There is a steady stream of articles, posts, and news items touting new “employee comfort” enhancements in company facilities. In just recent weeks, I have seen postings about a new coffee station in one facility. In another, the redesigned work area includes living room-like relaxation areas for employees to “connect and interact.” I have seen a variety of employee benefits added, such as meditation rooms or classes, yoga classes, de-stress rooms, new gourmet food courts, etc. Yes, from an employee perspective, these are nice, for sure! They make going to the workplace more enjoyable and fun. In many cases, they make it easier for working parents to balance work and family. And, because of this, it may even enhance employee retention and satisfaction. So, I am not trying to bash these efforts. Anything that can make the work experience more enjoyable and less stressful is good.

However, I think there is a perception that employee comfort efforts alone will drive an overall positive culture or drive improved productivity. I know many believe that a more enjoyable workplace automatically results in improved productivity and culture. I would suggest that this might be true in some cases, but there are other more important factors in play.

Many of my work years were spent in manufacturing facilities. I would say that in some of these, there were none of the employee comfort features that are becoming popular today. In fact, working conditions in some facilities were quite difficult. In some work stations, there might not even be air conditioning, much less a room to de-stress. Some of the work is dirty. The cafeteria, if there was even one, only offered a daily choice of a fried entree. Comfort was not a word used much to describe the work environment. However, some of the best employee culture experiences and highest productivity I ever personally witnessed occurred in those plants. Employees were engaged, enthusiastic, and dedicated to the work, the customer, and each other.

So, what is it that really makes a difference in employee culture and overall productivity? Are there factors you can list that truly make a difference? Everyone has an opinion on this, but let me list just six key things I have observed that make a difference in employee culture and productivity:

1. Unity in goals and purpose – When employees are bound together to accomplish an important goal, you’ll always be amazed at what they can achieve. I recall in my manufacturing plant life what occurred when an FDA inspection occurred. From the time the investigators arrived until they left, every individual at the plant was focused and engaged to produce a positive result. Collaboration and cross-functional interaction was never better than when the plant was focused on a positive FDA inspection result. When information was requested, everyone pulled together to provide it. Employees worked late and came in early to prepare and drive a positive result. It seemed that there was no time in the life of the plant when the employee population was more focused on a positive result than during an inspection. Then, when the inspection was over, the entire site celebrated. I often wished that we could somehow keep that spirit of teamwork and focus all the time. So, when employees know what needs to be done and can work together to achieve it, they can do phenomenal things. Just make sure that the goals you choose for that focus are goals that matter and will “move the needle”.
2. The ability to contribute and impact results – Almost every employee wants to make a difference. Employee morale suffers when employees feel the work they do – the way they spend nearly 50% of their awake time is spent – adds no value. I have seen this in every work venue possible: manufacturing plants, corporate settings, academia, government, etc. When an employee feels their work doesn’t matter – whether done well or poorly, on time or late – their attitude, productivity, and work quality all suffer. When we help every employee understand the value of their work, eliminate non-value added work, and ensure that individual employees are impacting the company and its customers, their performance improves.
3. Communication and feedback – Every employee also wants to know how they are doing. It is inexcusable for an employee to go into his/her year-end performance review conversation with no idea how their work performance is perceived by their boss. I have seen many instances where an employee excitedly attended that meeting feeling their performance “exceeding expectations” for the year, but received the bad news that they were rated “needs improvement.” Employees perform best when there is routine, consistent, and truthful feedback regarding what they are doing, how they are doing it, how they could improve, and how much they are appreciated. When you do this well, you don’t need “employee comfort” features to sustain employee engagement, interest, or productivity.
4. Frequent celebration of successes – Top employee cultures always celebrate and recognize successes… in fact, it is better to err on the high side in this regard. There is nothing that helps bond and motivate teams and individuals than having a pizza lunch to simply say “thanks” for a job well done. Identifying those efforts “above and beyond” tell the workforce that what they do matters and is noticed. If you have ever been to a soccer or basketball game with first-graders, you’ll notice that the kids are always looking to the sideline to ensure that their parents or grandparents were watching that last play. It matters that they notice and appreciate what they do. Employees are the same. It makes a significant difference when it is clear that efforts are genuinely recognized and appreciated.
5. A commitment to do things right – “Don’t do what I do, do what I say.” How many times have you heard or, better yet, observed this attitude? When an organization, from the leader on down, is committed to doing things right (e.g., safety, benefits, commitment to quality, adequate investment, and day-to-day philosophy), employees become more committed, focused, and dedicated. By showing a concern, thus, a commitment, to employees, you foster increased dedication and motivation.
6. Leaders that are trustworthy, involved, and that have integrity – Finally, and perhaps most importantly, the leaders of an organization determine overall employee satisfaction, engagement, and productivity. Someone once said, “An organization’s culture is defined by the worst behavior that is allowed to occur.” This puts the responsibility for employee satisfaction squarely on the shoulders of the leaders. Leaders must be trusted – what they say is truthful, open, detailed, and meaningful. Leaders must involved – they are engaged in the success of the organization, they are visible, they interact frequently, and they allow themselves to be vulnerable and knowable. And, leaders have integrity – followers always know that their leaders will do the right things, in the right way, at the right time. They never have to be worried about being embarrassed by their leaders. When leaders act and behave like this, you don’t need a smoothie station to keep employees coming back.

Yes, it certainly is important to work to make employees comfortable and accommodate their needs. We should make their time and effort spent at the workplace as enjoyable as possible.

But, please do not think that by providing a ping-pong table, employee engagement banners, “I love my job” coffee cups, or other amenities will substitute for creating a workplace marked by dedicated, enthused, engaged, and highly productive employees. It simply will not happen!

Thanks for all you do. Have one of your “best days yet!”

 

The thought comes to me often. My wife and I routinely watch our 3 and a half year-old grandson at our house during the week. He is all boy, going one hundred miles per hour all day long. He is into everything all at once and you can’t take your eyes off him for a moment. Yet, he has a very tender, sensitive side to him. He really likes to smell things… candles, food, acorns, worms… anything new. And, he really likes to help his Grandma cook. When she is preparing a meal, it never fails that he pulls up a chair right next to her, so he can watch and be in the middle of the action. I think he will always remember and cherish those times “helping” his Grandma cook.

I ran across the following this week. It was one of those friend-of-a-friend-of-a-friend posts on Facebook, but it made me pause and think when I read it:

“How do you say goodbye to the one who taught you everything? From learning the alphabet to baking the best goodies, she was by my side through it all. Having to say goodbye to two grandparents within two days is unimaginable but somehow, here I am having to figure it out. This may be the hardest thing I will ever have to endure but I know through God, I can get through it. Rest easy Grandma, you lived one heck of a life. I will love you forever and always.”               – Anonymous – 

Someday, our little grandson will have to face what this young lady faced this week… saying goodbye to the one that taught him how to make chocolate chip cookies. On the one hand, this is sad and heartbreaking. But, in another way, it can be a source of joy and encouragement to us. That Grandma mentioned in Facebook had a truly amazing impact on her granddaughter. Being by her side throughout her life was a blessing that we would each cherish. There is nothing more satisfying than pouring yourself into someone else, especially if that ‘someone else’ is a child.

So, that brings me to the question of the day… Are you pouring your life into someone else to the point that saying goodbye might be one of the hardest thing they would ever have to endure? Are you making a difference for a family member, a coworker, a neighbor, a classmate, or anyone else?

There have been a number of times in my life before or after meeting with someone when I think, “This (that) might be the last time I ever see him or her.” Let’s face it, there are always “last times” when we move, or change jobs, or shift to life’s next chapter. Recognizing and admitting this can bring a sense of sadness. But, when we can say that we did our best to make a difference to that person or that our life is richer for having known him/her, the sadness is somewhat tempered.

Saying goodbye is never easy, but when you’ve lived your life with intentionality – striving to make an impact – and worked to leave the very best of yourself behind, you know you’ve done your best. Thanks to all of you that have left such an imprint on my own life!

I spent almost all of my 40+ year working career involved in looking at the healthcare patient as a customer or end-user. Though we do our very best to consider our products and care from the patient’s perspective, it just isn’t the same as when you are that person in the hospital bed whose life and well-being depend upon those same products and services.

Over the last couple of weeks, I found myself looking up from the hospital bed again. This time, I had a total knee replacement. The procedure was relatively quick (about 45 minutes) and the hospital stay short (one night). But, it is amazing how such an event allows exposure to the entire healthcare system, end-to-end. For this surgery, I had x-rays, diagnostic blood tests, surgery, anesthesia, hospital care, physical therapy, home visits, pharmaceutical products, medical device products, etc. that illustrate both the good and not-so-good of our healthcare system.

Today, I would like to cover a few insights and perspectives that I have gained from this most recent experience. Keep in mind, this particular journey isn’t yet over… I am only about 18 days post-op. But, I think it is worth sharing what I have learned and observed that might benefit others.

1. Everyone loves to hate opioid pain medications… until they need them! – Opioid pain medications are on everyone’s evil drug list these days. While it is true that many ills in society are due to the addicting nature of these products (e.g., morphine, oxycodone, hydrocodone, etc.), try having major surgery without them! These products have an amazing ability to temper or eliminate the severe pain associated with surgery. I often find myself watching the clock in anticipation of my next pain-relieving dose. Thus, it is easy to see how one might become overly dependent on them. Finding that balance between benefits and risks is a challenge that we must somehow achieve. For now, I credit a large degree of the success of my surgery to opioids. For without them, I would not have been able to withstand the physical therapy that differentiates success from failure of this joint replacement.
2. Healthcare is becoming more patient-focused and outcome-based – I have definitely seen a shift in medical care toward results. Before choosing my surgeon, I studied his success and complication rates through internet searches. His standard protocol for post-op rehabilitation has changed in recent months to accommodate new research on eventual outcomes. Insurance companies have become much more focused on ultimate results and will withhold payment on treatments that are not statistically justified. Entire healthcare teams and individuals continuously seek input from customers (e.g., patients) through surveys, opinion polls, and feedback mechanisms. Of course, some of this outcome-based emphasis is good and some not-so-good. When it is directed toward continuous improvement of care and patient satisfaction, it is certainly good. However, when merely used to limit or shift costs and reimbursement, it falls short of desirable.
3. Strong teamwork and highly coordinated processes are replacing the silo treatment approach of the past – For my most recent knee replacement surgery, I have been amazed at the end-to-end teamwork evident. My past experience was that each phase of the process (surgeon, administrative, physical therapy, communication, etc.) was handled as a stand-alone entity. The surgeon did his work, then passed you along to the physical therapy team, etc. However, in this case, every piece of the process was coordinated and tied to each other piece. Prior to my hospital discharge, home visit appointments were made with a nurse and physical therapist. Everything needed for recovery was arranged and scheduled. A training session occurred before surgery that included my “joint coach” to ensure we both knew what to expect and what we needed to do together to be successful. I have been pleasantly surprised how each element of process has been integrated with each of the others.
4. Though patients have become more educated on healthcare options and expectations, every individual journey is unique – I have to admit that I probably read too much information on total knee replacement surgery before my own procedure. Though most of the information available on the internet speaks to the positive outcome expected, there are always horror stories that make you second guess your decision. Nonetheless, a patient these days can watch videos of actual surgeries, get a report card on the surgeon and hospital, get hundreds of testimonies from others that have experienced the same surgery, and be very knowledgeable on all aspects of the procedure. You can even “shop” various knee joint manufacturers for options, benefits, etc. in much the same way you might shop for a new car online! Despite this vast amount of available knowledge, the outcome and recovery for each patient is unique. My progress is different than anyone else that has ever had this surgery. Thus, all of this newfound knowledge doesn’t replace listening to the advice of the surgeon, therapists, and adhering to the program they outline.
5. A shift to modern analytics-based care is occurring – Every individual I encountered throughout my journey, thus far, has been extremely knowledgeable and professional. However, it is evident that the modern approach based strongly on analytics, trending, remote monitoring, etc. has not yet been fully embraced. Most have adapted well to this approach. However, some still prefer the “old days” of patient care and personalized service. I think this scenario plays out in every discipline and every field… some individuals prefer “the way we did it in the old days” to today’s approach. Both approaches are effective, but, perhaps, both are not equally efficient.
6. Everyone is a specialist – It has been clear to me these last few weeks that almost every person in the healthcare industry today has specialized in something. My surgeon specializes in knees and hips. It seems that the nursing staff has also migrated toward specialization. Has the day passed where an individual can successfully function as a “generalist” or must we all have one or more specialties to thrive in this new age?

I have been extremely satisfied with my care and recovery, thus far. I am doing my share to ensure a successful outcome, but I have been highly impressed with both the approach and individuals I have encountered along the way.

And, I think it is good to occasionally consider how the healthcare industry is changing. By doing so, we might conclude that changes to other pieces of the industry must also change (e.g., R&D, manufacturing, quality, engineering, etc.). When you look at the key six points I have outlined above, you’ll find these key topics that apply to everyone in every industry:

• risk/benefit assessment – seeking an appropriate balance
• outcome-based results – adding value
• strongly integrated teamwork – collaborating for the ultimate good of the customer (patient)
• continuous learning – educating yourself, staying current, seeking innovation
• embracing change – a willingness to accept a new approach, especially when the value is demonstrated
• specialization versus generalization – enhancing our personal value by enhancing our expertise

So, the question we should be asking ourselves is, “Am I doing what I can to enhance to ultimate experience for my patients, customers, coworkers, family, or associates?” I think there is something here that can help each of us become more valuable to our company and to others that we serve.

Have a great day!

This morning, my daughter related the following story about my three-year-old grandson:

“Last night, our son came into our room crying, saying he had had a nightmare. I’m thinking monsters or bad guys. Actually, his nightmare was that he was at the store buying a fidget spinner, and they only had girl colors.”

You see, what seemed like a nightmare to him was a very minor inconvenience to almost anyone else.

All of us have nightmarish things happen to us occasionally. Some are major and life-changing. Others are mere inconveniences. When they do occur, however, we have several choices how we might react:

1. We can hide our panic and deal with it ourselves – Our grandson could have pulled the covers over his head and tried to deal with his nightmare alone. That is a choice we all have and, frankly, the choice we make all too often. By hiding our fears, we often allow them to become bigger than they really might be. By bringing them out into the open, we can better face and defeat them.
2. We can be comforted that things will always be better when a new day comes – Time really does heal our hurts. Nothing seems to diminish a nightmare like the dawn of a new day. As time moves forward, we should become more confident that our fears cannot control us nor defeat us.
3. We can strike back and let the event control us – Our grandson could have reacted negatively by striking back at his parents, his sister, or others when the disappointments of his nightmare became known. When we strike back, we often allow the event to control us and distract us from the truth or the reality of the situation. Finding a way to master our fears without over-reacting is a key discipline that some never discover.
4. We can share it with someone we love and trust and get through it together – Our grandson made the right choice when confronted by his nightmare… he shared it with his mother and learned that together, they could confront any fear. Having someone in your life that will walk through the dark with you is important and crucial in dealing with our own struggles.
5. We can learn from the event and become stronger as a result – Today, our grandson knows that there are many places where he can find a fidget spinner with “boy colors.” His nightmare was not really worth the trouble. Likewise, when we learn from our fears, we become stronger and better able to deal with the troubles that could come tomorrow.

By this morning, our grandson had no ill effects from his nightmare. He remembered it, but knew that things are newer, brighter, and better with the new day. He also knew that he would not be defeated by his “nightmare”, especially if his stuffed kitty and battery-powered lightsaber were close-by.

Oh, the things we can learn from a child! How are you dealing with those fears that plagued you last night or today?

Let me start with this… I am not a Chicago Cubs fan! I have been a St. Louis Cardinals fan for nearly 60 years and there is one thing Cardinals fans do not do… they never root for the Cubs!

However, I do admire Cubs fans. Can you imagine going your entire lifetime never seeing your favorite team win the World Series or Super Bowl or Stanley Cup? The Cubs went over 100 years between championships, but their fans remained loyal. Their attendance was strong and their fans “fanatical” through all those barren years. They epitomized loyalty.

Loyalty used to be the standard, as well, in the workplace. Many individuals worked their entire lives for one company. And, companies rewarded loyalty. Companies stood by their employees through good years and bad.

Has loyalty become obsolete? I know of one individual that worked for his company for over 30 years. He was loyal to the company. During his last months with the company, he worked nearly every day leading his team through a challenging season of change. However, his company decided that a new direction was needed and cut ties with him. Instead of leaving the workplace with cake and punch and sincere thanks, he left quietly with only a severance package in hand.

Individuals, as well, seem to have little loyalty these days. I can’t tell you how many resumes I have reviewed over the years where the person has worked at 8 different companies in the last 6 years. Individuals, rightly so, have become aggressive in advancing their careers by changing jobs or companies.

Has the day arrived when employee or company loyalty should not be expected? What level of loyalty should we demonstrate? Loyalty is defined as a sense of duty or devoted attachment to someone or something. Loyalty is showing a commitment to someone or something to a higher degree than one might expect given the circumstances. For example, over the last 100 years, Cubs fans exhibited a sense of loyalty or commitment to their team much more so than one would expect given their lack of World Championships. I imagine that Cubs fans are much like Cardinals fans… it is less a choice you have made as it is a lifestyle you have been born or adopted into.

How much loyalty should an individual give a company? How much loyalty should a company give its employees? I believe the answer to that question comes in three parts:

1. Loyalty should be given as long as necessary to fulfill a promise or commitment – If you have made a commitment, you must keep it. For example, if you promise to complete a project or program or fulfill a time commitment, you should remain loyal until your commitment is fulfilled. You might argue that this is not really loyalty at all. However, a promise is a promise by whatever name you give it.
2. Loyalty should be given when one side has gone above and beyond toward the other – When one side has done something special or showered you with unmerited favor, they deserve a second or, perhaps, a third chance to earn your loyalty. Loyalty by one side should result in grace from the other.
3. Loyalty should be given when one side has an extraordinary desire to see the other side succeed – There are times when you remain loyal simply because you want to see something through to the end or you might show loyalty to a person, despite the company. This is honorable.

When one of these circumstances has occurred, we have an obligation to remain faithful and see it through beyond what might typically be expected. On the other hand, when one side repeatedly demonstrates a lack of commitment to or fails to embrace “doing the right thing” for the other side, it might be time to move on.

I believe that loyalty still has a place in today’s workplace. Sometimes, as loyalty is exhibited, it breeds more loyalty from the other side. For example, there have been several companies destroyed by recent hurricanes in the Southern USA that have committed to continue paying employees even while their businesses are being rebuilt. Such a commitment often elicits a strong sense of loyalty in return from employees that benefited from these acts. Likewise, companies often demonstrate a second chance to employees that have provided extended and faithful service. Yes, there is still a place today for loyalty.

Have a great day! And, despite a rough season… Go Cardinals (by the way, winners of 11 World Series titles)!

 

 

I have had a hard time lately getting an old Proverb out of my head:

“As water reflects a face, so a man’s heart reflects the man.” – Proverbs 27:19

This saying compares an individual’s heart to a mirror… it perfectly reflects the truth. Whatever you see in a man or woman’s heart, it defines them perfectly. There is no hiding the truth of a person when you see what is really in their heart.

So, that begs the next question, “What is a person’s heart? What should I be looking for? What things about a person defines the real person… their true character?” Of course, everyone has an opinion on character. Some say your character is who you really are when no one else is watching. Others say that your character is the way you think, feel, and behave. Still others talk about your character as a sort of moral compass which serves as your default mode regardless of the circumstances you face.

Certainly, all of these definitions of character make sense. Your character is what you really are. So, what are some observable attributes or behaviors that define character. If you had to develop a “character checklist”, what would you include? Likewise, if you wanted to assess your own character or that of your children, what tool would you use?

Following is a list of “character” attributes that can help define our true character. Of course, this is not a complete list. But, I have collected this list of characteristics that help me define a virtuous person… a person of character. This list is also a good way of assessing whether your children are developing a heart of virtue. I admit that this is not my own original list, but it includes contributions from many others and my own observations of people and behavior throughout my lifetime. In any event, here is my list of 33 “character” attributes:

1. Gratitude – Does the individual express a genuine sense of thankfulness for what they have, what others do for them, and the blessings in life they have been gifted?
2. Self-discipline – Does the individual possess the ability to get things done without nagging, urging, or threats? Does the person habitually fulfill their commitments?
3. Willingness and ability to work – Does the individual do their share, especially without being told? Has the person learned the value and benefits from work?
4. Hope – Does the individual have a sense of hope for the future and something on which to base that hope? Does the individuals live in the present and look forward to the future more than longing for or regretting the past?
5. An attitude of service – Does the individual put others before self? Does the person seek ways and opportunities to make life better for someone else?
6. Faith/Optimism – Does the individual live with a sense that “this could be their best day yet”? Does the person express an attitude that lifts others? Is the person confident in whatever the future might hold?
7. Contentment – Does the individual have a sense of satisfaction in their life? Has the person learned the art of being content, yet without sacrificing a desire to improve?
8. Desire to improve – Does the individual seek to learn from mistakes? Is the person seeking ways to enhance skills, abilities, and mind?
9. Responsibility – Does the individual assume responsibility or accountability for his/her own actions? Will the person typically “do what they say they will do”?
10. Compassion – Does the person truly care about others? Does their actions show a heart-felt compassion for the feelings and circumstances of others? Do their actions reflect this?
11. Humility – Is the person allowing their actions to speak louder than their words? Do they downplay their own contributions while enhancing that of others?
12. Perseverance – Will the person stay-with-it long enough to finish the task? Does the person finish what they start? Are they in it for the long haul?
13. Joy – Does the person have a genuinely happy disposition? Has the individual learned to express joy even when circumstances are negative?
14. Peace-loving – Does the person seek to bring about peace and consensus? Does the person diffuse negative circumstances?
15. Generosity – Does the person willingly give sacrificially to others? Does the person seek opportunities to share what they have to make a difference for others?
16. Kindness – Is the person kind to everyone in every situation? Does the person show the same level of kindness to those that can do nothing for them in return as they would for a VIP?
17. Purity – Does the person strive to be faithful, pure, and “clean” in what he/she says, does, supports, and encounters?
18. Courage – Is the person willing to stand up for what is right, even in the face of opposition? Will the person defend the defenseless?
19. Trust – Can the person be trusted in all things? Does he/she trust others?
20. Sense of self-worth – Does the person have a healthy understanding of their own worth to others and God? Does the person hold their head high or cower under pressure?
21. Respect for others – Does the person appreciate and respect the opinions, abilities, backgrounds, skills, and personality of others?
22. Mercy – Does the person express forgiveness and mercy frequently and freely?
23. Justice – Does the person seek that which is right, true, and fair? Does the person stand up for those than cannot do so for themselves?
24. Self-control – Does the person control their words, actions, and attitudes appropriately even when they are being mistreated?
25. Honesty and integrity – Can the person be counted on to be truthful and honest in all situations? Would others name this individual if asked to name individuals with integrity?
26. Willingness to submit to authority – Is the person willing to submit to others in authority over them? Do they respect their boss, their parents, and government officials? Do they reject rebellion as a normal response to not getting their own way?
27. Love – Does the person willingly express love for others? Is this individual willing to freely express their thoughts about and to others?
28. Confidence – Does the individual exude a sense of confidence in who they are and what they do? Will they look you in the eye when speaking? Is their handshake firm?
29. Desire for excellence – Does the individual seek to do their best in all things, small or large? Does the person strive to do things well rather than cut corners?
30. Desire to learn from others – Does the individual freely accept the teaching and counsel of others?
31. Desire to develop and enhance relationships – Does the individual understand and appreciate the importance of connecting personally with others? Does the person seek genuine relationships rather than less personal social connections?
32. Genuineness – Is the person the same in private as in public? Does the person express one persona with friends and another at work? Can you say about the person, “What you see is what you get?”
33. Love for God – Does the individual know God and outwardly express a love for Him? Is the person seeking to know God more and better? Does the individual live in a way in which he/she seeks to please God?

So, what does your heart say about you? Does your life routinely express these “character” attributes? Are your children growing to be virtuous adults? Are you helping them to develop a virtuous character?

How we live matters. Our actions and behaviors don’t lie. They define who we really are and what truly lies without our heart.

Have a great day! Remember, this really could be our best day yet!

Almost every day, a new approach for enhancing GXP compliance is proposed, espoused, or encouraged. Yet, our industry continues to experience problems with non-compliance. Some of these result only in adverse publicity for the recipient, though some result in potentially serious safety issues for consumers.

Is there anything truly new that can help us assess potential GXP concerns and, thus, drive compliance enhancement? Perhaps not. Nonetheless, I would like to pose a new way of looking at compliance that can possibly stimulate a new way of looking at these issues. I call this the contrarian’s approach to enhancing GXP compliance. You may have heard of contrarian investors… individuals that invest in companies experience bad news. A contrarian is someone that opposes or rejects popular opinion. In the world of compliance, a contrarian is not apt to automatically believe all the good audit reports they receive or the good inspection history of the site. The contrarian’s approach to compliance involves looking for bad news, not merely looking for what is going well. The contrarian asks the truly hard questions of compliance.

Let’s look at a few questions that can stimulate the contrarian’s approach. Ask these example questions of your team to generate alternative viewpoints of your own current compliance position.

1. If we have a recall next week, what will be the issue that caused it? Could we prevent it today, if we knew it?
2. If two individuals in your lab wanted to dry lab results, how could they do it given your current systems and protection of data? What would we have to do to prevent it?
3. What will be the primary concern noted on the next Warning Letter your firm receives? Do we have to accept that this will happen or change we change the future if we act today?
4. If your only job was preventing the next batch failure, what actions would you take today? What would you do if your job was literally in the balance?
5. If an angry employee wanted to sabotage a batch of product by mislabeling a few units, how would they do it? Is it possible that one angry individual could destroy your reputation as a company?
6. If someone wanted to hide your next stability (or sterility or environmental) failure, how would they do it? What systems have to be defeated for an individual to hide an undesired result?
7. If an operator needed to make unauthorized and undetected changes to a manufacturing process, how would they do it? Can you devise systems to prevent it?

These are only example questions. You could develop your own depending upon your operations. However, the concept is simple… if you wanted to foil your systems, could you do it and, if so, how? Or, if something bad was going to happen, what would it be and could you prevent it now, if you knew it?

GXP compliance is much more than following a checklist. It involves thinking beyond the regulations and seeking deeper, more complex answers. When you actually believe all the good audit reports you get each month, you are failing to recognize the underlying potential for disaster that could await. Think about using the contrarian’s approach to identifying possibilities that until today have not been adequately considered.

I have a new “summertime” neighbor that I am getting to know. His name is Ted and he is 87 years old. Ted is a great guy that has a lot of wisdom regarding life. Ted says, “Life is simple… get a job, take care of your family, and do the right thing.” He uses this example to explain most of society’s ills… homelessness, crime, family issues, etc. He feels that if you just follow these three simple rules, many of life’s challenges and problems would be avoided. Do you know… the more I think about Ted’s advice and philosophy, the more I tend to agree with him. Let’s take a look and see how right Ted really is on this.

1. Get a job – Ted believes that many of today’s issues could be solved if people would just get a job. This would take care of many financial issues, of course, but would also give people something to strive for, a place to go, and something productive to do. He is right that much crime is related to idleness and a feeling of hopelessness that comes with it. Where Ted lives, you can see a “help wanted” sign on the front of nearly every business in town. Finding a job today is much easier than it was just a couple years ago. Getting a job also help secure a stable future. So, Ted is right in many ways when he says getting a job is critical for a successful life.
2. Take care of your family – Another key component of Ted’s theory is to take care of your family. In other words, fulfill your responsibilities. This means to provide basic needs, help your children get an education, and support family members emotionally. Go to your kid’s events. Ensure they understand the importance of education. Take care of your house and property. Be there for them. Love your spouse. In short, do what you can to help your spouse and children be prepared to thrive in life. That is one of our basic responsibilities.
3. Do the right thing – Finally, Ted believes we should all do what we already know is the right thing. We all know what to do… no one needs to tell us. Be patriotic. Serve others. Pay our bills. Be a true friend. Help out those than need a hand. In short, live your life with character and integrity. Be a giver, not a taker.

So, what do you think? Sure, Ted’s philosophy is simple and makes sense. Why do we have to make it so complex and difficult. If we just follow these three simple rules, many of our problems… and, perhaps, many of society’s problems… could be solved.

Thanks for all you do! This could be our best day yet!

I love good guitar music. In fact, I’ve often thought of getting a guitar and learning to play. I have had this notion for many years. The problem is… I like to do other things too much. Playing the guitar well takes thousands of hours of practice and dedication. You see, I have the desire to play, but lack the determination. You can have all the desire in the world, but if you do not put that desire into action, you have gained nothing. Don’t confuse desire with determination.

People often get confused about basic concepts. Someone once said, “Don’t confuse effort with results.” This essentially means that some people always look busy, but, at the end of the day, their work product doesn’t measure up. We need to focus more on actual results than the “appearance” of work.

I have accumulated a few other similar concepts that can be confusing, if not fully understood. Let’s look at a few:

• Don’t confuse words with actions – Promises, commitments, and intent is easy to express with words. But, these words do not always turn into actions. Unless we put real effort to our words, they are empty and meaningless.
• Don’t confuse a boss with a leader – Leadership results from commitment, service, vision, and collaboration… not from a title. Real leaders don’t need a title to get things done.
• Don’t confuse compliments with the truth – Everyone likes to be stroked with words. However, there are times when we need to hear the unvarnished truth from others. We rarely improve when we always hears positives. Truthful feedback is often the very thing we need to rise to the next level.
• Don’t confuse a meeting with progress – I have frequently seen “progress reports” that state something like this, “A meeting was held to discuss next steps.” This comment is usually inserted simply because no other real progress has occurred. A meeting that generates real progress is much different than one that occurs simply to “kick the can down the road.”
• Don’t confuse a title with authority – People often believe that a person with the right title has the authority to get things done. Not necessarily true! The real authority or individual with the power to accomplish something often is unexpected or at a level much lower than you might imagine.
• Don’t confuse money with happiness – Financial strength does not correlate well with overall happiness. A lack of money can be life-limiting, but true happiness is more a function of attitude and contentment than it is financial success.
• Don’t confuse connections with friendships – In today’s world, we tend to accumulate and value connections or our network. However, when you begin valuing connections more than relationships or friendships, you lose a significant opportunity in life. We all need to take the time to grow and nurture these true relationships.
• Don’t confuse cost with quality – There is a tendency to believe that you always “get what you pay for.” This is not always true. Taking the time to truly investigate investments can help ensure that you get value or quality rather than simply a name brand.
• Don’t confuse a successful regulatory inspection with a strong compliance position – For those of us working in FDA/Global-regulated industries, there is a tendency, especially with top management, to believe that a good regulatory inspection equates to a strong compliance posture. Not necessarily true! Nor is the reverse… a difficult inspection does not mean you lack a strong commitment to compliance.  Compliance requires a long, consistent dedication to doing the right things day-after-day. There is no short-cut. And, one good inspection doesn’t necessarily mean that you have conquered compliance risk.
• Don’t confuse credentials with ability – There is a great temptation, when looking at resumes, to make assumptions based on the credentials/experience provided. However, I think we can all relate that great credentials do not necessarily correlate with ability. Let’s avoid the trap of making quick judgments and look deeper… look for evidence of value and results that can make a difference long-term.
• Don’t confuse silence with concurrence – When dealing with issues and teams, we often are tempted to assume that silence, or lack of disagreement, means that concurrence has been achieved. In fact, the exact opposite may be the case. Some individuals are reluctant to voice disunity, especially when they are in the vast minority. Seeking input from those that appear to be silent may reveal input that is sorely needed and lacking.

I could go on and on with additional examples. But, let’s stop for now. So, the take-away for today is this… take the time to fully consider what you see and what you get. Unless you look beyond the surface of people, events, and actions, you might miss the real point or value. We must stop taking the easy way out and look beyond the obvious. Only then, can we eliminate the confusion that can come otherwise. Let’s pause to seek wisdom that can allow us to be better and do better than we would have otherwise.

Have a great day!

She held her baby close, rocking him as he slept. She checked his diaper to determine if it needed changed. She nuzzled him and kissed him on the forehead. She talked to him quietly and said he enjoyed the music playing in the background. However, he didn’t respond to her. He didn’t move or make a sound. You see, the baby was just a doll and the mother was an 80+ year old in an elderly care facility.

I watched this lady care for her child recently and wondered how it is that some individuals become fixed at a certain point in their life without a chance to move forward. In the same facility, that evening, was another woman that continuously called for and spoke to her dog… one that didn’t exist.

What did I learn or observe from this experience just the other evening:

1. We need to be thankful for what we have… today! – We all have something to be thankful for, yet we are so consumed with our “to do” list for today that we often forget just how blessed we are. Don’t miss it!
2. We need to be compassionate to those around us – No one goes through life expecting or planning to spend their final years with severe memory problems, yet an increasing number of us will likely be impacted either directly or indirectly. We need to consider how we can make a day better for those impacted or those that care for them.
3. We need to remember that time passes quickly – Time is fleeting. It passes before our eyes in a blink. Don’t get so caught up in today’s troubles, problems, schedule, or responsibilities that you fail to enjoy the simple things. We all need to smile every day!

I wonder, if I ever have a pause in my memory, what stage in my life will I be caught. Will it be in my own childhood, or when my children were young, or later with my grandchildren? Will I be playing baseball or fishing or mowing the lawn? In reality, I’m not planning to worry about it today because I have things I plan to enjoy. As someone once said, “Don’t let yesterday take up too much of today.”

Enough of this… I’m heading to the lake for some fishing! Enjoy your day because it could possibly be your very best yet!