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Risk assessment Presentation by Affygility Solutions

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Dean Calhoun
Dean Calhoun

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  Assessments   The  Forgo1en  Art   #riskapi   1  
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  
What is Risk? 3  
Risk = _________ 4  
Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   5  
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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  
History 8  
1947 9  
’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  
NASA   11  
Nuclear  Reactors   12  
Governmental Regs & Standards 13  
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  
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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Risk Assessments Gone Bad! 21  
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Risk = Hazard X Probability 26  
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  
Types of Risks Assessments 28  
WHAT-­‐IF   29  
30  
HAZOP   31  
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Preliminary  Hazard  Analysis   33  
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BREAK 37
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
Affytrac QEA tool •  Perform qualitative exposure assessments •  Extremely flexible 39
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
30 seconds 2 minutes till start 41
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Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   44  
Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   45  
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Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   50  
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Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   57  
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Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   59  
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Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   63  
Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   64  
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Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   68  
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Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   75  
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Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   77  
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Risk = Hazard X Probability 80  
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  

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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  
  • 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  
  • 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  
  • 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  
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  • 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  
  • 58. 58  
  • 59. Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   59  
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  • 63. Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   63  
  • 64. Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   64  
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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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  • 77. Establish  the  Context   Hazard  Iden7fica7on   Communica7on   &   Consulta7on   Probability  Determina7on   Monitoring   &   Review   Risk  Evalua7on   Addi7onal  Controls?   77  
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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