Why Proper Risk Management Is Important to All Companies - Contact DB Performance Solutions For Assistance danbrown@dbpsllc.us

1. ISO 13485 & Risk Analysis Why Risk Analysis Matters Presented to ASQ Fox Valley Section 1208 October 6, 2009 By Daniel Brown, CQA on behalf of Eagle Registrations

2. ISO 13485 & Risk Analysis ISO 14971 Why this matters to Medical Device Manufacturers ISO 9001 & Risk Analysis ISO 31000 What this means for other manufacturers Overview 2 Copyright 2009 Daniel Brown

3. ISO 13485 & Risk Analysis 7.1 Planning of Product Realization The organization shall establish documented requirements for risk management throughout product realization. Records…shall be maintained. Note 3: See ISO 14971 for guidance related to risk management. 7.3.2 Design and Development Inputs e) the Output(s) of risk management (see 7.1). 3 Copyright 2009 Daniel Brown

4. ISO 14971 Application of Risk Management to Medical Devices – Released in 2007 Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. 4 Copyright 2009 Daniel Brown

5. Why Risk Analysis Matters - Medical Device Perspective Cost to human life if medical devices fail Different Classes of Medical Devices Active Implantable Active Implantable Sterile 5 Copyright 2009 Daniel Brown

6. Other Major Industries with Risk Analysis Aerospace & AS9100 Automotive & TS 16949 Telecommunications & TL 9000 6 Copyright 2009 Daniel Brown

7. ISO 9001 & Risk Analysis 0.1 General “The design and implementation of an organization’s (QMS) is influenced by: a) its organizational environment, changes in that environment, and the RISKS associated with that environment. FDIS 31000 7 Copyright 2009 Daniel Brown

8. ISO 31000 – FDIS Risk Standard Risk Management Should: a) create value. b) be an integral part of organizational processes. c) be part of decision making. d) explicitly address uncertainty. e) be systematic and structured. f) be based on the best available information. g) be tailored. h) take into account human factors. i) be transparent and inclusive. j) be dynamic, iterative and responsive to change. k) be capable of continual improvement and enhancement. 8 Copyright 2009 Daniel Brown

9. Why Risk Analysis Matters- Other Industries Perspective Briefly review what was presented Identify ways to apply training Request feedback on training session 9 Copyright 2009 Daniel Brown

10. Legal & Ethical Considerations Effective Risk Management is your best shield from lawsuits. Evidence of Due Diligence Reasonable actions. “O” ring issue with shuttle Firestone v Ford on exploding tires Ford with exploding gas tanks Suzuki Samurai Roll Overs Peanut Corporation of America 10 Copyright 2009 Daniel Brown

11. Preventive Action & Risk Analysis Many companies struggle with Preventive Actions ALL ACTIONS TAKEN AS A RESULT OF RISK ANALYSIS QUALIFY AS PREVENTIVE ACTION! Improve your bottom line, your compliance, and your corporate liability 11 Copyright 2009 Daniel Brown

12. Contact Information Daniel J. Brown Auditor, Eagle Registrations 312-615-3530 dan.brown@eagleregistrations.com www.eagleregistrations.com 12 Copyright 2009 Daniel Brown