ABSTRACT
This chapter has the purpose of linking Design Control requirements with Six Sigma. In specific, we will talk about Design for Six Sigma (DFSS) as a business process focused on improving the firm’s profitability by enhancing the new product development process. For the most part, if well devised, DFSS will help to ensure compliance with regulations,* though the original aim of Six Sigma programs has always been to positively hit the bottom line and to promote growth. We have chosen the product development domains (PDD) model from Chapter 3 as the DFSS methodology to follow, and the intent is to show that both roadmaps, DFSS and Design Controls, can be walked in parallel and thus take advantage of such synergies. The design control model (Figure 4.1) that we will follow is based on the waterfall model stated by FDA in their March 11, 1997, “Design Control Guidance for Medical Device Manufacturers.”** The DFSS methodology is the flow-down requirements/flow-up capabilities mentioned in Chapter 3. Later we will see that we are really talking about classical systems engineering (e.g., requirements management). The waterfall model and the methodology were also discussed in Chapter 4 of our first book. This book introduces the DFSS terms and makes the connection to design controls.
