epcis event-based traceability in pharmaceutical supply chains via automated generation of linked...

ISWC, 21st October 2014, Riva del Garda

Enabling EPCIS Event-Based Traceabilityin Pharmaceutical Supply Chains via

Automated Generation of LinkedPedigrees

Monika Solankihttps://w3id.org/people/msolanki

@nimonika

Aston Business SchoolAston University, Birmingham, UK

https://w3id.org/people/msolanki


Motivation

[email protected], @nimonika EPCIS Event-Based Traceability in Pharmaceutical Supply Chains


Visibility* in supply chainsVisibility is the ability to know exactly wherethings are at any point in time, or where theyhave been, and why.

*http://www.gs1.org/docs/GS1_SupplyChainVisibility_WhitePaper.pdf


http://www.gs1.org/docs/GS1_SupplyChainVisibility_WhitePaper.pdf

http://www.gs1.org/docs/GS1_SupplyChainVisibility_WhitePaper.pdf


Enabiling Visibility

Data/Knowledge SharingInformation and knowledge need to be interlinked, sharedand made available consistently along the supply chainnot least for regulatory reasons but also due to increasingconsumer demands of being able to track and tracecommodities.



Pharmaceutical supply chains

Flow of goods and flow of information (Abstraction)



Visibility in Pharmaceutical supply chains

Crucially Important!Counterfeiting has increasingly become one of the majorproblems prevalent in these chains. The WHO estimatesthat between five and eight percent of the worldwide tradein pharmaceuticals is counterfeit.



Visibility in Pharmaceutical supply chainsLegal requirements

Drug Supply Chain Security Act (DSCSA)

The Drug Quality and Security Act (DQSA), was signedinto law by President Obama in 2013.DSCSA outlines critical steps to build an electronic,interoperable system to identify and trace certainprescription drugs as they are distributed in the U.S.The system will facilitate the exchange of information at theindividual package level about where a drug has been inthe supply chain.

http://www.fda.gov/Drugs/DrugSafety/

DrugIntegrityandSupplyChainSecurity/

DrugSupplyChainSecurityAct/


http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/




Pharmaceutical supply chainsGS1 standards* for Visibility

GS1: a neutral, not-for-profit organization dedicated to thedesign and implementation of global standards andsolutions to improve the efficiency and visibility in supplychains.Core GS1 standards: EPCIS 1.1 & CBV 1.1GS1 US Secure Supply Chain Task Force: preliminaryimplementation guidelines* for applying GS1 Standards toU.S. Pharmaceutical supply chains for track and trace.

*http://www.gs1.org/healthcare/standards*www.gs1us.org/RxGuideline


http://www.gs1.org/healthcare/standards

www.gs1us.org/RxGuideline


EPC, EPCIS and CBV

The Electronic Product Code (EPC)*: provides productswith unique, serialised identities.Electronic Product Code Information Services (EPCIS)*:provides a set of specifications for the syntactic captureand informal semantic interpretation of EPC based productinformation.CBV* supplements EPCIS by defining the structure ofvocabularies and specific values for the vocabularyelements.Events as abstractions for traceability.

*http://en.wikipedia.org/wiki/Electronic_Product_Code*http://www.gs1.org/gsmp/kc/epcglobal/epcis

*http://www.gs1.org/gsmp/kc/epcglobal/cbv


http://en.wikipedia.org/wiki/Electronic_Product_Code

http://www.gs1.org/gsmp/kc/epcglobal/epcis

http://www.gs1.org/gsmp/kc/epcglobal/cbv


SW & LD for Visibility in Supply chains

Problem statement* Can we exploit EPCIS events for the automatedgeneration of provenance-based traceability/visibilityartifacts that can be shared across supply chain partners?

* Can we exploit EPCs of products to detect counterfeitsin the supply chain and utilise provenance to trace theirorigins?



SW & LD for Visibility in Supply chains

Potential solution & Proposed framework

Based on GS1’s EPCIS 1.1 and CBV 1.1 standards.A set of ontologies: EEM, CBVVocab, OntoPedigree.Streams of EPCIS events.Event-Based traceability artifact: Linked Pedigrees.Algorithm: automated generation of linked pedigrees fromEPCIS events and counterfeit detection.



EPCIS(1.1) Events: An informal Intuition

One generic and four specific physical event types

For this talk,EPCISEvent: the generic EPCIS event.ObjectEvent: an event that occurred as a result of someaction on one or more entities denoted by EPCs.AggregationEvent: an event that happened to one or moreEPC-denoted entities that are physically aggregated.TransactionEvent: an event in which one or more entitiesdenoted by EPCs become associated or disassociatedwith one or more identified business transactions.



Data model components

What(product(s)), Where(location), When(time), andWhy(business step and status) of events (product movement)occurring in any supply chain.

EPCsTimeRead PointsBusiness LocationBusiness stepsDispositionAction



EEM*: The EPCIS Event Model

Focuses on a tight conformance with the EPCIS 1.1standard and Simplicity.Explicitly defines relationships with CBV entities throughCBVVocab*.EEM has been mapped* to PROV-O*.

*http://purl.org/eem#*www.w3.org/ns/prov-o*http://purl.org/cbv#

*http://fispace.aston.ac.uk/ontologies/eem_prov.html


http://purl.org/eem#

www.w3.org/ns/prov-o

http://purl.org/cbv#

http://fispace.aston.ac.uk/ontologies/eem_prov.html


EEM Modules



EEM Entities: Mapping to PROV-O



Pedigrees

Most widely prevalent in the pharmaceutical industry.Pedigree (e-pedigree) is an audit trail that records the pathand ownership of a drug as it moves through the supplychain.Each stakeholder involved in the manufacture ordistribution of the drug adds information to the pedigree.“Event-based Linked Pedigrees”: pedigrees based on arelevant subset of the captured EPCIS events.

cf. COLD, DeRiVE @ ISWC 2013



OntoPedigree: A CO design pattern



Pharmaceutical supply chains

Flow of linked pedigrees (Abstraction)



Automated generation of Linked Pedigrees

Set of EPCIS events (cf. EEM ontology):Etypes = {Oe,Ae,Te}, where Oe is an ObjectEvent, Ae isan AggregationEvent and Te is aTransactionEvent.Set of business step types (cf. CBVVocab ontology):Bsteps = {com,pck , shp} representing the business stepsof “commissioning”, “packing” and “shipping” respectively.




Let I be the set of IRI references and G the set of RDF Graphs*An EPCIS event E is a 6-tuple 〈Ie, to, tr ,et ,bs,Re〉 where,

Ie ∈ I is the IRI for the event.to is the time at which the event occurred.tr is the time at which the event was recorded (timestamp).et ∈ Etypes is the type of event.bs ∈ Bsteps is the business step.Re is a non empty set of EPCs associated with the event.

* J. J. Carroll, C. Bizer, P. Hayes, and P. Stickler. Named graphs, provenance and trust.

In Proceedings of the 14th International Conference on World Wide Web, WWW ’05.

ACM, 2005.




An EPCIS event named graph, Eg , is a pair (In ∈ I,Ge ∈ G),where In is the name (as well as the IRI) of the event graph andGe is the RDF event graph.

Functions:The event graph: eventGraph

(Eg

)The event IRI: eventIRI

(eventGraph

(Eg

))Time of occurrence to:eventOccurrenceTime

(eventGraph

(Eg

))An EPCIS stream (Gs) is an ordered sequence of RDF triples〈(In,eventRecordedAt, tr ) : [to]〉 published at an IRI Is ∈ I, andordered by to. The set of triples in Gs are valid at timestamp tr .




Two step approach for extracting events from EPCIS streams

Step 1: (Qt ) All event graphs (serialised in TRIG) within atime interval of X hrs (tumbling windows) are selected fromthe event streamStep 2: (Qbs) All events corresponding to the businesssteps of commissioning, aggregating and shipping areextracted from each event graph.

Please refer to the paper for SPARQL queries.



Automated generation of Linked PedigreesCounterfeit EPC detection

All EPCs that are part of an Aggregation event have beenactually commissioned and asserted as part of an Objectevent.If the business step is “packing” for an Aggregation event,we further check if the EPCs included in the event haveindeed been commissioned as part of an Object event withbusiness step “commissioning”.SPARQL queries (to retrieve the events) + implementation(to check for counterfeits).Lazy approach: Counterfeit detection happens at pedigreegeneration time.Can be supplemented with other approaches forcounterfeit detection.


Automated Generation of Linked Pedigrees


EvaluationTwo critical timing requirements for pedigree generation.

The time taken to detect counterfeit products invarying volumes of shipments: This is important ascounterfeits have to be detected either before or along withthe pedigree generation.The time taken for pedigree generation: This time iscrucial as pedigree generation for a specific shipment mustbe initiated as soon as a shipping event for the shipment isrecorded. The pedigree must be published imminentlywhen the shipment is dispatched.



EvaluationEPCIS Event volumes

Data Sources: Sample EPCIS relational data, Greyliterature, interviews, surveys, EPCIS expertsAssumption: an average rate of production as 6 days perweek and 10 hours per day,Commissioning events generated based on the number ofitems ranging from 24,000 to 102,000 per day orapproximately 40 to 170 per minute.Aggregation and shipping events generated consideringaggregated items ranging from 100 to 500 (increments of100) per case and number of cases per pallet ranging from20 to 100 (increments of 20).Tumbling window sizes of 3, 5, 7 and 10 hours respectively.



Evaluation



Evaluation: Architecture and Implementation



Evaluation: Results



Summary

Semantic Web standards, ontologies and linked data canbe utilised to record and represent real time supply chainknowledge via “linked pedigrees”.EEM forms the basis for traceability in supply chains -Event-based Linked Pedigrees.Complex Event Processing over continuous streams ofsemantically interlinked EPCIS event datasets enableautomated generation of linked pedigrees, detection ofexceptions and validation of integrity constraints.The proposed approach is domain independent and canbe widely applied to most scenarios of traceability as longas there is conformance to EPCIS 1.1 in the supply chain.



Further informationM. Solanki and C. Brewster. EPCIS event-based traceability inpharmaceutical supply chains via automated generation of linkedpedigrees. ISWC 2014. Springer-Verlag.M. Solanki and C. Brewster. A Knowledge Driven Approach towards theValidation of Externally Acquired Traceability Datasets in Supply ChainBusiness Processes. EKAW 2014. Springer-Verlag.M. Solanki and C. Brewster. Modelling and Linking transformations inEPCIS governing supply chain business processes. EC-Web 2014.Springer-LNBIP.M. Solanki and C. Brewster. Detecting EPCIS Exceptions in linkedtraceability streams across supply chain business processes.SEMANTiCS 2014. ACM-ICPS.M. Solanki and C. Brewster. Consuming Linked data in Supply Chains:Enabling data visibility via Linked Pedigrees. COLD2013 at ISWC,volume Vol-1034. CEUR-WS.org proceedings, 2013.M. Solanki and C. Brewster. Representing Supply Chain Events on theWeb of Data. DeRiVE at ISWC. CEUR-WS.org proceedings, 2013.http://windermere.aston.ac.uk/~monika/ontologies.html

http://windermere.aston.ac.uk/~monika/publication.html


http://windermere.aston.ac.uk/~monika/ontologies.html

http://windermere.aston.ac.uk/~monika/publication.html

epcis event-based traceability in pharmaceutical supply chains via automated generation of linked...

Technology

supply chainnot

supply chainsvisibility

generic epcis event

supply chain partners

gs1s epcis

supplements epcis

supply chainsproblem

streams of epcis events