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Human error as a root cause
The document discusses the prevalence and implications of human error across various industries, noting that it is a major factor in accidents and quality defects. It emphasizes the need for deeper investigation into root causes and suggests implementing strategies such as training, a no-blame culture, and systematic error analysis to mitigate human errors. The document also categorizes different types of human errors and outlines contributing factors, highlighting the importance of understanding human limitations.
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Human error as a root cause
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- 2. Next hour willbe… HUMAN ERROR REGULATION TRUTH TRAINING & DEVELOPMENT TRENDS FACTS & FINDINGS ROOT CAUSE ANALYSIS
- 3. Trends 80 % Aviation accidents 94 % Car accidents 70-80% industrial accidents 90 % Cyber security firms 50 % Bio- Pharma firms
- 4. Facts & Findings FINDINGFACT TRUTH DEFINITION MINDSET On average, almost 30% of quality defects were attributed to human error and investigations into these root causes are generally poor and superficial. Training is only responsible for about 10% of the human errors that occur. Human error is an inherent part of human nature, and is always unintentional It can be reduced but more investigation needs to be done on understanding the root cause of it. Human error means that something has been done that was "not intended by the actor; not desired by a set of rules or an external observer; or that led the task or system outside its acceptable limits. Human error is a root cause. But…..
- 5. For industry : Humanerror is first line response View Point :Human error Batch release is driver of deviation closure; Human error deviation provide easiest closure with re-training as corrective action.
- 6. View Points on Humanerror Human error is the cause of accidents Bad things happen to bad people The Old View The New View System are inherently unsafe and people usually keep them running well. It is symptoms of trouble deeper inside in system All humans are fallible Systems are inherently safe & people introduce errors
- 7. Understanding of Human failure–part 1 Human Error Skill based errors Slip of action Lapses of memory Mistakes Rule-based mistake Knowledge- based mistake
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- 9. Understanding of Human failureHuman Error Skill based errors Slip of action Lapses of memory Mistakes Rule-based mistake Knowledge- based mistakeSlips and lapses : Slips and lapses occur in very familiar tasks which we can carry out without much conscious attention. E.g. driving a vehicle. These tasks are very vulnerable to slips and lapses when our attention is diverted even for a moment. Slips: ‘Not doing what you’re meant to do’. Lapses : ‘Forgetting to do something, or losing your place midway through a task.’ Mistakes: Mistakes are decision-making failures. E.g. an operator misinterpreting the sound of a machine breakdown and failing to switch off immediately. They arise when we do the wrong thing, believing it to be right. Violations: These are intentional failures – ‘deliberately doing the wrong thing’. ‘I felt I had no choice’ – (intentional due to the situation or rules). ‘I didn’t care about the consequences’ – (intentional violations). Violations Routine Situational Exceptional
- 10. Contributing factors for humanerror Human error Culture Training Personal factor Other factor Procedural gap Equipment design Organizational factor
- 11. Human weaknesses • Ittakes us long to automate a sequence of activities (playing an instrument). • Performing numerous task in parallel may easily fail. • Conditioned behaviour is very difficult to reprogram. • We see what we want to see. Human limitations Attention Memory Situation awareness Automaticity
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- 23. Human error Investigation Be quickwith the interview !!! Otherwise important information may get lost/biased. Analyze the information together with the interviewed colleagues. Preferentially let the interviewed colleagues draw the conclusions & define CAPAs for more acceptance. Remember! Most “Root Causes” are multi factorial Do consequent CAPA follow-up including effectiveness check to avoid recurrence of the issue. Communicate successful investigations/CAPAs!
- 24. Human error reduction Implementing a humanerror task force. Training to the important stakeholder. Identify weakness in involved processes. Setting up a human error database for tracking. Creation of questionnaire as guidance & framework for human error interviews. Implementation of “no blame people” concept. Human factor engineering
- 25. Thank You Author :Jignesh Bhadani (University 1st Rank holder in Biotechnology) “Biotech professional with keen interest in product quality and patient safety.”