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10 enhancements
for Infosys
1
Agenda
Process Manufacturing
OPM Positioning
Introduction to OPM
11.5.10 Enhancements
Future Direction
Questions and Answers
Process Manufacturing Market Profile
Industry Focus
– Pharmaceutical & Biotechnology Process 40%
– Food & Beverage
Discrete
– Chemical
– Metals & Paper
– Building Materials
Variability Process -
Discrete - and it kind of works
it works
The Supply Chain
Making “Stuff” vs. “Things”
Manufacturing Process
and Supply Chain Manufacturing
Discrete Manufacturing Process Manufacturing
• Uses Bills of Materials • Uses Formulas
• Builds, Assembles, Fabricates • Mixes, Blends, Transforms
• Makes “THINGS” • Makes “STUFF”
The Physical Inventory Test
Discrete Assumption
– Constant through time
Time
Process Realities
– Varies through time
Time
How Different are they?
Parts to Ingredients
BOM to Formula
Each to Batch (Bulk)
Rework to Recycle
Scrap to Byproduct
UOM to Multiple UOM
Constant to Variability
Specification to Attributes
Discrete Simple Process Complex Process
Item Number Item Number Item Number
Location Location Location
Quantity Quantity Quantity
Unit of measure Unit of measure
Tank/silo Tank/silo
Lot number Lot number
Aging information Sub-lot number
Classification Container ID
Container type
Aging information
Catch weight
Classification
Quality
Hazards Information
Bill of Material Assumptions
Yields
Complex
Costing
Status
Grade
Lot Sizes
Shelf Life
pH Factor Sequencing
Seasonality Catch Weight
Unique Process Requirements
• Formula Management
• Co-Products & By-Products
• Unit of Measure Conversion
• Quality Specifications & Control
• Lot Control
• Ageing & Expiry
• Yield & Loss Factors - No Scrap!
Unique Process Requirements
Lot Traceability
Packaging
Regulations – FDA & MSDS
Sub Lot Requirements
Catch Weight
Scheduling Needs
Agenda
Process Manufacturing
OPM Positioning
Introduction to OPM
11.5.10 Enhancements
Future Direction
Questions and Answers
Business Pressures
Variability Regulatory Compliance
• How do I create consistent • How do I comply with global
products using inconsistent and local requirements?
ingredients?
• How do I ensure lot traceability
• How do I achieve process and adhere to standards such
and reaction stability? as 21 CFR Part 11?
Step 10
Step 20
Waste
Data Applications
Server Server
OPM for the
Industries
OPM Customers
Consumer Goods Capabilities
Evolution of Oracle Applications in Consumer Goods
Current Differentiators… …with 11i.9… …new in 11i.10
• Mixed Mode Manufacturing • Process Manufacturing • Product Information Hub with
• Inventory Postponement –
21 CFR Part 11 Compliance UCCNet Support (11i.10+)
Optimization –
HACCP Quality Test Points • Discrete Manufacturing
• Supplier Collab & VMI –
Automatic Lot Grading – 21 CFR Part 11 Compliance
• Collaborative Planning
–
Manufacturing Scheduler • RFID Transactions
• High Volume Order Processing • Short Term Deployment Planning
• Supply Chain Exception Mgmt • Continuous Real-Time Demand
• Transportation Planning
• Real Time Order Promising Planning
and Visibility • Scarce Inventory Allocation
• Integrated Maintenance and • Enhanced Trade Mgmt. Tools
• Multi-Channel Order Capture Production Planning
• Enhanced Blanket Orders • Business Account Planning
• Advanced Pricing
and Releases • Integrated Sales Contracts
• EDI Transactions for POs,
Ship Notices, Invoicing & • Retroactive Promo Adjustments • Quick Ship User Interface
Warehousing • Promotional ROI Calculations • Customer Consigned Inventory
• Claims & Deductions Mgmt • 3rd Party POS Data Import • Retroactive Pricing in Purchasing
• Lot Traceability (to Calc Promotional Accruals) • Channel Budget Management
• Funds Management • Transportation Execution • Enhanced Management and
• Collaborative Sourcing Resolution of Promotional Claims
• Promotional Planning
• Advanced Product Catalog
Oracle confidential. This is not a commitment to deliver. Product directions are subject to change without notice.
OPM Consumer Goods Customers
Life Sciences Capabilities
Evolution of Oracle Applications in Pharma / Biotech
Current Differentiators… …with 11i.9… …new in 11i.10
• Clinical Trials Data Mgmt • 21 CFR Part 11 Compliance • Computer-Aided Formulation
• Adverse Event Reporting for Process Manufacturing • Stability Studies Management
• Thesaurus Management – Electronic Signatures • Environmental Testing
• Clinical Remote Data Capture – Electronic Records • E-Signatures on Documents
• Skills Database • Validation Procedures • Graphical Recipe Designer
• Process Manufacturing • Production Batch Record • Mass Quality Control
Keeping System
– Potency Support Result Entry
• Integrated Process Quality
– Expiration Dating
Workbench • Multiple Drum Receipt with
– Industry Compliant Recipes Automatic Lot Numbering
• Advanced Product Catalog
• Lot Traceability Genealogy • Enhanced Management &
• CRF* Design and Layout Resolution of Chargebacks
• Project Management Utility
• Flow Manufacturing • Procurement Contracts
• Direct Entry on PDF Forms-
• Inventory Optimization Enabled CRFs • RFID-Based Transactions
• Workflow-Enabled Quality • Multi-Lingual Remote Data
Management Capture Entry & Monitoring
*CRF = Case Report Form
Oracle confidential. This is not a commitment to deliver. Product directions are subject to change without notice.
Oracle Life Sciences Customers
Chemicals Capabilities
Evolution of Oracle Applications in Chemicals
Current Differentiators… …with 11i.9… …new in 11i.10
• Product Development for • Process Industry Procedures • Computer-Aided Formulation
Process Manufacturing and Business Flows for ISO • Stabilities Studies Mgmt
• Laboratory Spreadsheet Certification
• Reserve Manufacturing to
and Formula Analysis • 21 CFR Part 11 Compliance Sales Orders
• Dual Unit of Measure for • Sequence Dependent • Rapid Recipe Creation
Active Ingredients Scheduling
• Shelf-Life & Status Control • Lot-Specific Costing
• Quality-Driven Lot Usage • Environmental Monitoring
• Co- / By-Products and Production Control
• Lot Traceability • Product Data Management • Enhanced Co-Product Planning
• Shift Level Reporting via Process Parameters • Transportation Planning
• Asset Maintenance • Continuous Real-Time • Short Term Deployment Planning
• Supply Chain Planning Demand Planning • Customer Consigned Inventory
and Procurement • Integrated Maintenance • Integrated Sales Contracts
• EDI Transactions for POs, and Production Planning • Retroactive Pricing in Purchasing
Ship Notices, Invoicing &
Warehousing
• Transportation Execution • Business Account Planning
• MES Integration APIs • Collaborative Sourcing • Channel Budget Management
• Multi-Channel Order Capture • Advanced Product Catalog
• Real Time Order Promising • Enhanced Blanket Orders
and Visibility and Releases
Oracle confidential. This is not a commitment to deliver. Product directions are subject to change without notice.
OPM Chemical Customers
The Process Manufacturing
Marketplace
Source: Gartner
Recent Process Press
-AMR 2004
How Process Mfg Solutions Stack Up...
Capability Oracle SAP SCT Ross/CDC
Recipe Rules-Based
Production
+ o - +
Multi-Level Lot
Traceability
+ o + +
Formula-Based MSDS
Development
+ + - -
Proactive Quality
Workflows
+ + o -
Multiple Simultaneous
Cost Methods
+ + - +
Activity-Based /
Lot Costing o o - o
Potency Allocations + o + +
Step-Level
Production Mgmt
+ + - +
Electronic Signatures + + - -
Complex Process
Modeling
+ o - +
Integrated
Catch-Weights
+ - + +
94 % of SAP
process
manufacturing
customers cited
Lacking
functionality as
number 1 reason
for not using SAP
manufacturing
Agenda
Process Manufacturing
OPM Positioning
Introduction to OPM
11.5.10 Enhancements
Future Direction
Questions and Answers
Oracle Manufacturing
Product Family Mai
ntai
Process n
Design Plan Procure Fulfill
Mfg. and
Ser
vice
• Advanced • Advanced • Purchasing • Process • Order • Enterprise Asset
Product Supply Chain Inventory Management
• iProcurement Management
Catalog Planning
• Product • Configurator
• Sourcing • Complex
• CAD View • Inventory Development
• Advanced Maintenance, Repair
3D Optimization • iSupplier Portal
• Process Pricing & Overhaul
• Product • Global Order • Oracle Supplier Execution •
• Release CRL Financial
Intelligence Promising Network
• Process Management Management
• Demand • Procurement Planning
• Inventory • Network Logistics
Planning Intelligence
• Costing and Management (Network Asset
• Collaborative • Procurement MAC Tracking)
• Warehouse
Planning Contracts
• Process Quality Management
• Constraint Based • Services
• Regulatory • Transportation
Optimization Procurement
Mgmt
• OPM System
Admin
• ERES
OPM Understands your
Business Flows...
Customers
Optimized Schedule
Formula Batches Production
Approved
Product APS /
Suppliers
Costing MRP
Order
Requisition
Procurement
Raw Materials
OPM Product Development
A secure, configurable environment for bringing new
products to market
Experimental Regulatory
Lab Batches
Recipes Documents
Research Plant
Develop Pilot Launch
Trials
Item 9FA123
Standard:
1 Case = 10 LB 20.0 LB
vs
Lot Source
Where Used
Supply
Material
Production schedule requirements
plan
Inventory Purchase order
Production Transfer in
Oracle Process Planning MRP
Solution
Balance supply and demand
Consider all sources of supply and demand
Ingredient 1 Ingredient 2
10 Dispense
Resource+Activity Ingredient 4 Ingredient 5
Usage/Qty ERES
WF ERES
By-Product 1 Product 1
20 Weigh
Finish-to-Start
Resource+Activity
Usage/Qty ERES
Ingredient 3
Quality-Controlled Batch Processing
Control Production Variability with Quality
Checks
10 Weigh
Resource+Activity E-Sign
Usage/Qty 30 Blend 40 Package
Resource+Activity E-Sign
Usage/Qty
Hold Step for Quality
Sampling and Testing
E-Sign
Oracle Process Execution
Solution
Maximize production flexibility
Flexible scaling
Samples
Disposition Update Item
Workflow Lot Status/Grade
Oracle Process Quality Solution
Cost
Monitoring Allocation Analysis Valuation
Development
Multiple Costing Methods
Supports different costing needs
Process Manufacturing
OPM Positioning
Introduction to OPM
11.5.10 Enhancements
Future Direction
Questions and Answers
Topics
Process Inventory
Product Development
Quality Management
Regulatory Management
OPM System Administration
Process Planning
Process Execution
Process Costing
Process Logistics
Process
Inventory
New Feature Highlights
Process Inventory
Configurable by item
User-defined lot and sublot prefix
Manual override allowed
Suffix can be reset to fill in numbering gaps
Custom schemes supported via program exit
Zero pad option
“Smart” sublot suffix
– Sequential for a lot
– Resets for new lot
Process-Discrete
Inventory Transfer
Process-Discrete Inventory Transfer
generates
Formula
Recipe + Validity
Rules
Computer
Aided Formulation
Computer-Aided Formulation
Model Production Requirements to Target Specifications
Inventoried In-Process
Lot Properties QC Metrics
Computer-Aided Formulation
• Recalculate Material
and Yield Quantities
Target Product /
Product Recipe • Compute Batch
Characteristics (e.g., fat Customer Specs
content, potency, etc.)
• Automatically Revise
Lot Allocations
Organize specifications
and samples data
– Summary
– Details: Tests, Results
Improve quality
laboratory productivity
Simplify access to
Quality screens
Personalize workbench
with saved queries
Monitoring Specifications and Samples
Inspect quality levels of non-material sources:
– Warehouses or locations
– Generic or plant resources
Notify of out-of-spec conditions via the sample
group rejection workflow
Examples of uses:
– Monitor environmental controls (e.g. temperature)
– Inspect an equipment resource for proper
calibration
– Validate stability study storage chamber conditions
25°C
Stability Study Management
Variant
A1
Glass
40°C
01 3 6 9
12 18 24 months
75% RH
Variant Plastic
40°C
A2 0123 6 months
75% RH
Initial Polyethylene
Samples Variant 40°C
Batch A A3 75% RH 0 12 months
Quality-Driven Lot UOM Conversion
Leverage quality test result(s) to:
– Account for lot-to-lot quality variations
– Recommend lot-specific inter-class UOM
conversions
– Notify to update
conversions and on-
hand inventory
Automatic
Sample
Creation
Mass
Results
Entry
Regulatory Management
Regulatory Management
MSDS
E-business Document
Suite System
Selected
Effectivity
Firm Flag on Batch
Mass release
option
Auto Release of Suggestions
Semi-Auto/Manual Release
Release
selected
suggestions
Auto Release of Suggestions
Semi-Auto Release
Enter
Parameters
In-line Forecast Consumption
Line 2
Line 1
Process
Execution
New Feature Highlights
Process Execution
Resource Back Flushing
Support for Shop Calendar setups
Terminate Production Batch
Resource
Backflushing
Definition: Backflushing
Allocation Priority
for over-allocation
Reserving Against Process
Execution How to Use this Feature
User enters
reserved
quantities
Reserving Against Process Execution
Convert FPO to a Batch
Modify reserved
quantity, if
needed
Multiple
Lot Receiving
Receiving Multiple Lots
Description
Process Manufacturing
OPM Positioning
Introduction to OPM
11.5.10 Enhancements
Future Direction
Questions and Answers
Beyond 11i.10…
Inventory Convergence
Enhance Core Process Modules (Formulation
Management, Production, Quality,Costing)
– Campaign management
– Attribute driven manufacturing
– Outsourced manufacturing
Define Process Industries Requirements
– Product Life Cycle Management
– Inventory / Logistics / Transportation
– Planning
QUESTIONS
ANSWERS