Professional Development Day March 20 th 2014 Todays Discussion Points 2 Serialization Definitions and Drivers 1 Compliance Strategy 2 Operational Governance 3 Deployment Strategy ID: 784201
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Slide1
ISPE New Jersey Chapter Professional Development Day
March 20
th
,2014
Slide2Today’s Discussion Points
2
Serialization
Definitions and Drivers
1
Compliance Strategy
2
Operational Governance
3
Deployment Strategy
4
Early Lessons Learned
5
Slide3SERIALIZATION DEFINITIONS & DRIVERS
3
Slide4Business Drivers
4
Patient Safety:
Insure the integrity of pharmaceutical products throughout the supply chain
Counterfeiting deterrent
Deter re-introduction of stolen goods into supply chain (with T&T)
Allows “Authentication” through the supply chain
ePedigree – confirmed movement through legitimate supply chain
Compliance:
Increasing regulations
(US and Global)
US legislation:
requires ePedigree with pathway to Track and Trace. Unit level serialization by Nov 2017. EU Falsified Medicines Directive: requires serialization and tamper evidency in ~2017/2018 through EU country delegated acts (with pharmacy authentication)Emerging Markets: (Argentina, China, Turkey, India, etc.) have enacted Serialization regulations typically requiring Trace & Trace
Slide5Definitions: Regulatory Impact on Operations
Serialization
Applying a
unique
identification code to the retail unit of sale
Track and Trace
Determining the location of product as it moves through the supply chain
ePedigree
Documenting the chain of ownership of the product as it moves through the supply chain
Aggregation and Inference (required for T&T)Every item, case and pallet is assigned a serial numberItems are aggregated to cases (parent / child relationship)
Cases are aggregated to pallets
Unit level serial numbers can be “inferred” by reading the case or pallet serial numberAuthentication
Confirming the authenticity of the unique identification code, typically at the point of dispense
GS1Standards
5
Slide6COMPLIANCE STRATEGY
6
Slide7Compliance Strategy
7
Included as one component of a comprehensive supply chain security program
Work
with industry groups to understand and help develop standards and influence
the
approach (e.g
.,
PhRMA, EFPIA, GS1, Rx 360)Market alignment process to clearly understand the requirements for successful deploymentUnderstand the global landscape to minimize impact to your design strategyTracking SKU compliance
Slide8Market Compliance Enablement
Market
GL&S
Market
Serialization PMO
Supply
Network
Enabling
WS
BT
Enabling
WS
External
Supply
Enabling
WS
Market
Enabling
WS
Logistics / SC
Enabling
WS
Market
Artwork
BU
Mgt
Market Mfg
Market
Reg.
Affairs
Market Enabling Core Team
Activity:
Actively monitor mandates
Monitor in program local solution
Monitor in program enterprise solution for requirement changes
Activity:
Determine initial scope and sourcing strategy for mandate
Document mandate compliance milestones
Request and approve program funding
Initiate market engagement
Activity:
Form local market team and meeting cadence
Finalize approach and design for scope
Update Enterprise master schedule to include identified enablement activities
Activity:
Coordination of schedule and resources
Enable impacted Pfizer supply chain
Enable data management across Pfizer supply chain
Enhance Enterprise solution
Activity:
Onboard SKUs within the network
Monitor and track SKU onboarding / compliance
Activity
:
Transition supply chain and enabling functions to standard operational activity
Ongoing monitoring
Slide9External
Internal
Enterprise Solution
Local Solution
Global Landscape
9
LSP (O2C WH)
In-house (WMS WH)
Serialized Products from
Mfg
Non-Serialized Products from
Mfg
Serialization Data to/from Site Lines
Data Updates from Plant WH (including tracked shipments)
Data Updates
Internal
Serialized Product Data
Serialized Product Data
Serialized Product Data
Serialized Product Data
EU Member Markets
Phasing
Lot – 2015
SN – 2017
WH – 2019
T&T
–
2023
Authentication 2017 / 2018
Mandate Evaluation
Non-Core Examples
Distribution Serialized Product Data (Manual / Local BT Solution)
Slide10OPERATIONAL GOVERNANCE
10
Slide11Program Governance
Program Governance
Executive
Sponsor
Program Governance Committee
Supply Chain
Security
Program Operations
PMO Steering Team
PMO Program Leads
Supply Network
Enablement
Capital Controls
& Optimization
BT Solution
Enablement
External Supply
Enablement
Logistics & Supply
Chain
Enablement
Market Enablement
& BU
Engagement
Program Financial
Management
Industry Alignment /
Customer
Engagement
Day to day management of PMO
Coordination of workstream activities
Development of program metrics
Oversight and guidance of PMO workstream activities
Establish core solution strategies and scope
Obtain funding for workstream resources
Establish and monitor Program Deployment/Compliance Plan
Stakeholder communication and awareness
Endorse Program Deployment /Compliance Plan
Endorse cost avoidance strategies (sourcing changes)
Endorse investment deferrals and associated risks
Participate in quarterly updates and elevate issues
Corporate
spokesperson
Communicate business impact
Elevate issues to
Executive Leadership Team (ELT)
End User Chg Mgt
&
Training
Program Operations
11
Slide12Program Operations
Steering
Committee
PMO
GTS – GE
PGS BT
Trade
GTS – Packaging
GL&S
Market Enablement
Program Co-Leads
Program
Leads
External Supply
Program Co-Leads
Program Financial Management
CPA Allocation
Oper Cost ImpactsOperational Budgeting, Forecasting & Accounting
Industry Alignment /
Cust Engagement
E2E Pilots
Industry Engagement
Policy & Regulatory Influence
Market Enablement & BU Engagement
Country Engagement
Market Regulatory Requirements
Market Enablement
Logistics & Supply Chain Enablement
Global Process
Mgt
Logistics Deployments
Supply Chain SKU Onboarding
End User
Chg
Mgmt
& Training
“Operationalize” Serialization
End User / Process Change
Mgt
CI
Supply Network
Enablement
Solution Platform Architecture
Site Line Deployments
SKU Compliance
BT Solution
Enablement
Data Management Architecture
Solution Deployments
MDM
External Supply
Enablement
CMO Project / Relationship
Mgt
CMO Line Deployments
CMO Funding Model
Capital Controls & Optimization
Capital Planning & Optimization
Capital Funding & Controls
Capital Reporting
Program Operations
Network Compliance
Scope & Change
Mgt
Schedule
Mgt
Enterprise wide representation, participation and collaboration
Matrix organization with defined and integrated roles and responsibilities
Sourcing strategy for External & Internal site packaging lines12
Slide13DEPLOYMENT STRATEGY
13
Slide14Deployment Strategy
14
Engage
with Suppliers and Logistic Service Providers to create awareness, provide solution assistance and build
capabilities
Adapt work processes in line with
Serialization and Traceability requirements on network supply and distribution
strategies/practices
Build Serialization and Traceability competencies throughout the networkEstablish flexible technical solution based on standards are deployable in modulesDevelop a master plan to track and achieve compliance
Slide15Operating Model
15
Program Operations
Activity:
Actively monitor mandates / regulations not in scope of program
Monitor in program local solution requirement changes
Monitor in program enterprise solution for requirement changes
Monitor and bring back learnings from pilots
Activity:Determine initial scope and sourcing strategy for mandate
Document mandate compliance milestonesRequest and approve program fundingInitiate market engagementActivity:
Form local market team and meeting cadence
Finalize approach and design for scopeUpdate Enterprise master schedule to include enablement schedules from all workstreams impactedSecure site / source fundingActivity:
Coordination of schedule and resourcesEnable impacted internal supply chainEnable data management across internal supply chainEnhance Enterprise solutionLead change management and training across internal Supply ChainTransition to Enterprise support
Activity:
Onboard SKUs within the network Monitor and track SKU onboarding / compliance
Activity:Transition supply chain and enabling functions to standard operational activity
Ongoing monitoring
Activity:
Coordinate alignment of all workstreams to ensure successful mandate complianceManagement of Enterprise schedule Report Program and mandate statusManage Issue and risksMonitor and track progress across all in scope mandates
Manage program communications
Manage program scope and financials*Phases may occur in parallel or cyclical nature
Slide16Deployment Strategy
16
Understand Regulatory Landscape
Markets Served – US, EU and Emerging Market (i.e. Argentina, China, India, Korea, Columbia, Brazil, etc)
Product Portfolio vs. Line Allocation
Line Consolidation
Deferment Consideration
Line Assessments
Process Flow/Mapping - > Alignment and application of appropriate Global SolutionAsset - Upgrade, Redeploy vs. New
Collection and management of Master DataArtwork Change Management/Guidance DocumentsImpact on Supply Network
Slide17Packaging Line Serialization
Packaging Line enabling prerequisites:
Delivery of required equipment (e.g., new labeler or case packer)
Developing
SKU
artworkCompiling SKU master data (+50 elements / SKU)Availability of Serialization Solution Partner SME
Availability of
Serialization
SMEAvailability of BT Serialization SMEAvailability of production window (3 to 6 weeks of downtime)
SCT
17
Slide18Case
Packer
Cartoner
Case
Packer
P/V
P/V
A/P/
V
Conveyor
Online Serialization
& Aggregation (blisters)
Unit Level
Serialization
Case Level
Aggregation
Online Serialization & Aggregation
Online Serialization
Authentication blisters
Case
Packer
Case
Packer
P/V
P/V
Conveyor
Cartoner
Case
Packer
Labeller
Case
Packer
P/V
P/V
A/P/
V
Online Serialization
& Aggregation (bottles / vials)
Case
Packer
Labeler
Case
Packer
P/V
P/V
Online Serialization
Authentication bottles / vials
18
Slide19Case
Packer
Cartoner
(blister)
Case
Packer
P/V
P/V
A/P/
V
Conveyor
Unit Level
Serialization
Case Level
Aggregation
Online Serialization & Aggregation
Cartoner
(blister)
P/V
P/V
Case
Packer
manual or
semi-automatic
case packing
A/P/
V
Conveyor
Unit Level Serialization
Postponed Aggregation
Online Aggregation
for high volume SKUs
Postponed Aggregation
for low volume SKUs
(same site)
Cartoner
(blister)
P/V
P/V
Case
Packer
manual or
semi-automatic
case packing
A/P/
V
Conveyor
Unit Level Serialization
Postponed Aggregation
Postponed Aggregation
performed at second site
Vial Filling
Brite Stock
Brite Stock
Postpone Serialization &
Aggregation
at second site
Case
Packer
Case
Packing
P/V
P/V
A/P/
V
Conveyor
Serialization & Aggregation
Unit Serialization & Aggregation Alternatives
19
Slide20Supply Network Impact
Site
Warehouses
Schedule based on serialized lines
Manage serialized and non-serialized product
Aggregation rework
Sampling
Track shipments
Update serialization information in the SCTSerialization Supply Network Landscape
3rd Party Contract OperationsExtensive collaboration needed - understanding requirements and delivery Dynamic schedule: changing mandates and vendor readiness
Agreement on commercial impact (COGS impact vs.
funded capital)Opportunity to consolidate to fewer suppliers20
Sites
Line 1
Line 2
Line 3
Line 4
Line 5
Line 6
Impact on Sites
Capacity impact from deployments (3-6 weeks downtime)
OEE impact
Reduced agility for SKU movements between
pkg
lines
Exception handling
Slide21EARLY LESSONS LEARNED
21
Slide22Early Lessons Learned
22
Start Early – pilot early and often
Do not underestimate
complexity…
especially information technology
aspects
Partner with your serialization provider and align on the deployment schedule
Build technical and operational knowledge
Keep your antennae up – don’t ignore changing signals
Consider all impacts to your organization
Develop tools and toolkits to enhance competencies through your organization
Communicate, communicate, communicate – never too much
Slide2323
Mark Wessel
Global Serialization
Program Leader Global
Technology Services
Pfizer Global Supply