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E-grāmata: Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness

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  • Formāts: PDF+DRM
  • Izdošanas datums: 15-Apr-2008
  • Izdevniecība: Wiley-Interscience
  • Valoda: eng
  • ISBN-13: 9780470263914
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Medical Device Design for Six Sigma: A Road Map for Safety and EffectivenessPalielināt
  • Formāts: PDF+DRM
  • Izdošanas datums: 15-Apr-2008
  • Izdevniecība: Wiley-Interscience
  • Valoda: eng
  • ISBN-13: 9780470263914
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The first comprehensive guide to the integration of Design for Six Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness presents the complete body of knowledge for Design for Six Sigma (DFSS), as outlined by American Society for Quality, and details how to integrate appropriate design methodologies up front in the design process. DFSS helps companies shorten lead times, cut development and manufacturing costs, lower total life-cycle cost, and improve the quality of the medical devices. Comprehensive and complete with real-world examples, this guide:





Integrates concept and design methods such as Pugh Controlled Convergence approach, QFD methodology, parameter optimization techniques like Design of Experiment (DOE), Taguchi Robust Design method, Failure Mode and Effects Analysis (FMEA), Design for X, Multi-Level Hierarchical Design methodology, and Response Surface methodology



Covers contemporary and emerging design methods, including Axiomatic Design Principles, Theory of Inventive Problem Solving (TRIZ), and Tolerance Design



Provides a detailed, step-by-step implementation process for each DFSS tool included



Covers the structural, organizational, and technical deployment of DFSS within the medical device industry



Includes a DFSS case study describing the development of a new device



Presents a global prospective of medical device regulations





Providing both a road map and a toolbox, this is a hands-on reference for medical device product development practitioners, product/service development engineers and architects, DFSS and Six Sigma trainees and trainers, middle management, engineering team leaders, quality engineers and quality consultants, and graduate students in biomedical engineering.

Recenzijas

"The book is well-written and the authors use well versed descriptions, easy to read figures and tables, and industry-related examples and case studies to explain what can be very complex concepts and processes. This book would be a valuable resource for anyone in the field of medical device design." (Doody's Book Reviews, October 2008)

Foreword xvii
Preface xix
Medical Device Design Quality
1(24)
Introduction
1(1)
The Essence of Quality
2(3)
Quality Operating System and the Device Life Cycle
5(6)
Stage 1: Idea Creation
6(1)
Stage 2: Voice of the Customer and Business
7(1)
Stage 3: Concept Development
8(1)
Stage 4: Preliminary Design
9(1)
Stage 5: Design Optimization
9(1)
Stage 6: Verification and Validation
9(1)
Stage 7: Launch Readiness
10(1)
Stage 8: Mass Production
10(1)
Stage 9: Consumption
11(1)
Stage 10: Disposal or Phaseout
11(1)
Evolution of Quality
11(6)
Statistical Analysis and Control
12(1)
Root-Cause Analysis
13(1)
Total Quality Management
13(1)
Design quality
14(1)
Process Simplification
15(1)
Six Sigma and Design for Six Sigma
15(2)
Business Excellence: A Value Proposition
17(6)
Business Operation Model
17(1)
Structure of the Medical Device Qualtiy Function
18(4)
Quality and Cost
22(1)
Quality and Time to Market
23(1)
Summary
23(2)
Design for Six Sigma and Medical Device Regulation
25(28)
Introduction
25(1)
Global Perspective on Medical Device Regulations
25(3)
Medical Device Classification
28(1)
Medical Device Safety
29(2)
Medical Device Quality Management Systems Requirements
31(3)
Medical Device Regulation Throughout the Product Development Life Cycle
34(18)
Design and Development Plan
36(6)
Design Input
42(2)
Design Output
44(2)
Design Reviw
46(1)
Design Verification and Validation
47(2)
Design Transfer
49(1)
Design Changes
50(1)
Design History File
50(1)
QSIT Design Control Inspectional Objectives
51(1)
Summary
52(1)
Basic Statistics
53(20)
Introduction
53(1)
Common Probability Distributions
53(3)
Methods of Input and Output Analysis
56(2)
Descriptive Statistics
58(5)
Measures of Central Tendency
59(2)
Measures of Dispersion
61(2)
Inferential Statistics
63(7)
Paramenter Estimation
63(2)
Hypothesis Testing
65(4)
Experimental Design
69(1)
Normal Distribution and Normality Assumption
70(2)
Violating the Normality Assumption
72(1)
Summary
72(1)
The Six Sigma Process
73(16)
Introduction
73(1)
Six Sigma Fundamentals
73(1)
Process Modeling
74(2)
Process Mapping
74(1)
Value Stream Mapping
75(1)
Business process Management
76(1)
Measurement Systems Analysis
77(1)
Pocess Capability and Six Sigma Process Performance
78(6)
Motorola's Six Sigma Quality
82(2)
Overview of Six Sigma Improvement
84(2)
Phase 1: Difine
84(1)
Phase 2: Measure
84(1)
Phase 3: Analyze
85(1)
Phase 4: Improve
85(1)
Phase 5: Control
85(1)
Six Sigma Gose Upstream: design for six Sigma
86(1)
Summary
86(3)
Appendix 4A: cause-and-Effect Tools
87(2)
Medical Device Design for Six Sigma
89(48)
Introduction
89(2)
Value of Designing for Six Sigma
91(3)
Medical Device DFSS Fundamentals
94(2)
The ICOV Process in Design
96(2)
The ICOV Process in Product Development
98(2)
Summary
100(1)
Medical Device DFSS Deployment
Introduction
101(1)
Medical Device DFSS Deployment Fundamentals
102(1)
Predeployment Phase
103(22)
Predeployment Considerations
105(20)
Deployment Phase
125(3)
Training
126(1)
Project Financials
127(1)
Postdeployment Phase
128(1)
DFSS Sustainability Factors
129(3)
Black Belts and the DFSS Team: Cultural Change
132(3)
Summary
135(2)
Medical Device DFSS Project Road Map
137(22)
Introduction
137(2)
Medical Device DFSS Team
139(4)
Medical Device DFSS Road Map
143(11)
Phase 1: Identify Requirements
144(4)
Phase 2: Characterize Design
148(3)
Phase 3: Optmize requirements
151(1)
Phase 4: Verify/Validate the Design
152(2)
Software DFSS ICOV Process
154(3)
Summary
157(2)
Quality Function Deployment
159(18)
Introduction
159(1)
History of QFD
160(1)
QFD Fundamentals
161(1)
QFD Methodology
161(3)
HQQ Evaluation
164(1)
HQQ 1: The Customer's House
165(5)
Kano Model
167(3)
HQQ 2: Translation House
170(1)
HQQ 3: Design House
171(1)
HQQ 4: Process House
171(1)
Application: Auto 3D
172(3)
Summary
175(2)
DFSS Axiomatic Design Method
177(21)
Introduction
177(2)
Axiomatic Method Fundamentals
179(4)
Introduction to Axiom 1
183(2)
Introduction to Axiom 2
185(4)
Axiomatic Design Theorems and Corollaries
189(3)
Application: Medication Mixing Machine
192(1)
Application: Axiomatic Design Applied to Design Controls
193(3)
Summary
196(2)
Appendix 9A: Matrix Review
196(2)
DFSS Innovation for Medical Devices
198(42)
Introduction
198(1)
History of the Theory of Inventive Problem Solving
198(2)
TRIZ Fundamentals
200(9)
Overview
200(4)
Analytical Tools
204(1)
Knowledge-Based Tools
204(5)
TRIZ Problem-Solving Process
209(1)
Ideal Final Result
210(2)
Itself Method
210(1)
Ideality Checklist
211(1)
Ideality Equation
211(1)
Building Sufficient Functions
212(1)
Eliminating Harmful Functions
212(1)
Inventive Principles
213(6)
Detection and Measurement Concepts
219(1)
TRIZ Root Cause Analysis
220(1)
Evolution trends in Technological Systems
221(3)
TRIZ Functional Analysis and Analogy
224(1)
Application: Using Triads to Predict and Conceive Next-Generation Products
225(9)
Summary
234(6)
Appendix 10A: Contradiction Matrix
234(6)
DFSS Risk Management Process
240(19)
Introduction
240(1)
Planning for Risk Management Activities in Design and Development
241(3)
Risk Assessment Techniques
244(4)
Preliminary Hazard Analysis
245(1)
Hazard and Operability Study
245(1)
Failure Mode and Effects Analysis
245(1)
Fault Tree Analysis
246(2)
Risk Evaluation
248(2)
Risk control
250(1)
Postproduction Control
250(1)
Summary
250(9)
Appendix 11A: Robust Design Failure Mode and Effects Analysis
251(1)
Parameter Diagram
252(1)
Robust Design FMEA Elements
253(6)
Medical Device Design for X
259(32)
Introduction
259(3)
Design for Reliability
262(3)
Design for Packaging
265(4)
Design for Manufacture and Design for Assembly
269(12)
DFMA Approach
269(2)
DFMA in the ICOV DFSS Process
271(3)
DFMA Best Practices
274(6)
Example
280(1)
Design for Maintainability
281(1)
Design for Serviceability
282(8)
DFS Guidelines
282(3)
Application: Pressure Recorder PCB Replacement
285(5)
Summary
290(1)
DFSS Transfer Function and Scorecards
291(20)
Introduction
291(1)
Design Mapping
292(5)
Functional Mapping
293(1)
Process Mapping
294(3)
Design Mapping Steps
297(1)
Design Scorecards and the Transfer Function
297(5)
DFSS Scorecard Development
299(1)
Transfer Function Life Cycle
299(3)
Transfer Function Mathematics
302(4)
Transfer Function and Optimization
306(2)
Monte Carlo Simulation
308(1)
Summary
309(2)
Fundamentals of Experimental Design
311(42)
Introduction
311(3)
Classical Design of Experiments
314(10)
Study Definition
314(10)
Factorial Experiment
324(3)
Mathematical Transfer Function
325(1)
Interaction Between Factors
325(2)
Analysis of Variance
327(5)
2k Full Factorial Design
332(11)
Design Layout
333(1)
Data Analysis
334(1)
DOE Application
334(7)
The 23 Design
341(1)
The 23 Design with Center Points
342(1)
Fractional Factorial Designs
343(6)
The 23-1 Design
344(1)
Half-Fractional 2k design
345(1)
Design Resolution
346(1)
One-Fourth Fractional 2k Design
347(2)
Other Factorial Designs
349(1)
Three-Level Factorial Design
349(1)
Box-Behnken Designs
350(1)
Summary
350(3)
Appendix 14A
351(1)
Diagnostic Plots of Residuals
351(1)
pareto Chart of Effects
351(1)
Square and Cube Plots
351(1)
Interaction Plots
352(1)
Robust Parameter Design for Medical Devices
353(24)
Introduction
353(1)
Robust Design Fundamentals
354(3)
Robust Design and DFSS
355(2)
Robust Design Concepts
357(11)
Concept 1: Output Classification
357(1)
Concept 2: quality Loss Function
358(3)
Concept 3: Signal, Noise, and Control Factors
361(1)
Concept 4: Signal-to-Noise Ratios
362(1)
Concept 5: Orthogonal Arrays
363(2)
Concept 6: Parameter Design Analysis
365(3)
Application: Dynamic Formulation
368(8)
Summary
376(1)
Medical Device Tolerance Design
377(28)
Introduction
377(1)
Tolerance Design and DFSS
378(4)
Application: Imprecise Measurements
380(2)
Wors-Case Tolerance
382(6)
Application: Internal Pressures in Disposable Tubing
383(5)
Statistical Tolerances
388(6)
Relationship of Tolerance to Process Capabilities
389(1)
Linear Statistical Tolerance
389(2)
Nonlinear Statistical Tolerance
391(3)
Taguchi's Loss Function and Safety Tolerance Design
394(4)
Nominal-the-Best Tolerance Design
394(2)
Smaller-the-Better Tolerance Design
396(1)
Larger-the-better Tolerance Design
397(1)
High-vs. Low-Level Requirements' Tolerance Relationships
398(2)
Tolerance Allocation for Multiple Parameters
399(1)
Taguchi's Tolerance Design Experiment
400(4)
Application: Tolerance Design
402(2)
Summary
404(1)
Medical Device DFSS Verification and Validation
405(26)
Introduction
405(3)
Design Verification Process
408(11)
Building a Verification Prototype
416(1)
Prototype Testing
417(1)
Confidence Interval of Small-Sample Verification
418(1)
Production Process Validation
419(9)
Device Verification Analysis
427(1)
Software Validation
428(1)
Design Validation
429(1)
Summary
430(1)
DFSS Design Transfer
431(23)
Introduction
431(1)
Design Transfer Planning
432(1)
Process Control Plan
433(1)
Statistical process Control
434(4)
Choosing the Control Chart
435(2)
Interpreting the Control Chart
437(1)
Taking Action
438(1)
Process Capability
438(1)
Advanced Product Quality planning
439(7)
APQP Procedure
440(4)
Product Part Approval Process
444(2)
Device Master Record
446(7)
Document for Intendend Employees
449(2)
Adequate Information
451(1)
Preparation and Signatures
452(1)
Summary
453(1)
Design Change Control, design review, and Design History File
454(8)
Introduction
454(1)
Design Change Control Process
455(2)
Pre-and Postdesign Transfer CCP
455(2)
Design Review
457(2)
Design History File
459(1)
Summary
460(2)
Medical Device DFSS Case Study
462(26)
Introduction
462(1)
DFSS Identify Phase
462(5)
DFSS Characterize Phase
467(3)
DFSS Optimize Phase
470(10)
DOE Optimization Analysis
476(1)
DOE Optimization Conclusions
476(3)
DOE Confirmation Run
479(1)
DFSS Verify/Validate Phase
480(7)
Summary
487(1)
Glossary: DFSS Terminology 488(9)
Appendix: Statistical Tables 497(13)
References 510(13)
Index 523
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.
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