Three different situations that would call for third-party testing under final ruling 16 CFR 1107.
There are three basics instances that would require manufacturers/importers of children’s products to conduct independent third-party testing of their product.
“Initial” Third-Party Tests: Under the Consumer Product Safety Improvement Act of 2008 (CPSIA) there is a requirement that prior to new children’s products being placed into the marketplace they would be tested by an independent third-party for compliance of all safety regulations that would apply to it. This is generally referred to as “initial” third-party testing.
Third-Party Tests for “Material Changes”: After initial introduction of the product into the marketplace there could occur some changes to the product that might not be noticeable to a consumer but significant enough to affect a product’s ability to comply with all of the applicable safety regulations that it was originally certified under. Under the CPSIA these are called “material changes”. Some changes might be enough to be noticed by the consumer – a product that was originally made from metal is now made from plastic. Other changes might be more subtle – the red paint that a product is painted with was sourced from Supplier A is now sourced from Supplier B. Both cases are classified as “material changes” and under the CPSIA require independent third party testing to show the product still complies with all of the applicable safety regulations.
Periodic Third-Party Tests: The law recognizes that there are children’s products that might not undergo a material change for years. However it was not the intention of the law to allow those products to continue to enter the marketplace based on a single series of third-party tests done years before. To ensure compliance the CPSIA requires that children’s products be third-party tested from time-to-time. This ongoing testing is called “periodic testing”. The interval between this “periodic testing” can be defined by three methods a manufacturer/importer of record can choose; “periodic test plan”, “production test plan” or “ISO/IEC 17025:2005(E)”.
The gravity of testing and certification of children’s products can be underscored by a recent remark to more than 30 representatives of the toy industry at a recent Capitol Hill meeting with the Consumer Product Safety Commission (CPSC). Commissioner Nancy Nord acknowledged to the group that the January 1, 2012 enforcement date for CPSIA regulations will bring a change to the industry. All Stays of Enforcement will have expired and the CPSC will be more diligent in its review of toys at ports of entry and failure to comply with third party testing regulations will result in the holding up of the shipment and fines of up to $100,000.
2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your Testing and Labeling process 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!
https://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpg00BillJhttps://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpgBillJ2011-12-19 13:08:262011-12-19 13:08:26Three Possible Reasons for 3rd Party Testing
Updates Address Heavy Metals, Compositing, Bath Toy Projections and More
PR Newswire
WEST CONSHOHOCKEN, Pa., Dec. 16, 2011 /PRNewswire/ — As part of its continuing efforts to proactively address potential toy safety issues, ASTM International Committee F15 on Consumer Products has approved revisions to ASTM F963, Consumer Safety Specification for Toy Safety. Changes made to the standard include revisions to the section on heavy metals, the introduction of compositing procedures, and new safety requirements and technical guidance for bath toy projections, acoustics and other potential safety hazards in toys.
ASTM F963, under the jurisdiction of Subcommittee F15.22 on Toy Safety, includes guidelines and test methods to prevent injuries from choking, sharp edges and other potential hazards. The standard is reviewed and updated on a regular basis by the subcommittee, which includes technical experts from academia, consumer groups, industry and government.
“These revisions build on the already comprehensive F963 standard by proactively addressing areas where potential risks or opportunities for harmonization have been identified,” says Joan Lawrence, F15.22 chairman and vice president, standards and government affairs for the Toy Industry Association (TIA).
Revisions now approved for F963 include the following:
Heavy Metals — Limits for heavy metals in toy substrates have been added to the existing surface coating requirements. A soluble approach for determination of heavy elements in toys and toy components has been maintained as this has been demonstrated to be more closely correlated than total content with the amount of element which is bioavailable, and therefore with risk of toxicity.
Compositing Procedure for Total Heavy Metal Analysis — Revisions outline detailed procedures for accomplishing this end by specifying the conditions under which compositing is allowable, when a composite result may be relied upon without further testing, and when testing of individual samples must subsequently be performed.
Bath Toy Projections — Revisions are intended to address the potential hazards that may be presented by vertical, or nearly vertical, rigid projections on bath toys. This requirement is intended to minimize possible puncture or other hazards to the skin that might be caused if a child were to fall on a rigid projection.
Among other revised areas of the standard are sections on jaw entrapment; toys with spherical ends; stability of ride on toys; requirements for squeeze toys attached to rings; use of cords, straps and elastics; packaging film; and yo-yo tether balls.
As part of the landmark Consumer Product Safety Improvement Act (CPSIA) of 2008, the U.S. Congress endorsed both the F963 standard and the process under which it is developed and continually reviewed and revised. If the CPSC agrees that the revisions improve safety, ASTM F963-11 will replace the 2008 version of the standard as federal law in 180 days. For more information about the CPSIA and compliance with this law, visit the CPSC Web site, www.cpsc.gov.
ASTM International standards are available for purchase from Customer Service (phone: 610-832-9585; service@astm.org) or at www.astm.org.
ASTM International welcomes and encourages participation in the development of its standards. ASTM’s open consensus process, using advanced Internet-based standards development tools, ensures worldwide access for all interested individuals. For more information on becoming an ASTM member, please contact Leonard Morrissey, ASTM International (phone: 610-832-9719; lmorriss@astm.org).
For technical Information, contact: Joan Lawrence, Toy Industry Association, New York, N.Y. (phone: 212-675-1141; safety@toyassociation.org).
Follow ASTM Consumer Products news on Twitter @ASTMProductsRec.
Established in 1898, ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions around the globe.
https://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpg00BillJhttps://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpgBillJ2011-12-16 13:36:192011-12-16 13:36:19ASTM Toy Safety Standard F963-11 Is Issued
CPSIA Testing, Labeling and Certification – Part 5
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 fifth and final part of this article we will look at the requirements for manufacturers/importers under the recordkeeping part of the rule.
Recordkeeping
A manufacturer/importer of a children’s product must maintain the following records;
a copy of the Children’s Product Certificate (General Certificate of Conformity) for each product. The description on the certificate must clearly distinguish and define the product so that it is identifiable from others that the manufacturer/importer may have
records of each third party certification tests. The manufacturer/importer must have separate certification tests records for each manufacturing site even for the same product. The manufacturer/importer cannot assume that units of the same product manufactured in more than one location are identical in all material respects. Differences in power quality, climate, personnel, and factory equipment could materially affect the manufacture of the product.
records of one of the following for periodic tests of a children’s products
periodic test plan and periodic test results (every year)
production testing plan, production test results and periodic test results (every two years)
testing results of tests conducted by a ISO/IEC 17025:2005(E) accredited laboratory and periodic test results (every three years)
Manufacturers/importers must maintain the records specified for five years. These records must be made available to the CPSC upon request either in hard copy or electronic format, such as through an internet web site. These records can be maintained in languages other than English if they can be;
Provided immediately by the manufacturer/importer to the CPSC
Translated accurately into English by the manufacturer/importer within 48 hours of the request by the CPSC (or longer if negotiated with the CPSC staff
Product Labeling
This portion of the ruling outlines the program by which a manufacturer/importer of record may label a consumer product as complying with the certification requirements of section 14 of the CPSA. The labeling program is not mandatory and can be used at the discretion of the manufacturer/importer who must determine for themselves the cost versus benefit of the program. The label specifications are designed to avoid giving consumers the false impression that the product is neither a CPSC tested, endorsed or approved product. It also prohibits manufacturers/importers from implying through the manipulation of the font type, size or other means that the CPSC has tested, endorsed or approved the product.
The label to be printed must be printed in a bold typeface using an Arial font of no less than 12 points, be visible and legible and state: “Meets CPSC Safety Requirements” Depending on the product’s characteristics, such as size, surface finish or the presence of a smooth or flat surface, the CPSC has allowed with the Product Labeling rule to give manufacturers/imports flexibility in implementing this rule. The final rule does not allow for a symbol or a mark to show compliance as it might be misunderstood as a CPSC certification mark or endorsement of the product. The labeling can appear on the packaging, within the informational literature found with the product, on the product itself or all three.
2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your recordkeeping and labeling process 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.
https://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpg00BillJhttps://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpgBillJ2011-12-09 16:48:562011-12-09 16:48:56Record Keeping and Labeling Requirements for Children’s Products
CPSIA Testing, Labeling and Certification – Part 4
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 fourth part of this article we will look at the requirements for manufacturers/importers under the Undue Influence part of the rule.
Undue Influence
Each domestic manufacturer or the importer of a children’s product must establish procedures to safeguard against the exercise of undue influence on a CPSC accredited laboratory that could undermine the integrity of laboratory test data. While the importer is not directly responsible for the training of employees of foreign manufacturers on this matter, it does not absolve the importer of its duty to exercise due care when relying on test reports provided by the manufacturer from a CPSC accredited laboratory. The importer who issues a General Certificate of Conformity on a product that is based on test reports from a CPSC accredited laboratory over whom undue influence has been exercised provides a basis for the CPSC to deem the certificate invalid. The CPSC will hold the final product certifier (manufacturer/importer) responsible for exercising due care that component part or finished product manufacturers or suppliers have not exercised undue influence over CPSC certified laboratories.
At a minimum these procedures must include;
Training for every appropriate staff member on the safeguards by the manufacturer/importer designed to prevent undue influence on CPSC accredited laboratories along with a signed training statement from each staff member
Written policy statement from company officials that the exercise of undue influence is not acceptable
Procedure for retraining based on any substantive changes to § 1107.24
Procedure to notify the CPSC immediately of any attempt by the manufacturer/importer to hide or exert undue influence over test results
Procedure/mechanism for employees of the manufacturer/importer to report confidentially to the CPSC any allegations of undue influence
2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your company policies and include an Undue Influence component 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.
https://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpg00BillJhttps://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpgBillJ2011-12-08 14:54:072011-12-08 14:54:07Undue Influence – Establishing Your Company’s Policy
CPSIA Testing, Labeling and Certification – Part 3 Material Change
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 third part of this article we will look at the requirements for manufacturers/importers under the Material Change part of the rule.
Material Change
After the initial certification of a product, a “material change” in the product is a change that “could affect the product’s ability to comply with applicable rules, standards or regulations.” This could occur based on a change in product design, manufacturing process or the sourcing of component parts where the manufacturer/importer knows or should know could affect the products ability to comply with all applicable children’s product safety rules. At this point the manufacturer/importer must submit sufficient samples of the product to a CPSC accredited laboratory to test for compliance.
A manufacturer/importer whose product has undergone a material change cannot issue a new Children’s Product Certificate until this testing is done. Changes that cause a children’s product safety rule to no longer apply to a children’s product are not considered material changes. The extent of testing needed depends on the extent of the material change.
For example, if the children’s product was a cotton sweater with metal buttons that were certified under the lead limits of Section 101 of the CPSIA and were changed to wooden buttons would this be classified as a material change? Yes and No, changing to wooden buttons would eliminate the need to show continued compliance for lead limits under Section 101 of the CPSIA as natural wood is exempt from lead testing. However for other children’s product safety rules, such as small parts the change may be a material change.
The three major categories of material change are;
product design, which includes all component parts , their composition, and their interaction and functionality when assembled. The manufacturer/importer should evaluate the product as received or assembled by the consumer when examining product design
manufacturing process, is a change in how the children’s product is made which could affect the finished products ability to comply with the applicable safety rules. For each change in the manufacturing process, the manufacture/importer should carefully evaluate the product to ensure it still meets all applicable safety rules or if the change results in new rules being applied to it.
sourcing of component parts, is a change that results when the replacement of one component part of a product with another component part that could affect compliance. This includes, but is not limited to, changes in composition, part supplier, or the use of a different component part from the same supplier who provided the initial component part.
For a domestic manufacturer, there would be a special knowledge of its production design, components and, production processes not found with importers of record using foreign manufacturers. For example, a domestic manufacturer would know whether a new solvent contains any of the prohibited chemicals such as lead and phthalates, or a replacement mold is made from the same specifications as the previously compliant mold. Such changes would not be examples of “material change” and unless the importer of record has a very close working relationship with the foreign manufacturer, would not know.
2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your testing process 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.
https://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpg00BillJhttps://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpgBillJ2011-12-07 10:40:092011-12-07 10:40:09Defining a Material Change after Product Certification
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.
https://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpg00BillJhttps://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpgBillJ2011-12-06 13:16:282011-12-06 13:16:28Production Testing Plans – What you need to know
Three Possible Reasons for 3rd Party Testing
/in Posts/by BillJDecember 19,2011 by Bill Jacoby
Three different situations that would call for third-party testing under final ruling 16 CFR 1107.
There are three basics instances that would require manufacturers/importers of children’s products to conduct independent third-party testing of their product.
The gravity of testing and certification of children’s products can be underscored by a recent remark to more than 30 representatives of the toy industry at a recent Capitol Hill meeting with the Consumer Product Safety Commission (CPSC). Commissioner Nancy Nord acknowledged to the group that the January 1, 2012 enforcement date for CPSIA regulations will bring a change to the industry. All Stays of Enforcement will have expired and the CPSC will be more diligent in its review of toys at ports of entry and failure to comply with third party testing regulations will result in the holding up of the shipment and fines of up to $100,000.
2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your Testing and Labeling process 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!
ASTM Toy Safety Standard F963-11 Is Issued
/in News/by BillJUpdates Address Heavy Metals, Compositing, Bath Toy Projections and More
PR Newswire
WEST CONSHOHOCKEN, Pa., Dec. 16, 2011 /PRNewswire/ — As part of its continuing efforts to proactively address potential toy safety issues, ASTM International Committee F15 on Consumer Products has approved revisions to ASTM F963, Consumer Safety Specification for Toy Safety. Changes made to the standard include revisions to the section on heavy metals, the introduction of compositing procedures, and new safety requirements and technical guidance for bath toy projections, acoustics and other potential safety hazards in toys.
ASTM F963, under the jurisdiction of Subcommittee F15.22 on Toy Safety, includes guidelines and test methods to prevent injuries from choking, sharp edges and other potential hazards. The standard is reviewed and updated on a regular basis by the subcommittee, which includes technical experts from academia, consumer groups, industry and government.
“These revisions build on the already comprehensive F963 standard by proactively addressing areas where potential risks or opportunities for harmonization have been identified,” says Joan Lawrence, F15.22 chairman and vice president, standards and government affairs for the Toy Industry Association (TIA).
Revisions now approved for F963 include the following:
As part of the landmark Consumer Product Safety Improvement Act (CPSIA) of 2008, the U.S. Congress endorsed both the F963 standard and the process under which it is developed and continually reviewed and revised. If the CPSC agrees that the revisions improve safety, ASTM F963-11 will replace the 2008 version of the standard as federal law in 180 days. For more information about the CPSIA and compliance with this law, visit the CPSC Web site, www.cpsc.gov.
ASTM International standards are available for purchase from Customer Service (phone: 610-832-9585; service@astm.org) or at www.astm.org.
ASTM International welcomes and encourages participation in the development of its standards. ASTM’s open consensus process, using advanced Internet-based standards development tools, ensures worldwide access for all interested individuals. For more information on becoming an ASTM member, please contact Leonard Morrissey, ASTM International (phone: 610-832-9719; lmorriss@astm.org).
For technical Information, contact: Joan Lawrence, Toy Industry Association, New York, N.Y. (phone: 212-675-1141; safety@toyassociation.org).
Follow ASTM Consumer Products news on Twitter @ASTMProductsRec.
Established in 1898, ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions around the globe.
View this release on the ASTM Web site at www.astmnewsroom.org.
ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org
Read more: http://www.digitaljournal.com/pr/526007#ixzz1gixEdGE9
Record Keeping and Labeling Requirements for Children’s Products
/in Posts/by BillJDecember 9, 2011 by Bill Jacoby
CPSIA Testing, Labeling and Certification – Part 5
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 fifth and final part of this article we will look at the requirements for manufacturers/importers under the recordkeeping part of the rule.
Recordkeeping
A manufacturer/importer of a children’s product must maintain the following records;
Manufacturers/importers must maintain the records specified for five years. These records must be made available to the CPSC upon request either in hard copy or electronic format, such as through an internet web site. These records can be maintained in languages other than English if they can be;
Product Labeling
This portion of the ruling outlines the program by which a manufacturer/importer of record may label a consumer product as complying with the certification requirements of section 14 of the CPSA. The labeling program is not mandatory and can be used at the discretion of the manufacturer/importer who must determine for themselves the cost versus benefit of the program. The label specifications are designed to avoid giving consumers the false impression that the product is neither a CPSC tested, endorsed or approved product. It also prohibits manufacturers/importers from implying through the manipulation of the font type, size or other means that the CPSC has tested, endorsed or approved the product.
The label to be printed must be printed in a bold typeface using an Arial font of no less than 12 points, be visible and legible and state: “Meets CPSC Safety Requirements” Depending on the product’s characteristics, such as size, surface finish or the presence of a smooth or flat surface, the CPSC has allowed with the Product Labeling rule to give manufacturers/imports flexibility in implementing this rule. The final rule does not allow for a symbol or a mark to show compliance as it might be misunderstood as a CPSC certification mark or endorsement of the product. The labeling can appear on the packaging, within the informational literature found with the product, on the product itself or all three.
2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your recordkeeping and labeling process 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.
Undue Influence – Establishing Your Company’s Policy
/in Posts/by BillJDecember 8, 2011 by Bill Jacoby
CPSIA Testing, Labeling and Certification – Part 4
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 fourth part of this article we will look at the requirements for manufacturers/importers under the Undue Influence part of the rule.
Undue Influence
Each domestic manufacturer or the importer of a children’s product must establish procedures to safeguard against the exercise of undue influence on a CPSC accredited laboratory that could undermine the integrity of laboratory test data. While the importer is not directly responsible for the training of employees of foreign manufacturers on this matter, it does not absolve the importer of its duty to exercise due care when relying on test reports provided by the manufacturer from a CPSC accredited laboratory. The importer who issues a General Certificate of Conformity on a product that is based on test reports from a CPSC accredited laboratory over whom undue influence has been exercised provides a basis for the CPSC to deem the certificate invalid. The CPSC will hold the final product certifier (manufacturer/importer) responsible for exercising due care that component part or finished product manufacturers or suppliers have not exercised undue influence over CPSC certified laboratories.
At a minimum these procedures must include;
2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your company policies and include an Undue Influence component 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.
Defining a Material Change after Product Certification
/in Posts/by BillJDecember 7,2011 by Bill Jacoby
CPSIA Testing, Labeling and Certification – Part 3 Material Change
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 third part of this article we will look at the requirements for manufacturers/importers under the Material Change part of the rule.
Material Change
After the initial certification of a product, a “material change” in the product is a change that “could affect the product’s ability to comply with applicable rules, standards or regulations.” This could occur based on a change in product design, manufacturing process or the sourcing of component parts where the manufacturer/importer knows or should know could affect the products ability to comply with all applicable children’s product safety rules. At this point the manufacturer/importer must submit sufficient samples of the product to a CPSC accredited laboratory to test for compliance.
A manufacturer/importer whose product has undergone a material change cannot issue a new Children’s Product Certificate until this testing is done. Changes that cause a children’s product safety rule to no longer apply to a children’s product are not considered material changes. The extent of testing needed depends on the extent of the material change.
For example, if the children’s product was a cotton sweater with metal buttons that were certified under the lead limits of Section 101 of the CPSIA and were changed to wooden buttons would this be classified as a material change? Yes and No, changing to wooden buttons would eliminate the need to show continued compliance for lead limits under Section 101 of the CPSIA as natural wood is exempt from lead testing. However for other children’s product safety rules, such as small parts the change may be a material change.
The three major categories of material change are;
For a domestic manufacturer, there would be a special knowledge of its production design, components and, production processes not found with importers of record using foreign manufacturers. For example, a domestic manufacturer would know whether a new solvent contains any of the prohibited chemicals such as lead and phthalates, or a replacement mold is made from the same specifications as the previously compliant mold. Such changes would not be examples of “material change” and unless the importer of record has a very close working relationship with the foreign manufacturer, would not know.
2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your testing process 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.
Production Testing Plans – What you need to know
/in Posts/by BillJDecember 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;
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;
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.