Today’s Guest Post comes from Dr. Jeff Heyl, at Lincoln University in Christchurch, NZ. He is currently Associate Academic Dean and Director of the Centre for Lean Education and Research.
As the coronavirus crisis has developed, one key element of the response planning is accurate measurement of any infection. Unreliable measures meant that public health labs could not perform the disease surveillance required to predict and minimize harm before the virus became widely established. The impact has been magnified by the inability to rapidly expand the availability of testing. Yet developing tests for viral infections is a well-understood process. Within one week of the release of the genetic sequence of the virus, tests were successfully being administered in many countries. But the early test released in the US were flawed. What happened?
It seems the problem was a very basic manufacturing error. The CDC was charged with creating the initial test kits. They had considerable experience in this and placed well-qualified people in charge of the project. They also chose to manufacture the kits, and this is where the real problem arose.
The CDC failed to follow common laboratory protocols and procedures, which resulted in contamination of the components in the test kits. The test reported false positives at 24 of the 26 labs that received the early shipments. There should have been no confusion. The CDC had the protocols and procedures with complete documentation, but they were not followed.
The problem, however, started earlier during the design phase. A decision was made to include a 3rd component to the test, and this added complexity while not providing any useful information for the testing labs. It was intended to differentiate COVID-19 from other related viruses, but the genetic sequence of COIVD-19 is unique and the test was unnecessary. The CDC designed a product no customer needed or wanted.
So in a sense, it’s not surprising the test was fatally flawed. Two basic rules of lean were violated – customer focus and follow the rules. The failures may have resulted in higher rates of illnesses and fatalities. Most commercial failures don’t have such visible or tragic consequences, but their implications for firms implementing lean systems can be just as profound.
Great article!!