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Process Manufacturing

Safe Harbor Statement


The following is intended to outline our general
product direction. It is intended for information
purposes only, and may not be incorporated into
any contract. It is not a commitment to deliver any
material, code, or functionality, and should not be
relied upon in making purchasing decision. The
development, release, and timing of any features
or functionality described for Oracles products
remains at the sole discretion of Oracle.

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle At-a-Glance
Globally
#1 in Database
#1 in Supply Chain Mgmt
#1 in Customer Relationship Mgmt
#1 in Human Capital Mgmt
#1 in Industries
Founded in 1977. Headquarters in Redwood Shores,
CA with operations in 145 countries.

- Retail

286,000 total customers


235,200 database customers
37,500 applications customers
24,000 SMB apps customers
53,800 middleware customers

19,500 partners

- Public Sector

74,000 employees

- Professional Services

14,000 developers

- Financial Services

7,500 support staff

- Communications

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Agenda

Business Challenges
Oracles Leadership Position
Solution Overview
Customer Success

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Process Manufacturing At-a-Glance


Raw Materials,
Ingredients

Incoming inspection
Characterization

Value-Added
Transformation

Formula adjustments
Blending & processing

Finished
Goods

Packaging
Shipping

Quality, Compliance, Inventory


Work in process
Variability management

Process manufacturing is a complex operation, involving not


only delivery of the end product but also side streams, waste
streams, and recovery streams. Managing variability, consistency,
and quality are on-going procedures that involve taking samples and
making continuous adjustments. This requires visibility of real-time information
across manufacturing and the supply chain.

Nick Newton, IT Manager

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Process vs. Discrete Manufacturing


Process

Discrete

Variable ingredients, by-/co-products


UOM are material specific
Use multiple recipes and formulas
Need lot, grades, potency, shelf-life
Mixes, blends, transforms
Makes STUFF

Beverages,
Foods

24%

Chemicals,
Pharma

36%

Standard parts, components


UOM are by unit or by lot
Use complex multi-level BOMs
Need serial numbers, ECNs
Builds, assembles, fabricates
Makes THINGS

Paper,
Metals,
Fibers

20%

Process: 40%
Discrete: 60%

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Business Pressures
Regulatory Compliance
How do I comply with global

Variability
How do I create consistent

and local requirements?

products using inconsistent


ingredients?

How do I ensure lot traceability


and adhere to standards such
as 21 CFR Part 11?

How do I achieve process


and reaction stability?

Raw Materials,
Ingredients

Reduced Time to Market


How can I manage a growing
list of key product attributes?

How can I efficiently mass

Value-Added
Transformation

Finished
Goods

Lowest Total Cost


How can I meet quality,

delivery, and service demands


at a competitive price?

customize my products?

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Operational Challenges
Limited joint development
with poor recipe reuse

SUPPLIERS

R&D LAB

CUSTOMERS

High variability in release-to-

Material push

volume-production process

Materials,
Ingredients,
Quality Docs

By- / CoProducts

PROCESSING PLANT

Finished
Goods,
Quality Docs

Step 10
Materials
Inventory

Step 30

Step 40

Step 50

Finished
Goods

Step 20
Waste

Documentation required at every step for traceability & compliance


No status visibility between supply chain partners
Inefficient material and capacity utilization

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

A Need for Change


Leading Business Trends

Computer Assisted Recipe Formulation


Process Flexibility with Rapid Changeover
Renewed Emphasis on Product Safety
and Traceability

Increasing Collaboration with Suppliers


Continued Focus on Cost Containment

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Agenda

Business Challenges
Oracles Leadership Position
Solution Overview
Customer Success

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

What Customers are Saying


Our Oracle implementation will enable us to keep pace with
our rapidly changing market. For example, Oracle will allow us
to quickly understand our entire lot genealogy -- down to the
unit level -- in the event of tampering. The federal government
says you need to understand that product and everything that went into it.
Oracle enables that increased visibility, and that's very important.
-- Larry Renken, CIO

With our Oracle implementation, we have cut our


production lead time in half, achieved near perfect
inventory accuracy, and improved our ability to
provide sales follow- up on product samples and customer projects - vital
components of our customer service process.
-- Perry Cozzone, Chief Information Officer

Magnitogorsk Oracle has enabled management to view up-to-date


Iron &
production information online real-time, providing
Steel Works
better control across the production facility and

improving utilization planning.


-- Kazakova Olga, Head of Technology Department

What Customers are Achieving

Improved production efficiency by 7%


Achieved production time savings of 15%
Improved production accuracy by 18.6%
Provided faster access to accurate production costs
Cut production lead times in half
Achieved >99% percent inventory accuracy

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

A Few More Customers

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Agenda

Business Challenges
Oracles Leadership Position
Solution Overview
Customer Success

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Foundation:
Unified Information Architecture
Common data model

Develop
Contracts

Market

Projects
HR
Finance

Sell
Order

Customers,
Suppliers,

Plan

Products,

Maintain

Procure

enables a single source


of truth

Comprehensive suite of

applications designed to
work together

Robust set of integration


services based on open
standards

Modular deployment
by business flow

Service

Make
Fulfill

Single global instance


implementations

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Process Manufacturing Solution


Planning & Scheduling

Manufacturing
Intelligence

Flexible, Mixed Mode Manufacturing


Discrete Mfg
Process Mfg

Visibility from
Shop Floor to
Top Floor

ETO
ATO / CTO
MTS

Flow / Lean
Lot-Based

Manufacturing Execution
Sample

Analyze

Product
Lifecycle Mgmt

Adjust

Quality Mgmt

Warehousing /
Transportation

Asset
Lifecycle Mgmt

Lot / Serial Genealogy Tracking, E-Signatures


Project Tracking

Service

S95-Based Data Integration

Shop Floor Sys

Contract Mfgrs

Suppliers

Partner
Collaboration
and Visibility

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Process Manufacturing Flow


Capture
Customer
Demand

Schedule
Production

Analyze Quality
Auto-Allocate

Create
Sales Order

Procure
Materials

Capture Costs;
Analyze Variance

Create Recipe
(if custom)

Produce
Batch

Ship Product

Manage Regulatory
Documents

Assign Lots

Update
AR / GL

Closed-Loop Demand to Make Offering

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Process Manufacturing Solution


Enables you to

Accelerate Recipe Development


Manage Variability and Product Consistency
Optimize Capacity and Ingredient Usage
Drive Efficient, Compliant Shop Floor Production
Control Product Cost and Quality

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Recipe and Formula Development


Accelerate Collaborative Innovation
Recipe & Formula Development
Internal

Document
Mgmt
Electronic
Digital
Records

D
r
i
v
e
n

Process
Mfg Records
Recipe &
Knowledge
Repository

Secure
Access

S
O
P
s

Web-Based
Access

Formulate

Validate

Concept

W
o
r
k
f
l
o
w

Discovery

Marketing

All Other
Depts

Requirements

Approve &
Release

Specifications
Studies
Schedules

Schedule

Defects

External

Orders

Produce
Test &
Maintain

Retire

Testing
(Clinical
Trials)

Web-Based
Access

Customers

Suppliers

Partners

Process
Improvement

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

End-to-End Development Management


Collaborative Research
Formula / Recipe Mgmt
What-If Analysis

Formulate

Production Recipes
Change Control Processes
Workflow Driven

Validate

Approve
& Release

Lab Batches / Pilots


Master Batch Records
Tracking & Reporting

Lot, Sub-Lot, Contaminant Tracking


Special Packaging / Toxicity Insert
Included in Bill of Materials

Schedule

Supplier Mgmt
Production Planning
Multiple Plants

Produce

Test

Lot Quality / Consistency


Cert. of Analysis
Cert. of Conformance

Monitor & Adjust Performance

Process Repeatability
Yield Performance
Product Data Management
Role-Based Responsibilities

Complete Support
for FDA 21 CFR Part 11

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Graphical Recipe Designer

Simplify Product Collaboration and Development

Automatically
compute material
quantities and
anticipated yield
Easily view complete
product details from
intuitive graphical UI

Drag and drop items,


operations, and
process instructions

Initiate a status change and


approval process

Support e-records and


e-signatures where required

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Stability Studies

Measure the Effects of Environmental Aging

0 1

0 1 23
Production
Batch

12

18

24 months

months

Stability
Samples

Study Definition
Sample Numbering
Monitoring Specs
Storage Conditions
Storage Packaging
Testing Intervals
Item Specs

12

months

Base Monitoring
Specification

Overlay Monitoring
Specification (1)

Overlay Monitoring
Specification (n)

Work Flow Notices


Lab

Study

Study Execution
Technician Owner
Ensure Timely Execution of All Data Points
Assess Product Quality Over Time and Varying Environment
Capture Recommended Shelf Life and Storage Condition
Support Research and Development Activities
Comply With FDA Guidelines in Regulated Industries

Lab
Supervisor

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Compliant Approval Authorization


Ensure Participation by All Stakeholders

Mandatory Version Control


Automated Approval Cycle
Define Conditions for Recipe Component Use
Route Approvals to Groups / Individuals

Version 2

d
e
v
o
r r
p
e
p
o
s
A F U
b
a
L

By-product

Ingredient 5

Ingredient 2

Formulator Requests
Approved for Lab Use

Finished
Good

Intermediate

Ingredient 3

Packaging
item

Ingredient 4

Approved

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Process Manufacturing Solution


Enables you to

Accelerate Recipe Development


Manage Variability and Product Consistency
Optimize Capacity and Ingredient Usage
Drive Efficient, Compliant Shop Floor Production
Control Product Cost and Quality

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Computer-Aided Formulation

Model Production Requirements to Target Specifications

Inventoried
Lot Properties

In-Process
QC Metrics

Computer-Aided Formulation
Recalculate Material
Product Recipe

and Yield Quantities


Compute Batch
Characteristics (e.g.,
fat content, potency,
etc.)
Automatically Revise
Lot Allocations

Target Product /
Customer Specs

Optimize Lot Usage / Production Batch Properties


Use What if Simulation to Streamline Production Planning

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Least Cost Formulation

Optimize Costs While Managing Variability


Potential Ingredients

Least Cost Formula


Item

Product Specification
Regulatory
Composition
Nutrients
Chemical
Quality

Weight

Cost

Brix

----------------------------------Milk 15
825.07
0.3080
12.000
Milk 23
825.07
0.5234
14.600
Milk 12
825.07
0.3080
12.000
Sugar
329.31
0.3100
65.000
Chocolate
4.38
0.3200
33.000
Stabilizer 4
36.22
0.3800
0.000
-----------------------------------

Minimize cost
Plan production

Plan procurement
Enforce product
specifications

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Model Complex Process Flows

Control Chemical and Biological Reaction Variability

Variable Ingredients /
Phantoms

Flow

Flow

By-Products

Manage Co- and By-Products


Support Fixed and Linear Scaling

Co-Products

Catalysts / starter cultures


Waste

Track Step Level Reporting

Material / resource usage


Planned vs. actual
Substitutions

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Quality-Driven Inventory Attributes


Classify Inventory with Precision
Item
Warehouse
Location
Lot
Precise Inventory Tracking
Shelf life
Retest interval
Potency
Dual units of measure
User-defined classifications

Sublot
Status
Grade / Spec
Catch-Weight

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Multi-Level Material/Resource Traceability


Reduce Time to Resolve Issues

Lot Source

Supplier

Ingredients
& Resources

Intermediate or
Bulk Products

Finished
Product

Customers

Where Used

Improve Recall Responsiveness / Cost


Comply with FDA GxP and Safety Regulations
Trace Materials Enterprise-Wide to Analyze Vendor Quality

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Integrated 21CFR Part 11 Framework


Simplify Compliance Validation

Consistent User Experience


GxP-Critical Events
Supported

Industry Best Practice


Business Processes

Configurable
Approvals

Electronic
Signatures

Unbreakable
Security

Evidence
Store

Unified Technology

Strong Security
Reliable Electronic Signatures
Audit Trail Capabilities as Required by GxP

Comprehensive Operational
System Checks

Validate-able System

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Process Manufacturing Solution


Enables you to

Accelerate Recipe Development


Manage Variability and Product Consistency
Optimize Capacity and Ingredient Usage
Drive Efficient, Compliant Shop Floor Production
Control Product Cost and Quality

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Comprehensive Advanced Planning Solution


Leverage Real-Time Information and a Best-in-Class Planning Platform

Planning Products
Supply Chain Intelligence

Strategic Network
Optimization

Real-Time Sales and


Operations Planning

Demand Mgmt and

Advanced Forecasting

Predictive Trade Planning


& Optimization

Adv Supply Chain Plng


Production Scheduling
Global Order Promising
Collaborative Planning

From detail to summary

Inventory Optimization

Network Design
Real-Time Sales
and Operations
Planning

Demand Planning
Inventory Optimization
Supply Chain and Mfg Planning

Global Order Promising


Distribution Planning
Production Scheduling

Areas of Focus
for Process Mfg

SC Exception Management
Collaborative Planning

From short-term to long-term

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Multi-Channel Demand Planning

Become Demand-Driven -- Accurately Forecast and Predict Demand


Achieve real-time visibility to all demand signals
Accommodate multiple units of measure and currencies
Include point of sale information in real time
Move from a regimented periodic to a continuous demand
planning process

Use adv. analytics to accurately predict demand


Use any combination of quantitative or qualitative data to establish
a base line forecast

Utilize high precision statistical forecasting without requiring a


statistical background

Forecast based on attributes and characteristics

Rapidly reach an improved consensus number


Use multi-dimensional analysis to adjust, allocate, and rollup
Collaborate with internal and external constituents
Ensure responsiveness via workflow-driven forecast exceptions

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Execution to Constrained Plan


Optimize Inventory by Location and Quantity
Enterprise
Level

Region
Level
Plant
Level

Leverage current enterprise-wide data

Customize planner-specific views

Optimize inventory and resources

Planner workbench enables drag and

across supply chain in one step

drop rescheduling, what-if simulations

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Planning in Process Industries


Rule-Based Recipes Accommodate
Seasonality, Variability

Support SequenceDependent Setup (SDS)

Specify recipe conditions for seasonality,

Model SDS directly and schedule

equipment capacity, plants: global vs.


Local data, preferences and use

Products may have multiple valid recipes


Alter recipe for each production run
Demand
Quantity & Date

Recipe X
Formula X, v. 5

activities to reduce changeover time

No need to reduce resource efficiency


or utilization as a surrogate for
changeover time

L
L L

H M H

M H H

Route 1, v. 3

Validity Rules v1 v2 v3

Production
Batch

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Scheduling in Process Industries


Schedule
Complex Routings
Yields co-product
D to routing Y
60
10

40

20

50

30

80
110

70

Yields co-product
C to routing X

Product
A

90
100

Schedule Operations
with Hard Links

Schedule
Charges

OP 10
Act 1 Act 2 Act 3 Act 4
A1

A2

Mixer
OP 20

Act 1 Act 2 Act 3 Act 4


Product
120
B

Enable operations to run


simultaneously, feed one or
more operations, or be fed by
one or more operations
Specify multiple starting
operations and multiple terminal
operations for routings
Yield products at other
operations in addition to
the last one

B1

Standard Delay

B2

Max Delay

Packaging
Single activity, multiple charges

Support minimum and maximum


time offsets between operations

Schedule a charge as a
continuous process

Apply minimum and and


maximum offsets to charges

Apply operation dependencies


to charges

Respect shelf life of items


purchased from suppliers

Overlap operations by
incremental feeding to and
from chargeable resources

Respect on hand lot expiration


date when planning the use of
the lot to meet demands

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Distribution Planning

Optimize Supply Allocation to Distribution Centers


Demand Planning

Determine optimal supply allocation


from plants to distribution centers

Demand

Multi-Plant Planning

Supply

Fair share allocation


Inventory policy
Circular sourcing
Shipping method selection and load
consolidation
Global forecast local allocation of
supply across distribution network

Distribution Planning

Automatically generate transfers

DC

Distribute
RDC

Create internal transfers


Create consolidated shipments
Integrated with Transportation Mgmt
for carrier and mode selection

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Process Manufacturing Solution


Enables you to

Accelerate Recipe Development


Manage Variability and Product Consistency
Optimize Capacity and Ingredient Usage
Drive Efficient, Compliant Shop Floor Production
Control Product Cost and Quality

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Mfg Management + Shop Floor Control

A New MES Product Complements Oracle Process Manufacturing

OPM +
MES for
Process
Mfg

Corporate
Management

ERP

Plant
Management

MES

Process
Management

Process
Controls

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Enforce Step Level Management


React Immediately to Production Issues
Ingredient 1

Ingredient 2

10 Weigh
Ingredient 4
Resource+Activity
Usage/Qty

E-Sign

Ingredient 5

Product 1

30 Blend

Product 2

50 Package

40 Test

Start to Start
Resource+Activity
Usage/Qty

20 Heat

E-Sign

By-Product 1
Resource+Activity
Usage/Qty

E-Sign

E-Sign

Resource+Activity
Usage/Qty

E-Sign

Finish to Start

Ingredient 3

Record process parameters


Automatically calculate step quantities
Capture e-signatures as required

Compare and report planned vs.

work in process vs. actual


Make iterative real-time adjustments

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Dispensing / Pre-Weigh

Improve Accuracy & Compliance While Reducing Risk

Improve accuracy by
removing human interaction
Enforce compliance
- Configurable level of control on

Multiple methods
supported
Read Values
Direct from
Devices

process instructions enforce


best practices and regulatory
compliance

Reduce complexity & risk


- Simplified task- based operator
interface

- Consolidate systems
Generate
Labels

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Operator Workbench Guides Compliance


User is stepped through instructions & tasks

Direct link to SOPs


One-Click Access to
Transactional Forms
Configurable acknowledgement:
Optional
Required Acknowledgement
E-Signature(s)

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Process Manufacturing Solution


Enables you to

Accelerate Recipe Development


Manage Variability and Product Consistency
Optimize Capacity and Ingredient Usage
Drive Efficient, Compliant Shop Floor Production
Control Product Cost and Quality

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Multiple Cost Methods

Support All Phases of a Costing System

Material

Actual

Cost
Development

Acquisition

Overhead

Standard

Monitoring

Allocation

Resource

Lot

Indirect

Composite

Analysis

Valuation

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Process Manufacturing Quality


Sample, Analyze, Adjust

Receiving, In Process,

Material Usage Decisions


Batch Adjustments
Order Allocation

Shipping Inspection

Lot Expiration/Retest
Environmental Monitoring

Sample

Standardize

Tests and Methods


Sampling Plans
Specifications

Analyze

Disposition

Result Statistics
Stability Studies

Report

Certificate of Analysis
Lot Genealogy

Process Improvement

Workflow-Driven Processes and Electronic Records

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Pre-Defined Quality Workflows


Check Quality Throughout the Supply Chain

Receiving

Inventory

Suppliers

Production

Shipping

Customers

Automatic Workflow Notifications


at Each Quality Check Point for:

Sample Creation
Assay Testing
Sample Disposition Decision

Quality check points


CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Nonconformance Management
Capture and Record Deviations

Access directly from batch


Capture & document nonconformances / deviations
Configurable criticality
Informational
Resolution required prior to
completing batch or step
Configurable e-signatures

Incl. in control batch record


Critical nonconformances must

be reviewed and signed prior to


close of the batch
Leverages Oracle Quality

Any deviation from


the written procedures shall be recorded and
justified. -- 21 CFR Part 211.100,
Written procedures for deviations
CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Specifications Management

Capture and Meet Unique Customer Specifications

Customer
Specification
Item
Specification

Out-of-Spec

In-Spec

Out-of-Spec

Match
Min

Max

Define internal and customer products specifications


Match available inventory to customer specifications
Provide Certificate of Analysis (COA) with each shipment

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Available Throughout
Entire Offering

Seamless Data Integration


and

Business Intelligence
CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Integration and Intelligence Challenges

Fragmented Data Sources Coupled with the Need to Report Different


Levels of Information without Latency
Business
Planning and Logistics

Corporate BI initiatives typically centered around

Financial / Operational Management,


Plant Production Scheduling ...

financials or customer information


Lack of details and missing context for mfg intel.

Manufacturing
Operations Management

Poor integration between ERP and middle layer

Detailed Production Scheduling,


Dispatching, Reliability Assurance ...

Batch
Control

Continuous
Control

In-House

Discrete
Control

Out-Sourced

Actual Processes

of shop floor systems


Missing context -- from ground floor to top floor
Proliferation of non-standard legacy systems

-- MES, Quality, LIMS


Lack of integration standards; variety of protocols
Fragmented automation and controls market
Variety of production environments -- from

fully automated to completely manual

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Manufacturing Operations Center


ERP
Systems

- MES
- Quality
- Cost Mgmt

Cross-Plant
KPIs

Schedules
Item Master Data

Historical
Trends

Production Actuals

Contextualization
Engine

MES

Manufacturing
Operations
Data Model

Role-Based
Dashboards

Shop Floor Communication Drivers


Device-Generated Data

Automation
& Process
Control
Systems

PLC

Users

Corporate BI

Processing
Equipment

DCS

SCADA
Systems

Advanced Human
Process Machine
Control
Interface

Plant-Specific
KPIs
Real-Time
Updates

Plant Mgr /
VP of Mfg

Production
Manager

Standards-Based
Data Capture and
System Integration
for Seamless
Transactions with
Robust Reporting

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Shop Floor Data Contextualization


Convert Raw Data into Useful Business Information
Automation
& Process
Control Systems

ERP
Systems

Transform

DCS

ERP

Intelligence
Systems

Business Context
Data

PLC

SCADA

SCM

CRM

High
Resolution
Tag Data

Corporate
BI

Build
Context
Business
Events

Define data transformation rules


- Rules by tag type
- Business-oriented aliases for tags
- Additional tag attributes like rollover
values

Use pre-built rules or create new rules

Analyzable
Business
Data

Hub
Dashboards

Apply context to time series data


- Work Order
- WO Segment

- Product
- Shift

Apply out-of-the-box rules or


define new rules

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Role-Based Dashboards and KPIs


Deliver Performance Measures by Responsibility
VP of Operations
Plant Manager

Are we achieving our cost


and productivity targets?
Production Manager
Production Supervisor

What is happening now?


What happened last shift?
Operator
QA Engineer

How is the machine


performing?

Pre-built role-specific dashboards,


reports, and alerts

Graphical views
- Trend charts
- Graphs
- Tables

- Red-yellow-green
indicators

Embedded best-practice
calculations and KPIs

Analytic workflows to drive actions


Drill-downs into details for
root-cause analysis

Leverages OBIEE+
Configurable and customizable

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Example:

Production Throughput Analysis

Track Production and Identify Potential Bottlenecks


Supervisors,
Line Managers

Track against targets


for shift, day, week,
or month

Monitor backlogs by

Determine
equipment status

individual equipment
Click to
view alert
details

Plant Managers,
VP of Manufacturing

Visual cues
quickly indicate
production
status

View throughput by
product, plant, line,
and equipment

Analyze monthly trends


to ensure aggregate
performance

Monitor production
volumes & throughput from
anywhere in the enterprise

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Plus, Extensible Analytical Engine and


Dashboarding Tool
Build a Decision
Support System
Unique to Your
Environment

Accelerate

deployment
and adoption

Most standard
KPIs available
out-of-the-box

Easily adapt
dashboards
and metrics

Provides a
Easily identify, select, modify,
and format relevant KPIs

comprehensive
Operational
Intelligence
framework

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Process Manufacturing Solution


Integrated recipe collaboration
and management

Accelerate Recipe
Development

Formula Simulations, Model


complex process flows, qualitydriven lot & status control

Manage Variability and


Product Consistency

Rule-based production with


integrated supply chain
planning and scheduling

Optimize Capacity and


Ingredient Usage

Operator-centric workbenches
with built in approvals
Comprehensive costing methods
& enterprise quality management

Drive Efficient, Compliant


Shop Floor Production
Control Product
Cost and Quality

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Process Manufacturing Products


Develop
Contracts

Market

Projects
HR
Finance

Sell
Customers,
Suppliers,
Products,

Order
Plan
Procure

Maintain
Service
Fulfill

Make

Process Manufacturing
-

Recipe Devt and Mgmt


Production Scheduling
Process Execution
Quality Management
Cost Management
Regulatory Management

MES for Process Mfg


- Operator Workbench
- Dispensing

Mfg Operations Center

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Evolution of Oracle Process Manufacturing


Base Differentiators
Collaborative, rules-based
recipe development

Ingredient and process

variability management

Multiple cost methods


Real-time WIP visibility
Lot traceability
Co-products & by-products
Shelf-life and status control
Potency / grades
Integrated process quality
workbench

Manufacturing scheduler with


process production

Electronic signatures and

records for 21 CFR part 11

HACCP quality test points

New in 11i.10
Graphical recipe designer
Lot specific costing
Computer-aided formulation
Electronic records and

signatures document control

Enhanced customer quality


specification matching

Mass quality control


result entry

Enhanced co-product

planning (via advanced


planning integration)

Environmental testing
Multiple drum receipt with
automatic lot numbering

New in R12
Common inventory system
with process attributes

- Pricing on secondary UOM


- Item revisions
- Move orders
- High level reservations
Common item master
Least cost formulation
MES for Process Mfg
- Operator-centric workbench
- Dispensing / pre-mix
- Electronic MBR / CBR
- Non-conformance tracking
One-step electronic signature
Mfg Operations Center for
standards-based integration
and configurable reporting

Planning complex routings


CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

All Supported by Leading Technology

J2EE Application Server


Service-Oriented Architecture
Business Process Mgmt
Business Intelligence
Content Management
Identity Management
Collaboration Suite
Enterprise Portal
Business Integration
Data Hubs
Developer Tools
Web Services Management

Real Application Clusters


Advanced Security
Embeddable
Secure Enterprise Search
Data Warehousing
Server Virtualization
Enterprise Management
Partitioning
OLAP
Data Mining
Spatial Data
Secure Backup

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Agenda

Business Challenges
Oracles Leadership Position
Solution Overview
Customer Success

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

COMPANY OVERVIEW
Poland's top manufacturer of generic drugs
and a leading supplier of pharmaceutical
chemicals and services to customers
worldwide
Privatized in 2000; 2300 employees

CHALLENGES / OPPORTUNITIES
Lack of timely production and financial
data needed for daily business
decision-making
Lack of audit trails to comply with
regulatory requirements
SOLUTIONS
Live on E-Business Suite 11i
Process Manufacturing
Manufacturing Scheduling
Adv SC Planning, Demand Planning
Order Management
Warehouse Mgmt, Mobile SC Apps
Financials

CUSTOMER PERSPECTIVE
Since moving to a computer controlled
environment, we've seen higher production
quality, we've enhanced our analytical review
capabilities, and we generate less waste.
-- Tomasz Moys Director of JB Pharma

RESULTS

Improved materials usage by 7%


Expanded manufacturing capacity by 5%
Production time savings of approx. 15%
Consolidated 13 databases into one
Realized 23% net ROI over five years
Projected $2.8 million net benefits
through 2010

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

COMPANY OVERVIEW
Global manufacturing company
developing and supplying specialty
products for the pharmaceutical, food,
and non-toxic printing industries
International pharmaceutical group
engaged in R&D, manufacturing, and
marketing of pharmaceutical products for
sale principally in the prescription market
Specializes in seven therapeutic areas:
cardiovascular, thrombosis, oncology,
diabetes, central nervous system,
internal medicine and vaccines
$33+ billion is sales

CHALLENGES / OPPORTUNITIES
Cover the pharma manufacturing
processes including complex planning
Allow for full-time system availability for
manufacturing

SOLUTIONS
Live on E-Business Suite 11i
Process Manufacturing
Order Management
Advanced Supply Chain Planning
Constraint Based Optimization
Business Intelligence
RESULTS
Despite running SAP for Financials
and HR, Sanofi chose Oracle for Supply
Chain over SAP for chemical and
pharmaceutical manufacturing for
17 plants
FDA regulatory compliance, including 21
CFR Part 11
Single integrated solution for chemical
and pharmaceutical manufacturing
Integrated business intelligence and
management reporting

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

COMPANY OVERVIEW
UK's leading chilled dairy foods company
Dairies Division: Liquid Products,
Household, Ingredients (bulk and
specialist dairy products)
Processes 900 million liters of milk
annually in two plants
$2.6 billion in sales, 7500 employees

SOLUTIONS
Live on E-Business Suite 11i
Process Manufacturing
Advanced Supply Chain Planning
Financials
iProcurement
RESULTS

CHALLENGES / OPPORTUNITIES
Drive for innovation and improved food
quality
Emphasis on least cost in
commodities (milk to own label
supermarkets, exit cheese)
Drive for business process
improvements, with strong support for
relevant investment

Implementation live across multiple sites


(first site live in March 2006)

Real time information flows between


Manufacturing and Finance

Integrated Supply Chain planning for


improved forecast accuracy

Implementation with zero any


customizations

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

COMPANY OVERVIEW
Develops, manufactures, packages, and
distributes agrochemicals and pharmaceuticals to local & international customers
Two R&D centers and five manufacturing
facilities across India
$76 million in sales, over 700 employees

SOLUTIONS
Live on E-Business Suite 11i
Process Manufacturing
Enterprise Asset Management
Financials

RESULTS
CHALLENGES / OPPORTUNITIES
Unify and standardize business
processes across all plants
Reduce complexity of managing
diverse lines of business
Improve data consistency and
accuracy
Modernize operating procedures
according to global best practice

Chose Oracle over SAP


Reduced manufacturing costs through
smarter resource utilization and reduced
wastage

Lowered inventory costs through better


stock management

Cut production process cycle time


Implementation completed in < 6 months
across 5 plants in India

CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract

Oracle Process Manufacturing Solution


Accelerated Recipe Development
Variability and Product Consistency Management
Optimized Capacity and Ingredient Usage
Efficient, Compliant Shop Floor Production
Product Cost and Quality Control

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