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 continued testing using an accredited ISO/IEC 17025:2005 laboratory.
Who must comply with this requirement?
The party responsible for providing a written Children’s Product Certificate must comply with the periodic testing requirements. For products manufactured domestically, the manufacturer is responsible. For products manufactured overseas, the importer is responsible. This summary document generally refers to all responsible parties as the “manufacturer.” Certifiers of component parts used in children’s products must ensure that periodic testing has been conducted on the component parts.
What must a manufacturer do to comply?
If a manufacturer chooses to test its children’s products using a periodic testing plan with a maximum 1-year interval testing option, the manufacturer must:
- develop and implement a written periodic testing plan;
- conduct periodic testing of children’s products at a minimum of at least once per year using a CPSC-accepted laboratory; and
- keep records of all periodic test plans and test results for 5 years.
A manufacturer that chooses to test its children’s products using the 2- or 3- year interval options has different responsibilities, discussed below.
Do manufacturers who make children’s products in short production runs need to do periodic testing and have a periodic testing plan?
Generally, no. If a children’s product is exclusively produced in short production runs (and without any material changes during the production run), then periodic testing and a periodic testing plan are not required. Manufacturers that test and certify children’s products that are manufactured in a short production run do not have any periodic testing obligations under 16 C.F.R. § 1107.21. A “short production run” means a production run that is completed before a manufacturer otherwise would be required to test that product periodically, which is generally 1 year.
Note that material changes to a product – even a product produced exclusively in short production runs – would trigger additional third party testing requirements. If the manufacturer thinks a material change has occurred to the manufacturer’s children’s product, the manufacturer must resubmit the product or component part of the children’s product with the material changes to a CPSC-accepted laboratory for new testing so that a new Children’s Product Certificate may be issued for the children’s product. Full details about material change testing are available here.
Finally, while it may not be necessary to test each batch or each short production run of a children’s product that was previously tested and certified, manufacturers are cautioned to be conservative when a series of many short production runs, or batches becomes so frequent that CPSC staff could construe the production to be “continuing production” that would become subject to periodic testing requirements.
Does an importer have to comply with the periodic testing requirements?
Yes. An importer must also comply with the periodic testing requirements.
If, however, due to the nature of the business relationship, an importer exercises little or no control over the manufacturing process of a product or its component parts, it may be difficult or impossible for the importer to comply with these periodic testing requirements. In that situation, an importer likely will need to test each new shipment as if the product were being tested and certified for the first time.
If, however, an importer or manufacturer is relying on a supplier who complies with CPSC regulations because the supplier is required to comply with the regulations or because the supplier chooses voluntarily to comply, then the importer must exercise due care to ensure that its manufacturer has a periodic or production testing plan in place, that the manufacturer is following the plan and keeping the required records.
Do importers who import a children’s product and choose to test each shipment, need to conduct periodic testing and have a periodic testing plan?
No. Importers who choose to test each shipment of products do not have any periodic testing obligations under 16 C.F.R. § 1107.21.
(Note that although importers are not required to test each shipment, an importer likely will need to test each shipment in which that importer is not able to exercise sufficient control over the manufacturing process to ensure that no material changes have occurred and that the periodic testing obligations of 16 C.F.R. § 1107.21 are being met.)
Does CPSC have a model periodic testing plan?
No. It is not feasible for CPSC to create a model periodic testing plan due to the wide range of products manufactured, the variety of manufacturing processes used in manufacturing, and the different practices of individual manufacturers.
A manufacturer is expected: (a) to know the best way to achieve compliance of its product, and (b) to use its expertise about the product's design and manufacturing process to create a written periodic testing plan.
A “periodic testing plan” must be in writing, and no particular format is required. At each manufacturing site, the manufacturer must have a periodic testing plan for each children's product manufactured at that site. A periodic testing plan must include:
- the tests to be conducted;
- the intervals at which the tests will be conducted; and
- the number of samples tested.
For example, where a manufacturer uses die casting to produce a product and the manufacturer knows that the casting die wears down towards the end of its useful life, the manufacturer should design its periodic testing plan to increase the frequency of its periodic testing as the die ages. The physical dimensions of the die help assure compliance of the product and more testing of this product may be necessary because of "known manufacturing process factors which could affect compliance with a rule." Similarly, a manufacturer that makes products with complex mechanical structures may need to test more frequently than a manufacturer that produces a simple children’s product (e.g., basic, unpainted, solid wooden blocks). Products produced with complex mechanical structures present greater potential for production error, and therefore, may need to be tested more frequently.
Although not required, a manufacturer may wish to consider describing the rationale for the design of its periodic testing plan to memorialize the rationale and document the information available to the manufacturer at the time the plan was drafted. In the event that a health or safety problem with the product becomes evident later, retaining such information may provide the manufacturer and CPSC with an understanding of where and why the problem occurred.
How frequently must a manufacturer conduct periodic testing?
It depends. Periodic testing should be conducted frequently enough to provide the manufacturer or importer a high degree of assurance that continuing production of the children's product complies with all applicable children's product safety rules. If a manufacturer is relying on a “periodic” testing plan, testing must be conducted no less than once per year, and it may need to be conducted more often than once per year.
For example, the periodic testing rule states that in determining the frequency (by batch, lot, or other measurement) of testing ongoing production, 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; and
- the potential for serious injury or death resulting from a noncompliant children's product, among other factors.
Manufacturers should recognize that periodic testing is not the only way to have a high degree of assurance. 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 quality assurance/quality control (QA/QC) systems) should work together, in concert with periodic testing, to provide the desired high degree of assurance.
Can a manufacturer test its children’s product less often than a minimum of once per year?
Yes. If a manufacturer drafts and follows a “production” testing plan ─instead of a “periodic” testing plan─ the manufacturer is permitted to test its product at least once every 2 years. A production testing plan must be in writing, and no particular format is required. At each manufacturing site, the manufacturer must have a production testing plan for each children's product manufactured at that site.
A production testing plan is a plan describing actions taken by a manufacturer, other than third party testing, to help ensure continued compliance of a children’s product. The examples provided above, such as incoming inspection of raw materials, first party testing, in-factory QA/QC systems, which are used by a manufacturer to control for potential variability in its production process, should be included in a production testing plan. Again, CPSC does not provide a model production testing plan due to the wide range of products manufactured, the variety of manufacturing processes used in manufacturing, and the different practices of individual manufacturers.
- 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 by CPSC for the applicable children's product safety rule.
A production testing plan may include recurring testing or the use of process management techniques, such as control charts, statistical process control programs, or failure modes and effects analyses (FMEAs) designed to control potential variations in product manufacturing that could affect the product's ability to comply with the applicable children's product safety rules. A manufacturer may use nondestructive measurement techniques tailored to the needs of an individual product to help ensure that a product continues to comply with all applicable children's product safety rules. Any production testing plan must be effective in determining compliance and must include some testing, although the test methods employed are not required to be the test methods used for certification nor is it required to utilize a CPSC-accepted laboratory.
For manufacturers, there is a third testing option that permits the testing of the manufacturer’s children’s products every 3 years through the use of a testing laboratory accredited to ISO/IEC 17025:2005(E), and by testing the children’s products using the test methods specified in the standard or rule. This option is most likely applicable to larger manufacturers. Further details are available in the regulation.
Depending on which option a manufacturer chooses, a manufacturer only needs to develop one plan – either a production testing plan or a periodic testing plan.
What must a manufacturer using a production testing plan do to comply?
If a manufacturer chooses to test its children’s products using the production testing plan with a maximum 2-year interval testing option, the manufacturer must:
- create a written production testing plan;
- conduct production testing in accordance with its production testing plan;
- conduct periodic testing of children’s products at a minimum of once every 2 years using a CPSC-accepted laboratory; and
- keep records of all production test plans and test results (both periodic testing and production testing) for 5 years.
A manufacturer that chooses to test its children’s products using the ISO/IEC 17025: 2005 laboratory option with a 3- year periodic testing interval should consult the regulation for the manufacturer’s responsibilities.
How should a manufacturer select product samples for periodic testing?
The number and type of samples selected for testing in a CPSC-accepted laboratory must be representative of the production units that are not tested and must be sufficient to provide a high degree of assurance that the tests conducted for certification purposes accurately demonstrate that the non-tested children's products continue to meet all applicable children's product safety rules.
What if a component part of the children’s product is changed?
If, at any time after a children’s product is initially tested and certified, the product is materially changed , the product (or just the specific component that was changed) must be tested again for compliance, and the manufacturer or importer must issue a new Children’s Product Certificate. This is called material change testing and it is different from periodic testing.
A material change may mean the substitution of one component part for another, a change in a component part supplier, a design or manufacturing process change, or another product change that could affect the product’s compliance with applicable children’s product safety rules. By contrast, periodic testing is the third party testing of products in continued production, even where there have been no known material changes to the product since the product was initially tested and certified as compliant.
Do small batch manufacturers have to comply with the periodic testing requirements?
Unless there is an alternative testing requirement or an exemption, small batch manufacturers are required to comply with the periodic testing requirements for children’s product safety rules. To the extent that a small batch manufacturer may not be required to third party test a particular item (for a particular requirement), CPSC staff still expects a small batch manufacturer registered with the CPSC to exercise due care to ensure that its suppliers have continued to periodically test their component parts, even if the testing is first party testing.
This communication has been prepared for general informational purposes only and is based upon the facts and information presented. This communication does not, and is not intended to, constitute legal advice and has not been reviewed or approved by the Commission, and does not necessarily represent their views. Any views expressed in this communication may be changed or superseded by the Commission.