Errors happen time and time again – even in the GMP-regulated world. Dealing with them correctly is almost always a focus of inspections. Inadequate or poor root cause analysis has been one of the top issues in FDA warning letters for years.
Regulated companies are required to identify the underlying causes of an error as part of their deviation management. One challenge is that "human error" alone is not a legitimate justification. A thorough investigation using appropriate tools should help to define sustainable measures.
How do you systematically go into depth and detail? How can you gain a sufficient overview?
This topic is the focus of the "Root Cause Analysis" training course offered by the ECA Academy on October 28 and 29, 2025, in Hamburg.
Tim Ohlrich, Manager of GMP Compliance Projects at gempex GmbH, will support the event with his technical 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.
Other keywords from the program include 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).
Further information and the event program are available on the website of the organizer ECA, gmp-compliance.org, under course number 21877.
If you have any questions about root cause analysis or deviation management, please contact Tim Ohlrich, Manager GMP Compliance Projects, via contact@gempex.com.
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