Delivering a Comprehensive Serialization Traceability Program GS1 Global Conference 21 Oct 2015 Peggy Staver - Pfizer

Transcription

1 Delivering a Comprehensive Serialization Traceability Program GS1 Global Conference 21 Oct 2015 Peggy Staver - Pfizer

2 Overview Pfizer History What it Takes Strategies Organization Solutions Business-as-Usual Summary October 21,

3 Pfizer History Serialization Myth #1 There s Plenty of Time October 21,

4 Pfizer s History 2001 Serialization Initiatives Started 2005 VTag E2E Pilot 2010 Transitioned E2E Pilot 2013 Global Enterprise Architecture Compliance China, India II, Korea, US (Turkey, Argentina, Saudi Arabia Phase 1) Active China, Korea, US, EU, Brazil, Saudi Arabia Monitoring 20+ and counting 2014 Global Program Transformation 2014 to present compliance 20+ live sites/cmos (50+ lines), 6 logistics facilities and 50+ active ongoing implementations Collaboration GS1, Rx-360, regulators, trade associations, trading partners October 21,

5 Serialization Compliance Timeline Europe Legislation Argentina* Dec 2011 Phase I Nigeria** Jan Anti-Malarial SMS Solution Iran** 19 Jan 2015 Scratch Label Korea 01 Jan 2015 Phase II 30% SKU Saudi Arabia 21 Mar 2015 Phase I DataMatrix Nigeria** June 2015 Anti-infectives, SMS Solution Korea 01 Jan 2016 Phase III All Products Saudi Arabia 12 Mar 2017 Phase II Serial Number Europe Italy, Greece, Belgium Est. Q Europe Est. Q Turkey* 2010 Track and Trace India Export 01 Oct 2011 Phase I Tertiary Package India Export 01 Jan 2013 Phase II Secondary Package China Feb 2013 Phase I China Dec 2013 Phase II *Local Solution **Proprietary In Market Solution ***Pfizer Guidance. This is not an official mandated phase per DSCSA USA 01 Jan 2015 Phase I Product Tracing (Lot info) Argentina* Phase II April 30, 2012 Revised to Apr/Jun/Aug 2015 Brazil 10 Dec 2015 Phase I 3 Batches Australia 01 Jan 2016 Phase I - Coding Blood products Brazil 10 Dec 2016 Phase II All Products China 31 Dec 2015 Argentina* Phase III Phase III All Products Jan Revised to Apr/June 2015 Australia 01 Jan 2017 Phase II Serialization - Blood products USA 27 Nov 2017 Phase II Serialized Product Identifiers USA*** 27 Nov 2019 Phase II+ Inference of Serialized Product Identifiers USA 27 Nov 2023 Phase III Pkg. (Item - level) traceability Actively Monitoring UAE Jordan Taiwan Colombia Mexico Consultation Paper Egypt Philippines Pakistan Costa Rica Russia Ukraine India Domestic 10/21/ No Confirmed Law Draft Law

6 Key SUPPLY CHAIN DATA MANAGEMENT Internal Pfizer Serialization Enterprise Solution Overview US EU EM Total Supply Network xx PGS sites xx SKUs xx packs xx PGS sites xx SKUs xx packs xx PGS sites xx SKUs xx packs xx PGS sites xx SKUs xx packs US EU EM IC** Total Logistics x DCs x DCs* x DCs x LCs x sites Serialization Control Tower (SCT) External Pfizer Typically 1 integrated government report per mandate B2B integration with Trading Partners for traceability Some markets / other manufacturer s provision SNs US EFPIA (Europe) Local Markets Local Solution Brazil, China (Import), India Export, Korea, SA Phase II Argentina, China (Domestic), Nigeria, Turkey Role of Manufacturing, Logistics, CMOs Provision, apply and aggregate SNs Commission and notify SNs Manage inventory and SN data in parallel PCS Role of Downstream Supply Chain (Wholesalers, distributors, pharmacies, etc.) Fulfill authentication, track & trace, pedigree, and other requirements Capture events and report as required Manage inventory and SN data in parallel CMO Other Drug Companies Packaging Line Pfizer Site Pfizer / CMO Plant Warehouse InterCompany & Market Logistics Sites/ LSP Wholesale Distributor Hospital / Pharmacy / Patient **InterCompany Logistics Serial Number Management Event Capture Reporting Data Transport /Product Flows Serialized Product Data Out of Scope

7 Strategy Serialization Myth #2 Serialization is really just setting up your packaging lines with some bar code printers and scanners October 21,

8 What Does It Takes? Organiza tion Program Breadth? Global / Regional / Market Supply Planning / Manufacturing / Logistics / Commercial Solution Strategy Participants? Direct / Indirect Global / Local What to Implement? Regulation Interpretation Line Technologies Material Handling Data Management BAU October 21, Ongoing Operations? Operationalize Enterprise Support Maintenance

9 Strategies & Methodologies Alignment with business and investment plans Packaging network optimization (insource/outsource strategies, hubs, etc) Postponement and source strategies Work center, deferred aggregation or enable line Harmonized standards, modular build and consistent timing Global solution architecture Enterprise data management Agile and flexible Leverage existing solutions Compliance fulfillment Program Operating Model Holistic project management Serial Number Management Learning & continuous improvement October 21, SN Request SN Response External Collaboration Governments Other Mfs Line Management System Integration Services Provision Response Provision Request Plant Controller Operational Systems Plant Warehouse Mgt Serialization Control Tower (SCT) Note: Only certain shipments will require serial number tracking 1) Any customer sale shipments, 2) Product redirect shipments and 3) PCS shipments Typically intercompany shipments do not require serial number tracking Distribution Line Sys 1 Plant Sys 1 MRP Sys 1 O2C / Log Sys Line Sys 2 Other/SCT UIs Operational Services Notification Plant Sys2 Other/SCT UIs Black Box integration with CMOs MRP Sys 2 Other/ SCT UIs CMO Solutions CMO Solutions CMO Solutions SN Mgmt SN Mgmt Shipment Info Shipment SNs Notification Shipment SNs SN Mgmt Other/Manual UIs Shipment Info Shipment SNs Cust Return Info Cust Return SNs Repository / Reporting EPCIS Services Government Report Trading Partner Report Other Mfg Notification External Collaboration Governments Trading Partners 3 rd Party LSPs Other Mfg Product Availability product release trigger interface from LIMS/SAP or manual UI Oper Sys Batch Flag set at batch create via material master data setup

10 Commoditize Mandates Mandate Requirements Import Authentication Export Track & Track Mandate Classification Common Enablers Serial number provisioning Notification / commissioning Aggregation Serial number management Event Driven Reporting Government Trading Partners Other Manufacturers Business Events Provision & Apply Creation / Aggregation* Product Availability Tracked Receipts Tracked Shipment Compliance Reporting Serial Number Management (e.g. provision, commission, ship, rework, destruction, returns) Mandate Requirements Event Combination China Import ProvApply Notify Prod Avail Report SN Management Modifications Report Track Ship Report India Export Prov/Apply Notify Prod Avail Report Brazil Import Notify Prod Avail Receipt Report SN Management Modifications Report Track Ship Report US Track Prov/Apply Notify Ship Report SN Management Modifications EU Authentication Prov/Apply Notify Prod Avail Report October 21, * Aggregation is often needed for supply chain efficiencies

11 Program Operating Model Program Operating Model Market Sites & Supply Chain Market Monitoring Evaluation Engagement Enablement Compliance Management Business as Usual Monitor mandates Influence if needed Clarify requirements Evaluate scope Steering Team and Governance Committee approval Create local market team Deployment schedule Site / source funding Enable impacted internal supply chain and data management Conduct change management and training Onboard, monitor & track SKUs within the network Transition to standard operational activity Ongoing monitoring Program Operations Focus: Market Site & Supply Chain Market Enablement Projects: driven by market requirements Manage Supply: impact of executing enablement projects Ongoing Operations: execute on a strategy allowing the company to operate post program

12 Operational Learnings October 21,

13 Organization Serialization Myth #3 Give it to Engineering. They will get it done October 21,

14 Program Governance October 21,

15 BUILDING CAPABILITY Blended Teams Market: In-country team key to success Partnership & Influence Source Location: Ownership Drive operational & technical capability OPERATIONAL Site Project Manager TECHNICAL Implementation Lead Implementation Lead Site Solution Provider Liaison BT Enablement Team Supply Network Artwork Resource Supply Network Technical Resource Sustainable operations Site Specific Resources Serialization Solution Provider October 21, 2015 KEY Serialization Resource Site Resource 15 Solution Provider Hardware OEM(S)

16 Solution Serialization Myth #4 One size fits all October 21,

17 US DSCSA EU FMD India DGFT China EDMC Modular Building Blocks Reusable Parts Simple / versatile / agile Fulfill different independent functions Put together to address higher level needs October 21,

18 Standard Operational Processes Analyze overall network for event capture points in operations Lines / CMOs Plant warehouses Logistics network Market distribution network Identify operational requirements to meet / maintain compliance Normal go-forward process Exception handling Define Operations Requirement Flows Operationally agnostic to mandates Minimize operations impacts Automated and / or manual October 21,

19 Master Data Master Data is the DNA for the Serialization Program It is the Identity of the Product and Company Data with necessary elements It is the Bond that ties all internal and external supply chain solutions together Serialization Program Key Components Business processes are the work flows to be executed Master Data is the definition / identity of what the business processes are to be acted on and how Location Serialization Master Data Customer Other Item Partner Business Process Integration Many internal and external business systems need to be able to work interactively The master data serves as the bond that enables the different solutions to talk in a common language October 21,

20 Business-As-Usual Serialization Myth #5 Serialization only adds to product cost and does not create business value October 21,

21 BAU vs. Operationalization October 21,

22 How to Support? Challenge Many potential supply chain points of failures Efficiently find issue source Capture/manage issues traversing the supply chain Harmonizing business partners / tech teams Regulatory time constraints Explicit knowledge management October 21, 2015 Challenge Enterprise support: Learning solution, gluing existing support networks Support internal or external stakeholders Incident and Problem Management Routing mechanism: Fastest routing / resolution of issues traversing groups Enterprise Support (COE): Mgmt & SMEs for performance and stakeholder mgmt Learning machine that provides continuous support & solution improvement Accountability: From opening to closing of incidents 22 Monitoring problem management effectiveness

23 Summary Serialization Myth #6 Once I have funding approved, I can get this done in a couple of months October 21,

24 What Does It Takes? Organiza tion Program Breadth? Global / Regional / Market Supply Planning / Manufacturing / Logistics / Commercial Solution Strategy Participants? Direct / Indirect Global / Local What to Implement? Regulation Interpretation Line Technologies Material Handling Data Management BAU October 21, Ongoing Operations? Operationalize Enterprise Support Maintenance

25 Thank You!!! October 21,