Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Risk Analysis

1,164 views

Published on

Pete Davis, VP Research & Development Neomend

Published in: Technology, Business
  • I’ve personally never heard of companies who can produce a paper for you until word got around among my college groupmates. My professor asked me to write a research paper based on a field I have no idea about. My research skills are also very poor. So, I thought I’d give it a try. I chose a writer who matched my writing style and fulfilled every requirement I proposed. I turned my paper in and I actually got a good grade. I highly recommend ⇒ www.WritePaper.info ⇐
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here

Risk Analysis

  1. 1. 1 To err is human Pete Davis VP of Research & Development Neomend a subsidiary of Bard Davol
  2. 2. 2 Really – an R&D guy presenting risk analyses??
  3. 3. Risks exist because perfection doesn’t! 3
  4. 4. Communicating to Management the Value of Risk Management 4
  5. 5. 5 Risk Analysis Steps • Why Risk Management • Why ―Communicate‖ • Doing a Hazard Analysis...quickly • How to ―Communicate‖ to ―Them‖
  6. 6. 6 What is important • It’s about the Specs! • “A problem well defined is a problem half solved.” • John Dewey
  7. 7. 7 What does Quality ―control‖?
  8. 8. 8 Quality • Does not Design. • Does not Manufacture. • Does not Distribute. • Use? Possibly. • Words – No. • Control? Yes.
  9. 9. 9 Again, what does quality ―control‖?
  10. 10. 10 Think about these?
  11. 11. 11 Any impact on •Customers •Patients •Business •Environment
  12. 12. 12 Thoughts?
  13. 13. 13 • ISO 11540:1993 - Caps for writing and marking instruments intended for use by children up to 14 years of age -- Safety requirements • Specifies safety requirements for cap size, ventilated caps (vent area, air flow) and marking. Annex A describes the test for air flow. Caps which do not comply should have the instrument or its packaging labelled with a warning as to the dangers of asphyxiation from pen caps. • ASTM D4236 - 94(2005) Standard Practice for Labeling Art Materials for Chronic Health Hazards • Scope 1, 1.1... chronic health hazards known to be associated with a product or product component(s), when the component(s) is present in a physical form, volume, or concentration that in the opinion of a toxicologist (see 2.1.11) has the potential to produce a chronic adverse health effect(s). Writing Instrument Standards H i g h l i g h t e r
  14. 14. 14 Importance of Risk Management • Prepare and respond to your Customers! • Business strategy • Business security • Provide a Competitive advantage • Communicate information • Good news • Bad news • Not counting everything else – Regulatory requirement
  15. 15. 15 Evolving Process 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Feasiblity and Research Prototyping Development Clincal Trial Distribution Post-Market Survellance Known Unknown = Risk Risk needs a multi-functional approach!
  16. 16. 16 New requirements • Medical Device Directive 93/42/EEC (M5) • Add’s Usability - See Annex I, 1st paragraph • Subset of Risk Management • EC 62366 - Medical devices -- Application of usability engineering to medical devices
  17. 17. 17 Structure Design (ISO 14971) Process (ISO 14971) Usability (EC 62366) New Risks? Risk Analysis process Mitigation & Control
  18. 18. What is Usability • Usability is a characteristic of the User Interface that establishes Effectiveness, Efficiency, ease of User learning and User satisfaction. • Medical practice is increasingly using Medical Devices for observations and treatment of patients. Use Errors caused by inadequate Medical Device Usability have become an increasing concern. Many of the Medical Devices developed without applying a Usability Engineering Process are non- intuitive, difficult to learn and to use. • The Usability Engineering Process is intended to achieve reasonable Usability, which in turn is intended to minimize Use Errors and to minimize use-associated Risks. 18
  19. 19. What is Usability • The Usability standard specifies a Process for a Manufacturer to analyze, specify, design, Verify and Validate Usability, as it relates to Safety of a Medical Device. The Engineering Process assesses and mitigates Risks caused by Usability problems associated with Correct Use. • If the Usability Engineering Process has been complied with and the acceptance criteria documented in the Usability Validation plan have been met then the Residual Risks are presumed to be acceptable. 19
  20. 20. What is Usability? 20
  21. 21. 21 Risk Management System • ISO 14971: Medical devices — Application of risk management to medical devices • Selected definitions • Risk Management Sections • Areas that feed into Risk Management • Performing a Risk Analysis
  22. 22. 22 Risk • Risk has two components: • a) the probability of occurrence of harm; • b) the consequences of that harm, that is, how severe it might be.
  23. 23. 23 Definitions • Risk (as defined by dictionary.com) – • exposure to the chance of injury or loss; a hazard or dangerous chance • harm - • physical injury or damage to the health of people, • or damage to property or the environment • hazard - potential source of harm
  24. 24. 24 Definitions Cont’d • hazardous situation - circumstance in which people, property, or the environment are exposed to one or more hazard(s) • New consideration • residual risk - risk remaining after risk control measures have been taken • Note: not mitigation
  25. 25. 25 Definitions Cont’d • risk - combination of the probability of occurrence of harm and the severity of that harm • risk analysis - systematic use of available information to identify hazards and to estimate the risk • NOTE Risk analysis includes examination of different sequences of events that can produce hazardous situations and harm.
  26. 26. 26 Do you want more definitions? • Pressure is identifying a problem before launch! • Yes • No
  27. 27. 27 More • risk assessment - overall process comprising a risk analysis and a risk evaluation • Risk analysis + Risk evaluation • risk control - process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels
  28. 28. 28 More • risk estimation - process used to assign values to the probability of occurrence of harm and the severity of that harm • risk evaluation - process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
  29. 29. 29 More • risk management - systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk • risk management file - set of records and other documents that are produced by risk management • safety - freedom from unacceptable risk
  30. 30. 30 5 Steps 1.Risk analysis 2.Risk evaluation 3.Risk control 4.Overall residual risk evaluation 5.Production and post-production information
  31. 31. 31 Risk Control Order • ―...risk control options in the priority order listed...‖ a) inherent safety by design; b) protective measures in the medical device itself or in the manufacturing process; c) information for safety.
  32. 32. 32 Structure Design (ISO 14971) Process (ISO 14971) Usability (EC 62366) New Risks? Risk Analysis process Mitigation & Control
  33. 33. 33 ISO 14971 Flow Chart • Do you want to see them? • Yes • No
  34. 34. 34 Risk Analysis
  35. 35. 35 Risk Analysis
  36. 36. 36 Risk control
  37. 37. 37 Overall residual risk evaluation 37
  38. 38. 38 Production and post-production information
  39. 39. 39 Risk Management Report • Prior to release for commercial distribution • ―Audit‖ the risk management process. • Ensure that: • the risk management plan has been appropriately implemented; • the overall residual risk is acceptable; • appropriate methods are in place to obtain relevant production and post-production information.
  40. 40. 40 Risk Management Report Cont’d • The results of this review shall be recorded as the risk management report and included in the risk management file. • The responsibility for review should be assigned in the risk management plan to persons having the appropriate authority. • Compliance is checked by inspection of the risk management file.
  41. 41. 41 Pre control? Occurrence = 100%
  42. 42. 42 Risk: Combination of Occurrence and Severity Severity Neither of the others Medical Intervention Death ALARP Acceptable Acceptable Reduce Acceptable ALARP Reduce ALARP Reduce Low Med High Occurrence
  43. 43. 43 Sources of information Risk Mgt Design Customers Competitive Products Monitoring Feed back Patent filings Internal experience
  44. 44. 44 At your company? •Risk Management Procedure •Risk File
  45. 45. 45 The Risk/Hazard Analysis Process • Fun & Challenging • Exciting & Tense • Fulfilling & Thorough • Better than climbing Everest • Memorable • More?
  46. 46. 46 An Alternative Risk ―Analysis‖ Activity People Duration Risk analysis Team 1-2 days Risk evaluation 1-2 (max) 1 day Risk control Team via email TBD Overall residual risk evaluation Team 1 day Review and approve entire document Team TBD
  47. 47. 47 Consider the following order • Usability Risk Analysis • Only focus is Use, User, and Hazardous Situations • Design Risk Analysis • Only focus is Design • Usability is Input to Design • Process Risk Analysis • Only focus is Processes • IFU/Labels • Perform Usability Design Review
  48. 48. 48 Which is ―Best‖ • Do what is • Effective • Efficient • Increases information
  49. 49. 49 Part 1 - Risk Analysis • Address only • Harm • Severity • Hazardous situations • No numbers! • 1 day typical • 2 days if absolutely necessary • Very complex product? • Break into smaller chunks
  50. 50. 50 Part 2 - The ―Numbers‖ Severity Likelihood of Occurrence 3 - Death or Medical Intervention, Malfunction (reported to authorities) ALARP Reduce Reduce 2 - Product Specification, Packaging, Labeling(reportable to authorities) Acceptable ALARP Reduce 1 - No or little (trivial) harm Acceptable Acceptable ALARP Occurrence > 1 - Low 2 - Medium 3 - High [1] ALARP = As low as reasonably practicable
  51. 51. 51 Part 2 - Risk Evaluation Phase • Addressed by select subset of the Team • The ―others‖ will be able to comment on later. • Skill set • Product use • Human impact (clinical / safety issues)
  52. 52. 52 Part 3 - Risk Control • This is where the work begins. • How is Risk controlled? • How is risk control demonstrated?
  53. 53. 53 Populate the list in these phases • Design (show how risk is controlled by the design) • Documents • Procedures, reports... • Return to ―Control person(s)‖
  54. 54. 54 Part 4 - Post-control Numbers • Back to the ―2‖ people. • They fill-in the numbers.
  55. 55. 55 Next • Production (show how risk is controlled) • Documents • Procedures and reports • No inspection references • Return to ―Control person(s)‖
  56. 56. 56 Next • Labeling (show how risk is controlled) • Reference the IFU/DFU .... • Identify the specifics • Labeling is the risk control point of last resort • Return to ―Control person(s)‖
  57. 57. 57 Part 4 - Post-control Numbers • Back to the ―2‖ people. • They fill-in the numbers. • Draft the ―final‖ version
  58. 58. 58 Part 5 - Overall Risk Phase • Team regroups • Reviews and comments • Do a red-face test on the numbers • Hopefully little adjustment • Confirm the post control numbers • Agree that the overall risk is acceptable
  59. 59. 59 Summary Risk Statement • Risk Analysis: Product name (version?) • Performed per ISO 14971 (2007) • The overall risk is acceptable using the criteria defined in the Risk Management Plan (Procedure ???, Rev. ?)
  60. 60. 60 Risk analysis = Done!
  61. 61. 61 Doing a Risk ―Analysis‖ Activity People Duration Risk analysis Team 1-2 days Risk evaluation 1-2 (max) 1 day Risk control Team via email TBD Overall residual risk evaluation Team 1 day Review and approve entire document Team TBD
  62. 62. 62 Communicating • Telling good news is easy! • Keeping bad news quiet is easy! • Telling bad news is the hard!
  63. 63. 63 What I Look For • Facts...not Fiction • Solutions...not the problem(s) • Remember one of the 1st slides? • Timing, $$, resources • Impact on the Business. • Recovery strategy & solutions
  64. 64. 64 Example 1. A ―clearly defined‖ problem statement 2. Action plan • Containment + Corrective + Preventive 3. Solution (or high likelihood options) 4. Non-people resources (Est. $$’s) 5. People resources needed for success 6. Timing - estimated completion date 7. Impact of the ―do nothing‖ option • Without mentioning regulations or agencies?
  65. 65. 65 ―How‖ is the Risk standard set? • Who • How / Where • When • Why
  66. 66. 66 Who ―sets‖ the standard? • Management (Them...careful We are Them) • By approval of the Risk Management Procedure • By review of information provided at Management Review • Assumes information is being provided • By supporting and implementing related change
  67. 67. 67 Is complacency an option?
  68. 68. 68 Questions & Answers

×