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October 9, 2019
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Agenda
Managing the Risk
Risk Assessment Process Risk Management Tools Product Life Cycle Compliance Programs
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Managing the Process
Reporting Requirements Recall Preparedness
RECALLS Mitigating the Risk and Managing the Process October 9, 2019 - - PowerPoint PPT Presentation
RECALLS Mitigating the Risk and Managing the Process October 9, 2019 - - PowerPoint PPT Presentation
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
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MANAGING THE RISK
Risk Assessment Process
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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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Every Consumer Product Has Risk
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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
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Resources Available
Mandatory & Voluntary Standards Existing Data Behavioral Task Analysis Research
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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
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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
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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
- ther customer feedback
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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
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Conduct Research
Behavioral observations Sensory panels Focus groups Survey research
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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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Hazard Pattern Checklist (not all-inclusive)
Burns/Fires Eye Injuries Facial Suction Suffocation Impalement Puncture/Projection Choking/Aspiration Throat Impaction Lacerations Contusions Finger/Wrist Entanglement Ear Impaction Finger Entrapment Hair Entanglement
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Use Decision Tree
Top down method of analyzing a series of foreseeable events
ISO Guide 51 ISO 13077 EU Guidelines for Non-Food Consumer Products
Start Definition of intended use and reasonably foreseeable misuse Hazard identification Risk estimation Risk evaluation Is tolerable risk achieved? Stop Risk reduction
Risk analysis Risk assessment
YES NO
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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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MANAGING THE RISK
Risk Management Tools
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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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MANAGING THE RISK
Product Life Cycle
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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 Process Audits Pre-Shipment Inspection
Distribution
Return to Vendor Analysis C-TPAT / Security Audit
Vendor Selection Pre-Production Production
Loading Inspection GAP Analysis Sensory Testing Concept/ Design Review Supplier Qualification Risk Assessment Label Evaluation & Verification Production Monitoring Raw Materials Traceability Intervention Testing Compliance & Performance Testing Final Random Inspections
CUSTOMER DATA 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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Production
Testing
Safety Performance Quality Regulatory Requirements Function and Durability Claims Substantiation Sensory Evaluation Product Comparisons Corrective Action Plans
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)/PreShipment Inspections (PSI)
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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
- f their supply chain
Partners are considered low-risk Importer Self-Assessment Program (ISA) ISA-Product Safety
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Store/Merchandising
Market surveillance testing DC/Store inspections Vendor return analysis Failure evaluation Recall assistance Focus groups Inventory control
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MANAGING THE RISK
Compliance Programs
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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
- f any significant deficiencies or material weaknesses in the design
- r operation of such internal controls
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Risk Management Program
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
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Managing the Recall Process
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Recalls Happen (almost) Every Day
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CPSC Reporting Requirements Section 15 Section 37 Section 102
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PART OF
Consumer Product Safety Act
PART OF
Child Safety Protection Act
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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
SECTION 15
Reporting Requirements
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SECTION 15
How To Report
Firms must file a report with the CPSC Office of Compliance and Field Operations :
Electronically: SaferProducts.gov Telephone: 301-504-7520 Fax: 301-504-0359 Email: Section15@cpsc.gov Mail: 4330 East West Hwy, Bethesda, MD 20814
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Description of the product Name and address of the company (manufacturer, supplier, distributor, importer or retailer) The possible product defect or unreasonable risk of serious injury or death Nature and extent of the injury or possible injury associated with the product Name, address and telephone number of the person informing the Commission A timetable for providing information not immediately available
SECTION 15
What To Report
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SECTION 15
When To Report
Must report “immediately” Within 24 hours of obtaining the information CPSC encourages companies to report potential substantial product hazards even while their own investigations are continuing Firms may investigate the matter for 10 working days
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SECTION 15
Evaluation of Report
CPSC will evaluate whether or when a firm should have reported Evaluation is based on what the company actually knew about the hazard posed by the product or on what a reasonable person should have known about the product hazard A firm is deemed to know what it would have known had it exercised due care in analyzing reports of injury, consumer complaints, warranty of returns, reports of experts, etc.
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SECTION 15
Confidentiality of Reports
The Commission is prohibited to release information unless a remedial action plan has been accepted by the firm in writing, a complaint has been issued or the reporting firm consents to the release The reporting firm must mark “confidential” on the report if the information submitted is trade secret or confidential commercial
- r financial information
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SECTION 15
Criteria For Substantial Product Hazard
Pattern of defect Severity of risk Number of defective products distributed in commerce Likelihood of injury
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Hazard Priority System
Class A Hazard Exists when a risk of death or grievous injury or illness is likely
- r very likely, or serious injury or illness is very likely
Class B Hazard Exists when risk of death or grievous injury or illness is not likely to occur but is possible, or when serious injury or illness is likely or moderate injury or illness is very likely. Class C Hazard Exists when a risk of serious injury or illness is not likely but is possible, or when moderate injury or illness is not necessarily likely but is possible.
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Fast Track Product Recall Program
Firms that file Section 15 reports may wish to use an alternative procedure to expedite recalls Within 20 working days of filing a potential product defect report, the CPSC can implement a consumer-level voluntary recall Allows the firm and the Commission to create an immediate corrective action without spending time and other resources to investigate
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Fast Track Product Recall Program
Provide all information required for a full report Request to participate in this program Submit a proposed corrective action plan with sufficient time for the Commission to analyze any proposed repair, replacement or refund and to evaluate all notice material before implementation of the voluntary recall
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A firm must notify the Commission immediately if:
a product is the subject of at least three civil actions filed in federal or state court each suit alleges the involvement of the product in death or grievous bodily injury during two-year periods, each of the three actions result in either a final settlement involving the manufacturer in a court judgment in favor of the plaintiff manufacturer is involved in the defense of or has notice
- f each action prior to the entry of the final order
SECTION 37
Reporting Requirements
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What to report When and where to report Confidentiality of reports
SECTION 37
Other Information
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Child Safety Protection Act requires companies to report certain choking incidents to the Commission if:
a child, regardless of age, choked on a marble, small ball, balloon or small part; and as a result of the incident, the child died,suffered serious injury, ceased breathing for any length of time or was treated by a medical professional
SECTION 102
Reporting Requirements
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Name and address of the child who choked Name and address of the person who notified the firm of the incident Any resulting injuries or medical treatment Information about any changes made to the product involved or its warning labels Details of any public notice or other corrective action planned
SECTION 102
What To Report
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Must be filed within 24 hours of obtaining the information Must be filed with the Office of Compliance and Field Operations
- By Mail
- By Telephone (301-504-7520)
- By Fax (301-504-0359)
SECTION 102
When and Where To Report
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Recall Preparedness
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Consumer complaints Warranty returns Parts replacement Insurance claims or payments Product liability lawsuits Reports of production problems Product test reports Design evaluations / risk assessments SaferProducts.gov Recall websites
Product Recall Preparedness
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What is intended utility of the product? How is it supposed to be used, how could it be “misused”? Who is exposed to the product? What is intended age of the user, the target audience? Are certain age groups more exposed to potential injuries than others by using the product? What types of potential injuries can the product cause? What are patterns of consumer use? Are there similar products that have been recalled? What changes can be made to eliminate or reduce the potential hazards and risks?
Identify Product Defects
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Before any incident or recall, develop a recall plan with your team.
Establish a recall plan and team Clearly define team roles and responsibilities Create ready-to-go procedures, templates and scripts Practice and test all recall procedures
Prepare A Recall Plan
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Determine what the defect is and what caused it Locate unsafe products Determine if product failed to comply with safety regulations Verify the defect/non-conformity and severity of product failure through additional testing Inform appropriate regulatory bodies Discontinue product and shipment Notify distributors to stop selling the product Prepare a press release announcing recall Establish toll-free number to handle expected calls Estimate cost of the recall campaign Provide reports of the progress of the recall to the Commission Establish or upgrade quality control procedures to prevent similar recalls
Prepare A Product Recall
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Locate all defective product as quickly as possible Remove defective products from the distribution chain and from the possession of consumers Communicate accurate and understandable information in a timely manner to the public about the product defect, the hazard, and the corrective action
Objectives Of A Recall
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Joint news release from the CPSC and company Video news release Radio announcements Recall posters Information on the company websites Trade associations and newsletter services Social media sites – YouTube, Facebook, Twitter, Pinterest, Flickr, blogs… Formal notices to distributors, retailers, sales reps, end buyers Incentives to return the product
Communicating Recall Information
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Name and location of the recalling firm Name and description of the product Number of products involved Description of the hazard Number of reported deaths, injuries and incidents relating to that hazard Detailed description of the product including model numbers, colors, sizes and any labeling
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Photo of the product Where and when the product was distributed to end users Complete instructions on how to participate in the recall
Recall News Releases
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Determine suitable remedy Ensure replacement is safe and compliant Deliver your remedy in a timely manner Document all remedies delivered Segregate recalled items from non-recalled items that may also be returned by consumers Establish a product disposition strategy
Managing Remedies
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Records of complaints, warranty returns, insurance claims and lawsuits Production records Distribution records Quality control records Test reports Certificates of compliance Tracking label information Product registration cards
Maintaining Records
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Preparation is Essential Monitor the Market Reporting Procedures Roles and Responsibilities of Recall Coordinator and Recall Team Members
Product Recall Manual
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- 1. Product Evaluation
- 2. Identify Implicated Products
- 3. CPSC Notification and Recall Agreement
- 4. Product Removal
Recall Procedures
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Recall Resources
CPSC Recall Handbook
- www.cpsc.gov/s3fs-public/8002.pdf
Recall Websites
- cpsc.gov; recalls.gov; saferproducts.gov;
- www.healthycanadians.gc.ca/recall-alert-rappel-avis;
- https://ec.europa.eu/consumers/consumers_safety/
safety_products/rapex/alerts
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