© 2011 Underwriters Laboratories Inc. Product Recall and the Supply Chain: ISO Best Practices Robert Pollock Chair, US Technical Advisory Group for ISO PC 240 and ISO PC 243 Director, Market Surveillance UL

ISO Guidance Standards on Product Recall and the Supply Chain Why are they needed? -Distribution Chain extending -Growth in Out-Sourcing -Products becoming more complex -Globalization of product markets -Consumer confidence declining Proposal submitted by the ISO Committee on Consumer Policy (COPOLCO) to develop guidance on best practices to assist manufacturers and the entire supply chain

Supply Chain Chart

ISO – Consumer Product Safety: Practical Guidance for Suppliers Commitment to providing Safe Products by everyone in the supply chain Allocating Adequate Resources -Understanding government regulations wherever the product will be marketed -Competent Staff -Training -Continuous Improvement -Documentation Traceability across the Supply Chain Precautionary Approach

ISO Safety in Design -Design Considerations Foreseeable Use Foreseeable Misuse Unforeseeable Misuse -Exposure analysis -Hazard Identification -Risk Assessment -Risk Reduction -Risk Communication

ISO Safety in Production Design Validation Component Validation Prototype Production

ISO Safety in the Marketplace Pre-purchase Assessment Ongoing Assessment of Product Conformance Proactive Data Collection

ISO Guidance Standard on Consumer Product Recall and Corrective Action: Code of Good Practice Provide a more consistent approach to removing unsafe products from the global marketplace Improve Coordination between government and consumer goods organizations

ISO General Requirements Establish Recall Policy Maintain Documentation and Records Knowledge of Legal, Industry and Regulatory Requirements Establish Recall Management Team Identify people who have the authority to make decisions on recall Conduct Training and Recall Simulation

ISO Assessing the need for a product recall Data collection system (as specified in ISO 10377) Incident Notification Incident Investigation Assessing the Risk Traceability Product Recall Decision

ISO Implementing a Product Recall Recall Strategy, Objective, Design, Finance Communications Plan - supply chain and consumers - recall notice Implementing the Recall -Retrieving, replacing or repairing affected product -Destroying or Disposing of Affected Product Monitoring and Reporting Evaluate Effectiveness Review and Adjust Recall Strategy Cease Recall Activities

ISO Continual Improvements Review the Recall Process -How can it be made better? -Are there other related products that should be recalled? Review Effectiveness of Corrective Actions -Both of individual incidents and all recalls

Balloting for ISO and ISO Balloting should take place early next year for all ISO Member countries Please encourage the ISO designated organizations in your country to review, comment and vote on these standards