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Biorisk Management =
                 Assessment, Mitigation, Performance




Dr: Dina Ramadan
Microbiologist
Quality manager ,central health laboratory
Biorisk Mitigation




11/9/2012                        2
Mitigation Control Measures




  Engineering   Administrative   Practices and      Personal
   Controls       Controls        Procedures        Protective
                                                 Equipment (PPE)


11/9/2012                                                     3
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



  11/9/2012                                        4
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
  11/9/2012                                                  5
Con/ Mitigation Control Measures
2. Administrative Controls:
Policies, standards , and guidelines used to control
   risks




  11/9/2012                                            6
•   Policies and risk management plan
•   Records for accidents
•    laboratory Signs
•   training




11/9/2012                               7
Con /Mitigation Control Measures
3. Practices and Procedures:
 Processes and activities that have been
shown in practice to be effective in reducing
  risks




11/9/2012                                       8
Con/ Mitigation Control Measures
4. Personal Protective Equipment:
Devices worn by the worker to protect against hazards
 in the laboratory




  11/9/2012                                      9
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
      11/9/2012                                                                10
Car vs. Motorcycle Safety
Car safety is all about engineering systems




                            wwww




 Motorcycle safety is all about PPE
 What is more safe?
  11/9/2012                                   11
Elimination not doing the intended Work or Substitution
using different materials
Notes : Control methods at the top of the list are in general
   11/9/2012                                             12
more effective and protective than those at the bottom.
•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
    11/9/2012
Biorisk managment

                      Identification of
                         Biorisks


            Biosafety Risk       Biosecurity Risk
             Assessment            Assessment


            Biosafety Risk        Biosecurity Risk
              Mitigation             Mitigation

11/9/2012                                            14
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




    11/9/2012                                                              15
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


  11/9/2012                                  16
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)




  11/9/2012                               17
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.
    11/9/2012                                                 18
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
   11/9/2012                                             19
Control

               Policies      “what to do”



             Procedure           “how to do it”
                                    (SOPs)



              Structure             “Organization
                                     structure”



            Responsibility             “Who do what”


11/9/2012                                         20
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
   11/9/2012                  measures                   21
Improvement

Setting and achieving management goals based on
  internal and external feedback.

                     Improvement
                       measures




                   On-going process


  11/9/2012                                   22
Continuous improvement philosophy
PDCA: Plan-do-check-act as defined by Deming.




11/9/2012                                       23
AMP vs. PDCA
Assessment = Plan, Do, Check, Act
Mitigation = Plan, Do, Check, Act
Performance = Plan, Do, Check, Act




11/9/2012                            25
11/9/2012   26
Risk Management Process


       Risk         Risk
    Assessment   Mitigation   performance




11/9/2012                                   28
BIORISK MANAGEMENT

                 Identification of
                    Biorisks

   Biosafety Risk              Biosecurity Risk
    Assessment                   Assessment


     Biosafety Risk           Biosecurity Risk
       Mitigation                Mitigation


                    Performance
11/9/2012            Measures                     29
The AMP Model

                Biorisk Management
   Assessment          Mitigation       Performance


Risk/Hazard/threat    Biorisk Control    Processes
   identification       Measures          QA/QC
 Risk Assessment     Risk Management     Objectives


  11/9/2012
  30
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
11/9/2012                                                            31
The system starts to fall apart
                      QUICKLY

                                      Facilities
                     Organization
                         &                          Personnel
                     Management




                                      Quality             Documentation
             Customer
                                                               &
            Satisfaction
                                    Management               Control




                    Continual
                                                   Technical
                  Improvement
                                      Assessment




11/9/2012                                                                 32
11/9/2012   33

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Mitigation,performance

  • 1. Biorisk Management = Assessment, Mitigation, Performance Dr: Dina Ramadan Microbiologist Quality manager ,central health laboratory
  • 3. Mitigation Control Measures Engineering Administrative Practices and Personal Controls Controls Procedures Protective Equipment (PPE) 11/9/2012 3
  • 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 11/9/2012 4
  • 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 11/9/2012 5
  • 6. Con/ Mitigation Control Measures 2. Administrative Controls: Policies, standards , and guidelines used to control risks 11/9/2012 6
  • 7. Policies and risk management plan • Records for accidents • laboratory Signs • training 11/9/2012 7
  • 8. Con /Mitigation Control Measures 3. Practices and Procedures: Processes and activities that have been shown in practice to be effective in reducing risks 11/9/2012 8
  • 9. Con/ Mitigation Control Measures 4. Personal Protective Equipment: Devices worn by the worker to protect against hazards in the laboratory 11/9/2012 9
  • 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 11/9/2012 10
  • 11. Car vs. Motorcycle Safety Car safety is all about engineering systems wwww Motorcycle safety is all about PPE What is more safe? 11/9/2012 11
  • 12. Elimination not doing the intended Work or Substitution using different materials Notes : Control methods at the top of the list are in general 11/9/2012 12 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 11/9/2012
  • 14. Biorisk managment Identification of Biorisks Biosafety Risk Biosecurity Risk Assessment Assessment Biosafety Risk Biosecurity Risk Mitigation Mitigation 11/9/2012 14
  • 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 11/9/2012 15
  • 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 11/9/2012 16
  • 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) 11/9/2012 17
  • 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. 11/9/2012 18
  • 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 11/9/2012 19
  • 20. Control Policies “what to do” Procedure “how to do it” (SOPs) Structure “Organization structure” Responsibility “Who do what” 11/9/2012 20
  • 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 11/9/2012 measures 21
  • 22. Improvement Setting and achieving management goals based on internal and external feedback. Improvement measures On-going process 11/9/2012 22
  • 23. Continuous improvement philosophy PDCA: Plan-do-check-act as defined by Deming. 11/9/2012 23
  • 24.
  • 25. AMP vs. PDCA Assessment = Plan, Do, Check, Act Mitigation = Plan, Do, Check, Act Performance = Plan, Do, Check, Act 11/9/2012 25
  • 26. 11/9/2012 26
  • 27.
  • 28. Risk Management Process Risk Risk Assessment Mitigation performance 11/9/2012 28
  • 29. BIORISK MANAGEMENT Identification of Biorisks Biosafety Risk Biosecurity Risk Assessment Assessment Biosafety Risk Biosecurity Risk Mitigation Mitigation Performance 11/9/2012 Measures 29
  • 30. The AMP Model Biorisk Management Assessment Mitigation Performance Risk/Hazard/threat Biorisk Control Processes identification Measures QA/QC Risk Assessment Risk Management Objectives 11/9/2012 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 11/9/2012 31
  • 32. The system starts to fall apart QUICKLY Facilities Organization & Personnel Management Quality Documentation Customer & Satisfaction Management Control Continual Technical Improvement Assessment 11/9/2012 32
  • 33. 11/9/2012 33