| Many of the FAA's comment point at Boeing trying to push the regulatory timeline along despite elements (specifically software/firmware/avionics) appearing to be not sufficiently complete. This isn't the same thing as the design being fundamentally bad, or even the implementation being fundamentally flawed - it's just not done. What's not clear is why this is happening. To be clear, nearly all possible outcomes point at either a broken management, and/or engineering culture at Boeing, but all have different flavors. What points at it being a broken management culture (predominantly... this certainly doesn't rule out engineering problems) is this particular section: > Citing a “lack of data” and the absence of a Preliminary Safety Assessment for the FAA to review, the agency’s letter declares that Boeing hasn’t even met its own process requirements. > Boeing’s CCS “review dates have continuously slid over a year,” the letter notes. This section indicates that someone told regulatory to start a TIA process with FAA despite having not completed a review of a vendor supplied critical component (ie, follow their own plan). This indicates that multiple areas within the company which should have been involved (engineering, quality, and regulatory, as well as areas of the company concerned primarily with internal development, and out-sourced systems) were likely all overruled. These are all areas of the company that are supposed to be setup to stop bullshit other areas getting through. All of them have slightly misaligned interests relative to each other that generally tends to keep stuff in check. Quality is usually very very concerned with at the very least, following your own plan ('meeting its own process requirements'). No one at regulatory would have looked at these gaps (like not at least papering over missing their own process requirements), and thought that formally engaging would be a good idea. As someone working in medical devices, this definitely smells like something that management rammed through. This doesn't absolve any of other parties/groups of responsibility though. It just means that you have a problem beyond just your documented process, or technical capabilities/competence. |