Definitely. I never really understood why ISO 9000 was the focus. It's one thing to say, "We need operational definitions" and "Our procedures should be well

Definitely. I never really understood why ISO 9000 was the focus. It's one thing to say, "We need operational definitions" and "Our procedures should be well specified" but totally another to have all these consultants running about bikeshedding the format of the documents and things like whether you should be able to select and copy from a PDF file. Documentation systems don't give you quality, but something is needed to maintain the documentation of the system, so that you know how you got to where you are. I have been in many places where I wished that people would apply some of the system of profound knowledge. Just getting the PDSA cycle into effect on a few teams would have been great. More and more, though, it is hard to see how we should be measuring the capability of the system. Deming's examples are generally from things that lend themselves to time series analysis, preferably with small batch samples, like manufacturing processes. It is much harder, in my opinion, to determine what to even study in a software process or a medical care process. If you focus too much on a metric, it will become the goal. An interesting book to me was Juran on Quality By Design. It complements the systems approach with a design methodology based around trying to understand a lot of the ecosystem of the product. Juran, of course, was another Western Electric guy influenced by Walter Shewart.