1. 2018 International Product Safety Training Workshop
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. 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.”
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 Fatality / 100 million flights
Jan 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. Likelihood of Occurrence
Tolerable Risk 4
Fatal 3
Hospital l  2
Treated 1
Complaint
Property Damage
< 1 108
< 1 107
< 1 106
< 1 105
< 1 10⁴
< 1 10³
Likelihood of Occurrence
Severity

9. Likelihood of Occurrence
Tolerable Risk 4
Fatal
Category   3
Hospital
 Category 2
Treated 1
Complaint
Property Damage
< 1 108
< 1 107
< 1 106
< 1 105
< 1 10⁴
< 1 10³
Likelihood of Occurrence
Severity

10. Likelihood of Occurrence
Tolerable Risk 4
Fatal
Category   3
Hospital
 Category 2
Treated
Product A  1
Complaint
Product A 
Property Damage
< 1 108
< 1 107
< 1 106
< 1 105
< 1 10⁴
< 1 10³
Likelihood of Occurrence
Severity

11. Thank you Gene Rider, Principal Exponent, Inc. 420 Lexington Ave.
Suite 1740
New York, NY 10170
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. General principles concerning product safety requirements and risk assessment in the EU
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.

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 cases so far.

16. Some insight on the EU IT tool for risk assessment
12 November 2018
André Berends

17. Features
Available in all EU languages + Chinese

18. Features
Clear and concise user manual

19. Features Create a risk asssesment with different scenarios
Save: Download and save the risk assessment (.json format)
Load: Upload a risk assessment template (from your PC; .txt or .json format)
Print: Save your risk assessment as pdf or print it

20. In the near future Integration of new features
A 'library' : including risk assessment templates developed throughout the EU wide coordinated enforcement activities
An additional tab to allow for sensitivity analysis: taking into consideration the level of uncertainty when creating a risk assessment and establish the variation of the risk level when the estimated factors vary

21. Some examples

25. Thank you 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. Regulatory Authorities
In Search for Success Model
Regulatory Authorities
Proactive engagement
Close cooperation
Full transparency
Manufacturer

31. Product Safety Recall ≠ Disaster

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

33. 1 COMMUNICATION to customers
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 at airports

34. FULL SCALE
RECALL
97%
OF NOTE7S HAVE BEEN RETURNED GLOBALLY

35. 2 More than 700 engineers involved
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
DURABILITY TEST
VISUAL INSPECTION
CHARGE & DISCHARGE TEST
X-RAY
INSPECTION
DISASSEMBLING TEST
TVOC TEST
ACCELERATED USAGE TEST
DELTA OCV TEST

37. Working with Regulatory Authorities
Communications to air passengers
SIB R1 → SIB
Continuous constructive dialogue

38. Office for Product Safety and Standards
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