Human Error Root Cause Analysis Dashboard

Credits: Georg Digel

Human Error Root Cause Analysis Dashboard

“HUMAN ERROR” is not a valid Root Cause

🔷 EU MDR Compliance

Why “Human Error” doesn’t exist? ↘

Human Error

  • Blame people
  • In the same category of “User error”

Use error

  • Not blame people
  • Neutral regarding the cause
  • Treat use errors with the same rigor as technical defects
⚠️ “Use error” is still not the root cause of your problem.

Focus on the process ↘

Use error

Symptom = Obvious / Detectable manifestation of a causal factor

→
Process

The real RCA begins here 👁️ We need to focus here

→
Root cause

The main reason why a problem occurred

Human Factors consideration ↘

Do not stop here. Go and look for:
  • Why? Errors result from unmet human factors considerations in design and process
  • Human factors align machines, operations, and environments with human capabilities and limits

Why retraining is not correct? ↘

If your corrective action is:

Retraining
✗ Systemic issues are overlooked or ignored
✗ Individuals get all the blame, not the systems
✗ Failure to follow a procedure often reflects causes beyond training
✗ Use errors signal deeper quality system issues that retraining cannot resolve
✓ Identify procedural weaknesses (Focus on processes, not people)
✓ Implement actions like IT tool redesigns

Use errors classifications ↘

Adaptation from RISK MANAGEMENT for Medical Device Manufacturers [MD and IVD] Joe Smith – Chapter 28

Error (Inadvertent)

Thinking error
• Rule-based mistake
• Knowledge-based mistake

Actions:
• Focus on SOP
• Improve feedback & tools
• Focus on available information
Action error
• Action-based Slip
• Memory-based Lapse (Omission)

Actions:
• Provide resources/ time for task
• Remove distractions
• Implement warnings / checklist

Deliberate (Violations)

Exceptional

The problem here is mainly the quality culture

Situational

Improve risk perception (raise awareness of whys and consequences)

Routine

• Increase likelihood of detection and supervision
• Eliminate reasons to cut corners (e.g. unrealistic workload)
• Encourage reporting of violations to act and improve the system

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