Once upon a time: Part One

Sometimes it seems like a fairy tale when I talk about how things used to be. You see, I grew up in the late 50’s and 60’s at a time much different than today. There are a lot of things I miss from those days. Certainly, we have advantages today that were only scientific fantasy back then. But I do look back some days and wish that we could have kept some of those best things from back then.

I’m not sure when or why things changed. Did our society take a negative turn because of the assassinations and Viet Nam War back then? Did the internet change the course of our society? Or was it something else?

Today, I would like to talk about some of these things that I miss from back then. Perhaps this list will take you back in time, as well. The big question is how do we regain some of the good from those days? Is it even possible? Let’s look at the first seven items on my list. After I’ve had the chance to discuss all the items, I’ll offer my views on what we can do, individually and collectively, to regain the best of yesteryear… if it is not too late.

Once upon a time, there was…

  1. Resilience during difficult times – Perhaps it is because so many of us have never had to deal with extreme adversity, but too few individuals today are willing (or able) to persevere through challenging times. Let me provide an example… The pandemic has been severe with many bad impacts. However, how can we explain why these times are called the “great resignation?” Millions of individuals have dropped out of the workplace because they find it too difficult to commit to a 40-hour week, they simply do not want to stop working from home, or they find idleness too great a temptation. Why are mental health issues so prevalent today? Is it because there are more issues or because adversity is too much to handle? Individuals that have endured war, depressions, adversity… and survived, exhibit a “grit” that is rarely seen by individuals today when even a sideway glance can be viewed as harassment or a critical slight.
  2. Patience – Clearly, individuals in society today are less patient than in times past. In my former corporate role, our group hired many degreed individuals with 1-2 years of experience post-college. In many cases, these individuals after only a few months complained that they had not been promoted yet. One individual once said to me, “I’ve been here for over 6 months and have done everything you asked me to do. What does it take to get promoted around here? Maybe I need to leave and find a place that appreciates me more.” This individual didn’t understand the concept of growing and learning before assuming greater responsibility. Most of the individuals in my generation (I am 65+) probably received on average 5-7 promotions in their entire careers. That would be one every 6 years or so. Yet today, if an individual isn’t promoted within their first year, they view their career as a failure or the company as a bad employer. Immediate gratification has replaced long-term commitment.
  3. Willingness to “earn it” (versus sense of entitlement) – Similarly, there is a strong belief today that you should get simply because you exist. “I have a degree, so I have ‘earned’ a great salary and title.” Or “I am entitled to a house as nice as my parents’ house.” A sense of entitlement has replaced the concept of earning it. Perhaps this began when society started believing that competition is bad and participation is all that matters. Too many individuals are not willing to make the sacrifice of time, effort, or risk required to earn the benefits of life and work. I recall when you had to save 10% of the total cost of a house before a bank would provide a mortgage. You had to “earn” the right to purchase a house by sacrificing upfront. There is much more a feeling of “I deserve” rather than “I earned” today compared to years ago.
  4. Freedom of thought (and the drive to fight for it) – I remember going to the barbershop as a kid. It seems there were always 4-5 older men waiting in the shop, but it seems I never had to wait when I went to get my haircut. The guys would just sit and talk. However, I remember that they didn’t always agree with each other. In fact, I recall that they rarely agreed. However, they came back, day after day, just to sit and argue about the state of the world. I don’t think that could happen today. The minute a disagreement arises, someone leaves. There is no room for civil disagreement and discussion. You are either “for me or against me… nothing in the middle.” Also, it seems that few individuals today will fight for their say. You either quietly disagree and move on or capitulate. Someone recently recounted for me a conversation they had when they asked and individual whether he leaned toward Democrat or Republican in his views. His answer was, “It depends on who I am with at the time.” I long for the day when individuals were not afraid to speak their mind and would freely do so… with the result that we were all better as a result!
  5. Patriotism – When did it become politically incorrect to be a patriot? How could that even happen? I remember celebrating the July 4th holiday as a kid. It was possibly my favorite holiday of the year! We had a carnival in the park, an all-star baseball game with our rival neighboring town, and the best fireworks in the area. In between, we had a patriotic program in the bandshell where veterans were celebrated, the grand old marches were played by the band, and we were proud to be Americans. Sure, there are celebrations like that today, but more often, our elected politicians denounce our nation, its founding, and what our flag stands for. I’m reminded that “united we stand, divided we fall.” Which direction are we headed today?
  6. Affirmations of standards of behavior – When did it become a “problem” to hold individuals accountable for their behavior? I’m not really talking about those things that are in the gray areas, but standards of behavior that are clearly black or white. It seems today that it is OK to ignore the law or rules or basic decency unless the violation is especially onerous… or at least when they cross the lines of current progressive ideals. For example, it is now OK to loot, steal, and rob for the sake of equity. It is OK to lie simply because it benefits you. It is OK to cheat on your spouse or business partner or friend because “everyone else does it.” During the mid-20th century, standards of behavior were clear and to cross those lines was considered a serious offense to society. In many ways, it seems as though we are back in the old west where whoever has the biggest weapon makes the rules. Why is it so hard to stay within the standards of behavior that define a civilized society?
  7. Willingness to submit – In my working life, I observed and monitored the performance of literally thousands of individuals. There exists a small percentage of individuals that seem to have great difficulty keeping a job, staying in the workplace, or functioning successfully in this environment in which you are expected to do your job. In the vast majority of these cases, I have found that the individual has great difficulty submitting to authority. When you cannot accept or submit to a boss or leader or standard of expectation, it becomes nearly impossible to succeed. Think about the individuals you know that move from one job to another to another. Why is it that they cannot be content and successful? I think you’ll find that the single biggest reason is that they “had problems with their boss or expectations of the boss.” Perhaps this can happen occasionally, but when this becomes the theme of a career, you can bet that the root cause is an inability to submit to authority… an unwillingness to submit to the decisions made by someone else. Society has developed a problem with submission, as well. I’m not talking about blindly submitting to the whims of government, though we have all experienced that during the Covid-19 pandemic. I’m talking about an individual choice to do what’s best even when it may not be the best for me. I mean that willingness to set aside my own desires, pleasures, and wishes to serve another. However, I am hopeful. During the Russian invasion of Ukraine in 2022, there have been hundreds of cases of Ukrainian individuals submitting their own desires for a greater purpose. It is my hope that this represents today’s society more than the selfishness that seems so prevalent.

In coming posts, I’ll discuss several other things I miss from the past. These include:

  • Appreciation for excellence (versus expediency)
  • Sense of hope
  • Honesty/Truth
  • Willingness to sacrifice
  • Common sense
  • Contentment
  • Choosing to do what is right
  • Doing things that matter
  • Hard work
  • Basic kindness
  • Experiencing and expressing joy
  • Gratitude
  • Sense of commitment
  • Belief in God

More to come…. Have a great day and if you would add other items to this list, send them my way. I’ll be glad to add them and provide my perspective in coming posts.

Time is marching on

I reshared a post today called, “What would you say if you could speak to your Dad one more time?” I did that because my own Dad passed away exactly 30 years ago today. In many ways, that seems like a lifetime ago. In other ways, I remember it like it was yesterday. Time passes quickly.

Anyway, for those of you that still have your Dad with you today, take some time and give him a call. Don’t wait until it is too late to say what you need to say.

What would you say to your Dad if you had only one more chance?

what would you say

This coming Sunday is Father’s Day… the day we celebrate all the great things our Dads do for us. It is a day set aside for BBQ’s, outings with families, gifts, and fun. I remember as a kid celebrating Father’s Day doing the things we kids liked to do, not so much what our Dad really would like to do. But, he seemed to just enjoy being with us and doing what we wanted to do… that was just who he was.

However, for many, Father’s Day is a day spent caught up only in memories… thinking about those good times… and bad… with our Dad. Mine has been gone for almost exactly 25 years and I still miss him.

So, for today on The Porch, let’s reminisce about our Dads. Let’s consider what are those things we might say to our Dad if you had one more chance. I also solicited feedback on this question from a few friends to get a broader perspective.

I think the things we might say if you had one more chance fall into a few categories:

  1. “Thanks, Dad, for all that you taught me, especially ________.” I find myself wishing I could thank my Dad for all he taught me. He taught me how to treat and love a wife. He taught me responsibility, diligence, and to pursue excellence. He taught me to play baseball and to love the game. He taught me how to fish, hunt, and appreciate the outdoors. He taught me the importance of family and just “being there” for key events and activities. One of my friends said he would thank his Dad for teaching him how to fix old junk cars. That same friend is now passing that down to his own grandchildren. You may not realize it, but your own children and grandchildren are learning from you… good or bad.
  2. “Dad, I never really told you what I thought of you.” Many individuals I have encountered wish that they would have taken the time to tell their Dad what they really thought of them before they were gone. One of my friends does not have that regret. As part of her Dad’s honor flight trip to Washington DC, family members were asked to write a letter expressing their love and thanks to their Fathers. She had the chance to say exactly those things we all might wish we would have said. How fortunate she was… especially since her father passed away just one month later! Another of my friends mentioned how her Dad gave her the ability to take care of herself. He taught her how to hunt and fish and do things herself without depending upon someone else to do it for her. Being independent has been a blessing to her.
  3. “Dad, you were an amazing example to me, especially when you _________.” Several of the friends I asked to contribute to this talked about the example their father was… of kindness… of patience. One talked about how her father cared for her mother (his wife) tenderly for 14 years after her first stroke. Another mentioned how his father always encouraged him to look forward, not backward. I saw from my father the importance of hard work and of doing what you say you’ll do. I saw him dedicate his precious free time to children, helping to begin a little league baseball organization in my home town. He was a giver that lived an amazing life of service to others.
  4. “Dad, I wish you would have ________ before you died.” We often look back on the lives of our parents regretting what we did or didn’t do. One of my friends mentioned that she wished her father had done a better job preparing her mother to be a widow. He lived his life dedicated to her to the point that she was not ready to live alone after he was gone. She also said that his dedication to her occurred at the expense of relationships with other family members. Sometimes, being honest with our legacy and the brevity of life needs to be recognized, whether we like it or not. Another friend’s Dad died at a very early age. My friend wishes he had taken better care of himself. Several of my friends mentioned that they had never talked about God much with their Dads. The express that they wish they had that chance to ensure that they were ready when they crossed over that river of death.
  5. “I hope you are proud of me, Dad. I never would have accomplished _______ without your _______________ (sacrifice, encouragement, or support).” Several of those contributing to this mentioned the influence their Dad had on their own life. Finishing school, developing skills, learning self-reliance all things Fathers help encourage for us. For others, the sacrifices made by Fathers would be part of those “one more time” conversations. I often catch myself wondering and hoping that my own life reflects the dreams my parents had for me as I was growing up in my small home town.
  6. “I have tried to be just like you, Dad, especially __________.” My own father was a great example of integrity. He worked in the oilfield with men hardened by weather, adversity, and years of hard labor. Yet, to a man, they talked to me privately during my summer work there about how much they respected my father. Hearing that made me to be just like him! One of my friends commented that she always admired her Dad’s “giant personality”… love for people, friendliness, thoughtfulness… that she tried to adopt and emulate. Another friend said his own life has been much better because of the honor and integrity his father displayed over his entire life.
  7. “I wish you could have met your _________ (grandchildren, great-grandchildren, etc.). You would be so proud. In many ways, they are a lot like you.” My Father died when my children were all young. He would be so proud of them now! And, he would have truly enjoyed his seven great-grandchildren! Each of them has some element of him in their look, actions, or personality. How fun it would be to watch my parents meet them today! A friend mentioned that her son wished that he could have gotten to know his Grandfather better. He wishes they could take that camping trip together that they had been planning. That same friend wishes her Dad could have met her current husband. She said she thought he would really like him and be proud she had such a wonderful man in her life.
  8. “Dad, just in case there was ever any doubt, I just want you to know that I always loved you.” My friend mentioned that she was whispering her love for her own Father the very moment he died. How wonderful knowing that he never had to doubt it! I would love having the chance to just say it one more time!
  9. “I still smile every time I think about you, Dad. Do you remember the time we __________.” My Dad was fun! He had a great sense of humor and was constantly playing practical jokes on people. I have so many memories of him having fun. He made everything more fun just by being there. My wife and I still talk about his jokes and the pranks he pulled on us.
  10. “Dad, I miss doing __________ with you!” – One of my friends mentioned that he missed being able to go bowling or play golf with his Dad. Those of us that have lost our parents, often just wish we could spend more time doing the things we enjoyed with them. I remember fishing with my Dad while listening to the baseball game on the radio. One of my friends said he would say, “Thank you Dad for all the countless summer days of fishing together, I sure do miss you!”
  11. “Well done, Dad.” I would love the chance just to tell my Dad, “well done.” His life was too short, but full. He served in the military, enjoyed many hobbies, worked hard, raised three successful kids, was respected by others, and sacrificed his own interests for others. He loved his wife of 40 years and told me shortly before his death that he knew his eternal destiny was heaven. How could you ask for more?

I’m sure that every person would add their own item to this list. Sometimes, it is good just to pause to reflect on the wonderful life and wonderful parents we were blessed to experience.

For those fortunate enough to still have your Dad living, what is it from this list that you need to tell him? The rest of us would give anything for just one more chance to say what we need to say or neglected to say. Don’t let this opportunity pass you by. Someone once said,

“Never ignore a person who loves you, cares for you, and misses you. Because one day, you might wake up from your sleep and realize you lost the moon while counting the stars.” – Unknown

Father’s Day is also a good day to consider our own legacy. Are we doing everything we can today to leave behind those memories that will bring smiles years or decades from now? Are there changes you need to make to restore relationships that need mended? Let this time of reflection on your own life serve as a wake-up call, if needed.

Finally, to all you Dads reading this… thanks for what you do; thanks for the sacrifices you make; thanks for the example you provide; thanks for your unending support; and thanks for the love you show. It may not seem like much, but it means the world to some. Keep it up and finish strong!

Happy Father’s Day!

Key decisions that can affect the rest of your life

[Today, I am sharing an excerpt from my most recent book, “Yes, you can change your circumstances“. You can purchase this book in paperback, ebook, or hardback at Amazon: https://www.amazon.com/Yes-change-your-circumstances-extraordinary/dp/B09NH63Y53/ref=sr_1_1?crid=3HTBJCUM503YG&keywords=eldon+henson&qid=1643233626&sprefix=eldon+henson%2Caps%2C337&sr=8-1]

Everyone wants to realize a successful career, have a happy family, and enjoy the good things of life. Many are blessed to have all three of these. However, the sad fact is that many do not. Henry David Thoreau once said,

“The mass of men leads lives of quiet desperation.”

Many do not achieve complete success in life and, as they look back on their lives, admit that the reason can probably be traced to one or more key decisions.

Our lives are measured not by the company we keep, but by the decisions we make. A decision is, in effect, an exchange. We trade one thing or path for another. We give up one thing we can readily grasp within our hands for something completely different. We shift from one direction to a completely different one. We forfeit one thing that is replaced by a new thing. Decisions… exchanges… define our lives.

So, what are those key decisions we make in our lives that define us? Is it really possible to understand what those key decisions might be even before we come face-to-face with them? Can we really decide to decide? My belief is that there is always hope that we can change for the better. Even when we’ve blown it in the past, we can still reverse ourselves and make a better future life for ourselves and others.

Putting together a list of great exchanges we can make is both a risk and a challenge. Can you boil a successful life down to even 10 basic decisions in life? That is the challenge. However, if you even fail to try to create a vision for a successful life, you take the risk that you might be the reason someone could fail. Despite that, here is my list:

10 KEY EXCHANGES (DECISIONS) WE CAN MAKE THAT WILL LEAD TO A MORE SUCCESSFUL, FULFILLING LIFE

  1. Exchanging the ordinary for the excellent – There comes a day in life when you must decide whether you will be one that accepts the ordinary or mediocre versus the better choice of excellence. Doing things right. Doing them the right way. Giving your best in every situation. Giving your all. These things don’t easily come, nor do they come automatically. They come by choice. There is a conscious decision to be made that shifts us away from the easy road to the better road. Make that choice.
  2. Exchanging a focus on self for service to others – There seems to be an epidemic of narcissism in today’s world. Individuals are consumed by what will make them happy… what will be best for them… what can make them the most successful. However, there is a better way. A better choice is to exchange your life for one that serves others… that seeks to make a difference first for those around us. Spending each day striving first to serve others yields a more satisfying and, in my opinion, a more successful one. When you demonstrate a willingness to serve others, you automatically become a leader or one that others seek to emulate and follow. Becoming a better leader and a better person will enhance your life.
  3. Exchanging the recognition of others for the creation of value – Recognition is important in a world infused with social media. In an age of “selfies”, followers, and “likes”, individuals are consumed with how much love they get from the world. However, this creates no real value to anyone. A better choice is to seek ways to make a real difference in the world, not seek the adoration of an indifferent set of digital friends. Adding value will bring a sense of accomplishment that recognition could never provide. Deciding to be a doer makes the world around you a better place… and you a happier, more content person.
  4. Exchanging blame for accountability in what we do – Why do so few people accept responsibility for their own actions, decisions, and efforts? When did our society become one in which the greatest accomplishment seems to be the attainment of “celebrity victim?” Being a victim serves no one. Accepting accountability for your own actions does. Choosing to be accountable, rather than one seeking to blame automatically puts you in a better place… for everyone.
  5. Exchanging fear for adventure – Many individuals get into a rut and are glad to stay there. After all, there is safety in the rut. We know where it is and what can go wrong. However, we miss out on a lot of life when we stay in that rut. A failure to take an occasional, reasoned risk robs us of fun, adventure, and opportunity. Choosing to be a warrior, not a worrier, can bring joy, satisfaction, and adventure that the rut could never offer.
  6. Exchanging a love of work for a love for life – Let’s face it, work can bring much satisfaction and fulfillment. It can provide for our own identity and our desired lifestyle. However, just like anything else, out-of-balance focus on work can lead to the detriment of all other areas of our lives. An excessive love of work can cost us much, including our families. Achieving that balance of work and life is an important decision we must all make. Don’t fool yourself… it is a choice. Don’t lose your family for a title, money, or prestige. It is not worth it!
  7. Exchanging rebellion for compliance – I have observed many individuals that simply cannot keep a job or move from one thing to another without focus or aim. In many cases (not all), individuals that are unable to submit to authority (e.g., those that default to rebellion) struggle with working for others. Making the choice to submit, when needed – to follow the rules, to seek to comply with the basic rules of life – fare much better in life. Compliant individuals tend to achieve more success, as well. Certainly, there are times when we need to take a stand. But choosing compliance over overt rebellion is the better choice.
  8. Exchanging convenience for commitment – Many individuals have difficulty making and keeping a commitment. For example, marriage was originally designed to be a lifetime commitment. Most wedding ceremonies still use the phrase “till death do us part” in the vows exchanged. However, the divorce rates are still around 50%. Challenges with commitment are evident in other parts of our society, as well. Too many individuals choose convenience over commitment. However, when you choose to be a committed person, you are more likely to have stability in life and be seen as a person with integrity. Commitment is a choice… and one that puts us on a more satisfying and successful life path.
  9. Exchanging a reliance upon emotions for a reliance upon facts – As humans, it is easy to allow our emotions to dictate our actions. We react to the events in our life using our gut, intuition, or feelings. However, these emotions tend to taint reality. Failing to pause long enough to consider the true facts can deceive us. It is good to be emotional at times, but we need to ensure that we always utilize facts. For example, being able to step back and ask tough questions can keep us on track. Good questions might include, “Will this really matter? What is the real impact of this? How can I solve this both short- and long-term?” Choosing to allow emotions to drive our actions without considering the facts will almost certainly lead us to poor outcomes in life and work.
  10. Exchanging lies and deception for hope and encouragement – Our world is an ongoing challenge every day. There seems to be a battle of conformity versus morality. It seems that if enough people say something is right, it becomes right, whether or not it really is. This quote illustrates this well:

“Conformity is doing what everyone else is doing regardless of what is right. Morality is doing what is right, regardless of what everyone else is doing.” – Evette Carter

This is especially true when we consider our hope for the future. The world will try to deceive us by saying, “There is no God. There is no life after death. There is no hope after life is over.” These are lies! There is a God in heaven that loves us and wants to offer us hope for our eternal future. Exchanging these lies for the hope and encouragement that God offers through His Son Jesus Christ is our only hope (see: What is your hope?). In my life, the greatest exchange I ever made was the decision to accept this gift from God. Exchanging a life lived by my own standards for one based on the love and grace of my Father was the best decision I ever made.

There you have it! Outlined are the ten key exchanges or decisions that can make our lives productive, fulfilling, and meaningful for ourselves and those in our lives. These decisions can impact our work, our family, our friends, and our future. They can dictate whether we live with optimism and hope or fear and despair.

Take an honest look at your life against these key decisions. Have you already made the wrong choices? It is never too late to make a mid-course correction. It is never too late to change course. Even late in life, you can alter your legacy by the decisions you make today. Finally, consider whether you have made that greatest exchange… that one that determines your eternal destiny.

New Book! “Yes, you can change your circumstances”

I am very pleased to say that my newest book “Yes, you can change your circumstances” has been published and is available now in paperback from Amazon.com.

( https://www.amazon.com/Yes-change-your-circumstances-extraordinary/dp/B09NH63Y53/ref=sr_1_2?keywords=eldon+henson&qid=1639399334&sr=8-2&asin=B09NH63Y53&revisionId=&format=4&depth=1

(If the link above does not work, simply search for Eldon Henson on Amazon; Kindle version coming soon).

Here is the description of the book from Amazon:

Today’s pandemic is more than one of a virus that ravages and kills. It is one that leads to frustration with life’s circumstances; desperation; and a feeling by individuals that nothing I do can change things. I don’t believe that is true! I believe there is hope in the world and in the possibility of changing your circumstances by molding your mind, heart, and hands to do things differently. This book provides a pathway to a different life. It talks about and provides a recipe to change the way you think about life and offers specific approaches to do so. It will help you modify your heart in a way that your choices are better for you and others. And, the end result is a new way of living… a new approach to your day-to-day circumstances. Some of the topics discussed include: the elimination of “moles” in your life that rob you of joy; refining your character; the value of ordinary moments; seeing the positive rather than the negative; key decisions that can affect every aspect of your life; courage; contentment; overcoming adversity; enhancing relationships; measuring and refining your Positivity Index; Happiness Factors; and many others. This book includes 136 chapters or topics designed to help you not only realize how to think differently, but to act on those thoughts in ways you never thought possible. You will find nuggets of gold on every page, advice from dozens of others, and lists, recommendations, and advice that will both challenge and motivate you. In these troubled times, the wisdom you will glean from these pages will almost certainly create for you a new, more fulfilled, and more effective life. Don’t miss it!

The elements of this book were written over a period of 3-5 years for my blog, The Porch, and have been compiled to provide a life-guide for achieving an extraordinary life. I look forward to your thoughts after you get a chance to read it.

Have a great day!

What does “Follow the Science” Really Mean?

Science is taking a big hit these days. It is difficult to view the news without seeing or hearing individuals speak on behalf of “science” often while contradicting it. We see individuals on social media being critical of science, politicians touting or bashing it, and entire industries praising or dismissing it, depending upon their political or personal views. So, I thought it might be helpful to provide a “science refresher” that helps us all understand what it really should mean when we say, “Let’s follow the science.”

THE SCIENTIFIC METHOD

Let’s take a trip back to Junior High School science class to talk about the Scientific Method. The Scientific Method (according to Wikipedia) is “an empirical method of acquiring knowledge that has characterized the development of science since at least the 17th century. It involves careful observation, applying rigorous skepticism about what is observed, given that cognitive assumptions can distort how one interprets the observation.” The key to the scientific method is to remove subjectivity from the conclusions drawn. There are several steps to the Scientific Method (some say 6 steps, others 8… I’ll split the difference and use 7 in my list):

  1. Observe (ask a question) – In this first step, we must understand what problem we are trying to solve or what question we are trying to answer. Unless we can adequately and accurately describe the problem, we won’t truly be able to determine if our work was successful. Lewis Carroll once said, “If you don’t know where you are going, any road will get you there.” The same is true in science. If you are a scientist investigating potential weed killers, you begin your work by asking, “What chemicals might be useful in eliminating dandelions from the lawn without harming desirable grass?” You have described a problem or question that is clear, concise, and is measurable.
  2. Background research – The next step in the scientific method is to conduct some basic assessment or research to determine an approach you can use to solve your problem. For killing dandelions, you might do a literature search on herbicidal chemicals. For solving medical issues, you might evaluate case numbers, incident rates, severity, prevalence, etc. The purpose of this step is to prepare you for the next critical step.
  3. Develop a hypothesis – This step is perhaps the most important step of the Scientific Method because everything that comes next hinges upon whether it addresses your proposed hypothesis. Will xyz chemical kill dandelions without harming grass? Will this new drug substance cure that specific medical issue (or at least mitigate it)? In essence, the hypothesis determines what you test, how you test it, and how you’ll evaluate the data to reach a conclusion.
  4. Test or experiment – Testing your hypothesis involves developing a protocol that identifies the methods you will use, how much testing will occur, what controls will be in place (controls ensure that you are measuring a targeted response to eliminate other factors), and what criteria will be used to assess your results. The Scientific Method requires that your testing protocols be written and specific to allow independent duplication of results. Unless your experiments and results can be independently repeated and verified, you have not eliminated all doubt in your results. For your dandelion killer, you will identify how much chemical to apply, when, and how to measure results… all compared to a control lawn that is not treated. In drug studies, the clinical studies usually occur in phases from phase I (small experimental groups) to phase IV (large-scale studies treating hundreds or thousands of patients). 
  5. Data analysis – Once the testing is completed, an assessment of data is required. Typically, this analysis will utilize statistical methods to compare the test group (treated) against the control group (untreated). Unless there is a clear, statistically valid difference in the results, the treatment is not successful. 
  6. Reach and report conclusions – After all data are analyzed, conclusions are reached. Have you proven your hypothesis as true? Did the treated group outperform the untreated group? What have you learned regarding the treatment? Are there additional studies needed? Conclusions should be objective… untainted by personal views or thoughts not observed or results not obtained during the experimental step.
  7. Communicate results – Finally, all good science is made available to others in the pursuit of knowledge and advancement of the field of study. Others should be able to replicate your studies and, perhaps, build upon what you have learned. Unless you are willing to share results (or publish them), your conclusions may be considered questionable.

This is the Scientific Method. Every scientist should know, understand, and utilize these steps when reaching conclusions about unknown scientific topics. This is what it really means to “Follow the Science.”

So, what does all this mean to us in this day of scientific misinformation? What should we look for when trying to decide for ourselves what to believe or not? How can we be discerning when reading news articles or watching TV reports of scientific happenings?

I believe there are 10 things to watch for when trying to decide what to believe. Let’s look at my list:

  1. Science is based on facts, not opinions – Don’t believe “scientific” reports what cannot be supported by data. Just because someone wants it does not make it true. Science must avoid personal opinions, expedience, politics, and greed.
  2. Be skeptical – When someone touts “science” be sure you assess the information based on what I’m sharing with you here. Don’t believe it just because someone wants it… or even if you want to believe it. Claims must be based on the facts ascertained through appropriate scientific methodology.
  3. Conclusions must address a specific problem (or hypothesis) – I have personally seen too many claims made based on hearsay or random results. If you throw enough spaghetti onto the wall, some is bound to stick. Ask how the objective results tie back to the specific problem or question the study was trying to answer.
  4. Experimentation must include proper controls – Unless a study is comparing treated subjects versus untreated, it is impossible to show that the treatment is effective. Unless the final conclusions state something like “… when compared to the untreated population…”, it may not hold up under scientific scrutiny.
  5. Data must be statistically relevant – Just because a treatment shows “…10% improvement versus the untreated group…” doesn’t mean the results are statistically relevant. If the test populations are small, this improvement may just be a random result. 
  6. Conclusions must tie to both the problem and the data – Don’t be fooled by conclusions that do not address the test protocol and hypothesis. There are many individuals that will attempt to interpolate one set of results to another problem or issue. 
  7. Results must be repeatable – True scientific results are always repeatable. If you cannot show the same result under the same conditions, you cannot be assured that the results are true or legitimate. Likewise, researchers that are unwilling to share their methods and data may be attempting to hide true results.
  8. Conclusions must be open to review and scrutiny – Science is empirical, but it welcomes healthy debate. Many scientists disagree about the conclusions of studies, but they are willing to have discussions openly and honestly. When you see individuals avoiding discussion or debate, it should raise questions about the legitimacy of the study.
  9. For medical products, safety, purity, and effectiveness must be proven – When dealing with medical products (drugs, medical devices, etc.), it is imperative (and required by FDA and global health authorities) that the products be proven safe, pure, and effective. These authorities are highly professional and not impacted by political or other pressure to approve products that fail to meet these criteria. Thus, in my opinion, if a product is approved (or, in the case of some, have received emergency approval), they have met these thresholds for use.
  10. Science is not untrue simply because we don’t like the results – Just because we don’t like the results, doesn’t mean the results are not correct or true. Science is objective. That does not mean that it is totally free from scrutiny, review, or debate… it simply means that science has no room for subjectivity. Certainly, scientists often offer opinions. But these are typically based upon extensive experience conducting true scientific studies or is based on their expert knowledge given the objective data available.

Certainly, the context of this piece is the discussion we have all heard surrounding the COVID-19 pandemic. Much of what we hear or read cites “science” as the basis for requirements, restrictions, lockdowns, mandates, and limits. Some of this has at its core, true scientific information. However, much does not. Let me give some examples:

Science-based observations

  • Proper masks have been proven to be effective barriers against viral pathogens
  • All the approved COVID-19 vaccines have been proven to reduce the risk of serious infection
  • Proper distancing, ventilation, and sanitation can reduce the risk of COVID-19 transmission in some indoor environments

Whether you like it or not, the scientific data are conclusive that each of the above statements are true. Scientific studies have been conducted that unequivocally prove each. That does not mean that they are 100%. It simply means that the preponderance of statistically based data provides objective evidence that the statements are true.

NOT Science-based observations

  • If one cloth mask is good, wearing 2 or 3 will double or triple your protection
  • You don’t need a vaccine if you take enough of the right vitamins and nutritional supplements
  • If you wear a mask into the restaurant and remove it completely at the table while you talk and eat, you are still protected from COVID-19 infections

Each of these statements has been touted as “following the science” without any evidence that they are true. This reminds me of the adage, “If enough people say it with enough conviction, it must be true whether or not it is.”

So, I hope this has been a helpful refresher. My takeaway is this… don’t allow someone fool you by touting as science something that has not nor could likely ever be proven using the rigors of true science. Be skeptical but have an open mind as you sort through the information presented to you in the news or on social media.

Living without regrets

Summer finally ended for me a couple weeks ago. We winterized our lake cottage, shut everything inside, played one last round of golf with our northern friends, and said good-bye (for now) to our group of best friends for nearly 40 years. It was a glorious summer!

Looking back on the summer, our list of fun activities was endless… concerts, kayaking, fishing, family times, biking, ice cream (multiple times, I might add), board games, great food, quiet times on the deck, and wonderful times creating memories. Our summer was full, enjoyable, and lived without regrets.

There were some not-so-great times, as well. We said final good-byes to two wonderful friends… one passing with time to properly show his love to family and friends… one passing suddenly in the night. Both were wonderful individuals that loved their families, loved God, and lived full and fulfilling lives. Did they live their lives without regrets? I do know that each left a lasting impact on the lives they touched. Knowing them was a true gift to me!

So many individuals I know seem to be burdened with regrets. They look back on events of their lives with a “coulda, shoulda” attitude. They are so weighed down by these regrets that they fail to experience the joy of today or the hope of tomorrow. Yes, when given a chance, most of us would probably make a few different decisions in life but moving past them is important for our lives today.

How can we live today with no regrets? What is the secret to contentment now? The philosopher in me has pondered this for some time now and I would like to offer 6 suggestions that can help any of us live our lives with fewer regrets. See if you agree:

  1. Recognize that each past event is like a jigsaw piece in the masterpiece of our lives – I like to think of my life as a giant jigsaw puzzle that is shaped and built over the entirety of my life. It began back in my childhood playing baseball in my backyard with 15 friends in a small town. Other pieces were added as I grew, went to school, and began a family. Each event, good or bad, represents a piece of the puzzle that will someday be complete. I didn’t always understand why certain things happened, but, looking back, I can now see how I wouldn’t be me without them. Some of those pieces were difficult or resulted from my bad decisions. But they still fit in the puzzle. The puzzle will be complete someday and it will be clear why things happened as they did. Many pieces are already formed and in place, so nothing I do today can change them… nor should I linger on them. Don’t regret the past, learn from it… savor the memories… let the past make you a better person today.
  2. Get out and do things today… even if they involve risks – Studies have been conducted in which individuals on their deathbed are asked what regrets they had in life. Nearly everyone listed things they DIDN’T do rather than things they DID do as regrets. Let’s learn from that! What is it that you’ve always wanted to do that you have yet to try? Are you waiting for every detail to fall into place before you feel confident to decide? If we all waited until our confidence was 100%, we’d never try anything new. I frequently talk to others about the best time to retire. I am a strong advocate for individuals to retire the very first day they are financially able. Time continues to march along and the window of opportunity to enjoy our retired life is often limited by health or other uncontrollable factors. Do something! Don’t look back and regret it.
  3. Realize that joy and contentment are, to a significant extent, choices that we make… we control them – I often hear individuals talk about how joy and contentment will come into their lives in the future… when their children finish college or when their finances are better or when work gets better or when they become a partner or whatever. Someone once said, “A good day is defined, not by what happens during the day, but by how you react to those things that occur.” By the same token, joy and contentment are what currently resides inside us. We have already decided if we are living our life with joy or whether we are just trying to survive the day. Joy is a choice. The day we DECIDE that we will live and share a life of joy, regardless of what comes our way, is the day that we become more content in what we have and what we do.
  4. Savor today… tomorrow is not promised – She had a nice day with her husband. They were looking forward to an upcoming trip and had already started planning their winter in Florida. Tomorrow promised to be a enjoyable day… However, tomorrow never came for my friend this past July. Life is fragile. Despite our best plans, we cannot control our lives beyond this moment. Even though we know this intellectually, we still busy our days making plans, keeping our calendar current, and assuming that our time here will play out as we have imagined. When we begin living our lives as if today is our last day on earth, we start to see just how unimportant today’s worries really are. Ask yourself this question, “Will my biggest problem or worry today matter to anyone a year from now?” Stop assuming that your time is unlimited…. Stop worrying about the minor details of life…. Start savoring the joys of your life more.
  5. Make your life a gift to others – Life is a gift. We are the recipients of this gift. But we are a gift to others. How many times a day do you think of someone else in your life? I often think of my Dad and Mom drinking coffee in the mornings when I have my own. I think of my grandchildren in school. I wonder what my friends are doing during the day. I often remember many others in my life no longer with us. Others in our lives are doing the same thing! I think we would all be amazed at how many people in our lives think of us every day! Our life is a gift to others. We need to live our lives in a way that will enhance that gift. I want my grandchildren to have fond memories of me. That is why I try to be a positive influence in their lives. Consider the fact that you are on the hearts and minds of many others every day. Make those thoughts and memories positive; bring a smile to their faces when they think of you.
  6. Live your life with hope for your future – Too many people regret their past to the point that they fail to plan for the future. I’m not really talking about the short-term future here, but their eternal future. When you have peace with God, you attain an entirely different perspective on regrets of the past because you have been forgiven. God sent Jesus into the world to mend the broken relationship we have with Him because of sin. When we accept Jesus as our Lord, our past is forgiven, our present is enhanced, and our future is certain. If you wonder more about what this looks like, you can learn more here (What is your hope?).

I read an obituary this week for an individual that died at the age of 90-something. One of the comments read, “… She lived her life with very few regrets…” That’s what I plan to say at the end of my life. How about you?

Why I was one of the very first in line to take the Covid-19 vaccination

In the autumn of 2020, I volunteered to be in the clinical study for the Johnson & Johnson (J&J) vaccine against the Covid-19 virus. At that time, the Covid-19 pandemic was at its peak. Most schools were offering only remote learning. Many restaurants were closed or serving only carryout food. Mask mandates were nearly universal and the free life that we had known up to that time was in turmoil.

When I received the call saying that I (and my wife) had been selected to participate in the J&J vaccine clinical trial, there was no hesitation from either of us. We accepted the first date available and excitedly joined the study. We received our one-shot vaccination in early December 2020 with a 50% chance that we received the vaccine versus the placebo, but we were glad to participate. Late that night, we both awoke with mild side effect symptoms (chills, body aches, and, in the morning, fatigue) that subsided within 12 hours. So, we felt encouraged that we both received the live vaccine.

Why would we want to participate in a clinical trial for a vaccine that had never been commercialized previously with unknown potential side effects? Why would we potentially put ourselves at risk taking a vaccine with unknown safety or effectiveness?

Today, several vaccines have been in use globally for a number of months (3 in the US). A recent study cited by USA Today (USA Today by Taylor Avery published 7/12/2021) says that these vaccines have saved 279,000 US lives and prevented 1.25 million hospitalizations in their first six months of use. Yet, upwards of 40% of the US population remains unvaccinated. I am not writing this to be critical of anyone that has made the choice to not get a Covid-19 vaccination, but to just provide a few of my own reasons for being in that first group of individuals to be vaccinated:

  • My personal education and knowledge – My graduate studies included full semester courses in both virology and human immunology. So, I learned a bit about how viruses work and how our bodies respond. Vaccines are developed to teach our bodies to build antibodies to components of the virus particles that, when the real virus attacks us, will inactive the ability of the virus to infect us. The mRNA and J&J vaccines do this differently, but both have proven effective in providing this needed immunity. According to Dr. Adam Brady, Infectious Disease Specialist and Chair of the Samaritan Coronavirus Task Force (https://www.samhealth.org/about-samaritan/news-search/2021/02/09/covid-19-vaccine-side-effects-compared-to-other-vaccines) the side effects for the Covid-19 vaccines are greater than those experienced typically for a flu vaccine, but slightly less than you might experience for a shingles vaccination. There are slight risks with any vaccine, but there is no scientific reason why the Covid-19 vaccine should be more risky than any other.
  • My work experience in the pharmaceutical industry – I have worked in the pharmaceutical industry for over 40 years. During that time, I have hosted over 100 FDA inspections, provided thousands of communications to FDA, heard hundreds of FDA presentations at meetings, and read thousands of articles by FDA professionals. Though I have not always agreed with FDA individuals, I have never doubted their mission to provide only safe and effective products to consumers. In fact, the one thing that causes them to lose sleep is that they will approve a product that ends up doing more harm than good. They stake their professional reputation and life on the fact that they have done everything possible to protect the consumer. They often talk to industry about how they treat every decisions as though their own kids or grandkids will be using these products. Thus, I KNOW that their approval decisions for these products was based on science, not politics or outside pressures. It is simply not possible that these products could have been approved without adequate safety data. Consider the practicalities of an approval decision of this magnitude. Knowing that hundreds of millions of individuals would take a product and the visibility associated with it, would YOU want to be in a position to approve such a product unless you knew for certain that the data proved its safety? No FDA individual that I have ever known would rush, short-cut, or give less than a full review for such a decision.
  • My personal risk/benefit analysis – Life is full of risk versus benefit decisions. When the clinical study vaccine became available, my wife and I were faced with the very real risk of Covid-19 infection (we personally know many individuals that have had Covid-19) versus the minuscule risk of an adverse vaccine reaction. The risk of Covid-19 was undoubtedly higher (let’s say 1 in 100, for example) versus the adverse reaction risk (probably 1 in 1,000,000 or less). To me, it was a no-brainer. On a personal note, a close relative had Covid-19. This individual is about my age with no underlying risk factors. He was severely sick for about 3 weeks and still, one year later, has “long COVID” impact… increased anxiety, lingering cough, etc. Covid-19 presents a very real risk that far outweighed adverse reaction risk.
  • My appreciation of living freely – I want to live my life freely, without worrying about undue Covid-19 risks. I knew that if the J&J vaccine worked, it would totally change my ability to do the things I had always done without that underlying fear of catching the virus. Today, we know that our hopes were realized… the vaccine is so effective in preventing the most severe infection that we were quickly able to resume living life without Covid-19 worries. We don’t worry about transmitting Covid-19 to our grandkids. We don’t worry when we eat in a restaurant. We go to concerts. We are experiencing life much like we did before Covid-19. Certainly, there are no guarantees in life. There are rare cases in which individuals that have had the Covid-19 vaccination have been infected, hospitalized, or experienced death. However, that was also always the case with other vaccines, as well. However, it appears that the vaccines prevent over 95% of individuals from contracting a severe case.
  • My love for my family – Covid-19 quickly became a killer disease. Stories emerged within weeks of its emergence in the US of otherwise healthy individuals dying from Covid-19. It was especially severe for those with underlying conditions and those over 65 years of age. So, we knew we were in that most vulnerable population of individuals. We have three children and seven grandchildren. To protect them (and, from their perspective, to protect us), getting the vaccine early removed, to a large extent, the possibility of either putting them through the agony of watching our demise OR experiencing a long absence from them while we all quarantine. For all of the reasons noted above, taking the vaccine for us was an easy decision.

So, for those of you that have not yet decided whether to take this vaccine or for those of you resistant, why put yourself through the torture of “never knowing if today is the day” when a simple injection can significantly reduce this worry? As pressure mounts by government agencies, employers, and others, saying “no” to the vaccine may even carry greater personal impact relating to your education, possible career opportunities, or personal freedom. To me, making the decision to live my life as I choose without that ongoing, nagging fear of contracting a potentially fatal illness was an easy one.

Our politicians and news media have made this entire issue a messy one. We have been given mixed messages, contradictory information, shifting science, threats, and political advice about this vaccine. However, at the end of the day, you should rely upon the science (which I believe is unequivocal) and your own risk/benefit analysis, not emotion or fear. Either decision you make has risks, but which is most likely to impact you and those you love more severely? Saying “yes” to this vaccine does NOT mean that you have capitulated to the pressures of others. It simply means that you have done your homework and made the best decision, based on what you know, for you and your family. And, if you still believe that “no” is the best answer for you, I respect that. I simply wanted to share my own personal rationale for the decision I made back in December 2020. Have a great day!

The Philosophy of Risk in GXP Operations

How should we view risk when operating in a GXP environment? How much risk should we allow or tolerate? Can we ever get comfortable with ANY amount of risk?

We all have probably heard or read about one firm that recently lost several million doses of COVID-19 vaccine due to a manufacturing error. What might in the past have been a simple matter of financial impact to that firm today is an international incident. Not only do several million individuals miss a potential life-saving vaccine injection, but that firm’s past and present GMP issues have now been exposed. Everyone now knows the name of that firm and assumes, based on publicity, that the company’s products are potentially less than desired quality. Though I am not familiar with the circumstances of the manufacturing issues at that firm, it is safe to say that, in retrospect, some may say that too much risk was assumed or inadequately mitigated.

Is there a philosophy we should adopt when it comes to risk in GXP operations? In my book, Pragmatic GXP Compliance (available at Amazon at this link: https://www.amazon.com/Pragmatic-GXP-Compliance-Successfully-inspections/dp/B089M425M3/ref=sr_1_1?dchild=1&keywords=eldon+henson&qid=1619704518&sr=8-1), I discussed many practical applications of GXP compliance and how we should not simply avoid any risk. However, I think there are some larger, more philosophical, broader concepts on GXP risk that I think deserve some attention.

Allow me to discuss four of these concepts here:

ZERO RISK MUST NOT NECESSARILY BE OUR GOAL

Is is possible to avoid all risks in GXP operations? Certainly, the answer to that question is YES. However, your business may not be able to survive such an approach. For example:

  1. The Quality Unit could eliminate all risk by refusing to release any batch – if you never release a batch, you never incur regulatory or consumer risks
  2. To ensure that every unit is perfect, you could do 100% sampling and testing – sure, you would have no remaining product to sell, but at least you would have eliminated any risk
  3. You could hire an inspector to shadow every manufacturing and quality employee to ensure that every operation was done perfectly

You get the point… there is a balance we must seek in which our goal is not to completely eliminate all risk (too impractical, costly, or impossible), but it is to eliminate or avoid undue risk.

I am certainly not inferring that we must take more risks than necessary. There are situations in which doing more to eliminate risk is warranted. Let me provide an example in the area of Regulatory Affairs. Assume you are working to attain approval for a new product that will generate $365 million in annual revenues. Essentially, for every day of delay in achieving approval, your company loses $1 million in revenue. When assembling your regulatory submission, you always have options relating to more/less testing, additional scenarios, extended studies, more/less clinical participants, etc. In such a case, it may make more financial sense to do more upfront prior to submission to reduce the possibility that you will receive a Deficiency Letter which could delay approval many months. So, the question is, “Do we do more now (either in costs or time) to eliminate the risk of a Deficiency Letter with the assumption that we lose $1 million each day we don’t have approval?”

We must also not take risks when patient safety is potentially compromised. There are simply times when we must do more, spend more, and mitigate more to protect and serve our ultimate consumers. However, it is possible to do more potential consumer harm by striving for zero risk. Speed to market must be a consideration when dealing with life-threatening situations. Gretchen Rubin Voltaire once said: “Don’t let the perfect be the enemy of the good.” All factors must be considered when assessing your tolerance for consumer risk. Balancing the risk with the overall benefit must be a part of these conversations and action.

GXP REGULATIONS ALLOW AND RECOGNIZE SOME RISKS

Many individuals believe that GXP requirements are black or white with no room for alternatives. This is simply not true. Most experienced regulatory investigators understand this and allow for options where GXPs allow. Let’s look at one simple example. What is required by 21 CFR 211.142 (a)? This requirement simply states:

“Written procedures describing the warehousing of drug products shall be established and followed. They shall include: (a) Quarantine of drug products before release by the quality control unit.”

Notice that it does NOT state how these requirements must be met. This is a perfect example of how GXPs allow some flexibility in compliance. Let’s list some of the possible ways you can comply with this:

  1. Physical segregation – this system requires that you have separate physical storage locations for acceptable (released) and unacceptable (unreleased) products. You can only ship product from the physical location with released goods. And, you only store released goods in that location. Individuals constantly verify and monitor what is stored in that area.
  2. Visible indicators – this system requires that you place a visible indicator on each pallet or container of product as to its status (Hold, Released, OK, Not OK, etc.). Individuals shipping products will only select products that have a visible “released” status and this status is reviewed prior to shipment.
  3. Computer systems – this system involves a computerized inventory system that tracks through barcodes or other technology the status of all items. The system will select items to be shipped and verifies the released status of items before it will allow shipment. The system is validated to ensure that it properly functions under all circumstances.
  4. Combination systems – Most firms use a combination of approaches to fulfill this requirement. They may physically segregate and use computer systems. They may only physically segregate failing or non-conforming lots and use computer systems for typical operations.

The point is that GXPs allow us to design systems that fulfill the requirements, yet meet our own system needs.

Have you ever considered the origin of validation? Validation was not specifically discussed in the original GXP regulations issued in the 1970’s. Yet, it has become one of the most important elements of GXP manufacturing and testing. Validation originated because firms and regulators realized that we could never eliminate all risks in producing healthcare products. Thus, we needed a system for verifying that batches were consistent and acceptable beginning to end and from one day to the next. Validation became the means for ensuring that our components, processes, people, systems, testing, and controls all work together to provide consistency throughout the life of a process. Because we cannot test or inspect 100%, validation became the means for ensuring the quality of our products. Though most firms utilize similar approaches to validation, each firm must design its own approach.

My key point here is that there are multiple ways for complying with most elements of GXPs. The design of GXP requirements recognizes that each firm and each product is different. Finding an approach to comply and yet manage associated risks is the key challenge faced by healthcare industries. Someone once said (perhaps it was me) about those managing GXP operations:

“Anyone can make GXP decisions when dealing with black or white. We earn our pay by managing the gray.”

Finding a way to manage the everyday risks we face differentiates the excellent from the mediocre.

AVOIDING OR MITIGATING UNDUE RISK SHOULD BE OUR TARGET

If we cannot eliminate all risks, finding means to avoid or mitigate risks becomes our target. What risks are acceptable and which must be avoided? Much has been written about the topic of risk identification, assessment, and mitigation, so it is not my intent here today to restate that. However, I want to make two key points:

  1. We must identify our approach to risk tolerance – the first step in managing risks is to identify which risks we are willing to take, how far we go to mitigate these risks, and the potential impact if we are wrong. One approach is to develop a hierarchy for risk decision-making. When we understand our philosophy or approach to risk, that can guide the actions of every employee. For example, I have seen this hierarchy used:
    • Risk to patient safety – we will take no actions that will pose a risk to patients
    • Compliance to specific GXP requirements – we will always comply with specific GXP requirements
    • Compliance to industry standards or expectations for GXP requirements – we will always comply with requirements we know are expected
    • Internal values, policies, procedures, mores, or requirements – internal requirements are important, but will not take precedence over those above
    • Cost considerations – cost will never trump risks to patients, compliance, or company requirements
    • “Red-face” test – though our actions pose no patient risk, comply with GXPs, and follow internal procedures, would I be embarrassed by my actions if my spouse read about them in the newspaper?
    • Expediency or preferences – My personal preferences always come last
  2. We must communicate and formalize our approach to risk – In my experience, many of the product quality, compliance, and safety issues that have arisen are due to one individual making a decision in the midst or production or testing. Unless that individual understands the risks – and the company philosophy on those risks – undesired outcomes can occur. You cannot overemphasize your approach to risks in communicating to employees and in how you reward actions around those risks. In short, by developing a culture that clearly identifies, articulates, and rewards actions around risks, you enhance the potential for correct decision-making in the midst of problem solving.

BE WILLING TO DESIGN (AND DEFEND) SYSTEMS/PROCESSES THAT MAKE SENSE FOR YOUR OPERATIONS

Finally, understanding that risks are normal and that GXPs recognize that not all risks can be avoided, we must be willing to design systems and processes that make sense for our operations. AND, we must have the confidence and courage to defend these processes and systems when challenged. Many firms are so risk averse that they will spend any amount of money, take any amount of time, or expend any amount of resources to even avoid having to discuss it during a regulatory inspection (read “An FDA-483 observation is not necessarily the worst thing that can happen” in my book). This approach is not courageous or pragmatic.

“If every decision was black or white, they wouldn’t need you. Anyone can make that kind of decision.”

Be willing to defend what you do. Discuss the science behind your processes and systems. Demonstrate how you comply with GXP requirements and protect consumer safety. If you can do this with confidence, most regulatory investigators will be reasonable and open.