Experience is What You Get Just After You Needed It, Part 1

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.

The Crucial Nexus: Data Integrity in Pharmaceutical Manufacturing

Christine Feaster
May 17, 2024

Pharmaceutical Industry Trends for 2024 So Far

Christine Feaster
April 24, 2024

Decoding the Technical Transfer Process in Biotech Manufacturing

Sarah Boynton
April 23, 2024

Quality Executive Partners - IACET Accreditation

Ken Mead
April 9, 2024

Coaching and Correcting: A Focus on Behavior Over Blame

Sarah Boynton
November 1, 2023

The Importance of Roles and Responsibilities in Biotech Manufacturing & Human Error Prevention

Sarah Boynton
October 26, 2023

Remote cGMP Inspections and AI in Drug Manufacturing

Michelle Fishburne
October 11, 2023

4 Best Practices for Effective Investigation into Deviations

Sarah Boynton
September 19, 2023

The Art of Viral Vector Manufacturing: 4 Essential Controls to Prevent Cross-Contamination

Sarah Boynton
September 13, 2023

Practicing Risk Acceptance

Mark Roache
August 28, 2023

Annex 1 – Can we all take a deep breath now?

Vanessa Figueroa
August 24, 2023

In Cell and Gene, Good Science is Necessary, But Not Sufficient

Mark Roache
August 21, 2023

6 Ways To Achieve Manufacturing Audit And Inspection Readiness

Sarah Boynton
August 14, 2023

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

Mark Roache
August 10, 2023

Sterility Assurance Matters to This ONE

Greg Gibb
August 8, 2023

Enhancing Quality and Safety: 3 Essential Human Error Prevention Tools for cGMP Manufacturing

Sarah Boynton
August 3, 2023

Asia-Pacific Happenings: Samsung Bioepis Implements QxP Virtuosi®

Michelle Fishburne
August 2, 2023

CDMOs – Selecting the Right One for Each Manufacturing Stage

Christine Feaster
July 24, 2023

3 Types of Human Error and Potential CAPAs to Prevent Them

Sarah Boynton
July 20, 2023

Drug Shortages: Causes & Solutions

Christine Feaster
July 10, 2023

The 5 Questions You Need to Ask After a Human Error Event Occurs

Sarah Boynton
July 5, 2023

Understanding How Adults Learn

Mike Levitt
June 30, 2023

Annex 1 and Ensuring Filling Technologies Fit the Need

Natasha Howard
June 21, 2023

How to Solve Pharma’s Skilled Workforce Deficit

Jeff Roy
June 20, 2023

ChatGPT Told Me AI is “Imperative” in Pharma Manufacturing

No items found.
June 18, 2023

Get Ready: FDORA’s Unannounced Foreign Inspection Pilot Program is On!

Crystal Mersh
June 6, 2023

Nitrosamines Impurity Challenges

Christine Feaster
June 2, 2023

All You Need to Know About Contamination Control Strategies, Parts 1 and 2

No items found.
June 1, 2023

When is ISO 8 Not ISO 8?

Bob Ferer
May 30, 2023

Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing

Crystal Mersh
May 24, 2023

Pharmaceutical Quality is NOT a Spectator Sport

Mike Levitt
May 22, 2023

The Six Keys for Effective Deviation Investigators

Mike Levitt
May 18, 2023

There Has to be a Better Way to Train

Tyler DeWitt, Ph.D.
May 15, 2023

Cell and Gene: Article Series on CGT’s Key Drivers

Mark Roache
May 8, 2023

Bacterial Endotoxin Testing is on the Move

Christine Feaster
May 5, 2023

Top 20 Pharma Company Chooses QxP Virtuosi® Platform

Vanessa Figueroa
May 3, 2023

Crystal Clear: Controls Are Not Enough

Crystal Mersh
April 22, 2023

Myth #1: Complying with Regulations and Product Specifications

Brian Duncan
April 20, 2023

Myth #2: Proactively Remediating Bad Inspection Outcomes: What’s the benefit?

Brian Duncan
April 20, 2023

Is it Time to Outsource Internal Auditing?

Mike Levitt
April 18, 2023

Quality is Number One, Even When Trying to Address Supply Chain Issues

Christine Feaster
April 14, 2023

Don’t Be a Daredevil When Retrofitting Your Facility, Part 2

Bob Ferer
April 10, 2023

Don’t Be a Daredevil When Retrofitting Your Facility, Part 1

Bob Ferer
April 10, 2023