Biorisk management involves three key components: assessment, mitigation, and performance. Assessment identifies risks and hazards, mitigation develops control measures to reduce risks, and performance monitoring ensures the system is working properly through techniques like audits, inspections, and continuous improvement. Neglecting any one component can compromise the overall effectiveness of the biorisk management system.

1. Biorisk Management =
Assessment, Mitigation, Performance
Dr: Dina Ramadan
Microbiologist
Quality manager ,central health laboratory

2. Biorisk Mitigation
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3. Mitigation Control Measures
Engineering Administrative Practices and Personal
Controls Controls Procedures Protective
Equipment (PPE)
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4. Mitigation Control Measures
1. Engineering Controls:
Physical changes to work stations, equipment,
materials, production facilities, of the work
environment that reduce or prevent exposure to
hazards
I Lab design
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5. II SAFETY EQUIPMENT
1. Hoods
 Fume Hoods
Fume hoods are used when chemical reagents may produce
a hazardous fume.
Air flow should be checked to assure proper ventilation.
 Biological Hoods
Biological safety cabinets (BSCs)
it remove particles that may infect the person
working with the biologically infected specimen.
These hoods contain a HEPA (high-efficiency
particulate air) filter
2 Chemical storage equipment
Safety cabinets are required for the storage of
flammable liquids
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6. Con/ Mitigation Control Measures
2. Administrative Controls:
Policies, standards , and guidelines used to control
risks
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7. • Policies and risk management plan
• Records for accidents
• laboratory Signs
• training
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8. Con /Mitigation Control Measures
3. Practices and Procedures:
Processes and activities that have been
shown in practice to be effective in reducing
risks
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9. Con/ Mitigation Control Measures
4. Personal Protective Equipment:
Devices worn by the worker to protect against hazards
in the laboratory
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10. Advantages/Disadvantages
Control Measure Advantages Disadvantages
Engineering Efficient, Cost,
eliminates hazard complexity
Administrative Authority approach Indirect approach, primarily
addresses the human factor
Training and supervision
Practices & Procedures SOP based (standardized
requirements
approach)
PPE Does not eliminate hazard, PPE
Ease of use, relative cost
fails exposure happens,
uncomfortable, limits ability
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11. Car vs. Motorcycle Safety
Car safety is all about engineering systems
wwww
Motorcycle safety is all about PPE
What is more safe?
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12. Elimination not doing the intended Work or Substitution
using different materials
Notes : Control methods at the top of the list are in general
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more effective and protective than those at the bottom.

13. •first you must consider elimination or substitution
•A combination of control measures should be used based
on their effectiveness and your ability to implement them 13
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14. Biorisk managment
Identification of
Biorisks
Biosafety Risk Biosecurity Risk
Assessment Assessment
Biosafety Risk Biosecurity Risk
Mitigation Mitigation
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15. Biorisk Management
Assessment , Mitigation, Performance
•Elimination or Substitution
•Risk identification •Engineering Controls
•Hazard/threat identification •Administrative Control
•Likelihood evaluation •Practices and Procedures
•Consequences evaluation •Personal Protective Equipment
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16. what specific steps are still missing from
the system after assessment and
mitigation?
performance
Performance is the way in which someone or
something functions
Performance improves biorisk management
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17. How performance improve risk
management system
It give idea of the following:
 If your system work will ( control)
 If your system sustainable (assure)
 If the risk is accessible (improve)
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18. Performance
• The Trilogy of Quality
• Control Management
– Policy
– Procedure
– Structure
– Responsibility
• Assurance
Juran (1904-2008)
checking the system through
• Quality Planning
audits and inspections
• Improvement • Quality Control
Setting and achieving
management • Quality Improvement
goals based on internal and
external feedback.
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19. Control
It is the procedures undertaken by the laboratory staff for
theCONTINUOUS AND IMMEDIATE
monitoring of laboratory work in order to decide whether the
results are reliable enough to be released.
Through :
Validation/verification,
quality control,
proficiency testing,
specimen management
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20. Control
Policies “what to do”
Procedure “how to do it”
(SOPs)
Structure “Organization
structure”
Responsibility “Who do what”
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21. Assurance
checking the system through audits and inspections
Includes IQC, EQA, pre-analytic phase, test standardization,
post-analytic phase, Performance Evaluations
management, and organization (WHO, 1992)
Internal audit External
or self evaluation
evaluation
Improvement
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22. Improvement
Setting and achieving management goals based on
internal and external feedback.
Improvement
measures
On-going process
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23. Continuous improvement philosophy
PDCA: Plan-do-check-act as defined by Deming.
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25. AMP vs. PDCA
Assessment = Plan, Do, Check, Act
Mitigation = Plan, Do, Check, Act
Performance = Plan, Do, Check, Act
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28. Risk Management Process
Risk Risk
Assessment Mitigation performance
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29. BIORISK MANAGEMENT
Identification of
Biorisks
Biosafety Risk Biosecurity Risk
Assessment Assessment
Biosafety Risk Biosecurity Risk
Mitigation Mitigation
Performance
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30. The AMP Model
Biorisk Management
Assessment Mitigation Performance
Risk/Hazard/threat Biorisk Control Processes
identification Measures QA/QC
Risk Assessment Risk Management Objectives
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30

31. What happens if you focus all your energy
on one component?
Facilities
Organization
& Personnel
Management
Documentation
Customer Quality
&
Satisfaction Management Control
Continual
Technical
Improvement
Assessment
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32. The system starts to fall apart
QUICKLY
Facilities
Organization
& Personnel
Management
Quality Documentation
Customer
&
Satisfaction
Management Control
Continual
Technical
Improvement
Assessment
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