HUMAN

- Divya Krishnakumar
PURPOSE OF THIS SESSION

1. Understand Human Error

2. Underlying causes of Human Error

3. Resolution of Human Error

WHAT DO YOU THINK ABOUT THESE IMAGES?

Can we smoke
quietly?
WHAT DO YOU THINK ABOUT THESE IMAGES?

I only have
a human
mom.

¯\_(ツ)_/¯
WHAT DO YOU THINK ABOUT THESE IMAGES?

Oops, Sorry!
WHAT DO YOU THINK ABOUT THESE IMAGES?

Wait. So
where’s
the Bus
Stop?
WHAT DO YOU THINK ABOUT THESE IMAGES?

Is a sorry
sufficient here?
UNDERSTANDING
HUMAN
ERROR
WHAT IS HUMAN ERROR?

• Human error is when someone makes a

mistake which causes an accident or causes
something bad to happen.

What could be a few examples from

your work area?
STORIES IN AVIATION
• The Gimli Glider – Air • Air Ontario Flight 1363
Canada’s first Boeing 767

Who was at fault?

TO ERR IS HUMAN

• Studies tell us that EVERYONE commits errors

Human behaviour Human error is rarely People want to do

explains human error random. the right thing.

Therefore, looking at why and It is connected to the tools, We do what makes sense to us
how we behave in certain tasks and environment. That is, at the time given our focus of
situations helps to explain why it can often be predicted, and attention, knowledge,
we do what we do. in some situations, is inevitable. resources, time and goals
PERFECT HUMANS NEED PERFECT SYSTEMS

• Are systems and SOPs designed to prevent errors?

• People must create compliance using tools, systems

and technology

Therefore, systems that depend on

perfect behavior are fundamentally
wrong.
EXERCISE: Select one SOP from
your respective area where you find
maximum NC. Try to find out factors
that cause the NC other than human
error.
CONTRIBUTING FACTORS FOR SOP NON-
COMPLIANCE
Over complexity = confusion

Written for the

Written by the
auditor and not the
wrong person
user

Don’t reflect reality

Too many words
and ‘best practice’

Culture of Non- Poor layout, information inaccessible.

compliance Insufficient pictures, schematics, drawings
“JUGAAD” CULTURE
Most times, operators do the
job against all odds and do it
well. – The Great Indian
‘Jugaad’ Culture.

Following SOP and then doing

the task becomes impossible
with incompetent SOP and/or
tools and environment.

Most days, it holds the fort, but

some unfortunate day, it
doesn’t go as planned…
ROOT CAUSE OF ERROR

Factors leading to
Human Error
Human Error

Surface of the
Actual Problems
Problem
TRAINING – NOT A SOLUTION!

TRAINING
Factors leading to
Human Error
Human Error

Surface of the
Actual Problems
Problem
REGULATORY EXPECTATIONS

EU GMP Guidelines, Vol 4, Chapter 1

What do you think this means?

APPROACHING HUMAN ERROR RESOLUTION

“People don’t intentionally make mistakes. They

do the best they can with what they have
available.”

Human error is the consequence of a

desire to get the job done
UNDERLYING
CAUSES OF
HUMAN ERROR
WHY DO PEOPLE MAKE MISTAKES?

Mental Overload

Work Environment

Habituated Behaviour

Poor Understanding

Decision Making Issues

1. MENTAL OVERLOAD

Undefined
practices/ too
much choice
Too much text

Information
overload
Extreme Multi-
tasking
2. WORK ENVIRONMENT

• GIGO : Garbage in, Garbage

out.
• Stress, Fatigue, Dehydration
• Ergonomics - Comfort/
Discomfort of the operator
• Distractions – Noise, Sounds,
Smells etc.

Brain has limited capacity. Particularly what we call “Executive brain” – the brain we
use to try and understand, and for logical analysis and calculation
3. HABITUATED BEHAVIOUR

• Habits are patterns that allow us to

act without conscious thought

• Habits are a way of survival -> Free

up thinking space.

• Once formed, its impossible to break.

You can only replace!

• The strongest habit is always default.

4. POOR UNDERSTANDING
• Two areas :
1. Poor understanding
(education)
2. Lack of risk awareness
(consequences)

• Ineffective training

• Trainings are done but there is

failure to habituate it.
5. DECISION MAKING ISSUES

1.

2.

3.
REDUCING
HUMAN ERROR
APPROACHING HUMAN ERROR RESOLUTION

“Science of
Simplification”

Simplification is hard work. But it would

significantly reduce problems related to
human error.
1. MENTAL OVERLOAD - SOLUTIONS

Undefined
User Centered
practices/
Designs &too
muchpractices
Precise choice
Better design of
Too much
SOPs andtext
Batch
records

Information
Standardization
Minimize need overload
Multi-tasking
to multi-task
2. WORK ENVIRONMENT - SOLUTIONS

Stress :–Garbage
• GIGO Leads toin,
adrenaline
Garbage
rush
out. – FFF response and
‘cloudy’ thinking
• Stress, Fatigue, Dehydration
• Ergonomics – Comfortable
• Ergonomics
atmosphere -prevents
Comfort/less
Discomfort
distractions of theaids
and operator
work –
• ISO requirement
Distractions – Noise, Sounds,
• Shift
Smellstimings
etc. (might have
increased error rates) Monitor
shift timings continuously.

Avoiding
Brain stress
has limited will lead
capacity. to reduction
Particularly in reverting
what we call to old
“Executive brain” stronger
– the brain we
use to try and understand, and for logical analysis and calculation
habits
3. HABITUATED BEHAVIOUR - SOLUTION

• • Direct
Habitsand
areanalyze
patternsevery
that mistake
allow us to
quickly
act without conscious thought
• Precise practice and feedback (coach)
• Processes to have good (simple and
Habits are a way
• standardized) of survival
design. Easy to-> Free
form
up thinking
habits space.
with this.
• Use the habit loop to enforce new HABIT LOOP
habits. Colours/ symbols/ sounds can
• Once formed, its impossible to break.
be good cues. Design SOP and train
inYou cantoonly
a way replace! these.
incorporate

• The strongest habit is always default.

4. POOR UNDERSTANDING SOLUTION
• Two areas :
1. Poor understanding
(education)
2. Lack of risk awareness
(consequences)

• Ineffective training

• Trainings are done but there is

failure to habituate it.
5. DECISION MAKING ISSUES - SOLUTION

Use systematic approach – decision should be

1. simple, practical and evaluated

2. Fact based and risk-based decisions to be made

Use tools & techniques – FMEA, Information

3. management, decision trees etc.
EXERCISE: FORM
GROUPS OF 5
Take an Error cause and
find solutions. Try to
simplify things.
THANK
YOU