PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF...
Transcript of PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF...
![Page 1: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/1.jpg)
March 26, 2020
PRODUCT SAFETY:It’s More Than Regulatory Compliance
![Page 2: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/2.jpg)
I. INTRODUCTION
II. HAZARD IDENTIFICATION
III. RISK ASSESSMENT
IV. RISK MANAGEMENT
Agenda
![Page 4: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/4.jpg)
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
![Page 5: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/5.jpg)
Introduction
▪ Regulatory compliance is a minimum requirement
▪ Hazard identification and risk management
▪ Ensure continued compliance
▪ Safety-related recalls are still occurring
![Page 9: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/9.jpg)
Consider Human Factors
Human Factors Review - Goes Beyond the Standards
Try To Anticipate Foreseeable Use & Unintended Use Scenarios
Understand & Enhance Interaction Between Users & Products
![Page 10: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/10.jpg)
Perform Behavioral Task Analysis
Identify steps associated with product use
Assembly
Intended use
Foreseeable unintended use (misuse)
Cleaning
Troubleshooting
Disassembly
Storage
![Page 11: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/11.jpg)
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
![Page 12: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/12.jpg)
Global Regulations
Look beyond Canada regulations
International standards vary and are often more stringent
![Page 13: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/13.jpg)
Industry Standards
Voluntary standards address additional issues, including safety, quality and performanceAre voluntary standards truly voluntary?
![Page 14: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/14.jpg)
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
![Page 15: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/15.jpg)
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
![Page 16: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/16.jpg)
Anthropometric Data
Childata
Adultdata
Older Adultdata
Strength Data for Design Safety
![Page 17: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/17.jpg)
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
![Page 18: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/18.jpg)
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
![Page 20: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/20.jpg)
FMEA Can Quantify Risks
Process of systematically identifying hazards to determine outcome and level of risk
EU Guidelines for Non-Food Consumer Products
![Page 22: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/22.jpg)
Design Hazard Out
Likelihood of hazard occurring
Severity of potential injury
Technologically feasible
Financially feasible
High risk or high profile category
![Page 23: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/23.jpg)
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
![Page 26: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/26.jpg)
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
![Page 27: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/27.jpg)
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
![Page 28: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/28.jpg)
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
![Page 29: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/29.jpg)
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
![Page 30: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/30.jpg)
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
![Page 31: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/31.jpg)
Production – Testing
Safety
Performance
Quality
Regulatory Requirements
Function and Durability
Claims Substantiation
Sensory Evaluation
Product Comparisons
Corrective Action Plans
![Page 32: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/32.jpg)
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)
![Page 33: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/33.jpg)
Store/Merchandising
Market surveillance testing
DC/Store inspections
Vendor return analysis
Failure evaluation
Recall assistance
Focus groups
Inventory control
![Page 34: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/34.jpg)
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
![Page 35: PRODUCT SAFETY: It’s More Than Regulatory Compliancecontent.qima.com/rs/944-QDO-384/images/CAF Webinar... · info@qima.com 18 Use Standardized Checklist ISO Guide 50, ISO Guide](https://reader035.fdocuments.us/reader035/viewer/2022071013/5fcb47a5b4a414204d2e0894/html5/thumbnails/35.jpg)
Shared Goal
Safe and Compliant Product…
on time, within budget
And with minimized risk