1. Modern Testing Services
CPSIA Certification and Testing Program for Children’s Product & Non-Children’s Product
Your Quality Assurance solution

2. 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
Product Specifications
Documentation Storage

3. 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

4. The following children’s products or applicable rules, bans, and
standards require a certification program:
Baby walkers
Infant walkers
Children’s ATVs
Infant rattles
Children’s bikes
Pacifiers
Children’s bike helmets
Toys
Children’s bunk beds
Caps and toy guns
Children’s carpets and rugs
Children’s sleepwear
Children’s clothing
Durable infant products
Children’s mattresses/pads
Lead in surface coatings
Children’s metal jewelry
Lead in substrates
Children’s vinyl plastic films
Small parts
Cribs
ASTM F963
Dive sticks
Phthalates

5. The following general use products require certification per a Reasonable Testing Program:
Adult apparel
Garage door openers
Adult bikes
Lawn mowers
Adult bunk beds
Matchbooks
Adult carpets
Multi-purpose lighters
Adult vinyl plastic film
Adult ATV’s
Architectural glazing
General use furniture (coatings)
Candles (metal wicks)
Adult mattresses
CB antennas
Paint
Cellulose insulation
Refrigeration door latches
Child-resistance on portable gas containers Cigarette lighters
Special packaging under PPPA
Swimming pool slides
Contact adhesives
Unstable refuse bins
Fireworks

6. 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)

7. 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

8. 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

9. 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.

10. Material Change
Any changes of material in product design, or manufacturing process, including the sourcing of components parts, is required for new certification testing

11. Representative Sampling:
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. 11

12. Undue Influence
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

13. 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**

14. Record Keeping
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

15. Summary for Children Certification Program
Manufacturers
3rd Party Testing
Undue Influence Policy & Training
Continued Production
Initial Product Certification
Re-certification for material change
Periodic Testing
Either 1 of below options
Periodic Testing Plan
Production Testing Plan
Continued Testing by ISO accredited lab.
Children Product Certificate
At least 1 per year
At least 1 per 2 years
At least 1 per 3 years
All document and records shall be kept for 5 years
High Degree of Assurance

16. Product Specification
Buyer Requirement
Product Development
Product Specification
Procurement
Sourcing Information
Option 2 Manufacturer with Production Testing Plan
Process Flow
Document/Data Flow
Raw Materials
Incoming Material Quality Control (IQC)
Continued Production
Production Testing Plan
Raw Material / Semi-Product / Finished Product drawn for testing
Undue Influence Policy & Training Record
Production Test Result
Raw Material Ware House
Corrective Action If necessary
3rd Party Testing
Pre-Production
Certification Testing Result
Periodic Testing Result
Mass-Production
Record Keeping
by Document Management System
Product Warehouse
CPC

17. Testing Plan Comparison
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
Cost of Production Testing
Cost of Inhouse lab. investment
Medium (alternative test method allowed)
(method must same as 3rd Party testing)
Suitability – manufacturer size
Small
(no inhouse lab.)
with inhouse lab.
Large
with ISO accredited inhouse lab.
Variety of Product Type
Based on
1.Quality Management system use
2. Product Risk
3. Manufacturing process variability

18. Business opportunity we have?
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

19. Reference Materials: Items Website
Final Rule of Testing and Labeling Pertaining to Product Certification, (November 8, 2011)
Sample children's product certificates (CPC) 
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) 
FAQs of Certification and Third Party Testing
Information on Testing and Reasonable Testing Programs
Information on General Certificate of Conformity (GCC)
FAQs of Certification and Testing for General Use, or Non-Children's, Products

20. MTS Share Point for Reasonable Test Program
ProCompliance
MTS Share Point for Reasonable Test Program

21. ProCompliance
ProCompliance Sharing Logic: Facebook Connection

22. ProCompliance C1 C2 C3 Ax Ay VA VB VC P1 P2 P3 P4 P5 P6 Faber-Castell
HEB
(C2)
Costco(C3)
ABC Company
(VA)
P1, P2 P1 P2
CCC Production (VB)
P3, P4
FCC Company (VC) P5
P5, P6 Ax Ay VA VB VC P1 P2 P3 P4 P5 P6

23. 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 .

24. ProCompliance
A user-friendly Interface:

25. 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.

26. ProCompliance
Example 1: Holiday Times (VB)

27. ProCompliance
Example 2: The Children’s Place (C3)

28. ProCompliance Next Phase: Component sharing P1 P2 P3
Sky Helicopter(P1)
Landing Helicopter
(P2)
Toy Car
(P3) 

29. ProCompliance – Vendor’s Application
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.

30. Available Function for Vendor
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

31. ProCompliance – Buyer’s Application
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.

32. Available Function for Buyer
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

33. MTS Administration Role
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

34. Case Demo HEB TRU Michaels Vendor A Item1, Item2 Item2 -- Vendor B
HEB
TRU
Michaels
Vendor A
Item1, Item2
Item2 --
Vendor B
Item3, Item4
Item4
Vendor C
Item5
Item5, Item6

35. Your Quality Assurance solutions

36. Q & A Section Testing Your Quality Assurance Solution Auditing
Inspection
Q & A Section
Your Quality Assurance Solution