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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