Template Selection for Effective Risk Assessment

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

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.

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.

Introduction

• Brief overview of risk

assessment

• Importance of selecting the

right template

• Purpose of the presentation

Importance of
Risk Assessment

• Identifying potential risks
• Preventing biosecurity breaches
• Ensuring safety and compliance

WHO Risk
Assessment
Template

• Purpose: Global health

risks.

• Structure: Hazard

identification, risk
evaluation, risk
management.

• Key features:

Comprehensive, globally
recognized, adaptable.

Multiple Choice

1. What is the first step in the Risk Assessment process according to the WHO LBM 4 template?

• Identify hazards
• Implement control measures
• Assess risks
• Review controls

Fill in the Blank

2. The 2nd step on this template is ___________

Reorder

3. Reorder the following hierarchy of controls.

1

2

3

4

5

• 1
• 2
• 3
• 4
• 5

Netherlands
Biosecurity
Template

• Purpose: Biosecurity

threats.

• Structure: Threat

assessment, vulnerability
analysis, impact
assessment.

• Key features: Focus on

biosecurity, detailed
threat analysis.

BioRam
Template

Purpose:
Biosafety and biosecurity.

Structure:
Risk identification, risk analysis,
risk control measures.

Key features:
Integrated approach, tailored for
laboratory and research
environments.

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.

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

Multiple Choice

4. How many steps are outlined in the Risk Assessment process in the new DOH laboratory biosafety and biosecurity manual?

• 5
• 7
• 6
• 3

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

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

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

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

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

Criteria for
Selecting a
Template

• Factors to consider (e.g.,

organizational needs,
regulatory requirements)

• Adaptability and

scalability

• User-friendliness

Multiple Choice

5. How frequently should we perform a risk assessment?

• Quarterly or when minor changes occur
• Bi-annually regardless of changes
• Annually or when significant changes occur
• Once every 5 years

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.

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.

Acknowledgement

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."

Thank you for your listening!

Be Safe

Be Biosafe