Thursday, June 10, 2021

Design reviews and product liability

In my last couple of posts I talked about documented artifacts: that you should keep them only when you need them, but also that sometimes you need ones you didn't expect. Today I'd like to talk about one special case: design review minutes.

Whenever I've audited engineers (or almost), they've expressed resistance to having to keep written design review minutes – except in those few cases where the project made them use an automated design tool that required design review comments from somebody else before they could check in their work. In general the sentiment seems to be, "Look, I'm an experienced engineer. I know what I'm doing. Besides, I did ask Fred to look it over and we discussed some of the more interesting parts over lunch. Do I really have to write it down too?"

Of course I understand. At the time, it seems like an extra step, and a needless one. Who is ever going to care why you decided to use a 5 ohm resistor in that spot instead of a 10 ohm resistor? 

But let me tell you what a product liability attorney once told me, years ago. And then think about it.

Before I go on, it is important that I make a number of critical disclaimers. I am not a lawyer. It is not the purpose of this blog to offer legal advice, and no statement that I make here may be construed as legal advice. I might have misunderstood what this man told me, or the rules might have changed since then because it really was quite a few years ago. Before you rely on any of the concepts explained here, consult with professional legal counsel on your own. 

Also: Do not try this at home. Take only as directed. Do not bend, fold, spindle, or mutilate. And do not back up: severe tire damage.

Now, all of those things having been said ….

He started off by explaining that product safety law in the United States is a moving target. The general requirement for product safety is that you have to make a product as safe as the technology reasonably allows you to. So when there are improvements in safety technology, new products are held to a higher standard. But there is no requirement to retrofit older products that are already in the field. When anti-lock brakes were finally perfected, that did not trigger a recall of every car in the United States in order to replace the brakes.

Therefore, if somebody gets hurt while using your product and decides to sue the company, the plaintiff has to prove that you neglected to take some safety precaution that everyone else in the same industry was taking, during the time when that product was released. Maybe in the rare case this is obvious, but often it's not.

What happens next? 

Someone from the Engineering department has to testify in court. Now, the design engineer responsible for the product retired to the Bahamas twenty years ago, and died of old age fifteen years after that. So whoever shows up in court really doesn't know the history behind the product design. In particular, he can't answer the question, "Did the design engineer take into consideration all the currently-available knowledge about safe product design when working on this product?" 

What happens next?

Well, if the company can produce one sheet of paper with the words "Design Review Minutes" across the top, a date, a list of attendees, and some notes about the product design, then according to this attorney the Court is likely to rule that the responsible engineers "probably" discussed safety topics as well, since it is clear they were reviewing the design and the safety requirements in force at the time would have been common knowledge to all affected engineers. Therefore the Court is likely to rule that the plaintiff is forbidden to pursue a line of inquiry that vaguely accuses the engineers of some generalized carelessness or negligence. If the plaintiff has something concrete to go after, or some other line of inquiry to pursue, the case can proceed. If not, the case is dismissed and the company is off the hook.

Naturally we all hope that nobody ever gets hurt using your product. And, as noted in the disclaimers above, I can't actually promise it will be so easy in case someone does. But think about saving some basic design review minutes, just in case.

           

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