GE Healthcare China RoHS Compliance _______________________________________ Beth A. Hulse GEHC Global Regulatory Manager Environmental Products 4/17/07
Jun 20, 2015
GE Healthcare
China RoHSCompliance
_______________________________________Beth A. Hulse GEHC Global Regulatory Manager Environmental Products
4/17/07
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GE is a family of businesses aligned with our customers’ needs.
Healthcare
NBC Universal
IndustrialInfrastructure
Consumer Finance
A global company
Operations in over 100+ countries
300,000+ employees worldwide
Manufacturing facilities in 40+ countries
Commercial Finance
Infrastructure
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GE HealthcareGE Healthcare brings the world medical science and technologies that are helping to transform healthcare. We are working with our partners in healthcare to help them predict, diagnose, inform, and treat disease earlier than ever.
Diagnostic Imaging • Interventional Cardiology & Surgery • Clinical Systems Healthcare Information Technologies • Services • Bio-Sciences
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Diagnostic Imaging Providing healthcare professionals with highly detailed images of anatomy and function, through the latest technologies.Our LightSpeed VCT
scanner can capture a detailed image of the heart in just five heartbeats.
Interventional Cardiology & SurgeryInterventional imaging, surgery guidance, and orthopedic imaging products to help guide minimally invasive surgical and therapeutic procedures.
Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention.
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Clinical SystemsAdvancing every phase of patient care, from routine screening exams to life critical surgeries.
AirStrip OB allows physicians to remotely access current and historical fetal heart tracings, maternal contraction patterns, and other critical data from labor & delivery units with just a PDA or SmartPhone.
Healthcare Information Technologies Helping to digitize healthcare through radiology image archive and clinical information systems.
GE Healthcare Information Technologies provides a comprehensive array of innovative technologies that provide complete, connected and immediate information solutions.
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ServicesEnabling customers around the world to get the most out of their GE products through advanced support.
Our support analysts have access to a global customer support database, which allows them to share the most up-to-date technical information and helps them provide fast and consistent responses to you.
Bio-Sciences
Providing leading edge diagnostic imaging agents across all modalities through our Medical Diagnostic business.GE Healthcare has established
expertise in protein purification with gold standard chromatography systems. Our products are used in the manufacture of over 90 percent of all biopharmaceuticals on the market.
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GE Healthcare Strategy for China RoHS Compliance
Awareness of regulation
Understand the requirements
Determine products impacted
Communication across GE Healthcare
Upper management engagement & support
Develop operating mechanisms
Develop a sustainable solution
Track product compliance
Evidence of compliance
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Jurisdiction Status of the legislation
Covered EE Susbstances
Argentina proposed components used for repair or reuse and in new products. same scope as WEEE directive, medical devices, monitoring and control instruments
lead, mercury, cadmium, hexavalent chromium, PBB and PBDE
Australia proposed "RoHS type" "RoHS type"
Australia no but listed as priority chemicals
octa- pentaBDE.
Austria (EU) yes RoHS scope Lead; Mercury; Cadmium; Hexavalent chromium; and Polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) [with the exception of deca-BDE], which are used as flame retardants in plastics.
Belgium (EU) yes RoHS scope Lead; Mercury; Cadmium; Hexavalent chromium; and Polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) [with the exception of deca-BDE], which are used as flame retardants in plastics. homogenous material of 0.01% by weight for cadmium,Canada yes several products used by
childrencadmium, lead, mercury - prohibition.
China yes (not into force yet)
scope under prepraration Lead Mercury Cadmium Hexavalent Chromium PBB PBDE and other toxic and haz. substances or elements specified by the State.
Awareness of regulation
GE Corporate, GE Healthcare, and subscription tracking of new environmental regulations…all countries
Participation in Industry groups, i.e. electronics industry and medical device industry
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Industry group participation
Industry group meetings with MII with GEHC participation
GEHC meetings with government agencies
Participation in MII working groups
Legal interpretation
Understand the requirements
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China RoHS – Industry input
Joint Industry Position paper on Chinese substance restrictions
Many products of the electrical and electronic industry already fall under extensive regulations which include restrictions of hazardous substances. The ban of lead, mercury, cadmium, hexavalent chromium and the flame retardants PBB and PBDE according to Art. 4 of the Directive 2002/95/EC (RoHS) is part of many already existing European and national regulations on substances. Recently additional substance restrictions are coming forth from different regions of the world e. g. China, USA (California), Korea, and other countries. The substance restrictions of the new legislation are generally similar to European RoHS but differ in many details or have yet to be finalised.
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Determine Products Impacted
Review EIP list (Electronics Information Products)
Consultation with Industry groups for scope interpretation
Consultation with legal counsel for clarity
Questions from Industry groups or directly from GEHC to MII to understand product scope
FAQ’sElectronic Information Products
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Communication & Operating Mechanisms
Communication of regulation to stakeholders
Training on the regulation
Weekly operating mechanisms for affected functions
Development of GEHC position statements on how to comply
Consistency of engineering documentation
Product design reviews
Business and executive reviews
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China RoHS – Understanding the requirementsRequirements:• Label the product
• Provide X’s & O’s Haz substance table
• Update User manual for China Label & description
• Compliant w/Packaging std GB 18455-2001
logo 2 logo 1
• Spare parts do not require labeling
• Finished products in warehouse with Mfg date before March 1, 07 out of scope.
• Labeling for new products sold March 1 07, not refurbished or remanufactured
• Labeling not required for consigned products.
Items clarified during MII meetings:
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GEHC China RoHS Position Paper
…Common focus across GEHC
GEHC RoHS Requirements
Summary of RoHS DirectivesApplicable to GEHC Products
GEHC RoHS Position Paper
Defines RoHS compliance expected from GEHC suppliers
GEHC Engineering RoHS Req’ts
Translates RoHS requirements intoRequired GEHC Engineering Actions
GEHC Position Statement on China RoHS Labeling
Defines GEHC actions for compliance
with China RoHS labeling requirements
GEHC Engineering Documents
Translation of requirements across engineering
Sustainability…Engineering design tool in place for China RoHS compliance for existing and future products
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Product compliance – Example of GEHC tracker
Bus
ines
s
P&
L
RoH
S L
eade
r
100% 215 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
100% 161 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
100% 61 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
100% 144 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
100% 425 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
Engineering Operations QA
Track by business, by P&L, by product
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On site audits to insure compliance
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Summary and Key Takeaways
Understanding the regulation
Stakeholder engagement
Communication
Common focus across the business
Operating mechanisms & metrics
Sustainability
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Thank you
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Beth A. Hulse, GE HealthcareBeth Hulse is a Global Regulatory Manager for GE Healthcare. She is responsible for keeping the business abreast of new environmental regulations that impact the products and the environment. She is the global program manager for EU WEEE and RoHS, China RoHS, and upcoming regulations, leading global engineering, sourcing, operations, and service teams to deliver compliant products. Another area of responsibility is in leading the business in the digitization of International Trade Controls.
Beth has a Bachelor’s degree in Chemistry from Hanover College, two Masters of Science degrees in Manufacturing Management and Operations from GMI and Kettering University. She started her career at Whirlpool Corporation, advancing to Manager of Process Engineering, joined GE Appliances as an Advanced Manufacturing Engineering Leader leading multimillion dollar engineering programs, and came to GE Healthcare in 1996 progressing to GEHC Manager of Quality System Compliance and Environmental Health & Safety for Operations until her current role which she accepted in May 2005.