In pharmaceutical industry any investigation is concluded with "Human error" as root cause then understanding needs to be built for the root cause analysis. It is very easy to conclude as Human error, but difficult to justify. These Presentation includes 1. Trend of Human error in various industries. 2. Facts and Finding on Human error 3. Definition of Human error. 4. Viewpoint "Human Error" 5. Understanding of Human error part-1 and 2. 6. Contributing factors for human error. 7. Human weaknesses. 8. Human limitations. 9. Let's Have part (Secret game zone) 10. Human error investigation 11. Human error reduction 12. Thank you note

1. “HUMAN ERROR”
as a
Root Cause

2. Next hour will be…
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
FINDING FACT
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 :
Human error
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
Human error
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

8. Understanding of
Human failure-part-2
Violations
Routine
Situational
Exceptional

9. Understanding of
Human failure Human Error
Skill based
errors
Slip of action
Lapses of
memory
Mistakes
Rule-based
mistake
Knowledge-
based mistakeSlips 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 human error
Human
error
Culture
Training
Personal
factor
Other factor
Procedural
gap
Equipment
design
Organizational
factor

11. Human weaknesses
• It takes 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

12. Let’s have a fun

13. Let’s have a fun

14. Let’s have a fun

15. Let’s have a fun

16. Let’s have a fun

17. Let’s have a fun

18. Let’s have a fun

19. Let’s have a fun

20. Let’s have a fun

21. Let’s have a fun

22. Let’s have a fun

23. Human error
Investigation
Be quick with 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
human error
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.”