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
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