“The bigger things may age you, but it’s the little things that make you old.” W. Town Andrews

I remember a call from a friend of mine a few years ago who was working in a pharmaceutical plant that I had consulted for several  years earlier.

“George,” he said. “I have a problem. I was reviewing some documents, and I noticed that the copy I was looking at was different from the original document. When I checked the original, I found that the original data had been painted over with White-Out and a different number written over it.”

In the pharmaceutical industry, altering data is a big “no-no.” In general, when original data needs to be modified, the practice is to neatly draw a single line through the data so it remains legible, and then write the new data, your initials, the date, and the reason for the change, such as “writing error.” Not following this practice rigorously can lead to government actions ranging from FDA warning letters to criminal charges.

He took the document to the associate director who had made the alteration and she told him “not to worry about it.” He then took it to her supervisor, and was told that it was not going to be changed.

Now, this wasn’t a mission-critical document and it did not have any impact on the quality or safety of any shipping products. But it was against the company’s own written standard operating procedures and yet they didn’t fix it – they were going to ignore it.

My friend and I were both very surprised at this. Several years earlier, this never would have happened – this plant was known for best-in-class good manufacturing practices and regulatory compliance. But management had changed and a culture shift had also started.

A few years later, what had once been a thriving and productive facility was cited for numerous violations by the FDA and essentially shut down.

When I heard about this, I thought about the “broken window” theory in criminology, which comes from this example:

“Consider a building with a few broken windows. If the windows are not repaired, the tendency is for vandals to break a few more windows. Eventually, they may even break into the building, and if it’s unoccupied, perhaps become squatters or light fires inside.

Or consider a sidewalk. Some litter accumulates. Soon, more litter accumulates. Eventually, people even start leaving bags of trash from take-out restaurants there or breaking into cars.”

Maybe the altered document was the first “broken window.” Once it wasn’t fixed, it was easier to let the next infringement pass, and the next one after that, until the violations did begin to affect the quality of the products. But by then it was too late.

“Broken windows” can happen in all kinds of ways in any business. They can be things like unfixed software bugs, unanswered customer complaints, or disregarded safety practices. They are often cheap to fix, but also easy to ignore. And there’s usually someone who cares, like my friend, pointing them out.

Fix the “broken windows;” don’t ignore them.



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