Common Sense Quality
Waiting for a flight here in Colorado, and finally have some time to sit down and write! I spent the weekend snowboarding, and had quite a bit of time to think and reflect while on the lifts up to 12,000ft. 2ft of fresh powder was a nice added benefit!
Growing up in rural Oregon, we really only had one mountain that was doable for a day trip: Hoodoo. It’s a small family-run “resort” with a few old-style lifts and not much else going on. Because of its small size, to achieve the sense of adventure that we craved as kids, we had to spend time exploring the out-of-bounds backcountry. We would take the lifts up and then disappear, spending hours out there finding new runs, building jumps, and hiking around in the snow. Over time, I learned that to be a decent backcountry snowboarder, risk management is critical. Split-second left or right decisions will make or break (literally) your day.
Reflecting back on these early memories this week, I realized that the best choice (right or left) while ripping down through the trees was always the path of least resistance. You could go the harder route, but you would often end up getting buried in a tree well and calling your buddies to help dig you out. Initially it seems like a better adventure, but turns out to be no fun for anyone. As I grew older, I learned that the harder routes rarely paid off in our quest for adventure. Significant delays, loss of energy, and overall less enjoyment/adventure (not to mention possible injury).
I feel that we in the GXP world are still learning these lessons. We often take the path of greater resistance, but instead of seeking adventure we do it in search of compliance. It has been my experience, however, that compliance is most likely achieved when we take the path of least resistance. In 2025, GXP compliance can most accurately be summarized by extracting a common thread from FDA Warning Letters: “vigilant operations management oversight”. There is no way to vigilantly monitor complex and subjective workflows… impossible. Many folks agree with me, in theory, but have trouble making the jump and implementing lean GXP workflows, likely do to fear. Overcoming this fear can only be achieved via practice, just like back-country snowboarding. Start small, run a few pilots… Demonstrate the patient and business benefits (they will fully align if the proper resources are available), and start a cultural shift to the path of least resistance. In our governance workshops, we use a phrase to summarize the goal: “Common Sense Quality”.
With practice and determination, you will find that common sense quality relies on developing GXP workflows that choose the path of least resistance (Qualification/SOPs/training/etc…). Why are operators required to “train” on 14 random SOP’s per week? This is an example of the opposite of common sense quality, it is a company lost in the woods. These operators will likely get stuck in the trees and require rescuing! On the other hand, vigilant operations management oversight of the training program will result in assigning only the SOPs relevant to their workload, and supplement others via optional modules and/or periodic all-hands where site-wide trends are addressed.
Don’t be afraid – explore carving the path of least resistance and common sense quality, the adventure and rewards are epic!
