Periodic testing means testing that must be conducted for children’s products that are in continuous manufacture. This testing is in addition to the testing that was conducted when a children’s product was initially tested for certification or when the product was retested and certified following a material change. Periodic testing must be performed by a CPSC-accepted third-party laboratory.
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 laboratory, see 16 CFR § 1107.21.
Similar to the initial certification testing, the responsible firm is the domestic manufacturer for children's products manufactured domestically and the importer for children’s products manufactured overseas.
If a firm 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 firm that chooses to test its children’s products using the 2- or 3- year interval options have different responsibilities, discussed in the additional questions below.
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. Firms that test and certify children’s products that are manufactured in a short production run (less than 1 year) do not have any periodic testing obligations under 16 CFR § 1107.21.
Note that material changes to a product – even a product produced exclusively in short production runs – would trigger retesting. If the firm thinks a material change has occurred, the firm must retest the product or component part of the children’s product with the material changes using a third-party, CPSC-accepted laboratory and issue a new CPC.
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, firms 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.
Yes. An importer must also comply with the periodic testing requirements.
If 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.
A firm relying on a supplier who complies with CPSC regulations (either because the supplier is required to comply with the regulations or because the supplier chooses voluntarily to comply) must exercise due care to ensure that the supplier has a periodic or production testing plan in place and that the supplier is following the plan and keeping the required records. See 16 CFR part 1109 and our component part testing FAQs for more information on relying on a third party’s testing and/or certification.
No. Importers who choose to test/certify each shipment of products do not have any periodic testing obligations under 16 CFR § 1107.21.
It depends. Periodic testing should be conducted frequently enough to provide the manufacturer or importer with a high degree of assurance that continuing production of the children's product complies with all applicable children's product safety regulations. If a firm is relying on a periodic testing plan, testing must be conducted no less 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.
Firms should recognize that periodic testing is not the only way to have a high degree of assurance. Everything that a firm does to control potential variability in its production process (e.g., incoming inspection of raw materials, first party testing, in-factory quality assurance/quality control systems) should work together, in concert with periodic testing, to provide the desired high degree of assurance.
Yes. If a firm drafts and follows a production testing plan ─ instead of a periodic testing plan ─ the firm is permitted to test its product at least once every 2 years. Similar to a periodic testing plan, a production testing plan must be in writing, and no particular format is required. At each manufacturing site, the firm 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 firm, other than third-party testing, to help ensure continued compliance of a children’s product. Factors that are used by a manufacturer to control potential variability in its production process (such as incoming inspection of raw materials, first party testing, in-factory QA/QC systems) should be included in a production testing plan.
There is also a third testing option that permits the periodic testing of the manufacturer’s children’s products every 3 years for those firms that have an ISO/IEC 17025-accredited laboratory. This option is most likely applicable to larger firms. See 16 CFR § 1107.21(d) for more information.
CPSC does not provide 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:
- to know the best way to achieve compliance of its product, and
- 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, the firm 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 firm and CPSC with an understanding of where and why the problem occurred.
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; however, 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 regulation.
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 designed to control potential variations in product manufacturing that could affect the product's ability to comply with the applicable children's product safety regulations. A firm 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 regulations. 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. See 16 CFR § 1107.21(c) for more information.
If a firm chooses to test its children’s products using the production testing plan with a maximum 2-year interval testing option, the firm 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 firm that chooses to test its children’s products using an ISO/IEC 17025-accredited laboratory with a 3-year periodic testing interval should consult 16 CFR § 1107.21(d) for the firm’s responsibilities.
The number and type of samples selected for testing should 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 regulations. For example, 1 unit may be sufficient for a production run of 1,000 units but not enough for 1,000,000 units.
If the product is materially changed at any time after a children’s product is initially tested and certified, the product (or sometimes just the specific component that was changed) must be tested again for compliance and a new CPC issued. This is called material change testing and 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 regulations. 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.
For more information, visit our material change testing FAQs.
Yes, small batch manufacturers are required to comply with the periodic testing requirements. For Group B requirements that small batch manufacturers may rely on information other than third-party testing, CPSC staff still expects small batch manufacturers to exercise due care and ensure that its suppliers have continued to periodically test their component parts.