Medical Device Design for Six Sigma A Road Map for Safety and Effectiveness

by El-Haik, Basem; Mekki, Khalid S.

Edition: 2nd

ISBN13: 9780470168615

ISBN10: 0470168617

Format: Hardcover

Pub. Date: 2008-04-25

Publisher(s): Wiley-Interscience

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Summary

This Design for Six Sigma (DFSS) and risk management book provides the framework for identifying, assessing, and controlling risks that may be present in products, processes, projects, and operations through an algorithm of design using the six-sigma thinking, tools, and philosophy. The algorithm will also include the mathematical derivation for Six Sigma capability upfront, enabling design teams to change concepts that are not safe and effective upfront.

Author Biography

Basem S. El-Haik, PhD, is the CEO and President of Six Sigma Professionals, Inc. (www.sixsigmapi.com) in Canton, Michigan, and the author of many bestselling books on Design for Six Sigma. Dr. El-Haik is well known in the DFSS domain and has been a featured speaker at many technical conferences. He has seventeen years of experience in contemporary design and quality engineering methods and has trained, certified, coached, and monitored over 600 belts (Green Belts, Black Belts, and Master Belts) in DFSS and Six Sigma in both tracks: product and service (transactional). basem.haik@sixsigmapi.com

Khalid S. Mekki is a Quality Manager at Baxter Healthcare Corporation, where he has served in various capacities since 2001. He is working toward his PhD in industrial engineering at the University of Illinois at Chicago. Khalid holds a master's degree in mechanical/quality engineering and a bachelor's degree in mechanical engineering. He has led and completed numerous Design for Six Sigma projects.

Foreword	p. xvii
Preface	p. xix
Medical Device Design Quality	p. 1
Introduction	p. 1
The Essence of Quality	p. 2
Quality Operating System and the Device Life Cycle	p. 5
Stage 1: Idea Creation	p. 6
Stage 2: Voice of the Customer and Business	p. 7
Stage 3: Concept Development	p. 8
Stage 4: Preliminary Design	p. 9
Stage 5: Design Optimization	p. 9
Stage 6: Verification and Validation	p. 9
Stage 7: Launch Readiness	p. 10
Stage 8: Mass Production	p. 10
Stage 9: Consumption	p. 11
Stage 10: Disposal or Phaseout	p. 11
Evolution of Quality	p. 11
Statistical Analysis and Control	p. 12
Root-Cause Analysis	p. 13
Total Quality Management	p. 13
Design Quality	p. 14
Process Simplification	p. 15
Six Sigma and Design for Six Sigma	p. 15
Business Excellence: A Value Proposition	p. 17
Business Operation Model	p. 17
Structure of the Medical Device Quality Function	p. 18
Quality and Cost	p. 22
Quality and Time to Market	p. 23
Summary	p. 23
Design for Six Sigma and Medical Device Regulation	p. 25
Introduction	p. 25
Global Perspective on Medical Device Regulations	p. 25
Medical Device Classification	p. 28
Medical Device Safety	p. 29
Medical Device Quality Management Systems Requirements	p. 31
Medical Device Regulation Throughout the Product Development Life Cycle	p. 34
Design and Development Plan	p. 36
Design Input	p. 42
Design Output	p. 44
Design Review	p. 46
Design Verification and Validation	p. 47
Design Transfer	p. 49
Design Changes	p. 50
Design History File	p. 50
QSIT Design Control Inspectional Objectives	p. 51
Summary	p. 52
Basic Statistics	p. 53
Introduction	p. 53
Common Probability Distributions	p. 53
Methods of Input and Output Analysis	p. 56
Descriptive Statistics	p. 58
Measures of Central Tendency	p. 59
Measures of Dispersion	p. 61
Inferential Statistics	p. 63
Parameter Estimation	p. 63
Hypothesis Testing	p. 65
Experimental Design	p. 69
Normal Distribution and Normality Assumption	p. 70
Violating the Normality Assumption	p. 72
Summary	p. 72
The Six Sigma Process	p. 73
Introduction	p. 73
Six Sigma Fundamentals	p. 73
Process Modeling	p. 74
Process Mapping	p. 74
Value Stream Mapping	p. 75
Business Process Management	p. 76
Measurement Systems Analysis	p. 77
Process Capability and Six Sigma Process Performance	p. 78
Motorola's Six Sigma Quality	p. 82
Overview of Six Sigma Improvement	p. 84
Phase 1: Define	p. 84
Phase 2: Measure	p. 84
Phase 3: Analyze	p. 85
Phase 4: Improve	p. 85
Phase 5: Control	p. 85
Six Sigma Gose Upstream: Design for Six Sigma	p. 86
Summary	p. 86
Cause-and-Effect Tools	p. 87
Medical Device Design for Six Sigma	p. 89
Introduction	p. 89
Value of Designing for Six Sigma	p. 91
Medical Device DFSS Fundamentals	p. 94
The ICOV Process in Design	p. 96
The ICOV Process in Product Development	p. 98
Summary	p. 100
Medical Device DFSS Deployment	p. 101
Introduction	p. 101
Medical Device DFSS Deployment Fundamentals	p. 102
Predeployment Phase	p. 103
Predeployment Considerations	p. 105
Deployment Phase	p. 125
Training	p. 126
Project Financials	p. 127
Postdeployment Phase	p. 128
DFSS Sustainability Factors	p. 129
Black Belts and the DFSS Team: Cultural Change	p. 132
Summary	p. 135
Medical Device DFSS Project Road Map	p. 137
Introduction	p. 137
Medical Device DFSS Team	p. 139
Medical Device DFSS Road Map	p. 143
Phase 1: Identify Requirements	p. 144
Phase 2: Characterize Design	p. 148
Phase 3: Optimize Requirements	p. 151
Phase 4: Verify/Validate the Design	p. 152
Software DFSS ICOV Process	p. 154
Summary	p. 157
Quality Function Deployment	p. 159
Introduction	p. 159
History of QFD	p. 160
QFD Fundamentals	p. 161
QFD Methodology	p. 161
HQQ Evaluation	p. 164
HQQ 1: The Customer's House	p. 165
Kano Model	p. 167
HQQ 2: Translation House	p. 170
HQQ 3: Design House	p. 171
HQQ 4: Process House	p. 171
Application: Auto 3D	p. 172
Summary	p. 175
DFSS Axiomatic Design Method	p. 177
Introduction	p. 177
Axiomatic Method Fundamentals	p. 179
Introduction to Axiom 1	p. 183
Introduction to Axiom 2	p. 185
Axiomatic Design Theorems and Corollaries	p. 189
Application: Medication Mixing Machine	p. 192
Application: Axiomatic Design Applied to Design Controls	p. 193
Summary	p. 196
Matrix Review	p. 196
DFSS Innovation for Medical Devices	p. 198
Introduction	p. 198
History of the Theory of Inventive Problem Solving	p. 198
TRIZ Fundamentals	p. 200
Overview	p. 200
Analytical Tools	p. 204
Knowledge-Based Tools	p. 204
TRIZ Problem-Solving Process	p. 209
Ideal Final Result	p. 210
Itself Method	p. 210
Ideality Checklist	p. 211
Ideality Equation	p. 211
Building Sufficient Functions	p. 212
Eliminating Harmful Functions	p. 212
Inventive Principles	p. 213
Detection and Measurement Concepts	p. 219
TRIZ Root Cause Analysis	p. 220
Evolution trends in Technological Systems	p. 221
TRIZ Functional Analysis and Analogy	p. 224
Application: Using Triads to Predict and Conceive Next-Generation Products	p. 225
Summary	p. 234
Contradiction Matrix	p. 234
DFSS Risk Management Process	p. 240
Introduction	p. 240
Planning for Risk Management Activities in Design and Development	p. 241
Risk Assessment Techniques	p. 244
Preliminary Hazard Analysis	p. 245
Hazard and Operability Study	p. 245
Failure Mode and Effects Analysis	p. 245
Fault Tree Analysis	p. 246
Risk Evaluation	p. 248
Risk Control	p. 250
Postproduction Control	p. 250
Summary	p. 250
Robust Design Failure Mode and Effects Analysis	p. 251
Parameter Diagram	p. 252
Robust Design FMEA Elements	p. 253
Medical Device Design for X	p. 259
Introduction	p. 259
Design for Reliability	p. 262
Design for Packaging	p. 265
Design for Manufacture and Design for Assembly	p. 269
DFMA Approach	p. 269
DFMA in the ICOV DFSS Process	p. 271
DFMA Best Practices	p. 274
Example	p. 280
Design for Maintainability	p. 281
Design for Serviceability	p. 282
DFS Guidelines	p. 282
Application: Pressure Recorder PCB Replacement	p. 285
Summary	p. 290
DFSS Transfer Function and Scorecards	p. 291
Introduction	p. 291
Design Mapping	p. 292
Functional Mapping	p. 293
Process Mapping	p. 294
Design Mapping Steps	p. 297
Design Scorecards and the Transfer Function	p. 297
DFSS Scorecard Development	p. 299
Transfer Function Life Cycle	p. 299
Transfer Function Mathematics	p. 302
Transfer Function and Optimization	p. 306
Monte Carlo Simulation	p. 308
Summary	p. 309
Fundamentals of Experimental Design	p. 311
Introduction	p. 311
Classical Design of Experiments	p. 314
Study Definition	p. 314
Factorial Experiment	p. 324
Mathematical Transfer Function	p. 325
Interaction Between Factors	p. 325
Analysis of Variance	p. 327
2[superscript k] Full Factorial Designs	p. 332
Design Layout	p. 333
Data Analysis	p. 334
DOE Application	p. 334
The 2[superscript 3] Design	p. 341
The 2[superscript 3] Design with Center Points	p. 342
Fractional Factorial Designs	p. 343
The 2[superscript 3-1] Design	p. 344
Half-Fractional 2[superscript k] Design	p. 345
Design Resolution	p. 346
One-Fourth Fractional 2[superscript k] Design	p. 347
Other Factorial Designs	p. 349
Three-Level Factorial Design	p. 349
Box-Behnken Designs	p. 350
Summary	p. 350
Appendix 14A	p. 351
Diagnostic Plots of Residuals	p. 351
Pareto Chart of Effects	p. 351
Square and Cube Plots	p. 351
Interaction Plots	p. 352
Robust Parameter Design for Medical Devices	p. 353
Introduction	p. 353
Robust Design Fundamentals	p. 354
Robust Design and DFSS	p. 355
Robust Design Concepts	p. 357
Concept 1: Output Classification	p. 357
Concept 2: Quality Loss Function	p. 358
Concept 3: Signal, Noise, and Control Factors	p. 361
Concept 4: Signal-to-Noise Ratios	p. 362
Concept 5: Orthogonal Arrays	p. 363
Concept 6: Parameter Design Analysis	p. 365
Application: Dynamic Formulation	p. 368
Summary	p. 376
Medical Device Tolerance Design	p. 377
Introduction	p. 377
Tolerance Design and DFSS	p. 378
Application: Imprecise Measurements	p. 380
Worst-Case Tolerance	p. 382
Application: Internal Pressures in Disposable Tubing	p. 383
Statistical Tolerances	p. 388
Relationship of Tolerance to Process Capabilities	p. 389
Linear Statistical Tolerance	p. 389
Nonlinear Statistical Tolerance	p. 391
Taguchi's Loss Function and Safety Tolerance Design	p. 394
Nominal-the-Best Tolerance Design	p. 394
Smaller-the-Better Tolerance Design	p. 396
Larger-the-Better Tolerance Design	p. 397
High- vs. Low-Level Requirements' Tolerance Relationships	p. 398
Tolerance Allocation for Multiple Parameters	p. 399
Taguchi's Tolerance Design Experiment	p. 400
Application: Tolerance Design	p. 402
Summary	p. 404
Medical Device DFSS Verification and Validation	p. 405
Introduction	p. 405
Design Verification Process	p. 408
Building a Verification Prototype	p. 416
Prototype Testing	p. 417
Confidence Interval of Small-Sample Verification	p. 418
Production Process Validation	p. 419
Device Verification Analysis	p. 427
Software Validation	p. 428
Design Validation	p. 429
Summary	p. 430
DFSS Design Transfer	p. 431
Introduction	p. 431
Design Transfer Planning	p. 432
Process Control Plan	p. 433
Statistical Process Control	p. 434
Choosing the Control Chart	p. 435
Interpreting the Control Chart	p. 437
Taking Action	p. 438
Process Capability	p. 438
Advanced Product Quality Planning	p. 439
APQP Procedure	p. 440
Product Part Approval Process	p. 444
Device Master Record	p. 446
Document for Intended Employees	p. 449
Adequate Information	p. 451
Preparation and Signatures	p. 452
Summary	p. 453
Design Change Control, Design Review, and Design History File	p. 454
Introduction	p. 454
Design Change Control Process	p. 455
Pre- and Postdesign Transfer CCP	p. 455
Design Review	p. 457
Design History File	p. 459
Summary	p. 460
Medical Device DFSS Case Study	p. 462
Introduction	p. 462
DFSS Identify Phase	p. 462
DFSS Characterize Phase	p. 467
DFSS Optimize Phase	p. 470
DOE Optimization Analysis	p. 476
DOE Optimization Conclusions	p. 476
DOE Confirmation Run	p. 479
DFSS Verify/Validate Phase	p. 480
Summary	p. 487
Glossary: DFSS Terminology	p. 488
Statistical Tables	p. 497
References	p. 510
Index	p. 523
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