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TRANSCRIPT
© GS1 2015
EPCIS for Lunch
An introduction to the WHAT, WHEN,
WHERE and WHY of supply chain visibility
Craig Alan Repec, Senior Manager EPCglobal Technology – GS1
21 October, 2015
© GS1 2015
Identify Capture Share
© GS1 2015
The “Share” Layer of GS1 Standards
Master Data
• example: weight & physical dimensions of trade item class
• GS1 “Share” Standard: GDSN
Transactional Data
• Example: ORDERS, INVOIC
• GS1 “Share” Standards: GS1 XML, EANCOM
Visibility Event Data
• Physical activity in the supply chain of products and assets
• GS1 “Share” Standard: EPCIS
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© GS1 2015
EPCIS, a GS1 open standard . . .
• defines technical interfaces for capturing/sharing data
• defines a framework data model for event data
• helps create & share visibility data
• enables services and solutions for supply chain visibility
• was updated with the May 2014 release of EPCIS 1.1
• including support for Lot/Batch-based event data
• when used in a GS1 context, leverages GS1 Keys as the “what” and “where” of visibility events
• Approved as ISO/IEC 19987 in July 2015
© GS1 2015
Core Business Vocabulary (CBV)another GS1 “Share” standard
• Companion standard to EPCIS
• Supplements EPCIS’ framework data model
• Defines specific data values to populate EPCIS data model
• Ensures a common understanding of data semantics
• Critical to interoperability of EPCIS implementations
• Includes values & definitions for Standard Vocabularies
• Provides identification syntax rules for User Vocabularies
• Approved as ISO/IEC 19988 in July 2015
© GS1 2015
Four dimensions of an EPCIS event
WHAT objects are the subject of event?
Individual objects (SGTIN) or groupings (GTIN + Lot/batch)
WHEN did this event take place?
Date, time, time zone
WHERE did this event take place?
GLN of physical location & object’s subsequent whereabouts
WHY did this event take place?
Business step, Disposition, Source/Destination info
© GS1 2015
EPCIS event dimensions
“WHAT”
• Specifies what objects participated in the event
• Can be physical or digital objects
• EPCIS allows for two kinds of object identification:
• Instance-level
each identifier is unique to a single object
• Class-level
multiple objects carry the same identifier
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Batch/Lot vs. Serialized Visibility
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• Date of event
example: 2015-10-21
• Time of event
example: 21:33:00
• Time zone
example: UTC +10:30
EPCIS event dimensions
“WHEN”
© GS1 2015
EPCIS event dimensions
“WHERE”
• Read Point
specific place where an event took place, identified by GLN
• Business Location
whereabouts of the object after the event, identified by GLN
Read Points are often doors.
Business Locations are often rooms.
Business Location: University Clinic Xanadu
Business Location:Locked Storage #B7
Business Location:B-Wing NICU
Read Point: Dock Door 01
Read Point: Dock Door 02
Read Point: Door 2711
© GS1 2015
EPCIS event dimensions
“WHY”
Business Step• Business process context of event
example: Commissioning, Packing, Shipping, Unpacking
Disposition• Status of object subsequent to event
example: active, in_transit, sold, expired, recalled
Business Transaction• Link to transaction information
Source/Destination• Transfer of ownership or possession
© GS1 2015
EPCIS event types
Object Event
• Observation of (or assertion about) object(s)
Aggregation Event
• Association between containing/contained object(s)
Transaction Event
• (Dis)Association of object(s) to business transaction(s)
Transformation Event (new in EPCIS 1.1)
• Object(s) consumed as inputs, produced as outputs
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EPCIS event types
Aggregation Event
• Applied to set of contained/containing objects
• Strong physical relationship between containing/contained
EPCIS allows you to . . .
• ADD an Aggregation:• Child objects aggregated to parent • Creation of new aggregation or addition of new children
• OBSERVE an Aggregation:• Observation of an aggregation (may be incomplete)
• DELETE an Aggregation:• Objects have been disaggregated from parent• Removal of subset of children or entire aggregation
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EPCIS Aggregation EventCreating a Parent-Child logistical hierarchy
Aggregation eventsallow us to discoveradditional child unitsto trace further upstream
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EPCIS Aggregation EventDisaggregation
Disaggregation eventsallow us to discoveradditional parentIDsto trace further upstream
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EPCIS Object EventShipping
Shipping eventsallow us to discoveradditional GLNs of partiesfurther upstream
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EPCIS Object EventReceiving
Receiving eventsallow us to discoveradditional GLNs of partiesfurther upstream
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• Which parties have had contact with my shipment?
• When will the new vaccine be delivered?
• (When) was my shipment received by the recipient?
• Where was medication produced on April 11th shipped to?
• Which defibrilators are located where in the hospital?
• Where is all of the radioactive material at the clinic?
Visibility applications enabled by EPCIS
© GS1 2015
EPCIS implementations 2015 and beyond
• Food / Fresh Produce Packaging and Distribution
• Vehicle Visibility in Rail
• Port Management
• RTI management
• Asset management (tool/equipment inventory in Oil/Gas)
• Tobacco chain of custody
• Apparel Stock-Taking & Cycle Counting
• Pharmaceutical chain-of-custody
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Data Requirements • Packaging level: Secondary• Data elements: NTIN, Expiry date, lot/batch number, serial number
Deadlines• 2015: Lot based, using ASN (November 2015 for dispensers)• 2017: Serialization by manufacturers and repackagers• 2023: Full traceability of serialized items back to manufacturer or repackager
GS1 US Rx Guideline for DSCSA
www.GS1US.org/RxGuideline
• Includes application of EPCIS for serialized item-level traceabilityCommissioning, Packing, Shipping, Receiving, Unpacking, Dispensing, Destroying, Decommissioning(DSCSA transfer of ownership is recorded in the Shipping event)
EPCIS explicitly mentioned in Nov 2014 US FDA draft guidance as a means for interoperable exchange of pharmaceutical traceability data
USA: 2015, 2017, 2023Drug Supply Chain Security Act (DSCSA)
© GS1 2015
Why EPCIS-based traceability for DSCSA?
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Com-
missionPack Ship Rcv Unpack Pack
Dispense
Destroy
Decommission
Rcv Unpack <<Ship <<<<<<<
Manufacturer Distributor(s) Dispenser
Possibly
Repeated
DSCSA Data DSCSA Data
EPCIS includes the ability to query or ask for information:
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All events for Item “00312345325671”?
• Commissioning Event• Packing Event• Shipping EventEPCIS is
Global !4
EPCIS is Flexible
EPCIS is Extensible
© 2014 GS1 US ALL RIGHTS RESERVED
© GS1 2015
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Requirements
• Packaging level: Secondary and tertiary level packaging
• Data elements: National Number, Exp date, lot/batch, serial number
Deadlines
• Dec 2015: serialization and tracking data for 3 batches of product
• Dec 2016: serialization and tracking for all pharmaceuticals
GS1 Brazil guideline
www.gs1br.org/educacao-e-pratica/MateriaisTecnicos/Support%20Guide%20for%20Codification%20of%20Medicines.pdf
Brazil: 2015, 2016Anvisa regulation RDC54 – track & trace control system for drugs
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EPCIS 1.2currently being scoped, development pending
• EPCIS event retraction / correction
• Clarifying language of SHALL statements around “data”
• Addition of Business Steps and Dispositions for Pharma
• Clarification on use of master data, ILMD values
• Errata
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Initiatives focused on EPCIS for traceability requirements
• Create synergy through multiple organisations working together
• Share progress and current status
• Document commonalities in order to maximize synergy
For further information on GTCF contact Janice Kite [email protected]
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Global Traceability Coordination Forum (GTCF)
© GS1 2015
EPCIS, a GS1 open standard . . .
• defines technical interfaces for capturing/sharing data
• defines a framework data model for event data
• helps create & share visibility data
• enables services and solutions for supply chain visibility
• was updated with the May 2014 release of EPCIS 1.1
• including support for Lot/Batch-based event data
• when used in a GS1 context, leverages GS1 Keys as the “what” and “where” of visibility events
• Approved as ISO/IEC 19987 in July 2015
© GS1 2015
Craig Alan Repec
Senior Manager EPCglobal Technology
GS1 AISBL
T +32 2 788 78 16
GS1® - The global language of business
For further information on EPCIS, please contact: