Risk assessment Presentation by Affygility Solutions
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In this 81 slide presentation, Dean Calhoun of Affygility Solutions discusses the history of risk assessments, the regulations requiring risk assessments, and the different types of risk assessments. Several examples are provided.
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Risk assessment Presentation by Affygility Solutions
- 1. Risk Assessments The Forgo1en Art #riskapi 1
- 2. Presenta7on Overview Introduc7ons What is Risk? Overview of the Risk Assessment Process Governmental regula7ons and standards requiring risk assessments • Types of risk assessment methodologies • Why is this important? • Risk assessments as part of a potent compound safety program • • • • 2
- 5. Establish the Context Hazard Iden7fica7on Communica7on & Consulta7on Probability Determina7on Monitoring & Review Risk Evalua7on Addi7onal Controls? 5
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- 7. Risk Assessment Attempts to Answer • What can happen and why? • What are the consequences? • What is the probability of their future occurrence? • Are there any factors that mitigate the consequence of the risk or that reduce the probability of the risk? • Is the level of risk tolerable or acceptable? 7
- 8. History 8
- 9. 1947 9
- 10. ’50s – ‘60s Minuteman ICBMs History • 1947: “Engineering for Safety” paper presented at the Ins7tute for Aeronau7cal Science • 1950 – 1960: Minuteman ICBM • NASA • Nuclear reactors 10
- 11. NASA 11
- 13. Governmental Regs & Standards 13
- 14. OSHA’s Process Safety Management Governmental Regula7ons and Standards Requiring Risk Assessments • OSHA’s Process Safety Management of Highly Hazardous Chemicals: 29 CFR 1910.119(e) • OSHA’s Voluntary Protec7on Program • EPA’s Risk Management Plan Standard: 40 CFR 68.67 • UK’s The Management of Health and Safety at Work Regula7ons 1999 Chapter 3 • ANSI/AIHA Z10-‐2012 Occupa7onal Health and Safety Management Systems • IEC/FDIS 31010: Risk Management – Risk Assessment Techniques • BS OHSAS 18001: Occupa7onal health and safety management systems • MIL-‐STD-‐882E 14
- 15. EPA’s Risk Management Plan Governmental Regula7ons and Standards Requiring Risk Assessments • OSHA’s Process Safety Management of Highly Hazardous Chemicals: 29 CFR 1910.119(e) • OSHA’s Voluntary Protec7on Program • EPA’s Risk Management Plan Standard: 40 CFR 68.67 • UK’s The Management of Health and Safety at Work Regula7ons 1999 Chapter 3 • ANSI/AIHA Z10-‐2012 Occupa7onal Health and Safety Management Systems • IEC/FDIS 31010: Risk Management – Risk Assessment Techniques • BS OHSAS 18001: Occupa7onal health and safety management systems • MIL-‐STD-‐882E 15
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- 21. Risk Assessments Gone Bad! 21
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- 26. Risk = Hazard X Probability 26
- 27. Benefits of Risk Assessments • Compliance with regulatory, customer, and internally derived requirements. • Adequate identification of potential exposure risks prior to the design or operation. • Early identification of the effects of engineering or operational decisions. • May minimize the need for industrial hygiene monitoring for similar operations. 27
- 28. Types of Risks Assessments 28
- 29. WHAT-‐IF 29
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- 31. HAZOP 31
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- 33. Preliminary Hazard Analysis 33
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- 37. BREAK 37
- 38. Introducing OEL Fastrac™ • High quality OEL monographs • Browse or search our online catalog • Order online • Instant download Go to oelfastrac.com to place an order 38
- 39. Affytrac QEA tool • Perform qualitative exposure assessments • Extremely flexible 39
- 40. Follow Affygility dcalhoun@affygility.com twi1er.com/affygility h1p://www.linkedin.com/in/affygilitysolu7ons facebook.com/affygilitysolu7ons Search “Google+ Affygility Solutions Go affygility.com/podcasts or go to iTunes and search for “Biopharma EHS 40
- 41. 30 seconds 2 minutes till start 41
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- 44. Establish the Context Hazard Iden7fica7on Communica7on & Consulta7on Probability Determina7on Monitoring & Review Risk Evalua7on Addi7onal Controls? 44
- 45. Establish the Context Hazard Iden7fica7on Communica7on & Consulta7on Probability Determina7on Monitoring & Review Risk Evalua7on Addi7onal Controls? 45
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- 50. Establish the Context Hazard Iden7fica7on Communica7on & Consulta7on Probability Determina7on Monitoring & Review Risk Evalua7on Addi7onal Controls? 50
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- 57. Establish the Context Hazard Iden7fica7on Communica7on & Consulta7on Probability Determina7on Monitoring & Review Risk Evalua7on Addi7onal Controls? 57
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- 63. Establish the Context Hazard Iden7fica7on Communica7on & Consulta7on Probability Determina7on Monitoring & Review Risk Evalua7on Addi7onal Controls? 63
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- 68. Establish the Context Hazard Iden7fica7on Communica7on & Consulta7on Probability Determina7on Monitoring & Review Risk Evalua7on Addi7onal Controls? 68
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- 75. Establish the Context Hazard Iden7fica7on Communica7on & Consulta7on Probability Determina7on Monitoring & Review Risk Evalua7on Addi7onal Controls? 75
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- 80. Risk = Hazard X Probability 80
- 81. Follow Affygility dcalhoun@affygility.com twi1er.com/affygility h1p://www.linkedin.com/in/affygilitysolu7ons facebook.com/affygilitysolu7ons Search “Google+ Affygility Solu7ons Go affygility.com/podcasts or go to iTunes and search for “Biopharma EHS 81