Seven Year-End Reflections of a Regulatory Professional

It’s hard to believe that 2016 is almost over. For me, the months of November and December go by faster than any other 60-day period in the year. With the push to get things done before year’s end and the flurry of seasonal events, it can be hard to find the time to think about our jobs, the products to which we contribute, and the patients and other stakeholders that we serve. But it’s crucial that we take time—in spite of our busy schedules—to evaluate our job performance and devise strategies to improve services. As a quality and regulatory professional, my thoughts are focused on those two specific areas. But self-reflection applies to all members of an organization, from CEOs and CFOs to marketing, sales, and engineers.

We all must strive to avoid getting “stuck in our ways” and constantly doing things the same way based solely on past success. I am not saying that experience doesn’t matter; rather, I am advocating that we use the knowledge gained from our experience to determine the best methods for responding to industry changes. For me, taking the time to think about ways I can improve my interactions with and delivery to all my internal and external customers is a good start. 

Keep in mind this is not a personal improvement plan or a continual improvement plan for a department or company. Although this thinking session may positively impact improvement plans, its main purpose is to develop ways to use knowledge and skills to better deliver products and services to stakeholders.

You might be wondering why I have not discussed collaborating with a team to focus on continual improvement. There is a simple reason for this omission, though: A solo thinking session is actually a predecessor for further collaboration. Thus, I recommend taking some time for self-reflection.

I am sharing more than I usually do in this column because I think my insights will add value to any self-reflection process. My own musings in recent weeks have resulted in the list below, which I hope sparks some genuine contemplation and self-evaluation.

1. Am I using multiple technology platforms efficiently and effectively?  Should I add/modify/delete any apps? How proficient am I in social media? 
2. How well am I managing working smart vs. working hard? I am always busy, but am I as productive as possible? Hard work is unavoidable, but working smart is very important.  How can I work smarter? 
3. Is my plate too full? Am I trying to do too many things? Have I over-committed? When we try to do too many things, we often do very few of them well. Is the quality of my work suffering because I am managing too many projects? 
4. Do the things I love to do still add the most value to customers? Does my professional role still fit me or is there something else I should be doing? People change as do businesses. All good (and bad) things end at some point. Is it time to start anew professionally?
5. Am I delegating responsibilities adequately? Am I delegating them in a way that allows others to function optimally? Even if I love doing something, is there someone else who can do it better, or faster, or both? 
6. Am I making an effort to stay physically fit? This may sound cliché, but it is an important question to consider. Physical fitness has a direct impact on job performance, especially during the times we need to work hard. People often say they don’t have the time to get one or more tasks completed. We all have the same amount of time in a day, but our energy levels vary. Physical energy is really the more critical issue in job performance, not the lack of time. 
7. Am I achieving a work-life balance? This is a tricky question because I don’t believe we ever truly achieve a real work-life balance. We always tip the scales toward one side or the other. This is one of the most difficult questions for me to consider in a solo thinking session, because I naturally want to solicit my wife’s opinion. But the answer is buried deep inside me. Taking time to think about this issue keeps me focused on achieving a work-life balance.

These questions may not be the most impactful for you personally, but I hope they lead you to your own set of questions. I limit my questions to seven and spend no more than an hour answering each one. If you complete this exercise, I welcome your feedback. 

Have a happy, safe, and prosperous new year.

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James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at [email protected].