RECALLS Mitigating the Risk and Managing the Process October 9, 2019
Agenda Managing the Risk Managing the Process Q & A Session Risk Assessment Process Reporting Requirements Risk Management Tools Recall Preparedness Product Life Cycle Compliance Programs 2 2 info@qima.com info@qima.com
MANAGING THE RISK Risk Assessment Process 3 info@qima.com
Introduction Regulatory compliance is a minimum requirement Hazard identification and risk management Ensure continued compliance Safety-related recalls are still occurring 4 4 info@qima.com info@qima.com
Every Consumer Product Has Risk 5 info@qima.com
Identify Potential Hazards and Risks Human Factors Review - Goes Beyond the Standards Try To Anticipate Foreseeable Use & Unintended Use Scenarios Understand & Enhance Interaction Between Users & Products 6 6 info@qima.com info@qima.com
Resources Available Mandatory & Voluntary Standards Existing Data Behavioral Task Analysis Research 7 7 info@qima.com info@qima.com
Mandatory & Voluntary Standards Mandatory regulations are minimum requirements Voluntary standards address additional issues, including safety, quality and performance Are voluntary standards truly voluntary? International standards vary 8 info@qima.com
Review & Analyze Existing Data (external data) Incident/Injury Data, including NEISS Data Human Factors Research Journals Government and NGO Publications and Reports Medical/Social sciences publications – NIH, HFES Anthropometric data – Childata, Adultdata, Older Adultdata, Strength Data for Design Safety SaferProducts.gov CPSC, RAPEX and other international recalls Social media 9 info@qima.com
Develop Incident Feedback Loop (internal data) Customer Service Feedback Provide Toll-Free Phone Number Complaints and associated follow-up Returns/Replacement parts/Repairs On-line product reviews Feedback Safety-Related Issues to Product Designers and Engineers Central Repository for Incident Reports and other customer feedback 10 10 info@qima.com info@qima.com
Conduct Behavioral Task Analysis Identify steps associated with product use Each step has a decision juncture: • Product assembly • Intended Use • Foreseeable unintended use (misuse) • Cleaning • Troubleshooting • Disassembly • Storage 11 info@qima.com
Conduct Research Behavioral observations Sensory panels Focus groups Survey research 12 info@qima.com
Use Standardized Checklist ISO Guide 50, ISO Guide 51 Internal Hazard Pattern Checklist EU Guidelines for Non-food Consumer Products ISO 13077 Has the Hazard Been Addressed Hasards – Based on ISO Guide 60 Is the hazard Present 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 13 info@qima.com
Hazard Pattern Checklist (not all-inclusive) Burns/Fires Choking/Aspiration Ear Impaction Eye Injuries Throat Impaction Finger Entrapment Facial Suction Lacerations Hair Entanglement Suffocation Contusions Impalement Finger/Wrist Puncture/Projection Entanglement 14 14 info@qima.com info@qima.com
Use Decision Tree Top down method of analyzing Start a series of foreseeable events Definition of intended use and reasonably ISO Guide 51 Risk analysis foreseeable misuse Risk assessment ISO 13077 Hazard identification EU Guidelines for Non-Food Risk reduction Risk estimation Consumer Products Risk evaluation Is tolerable risk achieved? NO YES Stop 15 info@qima.com
FMEA Can Quantify Risks Process of systematically identifying hazards to determine outcome and level of risk EU Guidelines for Non-Food Consumer Products 16 info@qima.com
MANAGING THE RISK Risk Management Tools 17 info@qima.com
Apply the Safety HierarchyHierarc Effectiveness Design Guard Warn 18 info@qima.com
Design Hazard Out Likelihood of hazard occurring Severity of potential injury Technologically feasible Financially feasible High risk or high profile category 19 info@qima.com
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 20 info@qima.com
Warn About The Hazard 21 info@qima.com
MANAGING THE RISK Product Life Cycle 22 info@qima.com
Product Safety throughout the Life Cycle Social Supplier Sensory Risk Audit Qualification Assessment Testing Raw Materials GAP Traceability Analysis Raw Materials Testing / Quality & Testing to Failure Capability Audit Vendor Selection Label Evaluation & Concept/ Product Concept Verification Pre-Production Design Review In-Line / In-Process Inspection CUSTOMER DATA MANAGEMENT Intervention Production Testing Store / Compliance & Performance Testing Merchandising Transportation Production Distribution Monitoring Return to Vendor Analysis C-TPAT / Process Security Audit Loading Audits Final Random Pre-Shipment Inspection Inspections Inspection 23 info@qima.com
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 24 info@qima.com
Vendor Selection Initial factory qualification Social compliance/Ethical audit Manufacturing audit Hazard Analysis and Critical Control Point (HACCP) Capabilities and Capacity Recall history Quality management systems Financial stability Production monitoring Good Manufacturing Practices Environmental audit Product safety/Technical audit 25 info@qima.com
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 26 info@qima.com
Production Testing Audits/Inspections Safety Random Sample Selection Performance Process Audits Quality Production Monitoring Regulatory Requirements Top of Production (TOP) Function and Durability Initial Production (IPI)/First Line Inspections Claims Substantiation In-process/In-line Inspection (DUPRO) Sensory Evaluation Final Random Inspections Product Comparisons (FRI)/PreShipment Inspections (PSI) Corrective Action Plans 27 info@qima.com
Transportation / Distribution Loading Inspection C-TPAT Compliance • Voluntary supply chain security program, launched in 2001 • Over 10,000 certified partners • Partners must ensure the integrity of their supply chain Partners are considered low-risk Importer Self-Assessment Program (ISA) ISA-Product Safety 28 info@qima.com
Store/Merchandising Market surveillance testing DC/Store inspections Vendor return analysis Failure evaluation Recall assistance Focus groups Inventory control 29 info@qima.com
MANAGING THE RISK Compliance Programs 30 info@qima.com
Compliance Programs Provide employees with written standards/policies, compliance training, and the means to report compliance-related concerns confidentially Maintain and enforce a system of internal controls and procedures to ensure that the firm promptly, completely, and accurately reports required information about its products to the CPSC Ensure that information required to be disclosed by the firm to the Commission is recorded, processed, and reported per applicable law Establish an effective program to ensure the firm remains in compliance Ensure that prompt disclosure is made to the firm’s management of any significant deficiencies or material weaknesses in the design or operation of such internal controls 31 info@qima.com
Risk Management Program Test Program vs. Risk Management Program Risk Management Process Test Program 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
Managing the Recall Process 33 info@qima.com
Recalls Happen (almost) Every Day 34 34 info@qima.com info@qima.com
CPSC Reporting Requirements Section 15 PART OF Consumer Product Safety Act Section 37 PART OF Section 102 Child Safety Protection Act 35 35 info@qima.com info@qima.com
SECTION 15 Reporting Requirements A firm must notify the Commission immediately if a product: Fails to meet a consumer product safety standard or banning regulation Contains a defect which could create a substantial hazard to a consumer Fails to comply with a voluntary standard which the Commission has relied on, under the CPSA 36 info@qima.com
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