Biosafety risk m anagem ent : electronic tool 20 august 2008 - CIAB - - PowerPoint PPT Presentation

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Biosafety risk m anagem ent : electronic tool 20 august 2008 - CIAB - - PowerPoint PPT Presentation

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Biosafety risk m anagem ent : electronic tool 20 august 2008 - CIAB Toxicology Dept. Mathieu PAMPI N mathieu.pampin@afssaps.sante.fr Biosafety risk m anagem ent : electronic tool - Order 2 1 Septem ber 2 0 0 1 : traceability - Law of

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Biosafety risk m anagem ent : electronic tool

20 august 2008 - CIAB

Toxicology Dept.

Mathieu PAMPI N

mathieu.pampin@afssaps.sante.fr

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Biosafety risk m anagem ent : electronic tool

  • Order 2 1 Septem ber 2 0 0 1 :

traceability

  • Law of 2 0 0 4 + decree 2 0 0 9 : traceability

biosafety biosecurity In progress

  • Good laboratory practice for BSL3 and 4
  • Guideline biorisk management
  • Electronic tool for biorisk assessment (GeRBE)

(used for assessing applications and by the applicant if desired)

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RI SK : probability X gravity

Biosafety risk m anagem ent : electronic tool

To avoid : contamination dissemination Micro-organism Activity/ process Risk control measures

Biosafety RI SK :

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Biosafety risk m anagem ent : electronic tool

Risk analysis is a systematic use of information to identify specific sources of hazards and estimate the risk Risk evaluation Compares the estimated risk against given risk criteria using a quantitative

  • r qualitative scale to

determine the significance

  • f the risk

Risk Assessment Risk Evaluation Initiate Risk Management Process Risk Control

Risk Management tools & statistic toolbar

(Resources, Interfaces & Line functions)

Output / Results of the Risk Management Process Risk Communication

No additional risk

Risk Analysis Risk Mitigation

(incl. elimination and avoidance)

[Severity]

Review

(e.g. Inspections/Audits, Complaints)

Risk Acceptance Risk Reduction

[Probability ]

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Biosafety risk m anagem ent : electronic tool

Risk Assessment Risk Evaluation Initiate Risk Management Process Risk Control

Risk Management tools & statistic toolbar

(Resources, Interfaces & Line functions)

Output / Results of the Risk Management Process Risk Communication

No additional risk

Risk Analysis Risk Mitigation

(incl. elimination and avoidance)

[Severity]

Review

(e.g. Inspections/Audits, Complaints)

Risk Acceptance Risk Reduction

[Probability ]

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Biosafety risk m anagem ent : electronic tool

How does GeRBE w ork ?

Electronic tool for biorisk assessment (GeRBE)

  • Derived from Failure Mode Effects Analysis (FMEA)
  • Integrated micro-organism quotation/specificity
  • Integrated risk assessment (analysis & evaluation)
  • Integrated risk control measures
  • Help to decision on risk acceptance
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Biosafety risk m anagem ent : electronic tool

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Biosafety risk m anagem ent : electronic tool

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Biosafety risk m anagem ent : electronic tool

What can go wrong?

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Biosafety risk m anagem ent : electronic tool

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Biosafety risk m anagem ent : electronic tool

What are the consequence?

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Biosafety risk m anagem ent : electronic tool

What is the probability it would go wrong?

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Biosafety risk m anagem ent : electronic tool

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Thank you for your attention !

Biosafety risk m anagem ent : electronic tool