Pharmaceuticals

Enabling Superior Manufacturing Performance

with SAP ERP and SAP xMII at Roche
Robert Fretz
Head of Process Automation & MES
Roche Pharmaceutical Division
 Pharmaceuticals
Company Background and Challenges

Business Considerations

Solution Implementation and Benefits

Lessons Learned and Next Steps

Manufacturing Performance at Roche / Robert Fretz / 2

 Pharmaceuticals
Roche - Basic facts at a glance

• Founded 1896 in Basel, Switzerland

• Employing around 74‘000 people

• Currently active in 150 countries on all continents

• 2006 sales:
42.1 billion Swiss Francs

• Core businesses:
Pharmaceuticals and Diagnostics

• Number 1 in the global diagnostics market (in vitro), the

leading supplier of medicines for cancer &
transplantation and a market leader in virology
Manufacturing Performance at Roche / Robert Fretz / 3
 Pharmaceuticals
Manufacturing today has some key
challenges…
• Global Competitiveness is placing tremendous pressure on
cost, quality and responsiveness
– Business and financial impact of production exceptions
cannot be monitored or controlled at the enterprise level
– Plants use copies of master data creating compliance
and quality issues
– Production personnel lack the decision support
information to meet their targets

Connecting the Factory to the Enterprise and enabling Production

Personnel are critical to cost-effectively deliver on customer expectations

Manufacturing Performance at Roche / Robert Fretz / 4

 Pharmaceuticals
Root Cause: Manufacturing and Enterprise
business processes need to be synchronized
… How are we hitting our targets?
„ Total Cost of Production and Variance
? „ Labor and Resource Productivity
„ Order Fill Rates and Cycle Times
ERP „ Fixed and Variable Asset Utilization
DISCONNECT

DISCONNECT What’s happening during every shift?

„ Material availability and consumption
MES ? „ Capacity availability and utilization
„ Schedule changes
„ Product Genealogy tracking and QM

“Less than 1% of respondentsWhat’s happening

indicated thatatmanufacturing
each line? data is
„
? with ERP with no manual intervention”
automatically integrated Cycle Times / Operating Efficiencies
SFAC* „ Machine Breakdowns / Unplanned Downtime
AMR
„ Quality Research Customer Survey
Index
„ Predictive
September 2005
Maintenance requirements
SFAC - Shop Floor Automation and Control Systems
MES – Manufacturing Execution Systems
DCS – Distributed Control Systems
Manufacturing Performance at Roche / Robert Fretz / 5
 Pharmaceuticals
Production Challenges and Their Business
Implications

X
„ Learning about machine, material, and quality issues
too late to take action
Visibility
„ Customer orders lost on the factory floor
„ Little visibility into actual production costs or KPIs

„ Ability to respond rapidly and cost-effectively to

X
manufacturing exceptions
„ Ability to balance supply with demand priorities
Responsiveness „ Ability to exploit new profitable revenue
opportunities

„ Constant rework, overtime, expedite orders, and

X
shortages
„ Budget violations, inefficient processes and lost
Performance revenues
„ Lower customer satisfaction and employee
productivity and morale
Manufacturing Performance at Roche / Robert Fretz / 6
 Pharmaceuticals
Company Background and Challenges

Business Considerations

Solution Implementation and Benefits

Lessons Learned and Next Steps

Manufacturing Performance at Roche / Robert Fretz / 7

 Pharmaceuticals
Business Goal 'Operational Excellence' - Top
5

Excellence in Operations

Goal 1 Goal 2 Goal 3 Goal 4 Goal 5

Reduced Improved Better use of Top quality and Service level
manufacturing inventory assets efficiency in all excellence
costs situation processes

Metric 1 Metric 2 Metric 3 Metric 4 Metric 5

Revenue vs. Coverage days Revenue vs. Right first time On time in full
manufacturing of inventory manufacturing delivery
costs fixed assets

Manufacturing Performance at Roche / Robert Fretz / 8

 Pharmaceuticals
Manufacturing Challenge:
How to 'automate' from Start to Finish ?

• Product • Samples
Plan
Plan • Timeframe • Pass/Fail Release
Release
• Quantity • CoA
• Plant
• Cycle Times
• Units
• Quality Analyze
Analyze
Prepare
Prepare • Recipes
• KPI Metrics
• Master Batch Record
• Training

• Batch Record
Report
Report
• Exceptions
• Operator Procedures
Instruct
Instruct • Checklists
Covered by
• Automatic Execution Shop-Floor-Systems • Values
Operate
Operate • Machine Parameters • Checks Record
Record
• Recipe Execution • Events

Manufacturing Performance at Roche / Robert Fretz / 9

 Pharmaceuticals
Manufacturing Challenge:
How to 'automate' from Start to Finish ?

• Product • Samples
Plan
Plan • Timeframe • Pass/Fail Release
Release
• Quantity • CoA
• Plant
• Cycle Times
• Units
• Quality Analyze
Analyze
Prepare
Prepare • Recipes
• KPI Metrics
• Master Batch Record
• Training

• Batch Record
Report
Report
• Exceptions
• Operator Procedures
Instruct
Instruct • Checklists
Covered by
• Automatic Execution Shop-Floor-Systems • Values
Operate
Operate • Machine Parameters • Checks Record
Record
• Recipe Execution • Events

Manufacturing Performance at Roche / Robert Fretz / 10

 Pharmaceuticals
Manufacturing Challenge:
How to 'automate' from Start to Finish ?

• Product • Samples
Plan
Plan • Timeframe • Pass/Fail Release
Release
• Quantity • CoA
• Plant
• Cycle Times
• Units
• Quality Analyze
Analyze
Prepare
Prepare • Recipes
• KPI Metrics
• Master Batch Record
• Training

• Batch Record
Report
Report
• Exceptions
• Operator Procedures
Instruct
Instruct • Checklists
Covered by
• Automatic Execution Shop-Floor-Systems • Values
Operate
Operate • Machine Parameters • Checks Record
Record
• Recipe Execution • Events

Manufacturing Performance at Roche / Robert Fretz / 11

 Pharmaceuticals
Manufacturing Challenge:
How to 'automate' from Start to Finish ?

• Product • Samples
Plan
Plan • Timeframe • Pass/Fail Release
Release
• Quantity • CoA
• Plant
• Cycle Times
Prepare
Prepare
• Units
• Recipes SAP • Quality
• KPI Metrics
Analyze
Analyze
• Master Batch Record
• Training xMII
• Batch Record
Report
Report
• Exceptions
• Operator Procedures
Instruct
Instruct • Checklists
Covered by
• Automatic Execution Shop-Floor-Systems • Values
Operate
Operate • Machine Parameters • Checks Record
Record
• Recipe Execution • Events

Manufacturing Performance at Roche / Robert Fretz / 12

 Pharmaceuticals
Manufacturing Challenge:
How to 'automate' from Start to Finish ?

• Product • Samples
Plan
Plan • Timeframe • Pass/Fail Release
Release
• Quantity • CoA
• Plant
• Cycle Times
Prepare
Prepare
• Units
• Recipes SAP • Quality
• KPI Metrics
Analyze
Analyze
• Master Batch Record
• Training xMII
• Batch Record
Report
Report
• Exceptions
• Operator Procedures
Instruct
Instruct • Checklists
Covered by
• Automatic Execution Shop-Floor-Systems • Values
Operate
Operate • Machine Parameters • Checks Record
Record
• Recipe Execution • Events

Manufacturing Performance at Roche / Robert Fretz / 13

 Pharmaceuticals
What is the SAP xApp
Manufacturing Integration and Intelligence
(xMII)?
The SAP xApp Manufacturing Integration and
Intelligence (xMII) is a packaged composite
SAP NETWEAVER application that delivers:
Other SAP Bus. Solutions

Manufacturing
Intelligence
Dashboards SAP BI

mySAP ERP
mySAP SCM

SAP xMII

MES – Manufacturing Execution Systems, EMI – Enterprise Manufacturing

Intelligence, BW – Business Warehouse (from SAP)
SFAC – Shop Floor Automation & Control,
Manufacturing Performance at Roche / Robert Fretz / 14
 Pharmaceuticals
What is the SAP xApp
Manufacturing Integration and Intelligence
(xMII)?
The SAP xApp Manufacturing Integration and
Intelligence (xMII) is a packaged composite
SAP NETWEAVER application that delivers:
Other SAP Bus. Solutions

Manufacturing
Intelligence
Dashboards SAP BI

mySAP ERP
mySAP SCM

SAP xMII
Manufacturing Integration: A single
ISA-95 compliant layer enabling SAP ERP
Manufacturing Integration connectivity into real-time plant floor apps. (MES,
SFA, legacy apps.) to drive plant-to-enterprise
business process interoperability
Manufacturing Performance at Roche / Robert Fretz / 15
 Pharmaceuticals
What is the SAP xApp
Manufacturing Integration and Intelligence
(xMII)?
The SAP xApp Manufacturing Integration and
Intelligence (xMII) is a packaged composite
SAP NETWEAVER application that delivers:
Manufacturing Intelligence: Real-time
Other SAP Bus. Solutions

Manufacturing analytics engine that aggregates and delivers unified

Intelligence visualization of events, alerts, KPIs and decision
Dashboards SAP BI
support to production personnel thru role-based
dashboards

mySAP ERP
mySAP SCM

SAP xMII
Manufacturing Intelligence
Manufacturing Integration: A single
ISA-95 compliant layer enabling SAP ERP
Manufacturing Integration connectivity into real-time plant floor apps. (MES,
SFA, legacy apps.) to drive plant-to-enterprise
business process interoperability
Manufacturing Performance at Roche / Robert Fretz / 16
 Pharmaceuticals
What is the SAP xApp
Manufacturing Integration and Intelligence
(xMII)?
The SAP xApp Manufacturing Integration and
Intelligence (xMII) is a packaged composite
SAP NETWEAVER application that delivers:
Manufacturing Intelligence: Real-time
Other SAP Bus. Solutions

Manufacturing analytics engine that aggregates and delivers unified

Intelligence visualization of events, alerts, KPIs and decision
Dashboards SAP BI
support to production personnel thru role-based
dashboards

mySAP ERP Manufacturing Innovation: Web-services and

mySAP SCM content to rapidly design and deploy Composite
Business Processes, Applications and Metrics
SAP xMII
Manufacturing Intelligence
Manufacturing Integration: A single
Manufacturing Innovation ISA-95 compliant layer enabling SAP ERP
Manufacturing Integration connectivity into real-time plant floor apps. (MES,
SFA, legacy apps.) to drive plant-to-enterprise
business process interoperability
Manufacturing Performance at Roche / Robert Fretz / 17
 Pharmaceuticals
SAP xMII integrates manufacturing operations
with the enterprise,
and delivers actionable visibility…
„ Real-time events/alerts
„ Order status
SAP NETWEAVER „ Charge rates
„

Other SAP Bus. Solu tions

Life of inventory
„ Yields
• Plan work orders Manufacturing
„ Completions and usage
• Check resources Intelligence

SAP BI
Dashboards „ Start and stop times
• Create mfg plan
„ Quality and lab data
• Scheduling
„ Process history
• Release work order
„ Best practice deviations
• Close order
„ Efficiency
• Shipping and logistics mySAP ERP „ Downtime tracking
mySAP SCM „ Rework scrap rates

SAP xMII
Manufacturing Intelligence
Equipment Tracking and Performance Manufacturing Innovation Downtime and OEE Reporting

Manufacturing Integration

Manufacturing Performance at Roche / Robert Fretz / 18

 Pharmaceuticals
Challenge:
Company-wide production communication
Room MES LIMS Office Performance Office Release
Monitoring Client Report Client Report

……

Office Network

SCADA PROD Historian

MES Real-time Control Network

SCADA
MES
… SPS

Shop IPC
Floor Lab
Manufacturing Performance at Roche / Robert Fretz / 19
 Pharmaceuticals
Challenge:
Company-wide production communication
Room MES LIMS Office Performance Office Release
Monitoring Client Report Client Report

……

Office Network

SCADA PROD Historian

SAP
xMII
Horizontal and
Vertical
MES Real-time Control Network
Communication
SCADA
MES
… SPS

Shop IPC
Floor Lab
Manufacturing Performance at Roche / Robert Fretz / 20
 Pharmaceuticals
Challenge:
Company-wide production communication
Room MES LIMS Office Performance Office Release
Monitoring Client Report Client Report

……

Office Network

SCADA PROD Historian

SAP
xMII
Horizontal and
Vertical
MES Real-time Control Network
Communication
SCADA
MES
… SPS

Shop IPC
Floor Lab
Manufacturing Performance at Roche / Robert Fretz / 21
 Pharmaceuticals
Real-Time Integration Platform Selection Process
– Product Categories and Alternatives

– Enterprise Application Tools

lack of connectivity to manufacturing systems
no ‘portal’, no ‘dashboard’, no visualization features

– Integration only based on standards (e.g. OPC)

no workflow, transaction capabilities

– Selected product:

SAP xMII (Manufacturing Integration Intelligence)

• Workflow – Transaction Services

• Manufacturing, Database and SAP Connectivity
• Visualization Services

Manufacturing Performance at Roche / Robert Fretz / 22

 Pharmaceuticals
Real-Time Integration Platform
Pilot Project Objectives

• 1. Implementation of workflows and transactions in

reaction to events

• 2. Integration to enhance communication between

systems

• 3. Real-time process integration for time-optimized,

structured visualization of production data from
various systems

• 4. Better process understanding

Manufacturing Performance at Roche / Robert Fretz / 23

 Pharmaceuticals
Real-Time Integration Platform
Selection Process Proof of Concept (PoC)

– Generic use cases, typical for API (chem/biotech)

and galenical production
– If the product can cover all requirements in PoC, it
is suitable for all other manufacturing issues
– Less focus on visualization and dashboard in PoC,
because no technical risk
– Focus on technical risk :
• Connectivity – (Visibility) – Reactivity
• Product features:
• Integration – Dashboard – Transaction

Manufacturing Performance at Roche / Robert Fretz / 24

 Pharmaceuticals
Company Background and Challenges

Business Considerations

Solution Implementation and Benefits

Lessons Learned and Next Steps

Manufacturing Performance at Roche / Robert Fretz / 25

 Pharmaceuticals
Proof of Concept with generic Use Cases
Use Case (1) - Continuous Batch Cycle Monitoring

Use Case:
SAP xMII Dashboard
Real-time acquisition of batch KPI
directly at the end of batch and
presentation of measured and calculated
values (quality, duration of phases)
SAP xMII (SPC Engine,
Real-time KPI Calculation)
Goals:
ƒ Better process understanding (SPC)
ƒ Faster pro-active deviation management
ƒ Demonstrates the integration of shop Historian
floor data
ƒ Demonstrates reaction to events in the
process
SCADA

Manufacturing Performance at Roche / Robert Fretz / 26

Use Case (2) –

Pharmaceuticals
Download Order-Dependent Setpoints

Use Case: SAP ERP

Linking SAP order and product

information with the corresponding recipe
setpoints and sending them to the shop 1
floor Recipe

2 3
Goals:
„ Increase speed of bringing data together SAP xMII with Dashboard
„ Avoid failures from manual data entry
„ Demonstrates transfer of SAP ERP orders
4
„ Demonstrates download to shop floor

Shop floor /SCADA

Manufacturing Performance at Roche / Robert Fretz / 27
 Pharmaceuticals
Screenshot Use Case 2

Manufacturing Performance at Roche / Robert Fretz / 28

 Pharmaceuticals
Use Cases (3) –
Material Consumption / Goods Movement

Use Case:
SAP ERP
Automatic update of all material
consumptions in SAP directly after finishing
batch
SAP xMII: Real-time
Goals: Calculation

„ Acquisition / calculation of material

consumption of a batch over all process
units / batch phases Shop floor: Historian
„ Reducing manual effort
„ Demonstrates automatic feedback to SAP Shop floor: Manual data
ERP entry

Manufacturing Performance at Roche / Robert Fretz / 29

 Pharmaceuticals
Screenshot Use Case 3

Manufacturing Performance at Roche / Robert Fretz / 30

 Pharmaceuticals
Proof of Concept with generic Use Cases
Results Achieved

- All 3 Use Cases have been accomplished successfully

„ SAP xMII has the required functionality
„ SAP xMII can be easily controlled by the user
„ Trebing & Himstedt implemented the solution within
time and budget

- SAP xMII offers a powerful, but easy to handle

tool for Performance Monitoring and Plant-to-
Business Integration.

Manufacturing Performance at Roche / Robert Fretz / 31

 Pharmaceuticals
Results Achieved

„ Better process understanding enabling significant process

improvements
„ Real-time information flow through usage of a flexible IT-
System
„ Protection of investment for existing system environment
– just connecting, not replacing
„ Shift to workflow-oriented organisation and ‘Review and
Decision by Exception’
„ Prevention of false entries by avoiding multiple entries/
transfers in validated/quality-critical processes

The Roche Pharmaceuticals Division already realized significant process improvements by

Performance Monitoring and Plant-to-Business Integration with SAP xMII.
Further considerable gains and benefits are anticipated when the full potential of the solution
is exploited.
Manufacturing Performance at Roche / Robert Fretz / 32
 Pharmaceuticals
Company Background and Challenges

Business Considerations

Solution Implementation and Benefits

Lessons Learned and Next Steps

Manufacturing Performance at Roche / Robert Fretz / 33

 Pharmaceuticals
Lessons Learned…

– SAP xMII is easy to install

is powerful
easy to handle
– Connections to your own systems are
easy to establish - once you get
across the security barriers
Know your own systems, get support from the
network security organisation
– Transactions offer a wealth of
functionality – many ways to achieve a
result
Start with a proper design – as every software
project

Manufacturing Performance at Roche / Robert Fretz / 34

 Pharmaceuticals
Future Direction and Further Implementations of SAP
xMII
Use in 3 galenical sites
• Roche uses SAP xMII in 3 sites with galenical production
• Further Deployment already in productive use beyond
the 'Use case‘:

– Display and interactive handling of hygiene status

of assets and rooms

– Flexible, recipe and database controlled interactive

checklists for manually operated and automatic cleaning
operations

– Flexible, recipe and database controlled interactive lists for

checking of batch reports regarding completeness and
status for batch release

Manufacturing Performance at Roche / Robert Fretz / 35

 Pharmaceuticals
Further Implementations
Interactive handling of hygiene status

Manufacturing Performance at Roche / Robert Fretz / 36

 Pharmaceuticals
Further Implementations
Interactive checklist for cleaning operations

Manufacturing Performance at Roche / Robert Fretz / 37

 Pharmaceuticals
Further Implementations
Interactive list for checking of batch reports

Manufacturing Performance at Roche / Robert Fretz / 38

 Pharmaceuticals
Summary

– Once we had installed SAP xMII we

immediately found – and are still
finding - many additional uses
– SAP xMII will allow Roche to grow
new applications incrementally, step-
by-step
– SAP xMII will be an evolutionary
system - very much in line with our
drive for continuous improvement -
and will supprt Roche to achieve
‘Operational Excellence’

Manufacturing Performance at Roche / Robert Fretz / 39

 Pharmaceuticals
Enabling Superior Manufacturing Performance
with SAP ERP and SAP xMII at Roche
Robert Fretz Head of Process Automation & MES
Roche Pharmaceutical Division
 Pharmaceuticals
We Innovate Healthcare

Manufacturing Performance at Roche / Robert Fretz / 41