As leaders of people, families, teams, and individuals, we need to consider the power we have to impact others.  Though we may think, “What difference can I really make,” we have enormous opportunity to influence others.  For today, I thought it would be good to consider a few of these “opportunities” and think about what kind of influence you plan to have today:

1. A kind word can change despair into encouragement
2. A kind act can transform a bad day into a terrific day
3. A smile can convert stress into energy
4. A helping hand can pull someone out of the ditch and get them back on track
5. A listening ear can help another talk through their most challenging moment
6. A serving heart can inspire someone else searching for their own purpose
7. A hug can provide the strength to get through another day
8. An act of trust can bolster another’s confidence
9. An act of love can renew hope
10. A moment of humor can restore joy

Look around today for someone that needs you.  Look for that opportunity to make a difference for that one you live with, work beside, or interact with.  Yes, one person can make a difference… do so for someone else today.

I was recently reminded again of the fragility of life.  The day was just an ordinary day. “Kay” (a fictitious name is used here simply because this is still just too fresh) and her husband had a normal start to their day.  They were working on a project around the house… just doing ordinary things.  However, on this ordinary day, Kay, the aunt of my family member, had an accident at home that resulted in her death.  She was a wife, a mother, a grandmother, an aunt, a sister, a daughter… probably younger than many reading this now.  She lived her life loving her friends and family, serving others, and dedicated to God.  Well done, Kay!  She was a beautiful person that thought she was having just another ordinary day…

Kay’s tragic death should serve as a reminder to us all that we can never take anything for granted.  In fact, my reflections on her death bring up 7 things I believe we all need to consider to prepare for the day we leave this life.  Please take a look at my thoughts to see if you agree: 

1. Every day is a gift – It is very tempting to get swallowed up in the regrets of the past, our cares of today, or the worries of tomorrow.  But, today is the only day we are promised.  Thus, we need to live in the moment.  We need to focus our attention on today.  We are blessed to even have today, so let’s live it like the gift that it is!
2. If something needs to be said, say it! – How often have we regretted waiting to say the things we need to say until it is too late?  Is there something in your heart or mind today that, if circumstances would dictate, you would regret for the rest of your life?  Is there someone you need to forgive?  Is there a relationship you need to restore?  Is there someone you need to tell you love, or admire, or appreciate, or adore?  Is there someone you need to thank?  Today might be your last chance to say or do it.
3. We need to prepare others for our death – Let’s be practical… How can you help those left behind with the details on life moving forward?  Do you need to get your financial affairs in order?  Do you need a will?  Do you need to record specific details to pass along to make it easier for your spouse or children?  We need to honor them by not leaving them even more to make their lives difficult after we are gone.
4. We need to prepare ourselves for the day of our death – Do you believe in life after death?  Do you wonder?  Are you ready?  Do you have a hope for your eternal future?  If you would like to know my views and beliefs, you can find them in a previous post on The Porch.  Here is the link, if you are interested (What is your hope?).
5. Today is a day to be savored, enjoyed, and lived to the fullest – Are you holding back from living a full life?  Are you afraid to take risks?  To me, Kay’s death says once again that we need to take that trip we’ve been thinking about, or learn that new thing, or reconnect with a friend, or do something we’ve always dreamed of doing. Life should be enjoyed and if you are so deep in the rut of life you can’t see over the sides, it is time to do something new.
6. We should always consider, “What is the most important thing I could be doing today?” – We have a tendency to spend our time on things that don’t really matter much.  For example, is watching television or looking at our phone screen really the most important thing we should be doing today?  Granted, we do need some “down time.”  But, by asking ourselves this question often, we may be more inclined to make our hours and days count more for those we love and that love us.
7. Because life is fragile, we should consider how we will be remembered (and, adjust accordingly) – We each have in our hands the power to make life either better or worse for someone else.  We can be a giver or a taker.  We can choose to serve others or serve ourselves.  How will you be remembered?  What legacy will you leave?  We should all strive to be making a positive impact on those around us with every encounter we have.

Though Kay’s death is heart-breaking, we need to frequently remind ourselves:

“To the world, you may be one person; but to one person, you may be their world.”  – Anonymous

Though today may seem to be just another ordinary day, let’s use it to make a difference to those around us.  We only have one chance to live today to its fullest.  No, this is not an ordinary day… it is a special day that can mean the world to someone else. Yes, this could be our very best day yet… let’s cherish every minute!

How could Benjamin Franklin have been so smart about our world today?  After all, didn’t he live over two hundred years ago.  I’m referring today to this quote:

“He that is good for making excuses is seldom good for anything else.”
― Benjamin Franklin

How could Franklin have known that one of today’s most important “skills” is to carefully, quickly, and expertly offer an excuse for every failure to do what we said we would do or to explain our lack of effort to complete what was needed.

Let’s look at some examples:

• Does anyone else ever get tired of hearing, “I was just too busy” to do what I should have done?  This excuse is often used when one fails to fulfill a basic expectation (such as parenting) or promise.  An individual will always find time to do what they want to do.
• Have you heard this lately, “I would have gotten that done (or would have been there), but I had something else come up”?  Sometimes, things do come up.  However, most of the time, our failure to keep commitments is controllable.  That is, we choose to do something else instead of fulfilling our commitment.
• Or this, “It really wasn’t my fault…”?  Don’t you hate it when someone tries to pass the buck?  There is much more integrity in accepting responsibility than throwing someone else under the bus.

Yes, it is necessary occasionally to offer an explanation for our situation.  However, this can be done without acting as though you are a victim of circumstances or someone else’s failure.  Explain what happened and offer thoughts on what you might have done to better anticipate or remediate the events.

A worthy goal for us all is to become bad excuse-makers.  We should work to either more carefully monitor the commitments we make to better ensure success OR we should be more diligent in our efforts to avoid failure.  In many ways, we can avoid the need for excuses by making smarter choices ahead of time.  Becoming one that rarely has to offer an excuse should be something to which we aspire.

Finally, I appreciate what Roy Bennett had to say about the connection between maturity and excuse-making:

“Maturity is when you stop complaining and making excuses in your life; you realize everything that happens in life is a result of the previous choice you’ve made and start making new choices to change your life.”
― Roy Bennett

Consider today how you can become “the world’s worst excuse-maker.”  Consider how you can modify your choices to totally avoid the need for making an excuse.

Have a fabulous day!  Do something today to make this a better day for someone else.  

“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 make a decision?

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 make a decision 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 really 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 make a decision.  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 actually 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 back to 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 make a decision 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 is allowed to 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 maybe 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 make a decision because they believe that every decision must be perfect.  “Nothing can ever go wrong,” they think.  As a result, they delay making a decision 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 making a decision for no reason at all.  I frequently see individuals with 75% of the required information delay making a decision 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 us, 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 either overwhelming or irreversible.  Often, we wait to make a decision when we could have made a wrong decision and quickly fixed it before the decision was actually 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.”

Have a terrific day!

My wife babysits my three-year old grandson a few days each week.  He still takes a nap most days (a life-long habit we should all consider, by the way) and wants Grandma to lay with him until he goes to sleep.  The other day he told her, “If you not here when I wake up, I won’t be able to trust you anymore.”  So, he already has trust issues.

I think we all know the importance of trust.  It is critical for success at home, at work, and everywhere else we function.  It is that essential element for good teamwork.  And, it can make the difference between a fulfilling career and one that is drudgery.  Trust is so very important, yet it is hard to define and harder yet to refine and enhance.

Stephen Covey says of trust:

“Trust is the glue of life. It’s the most essential ingredient in effective communication. It’s the foundational principle that holds all relationships.”  – Stephen Covey – 

So, today, let’s take a look at six key truths about trust.  How can these truths help us to either trust others more or, better yet, elicit greater trust of ourselves by others:

1. Trust those that are truthful, even in small matters – “Whoever is careless with the truth in small matters cannot be trusted with important matters.” – Albert Einstein.  An individual that cherishes truth is one whom you can likely trust.  This individual honors truth and is likely to elevate truth above many other character attributes. When you find an individual that you know will not bend the truth, will convey it consistently, and be truthful to you, even when it hurts, is one that you can place significant trust.  Are you this kind of person?
2. Trust is earned through actions, not words – “Put more trust in nobility of character than in an oath.” – Solon.  Talk is cheap.  It is easy for most individuals to convincingly elicit trust through their words, promises, and commitments.  However, we have probably all been burned by the words of individuals that later proved to be untrustworthy.  Learn to observe trust through actions.  Does an individual do what they say they will do or routinely offer excuses?  We probably all know someone that prompts this thought, “Yeah, I hear what you are saying, but I’ll believe it when I see it.”  If an individual’s actions frequently do not back up their promises or words, You know that this is an individual that can’t be trusted with anything significant.  Do your own actions back up your words?
3. Trust is one of the greatest human attributes you can possibly earn – “To be trusted is a greater compliment than being loved.” -George MacDonald.  Trust does not come at “first sight.”  It must be earned over time, day-by-day.  When you find an individual you can trust, you have found a great gift.  Does anyone in your life count consider you that great gift of trust?
4. Trust is hard to find, but easy to lose –“I’m not upset that you lied to me, I’m upset that from now on I can’t believe you.” –Friedrich Nietzsche. I think we all agree that once trust has been broken, it is difficult, if even possible, to rebuilt or restore it.  To do so takes time, energy, and effort.  Even then, there will always be that nagging feeling about whether trust is warranted.  It is worth whatever it takes to ensure that trust is never broken in the first place.  Have you ever given anyone a reason to not trust you?  If so, have you confessed and committed to the long, tedious process of regaining that trust?
5. When you give trust to another, you tend to get more in return – “The chief lesson I have learned in a long life is that the only way you can make a man trustworthy is to trust him; and the surest way to make him untrustworthy is to distrust him.” – Henry L. Stimson. When you demonstrate to another that they have earned your trust, that trust tends to be rewarded.  An individual, knowing how fragile trust can be, will work hard to maintain the trust that you have given.  And, likewise, the one you trust is likely to trust you with the measure you trust them.  When you share trust, you are making a commitment to that person that may be stronger than any other commitment you can make.  Are you free about giving trust?  Is it possible that others do not trust you because you have not trusted them?
6. To truly trust others, you must have a level of trust in yourself – “Trust yourself. Create the kind of self that you will be happy to live with all your life.” – Golda Meir.  A person that does not trust himself/herself is easy to spot.  You can see it in their demeanor, approach to life, and actions.  Why would anyone place their trust in someone that clearly does not have that same level of personal trust?  Find your direction and go forward!  Don’t second guess what choices you make once you have diligently sought the best direction.  Life does not have a rear-view mirror.  Are you one that has difficulties trusting yourself?  Can you find a way to be more confident in your actions?

As a business leader, your ability to trust your team may very well define your own success. As a family member, or spouse, or friend, are you one that can be trusted in every situation, even the little ones?  What are you doing today to become even more trustworthy?

One action that you can take today in your own “trust journey” is to find someone that you can trust.  Have a frank conversation with that individual.  Ask if you are trustworthy?  Ask why or why not?  Talk about what might make you more trustworthy.  But, before you do this, be prepared for the answers you get.  Be open and be honest with yourself.  And, do not take it out on the individual you ask to be open and honest with you.  What you learn might make a significant difference in the rest of your life.

The question for today is, “Can you be trusted?”  Have you earned trust?  And, perhaps more importantly, what will you do differently after you get the answer.

Have a terrific day!  I hope this is your best day yet!  There is still that chance, you know.

 

My wife and I recently embarked on one of those “January projects” – you know the kind… clean out the basement.  This should not have been a terrible project because we just moved into our home a few years ago.  However, this time, we went through every box and tried to ask the question, “Someday, when we are gone, is this something anyone else would use or even care about?”  When you look at your junk treasures that way, it is amazing how more likely you are to throw them out.

Here are some of the things we finally threw out or gave away this time:  

• A box of 15 worn out pairs of shoes – these were all the same brand/model of shoes that I have been wearing for the last 20+ years.  Somehow, I was holding out hope that the company would offer a free refurbishment deal that restored every pair to like-new shape.  It was either that or I thought when times got hard, I might have to cycle back to some of these that might have a few more wearings in them.
• A box of Halloween costumes dating back to the 1970’s – there were some great old costumes in that box.  For example, there was part of an old clown costume – checkered vest, crazy pants, fake ears, and a goofy hat.  However, these were pretty worn out and besides, clown costumes are not really in vogue right now.  The box also had some of those old masks that attached to your face with the rubber band.  A hula skirt was also in the box.  Some of those costumes brought back good memories… others made me wonder exactly what we were thinking.
• A few old college textbooks and other reference materials – Other than the material being completely obsolete, everything anyone would ever need to know could be found in 15 seconds on Google anyway.  It was beyond time to pitch these!
• A few more of those “important documents” from your kids (e.g., coloring book pages, home-made/broken Christmas ornaments, etc.) – None of these met the “…would anyone else care about these” criteria.
• A large box of old company-logo giveaway items – We probably gave away a dozen old soft-sided bags, briefcases, carryon bags, etc. with the names of old companies (some of which no longer even exist) proudly displayed on their sides.  I’m sure the charity we hauled these to were giddy when they opened that box of joy!

Keep in mind, these were just a few examples of things that had to go this time.  Let’s just say that our basement now has room to actually walk around without tripping.

So, what is the point in this?  Why does this matter to anyone else?  I think this particular effort to get rid of these old, obsolete, or worthless items is something we all need to do in our home or work lives from time-to-time.  This might especially be true when it comes to our careers.  Here are a few analogies that come to mind:

1. Some experiences from our past might actually limit our career growth – There are things and experiences from our careers that tend to taint our thinking or our approach.  For example, if you tried something in the past that didn’t work, you might avoid a similar risk in the future.  Thus, your career is limited by those negative experiences of the past.  Now might be a good time to cast those negative experiences away.  Why not ceremoniously throw out those things that you know might be impacting you after all these years?  But, to throw them out, you might need to go back through a few old boxes that you’ve been holding.  Get rid of those things that are holding you back!
2. There is a time to stop believing that old, worn out practices might still work – Some of us might be stuck in the past regarding what worked then and how we used to do things.  It is time to move on.  I remember when individuals didn’t even type their own documents.  And, before voicemail, messages were recorded on pink message pads.  It is time that we embrace today’s technology.  Even better, we need to anticipate what technology will be used and what business processes will be in place in the next decade and get ahead of that curve now.  What “old practices” are you still tied to?  Believe me, they won’t come back.  That ship has already sailed.
3. Some of our past experiences might benefit others, so we need to give them away – In our recent clean out project, we accumulated a large pile of items that we knew would be useful to others.  We gave them to a charity that helps those going through life’s challenges.  Career-wise, we have all gained knowledge and experience that we need to pass along.  We need to be helping to develop those less experienced.  We need to be mentoring others and preparing them for future significant roles.  Think about what experiences you have gained that you should be passing along today… then, do it!
4. Many things we are holding onto won’t matter to anyone in five or ten years – We all tend to get caught up in the chaos and stress of today.  We try juggling too many balls and, as a result, often drop a ball or two.  The reality is that many of the things that tie us up in knots today won’t matter next month, or next year, or in 5-10 years.  When you think of things in terms of the long-haul, it tends to help us focus on those things that are truly important.  Are you still holding onto things or projects or stress that really won’t matter for long?  How can you clean up that mess?
5. A fresh start might help you look to the future with optimism – Sometimes, a significant clean up can give us a totally new perspective.  Our basement now conveys a totally different vibe when you walk through it.  Getting rid of the old and obsolete things that clutter up our lives automatically promotes a fresh approach… an optimism that cannot come otherwise.  Think about what you can do to create a fresh start and a new optimism in your own life or career.

Out with the old, in with the new…  That statement is more than words when it comes to your life or your career.  It can set an entirely new direction for your future.  And, it can turn around your thinking from regrets from your past to excitement about what comes next.  Think about how you can apply this to your own situation.  It just might make a difference that seemed impossible just a few days ago.

Have a great day!  Do something to make a difference for someone else today.  We each have the power to turn a bad day into a good day for someone else.  Give it a try!

I have always been intrigued by why some individuals are able to withstand and thrive through severely challenging circumstances, while many others wilt under pressure.  Why do setbacks often serve as the springboard for success for some and drive others into depression, fatigue, and failure?  Let me cite a couple of examples:

1. I have seen the short story recently about twin sons that were born into and lived through a childhood that included an alcoholic father that struggled with addiction throughout his life.  Whereas one son fell into the same habits of his father and became an alcoholic that struggled through life, the other used his father’s weakness to strengthen his own resolve to succeed in life without a reliance upon alcohol, drugs, or addiction to any other substance.  Why did one son follow in his father’s failing footsteps, while the other used his father’s addiction as a springboard to success? 
2. Individuals often attempt to start their own business which ultimately fails.  Rather than fall into a cautious shell and refuse to ever take another business risk, some individuals use this failure as a learning experience.  They quickly begin anew and, this time, by applying what they’ve learned, they see tremendous success.  Others, upon a single failure, resolve to avoid all future risks and never see their dreams of owning their own business fulfilled.

I believe the answer to these questions about overcoming failure or a personal disaster is mental toughness.  An individual with mental toughness is not deterred by failure or disaster or disappointment.  An individual with mental toughness has a long-term viewpoint, tends to persevere, will fight to be successful, and is not easily brushed aside.  A mentally tough individual will use life’s challenges to become better, become stronger, and become more diligent.

I recently toured the St. Louis Holocaust Museum and Learning Center.  It was an amazing experience!  While there, I was privileged to hear the grandson of a holocaust survivor (Burt Newman) tell the story of his grandmother Sophie that emigrated to the United States from Germany to escape the holocaust in her native Germany.  Though most of her family members (parents, seven sisters, their families, and many others) perished in the holocaust, Sophie and her two sons plus two sisters were able to emigrate to the St. Louis area.  Though she lost most of her family and all their earthly belongings in this historic disaster, she made a new life for her remaining family members by starting a business, working hard, and making the best of her new life.  Sophie persevered through her personal disasters, while many individuals experiencing much less of life’s challenges would wither under the strain.  In fact, there are individuals in society today that simply cannot exist if they experience any setback, disappointment, or challenge.  Sophie exhibited mental toughness that, despite the challenges she faced, allowed her to focus on a more positive future.  It was told that Sophie lived out her life helping others, encouraging her family, and demonstrating a love for others that is nearly unfathomable given her life experiences.

Mental toughness is not easy.  It often means we set aside our personal preferences, ambitions, and desires to push forward toward what we know is best overall.  It means putting one foot in front of the other, step-by-step, until we reach our destination.  It is tolerating a bad boss, bad breaks, and negative circumstances for a time until we can, hopefully, eventually turn things around.

Many today are quick to conclude or generalize that mental toughness is not as prevalent as it was in previous decades.  I disagree.  Surely, there are many today that have not HAD to exhibit mental toughness.  But, I argue that the young family separated by military service has mental toughness.  So does the young, single mother trying to get through the day.  The elderly couple facing another bout with cancer exhibits mental toughness every day.  The police officer struggling to persevere is mentally tough.  And, so is the teacher that works year-after-year in under-resourced classrooms to serve our children.  Mental toughness is all around us, if we choose to look for it.

So, when you are faced today with a challenge that makes you feel like giving up, cutting a corner, or wilting in frustration, consider others that know they cannot just go to the sidelines.  Mental toughness may be the difference between success or not.  Mental toughness may determine whether you make good decisions or poor, short-term ones.  Consider for yourself the role that mental toughness plays in your life and, potentially, your future.

Have a great day!  It might still be your best yet… there is still that chance!

 

What are those factors or predictors of success for regulatory GXP inspections?  Is it possible to know how your GXP inspection will go based on certain predictive criteria?  The answer to these questions is challenging and, at best, difficult to say.  I have seen some plants with excellent overall operations have significant issues raised during inspections and, of course, the opposite… sites that I know had numerous vulnerabilities, yet successful regulatory inspections.  However, my personal experience with several hundred regulatory inspections has revealed a number of items that I would term “predictors of success” that can help you ascertain the likely result of any specific plant inspection.  Having this understanding is helpful for your existing sites, but might be especially helpful in assessing new suppliers, newly acquired operations, or for leaders when first assessing operations.

These items, in total, are predictors of regulatory GXP inspection success: 

1. History of both site and company inspection results – If your company or particular site has a history of compliance concerns, even if no concerns for the specific site of concern have been noted, the scrutiny and likelihood of citations increases significantly.  Global GXP investigators do review the compliance history of a site and related sites for the parent company before beginning an inspection.  Investigators have been trained to “connect the dots” and look for patterns across the company for non-compliance.  Thus, any history of concerns at any location within the corporation elevates the risk for your site.
2. Plant profile or risk level (e.g., product portfolio) – Regulators have clearly mandated that inspections and depth of review vary as the risk profile for the site increases.  So, you can expect more frequent, more in-depth, and longer inspections for sites manufacturing parenteral pharmaceuticals than manufacturers of active pharmaceutical ingredient (API) manufacturers.  So, generally, the higher the risk level of your products, the more complex, and the more safety risk posed (e.g., sterile versus non-sterile), the greater the potential for compliance concerns and inspection success.
3. Number and severity of recent product quality or safety issues – Perhaps, the single most prevalent predictor of inspection success is the number and severity of recent product quality or safety issues, such as recalls, Field Alert Reports, issues noted in the press, etc.  These events will assuredly receive significant attention during inspections and regulators will typically spend inordinate time reviewing these events.  Their reviews will be deeper and more rigorous than for other systems and processes.  Because of the concern with public safety, these issues are highly prone to non-compliance citations.  Thus, the more of these you have experienced and the more severe risk to safety they get, the likelihood of non-compliance citations increases significantly.
4. Repetitive quality or compliance issues – One certain indicator of compliance concerns is the number or repeat issues noted in your quality systems.  For example, how prevalent are repeat complaints, repeat product failures, repeat inspection citations, repeat investigations, etc.  The fact that you have significant issues with repeat events indicates failing or inadequate root cause analysis and/or corrective and preventive action (CAPA) systems.  If these are deemed inadequate, you can nearly be certain of non-conformance citations and subsequent concerns.
5. Sophistication of quality and laboratory systems – Because of regulator emphasis these days on data integrity, having sophisticated systems that remove human interaction will eliminate some of the concerns experienced by some firms.  So, the more advanced these systems are, the less concern regarding data integrity SHOULD exist.  Certainly, you must have robust validation of these systems, but having systems considered in the industry to be state-of-the-art (such as laboratory information management systems, electronic laboratory notebooks, enterprise quality management systems, etc.) diminishes some of the potential non-conformance concerns that we have all read about in public press.
6. Trends for quality metrics – Quality metrics are another “hot topic” for GXP regulators.  If your systems include the tracking, trending, regular management review, and proactive action around findings, the risks for non-compliance citations during inspections are diminished, especially if trends indicate improving results.
7. “Trust” quotient for Quality leaders – You may not see this item on any other list of top concerns in anticipation of regulatory inspections.  But, in my extensive experience, the ability of regulators to develop a professional and trusting raporte with the site’s Quality leaders is a profound advantage.  So, if you can ascertain the “trust quotient” for your Quality leaders, you have a significant predictor of inspection success.  In my opinion, factors that should be considered in this “trust quotient” include: overall competence, demeanor under pressure (cool and confident), “command” presence before and during inspections (ability to instill professionalism, confidence, and efficiency in others), and ability to “connect” with others, including regulators.  So, in summary, a leader with a high “trust quotient” will exhibit these five “C’s”: competence, cool, confidence, command, and connection.
8. Proactive versus Reactive culture – You can get a very accurate and quick prediction of inspection success simply by gauging whether a site has a proactive versus a reactive culture.  Does the site already know its vulnerabilities and is working to remedy them?  Are there systems to predict when issues are eminent and the subsequent action to prevent them?  Or, is the site simply reacting to every individual event that occurs?  I tend to view this in terms of offensive versus defensive.  Is the site on the offensive to improve or is it simply in a defensive shell to fix issues that go wrong?  Identifying this can help you predict inspection success.
9. Technical competence across key functions – A strong compliance culture is often marked by a high level of technical competence across all functions, such as Manufacturing, R&D, Regulatory Affairs, in addition to Quality.  When it is apparent that these other functions have strength and understanding of GXP compliance and exhibits a real sense of proactive compliance, you can be certain that the overall compliance position for the site is strong.
10. Cost cutting environment not balanced by continuous improvement – Finally, cost improvement is a real factor in today’s competitive world.  There is nothing wrong with a concerted effort to eliminate waste and improve costs within a GXP manufacturing arena.  However, when the approach of these efforts is simply to cut costs without balancing it with continuous improvement (e.g., waste elimination, process improvement, working smarter, etc.), the risk for compliance concerns is elevated.  The extent to which these efforts seek to improve costs through continuous improvement can be indicative of the culture of compliance at the site.

Certainly, these items alone cannot tell a complete story.  We must certainly consider results of internal audits, industry/regulatory trends, unique vulnerabilities, quality costs, robustness of quality systems, etc.  However, if you endeavor to create a relatively manageable list of items that, in concert, can predict the relative compliance posture of a site, this list of ten items can provide a highly correlated assessment of inspection risk.  You can even quantify the relative risk of a site by grading the site in each of these ten items with a score that allows a rough comparison site-to-site (give each item a grade between 1 and 10, then total the score).

Understanding the relative risk of GXP inspection non-compliance can be very helpful in allocating resources, allocating funding, or decision-making regarding compliance enhancement activities.  Good luck in your own assessment of inspection readiness!

A few weeks ago, The Porch featured a post I called “My own personal balance beam.”  This item discussed the seven areas of my life that I feel must function in concert to have a truly balanced life.  Today, I wanted to share a few thoughts (50 in all) of practical things you can do to help achieve that balance we all desire.  General thoughts are nice, but we often value even more those recommendations that we can actually do… actions we can take… that can help us be successful. 

So, here is my list categorized in the seven areas discussed in the recent post (see the post here… My personal balance beam):

Faith (and Service to others)

1. Commit to some specific activity to serve others, either on a regular basis or a significant one-time activity – this is a great way to help your children understand the importance of serving others
2. Read the Bible through during the year
3. Find a source of daily inspiration (there are many available) that provide a motivating quote or commentary to start each day
4. Visit a home for the elderly and speak with some of the residents – they appreciate someone to listen to their stories, write a letter for them, or just sit and talk
5. Share what you believe and why you believe it with at least one person – then, listen to their story, as well – it is good to be able to vocalize what faith means to you and hear the same from someone else
6. Pay for what the car behind you bought the next time you are in a drive-through restaurant line – do it anonymously as a simply gesture of good will to another
7. Go out of your way to thank person in military service, a police office, or a first responder – a handshake and thank you is nice; paying for their coffee or doing something practical for them is even better

Family

1. Husbands, read The Wedding by James Patterson – this book is an easy read that will give you a fresh and potentially life-changing love for your wife (sorry, wives, I don’t have a similar recommendation for you)
2. Have a movie night once per month – be sure to include the popcorn
3. Try to have dinner all together at the same table at least 3-4 or more times per week – these times are precious, especially with kids in the house, for bonding, sharing, and strengthening your family ties
4. Split up family chores, commensurate with age and ability, to share home responsibilities and to teach responsibility
5. Call a family member that lives away at least once/week – sometimes, we tend to wait for someone else to call us rather than take the initiative to make the first move
6. Write a hand-written letter to your spouse or loved one – share with him/her what they mean to you and why you love them the way you do
7. Take that vacation or road trip you’ve been talking about, but have yet to do – my siblings and I still talk about our adventures on these trips when we were kids
8. Get together with your siblings to reminisce about your own days growing up
9. Plan and take your spouse on a weekend getaway, just the two of you – every couple should do this at least annually

Friends

1. Schedule (and fulfill) a monthly lunch out with one or more of your good friends – if you don’t put it on the calendar, it likely won’t get done
2. Write a letter to a past friend that you have not seen in over a year to reconnect – you might even thank them for what they have meant to your life or career
3. Surprise a friend with a coffee mug or other small gift from your next trip – even a small gesture shows you care
4. Look for an opportunity to meet a specific need for a friend, such as provide a meal card when a sickness occurs, then do it
5. Learn the birthdays for your colleagues and friends – then, remember them with a card or note – I think we all know the value of showing we care
6. Surprise a friend with a kindness that is unexpected and out-of-character for you – they need to learn that you aren’t totally predictable

Firm (or Work)

1. Organize your work life – delete unneeded files and folders, eliminate paper, and minimize the clutter in your work life
2. Begin preparing for your year-end performance review now – create folders for those highlights, commendations, etc. that will assist you later in the year when you write your self-assessment
3. Consider using a single notebook or journal for notes from meetings, phone calls, discussions, etc. rather than keeping individual pieces of paper for each event – the journal (e.g., very inexpensive composition notebook is fine) is easy to carry, gives you one thing to remember, and allows easy access without losing important information
4. Develop the habit of leaving work in time to attend important events and activities for your children/grandchildren/nieces/nephews – you may have only once chance to enjoy these and the kids always hope you’ll be there – besides, the work will be there when you return the next day
5. Keep your resume updated – it is not just for job searching, but to ensure that you track key career highlights and stay attuned to your own career progression
6. Increase networking with those outside your own company – re-establish contact with those ex-colleagues and stay in touch with those that already know you
7. Refresh your LinkedIn profile and content – in today’s world, LinkedIn has become the go-to source for recruiters and others that need to connect
8. Attend at least one local industry event that is pertinent to your job/function – these events are good for staying current in your field, but they are also good for networking

Fun

1. Play hide-and-go seek with your family indoors after dark – you will be amazed at how fun this is and the bonds and memories it grows
2. Plan a day trip once a month to a state park, museum, or other place where you can learn something new, experience something new, and have fun with your family
3. Create a photo book to preserve vacation photos or just typical photos from the past year – these books will become a tradition of fun that you cherish for years (our family uses Shutterfly, though we have also used Mpix)
4. Go fishing, ice skating, roller skating, rock climbing, fly a kite, etc. – just do something unusual and, possibly, as a surprise to the family
5. Read The Girl Who Loved Tom Gordon by Stephen King – this is not a well-known King book, but one that might give you a fun, new perspective on a great author (without the freaky sci-fi stuff common in many of King’s books)
6. Do something totally spontaneous and unexpected – last summer, I jumped into the kiddie swimming pool with my grandchildren fully clothed (yes, I had thought ahead to remove my wallet and phone) – these are some of those things that will be remembered long after you are gone
7. Go to see live music as much as you can – mix it up to see a variety of musicians at different venues – this can be both fun and rewarding
8. Have a pizza night at home making a variety of pizzas with different toppings – experiment with cooking to create an activity that everyone can enjoy

Physical (Fitness or Health)

1. Find a new or unique place to hike – perhaps, create a family challenge to take a 10-mile hike along a river or through the mountains
2. Dig that old bicycle out of the basement and try riding it – who knows, you might re-develop a new love for riding
3. Make one small change in your diet that will result in a health improvement – for example, eliminate chips or chocolate for one month (or begin having oatmeal for breakfast), then decide if you want to continue
4. Establish a goal that you can do with or with the support of your family, such as run a 5K, walk 10 miles, ride a bicycle 20 miles, etc. – many choose to increase their average number of steps over the course of the year
5. Turn off the television at least one evening a week and do something active – you can catch up with what you missed later, if you have a DVR anyway
6. Get an annual physical exam, especially if you have not had one in several years – others need to finally have that colonoscopy that they have neglected, that overdue mammogram, or that dental exam you’ve delayed

Function (or Mind or Learning)

1. Learn a new skill, such as a new software package, playing an instrument, trying a new sport
2. Create a personal journal to record special events, hopes and dreams for the future, and activities that you hope to remember in the future – I did this for 8 or 10 years when our three kids lived at home; it is fun to go back and read my thoughts and the specifics of the day when our kids were born, when big family events occurred, etc.
3. Read a non-fiction book at least once/quarter – studies have shown that some of the most productive and intelligent people in the world continue a habit of reading through their lifetime
4. Expand your appreciation for music or the arts – during the past year, I re-discovered a genre of music that I had forgotten even existed and, as a result, I gained a new appreciation for the lyrics and talents of that generation of musicians
5. Do something artistic – make a gift for someone else, paint a picture, write a poem, write a short story, etc.
6. Consider attaining a work-related certification – the benefit in learning a new area and gaining certification helps develop both your mind and your career

I’m sure you can think of many more.  The point is, find something specific you can do to create more balance in your life.  Don’t neglect any one of these areas, but work to attain some ongoing, consistent activities in each of these seven areas.  Early in a new year is a great time to start.

Have a great day!  This might just be our very best yet!

 

We are not even two weeks into a new year and I’ve seen it already… individuals frustrated because they have either already failed on “New Year’s resolutions” or they have given up ambition goals they set with the best of intentions last December.  When this occurs, individuals often either just give up or they simply cannot motivate themselves to re-start.

So, is there a way to stay motivated when you’ve already failed so early in the new year?  What practical steps can you take to keep going?  Though I am not a personal expert on sticking to those New Year resolutions we make, I have listed a few thoughts that might help you either stay on track or get back on track if you’ve had an early derailment:

1. Take a mulligan – One of my favorite golf terms is “mulligan.”  A mulligan is essentially a do-over… a second chance… a fresh start.  When golfing with friends, it is common that on the first hole, if you don’t like  your very first shot, you can have a mulligan, a second try with no penalty.  That way, you at least have a chance to begin your round without the bad vibes of a terrible first shot (that is, assuming your mulligan shot was better).  If you have missed a goal early, give yourself a mulligan and start over.
2. Focus on your mission, not your missed goal – We often become frustrated with missed goals without realizing that a goal is merely a small piece of the greater mission.  For example, a common resolution at the beginning of the year is to lose weight.  So, when you fail to make desired progress in January, we become frustrated and lose heart.  Individuals often give up because their viewpoint is too short-term.  In reality, when you attempt to lose weight, you are seeking a larger target… that is, you are truly trying to become more healthy overall.  Sure, losing weight is an important part of that, but if you take your eyes off the greater mission of a more healthy lifestyle, your frustration with missing a short-term target may appear overwhelming.  Keep your focus on the larger objective or mission.  When you focus on the longer-term objective rather than daily or weekly targets, you may become less frustrated and more motivated to persevere.
3. Re-adjust (this time more realistically) – We often fail to achieve objectives early in the year simply because they were not realistic in the first place.  For example (back to our weight loss scenario), some individuals may target a 20-pound weight loss in January.  Then, when they only lose 7-pounds, they become frustrated and look at their efforts as a failure.  More realistically, setting a target that is more achievable may keep you motivated.  I have found that early in such an effort, by setting a very comfortable goal early that is easily achieved, provides an early success that breeds more motivation and more success later.  Start more slowly, then ramp it up as you gain momentum.
4. Laugh it off, but “get back in the saddle” – Humor can often disarm failure.  For example, when learning to ride a horse, you might fall off a time or two the first few times trying.  If you can laugh it off and get back up, you will gain confidence and skill that makes it easier and easier.  Put early failures aside quickly and move on.
5. Enlist an accountability partner – If you experience early goal failures, it might be helpful to enlist someone else that can come alongside to assist you.  It might be motivating to have a running partner, for example.  A friend or partner that can challenge you, support you, laugh with you, or lift you back up is a valuable tool for achieving success.

I think my point today is this… Don’t give up!  Yes, it is early and you have fallen, but pick yourself up and get back at it.  A calendar is just an arbitrary marker.  Think about the suggestions above, pick one that might help and get going.  Whether you are trying to lose weight, live a more healthy life, enhance your own abilities, spend more time with family, or whatever, there is no bad time to begin anew.  Just go do it.  In the end, you’ll be glad you were persistent.

Have a fabulous day!