By Daniel R. Matlis
This article does not intend to take a position for or against regulation, bigger of smaller government. We are all entitled to our opinions and that issue is best addressed in front of a voting machine (paper, electronic or otherwise). So, on November 4th, VOTE.
Opinions notwithstanding, we operate in a regulated industry with rule books we must follow. This article offers a commentary on individual and organizational responses to existing regulations.
I recently attended the worldwide conference of one of the largest global technology companies (whose identity shall remain confidential) where I heard a senior executive touting the benefits of using technology to facilitate regulatory compliance.
As you know, I advocate the use of technology to address business challenges in a regulatory compliant manner. Technology can be a very useful tool to enable compliance by enforcing business and regulatory policies, sequencing activities to prevent opportunities for non-conformances and even predicting trends before they require corrective actions.
Nevertheless, the expression this executive used got me thinking about different philosophies on regulatory compliance. She said that technology can help companies comply “against” regulations.
At that moment I had an epiphany. I realized that individual and organizational responses to regulatory compliance fall into one of these categories.
- The Contrarian, who complies “Against the Regulations”:
These people look at regulations as rules to be worked around, seeking every loophole and every way to avoid complying with the regulation. For example, citing on the “typewriter rule” to avoid compliance with audit rail requirements of 21CFR§11. The logic might go something like this:” Our System is no different than a typewriter. We print every batch record at the end of each run, and we use paper as the official record, so why do we need audit trail functionality?
- The Zealot, who goes “Above and Beyond Regulations”:
These are the regulatory zealots. They over interpret regulations and seek to build fences around them to ensure the organization exceeds compliance requirements so that even if you miss the target, you have room because you aimed high. They go beyond “mistake-proofing” procedures with the goal of eliminating opportunities for error. In the process they often break Einstein’s rule on simplicity: everything should be made as simple as possible, but no simpler. The zeal to over document often leads to one of the top 483 findings; not following approved procedures -because they often cannot be followed.
- The Rationalist, who “Complies With Regulations”:
These people tend to look at a common sense approach to compliance. We look at regulations with a rational approach and take the opportunity to develop best practices where compliance is a byproduct of running a well governed, effective and streamlined business.
- The Illusionned, who seeks the “Regulatory Magic Box”:
Can you validate this for me? I don’t know what I don’t know. The Illusionned are looking for transfer of liability, if you do it, then you are liable for it (never mind that the FDA enforcement trends do not support this theory). They are often in search of a magic box that can create all the documentation required to validate a process or system with the wave of a wand (or a few magic keystrokes).
Whether our individual approach to regulatory compliance is coded into our DNA or learned, nurture or nature, I will leave to geneticists, psychologist and organizational behavioralists to address.
The great philosopher “GI Joe” said “knowing is half the battle.” Understanding an individual’s tendency toward regulatory compliance can help you choose the best approach to presenting and addressing compliance issues.
So, are you a Contrarian, a Zealot, a Rationalist or Illusionned?