© 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 10377 – 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 10377 - Safety in Design

- Design Considerations• Foreseeable Use

• Foreseeable Misuse

• Unforeseeable Misuse

- Exposure analysis- Hazard Identification- Risk Assessment- Risk Reduction- Risk Communication

ISO 10377 - Safety in Production

• Design Validation

• Component Validation

• Prototype Production

ISO 10377 - Safety in the Marketplace

• Pre-purchase Assessment• Ongoing Assessment of Product Conformance• Proactive Data Collection

ISO 10393 - 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 10393 - 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 10393 - 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 10393 - 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 10393 - 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 10377 and ISO 10393

• 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