Professional Documents
Culture Documents
2
Oracle Process Manufacturing
3
Food & Beverage Process Industry Value Chain
Suppliers Finished
Growers
Raw
Manufacturers Product Mfgr
Materials
Brokers
Distributors
Retailers
Business
Distribution
Channels Web Direct Consumer Customers
CONFIDENTIAL: All capabilities and dates are for planning purposes only and may not be used in any contract
Today’s Value Chain is Complex
• Geographically Distributed • Increasingly Collaborative
• Dynamically Networked • Product & Service Oriented
Value Creation
Suppliers Customers
Value Creating
Activities
Inbound Outbound Marketing
Operations Service
Logistics Logistics & Sales
Innovation
Procurement
Supporting
Activities
Human Capital Management
Financial Management
5
Information is Critical to Your Value Chain
Unplanned Disruptive
Scenarios Changes
External
Corporate
Processes &
Objectives
Information Internal Process Focus
Undefined,
Cross-LOB
Ambiguous
Programs
Information
6
Information is Critical to Your Value Chain
Information • PREDICT Market Requirements and Risks
Enables • INNOVATE & ADAPT to Drive Leadership
You to… • ALIGN Operations to Comply and Achieve
Business Goals
Changing
Market Unplanned Disruptive
Conditions Scenarios Changes
Undefined,
Cross-LOB
Ambiguous
Programs
Information
7
Oracle Process Manufacturing
8
Process Industry Business Drivers
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 and
• How do I achieve process and adhere to standards such
reaction stability? as 21 CFR Part 11?
Dull Finish*
(in millions of dollars)
Company Sales % Change Earnings % Change
Akzo-Nobel $1,597.0 0% $79.8 -26%
Sherwin-Williams 1,540.0 17 83.3 62
DuPont¹ 1,536.0 8 166.0 -12
PPG Industries² 1,332.0 5 9.0 -95
ICI 961.9 2 94.1 2
BASF 607.5 -7NA NA
RPM³ 516.3 9 4.5 -25
*First quarter sales and earnings for paints and coatings operations. NA=Not available. 1) Pretax
operating profit. 2) Includes $150-million pretax charge for nonrecurring legal settlement. 3) Fiscal
third quarter ended Feb. 28.
10
A Need for Change
Leading Business Trends
11
Traditional ERP Manufacturing Solution
MRP
Manufacturing
Process Discrete
Work Orders
LIMS / Quality
System Shop Floor System
14
Oracle Information Driven Manufacturing Solution
Global Order Promising Planning & Scheduling
Analytics
Predict Demand Innovate
Manufacturing Product
Intelligence Flexible, Mixed Mode Manufacturing Lifecycle Mgmt
Standard
Process ETO Discrete
ATO / CTO Warehousing /
MTS Lot-Based Transportation
Flow / Lean
Collaboration
MES Partner
Collaboration
Shop Floor Sys
and Visibility
Contract Mfgrs Suppliers
15
Process vs. Discrete Manufacturing
Process Discrete
• Variable ingredients, by-/co-products • Standard parts, components
• UOM are material specific • UOM are by unit or by lot
• Use multiple recipes and formulas • Use complex multi-level BOMs
• Need lot, grades, potency, shelf-life • Need serial numbers, ECNs
• Mixes, blends, transforms • Builds, assembles, fabricates
• Makes “STUFF” • Makes “THINGS”
Process: 40%
Discrete: 60%
Process vs. Discrete Manufacturing
Process Discrete
• Item/Ingredient • Part Number
• Formula/Recipe • BOM
• Yield • Scrap
• Dual UOM • UOM Conversion
• Non Linear Routing • Linear Routing
• Lot Trace • Serial Number
• Production Batch • Work Order
• Quality Assays • Pass/Fail
• Parent Lot/Child lot/Grade • Serial Number
• Gallons, Pounds, Pounds Solid • Each, Pieces
Oracle Process Manufacturing
18
Oracle Process Manufacturing
• Formula based planning
• Multiple versions
• Scaling, Theoretical Yields
• By-products/co-products
• Planning, Production, Costing types
• Recipe workbench
• 21 CFR Part 11 Compliant
• Electronic Signatures
• Electronic Batch Records
• World class Audit Trail
• Unbreakable Security
• Quality Control Workflows
• Process Oriented Production
19
Why is it Hard? Lot Genealogy
Yields
Complex
Costing
Lot Sizes
Shelf Life
Seasonality
pH Factor
Circular Processing Catch Weight
20
Oracle Process Manufacturing Overview
21
Design to Deliver Manufacturing
Supply Chain Management Flow
Sales Comprehensive
Process Mfg
Cost
Management Management
Solution
Process
Recipe & Formula Management Performance
Development (MES for Process) Analysis
Multi-Level
Procure Manufacturing Material/Resource
Materials Operations Center Traceability
API Interfaces
22
OPM Bundle
Becoming More Demand-Driven is High on
our Customers’ Agendas…
23
…but Difficult to Achieve with a Traditional
Disconnected S&OP Approach
High latency, limited collaboration, no consensus
forecasting
Your Company
Financial Production New Product Sales Marketing Measurement
Planning Planning Planning Quotas Forecasting and Reporting
Multiple,
Manual processes non-integrated
Multiple data sources systems
24
Improved Demand Management
Sense Demand: Arrive at a More Accurate Number
25
Real-Time Sales & Operations Planning
Shape Demand: Leverage More Frequent POS Data to
Drive Supply-Demand Balancing Decisions
26
Demand Signal Management
Critical Feed into S&OP
The Opportunity
• Drive sales and improve inventory
management by:
Oracle Collaboration Consumer Response
• Reducing demand latency
Pricing &
Promotion
Demand
Planning Supply Chain
• Providing data-driven, actionable
Management
Category
Management
Planning
Order
Fulfillment
intelligence
Consumer
Marketing Distribution
The Challenge
Product Retail
Sales &
Operations
Inventory
Optimization
• Integration with enterprise applications
Planning
Respond
Integrate
Capture
Analyze
Manage
– SOA Messages –
Retail DC/ Distributor Data APS to demand
• DC shipments
• DC inventory • Reduced manual
• DC replen. rules S&OP effort and cost
Other External Data
• Consistent data
• Retail loyalty DRP
• IRI/AC Nielsen more easily
• 3rd party leveraged across
demographic Oracle Demand SNO
Signal Repository teams and
• Causal (weather,etc.)
• RFID/EPC applications
• IMS, NDC, EDI (867, • Data sources centrally cleansed, PLM
852), Scripts, harmonized and aggregated
Pedigree • Pre-built dashboards and reports
• Unstructured text
• Powerful BI capabilities
• “Sense & Respond” event management
28
Closing the Sales & Operations Planning Loop
DSM will offer “out of the box” integration with Oracle Demantra
Sense Plan Demand Plan Supply
Sales & Inventory
Marketing Optimization
Strategic
Promotion
Network
Distributors / Consumers
Planning
Optimization
Suppliers
New Product Constraint
Forecasting Based
Scheduling
• Typically, they don’t have access to correlated and aggregate planning data unless it is presented in a
comprehensive spreadsheet or on paper
• Often, the decision is made to design and build a custom data warehouse that has no integration to the
source of the data and that is a limited representation of the data
• Supply chain executives have no time to learn power user interfaces that we developed for purposed
planning applications
30
Solution: Advanced Planning Command Center
Enables cross-planning process management,
decision making and automation
Volatility Compliance Chaos Operational Efficiency
Virtualization Risk Uncertainty Risk Management and Compliance
Globalization Consolidation Continuous Innovation
Pre-built, configurable Dashboards and Reports Scenario, Activity and Process Management
Planning
Workbenches
• Provides integrated analytics combined with process and activity management enable a more structured
approach to cross planning discipline processes, analysis and decision making – Everyone looks at the
same picture, no learning curve!
• Enables informed decision making through the ability to correlate data quickly and the provided drill downs
to the lowest level of detail
• Pre-built – Get started quickly for quick ROI
31
Advanced Planning Command Center
Key capabilities that enable cross-discipline
process management and analysis
Pre-Built Dashboard Pre-Built Dashboard
• Scenario Analysis
• Compare different scenarios, or plans, in customizable
analytical dashboards
• Configure exceptions (ibots) for alerting
• Scenario Management
• Define planning scenarios that span multiple constituents of the
planning community
• Assign scenario activities for execution by the planning
community
Output of Analytical Data • Optionally group scenarios together
Executed and Exceptions Activity Lists
• Combine plans together into scenarios after the fact
Archived Plans Executed Scenarios
• Copy scenarios for execution of new scenarios
Activities (tied to • Optionally, define Scenario Sets to group scenarios – Define
Scenarios) new scenarios for execution in the set; leverage Sets to search
Scenario for limited set of Scenarios
Management
Preconfigured Planning Processes • Activity Management
• Manage assigned activities; assign new activities to users
Plans linked to Scenario and Plan • Process Management
Scenarios output from executed • Link multiple planning processes together for automated or
processes manual execution
• Use Plan Archive to archive plan summary information
Planning Data Archived Plans • Optionally, configure to tie in non-Oracle systems
Plan • Optionally model and use approval and review steps
Archive
• Use system defined (BPEL) or user defined process activities
• Execute the process - plan results are stored and automatically
aggregated into analytical data
32
Dashboard: Demand & Supply
33
Demantra Real-Time S&OP
Enabling the next generation best-in-class S&OP
process
Sales and Operations Planning Process
• Move from a periodic reactive
process to a real time proactive
process
34
Oracle Demantra Demand Management
Real-time demand sensing and collaborative
consensus forecasting
35
Align With Real-Time S&OP
Leverage best-in-class Sales and Operations
Planning from Demantra
• Analytics-based demand management
• Capture all demand data in a central place
• Use analytics to develop a bottom-up forecast
• Workflow-driven collaborative planning
• Enable a workflow driven multi-disciplinary
collaborative process with all stakeholders
• Adaptable, configurable planning platform
• Web-portal based internal & external collaboration
• Profitably balance supply, demand
• Make allocation decisions,
• Tradeoff service levels & cost
• Monitor Performance
• Adjust demand, supply plans as conditions change
• Create incentives and promotions to close gaps
• Drive continuous improvement
36
Oracle Order Management
Customers Forecasting
Suppliers Order Accuracy
Complete Integrated
Collaboration Info Intelligence
Multi-Channel Enterprise
Demand Complete Business Flow Integration
37
Recipe & Formula Development
Recipe & Formula Development
Process Manufacturing Product Development delivers
comprehensive and powerful tools that allow process manufacturers
to manage the product lifecycle from inception through production.
With OPM Product Development, you can accelerate innovation to
market, assure consistent, quality products, and minimize costs and
compliance risks.
Enables Benefits
• Compliant approval authorization, e- • Secure and manage data
records & e-signature, mass search and • Accelerate recipe development
replace
• Manage variability and product
• Change management, recipe designer, consistency
least cost formulation
• Reduce costs and optimize formulas
• Process details, computer-aided
formulation, item substitution
• Least cost formulation, formula analysis
38
Process Product Development
Reducing Time to Market and Costs
Recipe & Formula Development
Internal
Testing Web-Based
(Stability W
Studies)
o Formulate Access
r
k
Concept
Engineering Manufacturing
Document f
l Validate
Mgmt
o
(MSDS)
w
Approve & Requirements
Electronic Release Sales & Mktg
D Specifications Purchasing
Digital r
Records Studies
i
v Schedule Schedules
e Defects
Process n
Retire
Mfg Records Orders Service Finance
S Produce
O
Recipe & P
External
Knowledge Secure s Test &
Access Maintain
Repository Web-Based
Access
Suppliers Customers
Process
Improvement
40
End-to-End Multi-Mode Execution Process Management
• Collaborative Research • Production Recipes
• Formula / Recipe Mgmt • Change Control Processes • Parent Lot, Child Lot, Contaminant Tracking
• What-If Analysis • Workflow Driven • Special Packaging / Toxicity Insert Included
• Least Cost Formulation • Least Cost Formulation in Bill of Materials
• Computer Aided Formulation • Computer Aided formulation • MES
• Process Repeatability
Complete Support
Manage ingredient
• Yield Performance
and process • Product Data Management
for FDA 21 CFR Part 11
variability • Role-Based Responsibilities EU &TGA Gap Guidelines
• Lot Costs S88
ISA 95 41
Recipe & Formula Development
Recipe Structure
Validity Rules
•Recipe Types
Costing Quality
•Effectivity Dates
•Capture Simultaneous Cost Methods •Planning Rules •Specifications
•Least Cost Formulation •Samples
•Evaluate / compare costs by method •Results
Recipe
•Graphical Recipe Designer
Formula -
Routing
Material List Resources
Requirement
INPUTS OUTPUTS Processing
Operations
•R/M •FG Instructions
•Int •By Text / Parameters Activities
•PKG •Co MES for Process Resources
Step/Material Association
42
Collaborative Access to Product Details
Quickly Develop New Formulations
43
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
45
Least Cost Formulation
Optimize Costs while Complying with Product Requirements
•Ingredients •Qty
•Apricot Juice •5
•Grapefruit Juice •25
•BRIX
•Grapefruit •8.00 •27 •70 •29.5
•%MOISTURE Juice
•SWEETNESS •Water •.75 •0 •100 •0
47
Recipe & Formula Development
Recipe & Formula Development
Process Manufacturing Product Development delivers
comprehensive and powerful tools that allow process manufacturers
to manage the product lifecycle from inception through production.
With OPM Product Development, you can accelerate innovation to
market, assure consistent, quality products, and minimize costs and
compliance risks.
Enables Benefits
• Compliant approval authorization, e- • Secure and manage data
records & e-signature, mass search and • Accelerate recipe development
replace
• Manage variability and product
• Change management, recipe designer, consistency
least cost formulation
• Reduce costs and optimize formulas
• Process details, computer-aided
formulation, item substitution
• Least cost formulation, formula analysis
48
Supply Chain Planning
Supply Chain Planning
provides enterprise-wide coordination to balance material supply with demand and to
ensure timely delivery of finished products. To balance inventory supply and demand,
OPM Material Planning examines pending inventory transactions, applies demand to
current inventory balances, suggests specific actions based on user-defined sourcing
rules, and projects inventory availability dates based on Unconstrained ASCP
recommendations. OPM Material Planning is more than typical MRP system planning
material. It will also provide the user a Rough Cut Capacity view of resource loading.
For CRP (Capacity Resource Planning) OPM uses Oracle ASCP in a constrained and
optimized plan.
Enables Benefits
• Access real-time information from sales, • Material and rough cut capacity planning
production and inventory to make quick • Enhanced co-product planning
and accurate decisions.
• Ability to perform on-line simulations
• Perform “what if” calculations to view and • Perform “what if” calculations to view the
react to the effects of unanticipated orders
effects of unanticipated orders
or shop floor problems such as resource
breakdowns and overloading. • Access real-time information from sales,
production, inventory
• Evaluate Firm Planned Orders before
implementing by checking ingredient and
resource loading availability then commit
FPO’s to production.
49
Supply Chain Planning
Optimize Inventory by Location and Quantity
Enterprise
Level
Region
Level
Plant
Level
50
Planning in Process Industries
Recipe X
Formula X, v. 5
L L M H H
Route 1, v. 3
Validity Rules
v1 v2 v3
Production
Batch
51
Distribution Planning
Optimize Supply Allocation to Distribution Centers
52
Enterprise-Wide Purchasing Automation
Drive Compliance and Manage Spending Behavior
Services
53
Oracle Sourcing & Procurement
Supplier
Streamline Procurement Processes Portal
Logistics
Services Approval Touchless Automated
Routing Buying Payment
Supplier
Engineered Settlement
Network
Goods Budget-Based
Procurement
Contract Supplier
Management Performance
Direct Profile
Materials Management
Enforce Policy Compliance
54
Source
Supply Chain Planning
Supply Chain Planning
provides enterprise-wide coordination to balance material supply with demand and to
ensure timely delivery of finished products. To balance inventory supply and demand,
OPM Material Planning examines pending inventory transactions, applies demand to
current inventory balances, suggests specific actions based on user-defined sourcing
rules, and projects inventory availability dates based on Unconstrained ASCP
recommendations. OPM Material Planning is more than typical MRP system planning
material. It will also provide the user a Rough Cut Capacity view of resource loading.
For CRP (Capacity Resource Planning) OPM uses Oracle ASCP in a constrained and
optimized plan.
Enables Benefits
• Access real-time information from sales, • Material and rough cut capacity planning
production and inventory to make quick • Enhanced co-product planning
and accurate decisions.
• Ability to perform on-line simulations
• Perform “what if” calculations to view and • Perform “what if” calculations to view the
react to the effects of unanticipated orders
effects of unanticipated orders
or shop floor problems such as resource
breakdowns and overloading. • Access real-time information from sales,
production, inventory
• Evaluate Firm Planned Orders before
implementing by checking ingredient and
resource loading availability then commit
FPO’s to production.
55
Inventory Management
Inventory Management
With Inventory Management you can improve inventory visibility,
reduce inventory levels and control inventory operations. All of your
material in each line of business and stage of the inventory lifecycle
can be tracked in a single system. Increased transparency will
reduce the need for local buffer stocks, and inventory will be located
where it previously wasn’t known to exist.
Enables Benefits
• Multi-purposed single item, dual & multiple • Satisfy customer demand quickly and
UOM, auto lot allocation, grade control, accurately
divisible lot control • Reduce costs with efficient Inventory
• Dual UOM, shelf life management, grade Management
control, lot level status control, physical • Reduce risk with rapid lot genealogy
and cycle counting, APIs analysis
• Parent / child lot tracking and traceability
• Ensure Regulatory compliance
• Audit trail, strong security, ERES,
Inventory tied to Regulatory
56
Inventory Management
Capture Location & Composition thoughout Lifecycle
58
OPM Multiple Units of Measure
L0t 001
2 Case = 20 Ltr 20.0 Ltr
vs
59
Automatic Lot Allocation
Creation FIFO
2/5/2008 2/1/2008 1/1/2008
Date
Lot A Lot C
Lot B
FEFO
Additionally, for customer shipments: Shipment
• Preferred Grade
• Match on Quality Specification
• Remaining Shelf Life
60
Inventory Management
Inventory Management
With Inventory Management you can improve inventory visibility,
reduce inventory levels and control inventory operations. All of your
material in each line of business and stage of the inventory lifecycle
can be tracked in a single system. Increased transparency will
reduce the need for local buffer stocks, and inventory will be located
where it previously wasn’t known to exist.
Enables Benefits
• Multi-purposed single item, dual & multiple • Satisfy customer demand quickly and
UOM, auto lot allocation, grade control, accurately
divisible lot control • Reduce costs with efficient Inventory
• Dual UOM, shelf life management, grade Management
control, lot level status control, physical • Reduce risk with rapid lot genealogy
and cycle counting, APIs analysis
• Parent / child lot tracking and traceability
• Ensure Regulatory compliance
• Audit trail, strong security, ERES,
Inventory tied to Regulatory
61
Comprehensive Process MFG Solution
with MES
Comprehensive Process MFG Solution
Process Execution ensures manufacturing consistency throughout the production cycle by
providing tight control over ingredients and processes, balanced with the flexibility to
respond to changing plant conditions
MES for Process Manufactring
(MES) provides intensive, multifaceted shop floor execution capabilities. The application
allows process manufacturers to deploy Oracle Process Manufacturing directly on their
shop floors as the manufacturing execution system (MES) as well as use Touch Screen
based devices.. MES for Process manufacturing eliminates many unnecessary and non-
value-added activities by providing a structured and standards-based shop floor execution
toolset.
Enables Benefits
• Model complex process flows, rule based • Maximize production flexibility
recipes, scaling • Drive efficient, compliant shop floor
• Automated reservations and lot production
allocations, incremental backflush, • Streamline production and compliance
dispensing / pre-weigh, operators reporting
workbench
• Manage variability and product
• Operators workbench e-records and e-
consistency
signature, non-conformance
• Computer-aided formulation, least cost
formulation
62
Production Scheduling in Process Industries
63
Comprehensive Process Mfg Solution
Manage Production to Ensure Optimal Conditions
Ingredient 1 Ingredient 2
10 Weigh
Start to Start
Resource+Activity E-Sign E-Sign Resource+Activity E-Sign
Usage/Qty Usage/Qty
20 Heat
By-Product 1 Product 1 Product 2
Resource+Activity E-Sign
Usage/Qty
Ingredient 3
• Compare and report planned vs.
• Record process parameters work in process vs. actual
• Automatically calculate step quantities • Make iterative real-time adjustments
• Capture electronic signatures as required • In-process samples and tests
64
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
ERP
Process Engineer
• Manage recipes & advanced process
Corp Mgmt instructions
Production Supervisor
MES • Create & manage batch status
• Log non-conformances
Corporate
Management ERP
OPM +
MES for
Process
Mfg Plant
Management MES
Process Process
Management Controls
67
Model Actual Scenario of Shop Floor
Improve inventory visibility at each stage
of the Supply Chain
Production Dispensing Production
• Reservation supply
Materials Manager
Supervisor Operator Operator
Complete &
Close Batch to assure inventory
meets customer
Review Control
needs
• High level
Batch Record
Lock Operation,
Follow PI,
• Detail Level
Execute Tasks
Reverse
Consensus forecast Dispense
Log Ingredients
Move Ingredients
To Staging
so that stock is
Location
Review and
Schedule
Dispense
Ingredients with
readily available
FPO / Batch
Approve Schedule & Reserve
Materials
Detailed Reservations
• Dispensing Locations
• Staging Locations
68
Supervisor Workbench
Graphical Dispense Planning View
Display Bucket
(Daily / weekly)
Dispense Planning
details at Area/booth,
Resource, Storage Area
Dispense Capacity
Plan Vs Actual
69
Dispensing Workbench
Improve Accuracy & Compliance While Reducing Risk
• Touch Screen enabled
• Improve accuracy by
removing human
interaction
• Generate Labels
• Enforce compliance
Multiple methods - Configurable level of
supported control on process
instructions enforce best
practices and regulatory
compliance
Certification
Setup for
Override Status
Organization,
Transaction
Criteria for
Enabling
Operator
Certification
72
Oracle MES for Process Mfg.
Additional Benefits
73
Comprehensive Process MFG Solution
with MES
Comprehensive Process MFG Solution
Process Execution ensures manufacturing consistency throughout the production cycle by
providing tight control over ingredients and processes, balanced with the flexibility to
respond to changing plant conditions
MES for Process Manufactring
(MES) provides intensive, multifaceted shop floor execution capabilities. The application
allows process manufacturers to deploy Oracle Process Manufacturing directly on their
shop floors as the manufacturing execution system (MES) as well as use Touch Screen
based devices.. MES for Process manufacturing eliminates many unnecessary and non-
value-added activities by providing a structured and standards-based shop floor execution
toolset.
Enables Benefits
• Model complex process flows, rule based • Maximize production flexibility
recipes, scaling • Drive efficient, compliant shop floor
• Automated reservations and lot production
allocations, incremental backflush, • Streamline production and compliance
dispensing / pre-weigh, operators reporting
workbench
• Manage variability and product
• Operators workbench e-records and e-
consistency
signature, non-conformance
• Computer-aided formulation, least cost
formulation
74
Electronic Batch Record/E-Signature
Electronic Batch Record/E-Signature
E-Records is a configurable framework for secure capture, storage, inquiry, and
printing of electronic records and electronic signatures (ERES) in compliance with
government regulations, such as the United States Food and Drug Administration (US
FDA) 21 CFR Part 11.
.
Enables Benefits
• Built-in Compliance • Reduced cost of compliance
• One-step e-signature with optional e- • Increased speed
record view • Improved collaboration
• Manages critical information related to • Enforced best practices
production orders, quality records, or other • Advanced search and analysis for audit
information key to conformance with FDA
Good Manufacturing Practices (cGMP), • Controlled document printing
75
Electronic Batch Record
Operation details,
including Process
Nonconformances Instructions and
Dispensing details
Operator Comments
76
Eliminate Massive Amounts of Paper
Completely replace paper batch records
with Electronic Batch Records
77
Electronic Batch Record/E-Signature
Electronic Batch Record/E-Signature
E-Records is a configurable framework for secure capture, storage, inquiry, and
printing of electronic records and electronic signatures (ERES) in compliance with
government regulations, such as the United States Food and Drug Administration (US
FDA) 21 CFR Part 11.
.
Enables Benefits
• Built-in Compliance • Reduced cost of compliance
• One-step e-signature with optional e- • Increased speed
record view • Improved collaboration
• Manages critical information related to • Enforced best practices
production orders, quality records, or other • Advanced search and analysis for audit
information key to conformance with FDA
Good Manufacturing Practices (cGMP), • Controlled document printing
78
Quality-Oriented Process Management
Enables Benefits
• Stability studies, lot expiration • Achieve product consistency
management, process control points, • Enforce proactive quality assurance
quality throughout the supply chain
• Streamline quality lab productivity
• Standardized inspection methodology,
workflow, e-records and e-signature • Assure customer and regulatory
compliance
• Automated test/lab assignment, quality
workbench
• Customer spec matching, CofA / CofC, lot
traceability
79
Quality-Oriented Process Management
Manage Variability and Assure Product Consistency
80
Pre-Defined Quality Workflows
Check Quality Throughout the Supply Chain
Suppliers Customers
Automatic Workflow Notifications
Production at Each Quality Check Point for:
• Sample Creation
• Assay Testing
Quality check points • Sample Disposition Decision
81
Nonconformance Management
Capture and Record Deviations
• Access directly from batch
• Capture and document
nonconformances / deviations
• Configurable criticality
- Informational
- Resolution required prior to
completing batch or step
- Configurable e-signatures
• Included 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 pro-
cedures 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
Out-of-Spec In-Spec Out-of-Spec
Specification
Item
Specification
Match
Min Max
83
Stability Studies
Measure the Effects of Environmental Aging
Base Monitoring
Specification
0 1 3 6 9 12 18 24 months
Overlay Monitoring
Specification (1)
0 1 23 6 months
Production Stability
Batch Samples
Overlay Monitoring
Specification (n)
Study Definition 0 12 months
• Sample Numbering
• Monitoring Specs
• Storage Conditions
• Storage Packaging Work Flow Notices
• Testing Intervals Lab Study Lab
Study Execution Technician Owner Supervisor
• Item Specs
• 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
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
Formulator Requests
Version 2 Finished
Good ‘Approved for Lab Use’
Packaging
By-product Intermediate
item
85
Quality-Oriented Process Management
Enables Benefits
• Stability studies, lot expiration • Achieve product consistency
management, process control points, • Enforce proactive quality assurance
quality throughout the supply chain
• Streamline quality lab productivity
• Standardized inspection methodology,
workflow, e-records and e-signature • Assure customer and regulatory
compliance
• Automated test/lab assignment, quality
workbench
• Customer spec matching, CofA / CofC, lot
traceability
86
Cost Management
Cost Management
Process Manufacturing (OPM) Costing combines detailed cost-tracking features with
flexible analytical tools to help process manufacturers determine their true product costs.
OPM Costing supports Standard, Actual and Lot costing types to calculate costs and
create reports to analyze data at the most granular level. Using Oracle Sub-ledger
Application, necessary accounting entries are created for all the transactions.
Enables Benefits
• Multiple cost methods: standard, actuals, • Optimize profits and margins
lot, composite • Capture precise product costs
• Co-products, by-products, unlimited cost • Facilitate proactive cost management
elements, cost allocations
• Assure proper accounting of resources &
• Cost monitoring, cost analysis materials
• Flexible account mapping, sub-ledger flow,
drilldowns
87
Cost Management
Analyze and Control Product Costs
Cost Management
Process Manufacturing (OPM) Costing combines detailed cost-tracking features with
flexible analytical tools to help process manufacturers determine their true product costs.
OPM Costing supports Standard, Actual and Lot costing types to calculate costs and
create reports to analyze data at the most granular level. Using Oracle Sub-ledger
Application, necessary accounting entries are created for all the transactions.
Enables Benefits
• Multiple cost methods: standard, actuals, • Optimize profits and margins
lot, composite • Capture precise product costs
• Co-products, by-products, unlimited cost • Facilitate proactive cost management
elements, cost allocations
• Assure proper accounting of resources &
• Cost monitoring, cost analysis materials
• Flexible account mapping, sub-ledger flow,
drilldowns
89
Performance Analysis
Performance Analysis
Daily Business Intelligence (DBI) for Manufacturing offers manager enhanced visibility
into their manufacturing operation. It enables them to maximize manufacturing
performance by enabling them to identify potential issues earlier and gives them a tool
to address them before they escalate into real problems.
Enables Benefits
• Reliable information directly from mission- • Make better faster business decisions
critical business applications • Improve manufacturing execution
• Manufacturing management, plan • Meet strategic objectives
management • Manage by exception
• Complete supply chain intelligence
offering with:
Customer fulfillment, shipping, inventory,
manufacturing, product cost, plan,
transportation and warehouse
management pages
• KPIs, graphs, charts, tables, drill downs
90
Performance Analysis
Real-Time
Results
Daily Business Intelligence
Reports for Manufacturing
Performance
Measures Comprehensive
presentation of real time
Manufacturing Data in
form of graphs, reports, etc
Manufacturing Plans
comparison, Resource
Utilization tracking
Graphs
92
Performance Analysis
93
Performance Analysis
Performance Analysis
Daily Business Intelligence (DBI) for Manufacturing offers manager enhanced visibility
into their manufacturing operation. It enables them to maximize manufacturing
performance by enabling them to identify potential issues earlier and gives them a tool
to address them before they escalate into real problems.
Enables Benefits
• Reliable information directly from mission- • Make better faster business decisions
critical business applications • Improve manufacturing execution
• Manufacturing management, plan • Meet strategic objectives
management • Manage by exception
• Complete supply chain intelligence
offering with:
Customer fulfillment, shipping, inventory,
manufacturing, product cost, plan,
transportation and warehouse
management pages
• KPIs, graphs, charts, tables, drill downs
94
Integrated Warehousing and Logistics
Carriers / Global
3PLs Customers
Portal / Collaboration
Messaging & Event Mgmt
Continuous Planning
95
Multi-Level Material/Resource Traceability
Multi-Level Material/Resource Traceability
OPM Quality Management offers comprehensive lot genealogy capabilities to trace
materials from receipt through customer shipment. It provides an easily accessible,
online record that indicates when lots were sampled for quality inspection and were
used in production, moved, or shipped as end products—the information needed to
prove compliance with government regulations, ISO 9000 requirements, or your
own internal quality standards.
Enables Benefits
• Reduce risk with rapid lot genealogy • Better Customer Responsiveness
analysis • Parent / child lot tracking and traceability
• Lot Genealogy with Sampling History • End to End Tracking
96
Multi-Level Material/Resource Traceability
Comply with Stringent Regulatory Requirements
Lot Source
Where Used
97
Multi-Level Material/Resource Traceability
Multi-Level Material/Resource Traceability
OPM Quality Management offers comprehensive lot genealogy capabilities to trace
materials from receipt through customer shipment. It provides an easily accessible,
online record that indicates when lots were sampled for quality inspection and were
used in production, moved, or shipped as end products—the information needed to
prove compliance with government regulations, ISO 9000 requirements, or your
own internal quality standards.
Enables Benefits
• Reduce risk with rapid lot genealogy • Better Customer Responsiveness
analysis • Parent / child lot tracking and traceability
• Lot Genealogy with Sampling History • End to End Tracking
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Pre-Built Process Manufacturing Mobile
Transactions
99
Pre-Built Inventory Transactions
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Manufacturing Operations Center
Manufacturing Operations Center
is a new solution built on a next generation Manufacturing Operations architecture,
leveraging the ISA-95 reference model. The solution the divide between relatively
stable world of business users relaying on ERP and back office applications and real-
time exception prone world of the manufacturing users relying on variety of shop floor
systems. Manufacturing Hub provides real-time visibility in to shop floor operations by
connecting to disparate data sources available on the shop floor including MES,
Quality, and Maintenance, LIMs, Historians as well as the automation and control layer.
The solution is also designed to orchestrate data flow between ERP and back office
applications and shop floor systems. Oracle Manufacturing Hub is the first solution in
the industry that provides out of the box operational analytics with flexibility and
configurability of a toolkit.
Enables Benefits
• Eliminate discrepancy between manual • Contextualize Plant Floor Data and
data and machine data Synchronize with ERP
• Perform preventive maintenance based • Provide Real-Time Intelligence for Plant
on machine “actuals” vs. “best guess” Operations
• Leverage Next Generation Manufacturing
• Achieve visibility for lean and six-sigma
Operations Architecture
programs
• Progressively eliminate on-hold and
other production issues
• Gain competitive edge by sharing quality
information with customers
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1
Mfg Integration & Intelligence Opportunity
Plus…
• Eliminate discrepancy between manual data and machine data
• Perform preventive maintenance based on machine “actuals” vs. “best guess”
• Achieve visibility for lean and six-sigma programs
• Progressively eliminate on-hold and other production issues
• Gain competitive edge by sharing quality information with customers
Next-Generation Architecture
• Built on a common abstraction layer
ERP of production / equipment data
Abstraction
Manufacturing Hub
• Leverage existing investments in plant
Layer
IT infrastructure – no rip & replace
Distributed Plant Systems
• Allows for gradual upgrade of plant
Automation & Control systems
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Oracle Manufacturing Operations Center
Users
- MES Corporate BI
ERP - Quality
Systems - Cost Mgmt
… Cross-Plant
KPIs
Schedules Historical Plant Mgr /
Production Actuals Trends VP of Mfg
Item Master Data
Contextual-
ization Manufacturing
Engine Operations
Plant-Specific
Data Model KPIs
(ISA-95) Role-Based Production
Real-Time
Dashboards Updates Manager
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Single Repository for Mfg Operations Data
Provide Consistent Information for
All Manufacturing Users
10
5
Role-Based Dashboards and KPIs
Deliver Performance Measures by Responsibility
VP of Operations
Plant Manager • Pre-built role-specific dashboards,
reports, and alerts
Are we achieving our cost
• Graphical views
and productivity targets?
- Trend charts - Red-yellow-green
- Graphs indicators
Production Manager - Tables
Production Supervisor • Embedded best-practice
calculations and KPIs
What is happening now?
What happened last shift? • Analytic workflows to drive actions
• Drill-downs into details for
root-cause analysis
Operator
QA Engineer • Leverages OBIEE+
How is the machine • Configurable and customizable
performing?
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6
Extensible Analytical Engine
and Dashboarding Tool
Build a Decision
Support System
Unique to Your
Environment
• Accelerate
Most standard deployment
KPIs available and adoption
out-of-the-box
• Easily adapt
dashboards
and metrics
• Provides a
comprehensive
Operational
Easily identify, select, modify, Intelligence
and format relevant KPIs framework
10
7
Deploy Based on Business Priorities
Generate Value Regardless of Implementation Scope
Manage
Line-by-Line or Work Plant-Wide Network of Plants
Center Performance and/or Contract Manufacturers
Local Global
Scope
10
8
Manufacturing Operations Center
Manufacturing Operations Center
is a new solution built on a next generation Manufacturing Operations architecture,
leveraging the ISA-95 reference model. The solution the divide between relatively
stable world of business users relaying on ERP and back office applications and real-
time exception prone world of the manufacturing users relying on variety of shop floor
systems. Manufacturing Hub provides real-time visibility in to shop floor operations by
connecting to disparate data sources available on the shop floor including MES,
Quality, and Maintenance, LIMs, Historians as well as the automation and control layer.
The solution is also designed to orchestrate data flow between ERP and back office
applications and shop floor systems. Oracle Manufacturing Hub is the first solution in
the industry that provides out of the box operational analytics with flexibility and
configurability of a toolkit.
Enables Benefits
• Eliminate discrepancy between manual • Contextualize Plant Floor Data and
data and machine data Synchronize with ERP
• Perform preventive maintenance based • Provide Real-Time Intelligence for Plant
on machine “actuals” vs. “best guess” Operations
• Leverage Next Generation Manufacturing
• Achieve visibility for lean and six-sigma
Operations Architecture
programs
• Progressively eliminate on-hold and
other production issues
• Gain competitive edge by sharing quality
information with customers
10
9
API Interfaces
API Interfaces
Oracle® Process Manufacturing (OPM) has the unique functionality that process
manufacturers need to run their businesses efficiently and effectively. However, sometimes
integration with other application software may be desired to extend and complement Oracle
Process Manufacturing’s capabilities, while still fully benefiting from its robust data model. To
address these requirements, Oracle Process Manufacturing offers application programming
interfaces (APIs) to enable easier integration legacy systems, in-house developed
applications, and third party software.
Enables Benefits
11
0
Standard Process Manufacturing APIs
Integrate Plant Devices and Legacy Systems
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Improve Accuracy
Capture data instead of typing it in
• Device Integration
• Provide standard integration points
• Weigh scales - Direct input during dispensing process
• Process equipment - Capture readings, such as temp, pressure,
speed
• Mobile Support
• Ingredient Issue
• Return Ingredient
• Return Product
• Create Product Lot
• Update Product Lot
• Backflush
• Update Resource
• LPN Transactions
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API Interfaces
API Interfaces
Oracle® Process Manufacturing (OPM) has the unique functionality that process
manufacturers need to run their businesses efficiently and effectively. However, sometimes
integration with other application software may be desired to extend and complement Oracle
Process Manufacturing’s capabilities, while still fully benefiting from its robust data model. To
address these requirements, Oracle Process Manufacturing offers application programming
interfaces (APIs) to enable easier integration legacy systems, in-house developed
applications, and third party software.
Enables Benefits
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3
For More Information
http://search.oracle.com
Process Manufacturing
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4
Additional Resources
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5
Course Agenda
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