GS1: Conformance Barcoding in Manufacturing
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Transcript of GS1: Conformance Barcoding in Manufacturing
GS1: Conformance Barcoding in Manufacturing
23/10/2013, Vision ID Manufacturing
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
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….
GS1 – ‘an unknown known’
4
ANAI (1984)
EAN (1997)
GS1 (2005)
Global reach, Local Presence
• 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
Not-for-ProfitCosts and savings
shared by members
Neutral
User DrivenMember organisation
driving Global Standards
…by
Speaking
one
language
GS1 Standards
The global language of business
6
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
Identify: Gs1 Identification Numbers
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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.
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
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.
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Conformance???
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What is required?
Barcode Software
The GS1 General
Specifications (Version 13)
A Printer
Regulatory Documents
Other documents, Helpdesk, Technical Guide etc.
The FDA’sUnique Device IdentificationRegulation
Not IF…
But WHEN
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Unique Device Identification
1. A standardized system to develop Unique Device Identification numbers (UDI)2. UDI in human readable and bar code/RFID on the device label3. Data to be submitted to the UDI Database 4. Users need your help to implement. FDA expects GS1 to play a major role.
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DI = Device Identifier
PI = Production Identifiers
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UDI
• DI
(static data)
• PI(dynamic data)
Static Data
Elements
• DI = primary access
key
• …
•…
AIDC
Machine –
readable Data
Carrier
• Linear Bar Code
• 2D Bar Code
• RFID
•…
UDID(database)
UDI/UDID - System
UDI system… overall System at a glance
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.
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What is Driving the Need ?
Current systems of product catalog numbers include duplicate identifiers for the different products across trading partners
Current system allows product re-identification by every stakeholder in the
supply chain, making product tracking efforts extremely difficult
ManufacturerProduct # 305905
DistributorProduct # MT305905
Hospital or Healthcare Provider Product # M-5905
Manufacturer Catalog # Description
Medtronic 305905 Mosaic ® 305 Porcine Heart Valve ………….
BD 305905 3mL BD SafetyGlide ™ Syringe ………..
J & J 305905 Protectiv ® IV Catheter System ………..
Source, Jackie Elkin, Medtronic
Which barcode do we scan?
Unique Device Identification UDI in the GS1 “AIDC World”(Automatic Identification and Data Capture)
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.
DI = Device Identifier
PI = Production Identifiers
20
UDI
• DI
(static data)
• PI(dynamic data)
Static Data
Elements
• DI = primary access
key
• …
•…
AIDC
Machine –
readable Data
Carrier
• Linear Bar Code
• 2D Bar Code
• RFID
•…
UDID(database)
UDI/UDID - System
UDI system… overall System at a glance
UDI in the GS1 System of Standards
PI =EXP: 2012-10-03LOT: ABCDEF123456Ser: 1234567ABCDEF
DI =GTIN: 5391234567892
DI = Device Identifier
PI = Production Identifiers
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UDI
• DI
(static data)
• PI(dynamic data)
Static Data
Elements
• DI = primary access
key
• …
•…
AIDC
Machine –
readable Data
Carrier
• Linear Bar Code
• 2D Bar Code
• RFID
•…
UDID(database)
UDI/UDID - System
UDI system… overall System at a glance
0
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
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24Source: FDA presentation UDI conference, Sept 2013
25Source: FDA presentation UDI conference, Sept 2013
HowGS1 can help – Ireland’s National Product Catalogue
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1. Load Data– The information supplier loads product and company information in its data pool
2. Register Data– A small subset of this data is sent to the GS1 Global Registry
3. Request Subscription– The information recipient, through its own data pool, subscribes to receive the information
4. Publish Data– The information supplier’s data pool publishes the requested information to the information
recipient’s data pool5. 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
Source
internal
database
Source
datapool
GS1
Global
Registry
Recipient
datapool
Recipient
internal
database
1
2
3
4
3
Manufacturers are able to provide data to all UDI databases and their customers (hospitals, distributors, wholesalers, GPOs) simultaneously, with one single connection.
One connection to UDI databases, Providers and other data recipients
Data is
provided
to the
FDA
GUDID by
the
Source
Data Pool
NEW UDI webpage: http://www.gs1.org/healthcare/udi
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The site will continue to be populated as more supporting documents are developed
EPCISSupply Chain Visibility
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.
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0
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 . . .
What is EPCIS ?
WHY
•Business Step (e.g., Pick-Up)
•Disposition (e.g., In Transit)
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)
...recorded as an EPCIS Event
EPCIS Events at supply chain read points
storage commssioning shipping
EventEvent
Event Event
EPCIS Repositories
EPCIS Capture of supply chain events
productionTransactionEvent
WHAT: SSCC 4001356.5900000817
GTIN 4026800.010421.101GTIN 4026800.010421.102
bizTransaction: desadv 471150825
WHERE: SGLN 4012345.00050.0
WHEN: 23.10.2009 14:47:00 UTC+1
ObjectEvent
WHAT: SGTIN 4026800.010421.101SGTIN 4026800.010421.102
WHERE: SGLN 4012345.01010.0
WHEN: 22.10.2009 09:25:00 UTC+1
WHY: packing
QuantityEvent
WHAT: GTIN 4026800.010421
QTY: 5
WHERE: SGLN 4012345.00031.0
WHEN: 22.10.2009 11:20:00 UTC+1
AggregationEvent
WHAT: SSCC 4001356.5900000817
SGTIN 4026800.010421.101SGTIN 4026800.010421.102
WHERE: SGLN 4012345.00040.0
WHEN: 23.10.2009 13:40:00 UTC+1
WHY: commissioning
The EPCIS enables real time visibility
• Tracking– Where are my objects now?
• Tracing– Where were my objects last Tuesday afternoon?
• Pedigree– Which parties were involved (chain of custody)?– Where has my object been along the way?
• Authentication– Are my objects likely genuine?
• Inventory– What is my current stock at one or more locations ?
• Returnables– Was the returned product legitimately purchased ?
• Recall1. Find impacted objects2. Initiate recall3. Follow recall progress
Conclusions
GS1: A Broad PortfolioGS1 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.
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.
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).
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.
• 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
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Leveraging global standards to reduce cost, complexity and support interoperability across the industry
Transport and Logistics
GS1 Upstream Integration
• GS1 Upstream Integration SolutionDesigned to address the challenges in supply chain integration and collaboration between manufacturers and their suppliers.
• GUSI: Global Upstream Supply InitiativeA 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.
Improved collaboration between manufacturers and their suppliers
GS1 Global Traceability Solution
• 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
Expert guidance for improving your traceability system at the lowest cost to meet regulatory and quality requirements
Contact Details:Alan GormleyConformance and training ManagerE [email protected] + 353 1 208 06 71W www.gs1ie.org