March 26, 2020

PRODUCT SAFETY:It’s More Than Regulatory Compliance

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I. INTRODUCTION

II. HAZARD IDENTIFICATION

III. RISK ASSESSMENT

IV. RISK MANAGEMENT

Agenda

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Every Consumer Product Has Risk

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Canada Consumer Product Safety Act (CCPSA)

• Administrative Monetary Penalties (Consumer Products)

• Asbestos Products Regulations

• Candles Regulations

• Carbonated Beverage Glass Containers Regulations

• Carpet Regulations

• Carriages and Strollers Regulations

• Cellulose Insulation Regulations

• Charcoal Regulations

• Children’s Jewellery Regulations

• Children’s Sleepwear Regulations

• Consumer Chemicals and Containers Regulations

• Consumer Products Containing Lead Regulations

• Corded Window Covering Products Regulations

• Cribs, Cradles and Bassinets Regulations

• Expansion Gates and Expandable Enclosures Regulations

• Face Protectors for Ice Hockey and Box Lacrosse Players

• Glass Doors and Enclosures Regulations

• Glazed Ceramics and Glassware Regulations

• Ice Hockey Helmet Regulations

• Infant Feeding Bottle Nipples Regulations

• Kettles Regulations

• Lighters Regulations

• Matches Regulations

• Mattresses Regulations

• Pacifiers Regulations

• Phthalates Regulations

• Playpens Regulations

• Residential Detectors Regulations

• Restraint Systems and Booster Seats for Motor Vehicles

• Science Education Sets Regulations

• Surface Coating Materials Regulations

• Tents Regulations

• Textile Flammability Regulations

• Toys Regulations

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Introduction

▪ Regulatory compliance is a minimum requirement

▪ Hazard identification and risk management

▪ Ensure continued compliance

▪ Safety-related recalls are still occurring

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Recent Recalls include:

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Chemical Issues

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Hazard Identification

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Consider Human Factors

Human Factors Review - Goes Beyond the Standards

Try To Anticipate Foreseeable Use & Unintended Use Scenarios

Understand & Enhance Interaction Between Users & Products

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Perform Behavioral Task Analysis

Identify steps associated with product use

Assembly

Intended use

Foreseeable unintended use (misuse)

Cleaning

Troubleshooting

Disassembly

Storage

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Hazard Identification Resources

Global Regulations

Industry Standards – mandatory and voluntary

Health Canada & International Recalls (CPSC, RAPEX, Product Safety Australia, OECD)

Incident / Injury Data, including NEISS Data

Anthropometric data – Childata, Adultdata, Older Adultdata, Strength Data for Design Safety

Internal Resources – complaints, returns, on-line reviews

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Global Regulations

Look beyond Canada regulations

International standards vary and are often more stringent

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Industry Standards

Voluntary standards address additional issues, including safety, quality and performanceAre voluntary standards truly voluntary?

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Canadahttp://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

United Stateswww.recalls.govwww.cpsc.gov/en/Recallswww.saferproducts.gov/search/default.aspx

Europehttps://data.europa.eu/euodp/en/data/dataset/rapex-rapid-alert-system-non-food

Australiawww.productsafety.gov.au/recalls

OECD – The Organisation for Economic Co-operation and Developmenthttps://globalrecalls.oecd.org

Health Canada and International Recalls

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Injury & Incident Data

NEISS Data (CPSC)

CHIRRP (Public Health Agency of Canada)

Human Factors Research Journals

Government and NGO Publications and Reports

Medical/Social sciences publications – HFES

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Anthropometric Data

Childata

Adultdata

Older Adultdata

Strength Data for Design Safety

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Internal Resources

Customer Service Feedback

Provide Toll-Free Phone Number

Complaints and associated follow-up

Returns/Replacement parts/Repairs

On-line product reviews / Social Media

Feedback Safety-Related Issues to Product Designers and Engineers

Central Repository for Incident Reports and other customer feedback

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Use Standardized Checklist

ISO Guide 50, ISO Guide 51

EU Guidelines for Non-food Consumer Products

Hasards – Based on ISO Guide 60 Is the hazard Present Has the Hazard Been Addressed

MECHANICAL HAZARD

Gaps and openings

Protrusions

Corners, edges and points

Projectiles

Hazards for small objects

Non-permeable enclosures

Inadequate stability

Inadequate structural integrity

Hazardous heights

Moving and rotating objects

Noise

Drawing hazards

Internal Hazard Pattern Checklist

ISO 13077

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Risk Assessment

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FMEA Can Quantify Risks

Process of systematically identifying hazards to determine outcome and level of risk

EU Guidelines for Non-Food Consumer Products

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Apply the Safety HierarchyHierarc

Warn

Guard

Design

Effectiveness

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Design Hazard Out

Likelihood of hazard occurring

Severity of potential injury

Technologically feasible

Financially feasible

High risk or high profile category

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Guard Against The Hazard

Physical Guard

Procedural Guard

Proper Manufacturing Controls

Select suitable vendor/factory

Review factory flowchart and quality control (QC) plan

• Critical processes

• In-factory testing

Start-up and In-process Monitoring

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Warn About The Hazard

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Risk Management

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Product Safety throughout the Life Cycle

Store / Merchandising

Transportation

Product Concept

Quality & Capability Audit

Social Audit

Raw Materials Testing /Testing to Failure

In-Line / In-Process Inspection

ProcessAudits

Pre-Shipment Inspection

DistributionReturn to Vendor Analysis

C-TPAT / Security Audit

Vendor Selection

Pre-Production

Production

LoadingInspection

GAPAnalysis

Sensory Testing

Concept/Design Review

SupplierQualification

Risk Assessment

Label Evaluation & Verification

Production Monitoring

Raw Materials Traceability

InterventionTesting

Compliance & Performance Testing

Final Random Inspections

CUSTOMERDATA MANAGEMENT

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Product Concept

Identify Potential Hazards, Regulatory Requirements, and Risks

Concept Review

Design Evaluation

Risk Assessment

Age Determination/Intended User

Testing & Labeling Requirements

Potential Risks with Compliance

Potential Risks with Manufacturing

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Vendor Selection

Initial factory qualification

Manufacturing audit

Capabilities and Capacity

Quality management systems

Production monitoring

Good Manufacturing Practices

Environmental audit

Product safety/Technical audit

Social compliance/Ethical audit

Hazard Analysis and Critical Control Point (HACCP)

Recall history

Financial stability

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Pre-Production

Raw Materials Qualification

Pilot Sample / First Run Product Compliance Testing

Research Testing / Testing to Failure

Production Readiness Review

Labeling Verification / Artwork approval

Performance & Aesthetic expectations

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Chemical Management

Know all the chemicals used in your factory

• Ensure no cross contamination

Involve the whole supply chain

• Raw material supplier

• Chemical companies

• Subcontractors

Have robust process for accepting incoming chemicals

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Production – Testing

Safety

Performance

Quality

Regulatory Requirements

Function and Durability

Claims Substantiation

Sensory Evaluation

Product Comparisons

Corrective Action Plans

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Production – Audits/Inspections

Random Sample Selection

Process Audits

Production Monitoring

Top of Production (TOP)

Initial Production (IPI)/First Line Inspections

In-process/In-line Inspection (DUPRO)

Final Random Inspections (FRI) / Pre-Shipment Inspections (PSI)

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Store/Merchandising

Market surveillance testing

DC/Store inspections

Vendor return analysis

Failure evaluation

Recall assistance

Focus groups

Inventory control

Test Program vs. Risk Management Program

Process Test ProgramRisk Management

Program

Product design / Packaging evaluation

Photo, Product name plate

Production readiness review

Raw materials / Preproduction testing

Research testing / Testing to failure

On-site validation / In-line factory audit

Finished product testing

Sample selection By Factory By Independent third party

Testing sample size Minimal Statistically valid

Testing frequency Once Statistically valid

Formal corrective action / Preventative action plan

Pre-shipment inspection

Risk Management Program

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Shared Goal

Safe and Compliant Product…

on time, within budget

And with minimized risk

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Smart solutions that bring

safety and trust to trade globally