zeptometrix corporation. export compliance program design and implementation business review and...
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ZeptoMetrix Corporation
Export ComplianceProgram Design and Implementation
Business Review and Capability Assessments (Internal vs. External)
Mandated Requirements for Exporting Companies Manual Design and Integration with Current Quality
System, (ISO 13485 / QSR cGMP) Define Employee Roles and Responsibilities Employee Training and Review Monitoring and Continual Improvement
ZeptoMetrix CorporationBusiness Review
ZMC is a fully integrated biotechnology company that services diagnostic and pharmaceutical companies worldwide
Company manufactures raw materials and diagnostic kit components used by scientists to develop testing kits and also products to maintain their quality control
Company ships biological materials, inactivated organisms, test kits and other related diagnostic products
United States Export Compliance Requirements
Appropriate Export Commodity Jurisdiction Dept. of Commerce (BIS) v. Dept. of Defense (DTC)
Overlapping and intersecting export controls Primary: Export Administrative Regulations (EAR), Dept. of
Treasury (OFAC); Foreign Trade Regulations (FTR), Dept. of Defense through ITAR
Know your product/service---see where it fits in the export regulatory scheme
There is no substitute for reading and cross-referencing those regulations applicable to your product and industry to understand your export responsibilities.
Manual Design Design Manual with focus on integration into Current Quality
System Manual should be written for hands on use, not as a show
piece for auditors Operations & Legal were the key drivers of the compliance
development process. Staff from various affected departments were consulted as needed Delegate revision responsibilities; maintained one working draft
Research and determine which US regulations are appropriate to your business
Identify key positions within the company that will play a role in Export Compliance (organizational chart)
Develop process maps to include Export Compliance into current company activities
Export Compliance Manual Sections 1. Export Management System Summary
Policy Statement; Scope of EAR
2. Administrative Elements Responsibilities; Record Keeping; Training
3. Order Processing System Flowcharts for New Customer Set-up, Order Process, & Export
Compliance Officer Decision Tree Narrative indicates where to screen, “hold” an order, and
instructions for resolving a “hold”
4. Export Licensing Requirements Product Commodity Classification Process
5. Export Licensing Requirements Restricted End-Uses and End-Users
6. Export Clearance
7. Appendices 1 – 19
ZMC Export Compliance Requirements
Dept of Commerce: BIS, subject to EAR (15 CFR 730 et seq) ZMC products are intended for commercial use, some capable of military application: “Dual-Use”
“General Prohibitions” of EAR are applied to all ZMC Product Orders:
Restricted End-Users, End-Uses, Embargoed Countries Red Flags and Anti-boycott Provisions Identify those ZMC Products on the CCL that require export licenses Special attention paid to those regulations dealing with Chemical and
Biological Weapons
Organization Chart
Order Process Flowchart
New Customer Set-up Flowchart
Employee Roles and Responsibilities Operations
Lead Export Compliance planning and design meetingsProcess map new export requirements into current
operations and optimize current system where appropriate
LegalConduct research and generate draft Export
Compliance Manual applicable to ZMC business focus
Work with Operations to streamline processes : minimize workflow interruption while staying export compliant
Assists in implementing and updating export compliance program
Employee Roles and Responsibilities Regulatory/Quality Assurance
Design new /modify existing standard operating procedures to integrate export compliance requirements
Implementation and training of new proceduresMonitoring and continual improvementAct as on-site Export Compliance Officer
ScientistsAssess new ZMC Products against Commerce Control
List (CCL) for ECCNUpdate MRP /database system with code for each new
product with ECCN; inform Export Compliance OfficerPrepare technical description of ZMC Products with
ECCN for BIS license application
Employee Roles and Responsibilities
SalesNew Customer Approval and set-up in billing system
Screen initial ZMC product inquires for “Red Flags” and Anti-boycott compliance
Process Orders: screen for restricted users/uses and whether product requires BIS export license due to ECCN designation
MarketingUpdate of company literature and website with Export
Disclaimers
Employee Roles and Responsibilities
DistributorsDefine processes for ZMC products with ECCNLetter of commitment for following US Export
Regulations
Shipping / ReceivingScreen each order against restricted uses/users, Red Flags
and embargo lists –e.g. “Shipping Solutions” softwareApply for BIS licenses when requiredAppropriate labeling and packagingMaintain shipping records in accordance with applicable
government regulations
Employee Training and Review
Identify Departments that require training (org chart)
Set up initial training sessions
Document compliance with written tests and keep on file with other employee training records
Troubleshoot system with various go, no-go situations
Monitor for continual improvement
Monitoring and Continual Improvement
Conduct annual training meeting for updates to export compliance
Export Compliance Officer and Legal are enrolled with BIS for regulatory updates via email
Annual Audits by Export Compliance Officer New Customer Records, Outbound Shipment Records, Employee
Training Records Review/amend where necessary standard operating procedures
that include export compliance components
Challenges Complexity of Export Compliance: Resources
(1) BIS website: “Compliance Guideline: How to Develop an Effective Management and Compliance Program and Manual” http://www.bis.doc.gov/complianceandenforcement/emcp_guidelines.pdf; see training modules, seminars, contacts
(2) EAR and related export regulations on-line
(3) Professional Organizations: e.g. Tradewin, Association of Corporate Counsel, Law Libraries: white papers, forms, seminars, consulting
(4) Massachusetts Export Center: consult and assistance
Challenges Streamlining Export Compliance
Understand export requirements well enough so that you can integrate compliance measures without strangling business efforts
Examples: (1) Sell ZMC Products with ECCN directly, not through distributors—
limit liability and processing time for license (2) Only code/document those Products with ECCN—not all ZMC
Products (3) Export Screening Software; expedite Export Compliance Officer
review of positive screenings (4) Company policy: do not bother with applying for license where
have verified positive screening for a restricted end-user, end-use, embargoed country
(5)Standardize forms: e.g. Product Commodity Classification, Customer Profile, Distributor Letters
New Export Compliance Regime Anticipated
ZeptoMetrix Corporation
878 Main StreetBuffalo, NY 14202
(800) 274-5487(716) 882-0920
(716) 882-0959 (FAX)
Contact Information
25 Kenwood CircleSuite 6
Franklin, MA 02038(866) 520-0588(508) 553-5800(508) 520-1525
www.zeptometrix.com
Elise S. [email protected]
John [email protected]