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

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 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)

Biosafety risk m anagem ent : electronic tool RI SK : probability X gravity Biosafety RI SK : Micro-organism To avoid : Activity/ process contamination Risk control dissemination measures

Biosafety risk m anagem ent : electronic tool Initiate Risk Management Process Risk analysis Risk Assessment is a systematic use of information to identify Risk Analysis specific sources of Risk Management tools & statistic toolbar hazards and estimate Risk Evaluation the risk (Resources, Interfaces & Line functions) Risk Control Risk evaluation Risk Mitigation (incl. elimination and avoidance) Compares the estimated [Severity] risk against given risk Risk Reduction criteria using a quantitative [Probability ] or qualitative scale to determine the significance Risk Acceptance of the risk Risk Communication Output / Results of the Review Risk Management Process (e.g. Inspections/Audits, Complaints) No additional risk

Biosafety risk m anagem ent : electronic tool Initiate Risk Management Process Risk Assessment Risk Analysis Risk Management tools & statistic toolbar Risk Evaluation (Resources, Interfaces & Line functions) Risk Control Risk Mitigation (incl. elimination and avoidance) [Severity] Risk Reduction [Probability ] Risk Acceptance Risk Communication Output / Results of the Review Risk Management Process (e.g. Inspections/Audits, Complaints) No additional risk

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

Biosafety risk m anagem ent : electronic tool

Biosafety risk m anagem ent : electronic tool

What can go wrong? Biosafety risk m anagem ent : electronic tool

Biosafety risk m anagem ent : electronic tool

What are the consequence? Biosafety risk m anagem ent : electronic tool

Biosafety risk m anagem ent : electronic tool What is the probability it would go wrong?

Biosafety risk m anagem ent : electronic tool

Biosafety risk m anagem ent : electronic tool Thank you for your attention !