Proud of taking part of it

1. Increasing OEE throughout Manufacturing Operations
Frederico França Giunchetti
Engineering Head – Cambé / Regional Engineering Coordinator - LATAM
a Novartis company

2. Objective
This study will present a real case in the Pharmaceutical industry
where, after starting up a new site and understanding its
competitiveness inside the Company and the Market, there was the
need to redraw processes.
By using some tools and concepts from TPM (Total Productive
Maintenance), Lean Manufacturing and Times-and-Methods,
implementing a losses tree structure for the main equipment and
rebalancing the products in the lines considering capacities and
flexibility, the Manufacturing and Packaging lines came up from
around 20% to 50% of OEE in less than 24 months.

3. Summary
1. Welcome to Cambé site, Brazil
2. Initial scenario
3. SPA – Process Improvement Culture in the site
4. Implementing OEE and its analysis from the beginning
5. Understanding the root-causes of equipment stoppages
6. People Development
7. Rebuilding the production / maintenance plans
8. Using the right equipment to the right product (Process Engineering)
9. Results
10. Next steps
11. Conclusion
12. Contact

4. 1. Welcome to Cambé site, Brazil
Capital: Brasília
Area: 8,5 millions km2
Population (2010): 190 Mio
Population Growth (2000-2010): 1,17% Cambé (PR) –
GDP growth: 7.5% (2010) São Paulo (SP)
~ 550 km

5. 2. Initial Scenario
Very high Lack of “prevention Imported equipment
throughput time mindset”, only without technical
High difficulties to (around 100 days) corrective actions assistance in the
hire qualified people region
in the region
Very young age average Lack of methodology for
in the site – lack of problems solving
professional experience Brandnew site in 2007
(2,5 years of operation)
Maintenance plans in
New equipment – low
Excel
level of maintenance
and breakdowns
Packaging and Production plans
Manufacturing developed manually
State-of-art GMP OEE around 20%
Motivated
and HSE
team
standards

6. 3. SPA – Process Improvement Culture in the site
SPA
Focused Autonomous Planned Training and
Improvement Maintenance Maintenance Education
5S Visual Controls Gemba Process Engineering OEE
Value Stream Mapping SMED Kaizen Standard Work PDCA
GMP HSE Kanban Ishikawa / 4Ms / 5W+1H Finance analysis

7. 4. Implementing OEE and its analysis from the
beginning (the rise of TPM in the site)
Start in a simple way: data collection doesn’t need to be automated
Definition of an objective way for the operator registers the cause of the
stoppage
Development of Excel spreadsheets to receive the data and automatically
calculate OEE, equipment utilization, MTBF, MTTR, etc.
Then the information is there for analysis!
• Stoppages hand- • Stoppages recorded manually by • Daily reports analysis by
written on templates one trainee in Excel files shop-floor staff
by operators

8. 0
5
10
15
20
Sem Programação
Refeição
MTBF (h/ Set Up Tipo A (Lote)
quebra/falha) Set Up Tipo C (Com
Set Up Tipo D (Sem
Aguardando Produto
Conjunto de
0
1.000
2.000
3.000
4.000
5.000
Organização Turno
Conj. Acionam. Eletro-
Raspador de pó
Jan
Limpeza Durante o
MTBF Acumulado
Falta de Mão de Obra
Limpeza Ferramental
Ajuste Fino
Fev
Balança (Aferição)
Amplificador
Conjunto de Punções
Sistema de Ar
Mar
Falta de Material
Ginástica Laboral
MTTR Acumulado
Material não
Treinamento/Reunião
Abr
Punções
beginning (cont.)
Mesa de Fill-omatic
Conjunto Fill-omatic
Lote Piloto
Mai
Set Up Tipo B
Plano de Limpeza
0
5
10
15
20
Energia Elétrica
Água Purificada
Jun
Aguardando
Aguardando
Aguardando
A
11
Stratification of stoppages
Aguardando SIDE
per equipment part and reason
Jul
1,2
Aguardando
Manutenção
Fette 1 Descompactação de
Qtdade de Set up´s
Sistema de
Ago
Coluna de Elevação
Conjunto Detector de
Check-master
0
B
Conjunto
0,0
Set
Rolo de Penetração
Fill-omatic
Amplificador
Check-Master
Out
Desempoeirador
Slow gate
Tempo médio de set up
2
Raspador de
C
Impressora
4,9
Nov
Falha de
0
1
0,2
0,4
0,6
0,8
1,2
1,4
Average setup tim e
Dez
2
D
%S
4,4
TGT
3ºturno
1ºTurno
2ºTurno
4. Implementing OEE and its analysis from the
PY
15
Total
0,0
0,5
1,0
1,5
2,0
2,5
3,0
3,5
2,1
(h)
0
2
4
6

9. 5. Understanding the root-causes of equipment
stoppages
SELADORA HOT MELT 02 BR11-P352-SE002 24.01.2009 Marcos Abra
GUK DE BULAS BR11-P356-ZZ001 12.05.2009 Marcos Abra
Problem solving Critical Analysis
GUK DE BULAS
ENCARTUCHADEIRA CARTOPAC
EMBLISTADEIRA BLIPACK 240 II
ENCARTUCHADEIRA CAM
BR11-P353-ZZ001
BR11-P353-CT001
BR11-P304-BP001
BR11-P354-CT001
01.06.2009
20.06.2009
24.06.2009
24.06.2009
Marcos Abra
Marcos Abra
Marcos Abra
Marcos Abra
BALANÇA GARVENS BR11-P354-CW 004 24.06.2009 Marcos Abra
tools SELADORA HOT MELT 04
GUK DE BULAS
BR11-P354-SE004
BR11-P354-ZZ001
Action
1) Seladoras Hot melt: Será realizado a task list de manutenção para os equipamentos de Hot melt, dividindo as
24.06.2009
24.06.2009
Marcos Abra
Marcos Abra
Responsible
Jun 2009 manutenções em dois periodos, sendo uma frequência semestral e a outra anual. Será realizada tambem a revisão
Marcos Abra
dos Spare Parts para que ocorra a substituição e envio de peças para reforma no período semestral ( Mangueiras
e módulo de Injeção).
2) Guk de Bulas: Será realizado a revisão da task list de manutenção para os Guk de bulas, dividindo as
Improvement manutenções em dois periodos, sendo uma frequência semestral e a outra bianual. Será realizada tambem a revisão
Plan dos Spare Parts para que ocorra a substituição e envio de peças para reforma no período semestral (Rolos de Marcos Abra
Borracha). Com o treinamento realizado com o técnico da ATIMA, nossos manutentores se capacitaram para
realizarem a manutenção deste equipamento.
Encartuchadeiras e Emblistadeiras: Esta em estudo a implantação de manutenção preditiva para estes
equipamentos( Termografia, Análise de Vibração e Lubrificantes ) o que proporcionará melhor acertividade nas Marcos Abra
atividades e previsão de tempo de máquina parada para manutenção, facilitando a negociação com pcp e produção.
Root Cause
Analysis
Action Plan Action Plan
3 4
A P
establishment
Losses tree C Do
5
stratification Problems
Stratification
2 Actions
Implementation
6
100% 0,7% 0,1% 1,4%
3,0% 3,4% 0,7%
5,6% 1,2% 5,6% 4,3% 3,8% 5,6% 2,6% 5,0% 1,6% 0,3% 5,0%
1,5%
11,8%
6,6%
7,8% 12,0%
15,9%
6,0% 7,8%
15,0%
7,6%
8,3% 9,9%
1 Measurable
20,0%
17,1%
15,4% 14,0% 13,6% 19,4% 6,4%
11,1%
7
80%
31,1% 23,7% 9,6%
28,8% 23,6%
29,5%
4,2%
34,7%
33,5%
21,3%
23,2% Improvement
48,0%
19,8%
10,6%
49,8% 8,1%
15,5%
8,7% 6,9%
13,2% 44,7%
5,1%
8,8%
5,8% 0,8%
Initial Situation Evaluation
46,4% 1,3% 1,4%
1,4%
60% 0,7%
8,3% 13,9% 16,4%
15,1%
13,1% 13,4% 11,2%
1,3%
3,1% 7,7% 16,7% Diagnosis
% h o ras
1,7% 0,9% 14,2% 6,2% 62,9%
16,4%
27,6%
10,4% 51,4%
10,2%
3,5%
1,1%
11,1%
8,3% 8,1%
12,1%
5,0% 85,8%
61,2%
3,4%
7,4%
Closing, lessons learned and roll out,
9,2% 1,7%
40% 20,0%
10,0% 14,0%
9,9%
63,8%
11,8%
70,8%
1,0%
if possible
Resultados 2,9% 54,1%
47,9% 49,5% 49,7%
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
43,1% 40,4% 0,5%
1
2
3
4
5
6
7
8
9
20% 40,8% 39,7% 39,8% 0,6%2,5% 2,5%
36,8% 2,0% 37,0% 37,6%
0% 28,8% 30,5% 25,0% 36,8% 29,1% 17,6% 0% 40,8% 37,0% 47,9% 63,8% 0,0% 0,0% 0,0% 49,5% 39,7% 43,1% 40,4% 27,6% 0,0% 0,0% 70,8% 39,8% 49,7% 0,0% 17,7% 17,5% 0,0% 54,1%
28,8% 30,5% 29,1% 27,6%
0,0% 10,0% 0,0% 25,0%
27,6% 0,0% 2,0% 10,2% 9,2% 0,0% 0,0% 1,1% 11,1% 8,3% 0,0% 11,8% 8,8% 5,0% 6,2% 2,5% 2,5% 7,7%
0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 17,6% 0,0% 3,5% 0,0% 0,0% 1,7% 0,0% 0,0% 0,0% 12,1% 0,0% 0,0% 0,0% 17,7% 17,5%
0,0% 0,0% 0,0% 0,0%
OEE daily
0,0% 0,0% 0,0% 0,0% 9,9% 51,4% 8,3% 13,9% 0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 3,1% 85,8% 0,6% 61,2% 1,4%
0% 0,0%
0% 16,4% 2,9% 1,3% 0,0% 0,0% 0% 0,7% 1,4% 0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 13,1% 13,4% 1,7% 0,9% 0,0% 0,0% 4,2% 0,0% 0,0% 0,0% 0,5% 11,1%
0,0% 5,8%
20,0%
1 19,8%
2 14,0% 10,6% 5
3 4 10,4% 68,1% 7 8 31,1%9 15,5% 16,4% 8,7%
10 11 12 13 14 15 15,1% 17
16 6,9% 18 13,2% 198,1% 20 11,2%21 22 23 15,9%24 14,2% 33,5% 6,4% 62,9%
25 26 27 28 297,6% 30 Acumulado
21,3%
0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 0,0% 9,6% 0,0% 0,0% 0,0% 0,0% 5,1% 0,0% 1,3% 0,0% 0,0% 0,0% 0,0% 0,0%
48,0% 20,0%
OEE 46,4% 17,1% 49,8% 15,4%
Perda de output Mecânica (Ajuste e Manutenção) 23,7% Elétrica (Ajuste e Manutenção)
7,8% 14,0% 13,6% 28,8% 23,6% 19,4% 44,7% 29,5% Limpeza
Ajustes Gerais Espera 0,0%
Set up 34,7%Outros
6,0% 7,8% 15,0% 0,0% 8,3%
3,0% 3,4% 11,8% 6,6% 0,7% 5,6% 1,2% 5,6% 12,0% 4,3% 3,8% 5,6% 2,6% 5,0% 1,6% 0,3% 5,0% 1,5% 0,7% 0,1% 1,4%
measurement
70,0%
60,0%
50%
50,0%
45,8% 45,9% 44,3%
42,7% 42,3% 41
,6% 41
,0%
O EE (% )
40,7% 40%
40,0% 39,5% 39,5% 38,8%
35,9%
33,4%
30,0%
26,5%
25,8% 25,5%
24,1
%
20,7%
20,0%
10,0%
0,0%
Resultados:
Jan Fev Mar Apr May Jun Apr Aug May Oct Jun Dez Jul Target PY
Jan Fev Mar Jul Sep Nov YTD Aug Sep Oct Nov Dez YTD Target PY
OEE

10. 6. People Development (Training and Recognition)
Development matrix for Analysis of each associate
Training Plan for:
each function: in his function:
•All equipment operators
•All equipment operators •All equipment operators
•All maintenance
•All maintenance •All maintenance
professionals
professionals professionals
• All lab technicians
•All lab technicians •All lab technicians
Implementation of a
Investment on trainings
recognition program for
the good ideas
People Development are high in the beginning.
(Keep in mind to have
(Productivity, Quality, HSE,
flexibility for the functions)
etc.)
Implementation (together with HR) of a good salary
Implementation of a
program in order to keep qualified people. It’s better
results-based BSC
to have few qualified and motivated people than
(Balance Score Card) for
having many low qualified and demotivated
the Maintenance team and
associates
main operators (analyze
the high-performers)

11. 7. Rebuilding the production / maintenance plans
Production Plans: Maintenance Plans:
• Production planning was controlled by Excel • Maintenance planning was controlled by Excel
spreadsheets, impacting highly the best productive spreadsheets, impacting highly the control, follow up and
sequence and, consequently, the product inventory and traceability of Maintenance Orders.
the work in process. Consequently, the Throughput time • There wasn’t any KPI to reflect the Maintenance
was very high: Performance.
Status before TPT focus: How we did it?
• Total TPT in days: 99 days YTD 2007 • Implementation of some main KPIs for Preventive
Maintenance, Calibration, Breakdown Maintenance and
How we did it? Utilities unavailability
• Monthly meetings to perform a critical analysis on the
• Tight inventory policy
KPIs, action plans and follow up on them
• Better sales forecast accuracy
• Implementation of a very simple version of SAP (Plant
• Improvement in the Manufacturing and Packaging Maintenance Module)
planning
• OEE measurement implementation
Results:
• Multi-disciplinary team focusing on troubleshooting, etc.
• Weekly meetings and action plan for each deviation
• Maintenance and Calibration execution above 95%
according to the schedule
Results after TPT focus: • 100% of Maintenance Orders traceability
• Total TPT in days: 27 days YTD 2008 •.OEE improvement

12. 8. Using the right equipment to the right product
(Process Engineering)
Some questions to be • What is produced?
• High or low speed answered by the Process • When is it produced?
equipment? Engineering • How much is produced?
• Ideal size of batches?
• Make-to-stock or make-to-order?
• Ideal number of
• What to produce automated and
headcounts per line?
what to produce manually?
• Ideal number of shifts?
Best scenario for lines • New or old lines?
• Number of technical
occupation x OEE x • Yield of each equipment?
complaints per line?
number of headcounts • Need of harmonization for different
• Outsourcing or insourcing?
cartons/cases/leaflets?
Total FTE / Shift Time (hours/year)
Machines Shifts Full Capacity Occupation
FTE Ind. Dir Available In Operation
9 0 3 3 6.240 2.143 21,3 mio blisters 7,5 mio blisters 35%
Line 2
18 0 6 3 6.240 5.177 15,7 mio cartons 13,0 mio cartons 83%
9 0 3 3 6.240 4.541 31,3 mio blisters 22,9 mio blisters 73%
Line 3
6 0 2 3 6.240 4.541 17,8 mio cartons 13,0 mio cartons 73%
9 0 3 3 6.240 4.023 35,2 mio blisters 22,9 mio blisters 65%
Line 4
6 0 2 3 6.240 4.023 17,3 mio cartons 11,2 mio cartons 65%
3 0 1 3 6.240 4.224 22,2 mio blisters 15,1 mio blisters 68%
Line 5
6 0 2 3 6.240 4.224 10,0 mio cartons 6,8 mio cartons 68%
9 0 3 3 6.240 3.632 27,3 mio blisters 16,1 mio blisters 59%
Line 6
6 0 2 3 6.240 3.632 12,0 mio cartons 7,1 mio cartons 59%
Printing Area 3 0 1 3 6.240 5.795 97.878 Kg 91.027 Kg 93%

13. 9. Results
Tableting
1.200 120
100,0 100,0
1.000 100
OEE%, Mio SDU/FTE
800 75,4 73,1 71,7 80
67,0
Mio SDU
62,1
600 60
58,4 59,4
50,5 53,6
400 40
20,7
200 900 20
689 980 1.024 645 800
- 0
2007 2008 2009 2010 2011 2012
Volume Volume / FTE OEE

14. 9. Results (cont.)
Maintenance and Utilities Costs Evolution
1300
1223
1200 1100
1100 1199 1031 1099
1000
90 0 1004 853 927
773
80 0
70 0 636
60 0 577
50 0 438 507
40 0
30 0 307
20 0
10 0
3 shifts 2 shifts 2,5 shifts 2,5 shifts
0
ACT 2 009 ACT 201 0 ACT 2 011 TG T 201 2
Production Maintenance (Th US $) Utilities (T h US$)
Infraestructure M aintenance (T h US$) Calibration: s it e ins tr. + QC equip. (Th US$)
1) Values are corrected by inflation (IGP-M) from Dec of the ACT-Year to April/2012 and converted into US$ by 2012 official Sandoz Exchange Rate
2) Personal Costs are not included

15. 9. Results (cont.)
Indicator:
Planned x Executed Preventive Maintenance
Diagram: 2012
110%
97,4% 98,6% 99,4% 99,1% 100,0% 99,5% 98,8% 100,0%
100% 95,8%
0% 0% 8% 3%
90%
80%
70%
60%
99% 99% 97%
50% 92%
40%
30%
20%
10%
0,0% 0% 0,0%
0% 0,0%
0% 0,0% 0% 0%
0,0% 0%
0,0%
0% 0,0% 0,0%
0% 0,0%
0% 0% 0%
0% 0% 0%
0% 0% 0% 0% 0%
PY09 PY10 PY11 Jan Fev Mar Apr May Jun Jul Aug Sep Oct Nov Dez YTD TGT12 GOAL
Waiting documentation % Completed documentation % Execution %
Results:
Indicator:
MTBF - MANUFACTURING
Diagram: 2012
70
60,4
60
50
43,4
40,83 41,7 41,7 41,7 41,7
MTBF (hours)
40 38,73 41,7
41,7 41,7
39,89 41,7 35,00
30
22,27
20
10
0,00 0,00 0,00 0,00 0,00 0,00 0,00
0,00 0,00
0
PY09 PY10 PY11 Jan Fev Mar Abr May Jun Jul Aug Sep Oct Nov Dez YTD TGT12 GOAL
MTBF MTBF Accumula ted
Results:

16. 10. Next steps
SPA
Focused Autonomous Planned Training and
Improvement Maintenance Maintenance Education
5S Visual Controls Gemba Process Engineering OEE
Value Stream Mapping SMED Kaizen Standard Work PDCA
GMP HSE Kanban Ishikawa / 4Ms / 5W+1H Finance analysis

17. 10. Next steps (cont.)
LEAN/6-
SIGMA Operational
Excellence
(culture that focus
on extreme Improvement TPM
efficiency) focused on (culture that focus
Value-added on efficiency and
reliability)
Prevention of
deviations and failures
Regulatory Compliance
(HSE, GMP, 5S)

18. 10. Next steps (cont.)
The search for the REAL NORTH

19. 11. Conclusion
In principle, to create a high competitive site comparing to others inside the Company or the
competitors you need:
1. Measurement and analysis of productive data, establishing and following action plans
(KPIs)
2. Methodology for root-causes finding in order to establish the “right thing – first time”
culture.
3. Investment in people: trainings, better salaries, face-to-face management in order to
understand what motivates each one
4. Routine for improvements discussions in productivity, quality and HSE
5. Budget establishment for improvements implementation
6. A very qualified team of Process Engineering in order to always indicate the fastest and
cheapest way to produce
7.For sure, specific softwares like MES (Manufacturing Execution System) will speed up the
improvement process and are very important in order to make easy having data.
8.On-the-job example coming from the mid and top-managements in order to show the new
CULTURE and challenging the status quo
9. And finally, a vision For the Process Improvement Program linked to the site / Company
visions, highly supported by the mid and top-level managements........a North to drive the
activities and to indicate a clear way to the target

20. 12. Contact
QUESTIONS
AND DOUBTS
Frederico França Giunchetti
frederico.giunchetti@sandoz.com