4th AfBSA Conference, 23-25 March 2015

Introduction to
Risk--based Thinking
Risk

Nicolas Bouchet, PhD – Burkina Faso

What is
« Risk-
Risk-based
Thinking » ?
Risk

Definition (ISO)
Effect on uncertainty on objectives

Risk is a combination of the probability of a hazard

resulting in an adverse event, times the severity of the
event
Risk Management

Identification, assessment, and prioritization

of risks followed by coordinated and economical
application of resources to minimize, monitor, and
control the probability and/or impact of unfortunate
events or to maximize the realization of opportunities
 Identify
Risks

Measure, Risk
control & assess &
monitor analyze
Risk
Management

Implement Plan
action
Risk Management

But risk is a management nightmare !

Calculated uncertainty is always incomplete

Risk--based thinking
Risk

Risk ≠ 0

Probability Severity
Risk--based thinking
Risk

Probability

Severity
Risk--based thinking
Risk

Probability

Severity
« Risk » : it’s not a new concept
« Risk » : new approach in the laboratories

It becomes mandatory
Risk--based thinking
Risk

In all the aspects of your life / job

Risk--based thinking
Risk

In all the aspects of your life / job

If you want to cross the road, you will ensure safe

conditions ; you won’t move if there a car in front of
moving.
Risk--based thinking
Risk

In all the aspects of your life / job

Insurance (healthcare, cars, part of your body, etc…)

Biosafety Biorisk Management (CEN 15793)

Quality / ISO ?
Risk--based thinking
Risk

Risk management is an increasily important business

driver and stakeholders have become much more
concerned about risk
Quality / ISO
Risk--based thinking
Risk

Risk management is an increasily important business

driver and stakeholders have become much more
concerned about risk
Quality / ISO

ISO 31000 : 2009

Implementation of Risk
Management principles
Risk--based thinking
Risk

Risk management is an increasily important business

driver and stakeholders have become much more
concerned about risk
Quality / ISO

ISO 15189 : 2012

ISO 31000 : 2009 Introduction to Risk
Implementation of Risk Management
Management principles
Risk--based thinking
Risk

Risk management is an increasily important business

driver and stakeholders have become much more
concerned about risk
Quality / ISO

ISO 15189 : 2012

ISO 31000 : 2009 Introduction to Risk
Implementation of Risk Management
Management principles

ISO 9001 : 2015

Key change : systematic approach to risk
Risk--based thinking
Risk

ISO 9001 (previous editions) specific clause for

preventive action

ISO 9001 : 2015 risk is considered and included

throughout the standard
Risk--based thinking
Risk

ISO 9001 (previous editions) specific clause for

preventive action

ISO 9001 : 2015 risk is considered and included

throughout the standard

By taking a risk-based approach, an organization

becomes proactive rather than purely reactive, preventing
or reducing undesired effects and promoting continual
improvement
Risk--based thinking
Risk

In a risk-based management system, preventive action is

automatic.
Risk-based thinking is something we all do automatically
and often sub-consciously.
Risk--based thinking
Risk

If you want to cross the

railways, you can cross
in a straightforward
manner

Opportunity to
reach across the
railways quickly, but the
risk of injury (or worse)
is high
Risk--based thinking
Risk

Or you can use the bridge.

But there is also a risk : you might be too late.
But the chances of getting hit by a train is very very small.
Risk--based thinking
Risk

The risk must be considered from the beginning of all

your processes, making preventive action part of strategic
planning as well as operation and review.

Risk-based thinking is already part of the process

approach. For e.g to cross the road I may go directly or I
may use a nearby footbridge. Which process I choose will
be determined by considering the risks.

Risk-based thinking makes preventive action

part of the routine
Risk--based thinking
Risk

Risk always negative ??

Risk--based thinking
Risk

Risk could be NEGATIVE or POSITIVE

Risk--based thinking
Risk

Risk could be NEGATIVE or POSITIVE

= Opportunities
You must try to You need to make
avoid it ! maximum use of that
Risk--based thinking
Risk

Risk-based thinking is taking into account the risk to

the overall management system

Improving achievement of defined objectives

The output will be more consistent

Customers increasingly assured of receiving a

product / service that is excepted
Risk--based thinking
Risk

Nurture a culture of proactive towards

improvement

Ensure consistency of quality of goods / services

Increase customer confidence and satisfaction

Intuitively, successfull companies already and always

use a risk-based approach
Risk--based thinking in laboratories
Risk
Risk Management in the lab : Scenario A
A medical laboratory provides direct on-line access
to results by patients
Risk Management in the lab : Scenario A
A medical laboratory provides direct on-line access
to results by patients

Unfortunately the medical LIS is breached and the

file of patient passwords compromised
Risk Management in the lab : Scenario A
A medical laboratory provides direct on-line access
to results by patients

Unfortunately the medical LIS is breached and the

file of patient passwords compromised

Sensitive medical information on a person of note is

made public
Risk Management in the lab : Scenario A
A medical laboratory provides direct on-line access
to results by patients

Unfortunately the medical LIS is breached and the

file of patient passwords compromised

Sensitive medical information on a person of note is

made public

Reputations are damaged

Impact on the laboratory & on patients
Risk Management in the lab : Scenario B (real
(real))
Introduction of a new test for STD that is technically
easier than the standard test
Risk Management in the lab : Scenario B (real
(real))
Introduction of a new test for STD that is technically
easier than the standard test

Despite the knowledge that the test has poor specificity,

the test is used both for patient testing and screening
Risk Management in the lab : Scenario B (real
(real))
Introduction of a new test for STD that is technically
easier than the standard test

Despite the knowledge that the test has poor specificity,

the test is used both for patient testing and screening

Many patients are incorrectly identified as having STD.

Unfortunately, this information is released
Risk Management in the lab : Scenario B (real
(real))
Introduction of a new test for STD that is technically
easier than the standard test

Despite the knowledge that the test has poor specificity,

the test is used both for patient testing and screening

Many patients are incorrectly identified as having STD.

Unfortunately, this information is released

Community reputation is harmed

Patients seek redress through litigation
Risk Management in the lab

What these scenarios have in common ?

Risk Management in the lab

What these scenarios have in common ?

Unhappy outcomes are the results of

UNRECOGNIZED & UNMANAGED RISKS

It seemed like a good

idea at the time
Risk Management in the lab

Risk management in laboratories is

a necessity
Identify the risk to minimize it

Necessity because :
Many samples lot of informations potential huge
impact of these informations on health of patients
poor information can lead to poor outcomes
Wide Risk Footprint

Risks
Wide Risk Footprint

Patients

Laboratory

Medical team
Risks
Hopital / institution

Environnement

Community
Risk Management in the lab

Risk management is a necessity

A necessity, but is it really

something new in labs ?
Risk Management in the lab

Reduction of the risk of error analysis

IQC, EQC, maintenance, internal audit, QI

Reduction of the risk of lab accidents

gloves, lab coat, alterness, training, SOP

Risk and labs biosafety management, audit, CAPA

management , continuous improvement, management of
complaints, errors reduction
Risk Management in the lab

Many way to make risk analysis & management

FMEA (Failure Mode and Effects Analysis)

Product evaluated
 Potential source of failure Criticality Control Valid
ation
Step or F C E S P C P D R Outco
compone
nt in A A F E R R R E E me
which I U F V O I E T C
failure
occurs L S E E B T V E O measu
U E C R A I E E V re
R T I B C N C E
E T I A T T R
Y L L I I Y
I I O O
T T N N
Y Y
 Potential source of failure Criticality Control Validati
on

Step or F C E S P C P D R Outcome
compone
nt in A A F E R R R E E measure
which I U F V O I E T C
failure
occurs L S E E B T V E O
U E C R A I E E V
R T I B C N C E
E T I A T T R
Y L L I I Y
I I O O
T T N N
Y Y
IQC IQC Degradati NO - - - Provide Conduct Rerun Review
2 on due to R storage stability with QC
fails improper E instruction studies another records
storage s QC
S regurlar
by user
U y
L
T
S
Risk Management in the lab

Many way to make risk analysis & management

FMEA (Failure Mode and Effects Analysis)

Product evaluated

FRACAS (Failure Reporting and Corrective Action

System)
Product in use
 Conclusion

Be AWARE of the Risks

nikolas.bouchet@gmail.com
kosgey.abigail@gmail.com