I am one of the most thorough people I know. Some may say a little anal retentive. When I leave my desk at night, everything is put away. And my lucky, trusty Green Cross pen is set at a 45 degree angle on a clean, white piece of paper. But I’m perfect for my job. After all we’re in an industry of details. The little things matter. I spend a great deal of my time checking and re-checking all the functions of my day-to-day tasks. It’s been said God is in the details, and I believe that’s true. In a time of so much rounding, it’s refreshing to be in our industry where everything is important. I just wish the whole world shared my monomaniacal vision of accuracy. From the orders at the restaurants I’ve sent back three times because everyone from the server to the cook could not be burdened with the accuracy of the job at hand, to the automotive mechanic that forgot to torque the drain plug on your oil pan, causing your engine to seize; rounding has become a plague.
I mean, I am absolutely astonished by how it is we have come this far, but still pounder the future if we do not add a bit more care in our daily functions. Every time I hear the Six Sigma term, I can’t help but laugh. Minuscule failure requirements are a joke. Ninety percent of my daily interactions with companies are a fail. Sorry I didn’t mean to get into a rant, but I’m sure you can relate to the new storm of inaccuracy.
But still we must be careful of the other side of the equation. Under our thick regulatory environment it’s easy to bog down to micro details and when we over-shoot the mark on the other side of the equation, we make it impossible for others to interpret our work.
If the bottle says “two pills every four hours,” taking 10 will have a bad outcome, just as taking one would have a bad outcome. Where we need to be is where we need to be, not less, not more.
Engineers, and I know I’m guilty of this myself, tend to major in minors. We tend to look through such a high resolution lens that we have a hard time seeing the entire scope of the project. We also lose sight of the fact that someone at some point is going to have to interpret our work, and if it’s too dense it’ll be impossible to interpret and to implement. I had a customer ask me last year to provide him a detailed multi-page report on the metallurgy of our base plate. This information was needed for the IQ he was engendering for his sterile device packaging validation.
Trying to understand the gravitational mass of your machine has will never be asked by an auditor and isn’t relevant to the total scope of your validation. If we get bogged down in our DOE work, we expand the numbers out so far until we create an outlier. If the outlier is statistically irrelevant, all we’ve done is work to find a problem that ultimately will not impact our process.
Thoreau said, “Work for progress, not perfection. I’m not sure I’d go that far. I guess my modified vision is: “Work for progress, while striving for perfection.
Steven Jobs famously said once when he was frustrated with the slow release of a product because the engineers were so bogged down trying to create perfection or as they referred to it as “art,” he simply replied, “Art ships.”
At one point the big rollup door at the back of our building has to send out products to pay our wages. We have to stay focused on the fact that we’re in manufacturing and products must go for the economic circle of life to continue. So go ahead, focus on perfection. Don’t waiver on details. But remember that a skilled engineer can meet both the mandate of quality and throughput.