CPSC STRATEGYIMPORT SURVEILLANCE &PRODUCT TESTINGDEAN W. WOODARD, DIRECTOR, OFFICE OF EDUCATION, GLOBALOUTREACH AND SMALL ...
One CPSC Strategy toProtect the Consumer• Education and outreachDomestic and international• Import SurveillanceLoading, in...
• Outreach/capacity building to ensure products meetU.S. safety standards• Close cooperation with other government product...
Domestic Outreach4University Outreach: establishing collaboration withuniversities in Asia and United States with an empha...
Education Outreach –University Level• Establishing collaboration with major U.S.universities with a presence in Asia• Expa...
• Dedicated resource to facilitate betterunderstanding and compliance• Commitment to small business (soleproprietorship up...
• Developing information and subject matter guidancetailored to small business – new pages with realisticFAQ’s written in ...
Global Outreach• Enhance partnerships with foreign regulatory partnersthrough training exchanges• Leadership positions in ...
Import Surveillance• Targeted Response• CPSC Staff Co-Located at busiest ports• Close scrutiny of import documentation for...
Entry Review Process withITDS/RAM10
Why Focus on Education andImport Surveillance?(Where is the value added?)• Raise level of quality/regulatory compliance at...
Decisive Response• Corrective Actions (Recalls)― Refund, credit, replacement, repair• Letters of Advice― Corrective Action...
Retail Surveillance• Targeted blitzes focused on items of concern such as:holiday toy safety, children’s products’ lead co...
Retail Surveillance• Includes in-store screening of products to ensureproducts are properly labeled, are contained in prop...
Retail Surveillance• If there is a question of whether the product may posea hazard, official samples are collected for la...
PRIMER: CONSUMER PRODUCTSAFETY IMPROVEMENT ACT (CPSIA)OF 2008Children’s products: designed or intended primarilyfor childr...
Key substantive requirements for children’s products:Lead content in accessible components (100 ppm)Lead in paint and surf...
Key process requirements for children’s products(including toys) primarily intended for children 12 yearsold and younger:•...
THIRD PARTY TESTINGFOR CHILDREN’S PRODUCTS• Initial Certification Testing– Enforced January 1, 2012 (most products)• Compo...
INITIAL CERTIFICATION TESTING• Identify applicable regulatory requirements for yourproduct• Based on:― Product/product cla...
INITIAL CERTIFICATION TESTING• Identify one (or more) CPSC-acceptedlaboratories to conduct testing for identifiedregulator...
COMPONENT PART TESTING• Voluntary; 16 CFR Part 1109• If a finished product manufacturer purchases acomponent from a suppli...
COMPONENT PART TESTING• The concept of due care is flexible, and it will varydepending upon the circumstances and the indu...
COMPONENT PART TESTING• For example, depending upon the industry and thecircumstances, the exercise of due care may includ...
COMPONENT PART TESTING• For example, depending upon the industry and thecircumstances, the exercise of due care may includ...
MATERIAL CHANGE TESTINGA material change means any change in the product’sdesign, manufacturing process, or sourcing ofcom...
MATERIAL CHANGE TESTING• If you – the manufacturer or importer – make amaterial change to the children’s product afterinit...
PERIODIC TESTING• If you – the manufacturer or importer – havecontinued production of your children’s product, youmust per...
PERIODIC TESTINGPeriodic testing helps provide a manufacturer with a“high degree of assurance” that its childrens productc...
PERIODIC TESTING• Periodic testing must be conducted at a minimum of1-, 2-, or 3-year intervals, depending upon whetherthe...
PERIODIC TESTING PLAN• 1-year minimum testing interval – but may need tobe more frequent.• A periodic testing plan must in...
PERIODIC TESTING PLAN• A “periodic testing plan” must be in writing, and noparticular format is required.• Key: Know your ...
PRODUCTION TESTING PLAN• 2-year minimum testing interval using a CPSC-accepted laboratory• During 2-year period, first par...
PRODUCTION TESTING PLAN• A “production testing plan” must be in writing, andno particular format is required• Key: Know yo...
PRODUCTION TESTING PLAN• A production testing plan must describe:– the quality assurance techniques used in themanufacturi...
PRODUCTION TESTING PLAN• A production testing plan must describe:– the intervals at which those tests or measurementswill ...
PRODUCTION TESTING PLAN• 3-year minimum testing interval using a CPSC-accepted laboratory• During 3-year period, first par...
RECORDKEEPINGPERIODIC/PRODUCTION TESTING• For 5 years, a manufacturer must maintain records of:– its periodic or productio...
RECORDKEEPINGINITIAL CERTIFICATION/MATERIAL CHANGE TESTING• For 5 years, a manufacturer must also maintainrecords of:– all...
TwitterFrequent Updates@CPSCSmallBizSlideshareDownloadable Presentationswww.SlideShare.net/USCPSCJoin the EXGO listserv fo...
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CPSC Strategy,Testing and Certification

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One aspect of CPSC strategy, discussion of testing and certification

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  • As of 2013, CPSC has over 400 accepted laboratories around the world
  • Best practice is to know all of this at the design stage. Design in safety. (Importers are at a disadvantage here. Importers will likely find themselves in the position of having to test more frequently due to lack of knowledge/input/control about product’s design/manufacturing process/material composition and uncertainly about material substitutions and other changes to the product from batch to batch. Much will depend on the relationships and contractual provisions with suppliers, and the due care that an importer exercises in overseeing those relationships.)
  • Conformity certificates furnished to retailers and distributors and CPSC/CBP, upon request. Not required to furnish to consumers.
  • A party “exercising due care” must use the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances. At a minimum, due care requires taking some affirmative step to ensure the validity of the test report or certification being relied upon. Actions taken by a certifier to ensure the reliability of test reports from a supplier may differ depending on the nature of the component part supplied, the risk of noncompliance, the industry involved, and the nature of the relationship with the supplier. A long-term relationship with a trusted supplier that receives a large portion of its profits from one manufacturer may not require the same level of inquiry or monitoring as that of a new supplier that provides parts to many different manufacturers infrequently. Depending on the industry and the facts, a certifier may take various actions in order to know something about the validity of the test reports or certifications being relied upon. Previously cleared language and ideas
  • A party “exercising due care” must use the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances. At a minimum, due care requires taking some affirmative step to ensure the validity of the test report or certification being relied upon. Actions taken by a certifier to ensure the reliability of test reports from a supplier may differ depending on the nature of the component part supplied, the risk of noncompliance, the industry involved, and the nature of the relationship with the supplier. A long-term relationship with a trusted supplier that receives a large portion of its profits from one manufacturer may not require the same level of inquiry or monitoring as that of a new supplier that provides parts to many different manufacturers infrequently. Depending on the industry and the facts, a certifier may take various actions in order to know something about the validity of the test reports or certifications being relied upon. Previously cleared language and ideas
  • Bullet #2Meaning that if you do not have "continued production", a new CPC will be required the next time you produce the product. (RJH)(This bullet may raise the issue of discrete mfg runs and the question "at what point has too much time passed between runs to define my process as continuous?“)
  • Periodic testing plan means testing with a CPSC-accepted laboratory. A manufacturer is expected: (a) to know the best way to achieve compliance of its product, and (b) to use its knowledge of the product's design and manufacturing process to create a written periodic testing plan. 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; andthe potential for serious injury or death resulting from a noncompliant children's product, among other factors. 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.
  • Periodic testing plan means testing with a CPSC-accepted laboratory. A manufacturer is expected: (a) to know the best way to achieve compliance of its product, and (b) to use its knowledge of the product's design and manufacturing process to create a written periodic testing plan. 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; andthe potential for serious injury or death resulting from a noncompliant children's product, among other factors. 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.
  • Production testing means just that, first-party testing during production using a plan you’ve crafted and implemented to ensure a high degree of assurance for continued production . CPSC-accepted labs and methods are not required for production testing during 2-year interval periodEverything 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 QA/QC systems), in addition to periodic testing, should work together to provide the desired high degree of assurance.Mention but no details on ISO/IEC 17025:2005 laboratory
  • Production testing means just that, first-party testing during production using a plan you’ve crafted and implemented to ensure a high degree of assurance for continued production . CPSC-accepted labs and methods are not required for production testing during 2-year interval periodEverything 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 QA/QC systems), in addition to periodic testing, should work together to provide the desired high degree of assurance.Mention but no details on ISO/IEC 17025:2005 laboratory
  • 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 QA/QC systems), in addition to periodic testing, should work together to provide the desired high degree of assurance.3- year testing interval based on conduct continued testing using an accredited ISO/IEC 17025:2005 laboratory. See the regulation for greater detail. Not going to address ISO/IEC 17025:2005 laboratory here, although it is basically a production testing plan but using CPSC approved test methods with the ISO laboratory.
  • 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 QA/QC systems), in addition to periodic testing, should work together to provide the desired high degree of assurance.3- year testing interval based on conduct continued testing using an accredited ISO/IEC 17025:2005 laboratory. See the regulation for greater detail. Not going to address ISO/IEC 17025:2005 laboratory here, although it is basically a production testing plan but using CPSC approved test methods with the ISO laboratory.
  • Production testing means just that, first-party testing during production using a plan you’ve crafted and implemented to ensure a high degree of assurance for continued production . CPSC-accepted labs and methods are not required for production testing during 2-year interval periodEverything 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 QA/QC systems), in addition to periodic testing, should work together to provide the desired high degree of assurance.Mention but no details on ISO/IEC 17025:2005 laboratory
  • CPSC Strategy,Testing and Certification

    1. 1. CPSC STRATEGYIMPORT SURVEILLANCE &PRODUCT TESTINGDEAN W. WOODARD, DIRECTOR, OFFICE OF EDUCATION, GLOBALOUTREACH AND SMALL BUSINESS OMBUDSMANNATIONAL RETAIL FEDERATION SUPPLY CHAIN SUMMITDALLAS, TEXASMAY 21, 2013UNITED STATES OF AMERICACONSUMER PRODUCTSAFETY COMMISSIONTHESE COMMENTS ARE THOSE OF THE CPSC STAFF, HAVE NOT BEEN REVIEWED OR APPROVED BY,AND MAY NOT NECESSARILY REFLECT THE VIEWS OF, THE COMMISSION
    2. 2. One CPSC Strategy toProtect the Consumer• Education and outreachDomestic and international• Import SurveillanceLoading, in transit, and dockside in USA• Decisive ResponseRecalls, letters of advice, civil penalties2May 21, 2013
    3. 3. • Outreach/capacity building to ensure products meetU.S. safety standards• Close cooperation with other government productsafety agencies on requirements and commonconcerns• Extensive programs for engagement of regulatoryagencies by assisting them in effective productsurveillance strategies, testing programs, and safetystandards3Global Outreach
    4. 4. Domestic Outreach4University Outreach: establishing collaboration withuniversities in Asia and United States with an emphasison manufacturing and the supply chain.Small Business Ombudsman: Dedicated resource tofacilitate better understanding and complianceCommitment to small business (sole proprietorshipupwards to small manufacturing plant less than 500employees)
    5. 5. Education Outreach –University Level• Establishing collaboration with major U.S.universities with a presence in Asia• Expanding our network of engineering & scientificdepartments at local universities• Increasing the visibility of CPSC among theacademic community• Establishing close ties with St. Louis University andDuke University Kunshan5
    6. 6. • Dedicated resource to facilitate betterunderstanding and compliance• Commitment to small business (soleproprietorship upwards to small manufacturingplant less than 500 employees)• Identify the broader issues of concern to the smallbusiness communityOffice of Education, Global Outreach, and SmallBusiness Ombudsman (EXGO)6Small Business Ombudsman
    7. 7. • Developing information and subject matter guidancetailored to small business – new pages with realisticFAQ’s written in plain English• Developing partnerships with associations andAlliances that represent small manufacturers, soleproprietorships, and handcrafters• Outreach includes webinars, presentations at tradeshows, and articles in publications• Full use of social media7Small Business Ombudsman
    8. 8. Global Outreach• Enhance partnerships with foreign regulatory partnersthrough training exchanges• Leadership positions in international organizationsICPSC and OECD• International Alignment Initiative– Australia, Canada, EU, USA– Seek consensus positions on hazards to children andsolutions– Improve safety through closely aligned safetyrequirements8
    9. 9. Import Surveillance• Targeted Response• CPSC Staff Co-Located at busiest ports• Close scrutiny of import documentation for anomalies• Inspection of containers9
    10. 10. Entry Review Process withITDS/RAM10
    11. 11. Why Focus on Education andImport Surveillance?(Where is the value added?)• Raise level of quality/regulatory compliance at pointof manufacture—safer for consumers• Interdicting noncompliant product at the ports levelsthe playing field for compliant manufacturers• World Class techniques such as TQM, 6 Sigma, ISO31000 shift the emphasis from detection toprevention11
    12. 12. Decisive Response• Corrective Actions (Recalls)― Refund, credit, replacement, repair• Letters of Advice― Corrective Actions, stop sales, seizure of goodsat the port• Civil Penalty― Penalties up to $15.15 million― Criminal Penalties― Injunctions12
    13. 13. Retail Surveillance• Targeted blitzes focused on items of concern such as:holiday toy safety, children’s products’ lead content,and poor quality electrical products13
    14. 14. Retail Surveillance• Includes in-store screening of products to ensureproducts are properly labeled, are contained in properchild-resistant packaging when required, and meetgenerally regulatory requirements and acceptedindustry voluntary standards. Includes on-site XRFtesting when feasible14
    15. 15. Retail Surveillance• If there is a question of whether the product may posea hazard, official samples are collected for lab analysis15
    16. 16. PRIMER: CONSUMER PRODUCTSAFETY IMPROVEMENT ACT (CPSIA)OF 2008Children’s products: designed or intended primarilyfor children 12 years old and younger – children’s toysare included.16
    17. 17. Key substantive requirements for children’s products:Lead content in accessible components (100 ppm)Lead in paint and surface coatings (90 ppm)Phthalates (0.1% per banned phthalate) – Toys andChild Care Articles (Sleeping & Feeding) OnlyToy Safety Standard (ASTM F963-11)17TOYSPRIMER: CPSIA
    18. 18. Key process requirements for children’s products(including toys) primarily intended for children 12 yearsold and younger:• Third party testing by CPSC-accepted laboratories• Conformity certificates issued by importers ordomestic manufacturers(Children’s Product Certificate)• Tracking labels18PRIMER: CPSIA
    19. 19. THIRD PARTY TESTINGFOR CHILDREN’S PRODUCTS• Initial Certification Testing– Enforced January 1, 2012 (most products)• Component Part Testing– Effective December 8, 2011• Material Change Testing– Effective February 8, 2013• Periodic Testing for Continued Production– Effective February 8, 201319
    20. 20. INITIAL CERTIFICATION TESTING• Identify applicable regulatory requirements for yourproduct• Based on:― Product/product class― Intended age audience & consumer use patterns― Product’s material composition15 USC §2063; 16 CFR §1107.2020
    21. 21. INITIAL CERTIFICATION TESTING• Identify one (or more) CPSC-acceptedlaboratories to conduct testing for identifiedregulatory requirements• Issue a Children’s Product Certificate (CPC)based on passing test results• Provide CPC to retailers and distributors and,upon request, to CPSC or Customs (CBP)15 USC §2063; 16 CFR §1107.20; 16 CFR 111021
    22. 22. COMPONENT PART TESTING• Voluntary; 16 CFR Part 1109• If a finished product manufacturer purchases acomponent from a supplier who voluntarily tests itsproduct (e.g., a paint supplier), that manufacturermust “exercise due care” to rely upon thecomponent part certificate or component part testresults in drafting its own Children’s ProductCertificate.22
    23. 23. COMPONENT PART TESTING• The concept of due care is flexible, and it will varydepending upon the circumstances and the industryin question.23
    24. 24. COMPONENT PART TESTING• For example, depending upon the industry and thecircumstances, the exercise of due care may include:― asking questions about testing and samplingprocedures;― requesting written test procedures;― ensuring the supplier’s third party laboratory isCPSC-accepted; or― spot checking a supplier’s test results;16 CFR Part 110924
    25. 25. COMPONENT PART TESTING• For example, depending upon the industry and thecircumstances, the exercise of due care may include:― visiting a supplier’s factory or third partylaboratory; or― agreeing contractually on testing andrecordkeeping.• Document your “exercise of due care”• Maintain records16 CFR Part 110925
    26. 26. MATERIAL CHANGE TESTINGA material change means any change in the product’sdesign, manufacturing process, or sourcing ofcomponent parts that a manufacturer exercising duecare knows, or should know, could affect the product’sability to comply with applicable federal consumerproduct safety laws and regulations.16 CFR Part 110726
    27. 27. MATERIAL CHANGE TESTING• If you – the manufacturer or importer – make amaterial change to the children’s product afterinitial certification, you must:―Retest the affected component part or theproduct for the rules potentially affected bythe material change; and―Issue a new Children’s Product Certificate• Mandatory; 16 CFR Part 110727
    28. 28. PERIODIC TESTING• If you – the manufacturer or importer – havecontinued production of your children’s product, youmust periodically retest your product using a CPSC-accepted laboratory• Periodic testing only applies if you have continuedproduction• Mandatory; 16 CFR Part 110728
    29. 29. PERIODIC TESTINGPeriodic testing helps provide a manufacturer with a“high degree of assurance” that its childrens productcontinues to be compliant with the applicablechildrens product safety rules while production of itsproduct continues – and not just at the moment ofinitial testing and certification.www.cpsc.gov/periodic-testing16 CFR Part 110729
    30. 30. PERIODIC TESTING• Periodic testing must be conducted at a minimum of1-, 2-, or 3-year intervals, depending upon whetherthe manufacturer has:― a periodic testing plan;― a production testing plan; or― plans to conduct production testing using anaccredited ISO/IEC 17025:2005 laboratory.16 CFR Part 110730
    31. 31. PERIODIC TESTING PLAN• 1-year minimum testing interval – but may need tobe more frequent.• A periodic testing plan must include:―the tests to be conducted;―the intervals at which the tests will beconducted; and―the number of representative samples tested.31
    32. 32. PERIODIC TESTING PLAN• A “periodic testing plan” must be in writing, and noparticular format is required.• Key: Know your product, your manufacturingprocess, including strengths and vulnerabilities.32
    33. 33. PRODUCTION TESTING PLAN• 2-year minimum testing interval using a CPSC-accepted laboratory• During 2-year period, first party testing (or othermeans of assessing compliance) is acceptable– CPSC-accepted labs and methods are not requiredfor production testing during 2-year interval33
    34. 34. PRODUCTION TESTING PLAN• A “production testing plan” must be in writing, andno particular format is required• Key: Know your product, your manufacturingprocess, including strengths and vulnerabilities34
    35. 35. PRODUCTION TESTING PLAN• A production testing plan must describe:– the quality assurance techniques used in themanufacturing process– the tests to be conducted, or the measurementsto be taken16 CFR Part 110735
    36. 36. PRODUCTION TESTING PLAN• A production testing plan must describe:– the intervals at which those tests or measurementswill be taken;– the number of samples tested; and– an explanation describing how these techniques andtests provide a high degree of assurance of continuedcompliance with the applicable regulations,particularly if they are not the tests prescribed forthe applicable childrens product safety rule.36
    37. 37. PRODUCTION TESTING PLAN• 3-year minimum testing interval using a CPSC-accepted laboratory• During 3-year period, first party testing must beconducted by an ISO/IEC 17025:2005-accreditedlaboratory• The tests conducted must use the methods in thestandard37
    38. 38. RECORDKEEPINGPERIODIC/PRODUCTION TESTING• For 5 years, a manufacturer must maintain records of:– its periodic or production testing plan;– its periodic and/or production testing results; and• Recommendation: Maintain documentation of theother actions the manufacturer has taken to secure ahigh degree of assurance that its products complywith the applicable childrens product safety rule.16 CFR Part 110738
    39. 39. RECORDKEEPINGINITIAL CERTIFICATION/MATERIAL CHANGE TESTING• For 5 years, a manufacturer must also maintainrecords of:– all Children’s Product Certificates;– all third party certification test results from initialcertification and material change testing;– and all descriptions of material changes in aproduct’s design, manufacturing process; andsourcing of component parts during the continuedproduction of a product.16 CFR Part 110739
    40. 40. TwitterFrequent Updates@CPSCSmallBizSlideshareDownloadable Presentationswww.SlideShare.net/USCPSCJoin the EXGO listserv forregular updates. Justsend Dean an email.Desktop ReferenceGuidewww.cpsc.gov/desktopguideDean W. Woodard, Director, Officeof Education, Global Outreach, andSmall Business Ombudsman (EXGO)dwoodard@cpsc.gov(301) 504-7651business@cpsc.gov(301) 504-799940

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