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© 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