Why Compliance is Key to Sustainability

Most discussions of sustainability tend to focus on energy management and other, similar “green” efforts. While those initiatives are important, I have long been of the opinion that there are four pillars supporting sustainability. Those pillars are: energy efficiency, emissions management, materials management and regulatory compliance. Sustainability is a large umbrella and it applies as much to the sustainability of our environment as it does to the sustainability of our businesses.

I’ll give a shout out here to John Nesi of Rockwell Automation for his insight on this view of sustainability years ago when the whole concept was just beginning to get serious attention in the industrial sector.

If you are unsure of the integral importance of compliance to your company’s sustainability, consider the recent news about Tylenol. If you have not already heard, the U.S. government has recently taken over three Tylenol plants following a number of drug recalls. In addition to overseeing production at these three facilities, the Food and Drug Administration is also conducting a criminal investigation into safety issues at the factories. The plants now under FDA supervision are in Las Piedras, Puerto Rico, Fort Washington, Pa., and Lancaster, Pa.

According to a report filed on CNNMoney.com, The FDA and the Justice Department have “taken action against McNeil PPC (the Johnson & Johnson division which runs these facilities) and two of its executives — its vice president of quality and its vice president of operations for over-the-counter products — for failing to comply with federally-mandated manufacturing practice.”

McNeil is now under consent decree with the FDA which requires it to follow a strict timetable related to bringing those three facilities into compliance. Failure to comply can result in McNeil being ordered to cease manufacturing, recall products and being fined $15,000 for each day and an additional $15,000 for each violation of the law. The fines can total up to $10 million annually.

The lesson here for designers or integrators of systems that will be used in regulated industries is to not overlook the importance of including compliance software as part of your solution offering. This software, for numerous industries, has been available for years. Avoiding the expense associated with the use of such software is not a cost/benefit rationalization. It’s a gamble — and a bad one at that.