GS1: Conformance Barcoding in Manufacturing
- 1. GS1: Conformance Barcoding in Manufacturing 23/10/2013, Vision ID Manufacturing
- 2. Agenda • GS1 Standards Overview – Identify – Capture – Share • Barcode conformance in Context – Unique Device Identification • Identify • Capture • Share • What Solutions can GS1 offer our members – Traceability – GUSI
- 3. Collaboration driving Standards adoption Vision ID is currently implementing a Standards based solution to become a certified solution provider • Implementing a Standards based EPC Global/RFID enabled solution. • Ensuring real time visibility of a companies assets • And more….
- 4. GS1 – ‘an unknown known’ Not-for-Profit CostsANAI savings and (1984) shared by members EAN (1997) Neutral …by Speaking GS1 (2005) one language Global reach, Local Presence User Driven Member organisation driving Global Standards • • • • • • • • • 111 Member Organisations 150 countries served 20 Industrial Sectors 3,000 staff globally 1.5 million companies 3,000 companies in Ireland 40 Years experience > 6 billion transactions daily ISO, CEN, ETSI, UNECE based standards 4
- 6. The global language of business GS1 Standards make it possible to identify, capture, and share information automatically and accurately about products, business locations, and more. Allow organisations to focus on how to use the information rather than how to get information 6
- 7. Identify: Gs1 Identification Numbers GS1 Identification Numbers are used to uniquely distinguish all products (trade items), logistic units, locations, assets, and relationships across the supply chain from manufacturer to consumer. 7
- 8. Capture: GS1 data carriers GS1 Data Carriers are capable of holding varying amounts of data to accommodate different needs such as batch/lot information and expiration dates. 8
- 9. SHARE: GS1 Data Exchange Interoperability, made possible by identification standards, data capture standards, and data exchange standards, allows product information to flow through the supply chain. 9
- 11. What is required? Barcode Software The GS1 General Specifications (Version 13) A Printer Regulatory Documents Other documents, Helpdesk, Technical Guide etc.
- 12. The FDA’sUnique Device Identification Regulation Not IF… But WHEN 12
- 13. Unique Device Identification 1. 2. 3. 4. A standardized system to develop Unique Device Identification numbers (UDI) UDI in human readable and bar code/RFID on the device label Data to be submitted to the UDI Database Users need your help to implement. FDA expects GS1 to play a major role. 13
- 14. UDI system… overall System at a glance UDI/UDID - System UDID UDI (database) • DI Static Data Elements (static data) • PI (dynamic data) • DI = primary access key •… •… AIDC Machine – readable Data Carrier • Linear Bar Code • 2D Bar Code • RFID •… DI = Device Identifier PI = Production Identifiers 14
- 15. UDI: Purpose A common, worldwide system for product identification should eliminate differences between jurisdictions and offer significant benefits to manufacturers, users and/or patients, and Regulatory Authorities. 15
- 16. What is Driving the Need ? Current systems of product catalog numbers include duplicate identifiers for the different products across trading partners Manufacturer Description Medtronic 305905 Mosaic ® 305 Porcine Heart Valve …………. BD 305905 3mL BD SafetyGlide ™ Syringe ……….. J&J Catalog # 305905 Protectiv ® IV Catheter System ……….. Current system allows product re-identification by every stakeholder in the supply chain, making product tracking efforts extremely difficult Manufacturer Product # 305905 Distributor Product # MT305905 Hospital or Healthcare Provider Product # M-5905 Source, Jackie Elkin, Medtronic
- 17. Which barcode do we scan?
- 18. Unique Device Identification UDI in the GS1 “AIDC World” (Automatic Identification and Data Capture)
- 19. UDI Unique Device Identification ...enabled by… GS1 Standards !! NOTE: At the time of this presentation the US FDA Ruling has just recently been published. As it is in-depth, and there were some changes in the final Ruling from the original proposed draft, it is recommended that you always refer to the final US FDA Ruling for all details.
- 20. UDI system… overall System at a glance UDI/UDID - System UDID UDI (database) • DI Static Data Elements (static data) • PI (dynamic data) • DI = primary access key •… •… AIDC Machine – readable Data Carrier • Linear Bar Code • 2D Bar Code • RFID •… DI = Device Identifier PI = Production Identifiers 20
- 21. UDI in the GS1 System of Standards DI = GTIN: 5391234567892 PI = EXP: 2012-10-03 LOT: ABCDEF123456 Ser: 1234567ABCDEF
- 22. UDI system… overall System at a glance UDI/UDID - System UDI 0 (database) • DI Static Data Elements (static data) • PI (dynamic data) UDID • DI = primary access key •… •… AIDC Machine – readable Data Carrier • Linear Bar Code • 2D Bar Code • RFID •… DI = Device Identifier PI = Production Identifiers 22
- 23. US FDA Global UDI Database (GUDID) • Global Unique Device Identification Database (GUDID) – Operated by the FDA to collect information on Medical Devices – Will have public facing website to share data with anyone (future) • All medical devices which are regulated under the UDI regulations will be required to be listed in the GUDID – Sunrise for each class is the same for GUDID as assigning a UDI • • • • Class III devices- 1 year from release of GUDID web interface Class II “life sustaining” devices- 2 years from release of GUDID web interface Class II remaining devices- 3 years from release of GUDID web interface Class I devices- 5 years from release of GUDID web interface 23
- 24. Source: FDA presentation UDI conference, Sept 2013 24
- 25. Source: FDA presentation UDI conference, Sept 2013 25
- 26. How GS1 can help – Ireland’s National Product Catalogue Source internal database 1 Source datapool 2 2. 3. 3 GS1 Global Registry 4 1. 3 Recipient datapool 4. 5. Load Data – The information supplier loads product and company information in its data pool Register Data – A small subset of this data is sent to the GS1 Global Registry Request Subscription – The information recipient, through its own data pool, subscribes to receive the information Publish Data – The information supplier’s data pool publishes the requested information to the information recipient’s data pool Confirm & Inform – The information recipient sends a confirmation to the information supplier via each company's data pool, which informs the information supplier of the action taken by the information recipient retailer using the information Recipient internal database 26
- 27. One connection to UDI databases, Providers and other data recipients Data is provided to the FDA GUDID by the Source Data Pool Manufacturers are able to provide data to all UDI databases and their customers (hospitals, distributors, wholesalers, GPOs) simultaneously, with one single connection.
- 28. NEW UDI webpage: http://www.gs1.org/healthcare/udi The site will continue to be populated as more supporting documents are developed 28
- 30. SHARE: GS1 Data Exchange Interoperability, made possible by identification standards, data capture standards, and data exchange standards, allows product information to flow through the supply chain. 0 30
- 31. What is EPCIS ? EPC Information Services (EPCIS) • GS1 / EPCglobal Standard since April 2007 • Defines data formats, capture and query interfaces • Supplements classic EDI • Requires serialized or batch identification • e.g. GTIN (object class) + serial number => SGTIN • Does not require RFID -> can also be used with bar codes EPCIS is an enabling tool for supply chain transparency and event-driven process optmization . . .
- 32. EPCIS Events at supply chain read points WHAT Individual object instances (e.g. SGTIN, SSCC, GRAI...) WHERE •Read point (SGLN) •Business location (SGLN) WHEN Time stamp of the event (date + time + time zone) WHY •Business Step (e.g., Pick-Up) •Disposition (e.g., In Transit) ...recorded as an EPCIS Event
- 33. EPCIS Capture of supply chain events EPCIS Repositories Event Event Event Event TransactionEvent storage commssioning production AggregationEvent ObjectEvent shipping WHAT: SSCC 4001356.5900000817 WHAT: SSCC 4001356.5900000817 4026800.010421.101 QuantityEvent WHAT: SGTIN 4026800.010421.101 GTIN SGTIN 4026800.010421.101GTIN 4026800.010421 SGTINWHAT: 4026800.010421.102 4026800.010421.102 GTIN SGTIN 4026800.010421.1025 WHERE: SGLN 4012345.01010.0 QTY: bizTransaction: desadv 471150825 WHERE: SGLN 4012345.00040.0WHERE: SGLN 4012345.00031.0 WHEN: SGLN 4012345.00050.0 WHERE: 22.10.2009 09:25:00 UTC+1 WHEN: 23.10.2009 WHY: packing 13:40:00 WHEN: UTC+1 WHEN: 23.10.200922.10.2009 11:20:00 UTC+1 14:47:00 UTC+1 WHY: commissioning
- 34. The EPCIS enables real time visibility • Tracking • Tracing • Pedigree • Authentication • Inventory • • – Where are my objects now? – Where were my objects last Tuesday afternoon? – Which parties were involved (chain of custody)? – Where has my object been along the way? – Are my objects likely genuine? – What is my current stock at one or more locations ? Returnables – Was the returned product legitimately purchased ? Recall 1. Find impacted objects 2. Initiate recall 3. Follow recall progress
- 35. Conclusions
- 36. GS1: A Broad Portfolio GS1 has active programs in several specific industry sectors. Healthcare: In over 50 countries worldwide, GS1 standards have been chosen to identify pharmaceutical products uniquely. Major regulatory bodies have endorsed them, including those in the US, Japan and the UK. Defense: Global Solutions offered by GS1 play a role in the defence sector including but not limited to procurement, logistics and asset tracking. GS1 standards are endorsed by the North Atlantic Treaty Organisation (NATO). Customs Transport & Logistics: Today no transport and logistics company can be efficient without robust information technology and data communication support. GS1 standards help hundreds of T&L companies.
- 37. GS1 Solutions GS1 Solutions bring together elements from the GS1 portfolio to address a specific business need A GS1 Solution is a set of elements from the GS1 portfolio that help companies resolve complex business issues, using GS1 Standards, GS1 Guidelines, GS1 Services, and other GS1 Solutions.
- 38. Transport and Logistics • AIDC: Quick start guide: GS1 Identification Keys in Transport & Logistics for the use of GS1 ID Keys in T&L • EDI (GS1 eCom): Standards for Transport Management available Implementation guides Standards for warehouse management under development • EPC/RFID: support to RAIL project initiated by GS1 Sweden. • Regional projects: Support and awareness of a range of regional projects including CASSANDRA, eFreight, APEC Supply Chain Visibility Leveraging global standards to reduce cost, complexity and support interoperability across the industry 38
- 39. GS1 Upstream Integration Improved collaboration between manufacturers and their suppliers • GS1 Upstream Integration Solution Designed to address the challenges in supply chain integration and collaboration between manufacturers and their suppliers. • GUSI: Global Upstream Supply Initiative A Working Group of The Consumer Goods Forum with manufacturers from CPG/Retail and their suppliers. Collaborating together to develop an upstream solution based on common scenarios, common processes, common electronic messages – in order to reduce complexity and implementation costs and create an exchange platform.
- 40. GS1 Global Traceability Solution Expert guidance for improving your traceability system at the lowest cost to meet regulatory and quality requirements • GS1 Global Traceability Standard - a unique solution to optimise the company’s traceability system based on internationally recognised standards already used in most supply chains • GS1 Traceability Assessment – a service provided by GS1 Global Traceability Auditors to assess your company’s traceability system and help you meet international regulations • Global traceability guidelines - for specific sectors • Expertise, training & implementation support by local GS1 organization
- 41. Contact Details: Alan Gormley Conformance and training Manager E alan.gormley@gs1ie.org T + 353 1 208 06 71 W www.gs1ie.org