SlideShare a Scribd company logo
1 of 4
What is periodic testing?

Periodic testing is third party testing that must be conducted, after the initial certification of
achildren's product, within specified maximum testing intervals depending on which of the three
options - explained in the following questions - that you choose. Periodic testing must be doneby
a CPSC-accepted third party laboratory.



How often do I have to do periodic testing?

How often periodic testing must be done depends upon which options you choose and upon the
facts and circumstances surrounding your particular product. The general principle set forth in
the regulation is that you, as the manufacturer, must have a periodic testing plan and
conductperiodic testing (using a CPSC-accepted laboratory) at least once per year.

In addition to the general principle of periodic testing described above, a manufacturer may also
choose to implement a production testing plan or conduct continued testing using an ISO/IEC
17025-2005-accredited lab. If you establish a production testing plan for your product, you must
conduct periodic testing at least once every 2 years. If you conduct continued testing using an
ISO/IEC 17025-2005-accredited lab, you must conduct periodic testing at least once every 3
years. Please refer to the regulation for further details about setting up a production testing plan
and conducting continued testing using an ISO/IEC 17025:2005-accredited lab. This summary
does not provide all of the details included in the periodic testing requirements.

Periodic testing may need to be conducted more than once per year and should be conducted
frequently enough to provide the manufacturer or importer a high degree of assurance that
continuing production of the children's product continues to comply with all applicable children's
product safety rules. You are expected to know whether the facts and circumstances of
manufacturing your product may warrant more frequent testing than once per year.

For example, the periodic testing rule states that in determining the frequency (by batch, lot, or
other measurement) at which testing of ongoing production should be performed, a manufacturer
may wish to consider various factors, such as high variability in test results, measurements that
are close to the allowable numerical limit for quantitative tests, known manufacturing process
factors that could affect compliance with a rule, introduction of a new set of component parts
into the manufacturing process, the potential for serious injury or death resulting from a
noncompliant children's product, and other factors, as set forth in 16 CFR § 1107.21(b)(2).

A manufacturer is expected to know the best way that compliance of its product can be achieved
and to use their knowledge of the product's design and manufacturing process to create a periodic
testing plan that provides the manufacturer with a high degree of assurance that its children's
product continues to be compliant with the applicable children's product safety rules. In one
example concerning "known manufacturing process factors which could affect compliance with
a rule," the Commission describes a situation in which a manufacturer knows that a casting die
wears down as the die nears the end of its useful life and states that the manufacturer may wish
to test more often as the casting die wears down. Similarly, a manufacturer who uses volatile
chemicals or produces products with complex mechanical structures, both of which have a
greater potential for production error than a simpler product, may need to test more frequently
than a manufacturer who produces, for example, basic unpainted, solid wooden blocks.

In addition, manufacturers should recognize that periodic testing is not the only way to have a
high degree of assurance. Rather, everything that a manufacturer does to control for potential
variability in its production process (e.g., incoming inspection of raw materials, first party
testing, in-factory QA/QC systems), plus periodic testing, should work together to provide the
desired high degree of assurance. In order to ensure continued compliance of its children's
products, a manufacturer is required to conduct periodic testing at least once per year, but a
manufacturer, depending on the qualities associated with their children's product, may wish to
add additional controls into its manufacturing process. It is also critical, and required by law, that
a manufacturer maintain records of its periodic testing plan and the other actions it has taken to
secure a high degree of assurance.

Animporter, or a manufacturer who exercises little or no control over the manufacturing
process,will need to exercise due care to ensure that it has the knowledge necessary to make
appropriate decisions about the frequency of testing necessary for continued production and
additional batches and lots of products.

What does a periodic testing plan look like? What does a production testing plan look like?

A periodic testing plan must be in writing, and it must include the tests to be conducted,
theintervals at which the tests will be conducted, and the number of samples to be tested. The
testing interval may vary, depending upon which children's product safety rule is applicable to
the product and the factors outlined in the regulation.

A production testing plan must be in writing and must describe the process-management
techniques used; 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 compliance with
the applicable regulations.

This summary does not include all of the details included in the periodic testing requirements.
Please refer to the regulation for further details about setting up a periodic or production testing
plan.



How long must I keep records of the testing and certification performed for each product?

You must maintain records for 5 years from the date of production of your product. The records
must include a copy of the Children's Product Certificate for each product, records of each third
party certification test (for each manufacturing site), descriptions of all material changes in
product design, manufacturing process, component part sourcing, test values and certification
test runs, undue influence procedures, and one of the following:

          i.   a periodic test plan and periodic test results;
         ii.   a production test plan, production test results, and periodic test results; or
        iii.   results of tests conducted by a testing laboratory accredited to ISO/IEC
               17025:2005 and periodic test results.



The records must be made available, in hard copy or electronically (such as through email or via
an Internet website), for inspection by the CPSC, upon request. Please refer to the regulation for
further details.

Component Part TestingIf my component part supplier has already third party tested part of
my product, can I rely upon that third party testing to issue a Children's Product Certificate
for my product?

Yes, provided that certain conditions are satisfied. The Commission has issued a rule regarding
testing component parts. You can rely upon the test results or a certification from a component
part supplier if the requirements in our regulation at 16 CFR part 1109 (pdf) are met. That rule
requires that in order to rely upon test results or a certification from a supplier, you must use due
care to ensure that the tests results or the certificate is valid, and be given access to the
underlying documentation, such as test results and attestations regarding how the testing was
conducted and by whom. Generally, certifications of a component part must satisfy the
requirement for a children's product certificate (pdf), and must be based on the results of testing
from a laboratory whose accreditation has been accepted by the CPSC.



Can I third party test all of the materials coming in to my factory instead of third party
testing the finished product?

It depends, but you may be able to use this approach depending on your particular product.

For safety rules that require testing of the finished product in order to determine compliance,
such as functional or mechanical testing, or the accessibility of component parts, the finished
product must always be tested.

For products that do not have such requirements, third party testing the incoming materials may
be acceptable, provided that no subsequent non-third party tested materials enter the production
process after the testing, and provided that no further chemical changes occur after the testing.
For example, a manufacturer who tests all of the color varieties of plastic pellets coming into its
factory that will be used in its plastic injection molding process would not need to test the final
products, even if the same pellets were used to produce a wide variety of plastic products
(subject to the caveats already described about functional and mechanical testing, if necessary.)
Do I have to retest the whole product if there is a material change to only one component
part of the product?

No. Component part testing may be sufficient for a material change to only one component.
When there is a material change to a component part of a product that does not affect other
component parts, and it does not affect the finished product's ability to comply with other
applicable children's product safety rules, then a manufacturer may issue a new Children's
Product Certificate based upon the earlier third party certification tests, along with the new test
results for the materially changed component part. Please refer to the regulation published in 16
CFR part 1109 (pdf) for those details..

For example, if you manufacture a painted wooden toy car, and you change paint suppliers, you
need to test only the paint (and not the metal axles) for compliance in order to issue a new
Children's Product Certificate. In other words, because the metal axles did not change, you do
not have to retest them. If, however, a component part is changed that may affect the proper
mechanical function of the finished product, then the whole product may need to be retested.



Are there any circumstances when I cannot rely on testing done by my component part
supplier?

Testing of the component part also must be sufficient to certify compliance of the product to a
particular regulation. For example, lead content and phthalate content testing on a component
part is sufficient to assess compliance because the chemical content of the component
presumably will not change when it is incorporated into the finished product. On the other hand,
a component part test may not be sufficient for a children's product that is being tested for its
structural integrity because that testing needs to be conducted on the finished product. Testing of
toys to the small parts regulation would be an example of where component part testing is not
appropriate. It is your responsibility to ensure that all required certification testing has been
completed before issuing a Children's Product Certificate.

More Related Content

What's hot

Good manufacturing and validation
Good manufacturing and validation Good manufacturing and validation
Good manufacturing and validation IshwarJadhav4
 
Analytical Quality Agreement Template
Analytical Quality Agreement TemplateAnalytical Quality Agreement Template
Analytical Quality Agreement Templatephillipsm4
 
Documentation with respect to release of finished pharmaceutical product
Documentation with respect to release of finished pharmaceutical productDocumentation with respect to release of finished pharmaceutical product
Documentation with respect to release of finished pharmaceutical productMadhuraNewrekar
 
Quality & GMP Presentation
Quality & GMP PresentationQuality & GMP Presentation
Quality & GMP Presentationmayydabajwa
 
Product development Global prospective
Product development   Global prospective Product development   Global prospective
Product development Global prospective Guru Balaji .S
 
Good Manufacturing Practices For Quality Control
Good Manufacturing Practices For Quality ControlGood Manufacturing Practices For Quality Control
Good Manufacturing Practices For Quality ControlDr Rajendra Patel
 
Vendor qualification flow chart
Vendor qualification flow chartVendor qualification flow chart
Vendor qualification flow chartBangaluru
 
Instant GMP Compliance Series - Improving Documentation
Instant GMP Compliance Series - Improving DocumentationInstant GMP Compliance Series - Improving Documentation
Instant GMP Compliance Series - Improving DocumentationInstantGMP™
 
Good Manufacturing Practices by InstantGMP
Good Manufacturing Practices by InstantGMPGood Manufacturing Practices by InstantGMP
Good Manufacturing Practices by InstantGMPAtlantic Training, LLC.
 
cGMP Training 2013
cGMP Training 2013cGMP Training 2013
cGMP Training 2013bloodbank
 
Market complaints and product recall
Market complaints and product recallMarket complaints and product recall
Market complaints and product recallpaideeksha
 
Quality control of pharmaceutical products
Quality control of pharmaceutical productsQuality control of pharmaceutical products
Quality control of pharmaceutical productsSiham Abdallaha
 
Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...
Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...
Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...Atlantic Training, LLC.
 
Quality assuranceandregulatorycomplianceforpharmaceuticalproduct(4)
Quality assuranceandregulatorycomplianceforpharmaceuticalproduct(4)Quality assuranceandregulatorycomplianceforpharmaceuticalproduct(4)
Quality assuranceandregulatorycomplianceforpharmaceuticalproduct(4)ceutics1315
 
Validation of raw materials
Validation of raw materialsValidation of raw materials
Validation of raw materialsNaincy Gupta
 

What's hot (20)

Good manufacturing and validation
Good manufacturing and validation Good manufacturing and validation
Good manufacturing and validation
 
Analytical Quality Agreement Template
Analytical Quality Agreement TemplateAnalytical Quality Agreement Template
Analytical Quality Agreement Template
 
Documentation with respect to release of finished pharmaceutical product
Documentation with respect to release of finished pharmaceutical productDocumentation with respect to release of finished pharmaceutical product
Documentation with respect to release of finished pharmaceutical product
 
Quality & GMP Presentation
Quality & GMP PresentationQuality & GMP Presentation
Quality & GMP Presentation
 
CPSC Strategy,Testing and Certification
CPSC Strategy,Testing and CertificationCPSC Strategy,Testing and Certification
CPSC Strategy,Testing and Certification
 
SOP
SOPSOP
SOP
 
Product development Global prospective
Product development   Global prospective Product development   Global prospective
Product development Global prospective
 
Good Manufacturing Practices For Quality Control
Good Manufacturing Practices For Quality ControlGood Manufacturing Practices For Quality Control
Good Manufacturing Practices For Quality Control
 
Vendor qualification flow chart
Vendor qualification flow chartVendor qualification flow chart
Vendor qualification flow chart
 
Instant GMP Compliance Series - Improving Documentation
Instant GMP Compliance Series - Improving DocumentationInstant GMP Compliance Series - Improving Documentation
Instant GMP Compliance Series - Improving Documentation
 
Good Manufacturing Practices by InstantGMP
Good Manufacturing Practices by InstantGMPGood Manufacturing Practices by InstantGMP
Good Manufacturing Practices by InstantGMP
 
cGMP Training 2013
cGMP Training 2013cGMP Training 2013
cGMP Training 2013
 
Market complaints and product recall
Market complaints and product recallMarket complaints and product recall
Market complaints and product recall
 
GMP-VENDORS SELECTION
GMP-VENDORS SELECTIONGMP-VENDORS SELECTION
GMP-VENDORS SELECTION
 
Quality control of pharmaceutical products
Quality control of pharmaceutical productsQuality control of pharmaceutical products
Quality control of pharmaceutical products
 
Audit
AuditAudit
Audit
 
Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...
Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...
Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...
 
Quality assuranceandregulatorycomplianceforpharmaceuticalproduct(4)
Quality assuranceandregulatorycomplianceforpharmaceuticalproduct(4)Quality assuranceandregulatorycomplianceforpharmaceuticalproduct(4)
Quality assuranceandregulatorycomplianceforpharmaceuticalproduct(4)
 
G m p 01
G m p 01G m p 01
G m p 01
 
Validation of raw materials
Validation of raw materialsValidation of raw materials
Validation of raw materials
 

Similar to Periodic testing requirements for children's products

2013 Testing & Certification of Consumer Products- 2013 Safety Academy (final)
2013 Testing & Certification of Consumer Products- 2013 Safety Academy (final)2013 Testing & Certification of Consumer Products- 2013 Safety Academy (final)
2013 Testing & Certification of Consumer Products- 2013 Safety Academy (final)U.S. Consumer Product Safety Commission
 
CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Product...
CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Product...CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Product...
CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Product...U.S. Consumer Product Safety Commission
 
VALIDATION BY DHIRAJ SHRESTHA
VALIDATION BY DHIRAJ SHRESTHAVALIDATION BY DHIRAJ SHRESTHA
VALIDATION BY DHIRAJ SHRESTHADhiraj Shrestha
 
Process Validation.pptx
Process Validation.pptxProcess Validation.pptx
Process Validation.pptxRameshAmuluru1
 
Pharmaceutical validation.pptx
Pharmaceutical validation.pptxPharmaceutical validation.pptx
Pharmaceutical validation.pptxArpithaNandakumar1
 
Validation of equipment copy
Validation of equipment   copyValidation of equipment   copy
Validation of equipment copysneha chavan
 
Raw Material Validation
Raw Material ValidationRaw Material Validation
Raw Material ValidationHiron Devnath
 
Pharmaceutical Qualification & Validation
Pharmaceutical Qualification & ValidationPharmaceutical Qualification & Validation
Pharmaceutical Qualification & ValidationPharmaceutical
 
Pharmaceutical Good Manufacturing Practices
Pharmaceutical Good Manufacturing PracticesPharmaceutical Good Manufacturing Practices
Pharmaceutical Good Manufacturing PracticesPharmaceutical
 
Dosage form validation
Dosage form validationDosage form validation
Dosage form validationprashik shimpi
 
Types of Validation and Government Regulations
Types of Validation and Government RegulationsTypes of Validation and Government Regulations
Types of Validation and Government RegulationsPratidnyaKodag
 
PET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET RadiopharmaceutialsPET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET Radiopharmaceutials@Saudi_nmc
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validationAtul Adhikari
 
Quality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticalsQuality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
 
GMP Sub Part E & F
GMP Sub Part E & FGMP Sub Part E & F
GMP Sub Part E & FHARDIK PATEL
 

Similar to Periodic testing requirements for children's products (20)

2013 Testing & Certification of Consumer Products- 2013 Safety Academy (final)
2013 Testing & Certification of Consumer Products- 2013 Safety Academy (final)2013 Testing & Certification of Consumer Products- 2013 Safety Academy (final)
2013 Testing & Certification of Consumer Products- 2013 Safety Academy (final)
 
CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Product...
CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Product...CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Product...
CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Product...
 
Process validation
Process validationProcess validation
Process validation
 
VALIDATION BY DHIRAJ SHRESTHA
VALIDATION BY DHIRAJ SHRESTHAVALIDATION BY DHIRAJ SHRESTHA
VALIDATION BY DHIRAJ SHRESTHA
 
Process Validation.pptx
Process Validation.pptxProcess Validation.pptx
Process Validation.pptx
 
Pharmaceutical validation.pptx
Pharmaceutical validation.pptxPharmaceutical validation.pptx
Pharmaceutical validation.pptx
 
Validation
ValidationValidation
Validation
 
Validation of equipment copy
Validation of equipment   copyValidation of equipment   copy
Validation of equipment copy
 
Raw Material Validation
Raw Material ValidationRaw Material Validation
Raw Material Validation
 
Pharmaceutical Qualification & Validation
Pharmaceutical Qualification & ValidationPharmaceutical Qualification & Validation
Pharmaceutical Qualification & Validation
 
Pharmaceutical Good Manufacturing Practices
Pharmaceutical Good Manufacturing PracticesPharmaceutical Good Manufacturing Practices
Pharmaceutical Good Manufacturing Practices
 
Dosage form validation
Dosage form validationDosage form validation
Dosage form validation
 
Vallidation
VallidationVallidation
Vallidation
 
Types of Validation and Government Regulations
Types of Validation and Government RegulationsTypes of Validation and Government Regulations
Types of Validation and Government Regulations
 
PET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET RadiopharmaceutialsPET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET Radiopharmaceutials
 
Process validation of tablets
Process validation of tabletsProcess validation of tablets
Process validation of tablets
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validation
 
Quality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticalsQuality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticals
 
PHARMACEUTICAL VALIADATION
PHARMACEUTICAL VALIADATIONPHARMACEUTICAL VALIADATION
PHARMACEUTICAL VALIADATION
 
GMP Sub Part E & F
GMP Sub Part E & FGMP Sub Part E & F
GMP Sub Part E & F
 

Periodic testing requirements for children's products

  • 1. What is periodic testing? Periodic testing is third party testing that must be conducted, after the initial certification of achildren's product, within specified maximum testing intervals depending on which of the three options - explained in the following questions - that you choose. Periodic testing must be doneby a CPSC-accepted third party laboratory. How often do I have to do periodic testing? How often periodic testing must be done depends upon which options you choose and upon the facts and circumstances surrounding your particular product. The general principle set forth in the regulation is that you, as the manufacturer, must have a periodic testing plan and conductperiodic testing (using a CPSC-accepted laboratory) at least once per year. In addition to the general principle of periodic testing described above, a manufacturer may also choose to implement a production testing plan or conduct continued testing using an ISO/IEC 17025-2005-accredited lab. If you establish a production testing plan for your product, you must conduct periodic testing at least once every 2 years. If you conduct continued testing using an ISO/IEC 17025-2005-accredited lab, you must conduct periodic testing at least once every 3 years. Please refer to the regulation for further details about setting up a production testing plan and conducting continued testing using an ISO/IEC 17025:2005-accredited lab. This summary does not provide all of the details included in the periodic testing requirements. Periodic testing may need to be conducted more than once per year and should be conducted frequently enough to provide the manufacturer or importer a high degree of assurance that continuing production of the children's product continues to comply with all applicable children's product safety rules. You are expected to know whether the facts and circumstances of manufacturing your product may warrant more frequent testing than once per year. For example, the periodic testing rule states that in determining the frequency (by batch, lot, or other measurement) at which testing of ongoing production should be performed, a manufacturer may wish to consider various factors, such as high variability in test results, measurements that are close to the allowable numerical limit for quantitative tests, known manufacturing process factors that could affect compliance with a rule, introduction of a new set of component parts into the manufacturing process, the potential for serious injury or death resulting from a noncompliant children's product, and other factors, as set forth in 16 CFR § 1107.21(b)(2). A manufacturer is expected to know the best way that compliance of its product can be achieved and to use their knowledge of the product's design and manufacturing process to create a periodic testing plan that provides the manufacturer with a high degree of assurance that its children's product continues to be compliant with the applicable children's product safety rules. In one example concerning "known manufacturing process factors which could affect compliance with a rule," the Commission describes a situation in which a manufacturer knows that a casting die wears down as the die nears the end of its useful life and states that the manufacturer may wish
  • 2. to test more often as the casting die wears down. Similarly, a manufacturer who uses volatile chemicals or produces products with complex mechanical structures, both of which have a greater potential for production error than a simpler product, may need to test more frequently than a manufacturer who produces, for example, basic unpainted, solid wooden blocks. In addition, manufacturers should recognize that periodic testing is not the only way to have a high degree of assurance. Rather, everything that a manufacturer does to control for potential variability in its production process (e.g., incoming inspection of raw materials, first party testing, in-factory QA/QC systems), plus periodic testing, should work together to provide the desired high degree of assurance. In order to ensure continued compliance of its children's products, a manufacturer is required to conduct periodic testing at least once per year, but a manufacturer, depending on the qualities associated with their children's product, may wish to add additional controls into its manufacturing process. It is also critical, and required by law, that a manufacturer maintain records of its periodic testing plan and the other actions it has taken to secure a high degree of assurance. Animporter, or a manufacturer who exercises little or no control over the manufacturing process,will need to exercise due care to ensure that it has the knowledge necessary to make appropriate decisions about the frequency of testing necessary for continued production and additional batches and lots of products. What does a periodic testing plan look like? What does a production testing plan look like? A periodic testing plan must be in writing, and it must include the tests to be conducted, theintervals at which the tests will be conducted, and the number of samples to be tested. The testing interval may vary, depending upon which children's product safety rule is applicable to the product and the factors outlined in the regulation. A production testing plan must be in writing and must describe the process-management techniques used; 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 compliance with the applicable regulations. This summary does not include all of the details included in the periodic testing requirements. Please refer to the regulation for further details about setting up a periodic or production testing plan. How long must I keep records of the testing and certification performed for each product? You must maintain records for 5 years from the date of production of your product. The records must include a copy of the Children's Product Certificate for each product, records of each third party certification test (for each manufacturing site), descriptions of all material changes in
  • 3. product design, manufacturing process, component part sourcing, test values and certification test runs, undue influence procedures, and one of the following: i. a periodic test plan and periodic test results; ii. a production test plan, production test results, and periodic test results; or iii. results of tests conducted by a testing laboratory accredited to ISO/IEC 17025:2005 and periodic test results. The records must be made available, in hard copy or electronically (such as through email or via an Internet website), for inspection by the CPSC, upon request. Please refer to the regulation for further details. Component Part TestingIf my component part supplier has already third party tested part of my product, can I rely upon that third party testing to issue a Children's Product Certificate for my product? Yes, provided that certain conditions are satisfied. The Commission has issued a rule regarding testing component parts. You can rely upon the test results or a certification from a component part supplier if the requirements in our regulation at 16 CFR part 1109 (pdf) are met. That rule requires that in order to rely upon test results or a certification from a supplier, you must use due care to ensure that the tests results or the certificate is valid, and be given access to the underlying documentation, such as test results and attestations regarding how the testing was conducted and by whom. Generally, certifications of a component part must satisfy the requirement for a children's product certificate (pdf), and must be based on the results of testing from a laboratory whose accreditation has been accepted by the CPSC. Can I third party test all of the materials coming in to my factory instead of third party testing the finished product? It depends, but you may be able to use this approach depending on your particular product. For safety rules that require testing of the finished product in order to determine compliance, such as functional or mechanical testing, or the accessibility of component parts, the finished product must always be tested. For products that do not have such requirements, third party testing the incoming materials may be acceptable, provided that no subsequent non-third party tested materials enter the production process after the testing, and provided that no further chemical changes occur after the testing. For example, a manufacturer who tests all of the color varieties of plastic pellets coming into its factory that will be used in its plastic injection molding process would not need to test the final products, even if the same pellets were used to produce a wide variety of plastic products (subject to the caveats already described about functional and mechanical testing, if necessary.)
  • 4. Do I have to retest the whole product if there is a material change to only one component part of the product? No. Component part testing may be sufficient for a material change to only one component. When there is a material change to a component part of a product that does not affect other component parts, and it does not affect the finished product's ability to comply with other applicable children's product safety rules, then a manufacturer may issue a new Children's Product Certificate based upon the earlier third party certification tests, along with the new test results for the materially changed component part. Please refer to the regulation published in 16 CFR part 1109 (pdf) for those details.. For example, if you manufacture a painted wooden toy car, and you change paint suppliers, you need to test only the paint (and not the metal axles) for compliance in order to issue a new Children's Product Certificate. In other words, because the metal axles did not change, you do not have to retest them. If, however, a component part is changed that may affect the proper mechanical function of the finished product, then the whole product may need to be retested. Are there any circumstances when I cannot rely on testing done by my component part supplier? Testing of the component part also must be sufficient to certify compliance of the product to a particular regulation. For example, lead content and phthalate content testing on a component part is sufficient to assess compliance because the chemical content of the component presumably will not change when it is incorporated into the finished product. On the other hand, a component part test may not be sufficient for a children's product that is being tested for its structural integrity because that testing needs to be conducted on the finished product. Testing of toys to the small parts regulation would be an example of where component part testing is not appropriate. It is your responsibility to ensure that all required certification testing has been completed before issuing a Children's Product Certificate.