compliance in plm webinar 1
TRANSCRIPT
Product Governance & Compliance
Webinar 1 - Compliance 101Presented by:
Charles Vernor, Solutions ConsultantDries D’Hooghe, Environmental Compliance Consultant
Who is ZWS?Zero Wait-State helps companies implement an effective PLM strategy
based on their specific business model
Services Products
implementation integration data migration DescriptionBuilder DesignState LoadState PDXState
Today’s Agenda
1. Compliance 101: What you need to know
2. Reasons for using Agile PG&C3. How Agile PG&C works4. Q&A
COMPLIANCE 101: WHAT YOU NEED TO KNOW
An overview of today’s compliance environment
What is product compliance? Why should I care?
• Developed in response to issues of safety, health, and wellbeing of individuals and the environment
• Exists in nearly every industry and applies to both discrete and process manufacturing
• It is an expected cost of doing business today
• Navigates industries in a better direction
• There are benefits to compliance (if you know how to leverage them)
What are Conflict Minerals?
• Conflict Minerals is a legislation that is introduced in section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act
• Applies to companies that file reports with the SEC under the Exchange Act
• Requires annual disclosure of any conflict minerals that are necessary to the functionality or production of a product
• Minerals originated (or financing conflict) in the DRC or adjoining country
• The common conflict minerals currently being evaluated are Tin, Tungsten, Tantalum, and Gold (commonly referred to as the 3TG substances)
Angola Zamb
ia
Tanzania
Uganda
Democratic
Republic of
The Congo (DRC)
Sudan
Congo Republic
Central Africa
RepublicRwanda
Burundi
• I am a private or foreign company. Does this affect me?– Even though you specifically do not have a reporting obligation or any duties
under the rules, you very likely supply products to public companies (directly or indirectly)
– Your customer will ask you for your product information to aid them in their reporting requirements
• I am a distributor. Does this affect me?– Yes, like private companies above, you will be asked for your product
information as it is your public customer’s obligation to report this.
• Accordingly, all companies should examine their supply chain so that they are prepared for customer inquiries
What are Conflict Minerals?
• Companies regulated by the SEC will need to file Form SD annually and disclose whether their products are:– DRC Conflict Free– DRC Conflict Undeterminable– Not found to be DRC Conflict Free
• The “DRC Conflict Undeterminable” response will only be available this year for large companies– Smaller companies have an additional 2 years (those with less than $75K in outstanding public
shares)– Companies reusing this exemption must show progress in their audits
• The next reporting deadline is May 31, 2015 covering the year 2014
• Recycled or scrap materials are considered “DRC Conflict Free” to promote the use of recycling and reuse
What are Conflict Minerals?
Conflict Minerals Reporting Template (CMRT)
• A free, standardized Excel reporting template developed by the Conflict-Free Sourcing Initiative (CFSI)– Founded in 2008 by members of the Electronic Industry Citizenship Coalition
• CFSI aims to certify all smelters as DRC Conflict Free on an annual basis
• Facilitates the transfer of information throughout the supply chain, including the country of origin and the smelters and refiner source
• All companies in the supply chain are obligated to send out updated forms to customers as compliance information changes
• CMRT can be filled out for various scopes:A. Company Level (Most common)B. Product Level (using a product list)C. User Defined
• Companies will use the completed CMRT to do the following:1. Determine a supplier’s compliance
based on their answers in the form 2. Roll up the compliance status up
through the product BOM to determine overall compliance status
3. Consolidate compliance information to fill out the CMRT form to their customers
Conflict Minerals Reporting Template (CMRT)
What is RoHS?• EU Directive 2002/95/EC of the European Parliament and of the council on the
Restriction of Hazardous Substances in electrical and electronic equipment• Involves the restriction of 6 substances:
• Maximum concentration is measured by homogeneous material, not the entire product– Homogeneous material - smallest amount that can be separated mechanically
• There is a list of exemptions for specific applications– Exemption requests from companies and organizations are continually evaluated– Some exemptions have an expiration and new ones get created
Substance Name Maximum Percentage Concentration
Maximum Concentration in PPM
Lead (Pb) 0.1% 1,000Mercury (Hg) 0.1% 1,000Cadmium (Cd) 0.01% 100Hexavalent chromium (Cr6+) 0.1% 1,000Polybrominated biphenyls (PBB) 0.1% 1,000Polybrominated diphenyl ether (PBDE) 0.1% 1,000
China RoHS and Other Regions• China has implemented similar (but not related) restrictions
– Same substances/limits as EU RoHS but may include more substances in time
– No allowed exemptions!– China RoHS has created a list of intended products in a “catalogue” of
Electronic Information Products (EIPs).– Products that fall under these EIPs must be marked with the logo,
compliance status, and must disclose the presence of certain substances
• Other regions have implemented similar RoHS policies for electronics– South Korea, Norway, Turkey, Ireland,
Sweden, and California
What is REACH?• REACH - Registration, Evaluation, Authorization and Restriction of Chemicals
• SVHC - Substances of Very High Concern:– Started on June 1, 2007 and is considered the strictest law to date for substances– Approximately every 6 months more substances are evaluated and added to SVHC list– Latest SVHC candidate list includes 161 substances (as of December 17, 2014)
• The maximum concentration value of the substances is 0.1%, measured in percentage of the entire “article”. – Article = Selling product
• Companies must report the SHVC to ECHA if article has more than the allowed concentration and it produces and/or imports greater than 1 ton per year
What is REACH?
• Candidate List:– For candidate SHVCs present in your product and above limit, you are obligated to
inform customers of the SVHC name and how the product can be safely used– This information must be made available within 45 days upon consumer request
• Authorization List (Annex 14): – Priority SVHCs on candidate list will be included in the authorization list– These SVHCs will not be allowed to be used, placed on the market, or imported into
the EU after a sunset date unless the company is granted an authorization. • Restricted Substances List (Annex 17):
– Companies must ensure that restricted substances in products do not exceed threshold limits set by REACH
What are FDA Regulations?Medical Devices, including:• simple items like tongue depressors
and bedpans• complex technologies such as heart
pacemakers• dental devices• surgical implants and prosthetics
Electronic Products that give off radiation, including:• microwave ovens• x-ray equipment• laser products• ultrasonic therapy equipment• mercury vapor lamps• Sunlamps
Cosmetics, including:• color additives found in makeup and
other personal care products• skin moisturizers and cleansers• nail polish and perfume
Foods, including:• dietary supplements• bottled water• food additives• infant formulas• other food products (although the U.S.
Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)
Drugs, including:• prescription drugs (both brand-name and
generic)• non-prescription (over-the-counter) drugs
Biologics, including:• vaccines• blood and blood products• cellular and gene therapy products• tissue and tissue products• Allergenics
Veterinary Products, including:• livestock feeds• pet foods• veterinary drugs and devices
Tobacco Products, including:• cigarettes• cigarette tobacco• roll-your-own tobacco• smokeless tobacco
Other Important Regulations• California Prop 65• Medical - BPA free• Colorants• Animal origins• Organic, GMO, etc.• Phthalates• Casino jurisdictions• Defense industry
standards• Firearm restrictions• Automotive emissions• Product safety standards• Recycling initiativesThe list goes on and on….
REASONS FOR USING AGILE PG&CAn explanation of how Agile PLM and PG&C can fit your needs
Versatility to the Core
• The design flexibility of the Product Governance and Compliance (PG&C) module can interpret many regulations
• Incorporates seamlessly with your Agile PLM data:– Bill of Materials (BOM)– Approved Manufacturer List (AML)– Workflow-driven Data Management– Triggers or invoked by other Agile
processes
Centralized Repository for Your Product Data
• Compliance data relates to your product design, so why track it separate from your BOM?
• By using Agile PLM to track product compliance, you avoid additional:– IT costs– Licensing– Software integrations– Application Training– Support Resources
Great tools for your Agile toolbox!• PG&C has the ability to be
customized to meet your needs:– Process Extension reports– Automated data retrieval from 3rd parties– Agile Notifications and custom alerts
• LoadState can greatly assist your compliance solution in many ways!
• Watch the next webinar for more info!LoadState
HOW AGILE PG&C WORKSInteractive Demonstration
WE WILL NOW OPEN UP THE AUDIO TO VIEWER QUESTIONS.
PART TWO WEBINAR“Wake Up Your Compliance With Automation”
April 15, 2015 at 10 am CST
