This document discusses the roles of maintenance in enabling operational excellence at pharmaceutical companies. It outlines how adopting a total productive maintenance (TPM) approach and focusing on planned maintenance, autonomous maintenance, and focused improvement can help reduce downtime and costs. Some key achievements discussed include implementing OEE metrics, developing energy management programs, and improving maintenance key performance indicators over time through the TPM approach. Challenges that can arise include lack of data accuracy, weak root cause analysis practices, and ensuring maintenance remains focused on business results and continuous improvement.

1. Maintenance Organization roles for
enabling Operational Excellence
a Novartis company
Marcelo Costa
Pharma M2R Minds 2014, Berlin - Germany

2. Agenda
Sandoz overview
Introduction
Roles and Traps towards Operational Excellence
Achievements
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3. Sandoz is a Novartis Group Company
Environment Patient needs
Affordable
options
Self-care
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Novartis portfolio
Full range
of health-care
options
Innovative
medicines
Prevention
Pharmaceuticals
Eye Care
(Alcon)
Sandoz – Generics and
Biosimilars
Consumer Health
(OTC)

4. Sandoz is a global leader in generics
6,252
5,875
2,580
2,237
2,095
11,071
1 Pro forma by including all acquired companies; figures reflect sales for generics and OTC businesses only, including API and excluding originator (e.g. Copaxone ®) and proprietary
business (e.g. Women’s Health)
Note: All trademarks, logos and pictures are the property of the respective owner
Source: Company annual and quarterly reports; Factset
4 Maintenance roles for enabling Operational Excellence | Pharma M2R Minds 2014, Berlin - Germany
Sells products in over 160 countries
Over 26,500 employees worldwide
Portfolio of 1,100 compounds
and 24,000 SKUs
Rich pipeline with 800 projects
Biosimilars pioneer and #1 globally
Leader in differentiated generics
(#1 in generic injectables,
dermatology, ophthalmics and
antibiotics)
Top Generic companies, 2013 sales1
USD million
2,157
1,815
9,159

5. Sandoz operates in over 160 countries
backed by a strong global network
Holzkirchen Rudolstadt
Melville /
Hicksville
Wilson
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Sandoz FTEs presence
Sales through local partners
Development
Production
Cambe Gebze Turbhe
Strykow /
Warszawa
Kaminoyama
Zhongshan
Barleben /
Osterweddingen
Boucherville
Broomfield
Unterach
Kalwe
Kundl /
Schaftenau
Ljubljana /
Mengeš
Spartan Jakarta
Mexico
Gerlingen
Prevalje /
Lendava
Algiers
Targu Mures
East Hanover

6. Agenda
Sandoz overview
Introduction
Roles and Traps towards Operational Excellence
Achievements
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7. Continuous Improvement Strategy
Planned Maintenance as one of the Key Pillars
Site Continuous Improvement
Process Engineering
Focused
Improvement
Autonomous
Maintenance
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Training and
Education
Office TPM
DRIVE*
OEE/ PRODUCTIVITY –– THROUGHPUT TIME –– COST SAVINGS
TPM - new In place
* program focused on bottom line
savings generated as a result of
Continuous Improvement activities
Planned
Maintenance

8. Introduction to TPM
Fundamental Objectives:
Prevent the equipment deterioration thru inspecting and operating it correctly
Establish the basic conditions to maintain equipment performance
Improve productivity and reduce of Repair and Maintenance costs
Develop people knowledge and skills
OPERATIONS MACHINE MAINTENANCE
Parents Baby Doctor
TPM is considered
as the “medical
science of the
interaction of
humans and
machines”
TPM “Vision to Success” in Pharma
It is a culture focused in the personnel and equipment improvement in order to produce quality
product the first time
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9. OEE implementation:
Concept definition
Pilot Lines
Expansion for tableting,
capsuling and
packaging lines
Losses tree stratification
Maintenance KPIs:
Equipment Unavailability
• Packaging Lines
• Tablet Press
• Utilities
• High Bay Warehouse
Preventive Maintenance %
Calibration %
Operational Excellence Award 2009
DRIVE program
Energy Management
Introduction of Energy Manager
PDCA cycle and Project Portfolio
Management
Introduction of Energy Team
Team Excellence Award 2011
Energy Team
2007 2008 2009 2010 2011 2012 2013
Maintenance KPIs:
MTBF and MTTR
• Packaging Lines
• Tablet Press
Energy Efficiency KPIs:
Electricity Consumption
LPG
Diesel
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Energy KPI:
Water Consumption
Additional responsibility
Equip. Qualification
Energy Management
System
On-line Electricity
Monitoring
Maintenance KPIs:
MTBF, MTTR for Utilities System
MTBF, MTTR and Unavailability for all
Manufacturing Area
Overdue Corrective Maintenance (30,
60, 90 days)
Overdue Predictive Maintenance (30,
60, 90 days)
Additional responsibility
Lab Equip. Maintenance
Planned Maintenance Roadmap
TPM Kick off
Planned Maintenance
as a fundamental pillar

10. Agenda
Sandoz overview
Introduction
Roles and Traps towards Operational Excellence
Achievements
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11. Increased Environmental Complexity
Operational Excellence embedded into daily maintenance activities
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Focused
Improvement
Planned
Maintenance
Autonomous
Maintenance
Training
Education
DRIVE
Quality HSE
Chaotic scenario at the beginning
of the Asset Care deployment
driven by:
High level of unplanned downtime
and maintenance activities
due to:
Initial Challenge:
Making TPM part of the
normal day to day activities
70-90%
10-30%
Corrective Maintenance
(emergency maintenance)
Preventive Maintenance

12. Maintenance as a value-adding department
Beyond asset downtime maximization
GMP
Impact
HSE
Impact
Business
Impact
12 Maintenance roles for enabling Operational Excellence | Pharma M2R Minds 2014, Berlin - Germany
impact
impact
impact
Critical Factors:
‘Criticality Assessment’
prioritises equipment in order
of importance to the business
and supports Maintenance
Strategy in terms of:
Tactics used for developing
maintenance plans
Priorities for Planning and
Scheduling
Spare Parts management
A. Product Quality
B. Health, Safety,
Environment
C. Business Impact

13. Asset Care Strategy connected to Business Needs
Reduction of maintenance costs through criticality/risk based approach to maintenance
Productive
Maintenance
Maintenance
Activities
Improvement
Activities
Preventive
Maintenance
Breakdown
Maintenance
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Autonomous
Maintenance
OPERATIONS
MAINTENANCE
Time Based
Maintenance
(TBM)
Condition Based
Maintenance
(CBM)
Clean to Inspect
“Sources of Contamination” and
“Hard to Access Areas”
Training in equipment Operation
and Failure Modes
Minor Breakdown
Maintenance
(BM)
Major Breakdown
Maintenance
(BM)
Standards for Cleaning, Inspection
and Lubrication
Planned Maintenance (PM)
Abnormalities identification and
elimination
Training in equipment Failure
Identification and Reporting
Predictive techniques
Early Detection of
Faults / Failures
Restore the Basic
Equipment
Conditions
Maintain Those
Conditions
Corrective
Maintenance
(CM)
Problem solving of
equipment failures
(Sporadic and
Chronic losses)
Training in equipment Failure
Correction (Skills Matrix)
Losses stratification
P-M Analysis
RCA
Recurrence Matrix

14. Critical Analysis of Maintenance Indicators
The Achilles' heel of Maintenance Department
1. Decision making based on gut-feeling
rather than data (no specific maintenance
KPI’s)
2. Lack of Failure analysis
3. Lack of meeting discipline and/ or
discussions without any outcome
Failure analysis and improvement
1. Select a failure and identify where
defects were first introduced through
the use of root cause analysis
2. Apply formal CI in maintenance
activities - use charts (indicators) to
prioritize problems and start with „A“
priorities
3. Empower your team towards
commitment (don‘t let accountability
fade due to not showing up)
Picture’s Source: II SEMINÁRIO AMAZONENSE DE MANUTENÇÃO Alan Kardec 25/05/12
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Overview
Do
WHO WHEN Status
Blisterflex Linha 2: Tivemos problema de quebra
de rolamento e desgaste das guias lineares
O conjunto encontrava-se danificado devido a soltura das
esferas do rolamento linear
Alteração da task list de manutenção
Marcos
Abra
30-mar-12 CONC LU DED
Cartopack Linha 2: Quebra de Taliscas
As taliscas se quebram devido o blister ter comprimento
mínimo estipulado, e caso haja alguma diferença entre as
mesmas ocorre o enrrosco e consequente quebra
Alteração do formato das guias de blister ( R$
8.000,00)
Marcos Abra30-mar-12 ONGOING
Blisterflex Linha 6: Tivemos problema de quebra
da mola de retorno da faca de corte.
Ocorreu a quebra da mola por fadiga Criação da Task list de manutenção para facas Marcos Abra30-nov-11 CONC LU DED
Cartopack Linha 6: Ocorreu um furo na mangueira
de sucção do vácuo na formação de cartuchos
A mangeira se desgastou por ficar em contato com a chapa
de proteção do equipamento
Criação de um ponto de apoio para fixação da
mesma
Tiago Lessa 15-jan-12 CONC LU DED
JAN
CAPDo
Check Analyse Plan Result

15. Predictive Maintenance
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Optimization of internal processes:
e.g. calibrations frequency
69%
90%
10%
Planned Maintenance
Continuous improvement of maintenance services
Spare parts: White vendor

16. Autonomous Maintenance
Simple mechanisms for addressing and solving problems, before they occur
- implement countermeasures against
contamination, hard to access areas to
clean, inspect and lubricate.
Initial Cleaning
4 1
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-Remove dust and dirt
on and around the
- equipment to
ensure basic
Inspection
- Identify inspection and
lubrication points
- Identify and inspect:
Flaws
Basic Conditions
Hard to access areas
Sources of contamination
Safety
Lubrication points
Surrounding area
Countermeasures
Abnormalities tagging
- Flaws, Basic Conditions and
Safety abnormalities are
identified and recorded
Establish the
basic
conditions to
maintain
equipment
performance
3 2
GMP rules
and enable
inspection

17. Autonomous Maintenance
Teamwork Communication Challenges
What theory says... What practice shows...
ZERO FAILURES
AND
ZERO DEFECTS
Autonomous
Maintenance
Planned
Maintenance
Level of responsibility drops (e.g. tagging)
Lack of teamwork (e.g. ‘You operate, I fix’)
Lack of knowledge transference for operators to properly
identify and fix abnormalities (e.g. tasks transfer)
Lack of feedback about abnormalities reported (tags)
Lack of top-down empowerment of maintenance staff
Natural resistance to change
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Maintenance Operations

18. Autonomous Maintenance
Operation asset care asset accountability
TPM is not a Maintenance program
− Engineering Know-How is crucial to
make it happen
PU Heads and Line Managers not
involved might lead program to fail
− Determine how fast result is attainable
− Training to the management group to
show them the value of the AM
The program is not incorporated to
the day job
− Objectives linked to bonus scheme
− Resources and support (external or
internal) planned in site’s budget
Equipment reliability driven
exclusively by maintenance staff
− Be more open to operator asset care
Personnel development for
unskilled workers
− OPL and skill matrix focused on raising
the skill of personnel to understand, own,
and improve their equipment
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19. Autonomous Maintenance
Maintenance enabling TPM tools against Quality issues
45
30
15
0
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# of deviations by cause
45
24 21 22

20. Housekeeping and 5S practices
Success is not only about application of tools, but also changing behaviours
Basic housekeeping is pivotal to reduce equipment failure, eliminate HSE
risks and uncover hidden waste
Contamination
Slackness
Vibration
ABNORMALITY
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Spare parts and materials
Productive area

21. Focused Improvement
Maintenance accountability for KPI’s data collection and PDCA cycle effectiveness
You don’t get clean
decisions from dirty data Check:
Lack of “accurate” data
− Stoppages booked by
operators not checked by
maintenance staff
− Seen as additional workload
− It‘s not about staff control
− SAP PM vs. OEE systems
Lack of root cause analysis culture
− Focus only on operational and short term
urgencies (no recurring down time analysis)
− Lack of transparency (“indicator phobia”,
misuse of data)
− Lack of sponsorship
− Unavailability of specialized resources
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Examine
and
Expose
problems
Analyse:
Counter
Solve
Plan:
Prevent
recurrenc
e through
improvem
ent
Do:
Execute
follow
standards
rules

22. Focused Improvement
PDCA cycle and Project Portfolio Management applied for Energy Management
Project Selection Portfolio Management
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23. Communication
Having TPM on the agenda at all levels of the organization is essential to its success
Monthly Agenda
Consultant
Agenda
Weekly Agenda
Lack of meeting discipline (e.g. people don‘t show up, not
sticking to the agenda)
Be organized (Visits can be a «burden» if not aligned with other site
priorities)
Create a local visual management (e.g. board) where main
information and updates can be posted
Show up with frequency (but not take the responsibility away from
the team)
Establish walk-troughs to check the work and coach the adjustment
Get site manager to visit the meeting regularly
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24. TPM experience
Right balance between maintenance staff and internal/ external consultants
Focus on Results
Ensure that the process does not
become more important than the business
results
Show how they will be successful
Improving the
equipment will be well-supported
by operators
External Support
Benchmark to other
sites to show practical
practices
More cultural
awareness and
understanding of local
situation
More knowledge of specific skills (e.g.
SAP-PM, PM tasks, etc.)
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Maintenance effectiveness
PM plans must have a formal annual
review process
PM tasks optimized acc. learnings and
specific knowledge
Solving well-known
problems will strengthen
support for the TPM
project
Empowerment
TPM implementation
is more efficient and
sustainable when the
Team owns it
Team members are
the best persons to
identify and eliminate problems
Reward for their contribution to change
success
Promote TPM and best practices on site

25. Agenda
Sandoz overview
Introduction
Roles and Traps towards Operational Excellence
Achievements
25 Maintenance roles for enabling Operational Excellence | Pharma M2R Minds 2014, Berlin - Germany

26. Maintenance Performance
Machine Unavailability trend and Maintenance Plans compliance
2,9%
Unavailability (Tableting)
-76,1%
1,0%
2013
1,4%
2012
0,7%
2011
1,8%
2010
4,1%
2009
2008
162
47
18
244
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-88,2%
1,1%
2013
1,1%
2012
1,4%
2011
2,3%
2010
3,8%
2009
9,6%
2008
Unavailability (Packaging)
+161%
166
2012
637
2011
2010
2009
2008
SAP-PM - Maintenance Plans
On Time Execution – Preventive Maintenance
98,7%
2012
98,3%
2011
97,4%
2010
95,8%
2009
91,7%
2008

27. Thank you for your time!
For further contact:
27 Maintenance roles for enabling Operational Excellence | Pharma M2R Minds 2014, Berlin - Germany