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’

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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

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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.

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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

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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 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