ICPHSO 2014 Advanced Compliance Course
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Transcript of ICPHSO 2014 Advanced Compliance Course
U.S. Consumer Product Safety Commission
1
Views expressed in this presentation are those of the staff and do not necessarily represent the views of the
Commission
Advanced Compliance Course
Saint Louis University April 23, 2014
Today’s Agenda Being Prepared Working with the CPSC Staff Field Investigator Visits
Consumers Retailers Manufacturers
Recall Effectiveness Recall Monitoring Monitoring Internet Sales Safe &Adequate Disposal of Recalled
Products2
3
Being Prepared Recall Handbook – Section 15 –
Defects March 2012 Home/Business & Manufacturing/Recall
Guidance Regulated Products Handbook
May 2013 Home/Business & Manufacturing/Recall
Guidance Handbook For Manufacturing Safer
Consumer Products July 2006 Products
Voluntary Standards Home/Regulations, Law & Standards
4
Being Prepared - Continued
Have internal controls and procedures in place to routinely review and capture data Update these frequently
Disclose required information to Regulators
Provide employees with training written standards and policies
Document everything in writing and make it available upon request
compliance training mechanism to report issues
Empower employees to disclose weaknesses to Executives
5
Being Prepared - Continued
Know how to Handle Returns from distribution chain
Parts orders Consumer complaints, claims, lawsuits online product reviews Product life testing Quality assurance/ product improvement Material changes Retailer reports/ feedback Incidents from CPSC saferproducts.gov
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Code of Federal Regulations
7
The C.F.R. is available at:
http://www.cpsc.gov/en/Regulations-Laws--Standards/Regulations-Mandatory-Standards--Bans/Regulated-Products/
What Prompts a CPSC Visit?
News Report
Follow-up to an in-depth investigation
Potentially hazardous product was identified but responsible firm is not clear.
Manufacturer, importer or retailer of possibly defective product was identified and additional information is needed to determine whether substantial product hazard exists.
Ongoing voluntary and regulated product standards compliance monitoring
Source Data
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• Hot Line reports
• Public Data base
• Civic groups
• Attorneys
• Retailers
• State death certificates
• MECAPS reports
• Consumers
• Internet surveillance
• Medical professionals
• CPSC Field Investigations
• Newspapers, radio, television, Internet, trade blogs, etc.
• Fire & police reports, Non-MECAP coroners, hospitals
Inspections
10
“There’s a CPSC Investigator Here to See
You…” Inspections are not
usually scheduled in advance.
The investigator will ask to meet with an officer of the corporation or the most responsible person on the premises.
12
Section 16(a) of the CPSAGrants CPSC investigators the right, upon presenting appropriate credentials and a written notice from the Commission to the owner, operator, or agent in charge, to enter and inspect, at reasonable times and in a reasonable manner:
(A) any factory, warehouse, or establishment in which consumer products are manufactured or held, in connection with distribution in commerce,
(B) any firewalled conformity assessment bodies accredited under section 14(f)(2)(D), or
(C) any conveyance being used to transport consumer products in connection with distribution in commerce.
How Does the Inspection Begin?
The investigator will present his/her credentials.
A “Notice of Inspection” will be issued.
The reason for the visit will be discussed.
What Must the Firm Provide?
Section 16(b) of the CPSA
All records, reports, books, documents, papers or labeling which show or relate to the production, inventory, testing, distribution, sale, transportation, importation, or receipt of any product or component thereof
Samples of the product
What Can the Investigator Ask to See?
Any factory area, warehouse area, or office area in which consumer products are manufactured or held in connection with distribution into commerce, or any area where documentation is held which is needed to complete the inspection.
The Following Information may be Reviewed
Trade/Brand names of products Complaint history for product(s) in
question Details of quality control and testing
programs Information regarding sources-
suppliers of sub-components Product coding system description Business Structure Product design history Sales records
Will the Investigator do any Testing?
The investigator may test random samples if the testing equipment is portable and available. Such testing may include XRF screening for lead, small parts testing and/or other product specific examination deemed appropriate.
Collection of Samples CPSC’s inspectional authority allows
for the collection of samples, component parts, materials, substances, products, containers, packaging and labeling.
Samples will be collected by the investigator personally, at random from the firm’s inventory.
Multiple units are usually collected to ensure enough units are available for adequate testing.
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Penalties for Non-Compliance with an
Inspection
Sections 19(a)(3) of the CPSA and 4(e) of the FHSA: It is unlawful for any person to fail or refuse to permit access to or copying of records . . . . or fail or refuse to permit entry or inspection.
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Penalties for Non-Compliance with an
Inspection Section 19(a)(3) of the CPSA: It is unlawful for any person to fail or refuse to permit access to or copying of records, or fail or refuse to establish or maintain records, or fail or refuse to make reports or provide information, or fail or refuse to permit entry or inspection.
18 U.S.C. Section 1001: (criminal statute) (1) falsifies, conceals, or covers up by any trick, scheme, or device, a material fact;
(2) makes any materially false, fictitious, or fraudulent statement or representation; or
(3) makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry
Can You Prepare for an Inspection?
If you are a manufacturer, retailer, or reseller of consumer products, know what rules apply to your business. Being informed is being empowered.
CPSC wants your business to succeed and your customers to be safe. We are a resource to educate you on the steps your business should take to comply with our safety rules.
Review our Business & Manufacturing guidance on CPSC.gov, watch our special presentations for industry from CPSC technical and compliance staff.
Maintain good records. Document the history of products from initial design to current QC reviews. Implement a first-class quality control system to ensure you meet U.S. consumer product safety requirements.
Investigations
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How does the CPSC Compliance Investigation
process work?
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Field investigation conducted Compliance initiates contact with
the firm Epidemiology conducts data
search Engineering performs testing
(both failure mode and performance testing)
Preliminary Determination made (for non- Fast-Track cases)
Negotiate recall Notification to consumers
Reporting Obligations Section 15 of the CPSA
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. 24
Reporting under Section 15(b) Covers both Fast Track and non-Fast Track We encourage reporting under Section 15 on
our website or via e-mail to the Section 15 mailbox. Faster, easier to track and routeAdd photos and other documents
On our website at: www.cpsc.gov On right hand side under “Businesses”
Or via email to: [email protected] We discourage reporting via phone, mailed
letter, or fax.Much slower, harder to track, and much
easier to get lost or duplicated during routing
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Why Not Report?
Not all Section15(b) reports result in recalls.
Approximately 40% of the Section15 reports received, result in no action by the staff.
Where the staff initiates its own investigation, the likelihood of eventual recall increases. Don’t wait for us to call you – you
should be calling us first!
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Staff Initiated Cases with and without PDs and CAPs
FY09 FY10 FY11 FY12 FY13 FY14
0
20
40
60
80
100
120
59
88 87
120
57
10
Staff Initiated Cases with PD and CAP
FY09 FY10 FY11 FY12 FY13 FY14
0
5
10
15
20
25
30
35
40
1618
23
26
40
2
Staff Initiated Cases No PD or CAP
FY09 FY10 FY11 FY12 FY13 FY14 as of 2/12
0
20
40
60
80
100
120
140
5988 87
120
57
10
16
18 23
26
40
2
75
106 110
146
97
12
All Staff Initiated Cases*by origin date
With PD and CAP No PD or CAP
21%
79%
17%
83%
21%
79%
18%
82%
41%
59%
16%84%
97%3%
Firm Reported Cases with and without PDs and CAPs
29
FY09 FY10 FY11 FY12 FY13 FY14
0
50
100
150
200
250
300
350
343
315289 297
103
2
Firm Reports with PD and CAP
FY09 FY10 FY11 FY12 FY13 FY14
0
50
100
150
200
250
167 163147
204 202
65
Firm Reports with No PD or CAP
FY09 FY10 FY11 FY12 FY13 FY14 as of 2/12
0
100
200
300
400
500
343 315 289 297
103
2
167163
147204
202
65
510478
436
501
305
67
All Firm Reported Cases*by origin date
With PD and CAP No PD or CAP
Cases and Reports with and without PDs and CAPs
FY09 FY10 FY11 FY12 FY13 FY14 as of 2/12
0
100
200
300
400
500
600
700
69% 69% 69% 64%
40%
16%
31% 31%31%
36%
60%
84%
585 584546
647
402
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ALL PD and CAP Cases No PD or CAP cases
Voluntary Recalls by Fiscal Year
FY10 FY11 FY12 FY13 FY14 as of 1/30
0
50
100
150
200
250
300
350
400
450
500
414 378 412345
96
62
3032
28
6
476
408444
373
102
Defect Regulated
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Field Investigator CAP Inspections
Corrective action is not over when recall is announced
Investigator will likely be visiting to review recall progress
Report any changes to the corrective action plan agreement
Have all possible distributors and customers been notified? How/ When? Review documentation. Should a second effort to contact customers be done? Should other means of notification be considered?
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CAP Inspections - Continued
Are there final numbers regarding the number of units involved? Additional models? Should the recall be expanded due to new information received due to publicity?
Examination and rough inventory of units already under firm’s control and not distributed. Properly segregated?
Reverse logistics: How are returned units being tracked? Proof of consumer destruction documented? Where are they being stored? Segregated from new units?
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CAP Inspections - Continued Have you been submitting required monthly
reports?
Records? Who is responsible for overall tracking? Have you taken steps to prevent previously returned recalled units from being sold?
Have you worked out a repair verification procedure? How will consumers/ retailers/ investigators know that future stock in store does not include non-refurbished/ old units that were recalled?
How many units have been returned/ corrected to-date? By what measure will you be satisfied?
Are products quarantined?
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When is a Recall Effective?
The purpose of the recall is to alert the public, and specifically the purchasers of the product, that the product may pose a hazard and what action should be taken
Comprehensive and continuing efforts must be made to reach all relevant consumers as quickly as possible
Some recalls have different success rates than others. Why? What creative methods have you used to reach your customers? 36
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Witness Reconditioning and Destruction
Product Disposal
Know if you will need special disposal for items like batteries or electronics (federal, state, or local laws.)
If retailers will be disposing or destroying the product or if you are using a 3rd party, we need to know.
Before you destroy, dispose, or recycle recalled products notify CPSC staff via e-mail to [email protected]
Field staff may witness destruction/disposal/recycling or require an affidavit to verify process.
Notify us of plan as early as possible. 38
CPSC Will Also Monitor Monthly progress reports – focus on
post-recall injuries Conduct Recall Verification
Inspection at recalling company Execute recall checks at points of
sale conducted by CPSC and/or State Investigators
Internet Surveillance Unit identifies sale of recalled products reported to [email protected] and through other sources
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FOR FURTHER INFORMATION:
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www.cpsc.gov
www.saferproducts.gov
Marc Schoem301-504-7520
Dennis Blasius262-650-1216