This document provides an overview of human error, including its causes and how it can be prevented. It discusses that human error is often cited as a cause in accidents and disasters across many industries. Regulatory bodies require confirming that process or system errors were not overlooked before attributing an issue to human error. The document then covers the psychology and science behind why humans make errors, identifying three stages of human cognition - planning, storage, and execution - where errors can occur. It also discusses types of errors like slips, lapses, and mistakes. Finally, it emphasizes that while human nature cannot change, the conditions where humans work can be changed to help prevent errors by considering factors like procedures, training, process design, environment, and

1. Human
Errors
- Evaluation and
Prevention
Presentation By :
Ms. Karishma R. Khemani
Quality Control (Investigator)

2. Human Errors can be
PREVENTED.
YES NO

3. 1. What is Human Error ?
2. Why focus on Human Errors ?
3. What are the regulatory requirements ?
4. Psychology and Science of Human Errors ?
5. Types of Human errors ?
6. Can we prevent human errors ?

4. What is Human Error ?
• Human error means that something has been done that was "not
intended by the doer; not desired by a set of rules or an external
observer; or that led the task or system outside its acceptable limits ".
• In short, it is a deviation from intention, expectation or desirability.

5. Why focus on Human Errors ?
1. Human error has been cited as a primary cause or contributing factor
in disasters and accidents in industries as diverse as nuclear power ,
aviation (pilot error), space exploration (e.g., the Space Shuttle
Challenger Disaster and Space Shuttle Columbia disaster), and
medicine / healthcare industries (e.g. Administration of incorrect
medication).
Human error is one of the many contributing causes of Risk events
(Patient safety).

6. $288,000
DIRECT COSTS
$1.2 million
INDIRECT COSTS
• Productivity loss
• Property damage
• Replacement worker(s)
• Hiring & training
• Legal costs
• Fines & penalties
• Investigation costs
• Brand & reputation
• Employee morale
• Customer dissatisfaction
2.

7. 3. All we Need is Prevention !
Studying Human Errors enables identification of exact cause of the ERROR.
The efforts to prevent those errors can be more localized.

8. What are the regulatory requirements ?
From Chapter 1 of the European GMPs:
1.4 (xiv): …Where human error is suspected or identified as the cause, this should
be justified, having taken care to ensure that process, procedural or system-based
errors or problems have not been overlooked, if present…
Our regulators see human error as a last resort. Their expectation is that you can - and have -
eliminated any possible process issues and confirmed that the individual had everything they
needed and simply wasn’t focused.
Industry sees human error as a first-line response. We almost assume our processes, procedures
and training are bulletproof, and the issue must have resulted from someone not paying appropriate
attention to what they were doing at the time. When we do look at our training, procedures or
process, we often verify that they make sense to us – the reviewer. And then we retrain the operator
on the same process or procedure, using the same training process – quickly! – so they can return
to performing the task again.
Regulatory
bodies
Industries

9. Why at all HUMANS make
ERRORS ????
Psychology and science of Human Errors ?

10. Laws of Nature
We accept and design for the laws of nature.
Example : If a bridge falls down, we don’t list “gravity” as
the root cause

11. Human Information Processing
Shared
Attention
Resources
Thinking/
Storage
Sensing/
Planning
Acting/
Execution

13. Stages of Human Cognition :
1. Planning stage  Mistakes (Knowledge based and Rule based errors)
2. Storage Stage  Memory Lapses (Skill based errors)
3. Execution stage Slip in action (Skill based errors)

14. Execution stage
Storage Stage Planning Stage

15. Skill based errors (Slips and Lapses):
• Skill based errors occur during highly routine activities
• Attention diverted from task due to external or internal factors
• Individuals have right knowledge and experience in this case
• The task has been performed correctly many times before
• Since the person is used to this task, it is performed with less conscious attention
• Automatic and unconscious reasoning
• Retraining and disciplinary action is not appropriate responses for such errors.
Slip of Action :
• Unintentional action
• Occurs at the point of task execution
• Performing right action on wrong object or performing wrong action on right object
E.g. Pressing wrong button
Loosening the valve when intending to tighten it
Transposing digits when copying numbers (0.81 instead of 0.18)

16. Memory lapse:
• Occurs after formation of a plan and before execution
• During the plan is stored in brain
• Instances of forgetting to do something, losing place in sequence of
actions or even forgetting the overall plan
E.g.
Omissions of steps in an action
Repetition of steps in an activity

17. Mistakes (Rule based and Knowledge based errors):
• Occur due to failures of planning
• Plans fail due to inexperience, lack of knowledge, or poor information
• These are not committed on purpose
• They can be rule based or knowledge based.
Rule based errors:
• Undesired outcome due to use or disregard of set of rules/rule
• Certain rules that may work in one situation may not necessarily work in other
situations
1. Incorrect application of good rule
2. Application of a bad rule
3. Failure to apply a good rule (Also called violation)

18. Knowledge based errors:
• Results from trial and error
• Insufficient knowledge to plan an outcome/action
• Result due to incomplete or incorrect knowledge or
interpreting the situation incorrectly

25. Wecannotchangehumancondition;but wecanchangethe
conditionswherehumanswork!

26. • Limited short-term memory• Personality conflicts
• Mental shortcuts (biases)• Lack of alternative indication
• Inaccurate risk perception (Pollyanna)• Unexpected equipment conditions
• Mindset (“tuned” to see)• Hidden system response
• Complacency / Overconfidence• Workarounds / OOS instruments
• Assumptions (inaccurate mental picture)• Confusing displays or controls
• Habit patterns• Changes / Departures from routine
• Stress (limits attention)• Distractions / Interruptions
Human NatureWork Environment
• Illness / Fatigue• Lack of or unclear standards
• “Hazardous” attitude for critical task• Unclear goals, roles, & responsibilities
• Indistinct problem-solving skills• Interpretation requirements
• Lack of proficiency / Inexperience• Irrecoverable acts
• Imprecise communication habits• Repetitive actions, monotonous
• New technique not used before• Simultaneous, multiple tasks
• Lack of knowledge (mental model)• High Workload (memory requirements)
• Unfamiliarity w/ task / First time• Time pressure (in a hurry)
Individual CapabilitiesTask Demands
Error Precursors
short list

27. Are You Perfect?
Have you ever pushed the wrong button on an instrument
or incorrect option on a software, left your car headlights
on, missed to place vial in correct position during an HPLC
analysis or unintentionally deleted a file on your
computer?
Wonder how often these (and more serious) errors occur?

28. So….How Should We Approach
Human Errors?

29. The procedure was inadequate, and not able to be followed:
Prior to categorizing the failure as a human error, assess your procedure for the
following:
Did the procedure specifically require the step to be performed?
Did the procedure describe how the step should be performed?
Do the procedure and the way the operation is being performed match?

30. The training didn’t prepare the person to perform the task:.
•Did the training reflect the procedure content – and are all operators performing the
task doing it the same way?
•Was it the operator’s first time performing the task independently? Were they allowed
enough practice on the task, or was training rushed? Was training time used for
appropriate training activities?
•Did the trainer verify the operator’s ability to perform each required element of the
task? Against what standard?
•Is all the information the trainee needs to perform the task correctly accessible to
them?
•Did the trainer teach them the correct way to do the task? Did the trainer have the
knowledge and skills required to teach it?

31. The process isn’t designed to prevent errors:
•Did the procedure reflect the current process, in its entirety?
•Is this process prone to errors? Why?
•Can one person realistically perform the process, or does it demand
multiple people (complexity, multiple tasks performed at once, etc.)?
•Is the procedure available to the operator while performing the task, or
are they performing from memory?

32. The environment in which they were asked to perform wasn’t
conducive to proper performance:
•Was the operator spread too thin? Were they assigned too many work
tasks at once?
•Was the operator rushing? Would structuring the person’s time or task
list differently have avoided the error?
•Did the operator ask for assistance and not get it? Were required
resources (like reviewers or witnesses) available when needed?
•Did the manager clearly set expectations that included performing the
task per the procedure, and with the procedure in hand?

33. Thank You !