- How to thoroughly investigate human error related deviations

Think about your process deviations within the manufacturing environment. Would you say more or less than most of them can be contributed to HUMAN ERROR?

According to Google, A quick search claims that human errors are to account for up to 80% of quality defects in production/manufacturing settings. Yet, contribution doesn’t always warrant accountability, meaning – just because the human is implicated doesn’t mean that these defects should be placed in a final categorization of Human Error, right? The EU-GMP Guidelines state:

EduraLex Vol 4. EU-GMP Guidelines, Chapter 1 (Pharmaceutical Quality System)
1.4 (xiv); ” Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedual or system-based errors or problems have not been overlooked, if present.”

That means finding out that a human was part of the error is only the beginning of the investigational process, which also means we just can’t stop there. But most of us do. And the failure to investigate in a specific direction gives us recurrence as our punishment.

Finding the driving force behind a human error related deviation (HErD) is done through the carrying out of a deep and thorough investigation, called a probe. A probe comes equipped with a method, proper instrument, or tool(s) to help reveal and identify the true root cause. The 3BMethod is that amazing guidance tool which will aid the user in finding the correct place to start probing and further discovering the true root cause of the HErD.

In this fun, yet highly informative course, you will be introduced to:

• the top MHRA Deficiencies & FDA 483s and Warning letter categories where the human is implicated
• The commonality and explanation behind undesirable behavior
• The constructs in which human error can be categorized.
• The behavioral root cause analysis (BRCA)methodology created and refined over the last 8 years by the instructor to help you probe/deeply investigate the human error related deviations (3BMethod)for better assignment of corrective/preventive actions that in turn will reduce recurrence in deviations

This lesson is 70% theoretical and 30% practical (group work and exercise will be given).

Learning Objective:

By the end of this course, attendees will gain the skill set necessary to dig beneath the symptoms of human error related deviations with the use of a behavioral framework created to assess and pinpoint the real root cause of these type of deviations. This methodology will help to better categorize human error related deviations for correct assignment of corrective/preventative actions = reduce recurrence in deviations.

Who Should Attend:

This course is intended for:
• Those responsible for performing RCAs
• Quality Assurance/Control/Compliance professionals: Team Leaders and Management within Quality Assurance and/or Production/Product Supply
• Specialists, Professionals, and/or Project Managers responsible for CAPAs, Risk Management, Deviations, change management, strategic operation, stakeholder management, training and/or global communication
• Team Leaders and Management within Regulatory Affairs and Research and Development should also attend.
• Manufacturing Excellence personnel, Compliance, and/or Health and Safety specialists


IndustryMedical Device, Pharmaceuticals
LevelBasic, Intermediate

Energy Kristina Hansen




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