Quality Management 2.0 Blog

Pushing the Frontier of Risk Assessment and CAPA

Posted by Mary McAtee on Sep 03, 2015 @ 02:00 PM

Technology is evolving more rapidly than at any point in history. We tend to think of seminal moments in Risk_Assessment__Corrective_Actions_Bloghistory, such as the invention of the steam engine and powered flight, as literal moments in time. The reality is that the invention of the steam engine by Fulton was only possible because of a long sequence of successive inventions he was able to capitalize on to change the world. If the ability to cast and temper Iron had not been improved on over the ages, Fulton could not have repurposed the concept used to pump water and compress air into the piston, cylinder and crankshaft. Fulton’s brilliance was harnessing known physical laws to use steam to develop and transfer energy into work.

So depending on your perspective, the invention of the steam engine which appears with a specific date on one of those illustrated timelines they were so fond of having in High School history books could very well have looked more like a Gantt chart starting with man developing fire.

News media outlets have been filled with stories about technological breakthroughs including self-driving cars and drones being tested to deliver everything from pizza to life saving medication

Unfortunately, I am going to lapse into cranky older person complaining about the instant gratification mindset of anyone younger than me… meaning almost everyone. The same news outlets that are gushing about each new development, follow the story with an equally disturbing sequence focusing on the dark side of the potential damage that can be caused by persons with ill intent. Self-driving cars and drones can and are being hacked and reprogrammed to cause harm and disruption. This juxtaposition of oppositional ideas cause weird images to flit through my mental field of view. I can see Buckminster Fuller high-fiving Alexander Graham Bell in excitement over each new idea and a legion of historical villains sneaking up on them ready to mount handguns on drones, already happened, and driving a hacked auto-piloted car onto the railroad tracks in the path of a robotic high speed Commuter Train.

A close examination of the development timeline for such world changing inventions as the steam engine and powered flight are littered with a trail of dead and injured early adopters of the new and untested technologies. Steam engine boilers exploded regularly and one of the Wright brothers sustained injuries in an early flight that compromised him physically for the rest of his life. I am not so sure that the public of today would tolerate similar fatal missteps during the early evolution of commercial drones or self-driven cars. Even though we seldom blink at the number of auto fatalities each year I suspect that the first failure of a self-driven car, especially if it involves innocent third parties will almost certainly trip a deployment and adoption circuit breaker of some sort. The technology will eventually take root and thrive in spite of the deaths and injuries but a crash of a commercial airliner attributed to a drone will be a very tough consequence to get past for the public. I don’t think we are, in point of fact, less risk aversive than our forbearers but I think we take comfort in not connecting the dots between the emerging technology and the deaths and injuries that are the unintended outcome. Almost all of us drive cars with keyless ignitions without concern beyond a computer savvy car thief. Data is just starting to emerge related to deaths and injuries caused by cars that continued to run in closed garages when the driver forgot to turn off the vehicle. This will almost certainly be addressed in a uniform fashion, as lessons learned, in the next generation design but no one will stop driving their keyless ignition vehicles based solely on this new data.

The hidden burden falls on development and engineering groups and their quality professional counterparts to improve their existing toolset for identifying and mitigating risk.

There is an enormous amount of pressure on companies to develop and make available new and exciting technologies while assuring reliability and protecting both the user community and public while being the first to market. Those are pretty much oppositional imperatives and a difficult balance to strike. Methodology such as FMEAs and tools such as fault tree analysis and risk based corrective actions and root cause analysis are penetrating rapidly into new industries beyond the automotive and aviation applications we most typically think of when discussing conventional risk management tools.

My long professional history and experiences tells me that we are overdue for a break through that will dramatically improve the current risk assessment and mitigation toolkit. Improvements in virtual modeling and increased capacity in the areas of advanced data mining will almost certainly result in faster, more accurate and dependable preventive tools. There is absolutely no way that technology or the public demand for the next new idea will slow down. We who are in the business of assuring that the new technologies are safe and dependable, within the boundaries of acceptable risk, need to up our game and rise to the challenge.

The next generation of design and quality professionals are cutting their teeth with the old toolkit and mentally identifying the shortcomings and determining those brave new ways of addressing them.

All of us should be prepared to embrace the tools that will be necessary to facilitate the pace and evolution of new technologies.

Tisha Tomlinson's Enterprise Risk Identification & Mitigation Webinar:  Potential Risks to the Enterprise...Activities Needed to Facilitate an Effective RIM Program

View the Enterprise Risk Identification & Mitigation Webinar

Topics: CAPA, FMEA

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