Quality By Design (QbD) and Six Sigma Principles: including Risk Management and FMEA

• Chapter 1, Quality by Design, QbD
• Chapter 2, Quality Function Deployment
• Chapter 3, Six Sigma and Quality Management
• Chapter 4, D-M-A-I-C
• Chapter 5, Six Sigma Tools I
• Chapter 6, Statistics for Quality
• Chapter 7, Six Sigma Tools II
• Chapter 8, Product Realization
• Chapter 9, Principles of Failure Modes and Effects Analysis
• Chapter 10, Principles of Risk Management

For product design and new product introduction, the voice of the customer must be at the heart of the process. If this is not realized early-on and by the many subject matter experts involved, new products have a high risk of been redundant commercially, lacking the required customer requirements and end up as costly mistakes for producers. This is the case for the design of many different products including technology devices, medical devices, automotive related products and features, information technology and communication related products. A number of principles can mitigate the risk of poor design decisions and unsatisfied customers.

Firstly, Quality by Design assures the right features, functionality and level of quality are factored into designs from the outset. Working hand-in-hand, Quality by Design and the tools of Six Sigma can allow companies deliver on cost, schedule and of most importance- the customer needs.

This book provides the fundamentals of applying Quality philosophies such as QbD, Quality Function deployment and Design for Quality during product development. Closely associated with these philosophies are process based methodologies, engineering tools and templates that relate to Six Sigma and Design for Six Sigma. Utilising these resources leads to more efficient project execution with a higher degree of critical thinking and decision making that is evidence-based and data driven. In addition, the role of Quality professionals when trained and aware of these tools can assist design teams, providing standard methods and ensuring quality and good design principles remain at the heart of the decision making process and product development.