Beyond Risk Assessment :

1. ICPHSO 2018 International Product Safety Training Workshop Beyond Risk Assessment: Novel approaches to using historic data to establish tolerable risk of product categories in diverse communities.”

2. Beyond Risk Assessment: Novel approaches to using historic data to establish tolerable risk of product categories in diverse communities.” ICPHSO 2018 International Product Safety Training Workshop André Berends, RAPEX Team Leader, European Commission, Directorate-General for Justice and Consumers Richard Frewin, UK’s BEIS Office for Product Safety and Standards Evelina Kurgonaite, Samsung Europe Gene Rider Exponent, Inc. Moderator

3. Tolerable Risk • Fatality Data: • March 2009 1 Fatality / 100 million flights • Jan 2009 50 Fatalities / 100 million flights • Expert Analysis: • Freak accident, public not to worry about flying

4. Risk Equation Risk is the product of Exposure and Hazard

5. Risk Equation ~0 ~0 It is efficient to manage Risk by eliminating Hazards.

6. Risk Assessment is a Probability • Likelihood of Occurrence • Likely Consequence if it Occurs

7. Hazard Does Not Equal Risk • Consider the hazardous bottle cap on the right. • Millions are distributed annually. • They are a choking hazard. • However: • They are generally not available to young children. • They are not attractive to young children. • They do not have significant play value. • They do not present an unreasonable risk of injury.

8. Tolerable Risk Severity

9. Tolerable Risk Severity

10. Tolerable Risk Severity

11. Thank you Gene Rider, Principal Exponent, Inc. 420 Lexington Ave. Suite 1740 New York, NY 10170 grider@exponent.com 1.630.258.0522 Exponent’s Consumer Product Safety Team has offered technical and regulatory experience in design, process safety, and failure analysis consulting for the consumer products industry for nearly 50 years.  Our global team of 700 scientists, physicians, engineers, and regulatory consultants provide clients with the critical technical analysis required for both day-to-day and strategic decision making.

12. Beyond Risk Assessment: Novel Approaches to Using Historical Data to Establish Tolerable Risk of Product Categories in Diverse Communities EU perspective 12 November 2018 André Berends

13. Authorities carry out effective market surveillance + powers to ensure that producers and distributors comply with their obligations. • Producers and distributors can place only safe products on the market. • Assessment of the safety of a product based on foreseeable use. • Risk assessment by identifying the seriousness of a hazard and probability of the hazard materializing. • A case-by-case assessment + a sound risk management to ensure follow up to reduce or eliminate the risk. • Risk assessments carried out by producers and distributors are not binding on authorities. General principles concerning product safety requirements and risk assessment in the EU

14. EU: A long and well-documented experience on assessment of risks ensuring a level playing field for a safe single market Our tools: Guidelines for the management of the community Rapid Information system: Part III.6 of the new Guidelines that have replaced Commission Decision 2010/15/EC (ex-Part IV.5) IT tool accessible to all to create a risk assessment based the above principles Alignment of approaches in the context of EU wide coordinated enforcement activities. Scientific evidence of the risks of the use of certain hazardous substances ► Legal restrictions

15. How to use historic data? Take account of risk assessments included in the EU rapid alert system for dangerous products (with publicly available summaries in the EU Safety Gate, 25 languages): Database with over 23000 cases so far.

16. Some insight on the EU IT tool for riskassessment 12 November 2018 https://ec.europa.eu/consumers/consumer-safety/rag/#/screen/home André Berends

17. Features Available in all EU languages + Chinese

18. Features Clear and concise user manual

19. Features • Create a riskasssesmentwithdifferent scenarios • Save: Download and save the riskassessment (.jsonformat) • Load: Upload a riskassessmenttemplate(fromyour PC; .txt or .json format) • Print: Save yourriskassessment as pdf or printit

20. Integration of new features • A 'library' : includingriskassessmenttemplatesdevelopedthroughout the EU widecoordinatedenforcementactivities • An additional tab to allow for sensitivityanalysis: takingintoconsideration the level of uncertaintywhencreating a riskassessment and establish the variation of the risklevelwhen the estimatedfactorsvary In the near future

21. Someexamples

25. Thankyou for your attention

26. ICPHSO Beyond Risk Assessment Panel Richard Frewin DMS, DTS, MCTSI UK Market Surveillance Coordination

27. Anatomy of Product Safety Recall:A Manufacturer’s Perspective 12 Nov, 2018 Evelina Kurgonaite Samsung Electronics

28. Consumer Trust • Research shows that customers today attach more importance to trust than most other considerations • It’s hard to win consumer trust and just as hard to maintain it

29. Consumer Safety • Robust QA Protocols • Swift decision making process • Transparent communication

30. In Search for Success Model Regulatory Authorities • Proactive engagement • Close cooperation • Full transparency Manufacturer

31. Product Safety Recall ≠ Disaster

32. Galaxy Note7 Recall 1 2 GET THE PHONES BACK FROM CUSTOMERS GET TO THE BOTTOM OF THE PROBLEM

33. 1 GET THE PHONES BACK FROM CUSTOMERS • COMMUNICATION to customers • Over 23 Million text messages & push notifications • FIRMWARE UPDATES to limit battery capacity • 60% cap → 0% cap • NOTE7 EXCHANGES atairports

34. FULL SCALE RECALL 97% • OF NOTE7S HAVE BEEN RETURNEDGLOBALLY

35. 2 GET TO THE BOTTOM OF THE PROBLEM • More than 700 engineers involved • Extensive root cause investigation • Round-the-clock repeated charge and discharge cycles on more than 200,000 Note7 & 30,000 individual batteries • Independent technical analysis performed • UL, Exponent, TUV Rheinland

36. Innovative QA Process • Tightened internal battery safety inspection process CHARGE & DISCHARGE TEST DURABILITY TEST VISUAL INSPECTION X-RAY INSPECTION TVOCTEST DISASSEMBLINGTEST DELTA OCVTEST ACCELERATEDUSAGE TEST

37. Working with Regulatory Authorities • Communications to air passengers • SIB 2016-14 R1 →SIB 2017-01 • Continuous constructive dialogue

38. Working with Regulatory Authorities • First government-backed Code of Practice (PAS 7100) for product safety recall in the UK • Improved communication • Speedier action on recall • Mutual benefit Office for Product Safety and Standards

39. Working with Surveillance Authorities • Identifying counterfeit products • Neither in the Government nor manufacturers’ interest to have these enter the EU market

40. Thank You