Actions you should take during those critical first 24 hours after closing an FDA inspection

FDA 2

Much has been written and said about preparing for an FDA inspection (or other regulatory inspection). However, I have not seen anything written which describes what actions are needed during the critical first 24 hours after the inspection closes. Certainly, you need to begin preparing any needed response to the inspection results, but there are a number of significant actions you must take during the first day post-inspection that could very well determine your success or failure for the next inspection.

Let’s take a look at those critical “first 24 hours” actions:

  1. Communicate results to management – Most firms have a policy or standard practice that communication to management regarding inspection results is required immediately after the closing conference. This is important. However, it is also important to communicate to management any other details or actions that could elicit future concerns (such as a Warning Letter) or items that should be addressed in other similar facilities. FDA expects that actions taken be global in application, so other sites should be made aware quickly of any issues that could apply there.
  2. Thank individuals involved in managing the inspection – It is essential that one of the first actions you take after the inspection is to personally thank those that worked so diligently to manage the inspection well. Those in the front room, back room, subject matter experts, and those working behind the scenes need to be identified and thanked for their work and actions leading up to and through the inspection. Many of these individuals worked far beyond their normal work schedule during the inspection and, in some cases, delayed vacations, missed family events, or postponed other important work to ensure the inspection was successful. Consider doing something special for key individuals, such as a gift certificate for two to dinner. Take the time very quickly after the inspection close-out to thank them both privately and publicly.
  3. Thank the entire site for supporting the inspection – A successful inspection result is always tied to the diligence and efforts of the entire site. A site-wide communication summarizing the basic results of the inspection and thanking the site for their efforts goes a long way to encourage future compliance and improvement activities.
  4. Begin laying the groundwork for the next inspection – In most cases, the data and information that will be reviewed during the next inspection begins the day after the inspection closes. The days after an inspection is NOT the time to become lax or less diligent. Emphasize to your inspection management team, the site management team, and all individuals at the site that it is important to remain diligent and exercise a high level of compliance every day and in every activity. This communication can be included in the site-wide communication mentioned above, a site-wide meeting, video, or other means, but it is important that you emphasize continued and ongoing diligence.
  5. Initiate actions to capture and sustain positive momentum – In many cases, the teamwork, effort, and cross-functional camaraderie experienced during an inspection is unmatched by any other activity that occurs at the site. For the period of the inspection, everyone is singly focused on a positive inspection result. Utilize this momentum and work to sustain it. Celebrate this success with a pizza party or other event. Utilize this momentum to tackle other important site projects. Quick action can ensure that you don’t merely get “back to normal” the day after the inspection closes.
  6. Assign responsibilities and actions for any needed formal response – The inspection may result in the need for a formal response back to FDA (or other regulatory agency). Verbal or written items should be addressed comprehensively, so beginning action early and assigning responsibilities for initial/immediate actions are needed early. These do not need to be completed in the first day, but individuals should begin these activities as soon as possible after the closing.
  7. Assign responsibilities and actions for any new “lessons learned” or “close calls” – Most inspections result in “close calls” or “lessons learned.” Assigning responsibilities for actions associated with these should also be made soon after the closing. Speedy action may improve quality, improve compliance, or reduce other risks.

The key point is that it is good to celebrate the conclusion of a regulatory inspection, especially if the result is positive. However, there are some actions you should take within the first workday after the inspection to ensure a smooth transition back to “normal”, to ensure that key contributors are recognized, and to ensure that actions are taken to set the stage for an even better result on the next inspection.

Good luck on your next inspection!

 

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A Thousand Lifetimes

I wanted to share something that I saw a few months ago that is meaningful to me, especially today. Carved in a memorial brick in a church in southern Florida, I saw this:

“To Ray: If I live a thousand lifetimes, you’ll still be my sweetheart. – From Maddy”

I don’t know Ray or Maddy. However, I was touched by Maddy’s sentiment to her beloved Ray. But, I wonder if she waited to tell Ray until it was too late.

Today is the 43rd anniversary of my marriage to Elaine. She is the greatest blessing of my life! The years have been full, fun, and fast. Through it all, there is no one I would rather spend my days with. She is my best friend and my sweetheart of a thousand lifetimes! Happy Anniversary, Elaine. I love you!

It is my wish for all of you that you might find the love and happiness that we share. If you have found that love, don’t wait another day without sharing what that person means to you. Express your love today. Don’t assume that you can wait till tomorrow. Say it while you still can.

Have a great day!

Overcoming ‘first day’ fears

first day

The coming end of summer brings the return to school. Over the last week or so, I’ve already seen dozens of ‘first day of school’ pictures. Most of these photos have children standing on the front steps holding their new, freshly stocked backpacks or a sign indicating that this is the day of firsts. I have also seen photos of teachers proclaiming their joy to return to the classroom.

For every ‘first day’, there is also a ‘last day.’ The first day of kindergarten, for example, signifies the end of a key phase of life for both the child and the parents.. a phase in which they had grown comfortable and confident. It means that the child is leaving behind something precious and special for something else that promises to be new and exciting, though, perhaps, a bit intimidating. In these ‘first day of school’ photos, you can almost see a sense of anxiety mixed with the anticipation. Starting something new is like that… anticipation, anxiety, excitement with a dash of fear or hesitation mixed in.

We experience many ‘first days’ throughout our lives… first day in a new job, first day in a new city, first day married, first day alone, first day as a parent, first day retired… Most of us just go with the flow regarding firsts. However, there are times when some forethought and planning would help us cope or prosper during these times of transition.

There are also times when individuals work feverishly to avoid a ‘first day.’ They either fear the unknown of a new chapter or they have become so comfortable where they are that they simply would rather take the risk of settling for their current situation than taking a step into the unknown. For example, I have known many individuals that have clearly reached a dead end in their career. Yet, they can’t or won’t take a step to explore new possibilities or new opportunities. By staying “comfortable”, they forfeit challenges, new relationships, and career advancement (including financial gain).

As a parent, we tell our fearful kindergartner that school will be fun and exciting and they will make new friends and learn so many new things. But, often, those same parents will continue going to the same dreadful job, doing the same things, because they are afraid to look at new opportunities themselves.

I have learned that there are three primary questions that you need to ask whenever you face or are contemplating a new ‘first day.’ By spending some time asking – and answering – these questions you can be better prepared for that next chapter that you face.

  1. What are you leaving behind? – When contemplating a next chapter, it is often good to take an inventory of what you have today. By objectively looking at your current situation, you can often identify whether a new start or next step is needed. From a career or life perspective, you should ask:
    • Will I reach my potential if I do not make a change?
    • Am I learning?
    • Am I having fun?
    • Will I reach my life goals (financial, work\life) if I stay?
    • What will I be doing in 5 years?
  2. What are the risks and benefits of your own ‘first day’? – Whether you know it or admit it or not, we all are risk managers. We mitigate an automobile accident by buckling our seat belts. We exercise caution when cleaning the gutters. We protect our children. In the same way, we exercise caution around ‘big changes’ in our lives. When faced with a big decision about your next potential ‘first day’, do a formal risk\benefit analysis… write it down! Often, this activity can make it clear what you need to do next.
    • What happens if you don’t make a change?
    • What is the best case and worst case scenario if you do make a change?
    • How will your life be different a year from now if you do make a change? Or, if you don’t?
    • Is you fear or hesitancy based on facts or emotions?
  3. What will I need to help me take that step toward a ‘first day’? – If you think a new direction or ‘first day’ is needed for you, what steps should you take now?
    • Be brave – Just like you might tell your new kindergartner, be courageous. There is nothing to fear. This is a new adventure. Good things are coming.
    • Get prepared – For a career change, do your research. What is your logical next career step? What skills do you want to highlight? What are your target companies? Who, in your network, do you need to speak with?
    • Focus on the facts – Eliminate the emotions that can drive your anxiety and give rise to second thoughts. Focus on where you want to be, what you want to do, and what steps are needed today. Don’t linger too much on the past and the good times you’ve experienced. Keep things in balance.
    • Remember other ‘first days’ in your life – You have done this before. You’ve gone through other ‘first days’ and they have been blessings in your life.

Sometimes in life, we just need to charge ahead with something new, something different. But at other times, we are not given a choice. The questions outlined above can even help with ‘forced transitions.’ Though it may be very difficult looking ahead in challenging times, we need to think about what’s next. How can you make the very best of the days, weeks, and months ahead? Recognize that leaving some things behind is very difficult, but that you can make the best of what lies ahead.

Enjoy this new school year. Watch the excitement of the kids as they become more comfortable with new teachers, new friends, and new surroundings. And, watch them grow in the process. With their growth, comes more confidence and more comfort. Let’s learn from the children as we contemplate our own next ‘first day.’

A meeting survival guide

meeting room

Who likes meetings? I dare say that none of us awakens in the morning excited about the meetings we get to attend that day. Thomas Sowell once said, “The least productive people are usually the ones who are most in favor of holding meetings. I would estimate that in my 40 years of work life, I probably attended more than 50,000 business meetings! At that rate, how many more do you have to look forward to?

So, what is the secret to surviving so many meetings? What tips can I pass along to help those that still have 20 or 30,000 meetings to attend in their career?

Here are a few suggestions I have for helping you survive your next thousand meetings. I’m sure there are others you can suggest, but these few cover some of the basic concepts that I have learned:

  1. Start and end on time – Few things drive me nuts more than wasting the time of everyone else to recap “what we’ve covered so far” for someone that is late for a meeting. To combat this, I always made it a point to start meetings on time. And, when someone comes in late, I simply tell them they can get with someone after the meeting to catch up on what they missed. After a time or two, every those chronically late begin showing up on time. Don’t allow one or two individuals to waste the time of others that made the effort to be on time. And, don’t allow meetings to extend beyond the time scheduled. This forces you to work efficiently and effectively to accomplish, at a minimum, the key objectives of that specific meeting.
  2. Have a purpose for every meeting – You should never organize a meeting without having (and communicating) its purpose. What are you trying to accomplish? What information needs shared? What decisions are needed? By clearly and carefully constructing the purpose statement, you can help ensure that everyone gets what is needed and that time is not wasted. I remember countless meetings where the organizer had waited weeks or months to get the key individuals in the room at the same time. However, due to a lack of organization, the ultimate goal of the meeting was not accomplished because the objectives were not outlined and articulated beforehand or at the beginning of the meeting. (Side note: If you have to entice individuals to attend your meeting with donuts or cookies, you might consider whether the meeting is that valuable. Though donuts at morning meetings is nice, it is preferred that participants attend because of the value of the meeting rather than the hope of getting that chocolate covered delight.)
  3. End every meeting as quickly as you can – How many meetings have you attended in which it seems the purpose was achieved in the first 15 minutes, but the meeting dragged on for another 45 minutes during which nothing new was accomplished? I remember a Senior VP once saying during a meeting, “I’m buying, so you can stop selling now.” He was referring to the meeting organizer continuing to pitch a recommendation longer than needed. When the purpose of the meeting is accomplished, adjourn… simple as that. If you demonstrate that YOUR meetings will be efficient and purposeful, you are likely to get attendance of needed participants in the future. If you know your time will not be wasted, you are likely to feel a meeting is important. Get it done, then move on!
  4. Stay focused on the meeting purpose – Another key reason you should clearly establish a goal or meeting purpose is to ensure that you stay focused on the task at hand. If you are the organizer, prevent participants from deviating into other subjects. Bring it back by saying something like, “That is an interesting subject, but let’s stay focused on our problem. We can possibly address that in another forum.” Too many meetings are hijacked by individuals that hope to use the group to address their own issue or situation. As the meeting organizer, it is your responsibility to keep the meeting on target.
  5. Take notes and summarize (especially if there are action items) – For every meeting, someone needs to take notes and summarize the results for all participants. This summary can be short and to the point or long and comprehensive, if needed. But, a summary sent to all participants is essential for ensuring the success of the meeting. A summary is essential if action items were assigned. Don’t assume that everyone left the meeting with the same understanding as you. Make sure by providing a summary.
  6. Handouts and PowerPoint presentations are OK, but there are rules – There are some individuals that will state that handouts and PowerPoint presentations are not acceptable in meetings. I disagree. These can be essential for keeping individuals focused, summarizing key background information, or directing the discussion. However, keep the following in mind when creating these:
    • Economize on words – only state what is essential
    • Don’t be cute – fancy graphics and automation can be a distraction
    • State the takeaway point on every page, slide, or document – state clearly in the header or banner what the reader needs to know (eliminate their need to study the slide and interpret its importance)
    • Keep it simple and easy to read – enough said
    • Minimize pages – when in doubt, leave it out
    • Include a summary or list of key takeaways – this is your opportunity to ensure that the reader “gets” your key points
  7. Everyone that attends a meeting should add or gain value – for some, the value obtained is information that can guide future actions. For others, the value is a decision or direction. For others, it might be sharing insight that participants might not have gained otherwise. Some individuals never participate or comment during meetings. A good practice is that before attending any meeting, commit to adding value by asking a question, making a comment, or volunteering for an action. I have found that participating in meetings, especially with senior management members present, is a good opportunity to demonstrate your own value to the organization. And, if you are the meeting organizer, don’t invite individuals that will not contribute or add value to the meeting.
  8. Come to meetings prepared – Many times I observed individuals coming to meetings unprepared to participate, unprepared to provide an update on prior actions, or unprepared to make needed decisions at the meeting.  Take a few minutes to get up-to-speed on the meeting purpose and come ready to add value to the discussion. 
  9. Pay attention – Do not attend a meeting simply to show your face. Do not attend a meeting, yet spend the entire time reading email. If you go, go prepared to focus on the subject and the discussion occurring.
  10. Only have a meeting if it is needed – Finally, and perhaps most importantly, don’t schedule a meeting unless it is necessary. Many of my 50,000 lifetime meetings could have been avoided if individuals had simply talked with each other beforehand. Things typically get done better and faster when the affected parties talk together in small groups… not in meetings at which individual egos and territorial protection comes into play. When at all possible, avoid having meetings that are not essential or purposeful.

I’m sure each of you could add a few additional items to this list. However, I have found that by following these ten tips, meetings can be shorter, more effective, and produce greater results.

Good luck with your meetings today! I hope they are shorter, better, and more enjoyable than you could have expected.

Yes, you can change your circumstances

contrarian

There are times in everyone’s life when you feel that your current circumstances are less than desired. You have a job that is not fulfilling. You have an unreasonable boss. Your marriage is struggling. You need financial assistance. You have family problems. You have legal problems. The list could go on and on. Sometimes, we just feel that things are not right and a change is needed, but we don’t know how to go about making the change.

Henry David Thoreau once said, “Most men live lives of quiet desperation and go to the grave with the song still in them.” We don’t have to live a desperate life.

Today, I would like to offer some practical assistance for those than need a life change, but are not sure of what to do next.

The first step in make a change is to recognize and take action on things that might be causing our current unsatisfactory circumstances.

Things to stop doing

  1. Stop feeling hopeless and helpless – Negative situations, especially if they seem to go on for too long, can make us feel that our situation is hopeless… that there is no way things will ever get better. This can deteriorate further to the point that we feel helpless to do anything about it. This attitude, unless stopped, can prevent us from ever escaping our difficult situation. The first step in make a life change is to believe that things can change and that they will get better.
  2. Stop blaming someone else or being the victim – When in a difficult situation, a natural tendency is to blame someone else for our problems. Or worse, we begin assuming that everything bad that happens to us is intentional and targeted. We must take charge of our lives and reverse the belief that anyone else can do what is needed to improve our situation.
  3. Stop feeling like it is too late to make a change – Regardless of our age or the length of time we have been staggered by our situation, it is never too late to reverse it. There are many stories of individuals in their 70’s or 80’s that have made significant life changes to made a difference in their happiness and well-being.
  4. Stop waiting for someone else or something else to happen – We must stop thinking that someone else will solve our problems. Taking charge of our own situation… our own happiness… our own career… must be personal and something we cannot delegate to anyone else.
  5. Stop continuing to make the same bad decisions – We typically cannot expect things to change as long as we continue making the same bad decisions or same poor choices. Recognizing this is essential to making a life change.

Now, let’s turn to some practical steps that we can take that can help us change our path or direction. Perhaps, you cannot try all of these, but possibly, you’ll find one thing that can make a difference and get you out of the rut you find yourself in today.

Things to start doing

  1. Serve someone else – I have found several times in my life when I face a difficult or challenging situation that serving someone else takes the focus off my own negative situation. When you can shift your focus, you often see things in a new light or gain new perspective. By serving someone else, you often find that making a difference for someone else is ultimately more gratifying that anything you are striving so diligently to attain.
  2. Chase your passion, not a title or position – Individuals typically spend around 40 years of their lives striving to climb the corporate ladder. This may be important for a number of reasons (e.g., financial stability, the corner office, etc.). However, when you change a title or position of status, you often miss out on things that can provide more satisfaction, enjoyment, and contentment. When you find that thing that drives you… your passion… your work responsibilities cease being “work” and become more something that you embrace and enjoy. If you are not satisfied in your work, it may very well be that your work is not aligned with your passions. In that case, it might be time to consider a change in career or direction.
  3. Be bold, courageous, and confident – Individuals often stay in difficult or unsatisfying situations because they fear doing anything else. When nurtured, this fear can become paralyzing and prevent us from being effective even in positions that we are fully capable of doing well. There comes a time when you need to be bold. There comes a time when you need to muster that courage that you’ve buried. Be confident that things will change for the better.
  4. Find a mentor or someone you trust – When you find yourself in a desperate or challenging situation, don’t think that you have to do it alone. Having someone that can offer unbiased advice or provide a different perspective is often an important step in extracting yourself from a deep rut. A mentor can often help, but we need to have one first. If you don’t have one, find one. Or, just find an individual that you trust who will NOT just agree with you, but offer clear thinking and options.
  5. Focus on the facts, not your emotions – The reason we find ourselves hopeless and helpless sometimes is because we become emotionally connected to the situation. When/If we are able to focus more on facts than emotion, our vision improves and we may be better able to see the next step we should take. Emotions are good, but can often make good decision-making more difficult.
  6. Practice active patience – “Patience is a virtue.” However, patience without action can result in malaise. Often, we need to connect action to our patience in the form of active patience. Active patience means that we are willing to wait, but, in the meantime, we are exploring options, researching the pros and cons, evaluating possibilities, and preparing for our next chapter. Just sitting back and waiting for things to happen if one way to ensure that you fall deeper and deeper into a rut that may be impossible to escape.
  7. Do something different (or learn something new) – Sometimes, doing something… anything within reason… can help lead us to our next chapter. Learning a new skill can help our career. Learning to play a musical instrument can create a new passion or new escape that can motivate us in a new way. Making a change can often stimulate a new direction in our life. So, just do something! Do something different!
  8. Adopt an attitude of gratitude – Our lives often become stale because we have forgotten how much we have or how much we have been blessed. If you need a change of attitude in your life, become a more grateful person. Be more thankful for what you have, for the opportunities you have that others don’t have, for the people in your life, and for your health and wealth. When we become more aware of our blessings, it becomes more difficult to feel sorry for what we don’t have or the situation we find so troublesome.
  9. Reinforce your marriage, your relationships, and your friendships – Great things often happen when we take the time to nourish the relationships we already have. When is the last time you did something special to enhance your marriage? Finding time to spend time with a family member, friend, or colleague can provide a new, fresh perspective to the problems plaguing you today. It might also inspire you to make the change you need to make.
  10. Expect something good – Being optimistic may be the most important element of changing your current situation. When you expect something good to happen, it usually does. When you expect something bad to happen, your worry drags you down, even if nothing bad does happen. Looking at the glass as half full can help inspire you to make the change needed, especially if you couple it with courage and boldness.

Many of you may find today that your life has no meaning or that what you do doesn’t matter. Finding hope can completely change your life. You might find help in this previous post (What is your hope?).

So, if you are in a situation today that needs to change or if you need to be motivated to take a step you know is needed, consider this your push… Stop doing things that keep you stuck in the rut and find something that can make change happen. Hopefully, something you’ve read here might help.

Have a great day!