Product Recall and the Supply Chain: ISO Best Practices

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 © 2011 Underwriters Laboratories Inc.

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

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Exposure analysis Hazard Identification Risk Assessment Risk Reduction Risk Communication

ISO 10377 - Safety in Production •

Design Validation

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Component Validation

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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