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?
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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
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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
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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
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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
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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
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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