Experience is What You Get Just After You Needed It, Part 2

The first part of this series was about seeing deviation investigations as high-value opportunities, instead of chores and drudgework. If you’ve come this far, the point has hit home with you, and you might be asking yourself what can be done to boil the ocean. Well, leading others starts with leading yourself. Here are the questions I ask myself when I want to invite others to join me in this different, more exciting perspective: 

  • What can I do to help my colleagues see deviation investigation as high-value work? 
  • How often am I tempted to accept a general cause of “human error” without asking what circumstances led to that human making that error? 
  • How well does my team record the learnings from the investigation, not just in procedure updates, but in education and training for a wide audience? 
  • Do I celebrate the completion of a difficult investigation, not just as a checkbox, but as a new level of understanding? 
  • How many repeat deviations do you see in your work? 

Vilfredo Pareto (yes, the same fellow attributed with the 80:20 rule) said, “Give me the fruitful error any time, full of seeds, bursting with its own corrections. You can keep your sterile truth for yourself.” 

Do you see errors as a chance to learn, to share that learning and understanding, or do you see errors as something to manage down? Do you put this into practice? How would your colleagues describe your approach to error and investigation? 

Click here to read Part 1 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. 

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