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Oracle Agile Product Governance & ComplianceDries D’hoogheSenior Director of Product Strategy

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FDA Regulations - QSR

There is Compliance!

The average $500M corporation is subject to 35-40 major regulatory disclosure mandates*.

Large corporation? Heavily regulated vertical? “We wish we were only subject to 40 regulatory mandates.”

Environmental Regulations (WEEE)

International ISO StandardsAudit Compliance

Operator Certification

Restriction of Hazardous Substances (RoHS)

Standard Operating Procedures (SOP)

Training RequirementsCompliance Reporting

Serial Number Traceability

Sarbanes / Oxley

Design for Six-Sigma

End-of-live vehicle (ELV)

TREAD act

CMII Practices

Registration, Evaluation and Authorization ofChemicals (REACH)

Eco-design (EuP)

*Source: WorldWatch, IDC

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And There is Going Green!Enabling the Eco-Advantage

Eco-Efficiency Eco-Innovation Eco-Transparency

• Protect business reputation

• Promote green brand

• Optimize resource utilization

• Minimize carbon footprint

• Design green products

• Implement green processes

OpportunityCost Brand

Product Lifecycle Management

Strategic Network Opt.Manufacturing

Business Intelligence & Sustainability Reporting

Transportation Management

Asset Lifecycle Management

Reverse Logistics

Self Service Governance, Risk & Compliance

Data Center Management

Service Execution

Procurement

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Business Challenges

• Design for Compliance/Green• Design for Environment, Design for Disassembly, Design for Recycling, …

• Evaluating Component Compliance• Data gathering, data validation and compliance

assessment

• Evaluating Product Compliance• Across variants, approved manufacturers lists

and approved suppliers lists• Risk analysis (exemptions, single sourced, …)

• Evaluating Product Network Compliance• Material Declarations• Declarations of Conformance

• Compliance Reporting• To customers• To authorities

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Customer Benefits• Decreases Compliance Costs• Reduces Business Risk• Compliance with Environmental &

Regulatory Requirements• Improved Operational Governance

Capabilities• Global Environmental Compliance

• Design for Compliance• Supplier Declarations• Risk Analysis

• Management of Standards & Regulatory• Compliance Validation

Agile Product Governance & Compliance™ enables organizations to manage product and program compliance against standards and regulatory requirements, providing assurance of effective compliance throughout the product lifecycle.

Agile Product Governance & Compliance

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REACH

• REACH = Registration, Evaluation and Authorization of CHemicals• European Community regulation on chemicals and their safe use

(EC 1907/2006)• Improve the protection of human health and environment through the better

and earlier identification of intrinsic properties of chemical substances (e.g., carcinogenic, mutagenic, toxic, bio-accumulative substances)

• Consolidates the EU chemicals laws in one legislation• Shift of responsibility and costs to the private sector

• Register chemicals properties and safe handling information intocentral database managed by European Chemicals Agency (ECHA)

• Identify suitable alternatives (substitutions) for dangerous chemicals

• Under REACH, certain Substances of Very High Concern (SVHCs)will be subject to authorization, which could eventually result in theirrestriction. Most substances will be subject to registration only.

• Until this authorization happens there is an SVHC candidate list.• Even though a substance only appears as a candidate SVHC, this might result in a de facto blacklisting of the

substance by the industry or consumers.

• Not all companies are legally required to be REACH compliant BUT those legal requirements drive broad, global supply chain requirements for all Agile PLM Customers.

• Just like RoHS did.

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SVHC Candidate List• Initial list published 28 Oct 2008• 15 substances as of 28 Oct 2008, 7 of

which are currently going through the authorization process

• New candidate SVHC substances will be added every 6 months

• Expected to eventually reach 1500 to 2000 substances

• Environmental groups have created their own wish list of SVHCs using the REACH SVHC definition. These substances could be added over time to the official SVHC candidate list.

• www.sinlist.org

• 267 substances

CAS No. Substance Possible Applications Category

101-77-9 4,4'- Diaminodiphenyl-methane

Curing agent for epoxy resin in PCB, preparation of PU, azo dyes in garments

Carcinogenic

81-15-2 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)

Cosmetics and soap perfumes Very persistent and very bioaccumulative

85535-84-8 Alkanes, C10-13 chloro (short chain chlorinated paraffins)

Leather coating, plasticizer in PVC and chlorinated rubber, flame retardant in plastic & textiles

Persistent, bioaccumulative and toxic and Very persistent and very bioaccumulative

120-12-7 Anthracene Source of dyestuff Persistent, bioaccumulative and toxic

1303-28-2 Diarsenic pentaoxide Insecticides, weed killer, wood preservatives, coloured glass, dyeing and printing

Carcinogenic

1327-53-3 Diarsenic trioxide Weed killers, timber preservatives, manufacture of special glass

Carcinogenic

117-81-7 Bis(2-ethylhexyl)phthalate (DEHP)

Plasticizer for resin, PVC, blister Toxic to reproduction

56-35-9 Bis(tributyltin)oxide Pesticide, fungicide in paint Persistent, bioaccumulative and toxic

85-68-7 Butyl benzyl phthalate Plasticizer for resin, PVC, acrylics Toxic to reproduction

7646-79-9 Cobalt dichloride Moisture indicator in silica gel, absorbent

Carcinogenic

84-74-2 Dibutyl phthalate Plasticizer, in adhesives and paper coatings; insect repellent for textiles

Toxic for reproduction

25637-99-4 and 3194-55-6 (134237-51-7, 134237-50-6, 134237-52-8)

Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified ( -HBCDD, -HBCDD, -HBCDD)

Flame retardant used in HIPS and textiles

Persistent, bioaccumulative and toxic

7784-40-9 Lead hydrogen arsenate

Insectides Carcinogenic and Toxic to reproduction

7789-12-010588-01-9

Sodium dichromate Chrome-tanning of leather, corrosion inhibitor in paints, mordant in textile dyeing process

Carcinogenic, mutagenic and toxic to reproduction

15606-95-8 Triethyl arsenate Intermediates for semi- conductor Carcinogenic

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Adapted from: Design Chain Associates Table

REACH Requirements for Article Manufacturers

Situation Pre-requisite Action REACH

Your product releases a substance (e.g. an ink cartridge releasing ink ) and is imported to, or made in, Europe

•The substance is intended to be released under normal and foreseeable conditions of use.

•The substance is not excluded from REACH or exempted from registration (Annex IV).

•The substance is not already registered for that particular use in articles.•The substance is/will be imported into the EU in quantities over 1 metric ton

per year per manufacturer or importer

You have to register that substance with ECHA

Article 7.1

Your product contains a candidate SVHC and is imported to, or made in, Europe

•Your article contains a candidate SVHC above a maximum allowable concentration level (0.1% weight by article weight)

•Note: Some countries have dissenting views and require 0.1% weight by component article weight. Remember that enforcement of REACH is at the country level.

•The SVHC will be imported into the EU in quantities over 1 metric ton per year per producer or importer

•Exposure of the substances to humans or the environment cannot be excluded (including disposal)

•The substance is not already registered for that particular use.

You have to notify the ECHA starting June 1, 2011 and thereafter within 6 months after an SVHC is placed on the candidate list

Article 7.2

Your product contains a candidate SVHC and is imported to, or made in Europe

•Your article contains a candidate SVHC above a maximum allowable concentration level (0.1% weight by article weight)

•Note: Some countries have dissenting views and require 0.1% weight by component article weight. Remember that enforcement of REACH is at the country level.

you have to provide the recipient of the article with sufficient information to allow safe use of the article including, as a minimum, the name of that substance

Article 33.1

Someone (not just customers but also consumers and environmental groups) asks about candidate SVHCs in your product

•Your article contains a candidate SVHC above a maximum allowable concentration level (0.1% weight by article weight)

•Note 1: Some countries have dissenting views and require 0.1% weight by component article weight. Remember that enforcement of REACH is at the country level.

•Note 2: This requirement starts as soon as an SVHC is added to the candidate list. This means that companies are already required since Oct 28, 2008 to provide this information when requested.

you must provide the requestor with sufficient information to allow safe use of the article including, at a minimum, the name of that substance within 45 days of the request, free of charge.

Article 33.2

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RoHS 2.0

• Currently in draft• Anticipated activation 4th Q of 2012, or 1st Q of 2013• Inclusion of category 8 and 9 products (medical devices and industrial

monitoring & control instruments)• Sunset seven of the current RoHS exemptions, include one new

exemption• Potentially add 4 new substances

• HBCDD - Brominated flame retardant• DEHP - Phthalate plasticizer in PVC• DBP - Phthalate plasticizer• BBP

• More standardized RoHS compliance checks and processes (“declaration of conformity”) are now required in order to put the CE mark on your products.

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What Does It Mean?

• Integrating compliance into your product development processes• Not a one-time high effort data collection exercise in Excel, Access or stand-alone compliance

tools focused on a particular regulation

• Develop a compliance roadmap

• Getting robust product compliance management systems• Staying up to date on regulations

• Trade associations, in-house legal team, consultants, legislation tracking services

• Developing a corporate environmental strategy in line with your business objectives• Lobbying? Alone or through trade group?

• Review agreements with partners and suppliers?

• Communication plan to mediate negative PR?Don’t-Ask-

Don’t-Tell Yes/No

Environmentally-Compliant Follower

Sustainable Developmen

t

Corporate Social

Responsibility

Picture: PRTM

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?

New Revor Version

Due

Diligence

Manufacturers,Suppliers

CorrectiveActions

Design for Compliance/Green Process FlowIntegrating Compliance in the Product Design Process

SCM

Content DBInternal DB

OutsourcedData Gathering

Measurements,Simulations

Design

ProductChanges

Quality

DfX

ProcurementShippingMarketing

Sales

Product Changes,Product Network Changes,Legislation Updates,New Customer Requirements

IPC 1752Custom Form

New Design orShipping Product

Product

Subassembly

Component

Supply Chain

Design

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Summary of solution

• With Agile Product Governance & Compliance, companies are enabled to:• Collaborate with suppliers to collect material data via supplier

material declarations.• Generate an environmental view of the product record to analyze for

compliance with different legislations and specifications.• Manage regulatory documentation and specifications• Track recovery manifests and disposal certificates of destruction• Manage compliance of outsourced design, manufacturing and

recovery partners through proactive audit and closed loop corrective actions

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What is WEEE?

• Aims to reduce the waste arising from electrical andelectronic equipment.

• Affects those involved in manufacturing, selling,distributing, recycling or treating electricaland electronic equipment

• By 13 August 2005:• Producers will be responsible for financing the

collection, treatment, recovery and disposal ofWEEE from private households and businesses.

• By 31 December 2006:• producers will be required to achieve a series of demanding recycling and

recovery targets for different categories of appliance

• Exemptions apply

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What is RoHS?

• “Roze”; Ross”, Ro-haas” – Hmmmm…. few haveagreed on how to pronounce it, even fewer canagree on how to comply

• From 1 July 2006 onwards: • Restricts the use of lead, mercury, cadmium,

hexavalent chromium, PBB or PBDE above acertain threshold value by weight byhomogenous material.

• Exemptions apply

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EU Laws Stimulate Global Cascade

California: Prop 65 restrictions on materials (e.g., lead cables) SB20 and SB50 set recycling limits in 2005SB423 harmonizes with RoHS January 1, 2007

EU: RoHS and WEEE China MII: WEEE in 2006, RoHS being finalized for 2006/2007

Korea: Industry agreements to limit certain materials and for products to be recyclable

Japan: Recycle target active for household electronics and chemical label plans in draft; “Mitsubishi Green 150 initiative active”

Brazil: Existing recycling targets for electronic products and batteries

EU: EuP Program Aug 2007—action required 2006

EU: REACH Program 2008+ votes in Nov 2005

Colombia—Draft National Hazardous Waste Policy

USA—Federal- Restricted Substances for Hg

Mexico’s Final List of Substances for Toxic Release Inventory and Final Rules on Wood Packaging

Chile’s proposal for a National Pollutant Tracking System

USA—Federal- Energy Efficiency (external power supplies)

Clear need for sustainable, global, environmental compliance programs.

Countries are rapidly implementing WEEE and RoHS requirementsNew European requirements (EuP, REACH)

Recycling, battery and packaging requirements are being updated

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China RoHS• Labeling and information disclosure

requirements on electronic information products (EIPs) since March 1, 2007 (pollution control symbol, environmentally friendly use period, packaging label and table of hazardous materials)

• EIPs listed in special “Catalogue” will have substance restrictions as well as a compulsory registration.

• Effective date still TBD for ban of six standard substances and pre-market compliance certification requirements (as of April 2007)

• Product scope, certification process, and maximum concentration values still to be determined

• Testing/Certification by Chinese labs only

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Japan RoHS / J-Moss Label

• Changes to Law for Promotion of Effective Utilization of Resources

• Not a ban for the 6 RoHS substances but labeling and declaration for certain products required

• personal computers (including CRT and LCD displays), air conditioners, televisions, microwave ovens, clothes dryers, electric refrigerators, electric washing machines, and copying machines

• Requires the orange “content mark” be applied if substances are used (unless exempt)

• The green mark is voluntary and is more of an eco-label

• If substances are used (even if covered by exemption), then material declaration is required

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Energy-using Product (EuP) Directive

• Example of an Integrated Product Policy (“Cradle to Grave” thinking) to most cost effectively reduce the environmental impact and resource use of a product.

• Member states must bring into force laws, regulations, and administrative provisions by August 11, 2007

• Provides EU-wide rules for “eco-design”• Framework Directive does not introduce

directly binding requirements for specific products, but defines conditions and criteria for setting such requirements (consumption of resources; emissions; waste generation; environmental impact of noise, vibrations, radiation and EMF; ..).

• Through subsequent implementing measures, requirements regarding environmentally relevant product characteristics (such as energy consumption) can be set and, once adopted, they can be adapted quickly

The generic product lifecycle

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Roadmap to Agile-based Compliance Management

Catch-up Phase Transition Phase Steady State

01/20/06 06/30/06

1 2 3

DeclarationManagement

• Data gathering for all parts in divisions centralized (“Compliance Manager”)

• Additional data gathering for standard parts on corporate level through content providers

• Data sources: Part Miner, supplier web sites, e-mail requests

• Data gathering for standard parts/part families (ecots) through content providers centralized on corporate level

• Gathering of data for standard parts that is not available from content providers and for custom parts in divisions centralized (“Compliance Manager”)

• Adding Agile based declaration requests and supplier portal to sources

• Gathering of data for standard parts that is not available from content providers and for custom parts in divisions decentralized (“Component Engineers”)

• Agile based declaration requests included in RfI/RfQ

SpecificationManagement

• Focus on RoHS specification (RoHS compliance information required)

• Introduction of JIG Level A & B (JIG A&B compliance information desired)

• Focus on JIG Level A & B incl. RoHS for homogeneous materials (complete compliance information required)

SubstanceManagement

• Focus on part/part family level compliance, yes/no information on part level required

• Substance level compliance, yes/no information on substance level desired

• Focus on substance level information, yes/no information on substance level required

• Partial material disclosure, ppm information on substance level desired

• Partial material disclosure, ppm information on substance required

Compliance Validation

• No BOM Roll ups• Manual validation using Agile import/export

functionality• Manual corrective action management

• Automatic BOM roll-ups with Agile PG&C• Automatic validation with Agile PG&C• Manual corrective action management

• Corrective action management with Agile PS&I

Compliance DataManagement

• Div 1: Continuing use of modified Agile PC instance

• Div 2, 3: Adoption of BCD Agile PC modifications

• Corporate: Roll out of PG&C 9.2 instance• Div 1: Roll out of PG&C 9.2 instance

• Multiple PG&C 9.2 instances corporate-wide (corporate level and divisions)

Customer Example

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Sample of Agile PG&C Customers

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Quote from Agile PG&C Customer

• “The enactment of ROHS and WEEE are positive initiatives for protecting the environment. At the same time, they add a new level of complexity in managing the design, production and delivery of our network performance analysis and service assurance systems. Agile PG&C provides a comprehensive solution for identifying and rolling up compliance information, which will enable us to make strategic decisions about our products to ensure availability, manage costs, and provide the best value to our customers.”

John Lane, Senior Compliance Manager,

Spirent Communications

Agile customer for 9+ years

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Quotes from Agile Customers

• “As a leader in the global storage market, implementing RoHS worldwide is a critical corporate initiative for us. We believe that the capabilities provided by Agile PG&C will be a key differentiator for us in the world market.”

Mike Heumann, VP of Marketing, Dot Hill

• “Meeting environmental compliance regulations is not just an issue of corporate responsibility, it is a requirement for doing business. Agile understands the importance of gaining real time visibility into product information and enriching it through supplier collaboration to meet these compliance requirements.”

Earl Wiggins, VP of Quality, Quantum Corp

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Agile PG&C Customers in the Media

• Arima Communications is a Arima Communications is a Taiwan-based leading Taiwan-based leading mobile phone providermobile phone provider

• Deployed PG&C as part of Deployed PG&C as part of Agile 9.2 to meet Agile 9.2 to meet environmental regulationsenvironmental regulations

• Press Release Highlights• Selected Agile because of its stellar reputation, its short implementation time,

and the quality of its local consulting team

• Agile 9.2 PG&C enables Arima to meet stringent environmental regulations, such as the EU’s RoHS, by managing environmental compliance across the product lifecycle to collect, track, analyze and report on hazardous material content in products

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Agile PG&C Customers in the Media

• Spirent is a global provider of Spirent is a global provider of systems that enable next-systems that enable next-generation networking generation networking technologytechnology

• Upgraded to Agile 9.2 to for the Upgraded to Agile 9.2 to for the enhanced overall functionality enhanced overall functionality & expanded version of PG&C& expanded version of PG&C

• Press Release Highlights• Agile customer for more than 9 years, recently upgraded and added PG&C

• Will ensure compliance with environmental standards, such as WEEE directive and RoHS, to deliver solutions to more than 30 countries

• Gained visibility into components with banned or restricted substances allows Spirent to take a more strategic approach to product planning & production

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Solution CapabilitySolution CapabilityBusiness IssueBusiness Issue

Agile Product Governance & Compliance Solution

Business BenefitsBusiness Benefits

Seamlessly integrate compliance information into transaction systems

Design for compliance through optimized

component selection

Flexible BI framework flexibly addresses

regulatory reporting requirements

Compliance management framework provides complete solution

Reduce total solution cost and risk

Reduce risk of non-compliance

Reduce cost of design for compliance

Increase revenues, comply to local

standards

Rapidly evolving compliance requirements

Compliance essential for exploiting New Market

opportunities

Compliance initiatives consume considerable IT

resources

Non-compliance involves considerable risk

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The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions.The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.

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Types of Compliance

• FinancialCompliance (SOX)

• Legal RiskMitigation

• ISO Standards

• ProductCompliance

• Product NetworkCompliance

• ITGovernance

Oracle GRC Solutions

Agile PLM Suite

Focus of Today’s

Discussion

• IT Governance• Information

Protection• Access Control• Auditability

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Consequences of Non-Compliance

• Exclusion from the market

• Stop ships

• Product returns

• Impact on brand perception

• Fines• WEEE: penalty for inadequate recovery• WEEE: penalty for failure to register

• >€1.5M and two years in prison in Estonia; to banned from market in Ireland; to €100K in Italy

• RoHS: >€1M in Spain and Estonia

• Criminal Charges

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Questions?

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PLM and the Risk of Non-Compliance

Product Lifecycle Cash Flow

Approval Volume Phase-Out

Cas

h F

low

Time

Develop

Next Generation ProductRamp to

volume 3

Reduce cost & supply risk

4

Reduce service & warranty costs

5Get to market faster

2

Develop Products “Right to Market”1

Proto NPI

Reduce cost and risk of non-compliance

6

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Global Environmental Landscape

Extended Producer ResponsibilityIncreasing environmental regulations

Integrated Product Policies

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Legal Requirements Drive Supply Chain Requirements

• Not all companies are legally required to be REACH compliant.

BUT

• Legal requirements drive broad, global supply chain requirements for all Agile PLM Customers.• Just like RoHS did.

Distributors

DownstreamUsers

Importers

Manufacturers or Producers

European Union

Non-EU Manufacturers

European Chemicals Agency

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What Does It All Mean?

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PG&C within the Oracle Product Compliance Framework

Data Acquisition& Collection

BOM Management & Compliance

Analysis

Synchronize Data to Transaction

Systems

Transaction Aggregation and

Legislative Reporting

Compliance-Based Transactions

Ship

Sell

AIA

Inte

gra

tion

Design for Compliance Compliant Selling Regulatory Reporting

Change Management

Pro

du

ct T

ran

sactio

ns

Produce

Dispose

RegulatoryReporting

LegislativeRequirements

Declarations

Suppliers

Content Providers

ERP

CRM

Logistics

Regulations & Specifications

Legislation Tracking

Corporate Rules and Procedures (Oracle GRC)

ERP

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Nature of Product ComplianceA Complex Interplay of Diverse and Specialized Skills

Regulations & Specifications

DataContent Providers

Application Integration and Reporting• Regulatory reporting requires regional and company-wide data aggregation across

products and product lines• Requires integration across multiple systems• Analytics for aggregation and aggregated reporting

Robust, Scaleable Software Applications• Robust data management and storage• Compliance roll-ups across parts, BOMs, configurations and revs.

Component and Material Compliance Data• Compliance data required information for parts, materials and subassemblies• Increasingly the domain of 3rd party content providers

Legislation Domain Expertise (Consulting)• Identify legislative requirements for individual company (no one-size-fits-all)• Based on company structure, company risk profile and types of products• Customer-specific requirements similar to becoming SOX or ISO compliant

AIA

Integration

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Agile PG&C Solution Overview

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Compliance Data Management

• Support for substances, substance groups, homogeneousmaterials and subparts in compositions

• Support for environmental attributes on parts and BOMs• Management and import of compositions and supplier

statements of conformance• Management of environmental specifications including exemptions and maximum

threshold values.• Ease of specification management throughout BOMs, Parts, Materials and AMLs.• Ability to maintain compliance at the part group level instead of managing it for

individual parts• Ability to call out materials from the drawings in order to assess and manage the

compliance of the materials.• Multiple compliance states provide a granular view of compliance.

Compliance information linked to the product record improves reuse and reduces errors. Specifications

ExemptionsSubstances

Substance GroupsMaterialsSubparts

Bills of SubstancesCompositions

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Declarations

• Integration with data content providers• Multiple types of declarations

• Support for substances (Mass, PPM, Yes/No)• Support for manufacturing information, part environmental information and exemptions• Up to full disclosure homogeneous material declarations

• Many data entry options (Self guided supplier portal, Excel, import/export)• Support for substance name aliasing• Support for standards based import/export formats: JGPSSI and IPC1752 • System assessment of compliance and completeness allowing management by exception• System calculation of Unreported portion and validation of full material disclosures• Configurable workflows including support for supplier sign-offs• Support both for supplier declarations as well as declarations to your customers

Gather information from data content providers, via standard industry formats or Excel based

templates

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Validations

• Compliance validation of parts and materials• Multi sourcing compliance across different suppliers of

the same part or material• Compliance validation across different manufacturers for standard components (AML)• Compliance status roll-up through different revisions of bills of material• Total substances roll-up through Excel• Support for information reuse with different specifications (multiple algorithms)• BOM Compliance Reporting to drill down to issues within a BOM and its associated

AMLs, also used for auditing.• Exclude non-product information such as manufacturing instructions and drawings from

compliance roll-ups.• Compliance impact assessment of proposed changes to BOM or AML (pending

revisions)

Compliance Roll-Ups help to manage compliance issues by exception

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Design for Environment (DfE) Analytics

• Out-of-the-box Excel based worst casehazardous substances roll-up

• Ability to connect custom analyses at multiple places within the application flow

• Custom analyses (BOM scoring, Pareto analysis, Supply Chain Risk) can be created by Oracle’s services organization, by partners or by the customer.

• % recyclable, reusable, recoverable analysis• Total substances content (e.g. gold)

Use embedded analytics to analyze designs and products for their

Design for Environment fitness.

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Audit

• Extensive history logging of events in Agile PLM forauditing and traceability purposes (who, what, when)

• Access control to compliance data (read, edit, under which circumstances)• Supplier declaration process including a supplier liability sign-off procedure• Ability to query and report against the entered compliance data (where used,

compliance reporting by supplier, by BOM, by commodity, by manufacturer, …)• Cross referencing of information between the different Agile modules (PG&C,

PC, PQM, PCM and PPM)• Validation Protocol Pack for FDA regulated companies

Agile’s security and change tracking features help you to maintain a very high level of

due diligence.