The fast track to SAP S/4HANA...14 SAP ECC SAP S/4 HANA Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb...
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Transcript of The fast track to SAP S/4HANA...14 SAP ECC SAP S/4 HANA Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb...
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Welcome and brief introduction
The FUJIFILM Diosynth case
S/4 approach and methodology
Wrap-up and questions
AGENDA
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FUJIFILM Diosynth Biotechnologies VP of Product Supply
Vice President of Product Supply at Hillerød factory
Please feel free to contact me at [email protected]
CHRISTIAN HOUBORG
Implement Consulting Group, Partner Planning & Execution Excellence
Leading SAP S/4 HANA Expert
Please feel free to contact me at [email protected]
ANDERS NØRTVED
CHAT
Write in the chat:1. Your name 2. Your company
HELLO!WHO’S HERE?
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FUJIFILM DIOSYNTHBIOTECHNOLOGIES
FUJIFILM Corporate Overview
Established
Chairman & CEO Shigetaka Komori
# of Employees
# of Subsidiaries
Revenue
Operating Income
279as of March 2019
72,332
President & COO Kenji Sukeno
as of March 2019
Jan 20, 1934
￥２,480 billion ($23b approx.)
￥240 billion (approx. $2.3b)
FY2019 (Estimation)
FY2019 (Estimation)
FUJIFILM Diosynth Biotechnologies - World Leading CDMO
+325ProjectsIn process
development and/ or manufacturing
3Technologies
Microbial
Mammalian
Viral / gene therapy
4Locations
14Licenses
For commercial manufacturing
Introduction to
FUJIFILM Diosynth Biotechnologies (FDB) is a leading contract development and manufacturing organisation (CDMO) providing process development and manufacturing of biologics.
At the Hillerød factory, there are currently 800 FTEs and plans to expand the capacity with investments of USD 928 million, which will increase the number of FTEs by 400.
During the coronavirus crisis, the Bill & Melinda Gates Foundation has booked capacity at FDB in Hillerød to help with production of medicine to fight COVID-19.
In April 2020, the factory in Hillerød went live with a Greenfield SAP S/4 Hana implementation.
FUJIFILM DIOSYNTH BIOTECHNOLOGIES
Manufacturing Site Hillerød
-70⁰ CelsiusWarehouse
800 m2
Assembly, Label and Pack Facility
4500 m2
Large Scale Biologics Manufacturing Facility
21,000 m2 Utilities & Link
2,500 m2
Quality Laboratories
4,600 m2
Administration4,200 m2
Canteen & Auditorium
1,500 m2
Warehouse4,700 m2
Project background
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WHY THE SITE IS IMPLEMENTING SAP
• The Hillerød site is the first of the four sites to implement SAP S/4HANA –the other sites run SAP ECC.
• With SAP S/4HANA, the site implements a long-term improved platform (the foundation bricks), supporting the future CDMO business model.
Building the foundation bricks for the future
• As part of the transition to FDB, the site in Hillerød needs to exit the Biogen Oracle platform and transition to the SAP platform.
• In April 2020, the plug to Oracle was pulled. SAP S/4HANA needed to go live prior to this date to avoid penalty clauses.
• Business operations need to continue As-Is.
Launching SAP to replace Oracle
• The Hillerød site is now the fourth biopharmaceutical manufacturing site of FDB.
• SAP is the ERP platform used across all FDB sites.
Merging into the FDB family
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Sub-projects
Plan Source Make (DS+FG) Sell/deliverCore process
Jaggaer Batch No. SyncadeAnalytics
Warehouse QA/QC Finance Master data Reporting Indirect procurement
Supporting processes
Project scope
SAP S/4HANA COVERS THE END-TO-END PROCESS
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SAP ECC SAP S/4 HANA
Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr
Scoping process and gap identification
Project mobilisation
New S/4HANAdirection set
Fit/gapand URS
workshopsProject kickoff
ECC blueprintpresentation
Project restartS/4HANA
Agile prototypingand design
URS approval
Dry-runtest
IQ test Go-live
End-usertraining
OQ test
PQ (UAT) test
Key design decisions
Project timeline
THE JOURNEY OF THE SAP PROJECT
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TIME SCHEDULE – VISUAL PLANNING
Examples of the project room
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HOW TO COPE WITH DISRUPTION
AND KEEPING A HIGH PACE?
IMPACT OF CORONA
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S/4HANA PROJECT APPROACH
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Six major elements were key in the success of this project
Change management and training
Automated testing
Stick to standard
Agile project approach
THE SIXPILLARS OF
THE PROJECT
Transformation of master data
GxP validation
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1. The scoping: Process model and
system overview
2. Process-oriented user requirement
specifications
3. Solution design accelerators/gap
analysis
4. System documentation, migration and
validation
5. Test, training and hypercare
6. Project and change management
Agile project management approach: efficient project execution in sprints with fast learning loops.
Change management: key focus on process alignment.
A successful SAP S/4HANA project approach in life science built around six core elements
Sample deliverables Sample deliverablesSample deliverables
Sample deliverables Sample deliverables
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ORGANISE TRULY PROCESS ORIENTEDSecure business ownership
Project scope
THE END-TO-END PROCESS OVERVIEW
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Enabling processes
Manage warehouse Support QA/QC Master data Product lifecycle maintenance Finance/accounting Reporting Non-functional
requirementsIndirect procurement
Core end-to-end processes
Collection and dunning
Manage billing and A/RDeliverManage sales orders
Manage customer and contract master data, incl. customer credit
Pick and pack
Sell/deliver: order to cash
Invoice receipt and paymentQuality control and releaseGoods receipt and stock placementRequisitions and procurementSourcing and contracting
Source: Procure materials and services
Make DS and FG
Quality controlWarehouse storageProduce productMaterial prepBatch preparation Batch disposition Kanban
Plan: Supply chain planning
Operational planningMaster planningSales and operations planning Scheduling Source DPand cell bank
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SAP project organisation
WarehouseJohnny Olsen (BPO)
• Kim Ringby
QualityDea Petersen
• Brian Jensen (BPO) • Mads Werenberg (CMO)• Harald Olsen (CLIN)• Luecia Branquinho (Supplier Quality)
Master DataJennifer Santos
• Lykke Andersen• Nicolai Lyster• Dorthe Jeppesen (BPO)
FinanceJørgen Nielsen (BPO)
• Pia Klausen• Jesper Christiansen• Mette Hage
• Therese Fabricius• Kieran Punch• John Nymark Jensen
Source (direct)Johnny Yu
• Eleni Pagoni
QC• Lars Pedersen• Bo Overgaard
Warehouse• Jed Lurie• Brett Mccubbin
Finance• John Nymark
Jensen
BPO• Gabriella Söderling
PlanThomas Steenholt
• Line Harrishøj• Mette Bang
BPO• Niklas Garborg
Make FGChristian Henriksen
• Christina Madsen• Andrew Murray• Pia Pedersen
Quality• Dea Petersen• Andreas Nielsen• Bo Overgaaard
Compliance• Lars Lundtorp
Prep/Review• Eva Jensen• Majbrit Eskildsen
Warehouse• Allan Senderovitz
Process Science• Martin Vorborg
BPO• Lenette Simonsen
Make DSClaus Valentiner
I&D • Camilla Hansen Man. Doc• Helene
Christensen Solution Prep• Jens Brejl Purification• Jesper Meyer Cell culture• Maria A. Zigova Man. Support• Sanne Falsing• Sofie Taylor QC Samples• Henriette Hørbov QA• Keld Siiger• Luna Formsgaard Warehouse• Farshad
Sharifzadeh• Brett Mccubbin BPO• Annika Petersen
Sell/ DeliverJed Lurie
• Naja Stewart• Marek Kulik• Søren Manniche
Warehouse• Brett Mccubbin
Finance• Pia Klausen
BPO• Susan Døj (BPO)
Indirect procurement• Søren Juul• Andreas Barsoe• Therese Fabricius• John Nymark Jensen• Morten Brøndum Pedersen
FDB
Implement
Implema
Sub-projects
Other external
Business ArchitectAnders Nørtved
Process Consultants
Anne, Lars, Driton
Business Track Leads/Coordinators
Business Cutover Manager
Palle Gregersen
SteerCoChairman: Christian Houborg
FDBD Project ManagerDorthe Jeppesen
Jaggaer Project Manager
Thomas Søefeldt
Batch No. Project Manager
Colin Peckett
Syncade Project Manager
Jakob Helsoe
Master Data SME’sS4 Technical Consultants
Release ManagerPaulius Pakalniskis
Technical Cutover Manager
Paulius Pakalniskis
Analytics Consultant
Analytics Project Manager
Colin Peckett
Integration and Development Consultants
QA Validation Mark Lund
Business AdvisorPreben H. Nielsen
IT Project ManagerColin Peckett
Training ManagerAdam Koziarz
Validation ManagerArild Juhl Larsen
PMO SupportLine Bering Kristensen
IT Solution ArchitectPaulius Pakalniskis
Data Migration Manager
Arjan Kroonen
S4 Project ManagerTonny Kvant
Solution ArchitectJohan Hedlund
Project ControllingKieran Punch
Change and Technical Advisory Board
Test/Defect ManagerMarinus G. Nejrup
Data Manager
Change ControlHeidi Christensen
Infrastructure SME + Change Manager
Troels Verholt
Business SMEs
Cutover Coordinator
Anders Aalborg Jacobsen
Training and Documentation
Nina Anker Nissen
Data validation and MDM
Julie Blom Hansen
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STICK TO STANDARDImplementation partner that knows SAP standard
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8-STEP PROCESS to establish a solid operating model design and high-level scope
Operating model
Identify key design questions
System landscape and integrations
Process landscape and application portfolio 1 2 3 4
Key design decision and high-level scope approval
Identify relevant SAP best practise
Identify and describeGAP to SAP best practice
GAP evaluation and rough estimation8 7 6 5
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SAP is a GAMP 5 and 21 CFR Part 11 compliant system. Thus utilisation of standard is as a starting point low risk. Customisations are high risk and expensive to build and maintain (high LCC). Below-listed method can limit the number of customisations:
Process model
URS – process flows and detailed descriptions
URS –GxP and critical require-ments
SAP best practise explorer
Design level 1-3 process landscape
Identify relevant SAP best practice
Design To-Be business processes inspired by SAP best practice
Write URS only focusing on GxP and business-critical requirements
Evaluate URS delta to best practice and identify GAPs
Revisit URS and remove non-critical requirements which lead to GAPs
URS CREATION BASED ON SAP BEST PRACTICE
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RISK-BASED APPROACHValidation, test and migration
Creation and approval of test strategy
Risk assessment of requirements and solutions
Creation oftest cases and detailed test plan
Test execution and defect reporting
Test execution and defect reporting
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HIGH-LEVEL TEST APPROACHA risk-based approach for testing as an accelerator
All end-to-end processes
Business process steps for critical core processes
Explicit requirements for critical processes
SEVERITY *
PROBABILITY *
DETECTABILITY =
RISK PRIORITY NUMBER (RPN)
No
change control
Change
control
User acceptance
test
Functional test
Installation qualification
Dry run Informal test of system and verification of test scripts
Verification of system installation, configuration and customisation
Testing of system functionality, inputting of normal and abnormal test cases according to functional specification
Verification of end-to-end processes, work instructions, testing of process flows and descriptions in URS
Time
Creation and approval of test strategy
Risk assessment of requirements and solutions
Creation oftest cases and detailed test plan
Test execution and defect reporting
Test execution and defect reporting
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HIGH-LEVEL TEST APPROACHA risk-based approach for testing as an accelerator
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Key elements in an S/4HANA project that must succeed
Change management and training
Automated testing
Stick tostandard
Agile project approach
THE SIX PILLARS OF
THE PROJECT
Transformation of master data
GxP validation
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IT’S TIME FORQUESTIONS
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