The Toy Industry Association recently launched the first phase of a new safety assurance programme for toys that includes procedures and audit mechanisms for hazard analysis, auditing manufacturing process controls and product safety testing. The Toy Safety Certification Program (formerly known as the Toy Safety Coordination Initiative) was conceived in August 2007 in response to growing public and congressional concerns about toy safety and is designed to prevent the introduction of hazardous toys into the U.S. marketplace primarily by reinforcing hazard analysis and testing and inspection systems in toy manufacturing.

TIA intends to implement various components of the TSCP in stages over the course of this year. The first phase of implementation began in February 2009 with the launch of a web-based electronic certification system (ECS) that will enable U.S. toy manufacturers and importers to comply with the general certificate of compliance requirements included in the Consumer Product Safety Improvement Act. According to TIA, the benefits of the ECS include:

• a single, easily accessible Web site that accommodates the needs of a broad range of suppliers, retailers and regulators;
• user-controlled organisation of certificates (e.g., grouping by key data such as product type, factory, etc.) and management of display results;
• secure access, user validation and tracking; and
• an ability to demonstrate compliance with legal requirements while maintaining the confidentiality of proprietary information.

Although the TSCP is an industry-driven voluntary initiative and the requirements included therein do not constitute a federal consumer product safety rule, many toy manufacturers are expected to require their suppliers to comply with all applicable aspects of the programme. In addition, the TSCP likely represents a bid by industry to influence the deliberations of the government regarding further regulations on toy safety. In order words, lawmakers and the Consumer Product Safety Commission could potentially be persuaded to incorporate certain aspects of the TSCP into their legislative and regulatory activities.

TSCP Overview

The primary objective of the TSCP is to provide a sustainable system to enhance both the reality and the public’s confidence that toys sold in the U.S. market are safe. The programme is based on three pillars: (1) hazard and risk assessment for toy product design; (2) factory process control audits; and (3) production sample testing to validate that the factory is producing, at the time of the sampling, toys that meet U.S. safety standards. These elements will be verified or audited by providers accredited to acceptable international standards by appropriate accreditation bodies.

The programme’s scope covers all toys as defined in ASTM F963 that are intended to be placed into commerce in the United States, regardless of the manufacturing or assembly location. Once a voluntary standard, ASTM F963 became a consumer product safety rule on 10 February 2009 as required by the CPSIA, although the CPSC will not begin enforcing the third-party testing and certification requirements to ensure compliance with that standard until 10 February 2010. Notably, the American National Standards Institute issued on 17 February an updated version of ASTM F963, denominated as ASTM F963-2008. Changes included in the updated standard include new safety guidelines for magnetic components in toys and a number of other potential hazards, including requirements to address potential strangulation hazards associated with yo-yo elastic tether toys. The updated standard does not affect the limits for lead or phthalates as prescribed in the CPSIA. If the CPSC agrees that these revisions improve safety, there will be a six month window before the new standard goes into effect.

According to TIA, a toy may bear a safety mark or seal on the toy itself or on its packaging upon successful conclusion of all applicable TSCP requirements. TIA hopes that the presence of the mark will enhance confidence that (1) any toy that bears it complies with all applicable U.S. regulations and consensus safety standards, (2) required samples have been tested from production and (3) the manufacturing facility has been assessed to determine its potential to provide adequate process control. The issuance of the mark itself will be controlled by an accredited certification body and a Web site will be developed to allow public identification of certified toys. TIA will own the mark and will assume responsibility for protecting against its counterfeit use.

The operational costs of the TSCP will be covered by fees charged by various third-party service providers while administrative costs will be covered by application fees paid to the programme administrator. A summary of the programme requirements as set forth in the TSCP Program Summary Document Version 2 is provided below.

Hazard Analysis and/or Risk Assessment Documentation

TSCP participants will be required to perform hazard analysis and/or risk assessment. This safety assessment should include a review of key elements of ISO/IEC Guide 50 and/or 51, Handbook for Manufacturing Safer Consumer Products (CPSC, July 2006), Risk Assessment Guidelines for Non-Food Consumer Products from the European Commission, or other similar standards. The hazard analysis and/or risk assessment will be the responsibility of the applicant, who may perform it in-house or delegate this function to a third party. Applicants are encouraged to perform the analysis and/or assessment as early in the design/manufacturing process as possible and ensure that personnel performing such analysis and/or assessment have the appropriate background and experience to complete it. The review must be conducted under the direction of a senior company official using systematic analysis tools.

Applicants must document the output of the hazard analysis and/or risk assessment process that occurred for each unique product. A unique product is one that differs from established toys in design, material or construction such that this difference could influence safety. The hazard analysis and/or risk assessment may refer to previous similar designs where appropriate. Attestation that the design hazard analysis and/or risk assessment has been accomplished, which must include a list of the standards and processes used to complete the analysis/assessment, must be provided to the certification body at the time of application.

Process Control Audits

The purpose of the process control audit system will be to evaluate a factory’s potential to consistently produce products free of non-conformities by assessing how well its internal systems are planned and designed to be technically sound. Factory process assessments will be conducted unannounced (except for the initial audit) by an independent audit company accredited by an accreditor that is signatory to the IAF MLA for management systems in accordance with ISO/IEC 17021. For each item on the factory audit checklist, the auditor will rate the factory’s performance as follows:

• Acceptable – Fully meets the requirement
• Needs Improvement – Isolated non-conformance(s) exist that are not evident of a systemic failure and are unlikely to create a product safety defect
• Unacceptable – Non-conformances exist that demonstrate a systemic failure or could create a product safety defect

The auditor will document observations made that led to each rating determination in sufficient detail to permit the factory to both correct any deficiencies and maintain acceptable performance. The factory will be responsible for developing and implementing a corrective action plan to address root causes of any rating of “Needs Improvement” or “Unacceptable.” Follow-up visits will be conducted as necessary to assess the successful completion of the corrective action plan and may result in a revised (improved) rating. Corrective action deadlines will be set by the audit company in conjunction with the factory based on the severity of the non-conformities and the amount of time required to implement and verify the effectiveness of the correction. Failure to meet the agreed corrective action plan will result in a failure to advance to a higher tier level.

Unannounced re-audits will also be conducted: (i) approximately once a year by the audit company; (ii) randomly by certification bodies as part of their internal quality control process; (iii) in the event of reasonably substantiated complaints and/or the need for remediation; and (iv) at the discretion of the TSCP executive director, such as for a factory that produced a non-conforming product subject to a recall.

Some of the areas that will be addressed during audit visits include:

• quality management system (documentation, procedures and records)
• factory facilities (calibration, internal laboratory, equipment and maintenance, and glass and sharp object control)
• resource management (organisation, training and control of sub-contractors)
• incoming material control (supplier management, material specifications and incoming inspection, including assurance that paints and surface coatings meet toxicological requirements)
• process and production control (plastic processing, metal processing, soft goods operation, electronics processing, decorating, assembly, final product control and traceability, and control and quarantine of non-conforming materials, components and assemblies)
• finished goods audits
• traceability (manufacturing date and location)

Factories will be classified as “awaiting audit” upon initial application to the programme and will generally be subject to testing frequency C, which requires minimum testing quarterly or every 150,000 units. Applicants may be considered for testing frequency B if they do not have a recall history and provide certain evidence regarding product quality and testing. Testing frequency B requires minimum testing semi-annually or at least every 500,000 units. The factory must allow an audit to be conducted within six months of the initial application and the audit company will rate the factory, based on its findings, as a Tier 1, 2 or 3 factory.

• Tier 3 – A factory that has been audited and found to be unable to demonstrate the presence of an effective basic process control system. In particular, it has serious shortcomings in sections of the checklist having a severity of “critical” or “major.” Subject to testing frequency C.
• Tier 2 – A factory that demonstrates an effective basic process control system. It must show full compliance with all “critical” requirements of the factory audit checklist and have an acceptable corrective action plan for achieving compliance with all “major” requirements or submit other evidence. Subject to testing frequency B.
• Tier 1 – A factory that demonstrates full compliance with all “critical” and “major” requirements of the audit checklist with an acceptable corrective action plan for compliance with any outstanding “minor” requirements prior to the next periodic re-audit. Subject to testing frequency A, which requires complete testing annually or at least every million units, as well as additional heavy metals testing at least annually.

“Critical” requirements are defined as those that are essential to ensure the continuing production of product that complies with all applicable safety standards. “Major” requirements are those that, although not absolutely essential, provide enhanced assurance of the continuing production of product that complies with all applicable safety standards, while “minor” requirements are those that support the continuing production of compliant product.

Product traceability will be required and the system for achieving compliance will be audited as part of the overall audit process. Wherever possible, the factory identification and date code will be on the product as well as the retail packaging (either the largest component, on a sewn-in label (soft toys), within a battery compartment or similar location). If it is not possible or practical to place identification on the product due to size or configuration of use, it must at least be on the retail packaging. Identification is also required on any master carton used for bulk shipping from factory to retailer/brand warehouse.

Testing

The TSCP testing component provides important evidence in the form of periodic testing of representative samples from production as to whether the entire conformity assessment programme is effective at a given point in time. Since production testing alone cannot provide assurance of the continuing production of product that complies with all applicable safety standards, factories must also continually conduct additional levels of testing such as material, component and in-process testing as a part of their overall process control programme. All tests must be performed by laboratories accredited to ISO/IEC 17025 by ILAC-recognised accreditation bodies or, in the case of art materials, the tests must be acceptable to a board-certified toxicologist as defined in Chapter 16 of the U.S. Code of Federal Regulations. Pre-production testing or testing of production samples is acceptable to demonstrate compliance with certain requirements. The TSCP Program Summary Document also includes guidelines for sampling products and additional information on test frequency.