How Operational Excellence can
Support Innovation and Growth
Annette Grundy
Head of Operational Excellence (PPI)
Pharma Services Group
Brisbane
20 May 2022
The world leader in serving science
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The opportunity
Many operations and quality teams face pressure to drive innovation, continuous improvement and a quality
culture.
How can operational excellence thinking, and tools support the business to meet strategic goals?
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The work environment – disrupted by Covid-19
Changes to remote working and absence of travel has accelerated the need for organizations to:
• find new ways of working – daily standard work and tier meetings
• increase the uptake of digital tools – for communication and problem solving
• change how team building and learning and development is delivered
• Virtual: job interviews, onboarding, gemba walks, audits, plant tours and client visits
How can we keep a quality culture alive?
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What is Operational Excellence?
Wikipedia tells us……
The concept of Operational Excellence was first introduced in the early 1970s by Dr. Joseph M. Juran while teaching Japanese
business leaders how to improve quality. It was formalized in the United States in the 1980s in response to "the crisis" among
large legacy companies whose market share was shrinking due to quality goods imported from Japan.
Operational excellence is a mindset that embraces certain principles and tools to create a
culture of excellence within an organization. Operational excellence means every employee can
see, deliver, and improve the flow of value to a customer.
This approach employs the tools of earlier continuous improvement methodologies, such as Lean Thinking, Six Sigma, OKAPI
and Scientific Management.
https://en.wikipedia.org/wiki/Operational_excellence
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What is the context of all these approaches?
LinkedIn article from 2018: What is the difference between Lean, Kaizen / PPI and Six Sigma?
PPI: Practical Process
Improvement
Kaizen: ‘A change for
the better’
https://www.linkedin.com/pulse/what-difference-between-kaizen-lean-ppi-six-sigma-michael-heidorn/
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What is the Practical Process Improvement (PPI)
business system?
• Developed by R Edward Zunich with resources written
by both Ed and Mike Bell
• 1st trialed at Thermo Fisher Scientific in 2002
• Enterprise-wide data based improvement program
• Utilizes the 8-step problem solving methodology
• Goal is to drive improvement across all parts of the
business
https://www.ppiresults.com/about.php
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Practical Process Improvement (PPI) @
• Improve profitability
• Value knowledge, expertise and effort
• See problems as opportunities
• Drives customer allegiance
• Defined roles
• Process champion
• Process manager
• Spokesperson, scribe, reorder, timekeeper – gets
everyone involved
Developed by Mike Bell and R. Edward Zunich
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What does this mean in
Biologics?
First some context
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>100,000 5,000 $1B $30B
Employees globally R&D Scientists/Engineers invested in R&D in revenues
The world leader in serving science
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Pharma Services is the Leader in Drug Development, Trial Logistics and Manufacturing
Patients
Drug substance and Drug substance and drug Lifecycle management and
drug product development product commercial manufacturing generic manufacturing
Clinical material distribution
Clinical trials manufacturing Clinical trials packaging
and logistics
Flexible business models. Customized to meet your unique needs
19 billion 136 million 1040+ 5,300
tablets, capsules, and softgels sterile liquid and Iyo vials in 2018 molecules developed clinical trials supported in 2018
produced in 2018
80+ 200+ 45+ 900+ 12,000
large molecule drug substance small molecule drug substance viral vector products clients employees
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Biologics
The world leader in serving science
Thermo Fisher Scientific Pharma Services: Biologics Services
Biologics drug substance sites Leading global biologic CDMO
St. Louis, Missouri > 30 years GMP manufacturing experience:
Princeton, New Jersey • Mammalian
• Clinical and commercial
Groningen, The Netherlands
• Single-use technology focus
Brisbane, Australia
Gene to patient solutions with Fisher Clinical Services
Biologics drug product sites
Flexible biomanufacturing solutions
Greenville, US
Monza, Italy Integrated drug substance and drug product:
Patheon® Quick to Care™ service
Ferentino, Italy
Key capabilities Flexible biomanufacturing solutions Expertise Experience
• Cell line development: Beacon® and • Multiple single-use platforms deployed • > 180 Tech Transfers executed** • > 11 years commercial manufacturing
ambr® 15 platforms experience
• Existing cell lines supported • > 72 Process Development programs
• Process development: ambr® 15 and 250 completed since 2017 • 4 commercial products
• Non-proprietary media and cell lines
and Freedom EVO® platforms
• 70 / 30 mAb vs. complex protein • 10 PPQ campaigns completed 2017-2019,
• Transfer at any stage
• Fed-batch, perfusion, and XD®
• > 40 combined DS and DP programs** • 6 PPQ campaigns planned 2020-2021
technologies • Predictive cost modeling to develop
biomanufacturing strategy • 62% small biopharma clients • > 20 late-phase, pivotal study,
• 34 K L single-use GMP capacity*
commercialization programs**
• > 100 GMP batches produced in 2018
• Coming on-line soon: Lengnau, Switzerland (Q3, 2022) and Hangzhou, China (Q3, 2022)
** Since 2015
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Broad Capabilities to Support Development, Clinical Trials, and Commercialization
Process development Clinical and commercial DS
Clinical and commercial DP manufacturing
(PD) manufacturing
Analytical method
Analytical method
qualification and
development
validation
Clinical /
Process Process Release testing DP release Clinical trial
Process commercial DP Fill / Commercial
transfer and engineering and stability testing and packaging and
verification production Finish supply
establishment (Optional) studies stability studies supply
campaign
2-12 L 10-50 L 250–2000 L 500–2 x2000 L or Analytical Methods Fill / Finish DP Only Methods Clinical Trial Only Commercial
(250 L) Pilot Scale Full Scale 5000L
• Release testing of • Liquid-filled Vials • DS Methods • Primary / • Liquid-filled Vials
• Process Scalability • Process Scalability • Clinical Material DS and DP • Lyophilized Vials performed by secondary labeling • Lyophilized Vials
• Tox Material • Tox Material • Viral Clearance • DS & DP Stability • Pre-filled Syringes DS QC Labs • Primary / • Pre-filled Syringes
• AD Testing and • AD Testing and • Reference • Small-volume secondary • Process Validation
non-cGMP stability non-cGMP stability standard Filling packaging • Technology
• Reference • Reference standard • Blinding Transfer
Standard • Comparator • Labelling /
sourcing Packaging
• Distribution / • QC testing
logistics • Post Marketing
• Cold-chain logistics Stability studies
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Broad Capabilities Supporting Successful Path to BLA
Phase I/II Phase III
Technology Transfer
Process Locked Down
and Optimization
cGMP Manufacture
Process Characterization, Process Validation,
Process Performance Qualification
Commercialization
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Biologics Brisbane
The world leader in serving science
Brisbane, Australia (BNE)
Clinical and commercial manufacturing
Award-winning facility for cGMP biologic Strong track record of performance:
manufacturing • >95% RFT
• Phase I, II and phase III clinical production and • 1 regulatory inspection (@2 yrs) and >12
supply to Nth Americas, EU, APAC, Middle client audits annually: 0 critical observations
East and Australia
• Successful PPQ /PV execution
Global project management – experienced
• >100 batches since cGMP opening in 2014 tech transfer teams
• 8 Phase III programs • Strong academic qualifications: 38% MSc /
PhD and 54% Bachelor Degree
Fed-batch, perfusion and XD® cell culture
• 40% of operations team > 15 years of
technology
experience with top 50 biopharma companies
• 100% single-use bioreactors, HyPerforma and
• Multinational experienced team >36
BIOSTAT®
nationalities represented on site
• 250L, 500 L and 2000 L scale
• In house commercialization experience
• 500 L Perfusion / XD® processes across multiple departments
In-house QC and QA, Data Integrity, Dual
Warehouse
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Importance of PPI to the organization
Marc Casper Presents at JPMorgan 40th Annual Healthcare Conference January 11, 2022
• “So the company today, we continue to grow and we continue to strengthen our industry leadership. We are
the world leader in serving science. Our customers know us for our exceptionally strong brands. We have $40
billion in revenue, over 100,000 amazing colleagues and we invest about $1.4 billion from research and
development on our product portfolio. We have industry leading scale. We have unmatched depth of
capabilities. That’s how our customers know us. And all of this is powered by our PPI business
system, practical process improvement, which allows us to continue to make the
company better everyday.”
Marc Casper
Chairman, President and CEO, Thermo Fisher Scientific
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Simple: PPI problem solving tools
• Meetings
• Brainstorming
• Quick Vote
• Check Sheets
• Pareto Charts
• Flowcharts
• Fishbone Diagrams
• Run Charts
• Control Charts
• 5 whys
• KPI leadership
• RCCM
https://www.ppiresults.com/about.php
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Waste considerations and PPI
https://www.quality-assurance-solutions.com/7-wastes.html
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Operational Excellence (OE) system
1. Strategy: Leadership creates the vision and values and distills them into strategic focus and direction.
2. Metrics: Balanced scorecards and strategic planning tools cascade down through an organization.
3. Culture: Staff members understand the strategy and are accountable for the results.
4. Processes: The organization has an integrated business process architecture.
5. Methodology: You apply discipline and rigor to continuous improvement through a method such as Lean Six
Sigma (LSS).
6. Project Management: In accordance with the Project Management Book of Knowledge (PMBOK), you apply
discipline and rigor to projects.
7. Tools: Embrace tools for solution delivery, problem solving, and continuous process improvement.
https://www.smartsheet.com/content/operational-excellence
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Context: overall business system
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Application of OPEX tools
Manual
Value Stream Map
Digital whiteboards – Stormboard, Miro etc
PPI 8-step Kaizen template Kanban Board
https://miro.com/features/
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System governance
• X-matrix linked to KPIs - STRATEGY
• Tier meetings and daily accountability – DAILY HUDDLES
• Project hopper – pipeline of projects for assessment and confirmed for upcoming Kaizen events,
with potential cost savings
• Maturity model – bronze, silver and gold
• Dashboards
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Digital governance
X-matrix, daily huddles, dashboards, metrics review, data
tracking, project dashboards, action tracking, gemba, JDI etc
Standardized workflows for
: operational excellence execution:
• Gemba walks • Guided PDSA, JDI and
• Just do it (JDI) DMAIC workflows
• 5S audits
• Engagement
• PPI financial metrics
Benefits
• Mobile apps for real time data capture
• Real time reporting and insights
• Best practice sharing across enterprise
• Integrates with PowerBI for advanced
reporting
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The how: PPI Busines System training pathways
Master Mentor Power User Change Champion Process Manager
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PPI culture and resourcing at Brisbane site
• Top-down support for PPI as an enterprise-wide process improvement system
• Global and site-based program – global training framework
• Site SLT modelling PPI practice and principles every day
• All staff undertake PPI induction
• Supervisors and managers undertake Leading Through PPI training
• Resourced with operational excellence practitioners at global and site level
• PPI is viewed as a development pathway for employees
• University interns participate in the PPI program and site projects – multi departmental immersion program
• Colleagues actively seek out process improvement opportunities (upskill, to lead or participate in a project)
• All staff can (and do) nominate improvement opportunities
• All teams actively engage in tier meetings (huddles), Gemba walks and JDIs
• Continuous improvement is embraced as part of the DNA at the site
• PPI drives a quality and accountability culture – visible leadership
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In conclusion
Like many organizations the Brisbane PSG Biologics site faces pressure to drive innovation, continuous
improvement and a quality culture.
This is achieved through using PPI and other Operational Excellence tools to:
• Develop strategy aligned to our mission: To enable our customers to make the world healthier, cleaner and safer.
• Link strategy to KPIs that are reviewed regularly using visual dashboards and focused strategy review sessions
• Drive accountability throughout the entire organization (client facing, supply chain, engineering, operations and quality)
Benefits:
• Provides a direct focus on the customer/client and with the patient in mind
• Ensures what we do is focused on improving the customer experience
• Clients see and feel improvements during their interactions with us
• Relentless focus on ensuring that we continue to deliver the best value to clients by undertaking activities that are value added and
aimed at delivering without adding internal costs
• Drives a quality culture throughout the site. It is a safe environment where issues are identified, resolution approach determined and
action tracking to ensures completion
This drives strong customer allegiance enabling the team to meet the business objectives and to deliver on our
mission
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Thank you
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