
Template Selection for Effective Risk Assessment
Presentation
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Professional Development
•
University
•
Practice Problem
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Michaella Sayo
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33 Slides • 5 Questions
1
Template Selection for
Effective Risk Assessment
A Comprehensive Guide of WHO,
Netherlands Biosecurity, BioRam, and
DOH Templates
Michaella B. Sayo, RMT, MSMT, CBP, IFBA PC
June 15, 2024
2
Key messages
1. Risk assessment is essential for identifying and managing
biosecurity risks, preventing incidents, and ensuring compliance
with safety regulations
2. Selecting an appropriate risk assessment template ensures
thorough and effective evaluation, tailored to specific
organizational needs and contexts.
3
Key messages
3. Each template (WHO, Netherlands Biosecurity, BioRam, DOH)
has unique strengths and weaknesses. Understanding these
differences helps in making an informed choice based on
comprehensiveness, usability, and adaptability.
4. Regularly review and update risk assessment templates to
maintain their relevance. Encourage questions and discussions to
enhance understanding and share practical insights for better
implementation.
4
Introduction
• Brief overview of risk
assessment
• Importance of selecting the
right template
• Purpose of the presentation
5
Importance of
Risk Assessment
• Identifying potential risks
• Preventing biosecurity breaches
• Ensuring safety and compliance
6
WHO Risk
Assessment
Template
• Purpose: Global health
risks.
• Structure: Hazard
identification, risk
evaluation, risk
management.
• Key features:
Comprehensive, globally
recognized, adaptable.
7
Multiple Choice
What is the first step in the Risk Assessment process according to the WHO LBM 4 template?
8
9
10
Fill in the Blanks
11
12
13
Reorder
Reorder the following hierarchy of controls.
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15
16
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Netherlands
Biosecurity
Template
• Purpose: Biosecurity
threats.
• Structure: Threat
assessment, vulnerability
analysis, impact
assessment.
• Key features: Focus on
biosecurity, detailed
threat analysis.
18
19
20
BioRam
Template
Purpose:
Biosafety and biosecurity.
Structure:
Risk identification, risk analysis,
risk control measures.
Key features:
Integrated approach, tailored for
laboratory and research
environments.
21
BioRam
Template
BioRAM is a computerized
risk assessment tool
developed by Sandia National
Laboratories, in partnership
with the international
community, to facilitate
laboratory risk assessments
by simplfying Risk
Characterization.
22
DOH Risk
Assessment
Template
• Purpose:
Public health risks, biosafety, and
biosecurity.
• Structure:
Hazard assessment, exposure
assessment, risk characterization.
• Key features:
Patterned after WHO Laboratory
Manual, detailed exposure
assessment, emphasis on biosafety
and biosecurity
23
Multiple Choice
How many steps are outlined in the Risk Assessment process in the new DOH laboratory biosafety and biosecurity manual?
24
25
Likelihood / Probability
Level
Descriptor
Example (ISO 14971)
Practical Example
1
Rare
< 1/1,000,000 but ≥ 1/10,000,000
Unlikely to ever happen
2
Unlikely
≤ 1/100,000 but ≥ 1/1,000,000
Once every few years
3
Possible
≤ 1/10,000 but ≥ 1/100,000
Once a year
4
Likely
≤ 1/1,000 but ≥ 1/10,000
Once every few months
5
Almost Certain
≥ 1/1,000
More than 1x/week
26
Consequences / Impact
Level
Descriptor
Likelihood Description
1
Moderate
Inconvenience or temporary discomfort
2
Results in temporary injury or impairment not requiring professional
medical intervention
3
Results in injury or impairment requiring professional medical
intervention
4
Major
Results in permanent injury of life-threatening injury
5
Severe
Results in patients death
Negligible
Minor
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28
29
Comparison of
Templates
• Side-by-side comparison of
WHO, Netherland Biosecurity,
BioRam, and DOH templates
• Criteria for comparison (e.g.,
comprehensiveness, usability,
adaptability)
• Pros and cons of each
template
30
CRITERIA
WHO TEMPLATE
NETHERLANDS
BIOSECURITY
TEMPLATE
BioRAM
TEMPLATE
DOH TEMPLATE
COMPREHENSIVENESS
High- covers a
wide range of
biosafety risks
Moderate- focused
on national
biosecurity
High-
Customizable
and interactive
High-Health
specific risks
USABILITY
Moderate-detailed
but comples
High-practical and
user friendly
High-user-friendly
interface
Moderate-
structured but
health specific
ADAPTABILITY
Moderate-
Internationally
applicable but less
flexible
Low-Tailored to
Duch context
High-highly
adapatable to
different contexts
Low-limited to
health sector
COMPARISON TABLE
31
CRITERIA
NETHERLANDS
BIOSECURITY
TEMPLATE
STRENGHTS
Comprehensive
, recognized
international
standard
User-friendly,
practical, specific
to national needs
Interactive,
adaptable,
easy to use
Health-specific,
ensures compliance
WEAKNESSESS
Complex,
resource-
intensive
Limited
applicability
outside
Netherlands
Tecnology-
dependent,
associated
costs
Limited to health
sector, not
comprehensive for
other risks
BEST SUITED
FOR
Organizations
requiring
detailed and
thorough risk
assessment
Dutch
organizations,
national
biosecurity needs
Organization
s with
technologica
l capabilities,
needing
adaptable
solutions
Government and
private organizations,
focusing on health-
related risk
COMPARISON TABLE
WHO
TEMPLATE
DOH TEMPLATE
BioRAM
TEMPLATE
32
Criteria for
Selecting a
Template
• Factors to consider (e.g.,
organizational needs,
regulatory requirements)
• Adaptability and
scalability
• User-friendliness
33
Multiple Choice
How frequently should we perform a risk assessment?
34
Key messages
1. Risk assessment is essential for identifying and managing
biosecurity risks, preventing incidents, and ensuring
compliance with safety regulations
2. Selecting an appropriate risk assessment template ensures
thorough and effective evaluation, tailored to specific
organizational needs and contexts.
35
Key messages
3. Each template (WHO, Netherlands Biosecurity, BioRam,
DOH) has unique strengths and weaknesses. Understanding
these differences helps in making an informed choice based on
comprehensiveness, usability, and adaptability.
4. Regularly review and update risk assessment templates to
maintain their relevance. Encourage questions and discussions
to enhance understanding and share practical insights for
better implementation.
36
Acknowledgement
37
Take home message....
"Effective risk assessment is not just about
predicting the future; it's about shaping it. By
choosing the right template, we pave the way
for safer, more secure environments, ready to
face whatever challenges come our way."
38
Thank you for your listening!
Be Safe
Be Biosafe
Template Selection for
Effective Risk Assessment
A Comprehensive Guide of WHO,
Netherlands Biosecurity, BioRam, and
DOH Templates
Michaella B. Sayo, RMT, MSMT, CBP, IFBA PC
June 15, 2024
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