Product Safety Compliance and Testing Programs - FDRAfdra.org/wp-content/uploads/2014/11/Product-Safety-and-Compliance... · © 2014 MetricStream, Inc. All Rights Reserved. Product

© 2014 MetricStream, Inc. All Rights Reserved.

Product Safety Compliance and Testing Programs Mitigate Risks and Ensure Compliance in the Supply Chain


Experts on Panel

Moderator

Andy Polk Vice President

Footwear Distributors and Retailers of America (FDRA)

Speakers

Ben Devito Global Sales and Technical Manager

Softlines for TÜV SÜD

Sam Mukherjee Senior Manager of GRC Solutions

MetricStream


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

TÜV SÜD in numbers: Growing Through Safety

1 One-stop technical solution provider

800 locations worldwide

employees worldwide 20,00

0

Billion in sales revenue

2.800

147 years of experience

TÜV SÜD Consumer Products & Retail Services

Regulations- An Overview 1

Testing and Test Planning 2

Record Keeping and Reporting 3

Vendor Management and Analysis 4

Nov 20, 2014

Consumer Products Slide 5

Product Safety Compliance & Testing Programs - Mitigate Risks and Ensure Compliance

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!

Nov 20, 2014 Consumer Products Slide 6


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!



Regulations – An Overview 1




Nov 20, 2014



Testing and Test Planning

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

Test Planning and Report Management


Your business challenges

TÜV SÜD Product Service Slide 10

Nov 20, 2014

Global market access

Product recalls

Regulation changes

Price pressure

Long time to market


Just a Little Mistake……………….

If your aim is off by just 1 degree you will miss the moon by about 15,125 miles!

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


Nov 20, 2014


The Spectrum


Nov 20, 2014


Design Concept Development Production

Raw Material Component Product

Less More Systems - Control

- Item Master - Vendor Master - BOM

- Mapping - Reporting - Analysis / Survey

•  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

Test Planning and Report Management






Nov 20, 2014


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


Nov 20, 2014


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”


Nov 20, 2014


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.

Slide 18

Component Part Testing -Example

IOR or Domestic

Manufacturer

Finished Product Factory

Component Factory X

Component Factory Y

Certificate 4 Certificate 3 Certificates 1 & 2

Assume the Factory is sourcing an identical buckle from 2 suppliers

Nov 20, 2014

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








Vendor Management and Analysis


Nov 20, 2014



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

How much are you spending, where and why?

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



2015 is here in just 41 days. !  The industry is reacting

!  Your supply chain partners are adapting !  So you can anticipate, prioritize and plan

Nov 20, 2014



Is it possible and for that matter practical to prepare for and comply with all that is regulated and required?


Technology Strategies to Help Optimize Compliance Programs

Sam Mukherjee Senior Manager of GRC Solutions MetricStream


•  Over 1,500 employees •  Headquarters in Palo Alto, California with offices worldwide •  Over 400 enterprise customers •  Privately held – backed by leading global VCs

About MetricStream

Integrated Governance, Risk and Compliance for Better Business Performance Vision

Solutions

•  Product Governance •  Quality Management •  Governance & Ethics •  Risk Management •  Audit Management

Partners

Differentiators •  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

Organization

•  Compliance Management •  Supplier Governance •  EHS & Sustainability •  IT-GRC •  Content and Training


Automate and Integrate Relevant Programs

Product Safety Compliance

Information Management

Policy & Compliance

Risk Management

Testing Management

Audit Management

NCM & CAPA


•  Risk 1

•  Risk 2

•  Risk 3 … … …

Risks

•  Control 1

•  Control 2

•  Control 3 … … …

Controls

•  Standard 1

•  Standard 2

•  Standard 3 … … …

Functions

•  Materials

•  Specifications

•  RSLs … … …

Product Information

•  Test Plan

•  Survey

•  Self-Assessment … … …

Tests

•  Risk-Based

•  Requirement-Based

•  Business Unit-Based

Assessment

•  Action Plan

•  Implement

•  Monitor

Issues

•  CPSIA

•  CA Prop 65

•  CCPA

•  …

Area of Compliance

•  Assertion 1

•  Assertion 2

Assertions

•  Procedure 1 •  Document 1 •  Work Instruction 1

… … …

Policies/Documents

Leverage Robust and Flexible Information Model


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

Organization

Testing Labs Suppliers


Supplier, Product & Chemical Information Management

•  Capture and map relevant supplier, product information from supply chain

•  Manage supplier and sub-supplier information, labs, third-party auditors

•  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

Product

Compliance Regulation

Raw-Materials Chemicals Supplier Country of

Origin


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


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


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


Product Testing Management

Product & Chemical Management

Test Requests & Data Gathering

Product Testing Statius

Test Planning & Management

Compliance Certification Management

Test Failures & CAPA Management


Product Safety & Compliance Audits Planning

Audit Program Management

Scoping / Scheduling

Finding Management

Audit Reporting

NCM / Corrective Actions

Fieldwork / Execution


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


Monitor & Track Program Performance


Product Safety & Quality Management

•  Ensure compliance with upcoming 2015 EU product safety compliance requirements

•  Automate, and integrate End-to-End quality assurance –  Inspection Management –  Quality Audit Management –  Product Risk Management –  Product testing –  Product & Supplier Non-

conformance –  Investigations and root cause

analysis –  Preventive actions, and curative

actions including product blocking, and recall management


Q&A

A copy of this presentation will be made available to all participants in next 48 working hours. Please visit www.metricstream.com for more details on upcoming webinars.

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!

Sam Mukherjee Senior Manager of GRC Solu5ons

Metricstream Email -‐ [email protected]

Ben Devito Global Sales and Technical Manager

SoClines for TÜV SÜD Email -‐ [email protected]

Andy Polk Vice President

Footwear Distributors and Retailers of America (FDRA)

Moderator Speakers


Thank You

Contact Us:

Website: www.metricstream.com | Email: [email protected]

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