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CPSIA Certification and Testing Program for Children’s Product & Non-Children’s Product
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Summary Chart of Requirements for Children’s and Non Children’s Products
Children’s products Non-children’s products
Certification Testing
Production Testing Plans Suggested
Material Change Tracking
Representative Sampling
Records of Undue Influence
Corrective Actions Suggested
Product Specifications Suggested Suggested
Documentation Storage
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Children’s Product Certification
• All children’s products require 3rd party testing at CPSC approved accredited test lab for all applicable requirements
• Written certification for each children's product must be based upon passing test results obtained from the required third party testing at a CPSC accepted laboratory.
• Final Rule of Children’s Product Testing & Certification 16 CFR 1107
Effective date of Children’s Product
Certification Program: Feb 13, 2013
• Baby walkers
• Children’s ATVs
• Children’s bikes
• Children’s bike helmets
• Children’s bunk beds
• Children’s carpets and rugs
• Children’s clothing
• Children’s mattresses/pads
• Children’s metal jewelry
• Children’s vinyl plastic films
• Cribs
• Dive sticks
• Infant walkers
• Infant rattles
• Pacifiers
• Toys
• Caps and toy guns
• Children’s sleepwear
• Durable infant products
• Lead in surface coatings
• Lead in substrates
• Small parts
• ASTM F963
• Phthalates 4
The following children’s products or applicable rules, bans, and standards require a certification program:
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The following general use products require certification per a Reasonable Testing Program:
• Adult apparel
• Adult bikes
• Adult bunk beds
• Adult carpets
• Adult vinyl plastic film
• Architectural glazing
• Candles (metal wicks)
• CB antennas
• Cellulose insulation
• Child-resistance on portable gas containers Cigarette lighters
• Contact adhesives
• Fireworks
• Garage door openers
• Lawn mowers
• Matchbooks
• Multi-purpose lighters
• Adult ATV’s
• General use furniture (coatings)
• Adult mattresses
• Paint
• Refrigeration door latches
• Special packaging under PPPA
• Swimming pool slides
• Unstable refuse bins
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Periodic Testing Plan
• All manufacturers must conduct Periodic Testing by third party conformity assessment body to ensure compliance.
– Test Interval of Periodic Testing (either one of below: )
At least once a year
At least once every two years (if manufacturers have a production testing plan)
At least once every three years (if manufacturers conducting testing to ensure continued compliance with the applicable children’s product safety rules using a testing laboratory accredited to ISO/IEC 17025:2005, and test to the same test methods required in certification testing)
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Periodic Testing Plan (cont’)
• Factors to be considered for testing interval included but not limited to: – High variability in test results
– Result close to the limit (eg. Marginal result)
– Manufacturing process factors that could affect the compliance
– Consumer complaints or warranty claims
– New components part added
– Potential cause injury or death from noncompliant
– High volume products manufactured or distributed widely in US
– Visually undetectable non-compliance
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Periodic Testing Plan (Cont’)
• Production Test Plan
– Production management techniques and tests to provide a high degree of assurance that products manufactured after certification.
– Use of Process Management Techniques
Control charts,
Statistical process control programs
Failure Modes and Effects Analyses (FMEAs)
Nondestructive and tailored measurement
Testing by documented testing methods
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Periodic Testing Plan (Cont’)
• Production Test Plan included below elements:
– Description of the production test plan included: Description of the process management techniques
Test to be conducted
Measurements to be taken
Intervals of tests or measurement taken
Number of samples tested
– Specific production test plan for each manufacturing site.
– The production testing intervals should be appropriate to provide a high degree of assurance.
• Any changes of material in product design, or manufacturing process, including the sourcing of components parts, is required for new certification testing
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Material Change
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• Samples tested for periodic testing must be representative of the production lot produced in the period.
• A sufficient number of representative samples must also be selected to support that inference.
• Documentation of how the samples were chosen and evidence of those samples (i.e., the date they were selected and testing results) must be maintained for the records.
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Representative Sampling:
• Manufacturer must establish procedures to safeguard against the exercise of undue influence on a third party conformity assessment body including:
– Written policy statement
– Staff Training with signing a statement attesting to participation
– Notification to CPSC immediately
– Any undue influence may be reported confidentially to the CPSC
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Undue Influence
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Corrective Action Plan
• Product are tested with FAIL test results with respect to any CPSC enforced specification, rule, law or standard.
• The Corrective action plan should clearly identify the steps should be taken by the manufacturer to investigate and remedy failure including:
– The changes of manufacturing process or equipment
– The changes products design and/or materials
– Other actions taken to ensure compliance
** Any changes of material in product design, or manufacturing process, including the sourcing of components parts, is required
for new certification testing**
• Manufacturers must maintain the following records in English (or by other language that translated into English accurately within 48 hrs) for 5 years either in hardcopy or electronically upon CPSC requested for inspection. – Children’s Product Certificate (CPC)
– Test Reports for Certification
– Periodic testing (either one of below: )
Periodic test plan + Periodic Test Results;
Production test plan + Production Test Results + Periodic Test Results;
Testing Results by ISO/IEC 17025:2005 accredited inhouse lab. + Periodic Test Results.
– Records of any material change, manufacturing process, sourcing of component parts in a product
– Records of undue influence procedures and training
– Corrective Action Plan & corrective actions taken
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Record Keeping
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Summary for Children Certification Program Manufacturers
3rd Party Testing
Initial Product Certification
Re-certification for material change
Periodic Testing
Periodic Testing Plan
Production Testing Plan
Continued Testing by ISO 17025
accredited lab.
Children Product
Certificate
At least 1 per 3 years
All document and records shall be kept for 5 years
High Degree of Assurance
Continued Production
Either 1 of below options
At least 1 per year
At least 1 per 2 years
Undue Influence Policy & Training
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Product Development
Procurement
Raw Materials
Incoming Material Quality Control (IQC)
Raw Material Ware House
Pre-Production
Mass-Production
Product Warehouse
Buyer Requirement
3rd Party Testing
Certification Testing Result
Periodic Testing Result
CPC
Product Specification
Sourcing Information
Production Testing Plan
Production Test Result
Corrective Action If necessary
Option 2 Manufacturer with Production Testing Plan
Record Keeping by Document Management
System
Undue Influence Policy & Training
Record
Raw
Mat
eria
l / S
emi-
Pro
du
ct /
Fin
ish
ed
Pro
du
ct d
raw
n fo
r te
stin
g
Process Flow Document/Data Flow
Continued Production
Items Option 1 Option 2 Option 3
Frequency of Periodic Testing
At least 1 per year At least 1 per 2 years
At least 1 per 3 years
Cost of Periodic Testing
High Medium Low
Production Testing Plan
Not Applicable Implemented Implemented
Cost of Production Testing
Not Applicable
Low Medium
Cost of Inhouse lab. investment
Not Applicable
Medium (alternative test
method allowed)
High (method must same as 3rd Party testing)
Suitability – manufacturer size
Small (no inhouse lab.)
Medium with inhouse lab.
Large with ISO 17025
accredited inhouse lab.
Variety of Product Type
Low High High
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Testing Plan Comparison
Based on 1.Quality Management system use2. Product Risk 3. Manufacturing process variability
• Develop the product specification for supplier
• Representative sampling – on-site pickup sample directly
• Gap analysis in factory to meet the option 2 [USD 850/manday]
• Quality management system consultant service. i.e help to renew/create the Quality manual
• Provide a Document storage Platform
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Business opportunity we have?
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Reference Materials: Items Website
Final Rule of Testing and Labeling Pertaining to Product Certification, (November 8, 2011)
http://www.cpsc.gov/businfo/frnotices/fr12/certrepr.pdf
Sample children's product certificates (CPC) http://www.cpsc.gov/businfo/cpc.html
Final Rule of Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party's Finished Product Testing or Certification, to Meet Testing and Certification Requirements (November 8, 2011)
http://www.cpsc.gov/businfo/frnotices/fr12/testrelyfinal.pdf
FAQs of Certification and Third Party Testing http://www.cpsc.gov/info/toysafety/3ptfaq.html
Information on Testing and Reasonable Testing Programs
http://www.cpsc.gov/businfo/generaluse.html
Information on General Certificate of Conformity (GCC)
http://www.cpsc.gov/businfo/gcc.html
FAQs of Certification and Testing for General Use, or Non-Children's, Products
http://www.cpsc.gov/businfo/generalusefaq.html
MTS Share Point for Reasonable Test Program
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ProCompliance
ProCompliance Sharing Logic: Facebook Connection
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ProCompliance
Faber-
Castell (C1)
HEB (C2)
Costco(C3)
ABC Company (VA)
P1, P2 P1 P2
CCC Production (VB)
P3, P4
FCC Company (VC) P5 P5, P6
C1 C2 C3
Ax Ay
VA VB VC
P1 P2 P3 P4 P5 P6
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ProCompliance
ProCompliance is a solution in compliance with a number of
regulations such as EU and US, a user-friendly, web-based artificial
intelligence application to store all the product information e.g.
technical files/reports ….etc .
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ProCompliance
A user-friendly Interface:
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ProCompliance
Product page pop-up after searching. Vendor of this product could post technical documents to the database for storage. Buyer of this product could browse the stored documents through this page.
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ProCompliance
Example 1: Holiday Times (VB)
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ProCompliance
Example 2: The Children’s Place (C3)
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ProCompliance
Next Phase: Component sharing
P1 P2 P3 Sky Helicopter(P1)
Landing Helicopter (P2)
Toy Car (P3)
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Application Form Submitted by Vendor.
Create Login Account for Vendor. Save the Record in Database.
Create Document Storage Folder for Each Product.
Provide Vendor with Login Information and User Manual of ProCompliance
Training Session may be Provided on Request.
ProCompliance – Vendor’s Application
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ProCompliance – Available Function for Vendor
ProCompliance Landing Page
Search
Upload documents
Download Documents
Individual Download
Download All at once
Check if any documents
missing
Show no. of Documents
Downloaded
Show Document versions with
dates View All Products
Check Available Products
Marketing Staff Received Application from Buyer.
Create Login Account for Buyer. Save the Record in Database
Provide Buyer with Login Information and User Manual of ProCompliance
MTS will create the relationship diagram between Buyer and Vendor
Training Session may be Provided on Request.
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ProCompliance – Buyer’s Application
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ProCompliance – Available Function for Buyer
ProCompliance Landing Page
Search
Download Documents
Individual Download
Download All at once
Check if any documents
missing
Show no. of Documents
Downloaded
Show Document versions with
dates View All Products
Check Available Products
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ProCompliance – MTS Administration Role
ProCompliance Landing Page
Search
Upload Documents
MTS Test Reports ONLY
Download Documents
Individual Download
Download All at once
Check if any documents
missing
Show no. of Documents
Downloaded
Show Document versions with
dates View All Products
Check Available Products
Create User ID for Clients
Record Clients’ Service Validity
in Database
Monitor the Expiry Date
Alert Client 1 Month before
Expired
Create Product Page
Grant Access Right to specific
Client
Keep Access Right Record in
Database
Monitor the correctness of Access Right
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HEB TRU Michaels
Vendor A Item1, Item2 Item2 --
Vendor B -- Item3, Item4 Item4
Vendor C Item5 -- Item5, Item6
Case Demo
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Q & A Section
