At my current location we develop products that are regulated by the FDA, so we must have a quality system based on CFR Title 21, Part 820. Around here, that quality system is called the Global Development Process or GDP. However, those regulations do not tell you how to build a quality product, just that you need to have a documented process and you need to follow it. Because the FDA allows companies to define their own quality process within the guidelines of Title 21, Part 820, when auditors come for an inspection, what they are looking to see if we are adhering to our own process.
For us, the GDP is simply the minimum requirements we must follow in order to be in compliance with the FDA. While our GDP explains the deliverables we must create and when, it does not provide any guidance on how to produce these deliverables. In addition, it is my understanding that while the GDP is focused on compliance for the FDA, it does not show how to build excellent products within the GDP. I am now part of the core team which will create a set of Lean tools that will help us create excellent products that excite our customers and better help their patients. This concept is calledDesign for Six Sigma (DfSS) and has been described to me as a way to build quality into our new products. I have been selected to be on this team to provide an Agile viewpoint and create tools that will aid software engineers make more robust products and apply widely-used “best practices”.
At first glance, DfSS sounds a lot like waterfall and I am a very Agile guy at heart. Initially, I was very skeptical about this initiative, but I have changed my thinking. This could be a very interesting avenue of study since most of my experience has been working on small teams creating small products using lightweight tools. However, big companies with complex hardware and software requirements, especially ones regulated by the FDA, need a different set of tools, tools that are a more heavyweight than I am used to.
I am not certain that the concepts of DfSS and Agile can be combined, but what intrigues me is the emphasis on the Voice of the Customer (VOC). If we remain committed to learning the VOC and focused on what the customer’s user needs, I can see how Agile and DfSS can play nice together. How that plays out in real life remains to be seen, but I definitely have an open mind that something “bigger” than Agile is needed for big companies and DfSS might be it. Perhaps DfSS is the way big companies make products in a recognizably Agile way?