As a regulatory professional, lately it has becoming glaringly apparent that the only way to be successful in a regulatory audit is to take a holistic approach to quality. Holistic can be simply defined as ‘emphasizing the importance of the whole and the interdependence of its parts’. Like holistic medicine, for a ‘healthy’ status with the regulatory agencies, a company, with all their individual components, must be firing on all cylinders in regards to compliance with the greater goal of quality. Now I fully understand this may sound like hippie nonsense, but before the incense candles, spirit crystals, and kumbaya songs come out, let me further explain this thought.
We are all hard-wired to react rather than prepare, this is basic human nature. Dealing with the uncertain is not a strong point for many people. There is a major difference between prepping for a hypothetical audit situation and having the FDA show up at your door. It takes a great deal of foresight and methodical planning (as a whole) well in advance to be ready for your next audit.
With a top-tier, systematic approach to compliance, at a certain point you are no longer defending your actions to an auditor; the actions begin to speak for themselves. You are not trying to ‘convince’ an auditor you took appropriate actions, that conclusion is drawn on their own accord. I keep a few quotes in a notebook at my desk, one of which is from the legendary football coach Chuck Knox, it reads as follows: “What you do speaks so well. There’s no need to hear what you say.”
With that said, here are a few long term efforts that speak volumes when preparing for an audit:
· Strong management involvement. Management must have a finger on the pulse of the company to ensure the ‘little things’ don’t end up becoming ‘big things.’ Minor issues, one-offs, and ‘almost tragedies’ need to be vetted and scrutinized by management. Important note, this is not at all to be confused with being minutia focused. Simply put: beaware of the potentially overlooked.
· Focus on ‘Big Wins.’ This may seem contrary to my last statement, but sometimes when you do the small things well, it’s easy to miss the gigantic issue staring you directly in the face. True masters of compliance understand potential regulatory shortcomings on a profound level, and use various systems, automation, and risk analyses to correct the things that really do matter. One way this is achieved by applying the ‘Pareto principle’ or ’80-20 Rule’ (80% of your benefits come from 20% of your efforts) to focus heavily on those tasks that contribute the majority of a given benefit. Of all 483’s issued, what are the twenty percent of all regulatory findings that cause eighty percent of all 483’s or vice-versa? If you follow the regulatory news to any extent you are already well aware of some of the current trends out there. Do your homework well before the exam. Know what other companies are getting cited for over, and over again. Hint: you can access 2,300+ 483’s at FDAzilla.com?
· Have a strong regulatory and compliance team. If there is anything a company can do to highlight their commitment to quality this is it. Managers, supervisors, floor level technicians, and lab analysts are very busy and highly overworked individuals. Having dedicated employees to write or review fully investigated deviations, generate appropriate corrective and preventative actions, assess and revise formal documents and operating procedures, perform internal audits and continuous improvement measures. Hiring talent has its price, but these tasks combined will most certainly provide the right bang for your buck to keep your company out of the regulatory news headlines.
· Scrutinize the status quo. I harp on this a lot but it is almost never a bad idea to bring in outside consultants to review your quality systems and key processes. Continue your due diligence, this should by no means act as a crutch but merely exist as an aide to ensure your systems are working optimally.
· Study the best. If you’re going to look at anyone in your industry, make sure it’s the best. Being the best is never an accident. Know what makes a proven winner in an audit situation. Case studies can be important tools in quality improvement.
There are a lot of bullet point posts out there that claim to provide step by step processes for guaranteed overnight results or ‘proven’ shortcuts to success. Unfortunately, there are no shortcuts to regulatory compliance in the pharmaceutical industry. If it was easy, everyone would do it. It will take you less time and less effort to do it the difficult way than it will to try the shortcuts. It takes a culture change and a great deal of preparation to instill a holistic effort to quality. Make these long term changes now and hopefully your company will reap the rewards for many years to come.