GxP System Efficiency Considerations



It's been a long time since I created a Blog. We've all had our challenges this last 24 months. Life is opening up again now it seems. While restrictions are easing off we all have healing to do. We will not only need to heal our bodies and psyche. We will need to heal our businesses. Some, I am sad to say, will not be able to reopen. For both large and small companies many will not be able to return or a rebuild may take many years. I see many YouTube videos from professionals that say we are yet to see the worst of this from a financial perspective. I pray that all those who read this are well. I'm here to help you strengthen your systems.


Why this topic?

The world is changing. Business and quality system efficiencies are more critical now than ever before. In a recent Biden State of The Union speak he mentioned driving down the cost of drugs. Since hearing him say this my mind has not stopped thinking about how it can be done. I can see all aspects of running this type of business. I know the regulatory side and the resources it takes to be compliant.


My expertise is in quality systems and I've been doing this for close to 30 years now. This system experience involved many aspects of what it takes to run Biotech, Pharma and Medical Device companies. I've even audited HR systems and touched those that involve supplier quality. I have a great understanding of why we do what we do. I have gained more understanding from running my own business. Further, I understand the people side to include what happens as the younger generation slides in as the greater knowledge base moves out.


Below you will find a list of important considerations when thinking about efficient systems. First, I provide a short interesting little story about systems efficiency evaluations.


Sometimes Spaghetti doesn't taste good:

I was the QS Manager for the organization. My supervisor, the VP of QA/RA, suggested that we evaluate the streamline of a system. There was request to bring all stakeholders into a meeting to conduct evaluation. We started with what became a spaghetti diagram. Yes, the process was so convoluted the process path looked like spaghetti on a plate and I am not exaggerating. While that wasn't so great it really was the resolution that was of major concern. If the system were to be corrected to what it should be a lot of people would lose their jobs. So, this leads me to the first item on our list.


Considerations when making change:

Conduct a high level anticipated initial consideration on how a change will or may affect staff levels.

  1. Work with finance to determine ROI

  2. Evaluate ROI against other projects. No need to start a project that won't yield good value.

  3. How long would it take to do this project?

  4. Who would need to be involved?

  5. Create:

  6. a current state diagram with key players the company can't afford to lose

  7. a Go-To process diagram with key players

  8. What product or systems might be affected?

  9. Do you need a CAPA?

  10. How will you evaluate if the change was a success later? Plan for it?

  11. Are there other projects in the pipeline that are similar or may have overlapping interests?

  12. Discuss with managers first to get buy in and learn of roadblocks

  13. Has anyone attempted this in the past?

  14. Are you undoing someone's past work that they may feel great pride or ownership in.

  15. How you communicate a change is critical. Did you know that adults typically need to hear something up to 7 times before they will even entertain change.

  16. Collect and evaluate all of the known faults of the current system.

  17. Ensure each of the known faults are addressed in the new change.

  18. How will you involve the organization?

  19. How will you communicate progress as you create and implement?

  20. Can you solicit help from other departments?

  21. Is there a young professional that would love the change to learn?

  22. Be sure to include Regulatory for any changes that require notification to regulatory bodies.

  23. Drawing changes?

  24. Procedure changes?

  25. Do you work in an organization that doesn't finish what they start? It' not worth starting to evaluate making a system more efficient if it will be derailed and commitments are not made. Still, keep in mind that flexibility is needed in any endeavor.

  26. The list goes on......and on.....right!

While it is not possible to list all change considerations, the above is a great place to start. I have assisted with many changes in many organization. Each change is ultimately it's own unique artistic wonder. Ultimately, systems efficiency rests on what you need to fix and accomplish. Do you need to shorten the time it takes to built something? In this case you will need to evaluate all steps and the time it takes to accomplish them. Then you need to gather the GEMBA and pull minds together to brainstorm solutions to resolve. However, as seen in the list above, there are more considerations than just the Go-To drawing.


EM Colorado can help you evaluate and effect change within your organization.


God bless all!


Joann




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