NSI Capacity Expansion Project
2014 Facility of the Year Award
Operational Excellence
Pfizer Grange Castle, Ireland
23 June 2015
Peapack, NJ
Agenda
Site Introduction
Project Overview
Process Description
Facility – ‘look and feel’
Project Execution
Operational Excellence
Agenda
Site Introduction
Project Overview
Process Description
Facility – ‘look and feel’
Project Execution
Operational Excellence
Pfizer in Ireland
Pfizer Ireland Key Facts
• 3,200 Pfizer employees
• Six locations around Ireland
• Manufactures some of Pfizer’s
best selling medicines e.g.,
– Lipitor (cholesterol reducing)
– Viagra (urology)
– Sutent (oncology)
– Enbrel (rheumatology)
– Prevenar (vaccine)
Grange Castle Site
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90-acre Co. Dublin. Ireland
Opened 2005, Initial investment ~$2B
1.1M sq.ft facility , ~ 1,000 FTEs
High Volume High Value Biologics, DS & DP
Grange Castle Products
$4B
$2B
$200M
Grange Castle is proud to be part of the biocommunity group
Grange Castle Site
Utilities
Drug Substance
Protein
Warehouse
Suite 1
Vaccine Conjugation
Suite 3:
Syringe Fill / Finish
NSI Suite 4
(Pegylation / Conjugation
NSI Suite 2:
Vaccine Conjugation
QC Labs
Admin
Agenda
Site Introduction
Project Overview
Process Description
Facility – ‘look and feel’
Project Execution
Operational Excellence
NSI Capacity Expansion – Business Drivers
• Post Wyeth acquisition Pfizer implemented a Plant
Network Strategy (NSI) to global rationalise
manufacturing capacity
• Grange Castle NSI Project to provide…
– Additional capacity to meet demand
– Increased volumes leading to reduced COGs
• Schedule Driven project to expedite significant
operational savings
Project Scope
• Demolition of existing Fill / Finish Suite
• Retro-fit new 10,000 sq. ft. Multiproduct
PEGylation & Conjugation facility (Suite 4)
• Retro-fit new 35,000 sq.ft. Vaccine Conjugation
Suite (Suite 2)
• Programme Capital Cost ~$160M
Key Project Stats
Total New Manufacturing Space
88,000 sq.ft
Total New Cleanroom Space
45,000 sq.ft
Total Site Construction Craft Man Hours
395,000
Peak Construction Crew
350
Total Piping Installed – % Sanitary
55,000 ft. – 65%
I/O Count
~6,000
Agenda
Site Introduction
Project Overview
Process Description
Facility – ‘look and feel’
Project Execution
Operational Excellence
Agenda
Site Introduction
Project Overview
Process Description
Facility – ‘look and feel’
Project Execution
Operational Excellence
Remove Clutter from Cleanrooms Where Possible
“If It Doesn’t Need to Be There… Then Get It Out ! ”
Interstitial & Tech Spaces
Good Coordination in Design = Good Access
Access to Tech Spaces from Interstitial Level
Multiproduct Design
Adaptable Rooms with Plug n’ Play Technology
Built in Flexibility - Disposable Technology
Maximise Automation – MCS & MES
Space for Area Information Centres
Maximised Use of Sliding Doors
Maximise Natural Light Penetration
Design for Visitors – Window Tours
Agenda
Site Introduction
Project Overview
Process Description
Facility – ‘look and feel’
Project Execution
Operational Excellence
NSI Project – Key Challenges
• Fast Track Project with aggressive schedule
• Complex Tech Transfers with scale up
• Demolition & Retro fit with proximity to commercial
operations
• Post Integration Site Transformation
NSI Project - 3 Key Focus Areas
1) Design
2) Construction
3) Operational Readiness
1) Accelerating A&E Design Progress
• Engaged Pfizer Project team co-located in A&E office
• Early interactive planning sessions, id. critical paths
• Daily stand up whiteboard meetings to resolve issues
– Think out side the box !
– Automation docs developed in A/E office in parallel
– Early standardisation of components, supported 3-D model
Key Take Away
• The efforts put into 3D model up front paid dividends during
construction and verification… schedule & quality enhanced
Design Execution S-Curve
Pfizer – Network Strategy Projects
(Overall Design S-Curve)
18%
100%
80%
Progress (%)
12%
60%
9%
Averaged
40%
13%/month for
6 months vs.
~8%/month typ
20%
6%
3%
9%
0%
Dec-10
Jan-11
11%
16%
14%
13%
14%
Feb-11 Mar-11 Apr-11 May-11 Jun-11
Monthly Actual
Cum. Planned
11%
Jul-11
4%
Aug-11 Sep-11
Cum. Actuals
0%
Cumulative Percent Complete (%)
15%
2) Accelerating Construction Schedule
• Ran as independent projects, opened up workfaces
• Just in time procurement of Trade Packages
– Better quality of award = less re-work
• All equipment and In-lines procured by A/E firm
– Available to support installation, Fewer delays = Fewer excuses!
• Installed walk on ceilings ahead of M&E first fix, - 3 months
• Multiple Piping Fabrication shops with night shift for install
Key Take Away
• Integrated Pfizer / CM team worked very well – enabled quick decision
making
Construction Execution S-Curve
Pfizer – Network Strategy Projects
25%
100%
20%
80%
18.5%/mth av
for 3 months
Vs.
10%/mth typ
15%
10%
60%
40%
5%
20%
0%
0%
Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12
Monthly Planned Pct
Monthly Actual Pct
Cumulative Planned Pct
Cumulative Actual Pct
Cumulative Percent Complete (%)
Monthly Percent Complete (%)
(Overall Construction Execution S-Curve for Suites 2 and 4)
Demolition – Construction MC
Timeline
Equipment Removal
April 2011
Mothballed Fill Finish Suite
March 2011
13
Months
Mechanical
Completion Apr 2012
Demolition Complete
Jul 2011
3) Operation Readiness Programme
• Task Duration & Resources per discipline
Inputs
• Believe in the process, some groups slower to buy in !
• Main deliverables - Documents, Training, Materials etc
• Reviewed with Leads
Process
• Weighting strategy
• Ownership of deliverables & dates
Output
Operations Readiness Plan –
Overall S Curve
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
• Earned Value
measured
• Review Weekly
• Mitigation Plans
Cum
Overall Planned %
Overall Actual %
Ops Readiness Programme
Take Aways
• Learn from the past… materials, documents and training !!
• Start early, ~1year out from Demo batches
• Create an ownership culture, hold people accountable
• Weekly / Daily ‘whiteboards’ helped with removing roadblocks
• Electronic batch records change the dynamic of a readiness program
vs. tradition Paper BR approach
Key Take Away
• Believe what s-curve is telling you - Hold people accountable for mitigations
NSI Project Phase KPIs
• Safety: Excellent performance
 TRIR ~0.35
 >1.1M man-hours without an incident
• Costs: Came in 3% under budget,
 contingency not used
• Schedule: All key milestones met
 BOD start to OQ completion in 24 months
• Quality: No end user adjustments at handover
 Mechanical rework <1%
Agenda
Site Introduction
Project Overview
Process Description
Facility – ‘look and feel’
Project Execution
Operational Excellence
Our Vision
Embed an OE Culture from Start Up
What would Success look like ….
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A Lean factory is well organised
Minimal search time for info, tools and materials
Free of all non-value-adding activities
Work flows without delay or rework
Output on target with minimal variation
Key processes visibly measured, understood, controlled....and
continually improving
Strategy - Lean Management System
“How we do business”
CI loop & Prioritisation
Opportunity
Trend (CAPA
effectiveness)
Strategy Deployment
Real time
documentation
50
POR Ramp
45
40
CI meeting to
show trends
Act
Plan
35
Immediate
action taken
CI
loop
25
15
Total
10
5
RFT specialist
enters it in the
tracker
Check
30
20
Communicate
and Implement
change
Do
Monitor
Change
Standard Work Design
Total Delay to start (October) - Hours
0
-5
JDI-M1
Daily
meeting SW
track
progress
Quick Changeover (SMED)
Visual Control
NSI
OE Strategy
Elements
Informatics
Tiered Accountability
Visual Workplace(5S)
Root Cause Analysis
Operator Care
Process Confirmation
Leader Standard Work
Operational Excellence Roadmap
LSW
M1s
Some Key ‘OE Tools’ used in NSI Start Up
1) Work Place Set Up - 5S
2) Standard Work
3) Tiered Accountability
4) Informatics Strategy
5) Six-Sigma M1 Problem Solving
6) Six-Sigma RFT approach to Tech Transfer
1) Work-place Set-up - 5S
The 5S Process Consists of Five Pillars
Shine
Clean and ready to use
Standardize
Maintain the gains / CI
Sustain
Self-discipline
(Sort / Set in order)
Shine
Standardise
Suite 2 Nov 2010
80
70
60
50
40
30
20
10
0
01/1
0 /09
Score from audits
Bio Analytical 5S audit scores 2009
Score
Dates of audits
Sustain
29/1
0 /09
A place for everything…
22/1
0 /09
Set in Order
15/1
0 /09
Necessary vs. unnecessary
08/1
0 /09
Sort
5S Roll Out – Can’t Start Too Early !
I.
Started with prelim. design
layouts flows
II. 3D model used to validate space
allocation
III. “The cardboard phase”, mock ups
field checked
IV. Finally creating the visual
workplace and certification
5S
2) Standard Work
• Standard work is a key Lean approach
• SW designed to make issues visible – deviations
from plan = CI opportunities
Team owns
the work
If < std then M1
If > std then M1
If = std run again
• CI culture is the end-game
Root cause ID
Real fix put in
place
Operations Team Workshops December 2012
Team Compares
actual vs.
standard
C.I.
Cycle
Team runs the
work (scientific
method
experiment)
Team
standardises
the work
Standard Work in NSI Start Up
Fixed Repeating Schedule
Frees Up White Space for CI
Tier 1
Index Cards
Non
Standard
Work
Job Cards
Standard
Daily
Activities
Batch
Batch
Sequence
Activity
Equipment Preparation
Buffer Preparation
Chemistry
MBC Fill
Act
Plan
Check
Do
Act
Plan
Check
Do
Act
Plan
Check
Do
Tier 2
Task
Tier 3 – Allocation of Work per Tech on Shift
SUITE 1 SHIFT B Tier 3 Schedule
TIER 3
06:45
1
Dave B
38318
2
Eamonn
38830
3
Pelicardo
38463
4
Andrea
(ERT) 38799
5
Michal Z
38828
6
Michal N
38838
7
Stephen
38451
8
Fergus
38460
9
Danny
38572
10
Dave M
38452
7
8
9
10
11
12
1
2
Handover
7F DMSO Transfer
7F DMSO Transfer
7F DMSO Transfer
7F DMSO Transfer
UF10 CIP&S
UF10 CIP&S
UF10 CIP&S
UF10 CIP&S
Handover
Close out 6B FDF
CIP&S
Close out 6B FDF
CIP&S
Close out 6B FDF
CIP&S
Close out 6B FDF
CIP&S
M1 Project
M1 Project
M1 Project
M1 Project
6
7
UF90 Prep
UF90 Prep
UF90 Prep
UF90 Prep
Handover
RWS UF01
3
RWS UF02
4
RWS UF03
5
RWS UF04
Handover
M1 Project
6B Poly Thaw Start
M1 Project
M1 Project
Handover
Holidays
Holidays
Holidays
Holidays
Holidays
Holidays
Holidays
Holidays
Holidays
Holidays
Holidays
Holidays
Handover
Handover
Documentation
Documentation
Documentation
Documentation
Documentation
Documentation
Mon WFI Samples
Mon WFI Samples
Mon WFI Samples
Mon WFI Samples
College
College
Handover
Handover
SIP PV41
SIP PV41
SIP PV41
Large Buffer PV41
Large Buffer PV41
Large Buffer PV41
Large Buffer PV41
CIP PV39
CIP PV68
CIP PV68
CIP PV68
CIP PV68
Scrap CRM
CIP PV39
CIP PV40
CIP PV40
CIP PV170
CIP PV170
CIP PV170
CIP PV170
Mobile Vessels
Handover
Handover
Holidays
Holidays
Holidays
Holidays
Holidays
Holidays
Mobile Vessels
Mobile Vessels
Mobile Vessels
Mobile Vessels
Mobile Vessels
Handover
SIP PV41
SIP PV41
SIP PV41
Large Buffer PV41
Large Buffer PV41
Large Buffer PV41
Large Buffer PV41
CIP PV39
CIP PV39
CIP PV40
CIP PV40
Handover
CIP PV68
CIP PV68
CIP PV68
CIP PV68
CIP PV170
CIP PV170
CIP PV170
CIP PV170
Handover
Close out 6B FDF
CIP&S
Close out 6B FDF
CIP&S
Close out 6B FDF
CIP&S
Close out 6B FDF
CIP&S
Training Champion
Training Champion
Training Champion
Training Champion
RWS UF01
RWS UF01
RWS UF01
RWS UF04
Handover
Handover
5S Workshop
5S Workshop
5S Workshop
5S Workshop
5S Workshop
5S Workshop
5S Workshop
5S Workshop
5S Workshop
5S Workshop
5S Workshop
5S Workshop
Handover
Handover
7F DMSO Transfer
7F DMSO Transfer
7F DMSO Transfer
7F DMSO Transfer
UF10 CIP&S
UF10 CIP&S
UF10 CIP&S
UF10 CIP&S
UF90 Prep
UF90 Prep
UF90 Prep
UF90 Prep
Handover
Handover
Tier 3
Process Step 1
Process Step 2
Process Step 3
etc.
Allocation
of work to
Tech 1,2,3,4
Standard Work in Start up – Take Aways
• Fewer delays – kept schedule on track
• Enhanced daily meeting effectiveness
• Reduced process variability
• Improved quality – RFT % high
Key Take Away
• Freed up ‘White space’ with technician on floor…Turbo boosted our CI Loop
(averaging ~25 improvements / technician / year)
Weekly
3) Tiered Accountability
All meetings are:
• Brief
• Stand-up
• In the workplace
• Defined by a visual display
Business
Team
9:00am
Projects
Supply Chain
Team
Just-Do-Its , Team
Based Problem Solving,
Projects
Shift
8:00am
Local Team
(Line and
Functional)
Shift
Handover
Meetings
Just-Do-Its
Just-Do-Its and
Team Based Problem
Solving
Leaders
Standard
Work
4) NSI Informatics Strategy
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Goal : An integrated data
aggregation and visualisation
solution for NSI continuous data
Turn data in knowledge!
200 C/KPPs, ~2000 NKPPs
Benefits:
Automation of the
routine process
monitoring
Real time e-mail alerts
if outside NOR
Automation of the
control charting of
process data for APQR
Define
Measure
Analyze
Improve
5) Six-Sigma DMAIC Method
• Method 1 - Structured approach to get to real root cause
• Cross functional team
• Reactive & Proactive M1s
• 100% Trained / 50% yellow belt cert for PVs
• Method 1s became the common language during start up
Effect
Cause
Materials
Measurement
Equipment
Problem
Statement
People
Environment
Methods
Control
6) Six-Sigma RFT approach to Tech Transfer
Proactive M1 use to develop TT plan early
 Learn lessons from previous TTs
Capture Tacit Knowledge
 Ops & TS Embeds at sending site
 Process SMEs secondments at receiving site
Perform Detailed Gap Analysis
 Deep dive… Focus on minimising Gaps, Risk assessments key
 Tracking Gap closure – Lab Studies & Demo Batches
Key Take Away
Very important to keep track of changes at sending site , weekly
communication via SMEs invaluable
5
6
Setting up NSI Project OE Philosophy
- What worked for us !
• Create clear OE vision , Keep it simple
• Best to build in from the start
• Open & candid communication
• People need to buy into it – “ it’s the way we do work
around here.. It’s not extra work !”
NSI Project – Operational KPIs
• Batch Schedule milestones met
• 33 PV batches over 6 months
– 100% success rate
– ‘Right First Time’ 85%
– Deviation Rate ~1.3/Batch
• Successful IMB / FDA inspection
Summary
NSI Project - Key Success Enablers
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Team empowered, experience w/ continuity
Clear communication of project vision
Detailed progress monitoring tools
Robust change management process
Operational Excellence built in from the start