Root Cause Analysis (RCA) is a key element of the quality management system in GMP-regulated companies. When applied correctly, it aims to identify and eliminate the underlying, actual causes of quality issues. The company learns from these issues, can take corrective action, and minimize identified weaknesses in the future.
Particular emphasis is placed on looking beyond the obvious, avoiding to end up with the infamous “human error.” A range of structured approaches and methods are available for this purpose.
But how to dive systematically into the details and explore the issue in depth? How to gain a sufficiently broad overview? What techniques and tools are available?
The ECA Academy’s “Root Cause Analysis” seminar, taking place on September 2 and 3, 2026, in Copenhagen, offers a training program on this topic. Workshops and presentations will cover relevant fundamentals and provide an overview of the subject.
Tim Ohlrich, Manager of GMP Compliance Projects at gempex GmbH, will support the event with in-depth expertise and best practices.
- Kick-off speech "When it's human" – the significance of human error and the importance of a good error culture in companies
- "Using 5 Whys and Ishikawa" – the "fishbone diagram" method
- Implementation of the method, strengths and weaknesses, typical errors in application, practical examples, and experience
- "RCA Completion" – a brief overview of the requirements for documenting root cause analysis and defining the right measures based on the results obtained.
The training also covers topics such as bow-tie risk management and problem-solving analysis, A3 methodology, human error-related deviations, and behavioral root cause analysis (bRCA) for human error-related deviations (HErD).
All information, including the complete program, is available on the website of the organizer, European Compliance Academy (ECA), gmp-compliance.org, under course number 22618 “Root Cause Analysis".
If you have any questions about root cause analysis or deviation management, please feel free to contact Tim Ohlrich, Manager of GMP Compliance Projects, at contact@gempex.com.
This might also interest you:
CAPA, Change Management and Change Control