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.

Workplace Stewardship: Impact on Culture and Performance

jefferson

A couple of years ago, I discussed the concepts and principles of workplace stewardship (Four Principles of Workplace Stewardship). Though it is important to understand that these principles exist, it is even more important to examine how to apply these principles. In effect, how can a solid understanding of these principles alter our actions in such a way that we see improvements in workplace culture? Then, as a result, what is the impact on individual and team performance?

To review, stewardship is the careful and responsible management of something entrusted to one’s care. So, for workplace stewardship, we have a responsibility to manage what gets done and how it gets done. It is not enough to achieve results alone; likewise, we can do things perfectly, but, without results, our business cannot survive. Creating that perfect balance, then, is our challenge.

The four principles of workplace stewardship are the principles of:

  1.  Ownership
  2.  Responsibility
  3.  Accountability
  4.  Reward

Today, let’s look at these in more detail and see how each can impact workplace culture and performance.

Principle of Ownership

  1.  I get to make meaningful decisions – I think everyone wants at least some autonomy in their job to make meaningful decisions. We all want to believe that we can personally make a difference. The primary basis of the Principle of Ownership is that we all have a key part to play in the role we play. Whether we serve as the CEO of a major corporation or provide face-to-face service to customers, we must make decisions every day that impact others. An owner of an ice cream stand cannot abdicate the need to decide what flavors to offer, who to hire, and what hours to be open. This Principle requires that we act like the sole owner of the function entrusted to our care. And, as the owner, we must act in a way that will meet the needs of our customers (both internal and external) and serve the needs of our business. So, in your current role, what do you own? What decisions must you make to ensure your function thrives? Have you been abdicating critical decisions that only you can make?
  2.  However, it is not mine – Being an “owner” in the workplace also means that I must share… it isn’t mine to hold alone. The best decisions are rarely made by one person acting alone. Information I hold is likely needed by others. I need to realize that the decisions I make impact others… in fact, they could impact MANY others. Have you ever worked with another individual that withheld information because they were insecure? The belief that “… as long as no one else has that information, I am indispensable.” Being an owner means you share resources, you share information, and you share decision-making. You work together to make the workplace better and to achieve better results. The best outcome usually comes when the power of the team functions together to achieve more than could have been achieved individually. And, as a leader, you need to learn when to let go. In my own experience, some of the greatest results ever achieved within my groups was when I relinquished control and allowed others to use their own abilities and creativity to achieve results. People are empowered when you give them freedom to operate and excel without the limitations incurred when you get in their way.
  3.  Achieving the greatest good for the most – The ultimate goal of an owner is to create the most value possible with the resources expended. In other words, a good owner is continuously striving to create results better today than yesterday. In our own workplace, we should be continuously asking questions about the value of what we do. For example, what things do we do that create no value? Should we continue them? If we stopped that activity, would anyone notice? I remember once stopping a report that had been generated each week for years. No one notice or asked why no report was issued. It was just that simple to save an hour each week to spend on things of greater value.

 

Principle of Responsibility

  1.  Others first – The first thing we must understand within the Principle of Responsibility is that it is not about us. Though we would like to think that our thoughts, ideas, and plans are most important, that is not necessarily the case. When we realize that our responsibility is to do what is best for the whole, not just me, we’ve taken a large step toward being the kind of coworker, leader, or teammate that will drive the most success with results and satisfaction in the workplace.
  2.  Doing my part – Another key factor in being a responsible individual is to do your part. I’ve seen many individuals that seek any possible excuse to not get their specific job done on time. As a key member of a group, we have to realize that we are all important components in a process. If any component fails to fulfill their part, the process could fail. Additionally, when one member fails to do his/her part – that is, he/she becomes a weak link – the impact to all other members is significant. Someone has to pick up the slack. One weak link, especially when it is simply by choice, can impact the morale of the entire group.
  3.  Getting things done, despite what others do (or don’t do) – Finally, we must all understand that there is no excuse to fail to achieve what is expected. That goes for individuals and teams. When one individual fails, others must fill that gap. When one individual cannot fulfill their task, others need to come alongside that person to do what is best for the whole. The bottom line is that getting things done is our responsibility. And getting things done often means we are outside our comfort zone, that we are taken advantage of, or that we don’t necessarily like the situation we find ourselves. We have to do what is necessary to meet the responsibilities we have accepted or been placed.

 

Principle of Accountability

  1.  Doing what you say you’ll do – With responsibility comes accountability. We all answer to someone. We all have others that depend upon us. I’m sure we have all worked with individuals that were very willing to make promises or commitments, yet it was rare when these were kept. Being a person that can be trusted to do what they say is a marker for credibility. An honorable individual – a person of integrity – does not have to be continually reminded to fulfill commitments.
  2.  Meeting expected timelines – Likewise, doing what we promise on the timetable promised is another factor that drives both results and morale. A family member made a contract with a contractor to perform work at their house last fall. The agreement was that the contractor would build a backyard pool beginning in March. However, excuse after excuse delayed the start of the project until June. At this point, no matter what the ultimate work quality might be or the service from this point on, the contractor is tainted because he failed to begin (and complete) the project when promised. Do what you say and do it on the timeline promised. It is basic element of that thing we call integrity.
  3.  Doing the right things the right way – Sometimes it is easy to get things done on time, but corners must be cut to achieve it. In the workplace, it is expected that we’ll do things the right way. It is a basic expectation that we will treat others well, that we’ll be kind, that we’ll be a good teammate, that we’ll add value. Knowing that our work reflects, not only on ourselves, but our teammates and our company should motivate us to be reliable and considerate of the expectations of others.

 

Principle of Rewards

  1.  Recognizing the efforts of others – One of the key “rewards” we receive in the workplace is the recognition from others of a job well done. Certainly, it is good to receive the praise of our boss. However, being recognized by peers may be even more desired. Think about a time when someone you work with every day said thanks for doing such a great job. It probably made your day! Seeing the good work of others and making a point to highlight it can make a significant different both to that individual and the team. Try it!
  2.  Passing it on – Similarly, when you are praised for a job well done, it is important to also recognize others that participated. When in doubt, praise the work of others. Be liberal in your recognition of others. It will pay off in both results and in creating a positive, collaborative workplace.
  3.  Fulfillment for a job well done – Finally, one of the rewards we receive is that of knowing that we made a difference to someone else. Helping the ultimate customer, providing a needed service, exceeding the expectations of others all feed our need of job fulfillment. I am convinced that many individuals lack fulfillment in their job because they see no value in what they do. When you walk to your car at the end of the day, you can hold your head high knowing that you did your part and made a difference to someone.

 

Finding joy in your work, contributing to something important, helping others become successful, being a man/woman of integrity, turning a bad day into a good one for someone else… these are the things that make work worthwhile. These are the things that show others you care. When everyone does these consistently, your results and culture will be the model for every other group. And, your results will consistently exceed expectations.

 

Pragmatic GXP Compliance

Pragmatic GXP Compliance

To everyone interested in or involved in GXP compliance, I am glad to say that my newest book titled, “Pragmatic GXP Compliance” has been published. It is available on Amazon at this link:

Pragmatic GXP Compliance

This book not a typical book on the nuts-and-bolts of GXP compliance, but one that has, as its goals:

1. EDUCATION – To help compliance practitioners teach others the importance of GXP compliance and create an enhanced culture of compliance

2. FOCUS – To provide focus on GXP compliance activities that are important and, thus, stop doing activities that provide no GXP compliance value

3. READINESS – To provide guidance on compliance and inspection readiness activities that focus on the “majors” and minimize activities that are meaningless

4. OUTCOMES – To provide tools and advice that enhance success of regulatory inspections and management of inspection outcomes

5. FUTURE – To provide perspectives and guidance on the future of regulatory inspections and activities that need to begin now

I think you will find nuggets of value in this work that will make it highly value-added as you seek to balance the need to fully comply with GXP requirements, yet do so efficiently.

A Kindle version should be available soon.

 

Career Accelerators

Finding the best path forward in your career is, possibly, the most challenging part of success in the workplace. To help with that process, today I am including an excerpt from my new book, Achieving your best day yet!: A more fulfilling career… a more impactful life (available from Amazon.com in either paperback or Kindle version). I hope this might provide encouragement or direction as you consider next steps:

 

Career Accelerators

Over the course of the last few years, I have had the privilege of hearing the detailed career journey experiences of over 20 successful executives. These individuals encompass many different disciplines and most covered multiple companies and very diverse experiences. Some have worked their entire careers at one company. Others have changed jobs many times. Most have relocated. Many have faced challenges, layoffs, acquisitions, divestitures, disappointments, victories, and any kind of career event you can imagine. All have had successful careers. Everyone has a unique career journey, but I have learned that each of these individuals experienced similar defining moments along the way.


The experiences of these individuals can help each of us better understand our own journey or at least anticipate what might occur and how we can prepare for them when they do occur.


Here are those key learnings shared by these successful individuals that either impacted or accelerated their career paths:


1. Don’t expect your career to be a straight line – The traditional thinking when you begin your career is that you will spend a few years at one level, then move to the next logical progressive position each few years in orderly, step-wise fashion. However, that is simply not the norm. Careers more often have several points when progress might involve a step sideways or even a downward move. Of the 20 or so career journeys I heard, probably half of them involved taking a lateral or downward moves out of necessity or as a result of another defining event. Be prepared for multiple career detours as you progress.


2. You will face multiple decision points – As with anything in life, your career journey will involve several significant decisions points. For example, all the executives I reference faced career-defining decisions. One had to decide whether to stay in research or move into more business-related areas. Others moved from Operations into areas completely outside it. Most had decisions about knowing when to stay or leave a company. Anyone starting early in their career must understand that key decisions will arise and you need to begin now considering what values you hold, what work you are most passionate about, and what risks you are willing to take to advance your career.


3. You will have setbacks – No successful executive has a setback-free career journey. All 20 of the executives faced adversity, such as a job loss, devastating defeat, or other seemingly crushing event in their career. However, each one took that event as a learning opportunity and moved on to something even better. In some cases, the executive mentioned that they would never have taken a risk on their own without the “push” they received by their unexpected event. So, when those events do occur, look at them as that push you need to do something different or go where you would not have otherwise. Learn from it and be better as a result.


4. Other individuals will impact you – Each executive mentioned the importance of other people in their career journey. Some talked about mentors, others about a boss that took a chance with them, and others talked about the immeasurable influence that a leader had on them. The point is that you cannot do it alone. You need to network, you need to have relationships, you need to open yourself up to what you can learn from others as you advance in your career. When you find such a person, don’t let them go!


5. Chasing a title or salary is a mistake – Each successful executive talked about their motivation. They talked about why they did what they did. None of them talked about chasing a title, except in the context in terms of how that sidetracked their career. No one benefited by taking a position merely for the title or merely for the increased salary. Learning what motivates you… learning where your passion lies… learning what is important to you will drive your career in positive ways that you’ll talk about decades from now.


6. You will feel completely overmatched at some point – Every individual mentioned a time when they assumed a role that they honestly felt they were not ready for. They all were in a position that felt overwhelming or too much. Yet, each talked about how much they learned from that experience… how much they learned about the job and how much they learned about themselves. Taking a role that seemed too much, taught them their limits. Had they never assumed a “stretch” position, they would have remained in their smaller, more confined place. Stretching taught them about thriving when they were uncomfortable.


7. Eventually, you will define career success in ways you never expected – Early in my own career, I defined success as the right job, with the right salary, in the right location. However, as I progressed through my career, I began finding greater career fulfillment in helping others achieve their own success. This same conclusion was true for most of the executives I know. Their career focus seems to change from a focus on their own personal success to the success of their teams and individuals around them. When you begin seeing the success others experience, you begin defining your own career as complete.


8. You own your own career – You cannot expect anyone else to manage your career. Certainly, you can rely upon mentors, bosses, and others to advocate for you. You can utilize their advice. You can lean on others for guidance. But, you cannot take the attitude, “I’ll just do my best and trust that things will work out,” and expect great things to happen. You need to take initiative. You need to take the ball and run with it yourself. The best advice I could give would be to envision what role or what responsibilities do you hope to have in five years. Ask yourself, “Can I get there from here?” If the answer is “yes,” then develop a plan that would make you the obvious choice when that opportunity arises. If the answer is “no,” then develop a plan to either make a significant career shift or begin looking for that next opportunity elsewhere.


9. Expect the unexpected – No individual has a career journey that did not involve an unexpected turn or two. You must expect it… or at least not be surprised when it happens. So, it is good to have alternate pathways in mind. Make yourself indispensable in more than one area. Become an expert in something else.


10. Some risks are necessary – It is almost inconceivable in this day to spend an entire career without being faced with “that risky decision.” Taking some risks is almost synonymous with success. You have to be willing to venture out of your comfort zone… out of that nice, easy rut that you find yourself in. You may have to move into a new functional area. You may have to relocate to a city where you know no one. You may have to take a temporary role. In hearing the career journeys of the individuals I mentioned, almost everyone mentioned a role they had where they knew very little about the job before taking it. Most said they had to sink or swim right away. And, most said those roles were amongst their most satisfying afterward. Don’t be afraid to try something entirely foreign to you! If you can make it with that kind of role, you can make it anywhere.


11. Some sacrifices are required – Most individuals agree that sacrifices may be required to advance your career. For some, it means moving your family away from family, friends, and comfortable surroundings to a new area. For others, it means financial and time sacrifices to pursue additional degrees. For others, it means assuming roles you may not have chosen in order to learn something new. In every case, individuals were faced with those difficult decisions that involved tough choices. So, just be prepared… nearly everyone faces that fork in the career road that means making either a safe choice or one that involves personal sacrifice.


12. Learn from both the good and the bad – Every individual experienced good situations in their successful careers. However, each also experienced a very difficult situation… a bad boss, bad company, difficult time, high stress, negative consequences, etc. The advice from these experienced individuals is that we must learn from every situation. With a bad boss, learn how to treat others. Learn what you will never do when you are in that role. In a stressful position, learn how to deal with the stress successfully. Learn about yourself. Learn how you thrive. Learn how to survive. Learn from both the good and the bad.


13. Your network is critical – Every successful individual develops and nurtures a network of others. Most individuals experienced career advancement because of someone they previously worked with or worked for. Many had career surprises because of someone they met, someone that knew a friend, or someone that had something in common with them. You will be surprised how impactful a good and growing network can be to your career. Nurturing it is essential.


14. Pay it forward – Every individual also stated that they eventually came to a point where their greatest career desire was to “pay it forward” — to give back to others in ways that others had benefited their own careers. Making a difference for someone else eventually became a key driver to each one. Giving someone else a hand in the same way they had benefited became a career driver. Service to others accelerated careers in some instances. When individuals stopped becoming focused only on their own success, they saw their careers advance faster and in ways they did not expect.

A career journey is perilous. It can be filled with risk, unknown pathways, detours, and, sometimes, fear. However, as you watch it unfold over the years, you’ll see that your own story, though unique, will mirror what others have experienced. You will see that you had to make career changes as conditions dictated, you were forced to make uneasy decisions, you took risks, you survived the setbacks, other individuals played a major role in your success, you found fulfillment in unexpected ways, and, despite your education and training, you had to thrive in unfamiliar surroundings at times. Your journey will likely include all the things that most successful executives face. Your ability to achieve ultimate success may depend on how you handle these events and situations as they occur. Don’t be surprised. Don’t be afraid. Charge forward with confidence. And, don’t forget to have some fun along the way.

Odds and Ends

Today, I have a few catch up items that I want to share (and, no, I won’t start with pandemic items):

  •  Legacy – I have been reading a book recently by Chris Brady titled PAiLS. Brady subtitles the book, “20 years from now, what will you wish you had done today?” The book spends a significant share talking about our legacy. Brady says that our legacy is everything we leave behind, such as material goods (things, money, etc.), memories (both good and bad), and the lasting impact we had on others. I have to admit that I often consider the first two categories of Brady’s definition. However, I had given little thought to the “legacy of impact” that lasts beyond our lives. When we are gone, will we leave behind us a world better than it was before our arrival? Are there individuals that will talk about what they learned from us? Will there be some that say, “He is the one that believed in me and gave me a chance when no one else would.” Have we developed leaders that have developed other leaders?  Will our lives be an example to others to do the right thing even when it was difficult, unpopular, or costly? Think about what you’ll leave behind other than you worldly goods and genetic code.

 

  •  Last times – I have experienced a few “last times” in recent months. Some of these have come with great sadness. For example, our family said our last good byes to two special ladies recently. We had to break a 36 year Memorial Day Weekend tradition with no chance to resume in future years… at least in the same way. Sometimes that last time comes suddenly and unexpectedly. The last day of school this year is a good example of that. How do you respond when you experience a “last time”? Do you despair or look at it as the end of one chapter which leads to new experiences in the next chapter? I’ve heard it said that almost everyone needs healing from the past, help in the present, and hope for the future. Finding a way to honor the past, find joy in the present, and look confidently to the future is, in my experience, the best way to deal with the last times we constantly face.

 

  •  Observations from pandemic times – OK, now I get to join hundreds or thousands of others in sharing some of my own observations from our ongoing pandemic experience. Here are a few of the things I think (or hope) that we have learned over the last few months:
    1.  We cannot assume anything – Back in mid-March, everyone had plans. Some were preparing for school proms, graduations, vacations, work projects, events with family. We all just assumed that everyday activities, such as school, would continue. However, as we have learned, we cannot take anything for granted. We cannot assume that we’ll continue to be able to do the things we enjoy or expect. Life is just that way and this pandemic season has taught us that in a huge way. We need to realize that each new day is a gift. No one is promised tomorrow. So, we need to approach each day as the special thing that it is.
    2.  We don’t need to be productive every minute of every day – I wonder how many more jigsaw puzzles have been completed this year compared to 2019. I know that we have completed a few at our house. I think that before the pandemic, we believed that our time was simply too valuable to do something as trivial as a jigsaw puzzle. We had to be productive to fully utilize each day, whether that was being consumed by work, racing to events for our children, or wearing ourselves out checking off our to-do list items. The pandemic changed all that and, at least in this one small area, I think we can be thankful for this reminder. Once in awhile, it is perfectly fine to set other seemingly higher priority activities aside to read a book, watch a TV show, play with our children/grandchildren, try something new, or simply enjoy the outdoor world around us.
    3.  We don’t know what others are experiencing, so we need to exhibit grace – Everyone is experiencing our season of pandemic differently. To some, it has been a time of severe loss (family members, jobs, our sense of security, our comfort zone). To others, it has been a time of frustration, sadness, and even anger. To others, it has been a time to catch up on activities you never really expected to do. The point is that everyone is experiencing something completely new. And, because we just cannot fully know what life has thrown at others, we need to react with a larger dose of grace. We need to be people of second chances. We need to give others a break and leave our judgment aside. Kindness is always appreciated and can possibly mean the difference between happiness or utter disappointment for someone else. Seals and Croft sang a song in the 1970’s called, “We may never pass this way again.” For us, this season may be the opportunity for a lifetime, so let’s make the most of it, especially when we have the ability to serve someone else.
    4.  We must not take things for granted – This really goes without saying. Who would have thought that life would be forever changed for everyone over the course of a couple months. There is so much to mourn… if we get bogged down in the past. The best way to deal with our discouragement, disappointment, and disruption is to savor those little things and those people that make life truly worthwhile.

 

  •  Personal note – Last month I indicated that my book “Achieving your best day yet: A more fulfilling career… a more impactful life” had been published. At that time, only the hard copy version was available on Amazon. Now, you can also obtain the book in Kindle format. If you are interested, the link to the Amazon page can be found here: Achieving your best day yet! (Kindle version)

 

That’s it for now. Have a great day and remember… today could be your best day yet… there is still a chance.

 

New Book Published: Achieving your best day yet!

Today is a big day for The Porch! My first book has been published and is available on Amazon. Here is the link: Achieving your best day yet! This book contains many of the topics previously discussed here, but is assembled in a way that can help an individual enhance their career at the same time they are becoming more impactful in their day-to-day life.

Take a look and I hope you might be encouraged to give it a try. Thanks and have a great day!

 

Modifying your approach in short-term leadership situations

Prior to writing their book, Launching a Leadership Revolution, authors Chris Brady and Orrin Woodward sought to determine the best possible definition of leadership. In the course of their research, they discovered over 800 different definitions for leadership. Some of the key terms they found appearing often in these definitions were: mobilizing, influencing, empowering, enabling, goals, vision, relationships, and directing. Certainly, there are other terms useful in describing leadership and great leaders. However, the point is that most of the discussions, definitions, and treatises on this subject deal with leading a group of individuals in the context of a permanent, or at least, a long-term assignment.

Much has been written about history’s best leaders. In fact, a Google search I just conducted for the word “leadership” revealed nearly 5 billion entries! Many books exist discussing the leadership of Winston Churchill during World War II, George Washington during Revolutionary War times, Abraham Lincoln dealing with the Civil War, and others. Most of these works discuss key relationships, trust, loyalty, and results that occurred over the course of years or even decades.

However, these seems to be a scarcity of literature or discussion dedicated to those tasked with leading a team to accomplish short-term objectives. For example, do the same leadership principles that apply to serving as Governor of a state apply to one leading a project to renovate a restaurant over a long weekend? How are the principles of leadership different for one leading a two-month project team tasked with identifying and correcting customer service issues versus the individual that will be leading that same customer service group for the next 5 years?

Before we look at the differences in leading a short-term versus long-term assignment, let’s look at key leadership principles that are the same. For the sake of this discussion, let’s use the definition of leadership published by Brady and Woodward in their Launching a Leadership Revolution book:

“Leadership is the influence of others in a productive, vision-driven direction and is done through the example, conviction and character of the leader.”

No matter what kind, type, or length of leadership situation you find yourself in, certain principles are the same:

  • Influence – Whether short- or long-term, when you lead, you are influencing others. Leaders compel – by their words, actions, efforts, and heart – others to want to accomplish a task. So, even in short-term situation, influencing others is THE key to success.
  • Productive – Leadership fails when the required task is not completed. Thus, regardless of the situation, results are important.
  • Vision-driven – All leadership situations require a vision/goal/objective that team members can aspire to achieve. Someone once said, “When you don’t know where you are going, any road will do.” A vision is required whether the leadership task will last one hour or 100 years.
  • Example – A good leader sets the tone by setting a good example. Whether you want it or not, others are watching the leader. The leader sets the pace, the level of quality, and the standard by which work is accomplished.
  • Conviction – Nothing gets done well without a strong belief that the work is worthwhile. When the leader believes strongly in an objective, this conviction is transferred to other team members.
  • Character – Even in short-term situations, more gets done better when the leader is worthy of following. A group with leader possessing integrity always accomplishes more than one lacking it.

So, how is leadership different when the situation is short-term? Should the leader lead differently for that weekend renovation project versus the long-term customer service team manager?

I believe the leadership for short-term projects should exhibit 7 key differences from those that might serve in longer-term situations. Let’s take a look at each one:

  1. Timing is more critical – Obviously, when you are dealing with a short-term project, you don’t have as much time to develop relationships, build team dynamics, and allow roles to develop organically. Thus, you need to consider short-cuts that facilitate faster responsiveness. Establishing processes for assigning work, reporting progress, escalating issues, and removing roadblocks must occur within hours or days rather than the much longer times that would be tolerable in a long-term situation.
  2. Leaders may have to be more directive, less collaborative – Because timing is more critical, the leader may need to become more direct in assigning activities and timetables. Short timing may require less time for collaboration, consultation, and discussion.
  3. Communication becomes more critical – In short-term situations, communication must accelerate. You must become more clear, more concise, and more consistent in communicating what, when, who, and how things must get done.
  4. Specific action items must be more defined – For short-term situations, “to do” tasks may have to be broken down into smaller pieces. Rather than allowing some ambiguity in tasks, you may need to define actions so clearly that all ambiguity is eliminated.
  5. Progress on critical activities must be reviewed more frequently – In a short-term situation, more oversight may be needed. In that regard, you may need to establish daily progress reports to ensure that everyone knows the status of all key activities and that issues are escalated immediately.
  6. Leaders must be more intentional – Leaders in these situations need to be more visible, more open, and more involved to ensure that timing is maintained. By working more closely with individuals on the team, they can more quickly see your example, your conviction, and your character.
  7. More risks may be necessary – Certainly, by short-cutting some of the well established principles of leadership, more risks are incurred. For example, by shortening the time allowed for discussion and input, you may miss some better options. When you reduce the opportunities for all members to share, you risk group think or the possibility of unknown barriers. These can be mitigated with improved communication and shared reporting.

A short-term assignment does not mean that all time-honored elements of strong leadership must be dismissed. On the contrary, a short-term assignment requires even greater leadership because of the compressed timeline. These efforts often fail because the leader failed to properly engage and involve members of the team.

Think about how you, as a leader, need to alter your approach in the face of short time or demanding deliverables.

(By the way, the book by Brady and Woodward is terrific! I highly recommend it.)