Non-value added, feel-good GXP activities that do nothing to advance compliance

FDA 2

If you are like me, you may have been frustrated from time-to-time expending significant resources to accomplish something that you know will not improve compliance or product quality. Yet, you continue doing it, you continue hiring individuals to do it, and you continue feeling as though you could be spending your time and money much more effectively elsewhere.

On top of this, regulated industries have been under increasing pressure to control costs, eliminate waste, and enhance efficiency. Is it even possible to eliminate some of these seemingly “untouchable” non-value-added GXP activities?

Today, I would like to list a few of my pet-peeve GXP activities and suggest possible alternatives that might add more value. I’m sure each of us in this industry could add activities to this list, but I will cover only 6 that come to my mind for this session:

  1. 25-Page SOPs – It is time to eliminate the notion that it is more important to include every possible detail in a Standard Operating Procedure (SOP) than creating a document that individuals will actually use to do the job. Certainly, you need to fulfill the need to have detailed procedures to ensure operators cannot ad lib. But, in the course of fulfilling normal duties, it is expecting too much to believe that operators will read the SOP line-by-line each time an action is performed when the SOP is dozens of pages. Instead, it is far better to consider one of these alternatives:
    • Break long SOPs into shorter, more simple procedures
    • Create simple work instructions that include only the details needed by operators to accomplish necessary tasks
    • Include imperative requirements in batch records with associated documentation of critical steps
    • Create graphical representation of steps that can be referenced at the work station or that can be used with computers, tablets, or smart phones
  2. Read and sign training documentation – Does anyone still believe today that asking someone to “read” and provide a signature/date is adequate training to ensure adequate understanding of documentation requirements? I have seen situations in which an employee will read/sign 50 SOPs in one day to document that they were “trained” on the procedure. Then, the firm will proudly present that it has a thorough and comprehensive training program knowing that these signatures do not represent comprehension or competence. Even a shift to require a quiz to demonstrate competency is not necessarily proof that the individual has the understanding today or, better yet, a year from now, to do the job properly or correctly. Possible alternatives include:
    • Shifting the focus from read/sign to more comprehensive use of the written procedure when the action is actually performed. It is more important to actually use the procedure today than to attempt to recall what you read months ago.
    • Use of presenter-led training to ensure that key elements of procedures are articulated and understood. In many cases, helping individuals understand the “why” for a requirement will promote better compliance than simply reading that an action is required.
    • Shift to a master/apprentice training relationship. This will ensure that the “apprentice” is training one-on-one by someone that is an expert on the procedure or activity.
    • A combination of all of these suggested approaches. Relying simply on one approach is not likely to be an approach best suited to every individual.
  3. Boilerplate IQ/OQ/PQ documentation – Somewhere along the line, I think we fooled ourselves into thinking that if we have enough pages in our IQ/OQ/PQ documents and do it every time, we have fulfilled the original intent of equipment or process validation. I have seen numerous examples of using standard protocol documentation to the extent that critical factors are forgotten or omitted. I believe taking the time to think through and apply good science is better than simply generating protocols that offer no value.
  4. Ignoring science simply because no action was required– Speaking of science… I frequently see examples where good science is ignored because there was no specification or requirement to document or explain events. We can become so focused on the requirements that we stop being a scientist. Using our training and experience is needed…. and, it is expected by FDA and global regulators.
  5. Retraining as a CAPA response – When retraining is our primary response to an event, my first response is that you didn’t truly identify the root cause. Overusing retraining as our default response offers no value and will only lead to a recurrence. Be more thorough to ascertain the real “why”. Then, apply actions that have a greater opportunity to remedy the failure.
  6. Reacting to every environmental excursion in low risk areas– Most firms with aseptic operations struggle with environmental failures. Reacting with due diligence is necessary for failures or excursions in critical, high-risk areas. However, continuing to conduct an investigation and react to every individual excursion in low risk areas is not adding value. It is better to formulate a system that uses these data as a monitor of how well the overall system is performing (e.g., cleaning, operator competence, training, engineering systems, etc.). Finding a way to monitor, but not overreact is needed. One question to ask is, “Is our facility/system designed to prevent every potential excursion in low-risk areas? If not, how can I extract meaning from individual results? Should I use individual results in a control manner (e.g., control charting) versus individual excursion/investigation/reaction?”

Avoiding these non-value added activities can free up resources to focus on more urgent compliance and product quality issues. Don’t be afraid to think outside-the-box to improve your operations. Don’t keep doing these activities simply because you have always done them. Apply good science to enhance what you do and how you do it. We can no longer afford to waste critical resources on these activities that do nothing to enhance compliance or product quality. Think about it!

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When it is all said and done…

jefferson

I have visited a number of “homes” of famous individuals in my time. I am always fascinated by the home office that, for the most part, has been left or restored to look as it did in that individual’s day. In many cases, most or all of the items in the office are the exact items owned by the individual. For example, in Thomas Jefferson’s home in Monticello, VA, you can see the actual desk and chair Jefferson used along with his writing materials, books, and other articles that reflected his interest in politics, science, and mathematics. In Thomas Edison’s home office at his Ft. Myers, FL winter home, you can see electronic devices, chemicals, and other artifacts that he actually used for his experimentation and work. Both of these offices reflect the men, their work, and their legacy.

When it is all said and done, we still remember Thomas Jefferson as an inventor, author, statesman, politician, and president. He was not a perfect man, but his legacy lives on nearly 200 years after his death. Thomas Edison is credited with 2,332 worldwide patents in his lifetime (1,093 US Patents covering a period of nearly 60 years). He is credited with inventing the light bulb, perhaps his most famous invention. When it is all said and done, Edison is remembered as possibly the most prolific inventor the world has ever known!

The phrase “when it is all said and done” is an interesting one. It infers a final accounting or final summary or final story associated with a person or an activity. For our purposes now, let’s allow it to refer to each of us and the final accounting credited to us. Today, I would merely like to pose 7 questions that, hopefully, will help you consider the impact you are making in the lives of those around you:

  1. When it is all said and done, how do you want to be remembered by your family? Will your legacy be one of integrity, honor, fun, and love, or will you be remembered in some other way?
  2. When it is all said and done, how do you want to be remembered in the workplace? Did you do things the right way? Did you serve others? Were you a person of character and integrity even when things didn’t go well?
  3. When it is all said and done, will you be remembered as a kind, loving person? Did you treat others fairly? Did you seek to make a positive difference to others?
  4. When it is all said and done, what did you leave behind for others? Did you focus your life on things that truly mattered or were your contributions cheap and easily blown away with the wind?
  5. When it is all said and done, will others remember you as a person of integrity? Did you keep your promises and vows? Did you give more than you took? Did you leave the world a better place because you were in it?
  6. When it is all said and done, will your memory bring a smile to others? Did you enhance the lives of others? Did you leave fun memories?
  7. When it is all said and done, what did you do with God? Did you accept Him or reject Him? Did you live with an eternal perspective or with a “what’s in it for me” philosophy? Did you accept Jesus as your Lord and Savior?

When your life story is “all said and done”, will it be one that made a positive impact on others or will it be something else? Is there something you are doing today that needs to change?

Have a great day! Remember, this could be your very best day yet! You never know when that day will come.

 

Our scars can give others hope

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I had total knee replacement surgery last September. My knee did fine and the surgery was a total success. I do have a scar, however. I don’t notice it much anymore, but the scar is about 7-8 inches long and is clearly visible when I wear short pants. I often see others notice it and, occasionally, someone will ask about it. For instance, those that have experienced the same thing will frequently ask, “So, how long ago was your knee surgery?” For other individuals that are nearing the same point with their own knees, they might ask, “I see that you have had knee replacement surgery. My surgeon has told me that mine is ready, but I haven’t decided yet. Can I ask you a few questions?”

I also have scars on both shoulders and my back. It seems that my scars, when noticed by others, provides a sense of kinship or connection to those that have experienced a similar event. And, for those that are approaching a similar surgery, my own scars become a source of information, comfort, and hope. It is amazing the number of times that I have spoken with others about my surgical experiences after which they express a sense of relief or appreciation to hear it from someone that has already successfully gone through it. Sometimes, talking through my scars gives others the hope that their own surgery will end their pain or problem.

Emotional scars can also help give hope to others. When you have experienced emotional pain in your own life, for example, the loss of a job, you have instant credibility with others when you talk with them about how they can best manage the interim period until their next job. When others experience the loss of a loved one, they can relate to you as you speak of your own loss and how you dealt with it.

The thing about emotional scars is that they are usually impossible for others to see… that is, unless you are willing to allow them to be seen. For others to benefit from your experiences (e.g., your emotional scars), you have to be vulnerable and allow it. Only then can you relate experiences, suggestions, and solutions that can provide hope to others. Too often, we try to quietly deal with our own pain and scars, but knowing that others might benefit should motivate us to be more open and trusting.

Sharing your own pain and frustrations can be beneficial to you, as well. It is sad to learn, all too frequently these days, of individuals that commit suicide despite seemingly having everything good life has to offer. Many of these individuals have wealth, fame, friends, and a future that make it appear that their lives are perfect. However, many of these individuals suffer emotional scars that they never share. Allowing others to understand and feel your own pain is often the first step to healing and attaining that hope we all need.

Think about your own scars today. Can you use them to make a difference for someone else? Or, are you experiencing a wound that may never properly heal unless you share it with someone else? This is a great day to begin sharing that hope with others… or yourself.

Have a great day!