News that Emergent BioSolutions had ruined 15 million doses of Johnson & Johnson's vaccine by mistakenly mixing it with ingredients from AstraZeneca’s vaccine became public last week. Quality control checks flagged the issue before the problematic batch affected more doses, but because the mix-up was the result of human error, the discovery raised questions about training and supervision.
Of course, these sorts of events are not uncommon in manufacturing and particularly in the making of vaccines, which is a complex and multi-step biological process. (It may be worth noting here that, in the past, the F.D.A. had a rule that prevented plants from making two live viral vector vaccines simultaneously, because of the potential for mix-ups and contamination.) But in the case of Emergent, there were smoke signals. A top federal pandemic official warned last June that the government contractor lacked enough trained staff and had a record of problems with quality control. And the New York Times reported just yesterday that between October and January, Emergent threw away up to three million doses of the AstraZeneca vaccine because of contamination or suspected contamination.
J&J has since moved to strengthen its control over Emergent BioSolutions’ work to avoid additional quality lapses. But damage has been done, and it’s an embarrassment to both companies.
“Take any system running at 80% capacity and the defects lay dormant. But once you speed up to full capacity, the growth of those defects outpaces the growth in production."
“On an analogous note, it’s Lucy and Ethel at the chocolate factory all over again,” says MIT Sloan Senior Lecturer John Carrier, who leads the new Executive Education course Building Organizational Resilience: A System Approach to Mitigating Risk and Uncertainty. Carrier is, of course, referring to the classic episode of the American sitcom I Love Lucy in which Lucy and Ethel have a brief stint working at a chocolate factory. All goes well when the candy comes through the conveyor belt at an easy pace, but when the belt speeds up and the quantity become preposterous, chaos ensue
“Take any system running at 80% capacity and the defects lay dormant,” explains Carrier. “But once you speed up to full capacity, the growth of those defects outpaces the growth in production. And that’s what happened at Emergent. Many companies fail to understand that risks don’t show up until the system is under stress.”
Carrier uses another analogy to explain Johnson & Johnson’s vaccine debacle.
“If you go to the store and buy a tomato, you’re buying the product. But let’s say you love this particular tomato enough to open a restaurant and now need a few thousand tomatoes a month. You are no longer buying the product; you’re buying the process. Can the supplier deliver the tomatoes on time, at the correct ripeness, in bulk? J&J was buying a process from Emergent, and one to which the success of their vaccines is inextricably linked.”
Carrier often reminds the participants of his courses that they can visit their suppliers before the accident or after—which do they prefer? “You can outsource production, but you can’t outsource the risk.” Although the issues may primarily lie with Emergent, J&J will ultimately end up paying for it.
“Could the company have taken steps to test the system before the pressure of delivering millions of doses was in full tilt? While it’s not possible to make a specific diagnosis without on-the-ground information, this incident follows the same systemic pattern we’ve seen time and time again—all the warning signals of an impending mishap were present and known well before the event and revealed themselves in a catastrophic incident once stress was applied.”
You can learn more about the controllable factors that lie behind nearly every industrial disaster—or near miss—in Carrier’s newest course, Building Organizational Resilience: A System Approach to Mitigating Risk and Uncertainty.