Marcelo Costa - Pharma Talk 2013 Berlin

a Novartis company
Process Engineering and
Operational Excellence synergy:
a key driver for boosting cost savings and productivity results
Marcelo Costa
Pharma Talk, Pharmaceutical Manufacturing Excellence 2013
4 June 2013 Berlin, Germany

2 Process Engineering and Operational Excellence synergy | Pharma Talk, Pharmaceutical Manufacturing Excellence 2013 | Berlin, Germany | 4 Jun 2013
About this presentation
 The material presented today is an adaptation of the practical
experience of a local Continuous Improvement Program
integration into an established Process Engineering area which
both supported a Pharmaceutical plant to boost its Packaging
Area‟s objective of increasing productivity
• Purpose
• Deployment
• Achievements

About this presentation
 The case study presented today is about an oral solid plant...
Global
pressure
Local
pressure
 COGS
 Headcount
 Service level
 No Global approach for continuous
improvement
 ....
 Pricing pressure
 Generic players
 Long production lead-times, low-level
agility
 No local approach for continuous
improvement in place
 ....

Contents
1) Introduction
2) Continuous Improvement Deployment
3) OEE TGT and Losses approach
4) OEE & Productivity
5) Throughput Time
6) Cost Savings initiative

Contents
1) Introduction
5) Throughput Time

ExcellenceOptimizationPreventionStabilizationCorrective Action
Continuous Improvement – The Dilemma
a long but sustainable
journey ahead...
straight to
big wins!
Build-up in excellence
Sustainability
Short term focus
Contingency
Operational Process Performance

Key Challenges
Scenario
Objective
Challenges
 Increase plant capacity
 How would we justify the
investment, and make sure
you got the right equipment?
 How much extra capacity
could we find if we had less
losses?
 What problems could be
resolved by bringing together
people from different teams?
 Increasing volume forecast
 Products insourcing to
increase supply flexibility and
allow Interco transfers
 OEE did not meet capacity
needs, FTE reduction
pressure

Contents
1) Introduction
5) Throughput Time

Integration towards Business Goals
 Total Productive Maintenance (TPM)
implementation
 Focused Improvement Pillar focused on
identifying losses, performance
indicators, actions prioritization and losses
reduction
 Autonomous, Preventive Maintenance and
E&T Pillars focused on restore of basic
machine conditions, preventive plans and
staff training
 Leadership on production lead time reduction
and other continuous improvement initiatives
 OEE, performance metrics and standards for
product costing
 Packaging Development: harmonization of
specifications, materials optimisation and
operational improvements
 Yearly budget: OEE TGT and utilization with
optimized line allocation
 Fine planning: best product sequence
 Cost savings management across the site
 Capital projects for Innovation & Technology
enhancement
OEE/ PRODUCTIVITY THROUGHPUT TIME
 Reinforce OEE as the tool for
systemic Capital Asset freeing up
 Identify the main causes of non-
productive time
 Standards for costing
 Output, material and headcount
optimization
 Product allocation and sequence
 Address the gap between bulk
production and packaging
 Reduce bulk holding time
impacts
 Synchronise support processes
Process Engineering Continuous Improvement
COST SAVINGS
 Capital projects & new
technologies
 Generate opportunities for
costing savings and investment
with attractive payback periods
within pilot areas as well as the
entire organization

Continuous Improvement Deployment
Process Engineering
Focused
Improvement
Autonomous
Maintenance
Planned
Maintenance
Training and
Education
Office TPM
Site Continuous Improvement
DRIVE
Project
OEE/ PRODUCTIVITY –– THROUGHPUT TIME –– COST SAVINGS

Contents
1) Introduction
5) Throughput Time

OEE
 KPI to measure the overall
„health‟ of the Manufacturing
Operation and the key enabler
to increase capacity, and so
reduce capital requirements
OEE deployment: Should I measure the OEE of all work centers?
 NO!
 Identify the constraint operations of the
plant, because bottlenecks limit the
throughput of the entire system
 Improvement to any of the other operations
is of no benefit to the total process
Actual Process output
Target Process output
Maximum potential output

Losses Tree and Improvement Approach
Losses Attack &
Elimination:
Changeover Time
and Stoppages
Reduction
Unscheduled
downtime
Set up
Effective
Uptime
Adjustment
Breakdown/
Failure
Speed Loss
Minor
Interruptions &
Others
Free capacity
Unscheduled
downtime
Set up
Effective
Uptime
Adjustment
Breakdown/
Failure
Speed Loss
Minor Interruptions
& Others
Standard
Speed
Increase
Losses Attack & Elimination
 increase availability by reducing speed
loss, stoppages and C/O time
Standard Speed Increase
 reduce Effective Uptime by increasing Maximum
Validated Speed
Losses Tree is a systematic approach to speed
up loss detection and priority-set loss elimination
Losses
Trend
Analysis
Achievement of TGT OEE
 State clearly the logic of why
you chose your projects:
“Seeing is Believing”
Improvement
Projects
Maintainance of TGT OEE:
 Focused on identifying the
outliers and preventing
recurrence

Bottleneck Analysis: Utilization Assessment
CAMBE FACILITIES FULL CAPACITY [ % ]
DISPENSING tons/year 64%
SMALL DISPENSING tons/year 66%
MIXING tons/year 66%
GRANULATION 300kg tons/year 65%
GRANULATION 30kg tons/year 72%
TABLETING mio/year 84%
CAPSULING mio/year 65%
COATING 300kg tons/year 88%
COATING 30kg tons/year 37%
BLISTERING mio/year 88% Little room for shifts increase
CARTONING mio/year 95% No room for shifts increase
655
108
63
88
316
265
4
264
6
315
417
58
208
171
51
CAMBE FACILITIES OVERVIEW
70
55
5
84
15
96
54
USED CAPACITYWORK CENTER

TGT OEE and Improvement Plan
 Line Utilization and TGT OEE setting:
 OEE calculation based on last year losses
tree and volume forecast at SKU level
 OEE challenged to achieve Target
Utilization level
 Working groups defined according to
Losses Prioritization, Pareto stratification
and output increase projects
 Lines with higher utilization to be
prioritized

Contents
1) Introduction
5) Throughput Time

Packaging Optimization Cycle (1 of 2)
Set up stratification:
A: simplified cleaning
B: A + form/ sealing exchange
C: full cleaning w/o tooling exchange
D: C + form/ sealing exchange
E: blister size change
1) Product Allocation:
Optimize packaging lines thru reducing tooling
format changes:
– set up downtime
– material losses
– operators patience...
A
B
C
D
E
 Find the right balance, useful rules:
• high machine output  same blister size, low
blister per package ratio, high volume products
• low machine output  high mix, low volume, but
evaluate “A or B” items allocated to ensure
beginning of the month production
Scenario 1: 1 blister format
(h) # average
Set Up A 252 234 1,1
Set Up B 54 32 1,7
Set Up C 10 6 1,6
Set Up D 226 91 2,5
Set Up E 0 0 0,0
541 363 1,7
Set Up Losses Tree: 14,8%
Scenario 2: 2 blisters format
(h) # average
Set Up A 252 234 1,1
Set Up B 54 34 1,6
Set Up C 10 5 2,0
Set Up D 113 45,5 2,5
Set Up E 273 45,5 6,0
701 364 2,6
Set Up Losses Tree: 19,1%

Cartoner output is the mandatory
output of the entire line
180 blisters
minute
90 cartons
minute
divided by
2 blisters
carton
Before
divided by
1 blister
carton
180 blisters
minute
180 cartons
minute
After
Example:
10
tablets
per blister
3
blisters
per carton
Before
15
tablets
per blister
2
blisters
per carton
After
Packaging Optimization Cycle (2 of 2)
2) Blister Optimization:
Reduce the number of blister per finished
good at SKU level:
– increase output
– reduce material consumption
3) Secondary and Tertiary materials
A B C
54 x 30 x 120
54 x 44 x 120

Capital Projects for productivity increase
FB insertion into SB
 What: new semi-automatic case packer along with packaging
material harmonization (from 3 FBs and 3 SBs to 1 FB and 1
SB) and optimization (FB positioning into SB according to Case
Packer working sequence)
 Why: reduction of one extra end-of-line FTE per shift
Leaflet
Folding Box
Shipping Box
Blister
Case packer
How would you justify
the investment, and
make sure you got the
right equipment?

 Identify, prioritize and attack losses through root cause analysis (CAPDo)
Focused Improvement
C
A P
D
High minor stoppages,
further analysis
revealed several short
adjustments
Focus group
Causes:
• Bulk clogging
• Wrong unclogging
procedure leading to
feeder tubes damage
• Unstable bulk
process control
(height)
• Vibration system not
working
• Occurrence of
damaged plugs
Actions:
• Revised preventive
plan according to new
findings
• Revised spare parts
list
• Bulk troubleshooting
• OPL training
23,4 down to 17,6 %
15,4 down to 8,0 %
How much extra
capacity could we
find if we had less
losses?
Feeding System as
the main cause

Implement countermeasures
and follow up
Remove dust and dirt on and
around the equipment to ensure
basic GMP rules and enable
inspection
Identify and inspect:
 Flaws
 Basic Conditions
 Hard to access areas
 Sources of contamination
 Safety
 Lubrication points
 Surrounding area
Cleaning
Inspection
Countermeasures
Abnormalities mapping
Flaws, Basic Conditions and
Safety abnormalities
identified and recorded
Establish the
basic
conditions to
maintain
equipment
performance
23
4 1
 Establishing simple and quick mechanisms for addressing and
solving problems by everyone, before they occur
 Enabling people to work and think at the same time!
Autonomous Maintenance
SC - Sources of Contamination
HRA - Hard to Reach Areas
Hard to Reach Areas
Sources of Contamination
A
B
E
E
D
CB
0
0
A
0
C
H
0
D
0
0
0
G
0 0
0
D

AM achievements
Basic Principles of GMP:
 Avoidance of cross-contamination and mix-
ups
HSE Risk Identification:
 elimination of safety failures

AM achievements
 One Point Lesson: preventing errors and multiplying knowledge
Correct vs. Incorrect: variable data assembling Correct vs. Incorrect embossing station set up

Pilot Lines Results
 Line 4: first TPM line
+68%
OEE: 30 to 50%

+80%
Output: 1.500 to 2.700 packs/h

+47%
OEE: 26 to 39%

+56%
Output: 900 to 1.400 packs/h

 Line 5: start up in Feb, first line with Early
Management approach

Overall Packaging Results
 OEE and productivity:
+23%

OEE: 40,8 to 50,1%
Productivity: 0,39 to 0,49
mio packs/ FTE
+24%

 Blister Optimization:
• 27 SKUs completed represent a
significant improvement in sustainable
packaging versus the packaging
solutions that before existed
Cost
savings
USD 201.200
Material
reduction
3,3 tons aluminum (lidding material)
7,7 tons PVC | 12.9 tons PVdC (forming
material)
Packaging
weight
reduction
SKUs specific: -9% for Trilax c/12 (3,6
tons/year);
-5% for Doxuran 30 FCT (1 ton/year)
GHG
emissions
transport
1,0 ton CO2e (from natural material only)
Other
savings
Waste reduction, improved packaging lead-
time and energy avoidance

Contents
1) Introduction
5) Throughput Time

Throughput Time
 Elapsed time from material issue to Quality release of finished product
buffer
Scenario
Objective
 Improve
systematically the
planning process
 Not stable production
planning
 High TpT numbers
Increasing
 High inventory levels
 Increased complexity
(e.g. batch re-
analysis)

Process Flow and Areas of Opportunity
Setor Pontos Críticos Documentação Fluxo Procedimento
Chegada defasada das documentações (produção, embalagem e CQ) x
Gargalo no acúmulo de documentação (tempo ocioso X picos de demanda) x
Stock Out, interrompendo o fluxo de trabalho x
Fluxo inadequado na Informação da data de validade do lote x
Tempo excessivo para o encerramento dos desvios e ocorrências x
Demora dos outros setores na correção dos documentos x
Preenchimento incorreto da documentação - Sandoz x
Preenchimento incorreto da documentação - Terceiros x
Revisão da doc muito abrangente, não permitindo uma análise profunda pelo setor acarretando na
passagem do erro para o próximo revisor
x
Controle de devolução de lotes de bulk para a Produção no caso de retrabalho x
Stock out (quebra da programação) x
Programação Embalagem: não recebe bulk no momento programado x
Material sem custeio (financeiro) x
Fluxo inadequado na Informação da data de validade do lote x
Erros na configuração da documentação (PDF), ex: número de dígitos menor que o necessário x
Inexistência da FT x
Falta de material na linha: estrutura incorreta x
Falta de material na linha: baixa performance da linha de embalagem x
Falta de material na linha: sem material para reposição da linha no estoque x
Falta de material no estoque acarretando mudança na programação x
Falta de material na linha: erro na pick list, quantidade reservada errada x
Fechamento "virtual", acarreta em um esforço extra de liberação parcial, ajuste de saldo x
Descrição do código do material incorreto (IFT com estrutura) x
Material na secundária incorreto (tamanho, tipo de bula ou cartucho) em relação à estrutura x
Secundária tem que realizar reconciliação do documento da primária antes do apontamento
Aguardar reconciliação do documento da primária para apontamento x
Reconciliação de documentação: falta de campos assinados x
Reconciliação de documentação: divergência na quantidade de material x
Material em QT na hora do apontamento x
Aluminio Impresso em QT na hora do apontamento x
Estrutura do produto não "respeita" a alocação x
Documentos com o mesmo tipo de grandeza porém cada um com uma unidade diferente ex: kg e g x
Ajuste de estoque: fluxo financeiro x
Falta de ferramental x
Ajuste de estoque:diferença entre a necessidade e o tam do lote padrão do cliente x
Atraso na geração do documento mestre (produtos novos ou alterações) x
Falta de material na pesagem: erro na pick list, quantidade reservada errada x
Ajuste de estoque:diferença entre a necessidade e o tam do lote padrão do cliente x
Erro na quantidade/ falta de material na pick list x IFP x
Ausência de MP dentro da área de pesagem (pick list correta) x
EPI adequados para situações ou produtos novos x
MP vencida (no momento da reserva estava ok) x
MP com problemas de qualidade x
Ajuste de estoque: fluxo financeiro x
Material sem custeio (financeiro) x
Custeio incorreto do produto (refazer processo IFS) x
Falta de material "não consumível" ex: sacos plásticos, lacre x
Falta de fração no pallet (pesagem, granulação, mistura) x
Inserção de dado incorreto no relatório (equipamento mistura) x
Perda de material pelo operador ou perda de material no bin x
Documentação: erro de transcrição x
Documentação: etiqueta, pesagem, assinatura x
Stock out (quebra da programação) x
Erros no preparo das "soluções" x
Erro na transcrição de informação (documentação CQ) x
Erro no input de dados (HPLC) x
Falta de reagentes x
Organização: MP analisadas junto com a ser analisadas etc... x
Impressão do método em toda a análise (perda de papel) x
Stock Out, interrompendo o fluxo de trabalho x
Perda da documentação x
OSS identificada apenas na reconciliação da documentação x
Gargalo de documentação no fechamento do laudo
Assuntos que deveriam ser vistos antecipadamente
Erros operacionais
Erros em documentos (treinamento, mudança no doc, etc)
Organização
Fluxo entre clientes (internos ou externos)
Planejamento/ Programação
Finanças
GQ
Embalagem
Produção
CQ
Staging Bulk Prod. QC Packaging QA
Waste
does not add any value
to a product
Incidental activity
Work that does not directly
add customer value, but
which is currently necessary
to maintain
Value-added activity
Work that directly increases
the value of the product
Opportunity Areas
1. Production Flows
2. Administrative
Flows
3. Material Flows
4. Documentation
43%
54%
3%

 Synchronisation between end of manufacturing and packaging
 Optimised sequence of orders - “packaging point of view” (pacemaker)
1. Production Flow Improvements
Production Control
Monthly planning
Dispensing
I I I
Granulation Tableting Packaging
Packaging
Pacemaker
Process
Production Control
Monthly planning
oxox
oxox
Dispensing Granulation Tableting
II I
1) High lead-time
2) Bulk capacity >
packaging

 Collaborative Planning Process with weekly reviews
• at SKU level – what, when, who and why!
2. Administrative Flow Improvements

Packaging
room
3. Material Flow Improvements
 Buffer between Manufacturing and Packaging was organized so that the bulk
operator should park the pallet in the correct line according to the product
allocation in Packaging
 Then, the packaging material from Staging is to be placed according to bulk
position

4. Documental improvements
 Finished good data-sheet simplification
As is
After
Improvement
Result D%
Checking items 13 8 - 5 - 38,5%
Page numbers 11 4 - 7
- 63,6%
Pages per year 13.200 4.800 - 8.400

TpT Results
400
600
800
1000
1200
1400
1600
1800
2000
WorkingProcess(kUSD)
PY ACT
-40%
950
960
970
980
990
1000
1010
1020
1030
1040
Volume(kbulkunits)
PY ACT
5%
-67%

TpT: 85,6 to 27,9 days
On time % (orders released on TGT): 30 to 71% +136%


Contents
1) Introduction
5) Throughput Time

DRIVE Project
 A global program that focuses on the tracking and reporting of cost
improvements
What problems could
be resolved by
bringing together
people from different
teams?

COGS reduction
0.28
0.02
0.45
Total Bulk
2.43
Total Bulk
2.15
Total Bulk
2.13 Total Bulk
1.69
0
1
1
2
2
3
3
Manufacturing Breakdown
0.05 0.01 0.09Pack 0.44 Pack 0.39 Pack 0.38 Pack 0.290
1
1
2
2
3
3
Baseline Short-term… Short-term… Mid-term…
Packaging Breakdown
0.33
0.03
0.53
TPC
2.87 TPC
2.54
TPC
2.51 TPC
1.98
0
1
1
2
2
3
3 Product Cost Evolution
• API Price negotiation
• Yield Factor increase
• Opadry scrap reduction
• Reduced Coating
processing time
• Batch size increase
• New API supplier
• Forming foil: new supplier
under development
• Lidding foil: 21 microns to 25
• Leaflet: New Supplier BID2012

 Bulk Production
What: automatic CIP detergent re-filling
Why: “always had been done” manually
by 2 operators
 Maintenance
What: calibration station for up to 8
equipment simultaneously
Why: speed up calibration task
previously done one after other
Initiatives across areas (1 of 3)

 Logistics In-bound
What: optimized layout and material flow
layout for sampling
Why: QC analysts spent much time
searching for materials to sample
 IT
What: 2S (Sort + Set in order) in Data
Storage for 100% of associates
Why: TechOps used to pay USD 95k
for data storage (almost 1 Tb) and
storage quota was almost exhausted
400
500
600
700
800
900
1000
DataStorage(GB)
Kick Off End of 2S's
-34%

 Utilities
What: Energy Management based on PDCA mindset
Why: offset production growths, pursue energy cost savings whilst reducing CO2
emissions
2007
2008
2009
2010
2011
2012
26,000
27,000
28,000
29,000
30,000
31,000
32,000
33,000
0 500 1,000 1,500
EnergyinGJ
mio SDU
Energy Trend:
Production vs. Consumption
Trend before EM*
*EM = Energy Management started in mid 2010 Trend first 2 yrs.
Trend after 2 yrs.

Takeaways
 Do not wait for a Global approach to start your journey into
Excellence, but it would help
 Do not ask your staff “what can we do better”, give them a structured
way where they need to work on
 Do not only rely on a few well-intentioned people to sustain your
journey, it must be part of your Company‟s “Values and Behaviors”
 Do not only design your Continuous Improvement program inside a
room, it must be fine-tuned together with your operational area
 Be careful with the bad apples, and believe in it, some of them are
probably sitting at your table.

Thank you! Vielen Dank!
For further feedback, questions and
suggestions please contact
marcelo.costa_rodriguez@sandoz.com
+49 39203 71-6762

Marcelo Costa - Pharma Talk 2013 Berlin

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