What does it mean to be extraordinary?

I was struck by an Elon Musk quote: “I think it is possible for ordinary people to be extraordinary.” Sure, that sounds right… anyone can be extraordinary if they are just willing to do what it takes. All it takes is a bit of extra effort, right?

Let’s start by looking at the definition of extraordinary. A quick Google search says that extraordinary is very unusual, remarkable; going beyond what is usual, customary, or regular. In short, extraordinary means to be exceptional; above and beyond; outside the norm. It means not being content with just doing what it takes to meet minimal expectations.

So, how would I define extraordinary? What are some examples of extraordinary?

  • In the fall semester at a midwestern university, 11,653 students made the Dean’s List for academic achievement. That is almost 52% of all undergraduate students! That either means that the school is full of academically outstanding students or that high grades are so easy to attain that it is almost a failure if you do NOT attain the Dean’s List. Do not expect any special recognition, awards, or recognition for merely doing what is expected or what everyone should be achieving. Certainly, it is a good thing to make the Dean’s List, but when 52% of all students achieve it, it is no longer considered special.
  • Don’t expect a pat on the back when you show up for work on time or do the “ordinary.” At each of my former employers, we all developed an annual list of objectives for the new year. We tracked our performance against these objectives which were specifically discussed at the year-end performance review. I recall numerous conversations with individuals that I managed in which, because they achieved their objectives, they felt their rating should be “exceptional” or “above expectations.” Yes, they may have achieved or exceeded results on these few objectives, but they failed to excel in their ordinary, base job functions. In essence, their overall performance was merely average, though their objectives were met. Extraordinary means that you accomplish something few others can do. It means your performance was greater than 90% of all others doing similar work.
  • I don’t think I’ve ever spoken to a hiring manager that said, “I just want to hire an ordinary candidate for this key position. It would be nice to do better than that, but I’ll just take what I get and hope for the best.” NO! Any legitimate leader will always seek to bring aboard the very best individual possible. So, what do you look for to find an extraordinary candidate? What differentiates an extraordinary candidate from an ordinary one? Let me provide a few examples. An extraordinary candidate:
    • Can provide a portfolio of demonstrated competence in prior jobs – Simply “holding” a position does not necessarily equate to competence. When I was looking to hire an exceptional candidate, I looked for evidence that the individual performed at a high level AND worked to pass that competence on to others. An exceptional candidate makes others around him/her better.
    • Can provide a list of specific accomplishments – The best predictor of success in a new position is to observe value in past positions. Accomplishments are more than simply performing a task or job… it is providing value to the organization that is measurable and specific.
    • Is one that does more than the minimum – I usually look for examples of how the candidate volunteered or assumed project or outside assignments. A candidate that gets personally involved in making the organization better is an individual that I expect will do the same in our organization.
    • Is independent and will help us avoid “group think” – The ordinary person often merely hopes to get through the day without creating waves, issues, or questions. The extraordinary person is not afraid to speak up, to offer a new perspective, and will challenge the status quo.
    • Will represent your values and the values of your organization to others well – An extraordinary individual will always represent the organization well and will demonstrate loyalty and trustworthiness. I usually looked for how the candidate spoke of prior leaders and organizations for clues regarding their integrity.

Being extraordinary is typically a matter of choices. An ordinary person chooses to accept mediocracy. An extraordinary person will make the choices and sacrifices necessary to go above and beyond. It doesn’t merely fall into your lap. So, is it possible for an ordinary person to be extraordinary? I believe the answer is “yes”… but becoming extraordinary means that we often do more than is expected, give more than we thought possible, and serve others even when we don’t have the energy. Being extraordinary means that we choose to make a difference in the organization and people we serve.

How are you viewed by others? Do they speak of you as being extraordinary? Will your children and grandchildren think of you as an extraordinary parent or grandparent? Would your spouse call you extraordinary? Today might be a good day to pause and consider the choices we make and how we hope to make better choices tomorrow.

New Book: Retirement is Underrated!

Today, I’m pleased to say that my third book has been published on Amazon. This one is titled:

Retirement is Underrated!: Practical step-by-step guide for making retirement the best time of your life

It is available on Amazon here: https://www.amazon.com/dp/B08W7DMX8X/ref=sr_1_6?dchild=1&keywords=eldon+henson&qid=1612978814&sr=8-6 in either paperback or Kindle version.

For those of you nearing retirement or even looking forward to that day, this book will help you get there faster and enjoy it more.

Taking the initiative to enjoy what comes, to share it with others, and to make a difference in whatever we do will be the ultimate yardstick for determining the success of our retirement.

Take a look and see if this book will help you prepare for retirement, enjoy it more when you get there, and learn the importance of finishing strong.

What if every employee was just like you?

Today, I would like to share an excerpt from my book, “Achieving your best day yet! A more fulfilling career… a more impactful life.” I think this piece touches on the issue of assessing employee performance that every leader faces. Yet, this question can also serve as that internal gauge with which we assess our own value within an organization, our community, or even our family. Take a few minutes to consider this critical question…

What if Every Employee was Just Like You?

I have frequently had discussions with colleagues about how to assess the performance or attributes of other employees. For example, what factors tip the scale when an employee is on the borderline of the highest rating at year end?  When assessing an employee’s performance, you naturally look at both their overall positive and negative contributions to the team or company.  However, it is often a challenge to determine exactly which way to go when that employee is squarely on the borderline between the two.  Or, if you are struggling to determine whether to hire a candidate, you might find yourself weighing the pros and cons to make that final hiring decision.

One of the ways I look at this situation to assist my decisions is to ask these questions about that individual, “What kind of company would we have if every employee was just like him/her? Would we have a great company?  Or, would it be mediocre?  Would our customers love working with us or hate it?”  It is amazing to me that when I ask these questions, my answer almost always becomes clear.  You form the culture of a company or team person-by-person, action-by-action.  And, having the wrong person can either make an unbelievably positive difference or it can destroy the team.   By making promotion, rating, and hiring decisions based on this set of questions, you can often see clearly the direction you should go.

In the same way, I find that asking those same questions about yourself during an introspective moment can have a profound impact on your own performance and direction. You might ask, “Would this company or team be better or worse if every employee performed just like me?  Or, behaved just like me?  Or, served others just like me?  Or, cared for others just like me?  Or, went the extra mile just like me?  Would this be a better place or more encouraging environment if every employee was just like me?”  If you can be honest about these questions, you can reveal ways that you can become a better employee, better person, or better friend.

Likewise, this same set of questions can help you self-assess in other areas of your life. If every spouse was just like me, would our society be better, happier, and more fulfilling?  If every father/mother was just like me, how would the kids of this world be different?  If every neighbor in our community was just like me, would this be a better place to live?  If every driver was just like me, would our roads be safer and happier?  If every friend was just like me, what would be different about our world?  It is never too late to make a difference.  It is never too late to make those around you better.  It is never too late to turn a bad day for someone else into a good day simply by serving their needs.  In short, it is never too late….

(This book is available through Amazon.com at the following link: https://www.amazon.com/Achieving-your-best-day-yet-ebook/dp/B087ZRSXP8/ref=sr_1_1?dchild=1&keywords=eldon+henson&qid=1611286201&sr=8-1)

It’s not destiny, it’s a choice

Have you ever heard someone say, “I guess it’s just my destiny…” when discussing disappointments in life? I remember the story of one individual that frequently expressed his career disappointments. He was within a few years of retirement and lamented the fact that it seemed that everyone had passed him by. Whereas he believed he had worked conscientiously to serve his company, his title had never risen to that of younger, less experienced colleagues. He ultimately came to believe that “it was just his destiny” to fall short. He failed to realize that his own lack of commitment, dedication, and overall effort was largely to blame for his limited career.

Certainly, there are circumstances in life that we cannot control. Accidents occur. Downsizing happens. Pandemics emerge. Though we like to think so, we do not control every circumstance in our life. When things happen that are unwanted and unexpected, we can become upset, disappointed, and defeated. However, the one thing we can control in any situation regardless of our circumstances is our attitude. Wade Boggs, the Hall of Fame baseball player once said, “Our lives are not determined by what happens to us but how we react to what happens, not by what life brings us but the attitude we bring to life.”

So, you see, to a very large degree, our lives are largely not the result of random events that we neither control nor appreciate. Rather, our lives are defined by the choices we make, whether good or bad. When we learn this critical truth, our lives can change in ways we might never have considered. For example:

  • Your path in life is not defined by the disadvantages of your childhood, but by the choices you make to overcome them.
  • Your career is not defined by your title, your salary, or your office location, but by how you choose to treat others and the positive impact you make during that career.
  • Your relationships are not defined by mistakes you have made in the past, but by how you’ve used those experiences to grow and become a better person.
  • Your impact on others is not defined by what is visible on the outside, but by the visible manifestations of the character that resides on the inside.
  • Your future is not defined by the past, but by the decisions you make today.

Today would be a great day to put aside the belief that we have no control over destiny and believe that, to a significant degree, we determine our own destiny by the decisions we make.

Below are some thoughts from others that should also help you understand your own responsibility in creating your own destiny.

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“The only person you are destined to become is the person you decide to be.” 
― Ralph Waldo Emerson

“Letting go means to come to the realization that some people are a part of your history, but not a part of your destiny.” 
― Steve Maraboli

“Destiny is not a matter of chance; it is a matter of choice. It is not a thing to be waited for, it is a thing to be achieved.” 
― William Jennings Bryan

“You are not the victim of the world, but rather the master of your own destiny. It is your choices and decisions that determine your destiny.” 
― Roy T. Bennett

“Don’t confuse poor decision-making with destiny. Own your mistakes. It’s ok; we all make them. Learn from them so they can empower you!” 
― Steve Maraboli

“The best years of your life are the ones in which you decide your problems are your own. You do not blame them on your mother, the ecology, or the president. You realize that you control your own destiny.” ― Albert Ellis

Christmas Memories

“Sometimes, you will never know the true value of a moment until it becomes a memory.” – Theodor Seuss Giesel (aka Dr. Seuss)

What do you remember about your Christmases as a child? Christmas was a big deal for my family. In fact, my mother would sometimes borrow money to buy Christmas gifts. Or, she would join a Christmas Club where you could contribute $5 or 10 a month beginning in January to have “extra” money for Christmas. 

Our Christmas tree was always up early to the point that by Christmas, thousands of dry, sharp needles had fallen to the floor. We decorated the tree with big light bulbs, glass ornaments that gradually reduced in numbers over the years, and an abundance of those silver foil icicles. 

We always visited Santa at the local American Legion Post and felt blessed to get a sack of chocolate cream haystack candy and an orange plus maybe a few nuts. 

Christmas morning was magical! We struggled to sleep and eventually, a rule was implemented that we could get our filled stockings any time after midnight, but we couldn’t wake up our parents until after 6am. Later, on Christmas Day, we visited my grandparents in the country.

At our own home, my wife and I have many special memories of Christmas. We always included church on Christmas Eve, special foods before bed, Swedish tea rings for Christmas breakfast, and fun family times on Christmas Day. 

On Christmas, I always remember the excitement my Mom and Dad experienced on Christmas. I remember our kids saying their parts in Christmas pageants. I remember assembling toys well past my own bedtime. And now, I remember more recent Christmases with our grandchildren. 

Yes, Christmas memories are special ones that should be cherished. I hope that in future years as my memory fades, I have somehow tucked these special memories in places that are protected and retained for the whole of my life.

Christmas should be cherished and savored, not rushed. I am hopeful that you are taking the time to soak in those special times you experience this season.

I am also reminded of the shepherds that were the first to hear about the newborn Savior on that first Christmas morning. In the book of Matthew 2: 9 – 10, it is said:

“An angel of the Lord appeared to them, and the glory of the Lord shone around them and they were terrified. But the angel said to them, ‘Do not be afraid. I bring you good news of great joy that will be for all the people.’”

The Good News… I hope that you believe that the real meaning of Christmas is that God became flesh and came to earth for us. He came to pay the price that we could never pay ourselves. The shepherds believed that. And, as a result, they were never the same. Experiencing the birth of Christ changed them. Hopefully, it has done the same for you. If you have not experienced this for yourselves, make this the year… make this the day.

“If you confess with your mouth that Jesus is Lord and believe in your heart that God raised him from the dead, you will be saved.” Romans 10:9

Have a Merry Christmas! I hope this is the best one you have ever experienced. I hope that you will pause to remember loved ones that have impacted your life. I hope that you will find great joy and create memories this year that never fade. All the best to you and your family from mine!

When is it time to change jobs?

The end of the year is often a time to look back. You have lived another year with memories, experiences, happiness, and, sometimes, regret and sadness. The end of the year is also a time to look ahead… to envision how the new year will be different. Often, your thoughts turn to the questions, “Is my career going where I had hoped? Will next year be different? Is it time to consider a job change?” When does it make sense to consider a new job? Are there indicators that can help direct me regarding this most difficult question?

Today, I would like to briefly pose 4 indicators that could say that 2021 may be the time to seek a new opportunity.

Indicators that it may be time to consider a job change

  1. When the cost of staying is greater than the benefit of leaving

Let’s face it… though there are benefits in our jobs, positions, and careers, there are also costs. Some of these costs are monetary, but, mostly, they involve our time, our emotions, our health, and our family. When these costs become too great, it may be time to consider a job change. Let me give an example… I was once in a position that demanded too much from many perspectives. The position and work environment were impacting my personal well-being and, most importantly, my family. Simply put, when you get that feeling of dread in your stomach on Sunday evenings about work the next day, it is time to consider a change.

2. When you are being abused or treated inappropriately

Some jobs are simply abusive. An individual boss can make life difficult. A work environment can by physically too demanding to the point that your health is impacted. Individual treatment can be sexually or racially uncomfortable or abusive. When you reach that point and feel that change is unlikely, it may be time to look for a new opportunity. Two cautions… first, don’t be a snowflake! Just because you don’t like doing what you are told or you don’t like working overtime, doesn’t mean the environment is abusive. Facing and conquering adversity defines our character. Persevering in times of difficulty build strength. Leaving simply because you don’t like something or someone is not the answer. Secondly, there are times when you need to stay and fight for change. Sometimes, one individual needs to be the change agent that will benefit others. It could be that you were put into this challenging situation simply because you are the only one to make a difference. However, there are times when you need to just move on.

3. If you can’t achieve in your career goals in a reasonable timeframe

One piece of advice I have always given individuals I mentor is this, “What do you want to be doing in 5 years? If you cannot achieve that here, it is time to move to a place where you can.” You need to be realistic about timeframes and achieving career steps, but if you get to the point that achieving your reasonable career advancement is not practical, the time has come to consider a change.

4. When a new opportunity arises that takes you toward your purpose or passion

Leaving a job should not often be to get away from something, but to move toward something better. When a new opportunity arises that takes you closer to your purpose in life or your passion, you need to take it. These opportunities may only arise 3 or 4 times in your entire career, so don’t pass them up. Finding and working in a field or company doing what you know you should be doing is rare. When you have that chance, don’t miss it.

One more word about new opportunities. If you are considering a job change solely to achieve a title or to attain a financial advantage, you may be sorry. Certainly, these are important as you advance in your career. But, you need to balance these with other intrinsic factors. Serving in a lower or less paying position may offer you more contentment, more family time, more opportunities to serve others, and more job and life satisfaction than taking a job change merely for a promotion or salary increase. There are times when saying “no” is the best answer to a new job opportunity. However, if you have reached that fork in the road when a change is indicated, be bold, do what you know you need to do, and don’t look back. You’ll never be sorry you took a job change if it leads to a more fulfilling and productive life for you and others.

Finding resilience in the face of a pandemic

When I was about 10 – 12 years old, possibly the biggest worry I had was whether my transistor radio had enough battery left to get me to the end of that night’s baseball game. I shared a bedroom with two brothers, so the only “safe” way to listen to the game was to put the radio under my pillow and listen. Many times, I fell asleep with the radio on and awoke with dead batteries. Life was so simple in those days.

Living during the pandemic of 2020 makes me recall those simpler days. Here we are in the ninth month of shutdowns, slumps, sadness, worry, protests, and hardship. Add to that the disappointments of what might have, could have, should have been. And, to top it off, we are merely hours away from what some are calling “the most important election of our lifetime.” Our kids are struggling to be in school, our businesses are barely staying afloat, and our emotions may be at the ragged edge. Yet, here we are on the cusp of what some have called “the upcoming long, dark winter.”

How can we stay optimistic at a time like this? Where is the light at the end of the tunnel? Can I just put a transistor radio under my pillow and everything will be alright? What can we do to press on and finish the course ahead? How practical advice can help us remain resilient during the next few months?

I have been trying to answer this question for myself as the weather has turned from perfect to chilly these last few days. My default is always to just trust the God that holds my life in His hands. However, I also think there are actions that He expects us to take that allow us to be brightness in the dark for others. There are 5 things I think that can help… if we’ll just do them:

  1. Keep things simple – I think that often I become stressed because my mind is working too fast on too many things. Right now, there are many things that can clutter our thinking. And, for the most part, you can’t even find an escape in mindless activities like television because of the political advertisements. Find ways to simplify your life. Turn off the TV. Instead of surfing the internet, try putting on some nice music and enjoy the autumn sunshine. Take a walk with someone you love. Clean out some clutter and give away what you don’t need or want. Watch an old, fun movie. When life gets too complex, find a way to make it simple. You don’t have to be accomplishing something 24/7.
  2. Stay focused on the most important things – Sometimes we become stressed because we are trying to do too much, too fast, for too many people. One of the tricks I have learned is to stop and ask, “What problem are you trying to solve right now? Will this matter tomorrow, or next week, or next year? Is it imperative that this get done right now? Can anyone else take something off my plate?” We need to focus on doing the most important things, so it is essential that we identify what those things are and spend our time accomplishing those. We can’t solve every problem today, but we might be able to make a dent in one or two.
  3. Let darkness be your friend – Back to my radio under the pillow… The other thing that I learned back in those days was that nighttime was a great time to think about the important stuff. It is a great time to think about what was good about the day. And, what I have to look forward tomorrow. It is a great time to plan. It is a time to smile. Darkness can be a scary, uncertain time. But, when you use that time to clear you mind and focus on positive things, just before sleep, you’ll awaken with a new attitude.
  4. Focus on the facts, not your emotions – People often view their lives as a mess because they have too many emotions tied up. They see everything through a lens of good, bad, hurt, happy, up, down, etc. When you are dealing with difficulties or complexities or frustrations, I have found it best to get back to the facts. “Just the facts, Ma’am,” as Sargent Joe Friday used to say on the show Dragnet. As difficult as it is, set aside your emotions and focus on the things you know to be true. Get a notepad and write down the facts. Then, use the facts to determine your next steps. Many times things can become so complex that we feel paralyzed and unable to act. Rather, get to the point where you can say, “What is my next step? What is the next thing I will do to move forward?” Identify the facts, then take a step of action.
  5. Think of your favorite things – Do you remember the song from the Sound of Music called My Favorite Things? Here are some of the lyrics:

When the dog bites;

When the bee stings;

When I’m feeling sad.

I simply remember my favorite things,

and then I don’t feel…. so bad

When life gets you down, when you lose hope, when you think that bad times will never end… remember your favorite things. Some of the things from just the last several months that I remember include:

  • Eating powder donuts in the morning sunshine at my grandson’s baseball game
  • Kayaking on the mirror-calm lake with my bride
  • Watching my grandchildren play in the water at the lake
  • Playing golf in the cool autumn morning sunshine with good friends
  • Playing table games and eating junk food with best friends
  • Seeing the beauty of the fall behind our house
  • Watching the night turn into day in the woods while deer hunting
  • Enjoying my wife’s terrific cooking on the deck overlooking the lake
  • See my grandson accept Jesus as his Lord
  • Having all my children and grandchildren under the same roof
  • Experiencing good health
  • Seeing a good friend get stronger after a health scare

When you need a boost, stop long enough to remember your favorite things… and why they matter.

Yes, these are difficult, challenging times. But, it is possible to stay resilient. It is possible to finish strong. It is possible to be the light someone else needs to make it through. Someone else may be counting on you. Find a way to keep going.

Being Decisive

Today I would like to share an excerpt from my book, “Achieving your best day yet! … A more fulfilling career… a more impactful life.” This book is available on Amazon in paperback or Kindle versions and can be found here: http://Achieving your best day yet! This excerpt is only one of 68 topics that can help drive your career or your life.

Making decisions seems to be a challenge that we all face. Let’s look at some of the negative impacts of indecisiveness and approaches to give us more confidence to “get off the fence.”

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Making Decisions

“I’ve never been able to plan my life. I just lurch from indecision to indecision.” –  Alan Rickman

How many of us have the problem mentioned above by Alan Rickman?  Indecision… that point where you have one foot in each of two places… the very comfortable place on the top of the fence… that oasis in the gray when everyone wants you in either the black or white.  Why is it so hard to decide between the piece of cheesecake or the blueberry pie for dessert?  What if I am wrong?  Why can’t I decide?

Indecision is a huge problem, not only for us in the business world, but for those managing a household, raising kids, or trying to function in a fast-paced world.  And, the impact of indecision can be both personal and practical.  Let’s look at a few of these impacts:

  • Indecision robs us of our peace – When you cannot decide about something important, it is difficult to have peace until a decision is made.  Indecision tends to be a constant companion during these times of turmoil.
  • Indecision delays action – Indecision is just a matter of procrastinating… putting off until another day what needs to occur today.  And, in the process, that lack of action may be causing personal or practical hardships for you or those around you.
  • Indecision frustrates those around us – We all know the frustration of waiting in line for someone else to decide.  We often just want to say, “Just do something…anything, but get going!”  Causing others to wait almost always causes irritation that can lead to anger.
  • Indecision can be a decision that we did not want to make – Failing to decide can actually be a decision.  Delayed decisions often require someone else to step in and make the decision.  And, when this occurs, we frequently think that gives us a license to criticize the decision.
  • Indecision is an indicator of one lacking confidence – An inability to make decisions often has, at its root, a lack of self-confidence.  The individual doesn’t want to disappoint someone else, or take a risk, or be wrong.  Much of this stems from a basic fear of rejection.  A self-confident person can typically make decisions quickly after available facts are known.
  • Indecision can lead to a cycle of indecision – Because an indecisive person is usually lacking in confidence, any negative consequences (even small ones) perpetuates the inability of that person to decide the next time.  After a few of these, the individual can almost become paralyzed when a decision is needed.  This cycle becomes harder to break the longer indecision can continue.

So, sure, it is easy to name and number the negatives of indecision.  But, how can we get ourselves out of this cycle of indecision?  Is it possible to become a more decisive person? Well, of course, I think the answer is yes!  We can push ourselves, albeit in a step-by-step fashion, toward becoming more decisive.  Here are a few of those steps:

  1. Eliminate “perfectionist thinking” – Many individuals cannot decide because they believe that every decision must be perfect.  “Nothing can ever go wrong,” they think.  As a result, they delay deciding believing that unless they can be 100% certain the decision is correct.  This “perfectionist thinking” can prevent some individuals from making even the easiest decisions.  By accepting that there is room for error and that the benefit might outweigh the risks, this stranglehold might lessen.  Read on….
  2. Realize that no decision (or one that is delayed) is often the wrong decision – We have all heard that no decision is, in fact, a decision.  When posed with an opportunity to accept a new job, no decision will eventually disqualify you from even having a decision to make.  Opportunities and situations often dissipate if the decision is delayed long enough.  In fact, this is what many hope will occur.  A decision delayed is a potential mistake avoided.  This thinking is wrong.  Very few good things in life ever come because we fail to be decisive.  And, many wrong decisions are made for us when we delay or avoid them.
  3. Understand the risks of both a bad decision and a delayed decision – Everything we do has risks.  We simply cannot avoid them.  By realizing the risks of a decision (or, the pros versus the cons), we can often generate data that can take some of the subjectivity out of a decision.  So, when faced with a challenging decision, consider the risks of each, quantify them (if possible), and help yourself see how a proactive, intentional decision can often do more good than harm, even when the decision is imperfect.
  4. Consider whether more time or more information will allow for an easier decision – A technique I often use when faced with a challenging decision is this… Is there any information that, if I gather it, will make this decision easier?  If I wait to make this decision, will it become easier or harder?  We often delay deciding for no reason at all.  I frequently see individuals with 75% of the required information delay deciding because they want to get to 80%.  That extra 5% requires time, energy and effort that does not truly increase the likelihood of a positive decision. Sometimes, you just need to decide based on what you have.
  5. Confidently assume the role of decision-maker when needed – We often don’t make decisions because we secretly hope someone else will assume the responsibility.  The fact is some decisions cannot be made by anyone else!  When you realize that only you can make the decision, you just need to step up, assume the role, and make the call.
  6. Realize that most wrong decisions are either not so bad or they can be fixed – In reality, most decisions are not so critical that the impact of a wrong decision is might either overwhelming or irreversible.  Often, we wait to decide when we could have made a wrong decision and quickly fixed it before the decision was made. When the impact is minor or reversible, go forward with confidence and believe that things will be better either way.

Becoming a more confident decision-maker is really all about becoming a more confident person.  When you realize that there are times when you simply must “go for it”, you start a new cycle of decisiveness.  Once you gain experience making decisions, and, sometimes wrong ones, you learn that the cost of delays, in both personal and practical terms, is too much to be anything less than decisive.

So, consider today how you can become a more decisive person.  Determine that we all must take risks and a considered decision is almost always better than either a delayed one or one never made at all.  Don’t be like Jimmy Buffett who said, “Indecision may or may not be my problem.”

“No more candy until you finish your donut” and other observations from the Pandemic Summer of 2020

It seems it has been six years since March, not six months! My wife and I spend the summers at a lake cottage, so it is not a bad place to attempt social isolation. Nonetheless, we had a terrific time with a few close friends, we enjoyed all the activities lake life offers, and we came home ready to get back into the “normal” life we enjoy the rest of the year.

Lake life offers quite a bit of time to reflect on current times. As we are now past Labor Day and the official end of summer, I thought it would be a good time to share some of my observations and thoughts relating to current times both as they relate to society and to our stage in life. Anyway, read on and ask yourself if you have had the same thoughts.

Observations and conclusions from the Pandemic Summer of 2020:

  1. Be flexibleanything can happen – I can’t count the number of times over the last few months that plans have been made only to be cancelled at the last possible moment. This has been a difficult lesson for me and my wife. We are planners. Our family calendar is never far away and we are diligent in looking ahead regularly. However, I think we are learning to be more spontaneous and “just take each day as it comes.” These times can really help break us out of that rigid shell we often find ourselves in. I have often said to others, “It is good to be in that comfortable, predictable rut.” However, when we stay in the rut, we often miss out on amazing things. This summer, we became very good at “back-up plans” which often consisted of nothing more complex that playing board games with friends. In reality, these “back-up plans” often result in more fun and greater memories than those planned events that we missed. Use this time to develop a less hurried, less stressed life. Learn to shift with the winds and enjoy what comes.
  2. Attitude is a choiceeven when you’re having a crummy day – Sure, things aren’t how we would choose. In many ways, it’s been a lousy year. However, when you pause to take a step back, you can probably name a number of “positives” that never would have happened if not for the pandemic. For me, spending more time with our Grandkids has been a blessing. A few days ago, my six year-old grandson told me, “You are the best Zombie Apocalypse teammate ever!” Now, would that have happened in any ordinary year? And, though it has been more difficult doing “normal” things this summer, we did spend more time than usual with a few close friends. Those times are precious! Rather than looking at the “woe is me” side of things, make the choice to see the positive.
  3. Be the differencesomeone you interact with today is on the edge of a crisis – Many of our friends and family are stressed beyond belief during this time. Today might be the day that someone you know is emotionally crushed by the weight they carry. We each have the power to be the difference in someone’s life. Taking away even a small portion of that weight they carry might be the difference between victory or defeat for them. Find some way to lessen the load for someone else. You might also be surprised about how that simple act might lessen your load, as well.
  4. Stay connected don’t fall into the trap of complete isolation – Covid-19 has been, possibly, the greatest excuse maker of all time. Many companies have reduced their service, their hours, or their payroll under the guise of Covid-19 impacts. We recently took our jewelry into a national chain jeweler for routine inspection. They could not even touch it “because of Covid-19.” We asked why not given the representative was already wearing gloves and a mask and she responded, “It wouldn’t be fair that we can inspect your jewelry here in Missouri when we can’t do that in some areas, like New York.” What? Are you kidding me? What does that have to do with anything? We bought our jewelry from you, we are here to get routine inspection, there is no Covid-19 risk to you or anyone else, and you give a ridiculous excuse like that? Other individuals use Covid-19 as an excuse to be isolated from friends and family. Some take this to an extreme. When you isolate yourself physically, it is even more important to stay connected through the phone or other means. Now is the time to double-down on staying connected to others. Don’t let yourself use Covid-19 as an excuse to avoid doing what you know you need to do.
  5. Accomplish something every dayfind a way to keep moving forward – I have been really impressed by individuals that have accomplished amazing things over the past 6 months. For example, I heard of one individual that has become a very accomplished guitarist during this time. Others, have read dozens of books. Others, have learned new skills. Maybe becoming an expert is not something you want to invest in, but doing something, every day, is important for us to stay moving forward. I actually keep a weekly checklist of things I plan to accomplish, then meticulously check the boxes when things are completed. Some of these things are simple or mundane, like washing the cars. However, there is something gratifying about completing a task. Admiral William H. McRaven gave a speech at a commencement address in 2014 titled, “Make your bed” (see the entire speech here: https://www.youtube.com/watch?v=pxBQLFLei70). Admiral McRaven talks about the importance of the simple task of just making your bed and how that task, when completed well, can make a difference in your day, your outlook, and your performance. Though you may feel you cannot do something great, at least do something…. and do it every day.
  6. Keep things in perspectivethese times define our character – Yes, the quote in the title of this post actually was heard around our place this summer. These have not been normal times. My grandson was being difficult one day at breakfast and his mom laid down the law…. no more candy until he finished his donut! When you look at life from the lens of only today, it is often clouded by the problems we face, the challenges in front of us, and the frustration we feel. However, by broadening that view, we can see the bigger picture. We can see that these difficulties will pass. Today’s frustrations will ease. Possibly, we won’t even remember a year from now our biggest challenges today. When we can focus on the facts, not our emotions, we can better react to our circumstances. Don’t let today’s frustrations impact the things you say and do that might negatively impact someone else.
  7. Find the humor laughter is great medicine, even in serious times – One day this summer, my wife and I decided to dig up and refresh a flower bed around our summer lake cottage. On about the 4th shovel turning over the dirt, a swarm of hornets boiled out of the hole. There must have been hundreds of these hornets flying and attacking. Immediately, I yelled, “Hornets!” My wife ran one direction and I ran the other. She ended up with about 5-6 hornet stings and I had around 10-12. And, they were very painful. The pain lasted the rest of the day and evening and into the next day. Sometime during the second night, the sting changed from pain to itching. The itching was intense and lasted a few more days until it was all over. It wasn’t fun at the time, but we laugh about it now. We have had fun re-enacting the event with our friends and how we frantically worked to get the hornets out of our pants and shirts. We need to see the humor in life. Sure, it is often easier to complain and moan about our circumstances, but laughter can keep us sane.
  8. Focus on todayeverything can change in a flash – I heard someone recently say that the worst purchase they ever made was to buy a 2020 planning calendar. Yes, we’ve all learned this year that plans can change in an instant. I would guess that over 95% of us had a major event, a trip, an annual event, or something similar cancelled this year. The pandemic has been a good lesson in the old proverb, “Don’t count on tomorrow; today is the only day we’ve been promised.” So, what’s a person to do with all the uncertainty around us during these times? A lesson for me has been to just focus on today. Focus more on the journey than the destination. Enjoy the blessings of the season. Cherish times with family members. Rest in the beauty of the day. In some ways, I think the pandemic has given a bit of freedom to deviate from the norm and experience things you never would have before. It has given us permission to slow our pace and limit the pressures that stress our lives. Use this time to just enjoy the day and times and events that await us today. Tomorrow will take care of itself.
  9. Extend gracewhy not be kind – There is too much anger in the world today. And, often, that anger spills out to those around us that don’t deserve it. During these times, we have a responsibility to protect those around us that may be experiencing life altering crises. So, when we have the opportunity, why not make the choice to show kindness? Why not extent a bit of grace that just might change the day for someone else? Why not give the person that cuts you off in traffic a pass? Why not give that sales clerk a smile instead of a snarl? Why not show extra patience with that individual on the phone that is simple doing his/her job? Let’s use this time to allow kindness to become our default behavior?
  10. Trust Godnow, more than ever, we should realize that we can’t control all our circumstances – I am a Believer in God and His Son Jesus Christ. So, it is natural for me to say that I trust God, even in difficult times. However, 2020 has been a year like no other. It has been a time when we see that, despite our best efforts, we can’t control the events occurring around us. We can’t solve every problem. We are at the mercy of things, people, events totally out of our hands. That is why it gives me great comfort to simply rest in the confidence that “God has this.” I don’t have to control the circumstances around me, even if I could, because the God who loves me is doing what is best for me. If you’ve never felt the peace that comes knowing that your present and future is in the hands of a mighty, just, and loving God, now is the perfect time to trust Him.

I haven’t give up on 2020 yet. There is still time to learn something new, to find a new friend, to accomplish something remarkable, and to make a difference. There is still time to enjoy the beauty of falling leaves, see the harvest, laugh at the first snowfall, and experience the magnificence of Christmas. There are still family gatherings to come, firsts and lasts, hands to hold, and memories to make. Resolve to make these coming last months of 2020 so amazing that they erase the difficulties we faced earlier in the year.

And remember, today could still be your best day yet! You just never know when something might happen that makes all the difference in the rest of your life. It just might happen today!

Educating Management about GXP Compliance: How much adulteration is too much?

 

Pragmatic GXP Compliance

[Today, I feature an excerpt from my latest book, “Pragmatic GXP Compliance” recently published. Recently, the CEO of a pharmaceutical firm had this to say about this book:

“I finished Pragmatic GXP Compliance today and have to say it is another excellent read. It really hits home with trying to improve our quality culture. My whole leadership team has read the book and absolutely raves about it!”

This book is available in either paperback or Kindle version and can be found at this link: Pragmatic GXP Compliance.]

How many of you have heard something like the following from management?

  • What’s the problem? All we’re talking about is a few specks in the tablets.
  • What do you mean we can’t release that batch? It met all the finished product specifications, didn’t it?
  • Can’t we just retest that batch to see if it is really OK?
  • How much adulteration is too much? (Note: Yes, I really did hear a member of management ask me that one time.)

Granted, comments like these should be rare in the 21st century. Nonetheless, helping management, especially when their background is in a non-scientific area, understand the basic elements and requirements of GXP’s is an ongoing challenge.

So, what is the proper approach for helping management, especially senior management, understand the important role they have in ensuring compliance with GXP requirements? Before we look at some specific approaches, let’s begin by reviewing management responsibilities in a GXP environment, the benefits of creating a strong compliance culture, and the enforcement options at the hands of regulatory agencies in the event we fail to maintain the necessary level of compliance.

 

Responsibilities of Management

What is it exactly that management must do to ensure an appropriate level of compliance? To understand how to best educate management about their responsibilities for GXP, it is best to review those responsibilities.

When operating properly in a GXP environment, management will:

  1. Create a mission, vision, and Corporate Quality Policy geared to GXP compliance – Perhaps, the most important responsibility for management is to create the overriding messaging of the importance of quality compliance. This is most often established through a mission statement and/or vision statement that clearly articulates the corporate commitment. Such a statement does a couple of things: it continuously reminds employees, stakeholders, and customers that quality compliance is important AND it ensures accountability. When your mission/vision statement declares a commitment to compliance, it makes it much more difficult organizationally to cut corners. A strong compliance commitment included in a mission or vision statement partnering with a Corporate Quality Policy works to establish that quality compliance is a value that cannot be compromised.
  2. Establish a Quality Unit with the proper organizational reporting structure – Of course, words are cheap. Saying that quality compliance is a value without demonstrating it through solid actions renders it meaningless. GXP’s require that complying firms establish a Quality Unit with adequate organizational strength to ensure compliance. In short, unless the Quality Unit has the ability to stop production or reject noncomplying products, its organizational strength is inadequate. In fact, GXP’s require that the Quality Unit be given status equivalent to functions such as Production, Engineering, and Supply Chain. Quality must sit at the table at which decisions are made that potentially impact quality or GXP compliance. Failing to create such a structure is a management failure that has severely impacted other firms (see Regulatory Agency Enforcement Options below).
  3. Create a Quality Unit with adequate credentials, numbers, and organizational support to execute GXP compliance – In addition to creating a Quality Unit with adequate organizational strength, management must ensure that members of the Unit have adequate training, experience, and skills to perform all GXP activities. This typically means that Quality Unit leaders have demonstrated ability leading their respective functions. It also means that management adequately fund the Unit. By this I mean enough resources are provided to perform all required activities. It is very tempting to focus resources on activities that “produce revenue” and view quality compliance personnel as overhead. I would argue that a properly resourced Quality Unit can often “pay for itself” by ensuring an ongoing supply of conforming, high quality products. Failing to resource quality functions adequately is a common root cause for firms cited for non-compliance issues.
  4. Create a periodic management review process that ensures management knowledge and oversight of Quality data and compliance performance – GXP’s require that management have a process in place to ensure awareness of quality compliance through a systematic review of quality performance data. Many firms conduct this formal data review on a monthly or quarterly basis. This review should be adequate to ensure that management is aware of potential adverse trends, quality compliance risks, and actual performance of products at the consumer level. This GXP requirement is one of the elements of the legal basis for “management is without excuse” (discussed below).
  5. Establish a visible and vocal quality compliance posture – Many GXP regulated firms establish a strong mission or vision statement accompanied by a Quality Policy, then never discuss quality compliance again. Management must make quality compliance an ongoing discussion point. For example, quality compliance should be a topic in town hall meetings, be a typical topic in company newsletters, receive significant discussion in annual corporate reports, and Quality Unit leaders should be routinely highlighted in forums with senior management. Company leaders should mention quality compliance performance in public venues. All of these combine to demonstrate clearly that quality and compliance are more than talking points, but values the help define the success of the company. In short, management must make clear that no year is a good year in which quality or compliance issues resulted in significant regulatory agency or consumer impact.
  6. Ensure ongoing commitment by recognizing and rewarding strong quality compliance performance – Companies are usually quick to highlight strong performance of sales and marketing organizations. Most firms have an “annual sales meeting” in which top performers are recognized and rewarded. However, do individuals involved in achieving significant achievements in the quality compliance arena similarly recognized and rewarded? A failure to do so often seems to relegate these individuals to second tier status when it comes to company success. Management must demonstrate the importance of quality compliance by recognizing and rewarding it.
  7. Establish systems to manage performance to ensure compliance – A basic responsibility of management is to manage performance. This also applies to GXP compliance. Creating goals and objectives that measure the output of the Quality Unit and associated contributors to GXP compliance (e.g., Production, Engineering, and Supply Chain) is critical to ensuring that needed ongoing level of performance in these areas.
  8. Establish an organizational structure and process for escalating known and potential quality compliance issues – Management must be involved in key decisions impacting quality compliance. Establishing such a process for escalating these issues is a responsibility often left to informal communication. Management of firms that give lip service to quality compliance will often work to abdicate their responsibility to be aware and involved in key decisions. I have even heard of firms that adjust their organizational structure to delegate these responsibilities to others. For example, I heard of one firm that had the Quality Unit reporting to the Legal Department, essentially allowing other senior management the shield of the Legal Department to deflect their responsibilities for quality compliance. Senior management at firms that are committed to quality compliance seek opportunities to be directly involved, not create ways to avoid it.
  9. Establish a process for identifying risks for non-compliance through audits, assessments, and data review outside the periodic management review process – Members of management at some firms are afraid of bad news. However, committed management will seek ongoing input into the performance of these quality compliance systems. Establishing robust internal audit programs, assessments of system performance (e.g., Supplier Quality performance), and ongoing review of performance data are signs of management committed to GXP compliance. I know one firm that formerly had their GXP Compliance Internal Audit function reporting directly to the CEO. This provided an ongoing, direct line of communication to the top manager of the company for potential risks. Later, this same company altered that organizational structure under a new CEO and eventually agreed to a consent decree and large fine to remedy ongoing GXP compliance issues. This organizational change may not have been directly involved, but I cannot imagine a significant slip in GXP compliance when the CEO was getting routine feedback on GXP performance from the leader of the Corporate Compliance function.
  10. Provide adequate resources and commitment to facilitate continuous improvement of systems, equipment, facilities, and personnel performance – In addition to the Quality Unit, it is a significant management responsibility to properly fund other continuous improvement initiatives. For example, new equipment, updated facilities, and enhanced personnel skills must be funded. You cannot establish solid systems and expect them to remain current without ongoing enhancement. I am aware of a firm that once had a facility so modern and advanced that US FDA personnel routinely visited the facility for training to see “how it should be done.” However, that firm failed to maintain and continuously improvement the operation and a few years later it was the source of a Warning Letter alleging poor maintenance and inadequate resourcing to perform basic GXP responsibilities.

 

Benefits of a Strong Compliance Culture

Aside from avoiding the negative consequences associated with inadequate compliance, there are other benefits to a strong compliance culture.

First, there is an element of organizational discipline needed for compliance. The mere fact that a strong compliance approach means that you have written procedures, trained employees, maintained equipment, and standards against which to measure performance… all key attributes of many successful operations. When your entire organization has the needed discipline to properly fulfill GXP requirements, success in other areas of the business is likely.

GXP requirements also include, as a built-in, critical element, systems for identifying and correcting problems. In effect, GXP’s drive toward continuous improvement. In a strong GXP environment, there is an ongoing culture of correcting issues, making the operation better, and preventing events that could negatively impact the business or product quality.

As we might expect, a strong culture of GXP compliance should result in better product quality. When processes are consistent, employees knowledgeable and disciplined, and practices in place to ensure that high manufacturing standards are achieved, we can be sure that we will experience fewer rejections, less product loss, and higher conforming finished product.

Finally, when we achieve a strong culture of compliance, the consumer or patient impact will be better. GXPs, by definition, exists to ensure the safety, purity, identity, strength, quality, and efficacy of distributed product. Thus, we should expect that the ultimate patient experience is higher when compliance is better.

 

Regulatory Agency Enforcement Options

Regulatory agencies have been given significant power to enforce GXP compliance. This is true globally. Reviewing these enforcement options with management can help inspire a greater respect for compliance.

Many of the “tools” used by regulators are well established and well known. For example, most individuals in this industry understand the significance of US FDA 483 items and their global equivalents. Likewise, the use of import alerts, recalls, debarments, seizures, injunctions, and fines are also well established.

There are a couple of enforcement options, though, that are valuable to review with management when discussing the need for enhanced GXP compliance. One example comes from the Danish Medicines Agency (DKMA) which suggested to Europharma DK ApS (a repackaging firm) that the firms needs a new CEO that will appropriately deal with compliance concerns. Apparently, repeated citations of GXP deficiencies did not elicit an adequate response, so DKMA used its influence to drive accountability to the top manager in the company. It has become increasingly common for regulatory agencies to publicly communicate that senior management bears the burden for compliance.

In the US, the “Park Doctrine” has been in use for several years to ensure that top management cannot abdicate responsibility for compliance. The Park Doctrine stemmed from a court decision that declared that management responsibility did not require “awareness of wrongdoing” to be considered liable for GXP deficiencies. In effect, any individual in the company that “is in a position in a corporation with responsibility and authority to prevent or promptly correct” a GXP problem could be held individually responsible for the violative acts. Thus, individual company officers (e.g., CEO, President, Senior Vice-President, etc.) have been prosecuted successfully with fines and imprisonment imposed.

So, management must understand that they cannot abdicate any responsibility for GXP compliance to others down the line in the company. Regulatory agencies now view members of top management as the responsible party for all activities relating to GXP compliance. Helping management understand this is an important step in their “education” about GXP compliance.

 

Approaches for Educating Senior Management

From a practical standpoint, we are now at that point where we answer the question, “What steps can we take to educate our management about their important role and responsibility in ensuring a strong GXP compliance culture?” I believe there are 4 key steps that can help management to become fully knowledgeable and supportive of these efforts:

  1. Review with them the management responsibilities, benefits of compliance, and regulatory agency enforcement options discussed above – Certainly, some individuals in senior management roles, especially those new to GXP regulated operations, do not have the experience to fully grasp the challenges and responsibilities included in their roles. For these individuals, it is imperative that they be exposed in detail to these elements. Helping them to understand their personal and individual responsibility may alone be enough to elicit full and active support. For example, a newly named CEO with a background only in Sales or Marketing is suddenly given responsibility for all operational functions, may feel that expending resources for activities “behind the scenes” is less valuable to the overall firm than spending on more visible sales or marketing initiatives. However, when they realize that, like others, they could be prosecuted for a failure to ensure GXP compliance regardless of whether they were personally aware of concerns, they tend to become much more active in learning and understanding how they can avoid compliance issues. However, senior managers do not often become full supporters of GXP initiatives simply out of fear. Thus, there is more to their education needed.
  2. Highlight the competitive landscape regarding GXP compliance posture – Most members of senior management are highly competitive. They continuously seek competitive intelligence to learn what their peers are doing and how they must react to remain in the game. Taking advantage of their competitive nature can be beneficial with GXP compliance, as well. Help management understand what actions peer companies are taking regarding compliance activities. For example, if a peer company is implementing a new software system that will provide more rapid and accurate data trending information, share that information. If a peer company has received a 483 citation for failing to properly resource GXP-required functions, use that to help justify your needs in similar situations. By using information of competitors, especially in what is considered your company peer group, you can often educate management on the need to support initiatives that strengthen compliance.
  3. Demonstrate the “value” of compliance – GXP practitioners should never avoid talking about the value of compliance to the company. In fact, speaking in “dollar terms” is often the best way to help others in management understand the need. In fact, if you cannot justify any expenditure in terms of value, it is probably not needed. I believe there are three areas of value that need to be re-enforced with management:
    • Cost of non-compliance – Most of us are familiar with the term “cost of poor quality.” This is useful for demonstrating overall loss for poor performance relating to product costs. However, a similar calculation is useful for demonstrating the value of a strong compliance operation. When you total all costs for non-compliance, the number can be substantial. These costs would include costs for: recalls, investigations, complaints, follow-up auditing, batch rejections for GXP failures, CAPA actions, etc. Calculate all costs associated with a failure to execute GXP compliance perfectly. This number will undoubtedly be larger than you expect and can be helpful to demonstrate the importance of a strong compliance culture.
    • Direct financial impact – Many individuals underestimate the direct financial value of a strong compliance operation. Consider the value of improved product release times on inventory costs, production planning, and product supply. If you could eliminate all time associated with retesting, investigations, and compliance failures, what would the direct impact be? Or, what would be the value to a faster new product approval time? For example, if you anticipate that a new product will generate $365 Million in annual sales, each day that final approval is delayed costs you $1 Million in sales…. Per day! With that in mind, how important is it to have a pre-approval inspection occur without compliance issues? How important is the entire effort to produce a “first-time right” submission package? Determine the direct value of perfect compliance and utilize that information to educate senior management.
    • Indirect financial impact – There is an opportunity impact for strong compliance. For some products, the potential market is impacted by your compliance position. The ability to do business is often strongly influenced for active pharmaceutical ingredient (API) suppliers by their current and future potential compliance position. The value of business opportunities cannot be overlooked as an element of the value of GXP compliance.
  4. Enforce the importance of “internal” and “external” reputation regarding GXP compliance – Finally, the impact of GXP compliance position on employees (internal), patients (external), and stakeholders (external) should not be ignored. Because so many companies have had business impacts due to poor compliance, it has now become an important recruitment tool. When you can portray a solid and respected GXP compliance position, it does help recruitment and retention of top talent. There is also certainly an impact to shareholders for the same reason. Finding a way to emphasize the fact that a company in GXP regulated industries must be considered a reliable and trusted compliance partner is another important educational tool for management.

Helping management understand the important role and responsibility of leading a GXP regulated company is a key factor to the success of that firm. Using the approaches outlined can facilitate that key educational process and instill quality compliance as a value that will not be compromised.