‘That escalated quickly!” is a common trope used in popular culture to describe when a situation gets out of hand before you’ve even had a chance to think about it. We don’t often use this trope in medicine, but I can think of nothing better to describe what has been going on in the United States with the coronavirus outbreak.

I am a physician scientist who practices infectious disease medicine and runs a research laboratory that specializes in viruses. I spend much of my time directing a clinical microbiology laboratory for a large academic medical center. If you’ve ever had a doctor tell you that they are going to test you for a virus, it’s teams like mine that develop and run that test.

When I first heard about the coronavirus outbreak in China, I had no idea I would soon be on the front lines of dealing with this outbreak.

The outbreak of the Covid-19 virus in China and the railway disruptions across Canada represent two different yet similar classic case studies. They remind us that nations and global economies are becoming increasingly interconnected. Incidents thousands of kilometers away are being felt locally. This is a result of the increasing importance of critical infrastructure (CI).

In order to mitigate these negative consequences to organizations—like lost revenue, lost customers and reputational damage—they must have well-structured and defined contingency plans in place to meet operational objectives.

What’s known as critical infrastructure has many different definitions within academic literature and among different governments worldwide. But essentially, CI can be defined as infrastructure so vital that its incapacity or destruction would have a debilitating impact on the economy or the defense of the country and therefore becomes a national security issue.

The Chinese character for “crisis” means danger and opportunity. The coronavirus, aka Covid-19, outbreak has already wreaked havoc in the global economy, curtailed international and even domestic travel, and caused roughly 7,146 fatalities to date around the world.¹ The reaction to this outbreak, as driven by corrective and preventive action (CAPA), may however save thousands of lives not only this year but in the future. It should also initiate serious thought as to the desirability of reshoring U.S. manufacturing capability that should have never been sent offshore in the first place, and generate new opportunities in distance networking technologies.

The Automotive Industry Action Group’s Effective Problem Solving manual (CQI-20) defines an outstanding nine-step CAPA process that is applicable to almost any problem a manufacturer might encounter. These are essentially:

Perhaps for as many as 40,000 years, people have been protecting their feet with some type of covering, initially using animal hides and fur. Today, footwear has become high-tech, sophisticated, and in some cases smart, incorporating sensors that communicate with apps on your phone. Much of the advancement in footwear is possible because of standards that address the basic performance and functionality, allowing manufacturers to go beyond the basics.

There are hundreds of standards for all types of shoes, from industrial work boots to high-heeled dress shoes and everything in between, and for the shoe materials and components. Most of these are published by private-sector standards-developing organizations, such as SATRA, ISO, and ASTM International. But what do I care if my shoes meet any standards? I just want them to look good, feel good, and be fit for my activity—running shoes for jogging, boots for hiking, high heels for dancing, safety shoes for work—that’s all there is to it, right? Not quite. In terms of construction, fit, comfort, functionality, and protection, footwear is probably the most complex of all the clothing that we wear.

I find that every so often it is good to step back and think about the current state of manufacturing in the broadest sense. We all see bits and pieces as part of our daily work with manufacturers across the country and from reading the news, but sometimes it can be difficult to fit those puzzle pieces into the whole.

This is the day I break out my trusty old charts and graphs and data points to try and work some augury on where we may be headed.

Overall, most indicators show the manufacturing landscape slowing. Whether the slowdown is a temporary aberration (we saw similar patterns in 2016, for example) remains to be seen. The current data do, of course, reflect some large OEMs (GM and Boeing, in particular) slowing production, the trade dispute with China, and an economic slowdown globally, concurrent with the one we’re experiencing here.

The Automotive Industry Action Group’s (AIAG’s) and German Association of the Automotive Industry’s (VDA’s) new Failure Mode and Effects Analysis Handbook (AIAG, 2019) offers significant advances over FMEA as practiced 15 or 20 years ago.¹ The publication is definitely worth buying because the new approach includes valuable methodology; this article will cover the most important points and highlights.

New features

The new process is qualitative rather than quantitative, which overcomes a major drawback of the previous approach. The older occurrence ratings were based on the probability of a failure, and the older AIAG manuals even tabulated recommended nonconforming fraction ranges. If, for example, the failure was 50 percent or more likely, the occurrence rating was 10 (worst possible on a 1 to 10 scale), while one or fewer per 1.5 million opportunities earned a rating of 1. These probabilities can be estimated from a process capability study, assuming that one is available; otherwise, one might easily have to guess.

After the first crash, of Lion Air in Indonesia in October 2018, people blamed poor maintenance and insufficient pilot training. When a second airliner, an Ethiopian Air aircraft, crashed in March 2019, similarities quickly transpired. There was no apparent external influence such as poor weather. Neither was there any interference with the flight decks, as in a hijacking.

In both cases the pilots could not keep the aircraft from nose-diving. Airlines and regulators around the world started grounding the MAX indefinitely. Australia’s Civil Aviation Authority prohibited any B737 MAX aircraft in its airspace, followed by New Zealand’s Civil Aviation Authority.

Surprisingly, the last authority to clamp down was the U.S. Federal Aviation Administration, the governmental body in charge of certifying aircraft.