Overview of testing, certification, and record keeping requirements for consumer products, including children's products. Addresses initial certification testing, material change testing, and periodic testing if you have continued production. Presentation also addresses optional component part testing. A review of mandatory recordkeeping requirements and undue influence training is also discussed.
2013 Testing & Certification of Consumer Products- 2013 Safety Academy (final)
1. EVERYTHING YOU EVER
WANTED TO KNOW ABOUT
TESTING AND CERTIFYING
CONSUMER PRODUCTS BUT
WERE AFRAID TO ASK
PANEL DISCUSSION
AT CPSC SAFETY ACADEMY
SEATTLE, WASHINGTON
SEPTEMBER 18, 2013
VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION.
2. THIRD PARTY TESTING
FOR CHILDREN’S PRODUCTS
1. Initial Certification Testing
– Enforced January 1, 2012 (most products)
2. Component Part Testing
– Effective December 8, 2011
3. Material Change Testing
– Effective February 8, 2013
4. Periodic Testing for Continued Production
– Effective February 8, 2013
3. INITIAL CERTIFICATION TESTING
• Identify applicable regulatory requirements
for your product
• Based on:
• Product/product class
• Intended age audience & consumer use patterns
• Product’s material composition
15 USC §2063; 16 CFR §1107.20
4. INITIAL CERTIFICATION TESTING
• Identify one (or more) CPSC-accepted
laboratories to conduct testing for identified
regulatory requirements.
• Certify in a Children’s Product Certificate (CPC)
based on passing test results.
• Provide CPC to retailers and distributors and,
upon request, to CPSC or Customs (CBP).
15 USC §2063; 16 CFR §1107.20; 16 CFR 1110
6. COMPONENT PART TESTING
• Voluntary; 16 CFR Part 1109
• If a finished product manufacturer purchases a
component from a supplier who voluntarily tests its
product (e.g., a paint supplier), that manufacturer must
“exercise due care” to rely upon the component part
certificate or component part test results in drafting its
own Children’s Product Certificate.
• The concept of due care is flexible, and it will vary
depending upon the circumstances and the industry in
question.
7. COMPONENT PART TESTING
• For example, depending upon the industry and the
circumstances, the exercise of due care may include:
– asking questions about testing and sampling procedures;
– requesting written test procedures;
– ensuring the supplier’s third party laboratory is CPSC-
accepted;
– spot checking a supplier’s test results;
– visiting a supplier’s factory or third party laboratory; or
– agreeing contractually on testing and recordkeeping.
• Document your “exercise of due care.”
• Maintain records.
16 CFR Part 1109
9. MATERIAL CHANGE TESTING
A material change means any change in the
product’s design, manufacturing process, or
sourcing of component parts that a
manufacturer exercising due care knows, or
should know, could affect the product’s ability to
comply with applicable federal consumer
product safety laws and regulations.
16 CFR Part 1107
10. MATERIAL CHANGE TESTING
If you – the manufacturer or importer – make a
material change to the children’s product after
initial certification, you must:
1. Re-test the affected component part or the
product to the rules potentially affected by the
material change; and
2. Issue a new Children’s Product Certificate
Mandatory; 16 CFR Part 1107
11. PERIODIC TESTING
Periodic testing helps provide a manufacturer
with a “high degree of assurance” that its
children's product continues to be compliant
with the applicable children's product safety
rules while production of that product continues
– and not just at the moment of initial testing
and certification.
www.cpsc.gov/periodic-testing
16 CFR Part 1107
12. PERIODIC TESTING
• If you – the manufacturer or importer – have
continued production of your children’s
product, you must periodically retest your
product using a CPSC-accepted laboratory.
• Periodic testing only applies if you have
continued production.
• Mandatory; 16 CFR Part 1107
13. PERIODIC TESTING
• Periodic testing must be conducted at a
minimum of 1-, 2-, or 3-year intervals,
depending upon whether the manufacturer
has:
a periodic testing plan;
a production testing plan; or
plans to conduct production testing using an
accredited ISO/IEC 17025:2005 laboratory.
16 CFR Part 1107
14. PERIODIC TESTING PLAN
• 1-year minimum testing interval – but may need
to be more frequent.
• A periodic testing plan must include:
• the tests to be conducted;
• the intervals at which the tests will be conducted; and
• the number of representative samples tested.
• A “periodic testing plan” must be in writing, and
no particular format is required.
• Key: Know your product, your manufacturing
process, including strengths and vulnerabilities.
15. PRODUCTION TESTING PLAN
• 2-year minimum testing interval using a CPSC-
accepted laboratory
• During 2-year period, first party testing (or other
means of assessing compliance) is acceptable
– CPSC-accepted labs and methods are not required for
production testing during 2-year interval period
• A “production testing plan” must be in writing,
and no particular format is required.
• Key: Know your product, your manufacturing
process, including strengths and vulnerabilities.
16. PRODUCTION TESTING PLAN
• A production testing plan must describe:
– the quality assurance techniques used in the manufacturing
process;
– the tests to be conducted, or the measurements to be taken;
– the intervals at which those tests or measurements will be taken;
– the number of samples tested; and
– an explanation describing how these techniques and tests provide
a high degree of assurance of continued compliance with the
applicable regulations, particularly if they are not the tests
prescribed for the applicable children's product safety rule.
16 CFR Part 1107
17. REASONABLE TESTING PROGRAM
FOR NON-CHILDREN’S PRODUCTS
• Commission has not issued a regulation mandating the
general requirements for a “reasonable testing program.”
• Staff guidance provided on the website suggests best
practices for a reasonable testing program – but the
guidance is not mandatory.
• General Conformity Certificate (GCC) is required.
18. REASONABLE TESTING PROGRAM
FOR NON-CHILDREN’S PRODUCTS
• A reasonable testing program should provide a
manufacturer or importer with a high degree of
assurance that its consumer product complies with the
applicable consumer product safety rule or standard.
• A reasonable testing program should be in writing and
should be approved by the senior management of the
manufacturer (or importer).
• Best practice to maintain your records on file in a manner
similar to the recordkeeping requirements that apply to
children's products.
19. REASONABLE TESTING PROGRAM
FOR NON-CHILDREN’S PRODUCTS
• Should be based on the considered judgment and
reasoning of the manufacturer (or importer) concerning
the number, frequency, and methods of tests to be
conducted on the products.
• Should be reasonable assumptions for the industry in
which the manufacturer (or importer) operates, including
such factors as:
– the nature and length of the manufacturer's relationship with
their vendors and suppliers,
– the types of materials and processes used in production,
including the potential for variability in those materials or
processes and potential for harm in the event of a problem.
20. RECORDKEEPING
PERIODIC/PRODUCTION TESTING
• For 5 years, a manufacturer must maintain records of:
– its periodic or production testing plan;
– its periodic and/or production testing results; and
– records documenting the testing of representative
samples, including the number of samples selected, the
procedure used to select samples, and the basis for
inferring compliance of the product based on the results of
the tested samples.
• Recommendation: Maintain documentation of the other
actions the manufacturer has taken to secure a high degree of
assurance that its products comply with the applicable
children's product safety rule.
16 CFR Part 1107
21. RECORDKEEPING
INITIAL CERTIFICATION/MATERIAL CHANGE TESTING
• For 5 years, a manufacturer must also
maintain records of:
– all Children’s Product Certificates;
– all third party certification test results from initial
certification and material change testing;
– and all descriptions of material changes in a
product’s design, manufacturing process, and
sourcing of component parts during the continued
production of a product.
16 CFR Part 1107
22. • For 5 years, each testing party and certifier must
have access to the following records:
– Test reports, including the test values, if any;
– Identification of the party that conducted each test.
– Identification of the:
• component part or the finished product tested;
• lot or batch tested;
• the applicable rules tested;
• testing method(s) and sampling protocol(s) used;
• date or date range when the component part or finished product
was tested;
RECORDKEEPING
COMPONENT PART TESTING
23. • For 5 years, each testing party and certifier
must also have access to the following records
and attestations:
– Component part certificate(s) or finished product
certificate(s), if any;
– Records to support traceability to the party that had
the component part or finished product tested;
– Attestation by the party conducting testing that it was
performed in compliance with section 14 of the CPSA,
part 1107, or any more specific applicable rules; and
16 CFR Part 1109
RECORDKEEPING
COMPONENT PART TESTING
24. – Attestation by each certifier and testing party that
while the component part or finished product was in
its custody, it exercised due care to ensure:
a) proper management and control of raw materials,
component parts, subassemblies, and finished products;
b) that the manufacturing process did not result in a
prohibited level of a chemical from any source; and
c) that no action or inaction subsequent to testing and before
distribution in commerce has occurred that would affect
compliance.
16 CFR Part 1109
RECORDKEEPING
COMPONENT PART TESTING
25. UNDUE INFLUENCE TRAINING
• Manufacturers and their employees must not
exert undue influence on testing laboratories to
alter test methods or test results that serve as the
basis for certifying a product’s compliance under
federal law.
• Every appropriate staff member must receive
training on avoiding undue influence and sign a
statement evidencing the training.
– Digital signatures are acceptable.
• Reports alleging undue influence can be filed
confidentially with the CPSC Office of the
Secretary.
26. 26
Testing Requirements For Children’s
Products
The testing must:
provide a “High Degree of Assurance” of
compliance with all children’s product safety
rules
27. 27
“A High Degree of Assurance
“A High Degree of Assurance” is based upon:
Knowledge of your products
Knowledge of how your products are
manufactured
Consistency versus variability
Measurements showing consistent performance
Control over component parts
28. 28
Toy Train – Ages 3+
Painted Wood, 5 colors,
Rubber Tires, Metal
Wheels, Magnet
Connectors
Made in established,
reliable toy factory –
used for 5 years
Past results have
consistently passed
ASTM F963 – toy
safety
29. 29
Toy Train – Ages 3+ Testing Plan
Tests to be conducted
ASTM F963 – Toy Safety
– Lead in paint
– Lead in substrate
– Phthalates
– Heavy metals
– Use & Abuse, etc.
Quantity
180,000 units
Production Schedule
10 weeks
30. 30
Toy Train – Ages 3+ Testing Plan
Testing stages
Raw Materials
– Paint,– Lead, Heavy Metals
– Metal components – Lead
– Rubber - phthalates
Pre-production
– Inline Production – Use & Abuse, XRF
Final Production - Full testing
Test Quantity/Frequency
3 pieces @25%, 50% and 75% production
Or week 2, 6, 10
1 piece @final production
31. 31
Girls Top – Sizes 2 – 6X
Mommy & Me cotton
knit top with sequin
trim, satin bows, screen
print graphics, glitter &
rhinestones
Factory used previously
for similar adult tops
Minor quality issues,
slightly late delivery
32. 32
Girls Top – Sizes 2 – 6X Testing Plan
Tests to be conducted
Flammability
Lead in paint – screen print
Lead in substrate – sequins, glitter
Tension – sequins, rhinestones, bows
Quantity
4,000 units
Production Schedule
3 weeks
33. 33
Girls Top – Sizes 2 – 6X Testing Plan (1)
Testing stages
Raw Materials
– Sequins, rhinestones, glitter – Lead
– Fabric – Flammability
– Screen print - lead
Inline production
– Tension, XRF
Final Production – Full testing
Test Quantity/Frequency
3 pieces @50% production
Or week 2
1 piece @final production
34. 34
Girls Top – Sizes 2 – 6X Testing Plan (2)
Testing stages
Raw Materials
– Fabric – Flammability
Pre-production
– Sequins, rhinestones, glitter – Lead
– Screen print – lead
Inline Production – Tension, XRF
Final Production – Full testing
Test Quantity/Frequency
3 pieces @50% production
Or week 2
1 piece @final production
35. Third Party Testing
www.cpsc.gov/testing
Desktop Reference Guide
www.cpsc.gov/desktopguide
CPSIA Resources
www.cpsc.gov/GettingStarted
Email list signup
www.cpsc.gov/smallbiz
Twitter
@CPSCSmallBiz
Slideshare
Downloadable Presentations
www.SlideShare.net/USCPSC
RESOURCES
37. Panelists:
Mary Toro
Office of Compliance
mtoro@cpsc.gov
Moderator:
Neal S. Cohen
Small Business Ombudsman
ncohen@cpsc.gov
THANK YOU
Jacqueline Campbell
Office of Hazard Identification &
Reduction
jcampbell@cpsc.gov
Louann Spirito Consumer Testing
Services, SGS North America, Inc.
Louann.Spirito@sgs.com