Product Safety Compliance and Testing Programs

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Norah Booth
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Product Safety Compliance and Testing Programs Mitigate Risks and Ensure

Experts on Panel Moderator Speakers Andy Polk

2 Experts on Panel Moderator Speakers Andy Polk Vice President Footwear Distributors and Retailers of America (FDRA) Ben Devito Global Sales and Technical Manager Softlines for TÜV SÜD Sam Mukherjee Senior Manager of GRC Solutions MetricStream 2014 MetricStream, Inc. All Rights Reserved.

3 Key Discussion Points Product / chemical compliance regulations, requirements and what is required Complying with multiple regulatory requirements Strategies to reduce administrative effort and program costs Collaborating with suppliers and other stakeholders in the supply chain Technology strategies to ensure compliance, reduce costs Q & A 2014 MetricStream, Inc. All Rights Reserved.

4 TÜV SÜD in numbers: Growing Through Safety 1 One-stop technical solution provider 147 years of experience 800 locations worldwide ,00 0 Billion in sales revenue employees worldwide TÜV SÜD Consumer Products & Retail Services

5 Regulations An Overview Product Safety Compliance & Testing Programs - Mitigate Risks and Ensure Compliance Regulations- An Overview Testing and Test Planning Record Keeping and Reporting Vendor Management and Analysis Slide 5 Consumer Products Nov 20, 2014

6 Regulations An Overview Federal! CPSIA! Dodd-Frank State! Prop 65, Green Chemistry, Transparency (SB 657)! Washington State, others Whether Testing or Auditing Related there are various levels of tracking and reporting required. PAPERWORK! Slide 6 Consumer Products Nov 20, 2014

7 Regulations An Overview Today s Discussion: What if you supervisor came to you right now and asked you; now that we are spending all this money on testing and auditing, and I hired you; are we in compliance with all the record keeping, tracking and reporting that is required? How do you know what is required and when? How do you make sure you have the right documents and reports? How do you make the correct submissions in a timely manner? Do you know what is in your products, is it safe and where did it all come from? Can you prove it! Nov 20, 2014 Consumer Products Slide 7

8 Testing and Test Planning 1 Regulations An Overview 2 Testing and Test Planning 3 Record Keeping and Reporting 4 Vendor Management and Analysis Product Safety Compliance & Testing Programs - Mitigate Risks and Ensure Compliance Slide 8 Consumer Products Nov 20, 2014

9 Test Planning and Report Management Your testing and factory management program can be and should be much more than transactional. Vendor/Factory Analysis Testing Audit/Compliance tracking Supply Chain Survey Tracking and Report Development and submission When is the next event due? Testing, Auditing, Reporting Goals: Reduce Errors and Costs, An Improved Supply Chain Slide 9 Consumer Products Nov 20, 2014

10 Your business challenges Product recalls Regulation changes Long time to market Global market access Price pressure Nov 20, 2014 TÜV SÜD Product Service

11 Just a Little Mistake. If your aim is off by just 1 degree you will miss the moon by about 15,125 miles! Slide 11 Consumer Products Nov 20, 2014

12 Testing and Test Planning The entire Product Development and Supply Chain Cycle should anticipate all of the various testing, auditing requirements It is best practice to be able to manage at the lowest level possible - Save Time - Save Money Lowest Level means Item Tracking/ Component Tracking at the earliest possible time - Eliminates duplicative testing - Right the first time and as early as possible - Reducing costs and improving Supply Chain performance Slide 12 Consumer Products Nov 20, 2014

13 Testing and Test Planning The Spectrum Concept Design Development Production Raw Material Component Product Less Systems - Control More - Item Master - Vendor Master - BOM - Mapping - Reporting - Analysis / Survey Slide 13 Consumer Products Nov 20, 2014

14 Test Planning and Report Management Vendor Management and Analysis Vendor/Factory analysis Testing Audit/Compliance tracking Supply Chain Survey Tracking and Report Development and submission When is the next event due? Testing, Auditing, Reporting Slide 14 Consumer Products Nov 20, 2014

15 Record Keeping and Reporting 1 Regulations An Overview 2 Testing and Test Planning 3 Record Keeping and Reporting 4 Vendor Management and Analysis Product Safety Compliance & Testing Programs - Mitigate Risks and Ensure Compliance Slide 15 Consumer Products Nov 20, 2014

16 Record Keeping and Reporting CPSIA Testing and Certification Rule (Mandatory as of Feb 8, 2013) Testing and Certification Rule (Mandatory as of Feb, 2013) Certificates - CPC (Children s Product Certificate i.e. GCC ) Production/Periodic Test Plan sample selection process and test interval Failure Response- and remedial action plan Material Changes (product specifications and BOM) - Recertification Undo Influence need a corporate policy and training Record keeping 5years, including test reports/available to the CPSC within 48 hours Standard - High Degree of Assurance pretty sure that each unit produced is in compliance Slide 16 Consumer Products Nov 20, 2014

17 Record Keeping and Reporting Component Part Testing Rule (Voluntary), does not require the use of CPSC accepted labs: Identification of component - Lot/Batch Number Traceability of component to final product Appropriate CPSC testing rule Identification of test methods and sample protocols Dates when component part was tested Component part test certificate and test reports Traceability Attestations o the supplier and IOR must attest they did nothing to compromise continued compliance with standards (Comingling) o The lab has to attest we followed required CPSC test procedures, incorporated into the report. Standard Due Care Slide 17 Consumer Products Nov 20, 2014

18 Component Part Testing -Example The number of certificates you need to control grows geometrically as the number of components tracked increases. The certificate needs to be available before importing and distribution into commerce, by hard copy or electronic means. IOR or Domestic Manufacturer Certificate 4 Assume the Factory is sourcing an identical buckle from 2 suppliers Finished Product Factory Certificate 3 Component Factory X Component Factory Y Certificates 1 & 2 Slide 18 Nov 20, 2014

Form SD - CSR or Codes of Conduct - Transparency o Uzbekistan Cotton o

19 Record Keeping and Reporting Other Considerations USA - Reporting Washington State and Others Auditing and Surveying - Conflict Minerals, Form SD - CSR or Codes of Conduct - Transparency o Uzbekistan Cotton o Anti Slavery Global - REACH - China GB - ZDHC Slide 19 Consumer Products Nov 20, 2014

20 Vendor Management and Analysis 1 Regulations An Overview 2 Testing and Test Planning 3 Record Keeping and Reporting 4 Vendor Management and Analysis Product Safety Compliance & Testing Programs - Mitigate Risks and Ensure Compliance Slide 20 Consumer Products Nov 20, 2014

21 Vendor Management and Analysis How much are you spending, where and why? Cost of Testing and Audits Cost Components - component testing - duplicative testing - Are you testing at all! - Auditing Costs Cost Analysis - Cost - Cost per o unit o brand o region Slide 21 Consumer Products Nov 20, 2014

22 Vendor Management and Analysis Some things are predictable and under our control.! We will continue to react! Ca. Prop 65 notices /Safer Consumer Products (Green Chemistry)! Regulations from the CPSC! Increasing competition and globalization! More emphasis on sustainability and chemical testing You need to know what is in your products and where they are coming from Slide 22 Consumer Products Nov 20, 2014

23 Vendor Management and Analysis Is it possible and for that matter practical to prepare for and comply with all that is regulated and required? 2015 is here in just 41 days.! The industry is reacting! Your supply chain partners are adapting! So you can anticipate, prioritize and plan Slide 23 Consumer Products Nov 20, 2014

Technology Strategies to Help Optimize Compliance Programs Sam Mukherjee Senior

About MetricStream Vision Integrated Governance, Risk and Compliance for

Management Governance & Ethics Risk Management Audit Management

Content and Training Partners Organization Differentiators Over 1,500

Over 400 enterprise customers Privately held backed by leading global VCs

for all GRC needs Cross-industry Best Practices and Domain Knowledge

25 About MetricStream Vision Integrated Governance, Risk and Compliance for Better Business Performance Solutions Product Governance Quality Management Governance & Ethics Risk Management Audit Management Compliance Management Supplier Governance EHS & Sustainability IT-GRC Content and Training Partners Organization Differentiators Over 1,500 employees Headquarters in Palo Alto, California with offices worldwide Over 400 enterprise customers Privately held backed by leading global VCs Technology - GRC Platform 9 Patents Breadth of Solutions Single Vendor for all GRC needs Cross-industry Best Practices and Domain Knowledge ComplianceOnline.com - Largest Compliance Portal on the Web 2014 MetricStream, Inc. All Rights Reserved.

26 Automate and Integrate Relevant Programs Information Management NCM & CAPA Policy & Compliance Product Safety Compliance Audit Management Risk Management Testing Management 2014 MetricStream, Inc. All Rights Reserved.

27 Leverage Robust and Flexible Information Model Area of Compliance Functions Product Information Risks Controls Tests CPSIA Standard 1 Materials Risk 1 Control 1 Test Plan CA Prop 65 Standard 2 Specifications Risk 2 Control 2 Survey CCPA Standard 3 RSLs Risk 3 Control 3 Self-Assessment Assertions Policies/Documents Assessment Issues Assertion 1 Assertion 2 Procedure 1 Document 1 Work Instruction 1 Risk-Based Requirement-Based Business Unit-Based Action Plan Implement Monitor 2014 MetricStream, Inc. All Rights Reserved.

28 Automation to Enhance Collaboration Alerts and notifications for regular communication to stake holders Collaboration between suppliers and third-party testing labs Supplier surveys to gather information Automate and manage Product Testing, certification etc. Collaborate with suppliers to remove / replace candidate chemicals Manage non-conformance & corrective actions Capacity Building & Training Programs Suppliers Organization Testing Labs 2014 MetricStream, Inc. All Rights Reserved.

Supplier, Product & Chemical Information Management Capture and map relevant supplier, product information from supply chain Product Manage supplier and sub-supplier information, labs, third-party

29 Supplier, Product & Chemical Information Management Capture and map relevant supplier, product information from supply chain Product Manage supplier and sub-supplier information, labs, third-party auditors Compliance Regulation Raw- Materials Chemicals Supplier Country of Origin Include components, raw-materials, specifications, chemicals, thresholds etc. Facilitate supplier declaration through supplier surveys Leverage BOM, MSDS etc. Manage relationships between supplier, product, material, attribute and compliance Enable traceability and visibility across the supply chain 2014 MetricStream, Inc. All Rights Reserved.

Policies for Effective Compliance Create, communicate and manage policies, controls & expectations Product safety Compliance Testing Quality Update procurement and supplier policies to facilitate

30 Policies for Effective Compliance Create, communicate and manage policies, controls & expectations Product safety Compliance Testing Quality Update procurement and supplier policies to facilitate compliance Harmonize & Map policies to multiple compliance requirements Regular training & capacity building programs on regulations Collaborate with suppliers on policy exceptions and potential risks Leverage supplier surveys & assessments to ensure compliance 2014 MetricStream, Inc. All Rights Reserved.

Map Standards & Requirements to Products Leverage regulatory intelligence Identify new requirements updates on existing

31 Centrally Manage Multiple Compliance Requirements Create centralized compliance library EU Product Safety, CPSIA, Toy Directive etc. Map Standards & Requirements to Products Leverage regulatory intelligence Identify new requirements updates on existing requirements Facilitate compliance assessments through surveys and audits Store and manage certifications Monitor and track compliance violations, progress of corrective and preventive actions 2014 MetricStream, Inc. All Rights Reserved.

Product Risk Assessment & Management Supplier & Product Risk Assessment & Management Identify and manage risks in central library Design hazard risk analysis Failure mode analysis for both design and

32 Product Risk Assessment & Management Supplier & Product Risk Assessment & Management Identify and manage risks in central library Design hazard risk analysis Failure mode analysis for both design and production Regular risk assessments on products and suppliers Facilitate Risk-based audits, tests Create and manage controls & procedures including risk mitigation plans 2014 MetricStream, Inc. All Rights Reserved.

33 Product Testing Management Product & Chemical Management Compliance Certification Management Test Planning & Management Product Testing Statius Test Failures & CAPA Management Test Requests & Data Gathering 2014 MetricStream, Inc. All Rights Reserved.

34 Product Safety & Compliance Audits Planning NCM / Corrective Actions Scoping / Scheduling Audit Program Management Audit Reporting Fieldwork / Execution Finding Management 2014 MetricStream, Inc. All Rights Reserved.

Product Non-Conformance & Corrective Action Management Capture non-conformance from all program elements policy non-conformance Test failures risk assessments safety audits Customer complaints

35 Product Non-Conformance & Corrective Action Management Capture non-conformance from all program elements policy non-conformance Test failures risk assessments safety audits Customer complaints Collaborate with supplier and internal teams to develop and implement corrective actions Product Recall Track and Monitor implementation to closure 2014 MetricStream, Inc. All Rights Reserved.

Product Safety & Quality Management Ensure compliance with upcoming 2015 EU product safety compliance requirements Automate, and integrate End-toEnd quality assurance Inspection Management Quality

37 Product Safety & Quality Management Ensure compliance with upcoming 2015 EU product safety compliance requirements Automate, and integrate End-toEnd quality assurance Inspection Management Quality Audit Management Product Risk Management Product testing Product & Supplier Nonconformance Investigations and root cause analysis Preventive actions, and curative actions including product blocking, and recall management 2014 MetricStream, Inc. All Rights Reserved.

38 Q&A Moderator Speakers Ben Devito Global Sales and Technical Manager SoClines for TÜV SÜD - bdevito@tuvam.com Andy Polk Vice President Footwear Distributors and Retailers of America (FDRA) Sam Mukherjee Senior Manager of GRC Solu5ons Metricstream - smukherjee@metricstream.com Please submit your questions to the host by typing into the chat box on the lower right-hand portion of your screen. Thank you for participating! A copy of this presentation will be made available to all participants in next 48 working hours. Please visit for more details on upcoming webinars MetricStream, Inc. All Rights Reserved.

PVH Chemical Management Commitment and Action Plan

PVH Chemical Management Commitment and Action Plan PVH Chemical Management Commitment PVH is committed to eliminating hazardous chemicals from our products and manufacturing processes, a goal we first