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Risk Based Decision Making:

Practical Application of Risk


Assessment

Structured Decision Making

Helps to overcome these in built weaknesses



Design a SIMPLE process

Use it until it becomes habit

Refine and improve but KEEP IT SIMPLE!

Learn from your mistakes

Structured Decision Making


Buzz

ReviewGroup
and reflect on what
has been discussed

Brainstorm all of the essential elements of a good decision


making process

Individually(post its)
In your groups

Design a process flow for structured decision making

Risk Based Decision Making


A structured approach /

Understand the situation first

Hold on to the BIG PICTURE

Be comfortable with your level of uncertainty



Seek the advice and wisdom of others

THEN assess risk

THEN manage risk

Understand the Problem


Obtain

HARD data and information


THE WHO
THE WHAT
THE WHY
THE HOW
THE WHEN
BUT AVOID PARALYSIS BY ANALYSIS

Always Be DATA DRIVEN

Base decisions on facts, not assumptions

Data must be
Accurate
Reliable
Unbiased
Well presented

Keep the BIG PICTURE


Avoid getting sucked into detail early on
The 5Ws and the HOW 5W
Magnitude of the problem or situation
Single or multiple batches?
One or more plants?
Direct patient risk?
Regulatory or compliance risk?
Risk to supply chain?

Peeling the Onion


Purpose
Encourage investigation leaders to undress the problem

Avoid getting into excessive detail too soon

Root Cause

Establish your Level of


Uncertainty
Accept that you will never FULLY understand the problem

There will always be some uncertainty

The smaller the level of uncertainty the better the decision

The investigation must reduce uncertainty to an acceptable level


Key Questions to Ask

What do I know?(HARD data, indisputable facts)



What assumptions can I safely make?(based on experience, intuition
and soft data)

What DONT I KNOW?

A Simple Fact
YOU CANT MAKE THE RIGHT DECISION WITH A HIGH LEVEL OF
UNCERTAINTY!

Ask the RIGHT Questions

Questions to ask LISTEN



ACTIVELY
OPEN: To gather information

PROBING: To focus on specific issues

CLOSED(yes or no): To obtain agreement


/
SUMMARY: To confirm understanding

HYPOTHETICAL: To generate ideas

Questioning Skills:
Ask the RIGHT people
Ask a broad audience
OPERATORS and SUBJECT EXPERTS
Generalist

Explore differences of opiniondont ignore

KEEP AN OPEN MIND


And listen

Assess Risk
What is Risk?
Risk is the PROBABILITY of harm and the SERVERITY of HARM

Risk Identification?
What can actually go wrong? ?

Risk Analysis
What are the possible consequences(SERVERITY) of harm to the
PATIENT and the BUSINESS?

What is the PROBABILITY of OCCURRENCE?

What is the LIKELIHOOD of DETECTION?

Risk Analysis
After every Risk Analysis
Take time out
Ask yourself DOES THIS FEEL RIGHT

Professionally
Morally
Ethically
Beware of the Management Hat

Risk Evaluation
Comparison of risk vs. criteria
Assign PROBABILITY and SERVERITY
May be quantitative or qualitative

Risk Control
Is the risk unacceptable?
What can be done to
Reduce risk?
Eliminate risk?
Must be PROPORTIONATE!
Risks
Benefits
Resources

Risk Reduction
Mitigating SEVERITY
Reducing PROBABILITY
Increasing DETECTABILITY(CARE!) ( !)
and then RISK ACCEPTANCE

FinallyALWAYS BE
SYSTEMATIC
Look at symptoms
Get good quality data
Analyze and understand
Consult others
Problem statement
Investigate and risk assess
DECISION!

Make the Decision but


Remember

The ripple affect. Be prepared for resistance and disagreement



Think long and hard about communication

FACE to FACE is the only way. Dont be a coward

Top down vs. bottom up


vs.
Involve stakeholders in the decision break them in slowly

Document everything. Remember your little black book

One Last Word


The process may appear linear but decision making isnt

Decision making is a recursive "process

You move up and down the decision making process

Whole Brain Thinking:

Research has shown that most of us only use 4-5% of our


intellectual capacity

Dont worryits not your fault. Youve been educated that way

Schools focus on left brain thinking(limited capacity)



The unlimited capacity of right brain largely ignored

Right Brain Thinking: Tools and


Techniques
Lateral thinking
Brain storming
6 Hats Thinking
Mind Mapping
And more

Essential Messages
Remember, our brains are designed for speed not accuracy

Be systematic. Practice-refine-improve-practiceBUT KEEP IT


SIMPLE!

Look after your brain and it will look after you

Learn from your mistakes and those of others