David Amos DFSS Deployment Director
Ford Motor Company
"A must–read road map . . . Dr. Thornton cogently explains the importance and the effective implementation of variation risk management across the enterprise to managers, designers, and customers alike."
Mike Vander Wel, PE Build Integration/Final Assembly Manager
7E7 Commercial Airplane Program
Boeing Commercial Aircraft Group
"Dr. Thornton has developed a straightforward and simple way to use this process for aligning customer requirements, product design, process capability, and quality inspections. It works well in the real world!"
Thomas Gonzalez Divisional Vice President, Quality Assurance and Regulatory Affairs
Immunoassay and Clinical Chemistry
Abbott Diagnostics Division
Written by Anna C. Thornton, the well–known author who coined the phrase "variation risk management," this comprehensive book presents new methods and implementation strategies based on her research of industry practices and her personal experience with such companies as Baxter Healthcare Corporation, The Boeing Company, Boston Scientific Corporation, Eastman Kodak Company, Ford Motor Company, Johnson & Johnson, Lockheed Martin Corporation, Northrop Grumman Corporation, and many others.
Variation Risk Management helps businesses in product development and production focus their company variation reduction and quality efforts with quantitative methods that have proven successful at top corporations. Step–by–step guidelines demonstrate how to implement and apply variation risk management to real–world problems within the existing systems of an organization.
1.1. The Competitive Advantage of VRM.
1.2. Guide to Readers.
2. Basics of Variation Risk Management.
2.1. Basic Principles of VRM.
2.1.1. VRM Must Be Holistic.
2.1.2. VRM Must Be Process Oriented.
2.1.3. VRM Must Be Data Driven.
2.2. Variation and Its Impact on Quality.
3.1. Definition of Key Characteristics and Variation Flowdown.
3.1.1. Key Characteristics.
3.1.2. Variation Flowdown.
3.2. Defining the Scope of the VRM Application.
3.3. Identifying Critical System Requirements.
3.3.1. Identify the Voice of the Customer.
3.3.2. Identify Specifications and Requirements.
3.3.3. Identify Critical System Requirements.
3.4. Identifying System Key Characteristics.
3.4.1. What Is a System Key Characteristic?
3.4.2. Examples of System Key Characteristics.
3.5. Creating the Variation Flowdown.
3.5.1. What Information to Gather.
3.5.2. How to Conduct the Top–Down Process.
3.5.3. How to Conduct the Bottom–Up Process.
3.5.4. How to Conduct and Document the Identification Procedure.
4. Overview of Assessment.
4.1. Assessment during Product Development.
4.2. Assessment during Production.
5. Assessment of Defect Rates.
5.1. Predicting the Frequency of Defects.
5.1.1. Variation Models.
5.1.2. Prediction Tools.
5.2. Estimating the Contributions of Part and Process KCs.
5.2.1. Qualitative Analysis of Variation Contribution.
5.2.2. Quantitative Analysis of Variation Contribution.
5.3. Measuring the Frequency of Defects.
5.4. Measuring the Contributions of Part and Process KCs.
6. Assessment of Cost and Risk.
6.1. Cost and Risk Assessment during Product Development.
6.1.1. Qualitative Assessments.
6.1.2. Step Cost Functions.
6.1.3. Continuous Cost Functions.
6.2. Total Cost of Variation Assessment during Production.
6.2.1. Cost Sources.
6.2.2. Representation of the Total Cost of Variation.
6.2.3. Cost Analysis and Aggregation.
7. Assessment of the Quality Control System.
7.1. QC Plan Maturity.
7.1.1. Detection Capability and Effectiveness.
7.1.2. Diagnosis Capability.
7.1.3. Efficient Resource Utilization.
7.2. QC Location in the Manufacturing Process.
7.3. QC Effectiveness Matrix.
8.1. Mitigation during Product Development and Production.
8.1.1. Mitigation during Product Development.
8.1.2. Mitigation during Production.
8.2. Identifying Mitigation Strategies.
8.2.1. Design Changes.
8.2.2. Manufacturing Process Changes.
8.2.3. Manufacturing Process Improvements.
8.2.4. Monitoring and Controlling Manufacturing Processes.
8.2.5. Testing and Inspection.
8.3. Selecting a Mitigation Strategy.
8.4. Selecting a Project Portfolio.
8.5. Executing Mitigation Strategies.
9. Integration of Variation Risk Management with Product Development.
9.1. Basics of Product Development.
9.1.1. Stage Gate Product Development Process.
9.1.2. VRM during Product Development.
9.2. Requirements Development.
9.3. Concept Development.
9.4. Product Architecture Design.
9.5. System Concept Design.
9.6. Detail Design.
9.7. Product Testing and Refinement.
9.8. Transition to Production.
9.8.1. Handling Customer Complaints.
9.8.3. Documenting the Key Characteristic Plan.
9.9.1. Continually Monitor Total Cost of Variation.
9.9.2. Track Customer Complaint Data.
9.9.3. Review Quality Control Data.
9.9.4. Track Impact of Changes.
10. Roles and Responsibilities in Variation Risk Management.
10.1. Product Development.
10.1.1. The Integrated Product Team Approach.
10.1.2. Expert Teams.
10.2.1. Production Teams.
10.2.2. Expert Teams.
10.3. Suppliers Roles and Responsibilities.
10.3.1. Role of Suppliers during Product Development.
10.3.2. Role of Suppliers during Production.
10.3.3. What Does a KC Mean to a Supplier?
11. Planning and Implementing a Variation Risk Management Program.
11.1. Planning a VRM Program.
11.1.1. Gathering Management Support.
11.1.2. Gathering Organizational Support.
11.1.3. Baselining the Existing VRM Processes.
11.1.4. Formalizing VRM.
11.1.5. Developing KC Tracking Methods.
11.1.6. Identifying Lead Users.
11.1.7. Developing Training Materials.
11.2. Implementing the VRM Program.
11.2.1. Identifying Initial Projects.
11.2.2. Training the Team.
11.2.3. Applying VRM.
11.2.4. Gathering Feedback.
Appendix A: Maturity Models.
Appendix B: Process Capability Databases.
B.1. Background on Process Capability Data.
B.1.1. Importance of Using Process Capability Data.
B.1.2. Structure and Content of a Process Capability Database.
B.1.3. Difficulties in Implementing Process Capability Databases.
B.2. The Right Structure.
B.2.1. Designing the Indexing Scheme.
B.2.2. Choosing the Database Implementation Approach.
B.2.3. Creating the User Interfaces and Data Analysis.
B.3. The Right Data.
B.4. The Right Management Support.
B.5. The Right Usage.
B.6. Implementation of a Process Capability Database.
B.6.1. Who Should Be Involved.
B.6.2. What Decisions Should Be Made.
B.6.3. Implementation Steps.
Appendix C: Other Initiatives.
C.1. Six Sigma.
C.2. Design for Six Sigma.
C.3. Lean Manufacturing.
C.4. Continual Improvement, TQM, and Kaizen.
C.5. Dimensional Management.
C.6. Design for Manufacturing.
C.7. Quality Function Deployment (House of Quality).
Appendix D: Summary of Process Diagrams.