2021 - 03 - qima webinar - product safety - its more than
TRANSCRIPT
Product Safety - It’s More Than Regulatory CompliancePresenter: Susan DeRagon | Date: March 25, 2021
Introduction
Hazard Identification
Risk Assessment
Risk Management
Agenda
1.
2.
3.
4.
US consumer product safety rules & statutes
CPSC rules include:
Federal Hazardous Substances Act (FHSA)Flammable Fabrics Act (FFA)Consumer Product Safety Act (CPSA)Consumer Product Safety Improvement Act (CPSIA)Poison Prevention Packaging Act (PPPA)Labeling of Hazardous Art Materials Act (LHAMA)
FDA rules include:
Federal Food Drug and Cosmetics Act (FFDCA)Food Safety Modernization Act (FSMA)
FTC rules include:
Textile Fiber Products Identification ActCare Labeling of Textile Wearing Apparel & Certain Piece Goods
Introduction
Regulatory compliance is a minimum requirement
Hazard identification and risk management
Ensure continued compliance
Safety-related recalls are still occurring
Consider human factors
Human factors review – goes beyond the standards
Try to anticipate foreseeable use & unintended use scenarios
Understand & enhance interaction between users & products
Perform behavioral task analysis
Identify steps associated with product use
Assembly
Intended use
Foreseeable unintended use (misuse)
Cleaning
Troubleshooting
Disassembly
Storage
Hazard identification resources
Global regulations
Industry standards – mandatory and voluntary
Health Canada & International Recalls (CPSC, Safety Gate, 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
Global regulations
Look beyond US regulations
International standards vary and are often more stringent
Industry standards
Voluntary standards address additional issues, including safety, quality and performanceAre voluntary standards truly voluntary?
Canadahttp://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php
United Stateswww.recalls.govwww.cpsc.gov/en/Recallswww.saferproducts.gov/search/default.aspx
Europe
https://ec.europa.eu/safety-gate-alerts/screen/webReport
Australiawww.productsafety.gov.au/recalls
OECD – The Organisation for Economic Co-operation and Developmenthttps://globalrecalls.oecd.org
International recalls
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
Anthropometric data
Childata
Adultdata
Older Adultdata
Strength data for design safety
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
Use standardized checklist
ISO Guide 50, ISO Guide 51
EU Guidelines for Non-food Consumer Products
Hazards – 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
FMEA can quantify risks
Process of systematically identifying hazards to determine outcome and level of risk
EU Guidelines for Non-Food Consumer Products
Design hazard out
Likelihood of hazard occurring
Severity of potential injury
Technologically feasible
Financially feasible
High risk or high-profile category
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
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
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
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
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
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
Production – Testing
Safety
Performance
Quality
Regulatory requirements
Function and durability
Claims substantiation
Sensory evaluation
Product comparisons
Corrective action plans
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)
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 Program Risk 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
Shared goal
Safe and compliant product…
on time, within budget
and with minimized risk
Email: [email protected]: www.qima.com