Process and operational excellence synergies

a Novartis company
Process and Operational Excellence
synergies:
key drivers for cost savings
Marcelo Costa
SCM World Webinar 2013

2 Process and Operational Excellence synergies | SCM World Webinar 2013
About this presentation
 The material presented today is an adaptation of the practical
experience of a Continuous Improvement Program integration
into an established Process Engineering department which
supported a Pharmaceutical Packaging Operations plant to
boost its objective of increasing productivity

Contents
1) Introduction
2) Continuous Improvement Deployment
3) OEE, Losses Tree and Process Improvement Cycle
4) Packaging Optimization Approach
5) Throughput Time Approach
6) Cost Savings Approach

Contents
1) Introduction

Introduction
 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
 ....

Excellence
Optimization
Prevention
Stabilization
Reactive Action
Continuous Improvement – The Dilemma
a long but sustainable
journey ahead...
straight to
big wins!
Operational Process Performance
Build-up in excellence
Sustainable gains
Short term focus
Contingency (quick wins)

Key Challenges
Scenario
Objective
Challenges
 Increase plant capacity
 How would we justify the
investment making it sure we
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

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
New In place

Integration towards Business Goals
OEE/ PRODUCTIVITY THROUGHPUT TIME
 Reinforce OEE as main tool for
systemic Capital Asset freeing up
 Identify the main causes of non-
productive time
 Accurate 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
COST SAVINGS
 Capital projects & new
technologies
 Generate opportunities for costing
savings with attractive payback
periods within pilot areas as well
as the entire organization
Process Engineering Continuous Improvement
GoalsEnablersKeyDrivers
 OEE, performance metrics and standards for product
costing
 Packaging Development: harmonization of
specifications, materials optimisation and operational
improvements
 Yearly budget: OEE TGT, utilization, and optimized
product line allocation definition
 Fine planning: best product sequence to minimise the
number of difficult changeovers
 Cost savings portfolio management across the site
 Capital projects for Innovation & Technology
enhancement
 Total Productive Maintenance (TPM)
 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
New In place

Contents
1) Introduction

OEE
 KPI to measure the overall ‘health’ of
the Manufacturing Operation
 The key enabler to increase capacity,
through making maximum productive
use of the asset capacity and resources
OEE deployment:
Should I measure and
improve the OEE of all
work centers?
 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
Losses Attack &
Elimination
Unscheduled
downtime
Set up
Effective
Uptime
Adjustment
Breakdown/
Failure
Speed Loss
Minor
Interruptions &
Others
Free up
capacity
out of existing
facilities and
personnel staff
Unscheduled
downtime
Set up
Effective
Uptime
Adjustment
Breakdown/
Failure
Speed Loss
Minor Interruptions
& Others
Standard
Speed Increase
Losses Tree is a systematic approach
to priority-set loss elimination
Losses Attack &
Elimination
Increase
availability by
reducing speed
loss, stoppages
and changeover
time
Standard Speed
Increase
Reduce
Effective
Uptime by
increasing
maximum
validated speed
Losses Tree is used to create transparency on
the major areas of non-productive time
Losses Definition
Losses Identification
Working teams
(Priority Teams)
Application of Root
Cause Analysis Tools
CAPDO, PM Analysis
5 WHYs, 4M’s, etc.
Evaluating Results
Monitoring Results
Sustain counter
measures
to avoid reoccurrences
Roll out
New Technologies
(e.g. feeders)
Blister Optimization
Bulk in-process control
(e.g. tablet hardness)
Packaging material
enhancement
Machine capability

Improvement Projects
Defined in the yearly budget during
capacity planning  OEE TGT
Losses Trend Analysis
Focused on identifying the outliers and
preventing recurrence according to losses
prioritization
Continuously Periodically
OEE
Monitoring & Evaluation
Losses Tree
Correction & Prevention
Daily Operations
Meeting
daily task accountability,
team board
Weekly Performance
Meeting
top problems and
solutions, action tracking
Yearly OEE
Target
Monthly Performance
Review
overall plant performance
project management
Yearly OEE
Review
Achievement of OEE TGTMaintenance of OEE TGT
Process Improvement cycle
1st wave 2nd wave 3rd wave

Contents
1) Introduction

Packaging Optimization Cycle
Product
Allocation
Capacity
Assessment
Product Design
Capital Projects
Process
Improvement
 Leveling of packaging lines and bottleneck analysis
 Operations utilization assessment and OEE TGT calculation
 Process Improvement Cycle
 Rationalization of packaging machine set ups
 Blister optimization
 Packaging materials harmonization
 Capital projects for productivity increase5
4
1
2
3

1) Capacity Assessment
L6
L5
L4
L3
L2
CAMBE FACILITIES FULL CAPACITY [ % ]
DISPENSING tons/year 64%
SMALL DISPENSING tons/year 66%
MIXING tons/year 66% L1
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 CAPACITY
WORK CENTER
 Bottleneck analysis to define working areas of process improvement:
1st Level
2nd Level

 Lines Utilization and OEE TGT definition:
OEE calculated in order to
achieve Target Utilization:
 based on previous year losses
 next year volume demand
OEE challenged for:
 stretching Target Utilization
 redefining an achievable OEE
(should still be a step change)
1) Capacity Assessment
Working groups must be
defined according to:
 Bottleneck lines (higher
utilization) to be prioritized
 pareto losses stratification
 output increase projects
(products with higher
contribution to utilization)
1 2

Achievement of OEE TGT: Identify process improvement projects ensuring sustainable problem solving
2) Process 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

Maintenance of OEE TGT: KPIs actively used to generate reactive and preventive actions
Overview
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 CONCLUDED
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 CONCLUDED
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 CONCLUDED
JAN
CAPDo
Result CommentsCheck Analyse Plan
Do
MTBF - PACKAGING
22,04
37,77
48,45
33,05
20,36
38,69
44,31
82,68
77,08
46,86
71,71
44,42
37,00
22,04
33,72
36,89 44,71
41,17
42,69
40,00
35,21
35,78 36,98
40,43
43,18
43,56
44,42
0
10
20
30
40
50
60
70
80
90
PY10 PY11 Jan Fev Mar Abr May Jun Jul Aug Sep Oct Nov Dez YTD TGT12
MTBF(hours)
MTBF MTBFAccumulated
WHY? Losses tree review, countermeasures and improvement ideas - action plan, follow-up and feedback
WHO? Process improvement associate, line technicians and operators
WHAT? Dashboards and line boards (OEE & weekly planning, TPM)
WHERE? Line
WHEN? Weekly according to defined meeting calendar
HOW?
1 2 4 5 6 7 8 9 11 12 13 14 15 16 18 19 20 21 22 23 25 26 27 28 29 30
Line 1
Line 2
Line 3
Line 4
Monthly Performance Review
Weekly Performance Meeting
2nd
and 3rd
W: Line prioritization according to deviations from targets - Trigger Root Cause Investigation when required
(30min)
Management team
Working Groups Working Groups
1st
W: Visualization of relevant information directly on the shopfloor (10 min each line)
4th
W: Follow-up according to was planned during weeks 2 and 3 (20 min)
5th
W: Review performance, feedback about counter measures and recognize main issues
Area
Week 1 Week 2 Week 3 Week 4 Week 5

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
Autonomous Maintenance:
 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!
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

Basic Principles of GMP:
 Avoidance of cross-contamination and mix-ups
HSE Risk Identification:
 elimination of safety failures
One Point Lesson:
 preventing errors through knowledge
spreading
Correct vs. Incorrect:
variable data assembling
Correct vs. Incorrect:
embossing station set up

3) Product Allocation
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 format change
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 output machine  same blister size, low
blister per package ratio, high volume products
• low output machine  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%
• Lines with same
embarked
technology
• B2 with 1 blister
format, B1 with 3
blister formats
• B2 with a favorable
product mix
• As result, B2
capacity is almost
3 times higher than
B1
Blister format

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
4) Product Design
Blister Optimization:
Reduce the number of blister per finished
good (SKU):
– increase output
– reduce material consumption
Secondary and Tertiary materials
A B C
54 x 30 x 120
54 x 44 x 120

5) Capital Projects
Project: semi-automatic case packer
Capital Projects for productivity increase
 Elimination of manual
handling (reduction of
one extra end-of-line
FTE per shift)
Evaluation of material
specification complexity
Evaluation of operational
issues
Harmonization:
 From 3 Folding
Boxes to 1 FB
 From 3 Shippers to 1
Optimization:
 FB positioning into
SB according to
Case Packer working
sequence
How would you
justify the
investment, and
make sure you got
the right
equipment?
Project: full packaging line (primary and secondary)
 Replacement of old-fashioned
primary machine which required
100% manual inspection of
blisters
 Elimination of manual packaging
line (10 FTEs per shift)
 Insource of alu x alu products
Evaluation of material
specification complexity
Evaluation of
operational issues
Harmonization:
 Products from 6 blisters
stacking to 4
 Allocation to lines with
same blister format
Optimization:
 New blister insertion
system for high blister
stacking products

Packaging 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

Packaging Area 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

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

Process Flow Study 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
Areas of Opportunity
1. Production Flows
2. Administrative Flows
3. Material Flows
4. Documentation
43%
54%
3%
Brainstorming

 Synchronisation between end of manufacturing and packaging
 Optimised sequence of orders - “packaging point of view”
(pacemaker)
1. Production Flows
Production Control
Monthly planning
Dispensing
I I I
Granulation Tableting Packaging
Packaging
Production Control
Monthly planning
oxox
oxox
Dispensing Granulation Tableting
II I
before
after
- pacemaker process,
monthly demand
scheduling
Lead Time =
WIP /
Production
Rate

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

packaging
room
3. Material Flows
 Bulk pallets in parallel to packaging rooms:
bulk operator left the pallet in any open
position
 Buffer not organized according to lines
product allocation
 Too many time wasted searching from the
right bulk batch
 No visual management if a batch was left
behind
before after
 Bulk pallets in line with rooms: bulk operator places
the pallet in the correct line according to the product
allocation
 Packaging material from Staging to be placed
according to bulk position and priority
 Reduced time to search for materials even if product
prioritization has been changed
 Clear visual management of all batches

4. Documentation
 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
before after

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%
 What problems could
be resolved by
bringing together
people from different
teams?

Contents
1) Introduction

Costing Savings Approach
 DRIVE is a global program that focuses on tracking and reporting of
cost improvements initiatives

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
(2012)
Short-term
(2013)
Mid-term
(2015)
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 2)
 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

Initiatives across areas (2 of 2)
 Utilities
What: Energy Management based on PDCA methodology
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 having a global support would spare you a lot of stress
 Do not copy and paste Continuous Improvement programs to your organization
• it must be devised based on your needs and adapted to your company’s culture
 Do not ask your staff “what can we do better?”
• give them a standard framework to focus on the process and results – What to
do and When to do It
 Do not work harder, work smarter
• priority-set loss elimination
 Do not only rely on a few well-intentioned people to sustain your journey
• drive accountability through company’s Values and Job descriptions
 Bad apples can jeopardize your Excellence journey
• Leader’s job is to make sure things are working - no pain no gain

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

Process and operational excellence synergies

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