A few years ago, I attended a workshop that included people doing research in safety cases and professionals considering adopting them in their fields. Many of the latter worked for U.S. regulatory agencies, including the Nuclear Regulatory Commission, the Food and Drug Administration, and the Federal Aviation Administration. We had been asked to make short presentations of problems in our fields where we saw potential opportunities that safety cases could perhaps help address. As we did, it quickly became obvious that while the technical details of what each of us faced were different, overall we shared many similar concerns. And if there was a common thread, it was striving to assure and maintain safety in the face of an accelerating rate of change of technology. I could not help but wonder if the story around this winter’s grounding of the 787 Dreamliner would intersect that concern.
If you’re not familiar with the issues around the use of lithium batteries on the 787, a plethora of articles available online discusses them ad nauseum. An April 25 opinion piece in The New York Times caught my eye. The author, James E. Hall, a former chairman of the National Transportation Safety Board, noted:
“As a former chairman of the safety board, I know firsthand that effective government oversight helps prevent fatal airplane accidents. For decades, the FAA has used what it calls ‘designated airworthiness representatives’ to certify that aircraft meet government safety standards. They were experts selected and supervised by the agency, even if they worked for the manufacturer. But in 2005, the FAA changed the process of selecting those designees, ruling that aircraft manufacturers who qualified under the new procedures could choose their own employees to certify their planes…
The first hearing on Capitol Hill on the 787 was held just one week ago. But some of the testimony was very telling. The Government Accountability Office questioned the FAA’s ability to maintain the up-to-date knowledge necessary to approve new equipment, and the Department of Transportation’s inspector general criticized the agency for failing to ensure that personnel designated by aircraft manufacturers to certify their aircraft or components were competent to do so.”
I don’t believe for a minute that anyone would deliberately return a known unsafe airplane to flight. But the stories behind the Challenger and Columbia space shuttle accidents remain instructive as sources of examples of how an organization fundamentally devoted to safety could miss what in retrospect seem obvious signals of safety being sacrificed to production pressures. Hopefully, the FAA takes a hard look at the results of the recent changes in its practices. And hopefully, those of us responsible for the safety of rapidly changing medical technology examine the Dreamliner story for anything it can tell us.
The Dreamliner fleet returned to service Sunday morning (April 28) with an Ethiopian Airlines flight from Ethiopia to Kenya.
Systems Engineering Manager
Department of Biomedical Engineering
Massachusetts General Hospital