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  • Lorrie D. Divers, President, QRCP Solutions, Inc.


Two seemingly unrelated bits of information converged this week to put me in a reflective mood about how I have seen quality assurance and regulatory compliance change in many positive ways over the course of my career.

The first was an excellent SQA sponsored webinar from last November that I caught up with listening to on line. The presentation was titled, ‘Tactical Questioning’ and was delivered by retired FBI Agent William Vincent. It was a fascinating review of the effective rapport-based interviewing techniques increasingly used by law enforcement personnel and how these techniques could be/are being applied in the FDA regulated environment.

I am totally over-simplifying this excellent presentation, but one of my take home messages recalls the cliché about flies, vinegar, and honey: In almost all audit and inspection situations, an adversarial/confrontational approach is less likely to result in open, honest communication and the exchange of information necessary to accurately and fairly assess regulatory compliance and quality. I have personally experienced the progression to this positive approach over the years, as well as experienced the unproductive outcome when audits or inspections veer more towards combat than mutual respect and communication.

Which brings us to the second bit of information that seems unrelated to quality assurance in any way, but I think illustrates the benefits of taking a different approach. This article from Inc. by Justin Bariso walks us through how the lovely singer Celine Dion recently handled an unexpected encounter with an ardent fan. It’s a fascinating explanation of how emotional intelligence skills can be effectively applied in real ways in challenging circumstances:

Achieving a good outcome in a potentially less than pleasant situation – like an audit or regulatory inspection – is much more likely when we take a positive, personal approach. As the SQA presenter said, ‘rapport’ doesn’t mean ‘nice, like I’m your best friend’ but it does mean a shared understanding of the goals and mutual trustworthiness.

For me, the objectives of quality assurance and regulatory compliance are (and always have been):

  1. Protecting the rights, safety and welfare of the subjects who participate in clinical trials

  2. Ensuring the data produced during clinical research and development is accurate, complete, reliable, reproducible, and reconstructs what was done and how it was done

  3. Helping organizations involved in clinical research and development and clinical trials – sponsors, study sites, IRBs, CROs, laboratories, and other service vendors – do everything they can in practical, effective ways to consistently achieve and maintain the first two objectives.

I am always seeking to learn and improve myself. Many people select a word or phrase at the beginning of each year to serve as a kind of mantra or guide for their personal growth objectives for the year. Based on this week’s seemingly unrelated topics, my word for 2018 might be ‘serendipity [noun]: the occurrence and development of events by chance in a happy or beneficial way; synonyms: (happy) chance, (happy) accident, fluke.’ What is your word for the year?

PS - If you are in the quality assurance field, be it GLP, GCP, or GMP and you are not a member of SQA, I strongly encourage you to join. There are many excellent learning opportunities available both remotely and at annual and chapter meetings.

Let’s start a conversation! Follow QCRP Solutions, Inc. on LinkedIn for more quality assurance, regulatory compliance and process excellence topics. Or contact me at to learn more about our services.

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