Seite 518]
1.25 - Appendix: Statistical Tables [Seite 527]
1.26 - References [Seite 540]
1.27 - Index [Seite 553]
1.28 - EULA [Seite 559]