Requirements for Manufacturers/Importers under the Periodic Testing Plan part of the CPSIA section 102 rule. Are YOU Ready?
December 6, 2011 by Bill Jacoby,
CPSIA Testing, Labeling and Certification
In 2012 companies will quickly have to deal with the final ruling issued by the CPSC under 16 CFR 1107 as mandated by the CPSIA Section 102. In this new ruling the CPSC has outlined standards for manufacturers/importers to show compliance with existing safety rules, bans and standards for the products they produce. The rule can be broken out into five (5) major areas; the types and frequency of testing, what constitutes a material change in a product, the requirements and procedures and training for an undue influence program, general recordkeeping requirements and label requirements for products complying with consumer safely rules under the CPSA.
In the first part of this article we will look at the requirements for manufacturers/importers under the Periodic Testing Plan part of the rule.
Periodic Testing Plan
Under a Periodic Testing Plan the certifier (domestic manufacturer or importer) would be required to develop a testing plan that would ensure a children’s product manufactured continues “with a high degree of assurance” to meet the safety standards that the product was originally certified under. The certifier of a children’s product must also determine the frequency of periodic testing (no less than once per year) and the number of samples to be tested. There are provisions within this rule that would allow the manufacturer to extend the testing frequency to either two (2) years or three (3) years and will be discussed in a later article.
The CPSC has stated in its comments on this rule that it does not want CPSC accredited laboratory’s determining the number of samples that should be submitted for testing. The CPSC expects the domestic manufacturer/importer to specify to the laboratory the number of samples needed for testing in order to show compliance for the product. With the wide variety of children’s products, manufacturers, and manufacturing processes that would be subject to this rule, the CPSC felt it would be impractical to give guidance on specific sampling methods that could be applied to all products. It is therefore important for the domestic manufacturer/importer to use their knowledge of the product and how it is manufactured in order to determine a method for determining the number of samples needed for testing. Whatever method is chosen it must clearly document that a sufficient number of samples were selected in order to achieve “a high degree of assurance” for compliance.
In general a Periodic Testing Plan must include:
- the tests to be conducted
- the intervals at which the tests will be conducted
- the number of samples to be tested
If the Periodic testing plan is conducted by the manufacturer (foreign or domestic), then each manufacturing site must have a periodic testing plan specific to each children’s product manufactured at that site. If the importers of record are conducting the periodic testing plans then these plans must be retained by the importers of record.
The testing interval for a periodic testing plan may vary depending on the specific children’s product rule and the nature of the product but may not exceed one year. Factors with which a manufacturer/importer may use to determine the testing interval are;
- Extreme variance in test results (from sample to sample)
- Results that are close to the allowable regulatory limit
- Known factors in the manufacturing process that could affect compliance for a rule (example would be a casting die that has a useful wear life and is nearing the end of that wear life)
- Consumer complaints or warranty claims
- New or newly sourced component parts that are introduced into the assembly/manufacturing process
- After the manufacture of a fixed number of products
- The potential for serious injury or death resulting from a noncompliant product
- A dramatic increase in the number of products produced annually
- How often similar children’s products are tested by other manufacturers
The CPSC has also stated that domestic manufacturers/importers my use the testing certification from suppliers of component parts in order to show final product compliance as long as it meets the requirements under 16 CFR 1109 which outlines the conditions for relying on component part testing for certification.
Finally, the domestic manufacturer or importer is responsible for issuing a Children’s Product Certificate for the children’s product they manufacture or import. For the importer using a foreign manufacturer issuing a Children’s Product Certificate involves one of two choices; one, if the importer has documentation of the manufacturing process (changes in suppliers, changes in component parts, etc.) and the testing data (laboratory report) then it can issue a Children’s Product Certificate for that product or two if the importer has no knowledge of the manufacturing process then it should treat each shipment as a discrete lot and subject it to certification testing. At this point the CPSC feels that the importer does not know whether material changes have been made to the product since its last shipment. In regard to that shipment, the CPSC has put forth that it is not considered continuing production of the product and is therefore not subject to the periodic testing requirements.
2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review or create your Periodic Testing Plan to make sure it contains all the elements as outlined under 1107 including record keeping. We also can provide services for Sourcing/Project Management testing for any new products you have in development or act as a liaison between you and your factory. Contact us today and see how we can save you money!
Bill Jacoby is the founder principal at Jacoby Solutions and developed the CORE Audit™ (Compliance Operations Readiness Engagement Audit), the company’s proprietary approach to business operations readiness A one-stop shop for manufacturing and distribution companies in need of a solutions partner who can help them evolve their business while keeping an eye on compliance, Jacoby Solutions saves companies time, money and resources while helping them become CPSIA ready.