People in our industry, used to working under GxP controls, are familiar with what to do when we encounter unexpected results; We open a deviation investigation. We all know someone who is a really skilled investigator. Part technologist, part human behavior specialist, with structured, disciplined yet creative thinking, they remind us of the best TV detectives. One of the best deviation investigators I know reminds me of Columbo, played by Peter Falk. His ability to ask “just one more question” to get to the root cause is impressive, so it may not surprise you to know that he used to be a police officer!
Getting to the deep insight of the real root cause is crucial, both for prevention of reoccurrence and also for full and complete assessment of impact. Many of you will now be expecting me to talk about avoiding assignment of personnel as a root cause, or to not just retrain the colleague who fell down the hole. While these points are all dear to me, I want to talk a little about what comes after we identify the cause.
When something goes wrong, we have already paid its price at the moment of occurrence. The cost is already set, in terms of lost material or effort or other impact. It’s the job of the investigator to harvest all the value possible from the learning experience to make that cost worthwhile. Instead of thinking of the investigation as a chore, our detective heroes must mine the situation for something worth more than gold, more even than a difficult-to-make recombinant… the learning and the experience. And then, once this gem is uncovered, to share it with everyone.
How do we share this hard-won knowledge and experience? We need to put as much effort into recording and teaching the why of things, the mechanisms of failure, as we do in reflexive procedure updates that we so readily adopt.
The learning experience is expensive, it comes at the cost of incurring a problem. Define it, record it, and learn from it. Share the learning to avoid recurrence. Maximize the value of the experience so that you can prevent the same thing from happening again, or at least manage it more effectively if it does reoccur. Make sure that next time, the experience is there before you need it. If we don’t, we are at least sure to have another opportunity to learn.
Click here to read Part 2 of “Experience is What You Get Just After You Needed It.” Also, if you would like to read the first two articles in Mark’s 2023 six-part series in Cell & Gene, click here to begin: “Cell and Gene: Article Series on CGT’s Key Drivers.”
Mark Roache, QxP VP of Cell and Gene Therapies, has spent his 30-plus year career in GXP. Mark was the Chief Quality Officer for AveXis (now Novartis Gene Therapies) at the time of Zolgensma launch. He was previously Senior VP of Quality for KBI (a CDMO with cell-therapy capabilities) and has held other senior Quality roles at Novartis, Merck and Bayer.
