Take the Lead when It Comes to Compliance

Take the Lead when It Comes to Compliance

Mark Crawford

Even though it’s easy to complain about regulatory agencies, without them things tend to get worse, not better (the financial industry, for example). There will always be companies that, when regulatory agencies aren’t looking over their shoulders, are tempted to slack off a bit, especially when the economy is tough, money is tight, and there are plenty of fires to put out.

So resist the temptation to slide (it’s always rough at the bottom). Be your own regulatory cop, whether you are being watched or not. Invest in whatever is necessary to fully understand compliance regulations, meet them, and even exceed them—for the simple reason that it is the best thing to do to protect yourself and your customers.

With the way cuts are going these days, this increasingly is a good strategy to take

For example, the FDA raised the bar with the Food Safety Modernization Act, but Congress cut more than $200 from FDA’s food safety budget for the 2012 fiscal year, making it nearly impossible to meet that program’s expanded goals, including the higher number of inspections. The FDA simply will not have the staff or resources required.

Painful (and dangerous) cuts are also happening overseas. For example, in England, the Department for Environment, Food and Rural Affairs (DEFRA) had its overall budget slashed by 30 percent.

“DEFRA’s budget will shrink by about US $1.142 billion by the end of the four-year spending period in 2015,” indicates Vicky Kenrick, communications specialist with Allen & York, an international sustainability recruitment consultancy. “As a result, the department and its agencies—including the Environment Agency, which monitors pollution and protects against flooding, and Natural England, which helps look after the natural world—will have to shed 5,000-8,000 out of its total 30,000 jobs.”

She also notes that HSE (England’s equivalent of OSHA) is under pressure from the Department for Business, Enterprise and Regulatory Reform to limit the number of on-site inspections it performs. With cuts of 35 percent to the HSE budget, British employers will no longer face automatic health and safety inspections.

This is already having serious (and deadly) ramifications—for example, with fewer inspectors coming visiting construction sites, workplace fatalities in the construction industry are already on the rise.

“HSE figures were revealed at the London conference on Safety Schemes in Procurement,” adds Henrick. “The provisional statistics revealed that the 2010-11 period saw an increase of 15 percent in May over last year’s low of 42 deaths.”

Even though there are fewer inspections happening, regulations are still in place, of course (as are penalties, fines, and lawsuits from harmed consumers). Therefore the responsibility to ensure product quality, process validation, and workplace safety lies even more with the corporation.

With less input coming from the FDA and other agencies, do companies have the internal resources and knowledge to manage everything on their own?

Chances are they don’t, especially if they still face tight budgets and hiring freezes. Even though FDA may seem occasionally interfering, many companies rely on its periodic input and sort of view the organization as part of the family (even though, at times, it seems more like the dysfunctional relative that shows up on holidays).

“Self-regulation provides another reason for corporations to allocate occupational safety and health responsibilities to existing environmental professionals,” says Henrick. “Employees with a certification from the National Examination Board in Occupational Safety and Health and previous health and safety experience make them a very valuable asset.”

Henrick is absolutely correct.
Just because the FDA or some other agency fails to inspect you doesn’t excuse you from liability. Companies must take the lead to protect themselves and their customers by building up their own in-house expertise and training and/or connecting with consulting firms who know what you need to know about maximizing quality, minimizing risk, and exceeding expectations.

Pilgrim Quality Solutions

Pilgrim pioneered quality management software more than 25 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities.