2012 safety academy: compliance overview

25
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 Operations Safety Academy September 20, 2012 Marc J. Schoem Acting Director

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Acting Compliance Director provides overview of compliance operations for 2012

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Page 1: 2012 Safety Academy: Compliance Overview

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

Page 2: 2012 Safety Academy: Compliance Overview

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

Page 3: 2012 Safety Academy: Compliance 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

Page 4: 2012 Safety Academy: Compliance Overview

Compliance Activities

4

Defect Investigatio

ns

Enforcement of Rules and Bans

Corrective Actions/Rec

alls

Market Surveillance

Field Operations

Import Surveillance

Sanctions/ Penalties

Page 5: 2012 Safety Academy: Compliance Overview

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

Page 6: 2012 Safety Academy: Compliance Overview

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

Page 7: 2012 Safety Academy: Compliance Overview

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

Page 8: 2012 Safety Academy: Compliance Overview

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.

8

Page 9: 2012 Safety Academy: Compliance Overview

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

Page 10: 2012 Safety Academy: Compliance Overview

Section 15 Reporting Trends

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Page 11: 2012 Safety Academy: Compliance Overview

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

11

Page 12: 2012 Safety Academy: Compliance Overview

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

Page 13: 2012 Safety Academy: Compliance Overview

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

Page 14: 2012 Safety Academy: Compliance Overview

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

Page 15: 2012 Safety Academy: Compliance Overview

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%

Page 16: 2012 Safety Academy: Compliance Overview

Voluntary Recalls by Fiscal Year

16

Page 17: 2012 Safety Academy: Compliance Overview

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

Page 18: 2012 Safety Academy: Compliance Overview

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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

Page 19: 2012 Safety Academy: Compliance Overview

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.

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Page 20: 2012 Safety Academy: Compliance Overview

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

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Page 21: 2012 Safety Academy: Compliance Overview

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

Page 22: 2012 Safety Academy: Compliance Overview

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Use of Social Media in Consumer Notification

Office of Compliance and Field Operations Priorities

Page 23: 2012 Safety Academy: Compliance Overview

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

Page 24: 2012 Safety Academy: Compliance Overview

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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Page 25: 2012 Safety Academy: Compliance Overview

Consumer Product Safety Commission

Mr. Dean W. Woodard U.S. CPSC Director Office of Education, Global Outreach, and Small Business Ombudsman

[email protected] [email protected]