2012 safety academy: compliance overview
DESCRIPTION
Acting Compliance Director provides overview of compliance operations for 2012TRANSCRIPT
U.S. Consumer Product Safety Commission
This presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of the Commission.
Office of Compliance and Field OperationsSafety Academy
September 20, 2012
Marc J. SchoemActing Director
Office of Compliance and Field Operations
Defect Investigation
s Division
by Hazard
Regulatory Enforcement
Division
by Hazard
Field Investigations Division
by City/State
2
Overview
Compliance Meeting CPSC Strategic Goals
• Rigorous Hazard Identification• Retail Product Surveillance – Sample Collections• Internet Website Surveillance• Resale and Thrift Store Product Surveillance• In-Depth Investigations• Supporting Import Surveillance at Ports
• Decisive Response• Establishment Inspections• Identification of Defective and Violative Products• Timely Investigations and Preliminary Determinations• Timely Referrals to OGC of Potential Section 15(b)
Reporting Violations3
Compliance Activities
4
Defect Investigatio
ns
Enforcement of Rules and Bans
Corrective Actions/Rec
alls
Market Surveillance
Field Operations
Import Surveillance
Sanctions/ Penalties
5
Surveillance Databases
Injury and Potential
Injury Incident Data
Death Certificates
In-Depth Investigation
s (IDIs)
National Electronic
Injury Surveillance
System
IPII DTHS
INDP
NEISS
In-Depth Investigations
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12as of9/18
5,036 5,057 4,9845,277
4,8404,614 4,746
5,513
6,178
4,295
3,800
6
Surveillance Activities
7
Retail•Program plan for regulated products; surveillance for defects and other risks
Internet•Check for conformity with regulations and for recalled products
Ports and Airports
•Investigators at key ports of entry•Analysts identify most likely at-risk products
Reporting Under Section 15
• When to report:• The manufacturer, importer, distributor, or
retailer is required to report immediately upon obtaining information which reasonably supports the conclusion that a product:
• Fails to meet a rule, regulation, standard, or ban under the CPSA or any other statute enforced by the CPSC;
• Contains a defect which could create a substantial product hazard to consumers; or
• Creates an unreasonable risk of serious injury or death.
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Reporting Under Section 15
What to Provide When ReportingInitial Report• Details about product, stop sale date, potential
defect and hazard, samples, and all available information
Full Report• All information requested in 16 CFR §1115.13
with regard to manufacturer, product, defect, and injuries
9
Section 15 Reporting Trends
10
Overview of the Section 15
Defect/Hazard Process
Section 15 Report/ Sample
PI/CA Case
PreliminaryDetermination
Contains DefectAction Against
the Product
No ActionAgainst the
ProductEvaluation by Expert Staff Engineering,
Human Factors, Health Sciences
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Identifying Defect/Hazard
• Pattern of Defect• Identification of defect, flaw, error and
issues associated with design, engineering, quality control, labeling, use, assembly.
• Number of Defective Products• Distributed into commerce
• Severity of Risk• Severity of injury• Likelihood injury will occur• Vulnerable population affected
12
Overview of the Regulatory Process
Testing for the standard
Banned OrMisbranded
Product
No ActionAgainst
the Product
Applicable Regulation
Regulatory Case Corrective
Action Plan
• 13
13
Implementing a Product Safety Recall
14
ConsumerNotification
Stop Retail Sales
Stop Distribution
Redesign?
Stop Production
Decision to Recall
Disposal?Repair?
Return forRefund
Repair/ReplaceIncentives/Disposal
Fast Track Case Percentages of All Section 15 Reports
15
FY 02 FY 03 FY 04 FY 05 FY 06 FY 07 FY 08 FY09 FY10 FY11 FY12 as of 9/18
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
57%52%
56%
48% 49%54%
56%52% 51%
48%43%
Voluntary Recalls by Fiscal Year
16
Recalls and LOAs by Fiscal Year
FY06 FY07 FY08 FY09 FY10 FY11 FY12 as of 9/180
100200300400500600700800900
10001100120013001400150016001700180019002000
473 478618
498 476413 422
681 704
9151029
1907
1627
2109
Recalls LOAs
17
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Manufacturing, distributing, or importing any product that does
not comply with a mandatory standard
Failing to report information as required
by CPSC statutes
Selling a recalled product
Exporting a recalled product for sale
Violations/Prohibited Acts
Office of Compliance and Field Operations Priorities
• Implementation of Field Investigative Enforcement Programs
Cribs MattressesVGB Pool Safety Act Bed RailsFireworks Toddler BedsToys Baby WalkersChildren’s Sleepwear Bath Seats
• Testing & Certification Requirements for Children’s and
Non-Children’s Products.
19
Office of Compliance and Field Operations Priorities
• Recall Effectiveness
• Review Use of Product Registration Cards• Review Use of Social Media
• Review of Internal Procedures• Review and Update of Defect and Regulatory• Procedures and Investigative Letters• Advance Section 6(b) Notice of Investigations• More Timely Response• Broader More Consistent Public Notification Through
Voluntary Corrective Actions Plans and Letters of Advice
20
Office of Compliance and Field Operations Priorities
Recall MonitoringReverse Logistics
• Reverse distribution or product return• how you get the product back from distribution
• Reverse logistics plan should outline details such as: • how to quarantine the product • how to get the product returned • how to remove the product from shelves• how to repair, replace, or dispose of the product
• Provide your reverse logistics plan to Compliance staff with your Corrective Action Plan (CAP) and Full Report.21
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Use of Social Media in Consumer Notification
Office of Compliance and Field Operations Priorities
Industry Guidance
• www.cpsc.gov• “Business” section of website• www.recalls.gov • Monitor CPSC Activities through:
• Frequently Visiting CPSC Website
• Recall Announcement Subscriptions
• Public Calendar Subscriptions
• CPSC Electronic Reading Room Inquiries
• CPSC Clearinghouse Letters
• Seminar Attendance (Trade Shows/ICPHSO)
• CPSC Public Database23
Contact Information
Marc J. SchoemActing Director
Office of Compliance and Field Operations
U.S. Consumer Product Safety Commission
[email protected] 301-504-7520 – phone
240-638-6955 – mobile
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Consumer Product Safety Commission
•
Mr. Dean W. Woodard U.S. CPSC Director Office of Education, Global Outreach, and Small Business Ombudsman