Are You a Boiling Frog Where Compliance is Concerned?

Are you a boiling frog where compliance is concerned? What happens in your organization when people responsible for GMP compliance or business integrity fail to do their job? Does anyone in positions of authority get excited and demand answers as well as improvement? Or is the slow-motion reaction one of business as usual and/or defensive cover-up? Unfortunately it seems, many workplaces and organizational leaders in the pharmaceutical and biomanufacturing industry operate with a boiling frog mindset. Remember that story? You place a frog in a boiling pot of water “ and it immediately jumps out. But if you place that same frog in lukewarm water, it just sits in the pot. As you begin to turn the heat up slowly, the frog continues to sit. From the frogs perspective, nothing has really changed in their environment. Given enough time, the frog is boiled to death as the heat continues to rise. The same thing happens in an organization which tolerates attitudes and behaviors out of alignment with company and regulatory requirements in the areas of GMP compliance, business ethics, or professional integrity. This accountability failure starts at the top of a manufacturing site and/or corporate organization and slowly filters down to frontline employees. It manifests itself when audit findings and recommendations from committed quality or compliance professionals are marginalized or go unheeded and unanswered. Its easily identifiable when action plans or legacy plans are constantly put in place, but never actually or fully implemented. It reveals itself when internal complaints are whitewashed or worse, the offending employee with the bad attitude is retaliated against. In the end, the organization establishes and reinforces a workplace culture where employees are expected to act like frogs. They sit and wait for the next round of heat without taking action to escape an unacceptable environment. The net result is a workplace where expensive lessons are learned: wasted materials, recalled product, warning letters, consent decrees, or ongoing inspections and investigations. And if youve ever worked in one of these types of organizations, then you know theyre stressful, tense, and unsatisfying places to practice your profession or craft. This failure in accountability needs to be identified and resolved at every level of an organization, if its really dedicated to compliance, integrity, and performance. Here are some warning signs “ in the form of justifying statements - that might alert you to the presence of attitudes or behaviors setting your organization up for the boiled frog mindset: 1. We dont have a compliance or ethics issue. 2. Its someone elses job to stand up or speak up. 3. Lets worry about it later, we have too much to do right now. 4. The FDA never found it in all their inspections. 5. Well, the FDA approved it. 6. This complaint is from a disgruntled employee. Do any of these sound familiar? If so, it may be time for a reality and attitude check. Is the heat starting to rise in your organization and you just havent noticed or been paying attention? Maybe its time to quit thinking like a frog in the safe environment of your pot of water. Maybe its time to jump into action!