Production Testing Plans – What you need to know

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December 6, 2011 by Bill Jacoby

CPSIA Testing, Labeling and Certification – Part 2

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 second part of this article we will look at the requirements for manufacturers/importers under the Production Testing Plan and ISO/IEC 17025:2005(E) part of the rule.

Production Testing Plan

As discussed earlier, after the initial certification of the product by the domestic manufacturer or importer of record the product must undergo periodic testing to show continued compliance with the same safety rules, bans and standards it was originally certified under.  As outlined in Part 1 of this article, one option is to test the product under the Periodic Testing Plan.  Another option, which we will discuss now is called the Production Testing Plan.  A Production Testing Plan would be conducted at the manufacturing site whether it be domestic or foreign and would outline the production management techniques and tests that would be performed to show the continued compliance of the products produced.  A Production Testing Plan may include these following elements;

  • recurring testing at the factory and/or the laboratory
  • the use of process management techniques
    • control charts
    • statistical process control programs
    • failure modes and effects analyses (FMEA)
  • measurement techniques (nondestructive)

Whatever Production Test Plan is designed by the manufacturer it must be effective in showing continued compliance with the safety standards that the product was originally certified under.  Production Test Plans cannot consist solely of mathematical methods but must include some testing.  The CPSC has allowed that testing DOES NOT need to be the same test methods used for certification of the product.  If these test methods are different from the certification testing the manufacturer must document the production testing methods used to show how these methods ensure continuing compliance for safety certification of the product.  For example, if under the original certification a component of the product was tested under the small parts regulation, then the manufacturer may demonstrate continue compliance by measuring how affectivity that component is attached to the product.

A Production Testing Plan must contain the following items;

  • a description of the production testing plan to include;
    • a description of the process management techniques used
    • the tests to be conducted
    • the measurements to be taken
    • the intervals at which the tests or measurements will be made
    • the number of samples tested
    • the basis for determining that the combination of process management techniques and tests continued compliance of the product if the tests used are not the same as the ones used for certification of the product
    • a copy of the production plan at each manufacturers site and a specific plan for each children’s product manufactured there
    • a production testing interval that would ensure that any sample selected for production testing would comply with all applicable children’s product safety rules

 

If the production testing plan fails to provide that “high degree of assurance” of compliance for the products tested, the CPSC may require the manufacturer to show compliance using the Periodic Testing Plan as discussed in Part 1 of this article.

 

An importer can arrange for a foreign manufacturer to develop and conduct a production testing plan for a product.  The same production testing plan from another party may be used by multiple importers as a means of increasing the importers’ maximum periodic testing interval to two years.  The importer, as the product certifier, must use due care to ensure that the implementation of a production testing plan by the manufacturer ensures with a “high degree of assurance” that continuing production complies with the applicable product safety rules.

 

ISO/IEC 17205:2005(E)

A modification of the Production Testing Plan, would require manufacturers to conduct any testing done under the plan using an ISO/IEC 17205:2005(E) laboratory.  These tests which would be done by a CPSC accredited laboratory must be conducted at least every three years.  The manufacturer must ensure that the same test methods used for certification of the product are used to show continued compliance of the applicable children’s product safety rules.  Using the information obtained from this testing, the manufacturer will determine the appropriate testing interval and the number of samples needed for periodic testing to ensure continued compliance.

If this continue testing fails to provide the “high degree of assurance”, the CPSC may require the manufacturer to show compliance using the Periodic Testing Plan.

The advantages of these two test plans would be to extend the length of time between certification testing form annually to every two or three years, depending on the testing plan selected.  If the certifier of the product is an importer of record using a foreign manufacturer, the importer must closely work with the foreign manufacturer to ensure that either testing plan be well documented and shows that continued production of their product complies with all applicable product safety rules.

 

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 Production 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.

Requirements for Manufacturers/Importers under the Periodic Testing Plan part of the CPSIA section 102 rule. Are YOU Ready?

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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.