compliance in plm webinar 3
TRANSCRIPT
Product Governance & Compliance
Webinar 3 - The Ever Changing Regulatory Environment
Presented by:Charles Vernor, Solutions Consultant
Dries D’Hooghe, Environmental Compliance ConsultantGuest: Sub-Zero Wolf
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
DescriptionState DesignState LoadState
RevState DocState
Today’s Agenda
1. Future of Current Regulations2. New Regulations to Monitor3. ZWS Approach to Compliance
Implementations4. Customer Story – Sub Zero-Wolf5. Q&A
FUTURE OF CURRENT REGULATIONSChanges to expect from regulations that are already being enforced by your
organization
Conflict Minerals• 2015 is the last year that large companies can exercise the use of “DRC
Undeterminable” exemption– Smaller companies have an additional 2 years (those with less than $75K in
outstanding public shares)
• A new CFSI-CMRT Template (Rev 4.0) is available for 2015 filings– Changes include updated Standard Smelter List and translation improvements for
questions and answers– Use of 3.XX template format is encouraged for May 31, 2015 reporting deadline
for 2014 data
• CFSI Certified Smelters list is now available in Excel formathttp://www.conflictfreesourcing.org/media/StdSmelterList_RevHistory_Apr2015.xlsx
EU REACH 2018• REACH continues to evaluate new SVHCs every 6 months
• Chemicals that are manufactured or imported between 1-100 tons per year per company are to be registered by May 31, 2018
• Late pre-registration period ends on May 31, 2017
• Late pre-registration is only obligatory if companies want to benefit from the extended registration deadlines
RoHS Exemptions• Several new exemptions have been introduced:Substance Application Expiration Date
Mercury in intravascular ultrasound imaging systems June 30, 2019Lead in polyvinyl chloride (PVB) sensors in in vitro diagnostic medical devices
December 31, 2018
Cadmium in downshifting cadmium-based semiconductor nanocrystal quantum dots for use in display lighting applications
June 30, 2018
RoHS Exemptions• And several exemptions will expire soon unless
renewed:Exemption Expiration Date
Exemption 4d for mercury in high pressure mercury (vapour) lamps April 13, 2015 (Expired)
Exemption 2 (b) 2 for mercury in non-linear halophosphate lamps April 13, 2016Exemption 33 (Annex IV) for lead in solder on populated printed circuit boards for class Iia mobile medical devices expires June 30, 2016
Default expiration date for exemptions in Electrical and Electronic Equipment (except RoHS Categories 8 and 9), where not otherwise specified Substance restrictions extended to in vitro medical devices
July 21, 2016
RoHS Proposed Substances• The EU Commission is proposing to restrict four plasticizers
(DEHP, BBP, DBP, DiBP) and one flame retardant (HBCDD)
• All of these substances were identified as REACH SVHCs
• No timeline has been communicated, but the earliest restriction date could be mid-2017 through 2019
• Additional substances envisioned are TBBPA (flame retardant), MCCP (flame retardant/plasticizer) and PVC
NEW REGULATIONS TO MONITORA preview and explanation to compliance initiatives coming soon
Canada - BNST Substance Restriction
• Canadian Regulation “Prohibition of Certain Toxic Substances Regulations, 2012 (the Prohibition Regulations)” came into force on March 14, 2013
• 2 year exemption was given for the EEE industry, which expired on March 14, 2015
• BNST stands for “Benzenamine, N-phenyl-, Reaction Products with Styrene and 2,4,4-Trimethylpentene”
Canada - BNST Substance Restriction
• May be found in lubricants that are sometimes used for high-speed electrical motors in electronic products (such as hard disk drives)
• This Regulation prohibits the manufacture, use, sale, offer for sale or import of BNST (or products containing BNST) into Canada
• Under certain conditions, renewable 1-year permits can be granted for companies that provide a transition plan
California Green Chemistry Initiative
• Also known as “California REACH”
• The California Department of Toxic Substances Control (DTSC) recently released the Priority Product Work Plan on April 16
• A 3 year plan to “accelerate the quest for safer products” under the Safer Consumer Products Act (SCPA), established in October 2013
• May result in products being forced out of the California marketplace if offending chemical ingredients are not removed
Priority Product Work Plan Focus Areas
• The types of companies targeted by the plan:– Manufacturers– Retailers– Importers
• The product categories that are affected:– Beauty– Personal care, and hygiene products– Building products– Household and office furniture and furnishings– Cleaning products– Clothing– Fishing and angling equipment– Consumable office machinery
ZWS APPROACH TO COMPLIANCE IMPLEMENTATIONS
We’ll explanation why our methodology works for your project’ budget and needs
A 3 Phase Strategy Ensures Success
1. IMPLEMENT
• Basic setup of the PG&C module and fields
• Set up specification, substance, and exemption libraries associated with your compliance regulations
• Resolve any issues that may impact compliance automations and processes
2. CUSTOMIZE
• Install LoadState product for compliance data import
• Deliver PX automations for BOM management and compliance reporting
• Automate workflows and other tasks to increase regulatory efficiency
• May be separated into multiple phases based on solution scope
3. STRATEGIZE
• Incorporate compliance metrics into other areas of Agile PLM
• Improve AML vendor selection and product design alternatives that reduce legal and environmental risk
• Introduce compliance research earlier into the product release process
ZWS Approach Benefits• A complex implementation broken into logical and
manageable phases
• Reduces solution dependencies and testing effort
• Faster delivery with reduced cost
• Avoids perpetual development pitfalls
CUSTOMER STORY – SUB ZERO-WOLFSuccess story of PG&C and LoadState, and benefits resulting from the implementation
IMPLEMENTING PRODUCT GOVERNANCE & COMPLIANCE
Sub-Zero's Implementation of PG&C
1. PG&C Module
2. Business Process Development
3. Continuous Improvement
PG&C Module
• Standard Software Configuration
• Data Migration • Loadstate
Business Process Development• Developed Role with Software
• Transferred Responsibilities • Process Drives the System
Continuous Improvement• Developing Role
• Non-restrictive configuration
• Compliance Lifecycle
Product Governance & Compliance
• PG&C Module
• Business Process Development
• Continuous Improvement
WE WILL NOW OPEN UP THE AUDIO TO VIEWER QUESTIONS.
