mitigation,performance
TRANSCRIPT
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Biorisk Management = Assessment, Mitigation, Performance
Dr: Dina RamadanMicrobiologist Quality manager ,central health laboratory
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Biorisk Mitigation
Lab and
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Engineering Controls
Administrative Controls
Practices and Procedures
Personal Protective
Equipment (PPE)
Mitigation Control Measures
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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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II SAFETY EQUIPMENT1. Hoods
Fume HoodsFume 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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Con/ Mitigation Control Measures
2. Administrative Controls: Policies, standards , and guidelines used to control
risks
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• Policies and risk management plan• Records for accidents• laboratory Signs• training
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Con /Mitigation Control Measures3. Practices and Procedures: Processes and activities that have been shown in practice to be effective in reducing
risks
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Con/ Mitigation Control Measures
4. Personal Protective Equipment: Devices worn by the worker to protect against hazards
in the laboratory
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Advantages/Disadvantages
Control Measure Advantages Disadvantages
Engineering Efficient,eliminates hazard
Cost,complexity
Administrative Authority approach Indirect approach, primarily addresses the human factor
Practices & Procedures SOP based (standardized approach)
Training and supervision requirements
PPE Ease of use, relative cost Does not eliminate hazard, PPE fails exposure happens, uncomfortable, limits ability
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wwww
Motorcycle safety is all about PPEWhat is more safe?
Car vs. Motorcycle SafetyCar safety is all about engineering systems
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Elimination not doing the intended Work or Substitution using different materialsNotes : Control methods at the top of the list are in general more effective and protective than those at the bottom.
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•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
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Biorisk managment
Biosafety Risk Assessment
Biosecurity Risk Assessment
Biosafety Risk Mitigation
Biosecurity Risk Mitigation
Identification of Biorisks
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Assessment , Mitigation, Performance
•Risk identification•Hazard/threat identification•Likelihood evaluation•Consequences evaluation
Biorisk Management
•Elimination or Substitution•Engineering Controls•Administrative Control•Practices and Procedures•Personal Protective Equipment
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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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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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Performance
• Control – Policy– Procedure– Structure– Responsibility
• Assurance checking the system through audits and inspections• ImprovementSetting and achieving management goals based on internal and
external feedback.
• The Trilogy of Quality Management
Juran (1904-2008)
• Quality Planning
• Quality Control
• Quality Improvement
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ControlIt 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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Control
Policies
Procedure
Structure
Responsibility
“what to do”
“how to do it” (SOPs)
“Organization structure”
“Who do what”
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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 or self
evaluation
External evaluation
Improvementmeasures
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Improvement
Setting and achieving management goals based on internal and external feedback.
On-going process
Improvementmeasures
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Continuous improvement philosophyPDCA: Plan-do-check-act as defined by Deming.
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AMP vs. PDCAAssessment = Plan, Do, Check, Act
Mitigation = Plan, Do, Check, Act
Performance = Plan, Do, Check, Act
AMP
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Risk Management Process
Risk Assessment
Risk Mitigation performance
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Biosafety Risk Assessment
Biosecurity Risk Assessment
Biosafety Risk Mitigation
Biosecurity Risk Mitigation
Performance Measures
Identification of Biorisks
BIORISK MANAGEMENT
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The AMP Model
Biorisk Management Assessment Mitigation Performance
Risk/Hazard/threat identification
Risk Assessment Biorisk Control Measures
Risk ManagementProcesses
QA/QCObjectives
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What happens if you focus all your energy on one component?
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The system starts to fall apartQUICKLY
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