Transcript Hong Kong manufacturer training

U.S. Consumer Product Safety Commission
How the CPSC
Identifies and Manages Risks Related to
Consumer Products
China, August 29 - September 2, 2014
Andrew Trotta
Director, Electrical Engineering Division
This presentation was prepared by CPSC staff. It has not been reviewed or approved by the Commission and may
not reflect its views.
How CPSC prevents injuries and deaths?
Regulations
Product
Standards
Identifies,
monitors,
analyzes trends
Conducts risk
assessments
Conducts
research
Educates on
manufacturing
for safety
Educates on safe
use
Surveillance:
retail, Internet,
ports
Investigations,
Recalls,
Compliance
2
What are the circumstances that
trigger CPSC involvement?
CPSC is a data-driven agency and performs analysis
based on:
• Post-market incidents
• Reports of injuries, and incidents from multiple
sources:
– CPSC databases
– Public sources, including firms and manufacturers
– Shared information with domestic agencies
– Shared information with international partners
3
What are the circumstances that
trigger CPSC involvement?
• Products that fail to comply with a
technical regulation or ban
administered by CPSC
• Products that contain a defect which
could create a “substantial product
hazard”
4
What are the circumstances that
trigger CPSC involvement?
• Products that fail to comply with
voluntary standards and present a
“substantial product hazard”
• Products that create an “unreasonable
risk” of serious injury or death
5
Product Safety Concerns
“Substantial Product Hazard”
1
A failure to comply with an applicable
consumer product safety rule under [the
CPSA] or similar rule, regulation, standard,
or ban under any other Act enforced by the
Commission which creates a substantial risk
of injury to the public,…
1
Section 15 of the Consumer Product Safety Act (CPSA)
6
Product Safety Concerns
“Substantial Product Hazard”
1
or a product defect which (because of the
pattern of defect, the number of defective
products distributed in commerce, the
severity of the risk, or otherwise) creates a
substantial risk of injury to the public.
1 Section
15 of the Consumer Product Safety Act (CPSA)
7
Risk Management Process
Data
Collection
Hazard
Identification
Risk Analysis
Probability of
Hazard
Occurrence
and
Consequence
Risk of that
Hazard
Occurring that
Often With
That
Consequence
Risk
Assessment
and
Prioritization
Comparing
Risk to
Acceptability
Criteria
Risk
Assessment
Actions to
Reduce Risk
Ensuring
Compliance
What
Actions Do
We Take to
Manage
That Risk?
How Do We
Help Ensure
Compliance
With Risk
Management
Strategy?
Evaluate
Results
Are Our
Actions
Effective?
Risk
Management
9
Data Collection
• National Electronic Injury Surveillance
System (NEISS)
– Data collected from approximately 100 hospital
emergency departments around the country
– Data weighted to provide consumer injury
estimates nationwide
• Death Certificates collected from all states for
codes that likely involve consumer productrelated deaths
9
Data Collection
• Saferproducts.gov
• Hotline (800-638-CPSC)
• News clips
• In-depth investigations
10
Data Collection
• Additional Surveillance Data from:
– National Burn Center Reporting System
– National Fire Incident Reporting System
– Poison Control Centers
• Collection of actual samples or a similar
sample involved in an incident, purchased
at a retailer or seized at a port
11
Hazard Identification
An interdisciplinary team of subject matter experts
reviews incidents to:
• Identify hazards described
• Examine chain of events
• Review circumstances of incident and other
consequences that could have resulted
• Identify incident hazard patterns
• Screen for trends and emerging hazards
12
Hazard Identification
For physical samples, an interdisciplinary team
of subject matter experts evaluates the samples
to:
• Identify hazards described
• Determine the modes of failure
• Determine compliance with existing safety
standards or regulations
13
Risk Analysis
Based on the evaluation of the data or
physical sample, an interdisciplinary team of
subject matter experts:
• Makes a qualitative evaluation of risk,
based on how often the hazard may occur
and how harmful the hazard is
• Captures all risk analysis in new internal
database for longer-term pattern analysis
14
Risk Assessment and Prioritization
Based on the results of the risk analysis, the
CPSC compares the evaluated risk to the
acceptable level of risk.
The criteria for acceptable level of risk is based
on:
• Nature of hazard (e.g. level of consumer
involvement, etc.)
• Likelihood of occurrence
• Severity of injury
• Likely users of product
15
Risk Assessment and Prioritization
Prioritization is based on the gap
between the current risk posed by the
product and the acceptability criteria,
and it is influenced by the degree to
which CPSC actions are estimated to
mitigate the risk (addressability).
16
Actions to Reduce Risk
Actions to reduce risk to acceptable levels:
•
•
•
•
Participate in the improvement or creation of
voluntary standards
Improve or create technical regulations
Reach out to manufacturers, distributors,
and importers
Educate the public
The result is a strategy aimed at first lowering and
then maintaining risk at acceptable levels.
17
Compliance With Risk
Management Strategy
Manufacturers, importers, and retailers have
obligations that could include:
• Testing and certification
• Third-party testing and certification
• Follow CPSC regulations, voluntary
industry standards, and best
manufacturing practices
18
Compliance With Risk
Management Strategy
Actions by CPSC to monitor compliance
with meeting safer CPSC requirements
may include:
• Port surveillance
• Market surveillance
• CPSC internal testing
19
Compliance With Risk
Management Strategy
Compliance actions are taken when a product
does not meet CPSC requirements and/or
contains a defect that presents a substantial
product hazard.
Compliance actions may include:
•
•
•
•
Stop sale
Design change
Recall to consumer and/or at distribution level
Repair, replacement, and/or refund
20
Evaluate Results
CPSC monitors and evaluates the hazards
related to products to see if safety concerns
are adequately addressed.
CPSC performs data-driven evaluations to
answer:
• Are our actions effective?
• Are we reducing the likelihood of occurrence?
21
Evaluate Results
CPSC performs data-driven evaluations to
address the following:
• Are we reducing the severity of the injury?
• Are we reducing the risk and thus closing the
gap between actual level and acceptable level of
risk?
• Are manufacturers, importers, and retailers
complying with CPSC requirements?
22
• Andrew Trotta
• Director, Electrical Engineering Division
[email protected]