001 opm concepts, overview & drivers

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<Insert Picture Here> Process Manufacturing Drivers, Concepts & Overview August 18 th , 2008 AGSS Process Manufacturing Sales Support Team

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Page 1: 001 OPM Concepts, Overview & Drivers

<Insert Picture Here>

Process Manufacturing Drivers, Concepts & Overview

August 18th, 2008

AGSS Process Manufacturing Sales Support Team

Page 2: 001 OPM Concepts, Overview & Drivers

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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 decisions.The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.

Page 3: 001 OPM Concepts, Overview & Drivers

3

Oracle Process Manufacturing

Key Business Challenges in Process Manufacturing Industries

Evolution to Information Driven Manufacturing

Design to Deliver Process Manufacturing Flow

Page 4: 001 OPM Concepts, Overview & Drivers

Food & Beverage Process Industry Value Chain

Suppliers

Customers

Finished Product Mfgr

Distribution Channels

RawMaterials

Distributors

GrowersManufacturers

Business

ConsumerWeb Direct

Product Dev.

Manufacturing

Retailers

Marketing

Sales Brokers

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

Page 5: 001 OPM Concepts, Overview & Drivers

5

Today’s Value Chain is Complex

Suppliers Customers

InnovationInnovation

ProcurementProcurement

Human Capital Management

Va

lue

Cre

atin

gA

ctivities

Su

pp

ortin

gA

ctivitiesFinancial Management

• Geographically Distributed• Dynamically Networked

• Increasingly Collaborative• Product & Service Oriented

InboundInboundLogisticsLogistics OperationsOperations OutboundOutbound

LogisticsLogisticsMarketingMarketing& Sales& Sales ServiceService

Value Creation

Page 6: 001 OPM Concepts, Overview & Drivers

6

Information is Critical to Your Value Chain

Resulting in Rigid Processes Optimized for Static Market Conditions

Undefined, Ambiguous Information

External Processes & Information

Corporate Objectives

Unplanned Scenarios

Cross-LOB Programs

Internal Process Focus

Disruptive Changes

InboundLogistics

OperationsOutboundLogistics

Marketing& Sales

Service

Historically, Companies Focused on Perfecting

Internal Operations…

Page 7: 001 OPM Concepts, Overview & Drivers

7

Information is Critical to Your Value Chain

• PREDICT Market Requirements and Risks• INNOVATE & ADAPT to Drive Leadership• ALIGN Operations to Comply and Achieve

Business Goals

InformationEnablesYou to…

PredictPredict Align, ComplyAlign,

ComplyInnovate , AdaptInnovate , Adapt

Value Chain Focus

InboundLogistics

OperationsOutboundLogistics

Marketing& Sales

Service

ChangingMarket

Conditions

Undefined, Ambiguous Information

Corporate Objectives

Cross-LOB Programs

Disruptive Changes

External Processes & Information

Unplanned Scenarios

Page 8: 001 OPM Concepts, Overview & Drivers

8

Oracle Process Manufacturing

Key Business Challenges in Process Manufacturing Industries

Evolution to Information Driven Manufacturing

Design to Deliver Process Manufacturing Flow

Page 9: 001 OPM Concepts, Overview & Drivers

9

Process Industry Business Drivers

Variability• How do I create consistent

products using inconsistent ingredients?

• How do I achieve process and reaction stability?

Lowest Total Cost• How can I meet quality, delivery,

and service demands at a competitive price?

• How can I minimize waste and emissions?

• Manage the production process to deliver profitable, regulatory-compliant, high-quality products

Raw Materials,Ingredients

Value-Added Transformation

Finished Goods

Regulatory Compliance• How do I comply with global

and local requirements?

• How do I ensure lot traceability and adhere to standards suchas 21 CFR Part 11?

Reduced Time to Market• How can I manage a growing list of

key product attributes?

• How can I efficiently mass customize my products?

• Achieve global visibility with ability to manage plant specific variability

• Create and execute an optimal production plan

Page 10: 001 OPM Concepts, Overview & Drivers

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1. Labor costs rising globally – resulting in outsourcing to lower cost labor markets

2. Energy Prices continue to Rise resulting in cost increases in downstream products due to energy consumption in manufacturing process:

– Gasoline– Electricity– Plastics– Paper

3. Raw Material Costs rising

Escalating Cost Pressures

Rising raw material costs put a crimp in first-quarter profits at paints and coatings companies. The first quarter is typically the slowest for paintmakers, particularly in the architectural coatings sector because of the weather, producers say.

Dull Finish*(in millions of dollars)Company Sales % Change Earnings % ChangeAkzo-Nobel $1,597.0 0% $79.8 -26%Sherwin-Williams 1,540.0 17 83.3 62DuPont¹ 1,536.0 8 166.0 -12PPG Industries² 1,332.0 5 9.0 -95ICI 961.9 2 94.1 2BASF 607.5 -7NA NARPM³ 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.

Page 11: 001 OPM Concepts, Overview & Drivers

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• Accelerating Time to Market

• Managing Variability and Consistency

• Optimizing Capacity and Ingredients

• Controlling Product Cost and Quality

• Reducing Complexity

• Getting Timely Information to Make Decisions

A Need for ChangeLeading Business Trends

Page 12: 001 OPM Concepts, Overview & Drivers

14

Work Orders

Traditional ERP Manufacturing Solution

Inventory Management

MRP

Manufacturing

Process Discrete

Shop Floor System

White Board / Spreadsheets

Bills of MaterialsRecipes

Routings

LIMS / Quality System

Analysis via Spreadsheets

Page 13: 001 OPM Concepts, Overview & Drivers

15

Lot / Serial Genealogy Tracking

Quality MgmtAnalyzeAnalyze AdjustAdjustSampleSample

Project Tracking

Manufacturing Execution

Oracle Information Driven Manufacturing Solution

ProductLifecycle Mgmt

Warehousing / Transportation

Service

AssetLifecycle Mgmt

Planning & Scheduling

Flexible, Mixed Mode Manufacturing

Process

Flow / Lean

Standard Discrete

Lot-Based

ETOATO / CTO

MTS

Shop Floor Sys

PartnerCollaboration and VisibilityContract Mfgrs Suppliers

Manufacturing Intelligence

Visibility from Shop Floor to

Top Floor

Global Order Promising

Collaboration

Analytics

MES

Predict Demand

Adaptive Quality

Innovate

Page 14: 001 OPM Concepts, Overview & Drivers

Process vs. Discrete Manufacturing

• 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”

Process Discrete• Standard parts, components• UOM are by unit or by lot• Use complex multi-level BOMs• Need serial numbers, ECNs• Builds, assembles, fabricates• Makes “THINGS”

Beverages,Foods

Paper, Metals,Fibers

Chemicals,Pharma

Discrete: 60% Discrete: 60%

Process: 40%Process: 40%

36%24% 20%

Page 15: 001 OPM Concepts, Overview & Drivers

Process vs. Discrete Manufacturing

• Item/Ingredient• Formula/Recipe• Yield• Dual UOM• Non Linear Routing• Lot Trace• Production Batch• Quality Assays• Parent Lot/Child lot/Grade• Gallons, Pounds, Pounds Solid

Process Discrete• Part Number• BOM• Scrap• UOM Conversion• Linear Routing• Serial Number• Work Order• Pass/Fail• Serial Number• Each, Pieces

Page 16: 001 OPM Concepts, Overview & Drivers

18

• Process Inventory Model

• Parent/Child Lots,Status, Grade, shelf life

• Concurrent UOMs

• Full bi-directional Lot Tracing

• Process Cost Model

• Concurrent tracking of standard and actual costs

• ABC style allocations

• Unlimited calendars, periods, methods, elements

• True Co-packer/Tolling cost

• Stability Studies

• Least Cost Formulation

Oracle Process Manufacturing

                      

      

Page 17: 001 OPM Concepts, Overview & Drivers

19

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

Page 18: 001 OPM Concepts, Overview & Drivers

20

Potency

% Solid

Multiple Units of Measure

pH Factor

Multi-PlantManufacturing

FluctuatingCommodityPrices

ComplexCosting

Alternative Routings

Alternative Formulas

Sequencing

Quality Attributes

Grade

Status

Lot Sizes

Yields

Shelf LifeSeasonality

Viscosity

Toxicity

Catch Weight

Why is it Hard?

Circular Processing

Lot Genealogy

Page 19: 001 OPM Concepts, Overview & Drivers

21

Oracle Process Manufacturing Overview

Key Business Challenges in Process Manufacturing Industries

Evolution to Information Driven Manufacturing

Design to Deliver Process Manufacturing Flow

Page 20: 001 OPM Concepts, Overview & Drivers

22

Design to Deliver ManufacturingSupply Chain Management Flow

Procure Materials

Comprehensive Process Mfg Solution

Supply Chain Planning

ManufacturingOperations Center

Cost Management

Electronic Batch Record/E-Signature

Demand Management

Recipe & Formula Development

Quality-Oriented Process Management

Shipping & Transportation

Multi-Level Material/Resource Traceability

Inventory Management

Performance Analysis

Process Management(MES for Process)

API Interfaces

Sales Management

OPM Bundle

Page 21: 001 OPM Concepts, Overview & Drivers

23

Becoming More Demand-Driven is High on our Customers’ Agendas…

• Increasing margin pressure

• Supply chains are notoriously inefficient

• Need better and more timely product distribution data

Leading companies are looking to become more demand-driven as a key enabler of profitable growth

Page 22: 001 OPM Concepts, Overview & Drivers

24

Multiple,non-integrated

systems

Manual processesMultiple data sources

FinancialPlanning

New ProductPlanning

SalesQuotas

ProductionPlanning

Measurementand Reporting

MarketingForecasting

Your Company

…but Difficult to Achieve with a Traditional Disconnected S&OP Approach High latency, limited collaboration, no consensus forecasting

No connection between plans, plans not tied to executionMisalignment between metrics and objectivesUnreliable forecasts and production plans

?

Page 23: 001 OPM Concepts, Overview & Drivers

25

Improved Demand ManagementSense Demand: Arrive at a More Accurate Number

Gain real-time visibility to all demand signals • Accommodate multiple units of measure and currencies for

Sales, Marketing, Customers, Suppliers

• Include point of sale information in real time

• Forecast at a more detailed level – store, shelf, etc.

• Move from a regimented periodic to a continuous demandplanning process

Accurately predict demand via adv. analytics• Establish baseline forecast from quantitative & qualitative data

• Utilize high precision statistical forecasting without requiring a statistical background

• Forecast based on attributes and characteristics

Rapidly reach a better consensus-based forecast• Use multi-dimensional analysis to adjust, allocate, and rollup

• Collaborate with internal and external constituents

• Ensure responsiveness via workflow-driven forecast exceptions

• Capture contract win assumptions w/ assumption-based forecasting

Page 24: 001 OPM Concepts, Overview & Drivers

26

Real-Time Sales & Operations PlanningShape Demand: Leverage More Frequent POS Data toDrive Supply-Demand Balancing Decisions

Profitably balance supply, demand & budgets• Make allocation decisions while trading off service levels & cost

• Balance the needs of many customers in different channels

• Examine throughput on the most critically constrained resources or suppliers, and profitability by product family

Monitor performance, manage exceptions• Adjust demand or supply plan as conditions change

• Create sales incentives and promotions to close gaps

• Drive continuous improvement

Use workflow-driven collaborative planning

• Enable a workflow-driven multidisciplinary collaborative process that includes Manufacturing, Finance, Sales, Marketing, and external stakeholders

• Adapts to business process via configurable planning platform

• Achieve internal & external collaboration via web-based portal

Page 25: 001 OPM Concepts, Overview & Drivers

27

Demand Signal ManagementCritical Feed into S&OP

Consumer

Distribution

Pricing &Promotion

ManagementSupply Chain

PlanningOrder

Fulfillment

DemandPlanning

InventoryOptimization

Sales &OperationsPlanning

SupplyNetworkDesign

CategoryManagement

ConsumerMarketing

PerformanceManagement

RetailExecution

ProductInnovation

ConsumerConsumer

Distribution

Pricing &Promotion

ManagementSupply Chain

PlanningOrder

Fulfillment

DemandPlanning

InventoryOptimization

Sales &OperationsPlanning

SupplyNetworkDesign

CategoryManagement

ConsumerMarketing

PerformanceManagement

RetailExecution

ProductInnovation

The Opportunity

• Drive sales and improve inventory management by:

•Reducing demand latency•Providing data-driven, actionable intelligence

The Challenge

• Disparate downstream data sources

• Data cleansing, harmonization and integration

• Integration with enterprise applications

• Readiness of enterprise applications to drive specific operational changes

The Solution

Oracle Demand Signal Management

Oracle Collaboration Consumer Response

Patient

Page 26: 001 OPM Concepts, Overview & Drivers

28

Oracle DSR Solution Concept

TPM

TPO

APS

S&OP

DRP

SNO

PLM

• More timely data to better sense, shape and respond to demand

• Reduced manual effort and cost

• Consistent data more easily leveraged across teams and applications

– S

OA

Mes

sag

es –

Ag

gre

gat

ed D

eman

d S

ign

als

• Data sources centrally cleansed, harmonized and aggregated

• Pre-built dashboards and reports• Powerful BI capabilities • “Sense & Respond” event management

Cap

ture

Man

age

An

alyz

e

Res

po

nd

Oracle Demand Signal Repository

Inte

gra

te

• POS sales• Price• Store inventory• Promotional plans• Store replen. rules• Store forecasts

Retail Store Data

• DC shipments• DC inventory• DC replen. rules

Retail DC/ Distributor Data

• Retail loyalty• IRI/AC Nielsen• 3rd party

demographic• Causal

(weather,etc.)• RFID/EPC• IMS, NDC, EDI

(867, 852), Scripts, Pedigree

• Unstructured text

Other External Data

Page 27: 001 OPM Concepts, Overview & Drivers

29

Closing the Sales & Operations Planning Loop DSM will offer “out of the box” integration with Oracle Demantra

Warehouse Management

Consensus Forecast

Transportation Management

Su

pp

liers

Sense

Sy n

di cat ed

, PO

S, P

edi g

ree , D

i rec t Da ta E

xchan

ge

Promotion Planning

Market Demand

Forecasting

New Product Forecasting

Dis

tribu

tors

/ Co

ns

um

ers

Plan Demand

Evaluate Supply

Constraints

Strategic Network

Optimization

Inventory Optimization

Plan Supply

Constraint Based

Scheduling

Sales & Marketing

Su

pp

li er Co

ll abo

ra ti on

Manufacturing Execution

Process Control

DCS / PLC

Execute

Measure Performance

Analyze

In-Process Analytics

Design for Quality

PLM

Track & Trace

Consensus Supply Plan

DemandSignal Mgmt.

Manufacturing Hub

Oracle Today

Partner SolutionsOracle Strategy

Page 28: 001 OPM Concepts, Overview & Drivers

30

The Great Information Divide Is Still There

• 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

How do the supply chain executives get access to actionable information?

Manual Co-ordination Across Functional Groups

UncertaintyVirtualization

Chaos

Globalization

Volatility

Consolidation

Risk

Compliance

Continuous Innovation

Operational Efficiency

Risk management and Compliance

Emails, Phone calls Spreadsheets, Reports

Page 29: 001 OPM Concepts, Overview & Drivers

31

Solution: Advanced Planning Command Center

• 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

Enables cross-planning process management, decision making and automation

UncertaintyVirtualization

Chaos

Globalization

Volatility

Consolidation

Risk

Compliance

Continuous Innovation

Operational Efficiency

Risk Management and Compliance

Preconfigured Analytics Model

Scenario, Activity and Process ManagementPre-built, configurable Dashboards and Reports

PlanningWorkbenches

Page 30: 001 OPM Concepts, Overview & Drivers

32

Advanced Planning Command Center

• 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• Optionally group scenarios together• Combine plans together into scenarios after the fact• Copy scenarios for execution of new scenarios• Optionally, define Scenario Sets to group scenarios – Define

new scenarios for execution in the set; leverage Sets to search for limited set of Scenarios

• Activity Management• Manage assigned activities; assign new activities to users

• Process Management• Link multiple planning processes together for automated or

manual execution• Use Plan Archive to archive plan summary information• Optionally, configure to tie in non-Oracle systems• Optionally model and use approval and review steps• Use system defined (BPEL) or user defined process activities• Execute the process - plan results are stored and automatically

aggregated into analytical data

Key capabilities that enable cross-discipline process management and analysis

ExceptionsAnalytical Data

Pre-Built Dashboard Pre-Built Dashboard

Planning Data Archived Plans

Activity Lists

Preconfigured Planning Processes

ScenarioManagement

PlanArchive

Plans linked toScenarios

Executed Scenarios

Output of Executed andArchived Plans

Scenario and Plan output from executed processes

Activities (tied to Scenarios)

Page 31: 001 OPM Concepts, Overview & Drivers

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Dashboard: Demand & Supply

Page 32: 001 OPM Concepts, Overview & Drivers

34

Demantra Real-Time S&OP

• Move from a periodic reactive process to a real time proactive process

• Start quickly with best practice templates and easily adapt to your business

• Sense, shape, and respond to demand

• Drive tactical decisions into execution and monitor performance

Sales and Operations Planning Process

Product ReviewDemand Review

Supply ReviewExecute and Measure

Sense

Shape

Respond

Management Review

Enabling the next generation best-in-class S&OP process

Page 33: 001 OPM Concepts, Overview & Drivers

35

Oracle Demantra Demand Management

• Sense demand real-time• Capture demand more frequently, closer to the point of consumption• Capture demand and forecast at more granular level (store, shelf,

attributes, product characteristics)• Achieve consensus demand number more quickly by involving all

constituents at the same time, including customers• Quickly identify and react to demand changes and exceptions

• Improve forecast accuracy• Leverage advanced statistics for more accurate demand number• Use any combination of quantitative or qualitative data to establish your

base line forecast• High precision statistical forecasting, no statistical background required –

Superior Bayesian-Markov forecast analytics• Forecast based on attributes and characteristics• Leverage Advanced Forecast Modeling for promotion lift decomposition

and causal analysis

• Shape demand for profitability• Plan new product introductions• Plan promotions and sales incentives• Identify cross selling opportunities

• Evolve to real-time S&OP• Profitably balance supply, demand, and budgets• Align strategic and tactical plans• Role based process, proactively managed via workflow

Shipments

Marketing

forecast

Order

history

CHANNEL DATA

Customer

sales

CollaborationWorkbench

Demand Hub and Seeded Worksheets

Real-time demand sensing and collaborative consensus forecasting

Page 34: 001 OPM Concepts, Overview & Drivers

36

Align With Real-Time S&OP

• 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

Leverage best-in-class Sales and OperationsPlanning from Demantra

Page 35: 001 OPM Concepts, Overview & Drivers

37

CompleteInfo

CompleteInfo

CollaborationIntegratedIntelligence

EnterpriseIntegrationComplete Business Flow

Web Store

Call Center

Field Sales

EDI

Service

Multi-ChannelDemand

Planning

Purchasing

DiscreteManufacturing

ProcessManufacturing

Finance

LogisticsCustomerSystems

CustomersSuppliers

ForecastingOrder Accuracy

Oracle Order Management

PlanShip-ment

PlanShip-ment

Pick, Pack& Ship

Pick, Pack& ShipTrack &

DeliverTrack &Deliver

Invoice/PaymentInvoice/Payment

CheckAvailability

CheckAvailability

ScheduleSchedule

Con-figureCon-figure

PricePrice

Tailorable,Workflow

DrivenProcess

Page 36: 001 OPM Concepts, Overview & Drivers

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Recipe & Formula Development

Recipe & Formula Development Recipe & Formula Development Process Manufacturing Product Development deliverscomprehensive and powerful tools that allow process manufacturersto manage the product lifecycle from inception through production.With OPM Product Development, you can accelerate innovation tomarket, assure consistent, quality products, and minimize costs andcompliance risks.

Enables• Compliant approval authorization, e-

records & e-signature, mass search and replace

• Change management, recipe designer, least cost formulation

• Process details, computer-aided formulation, item substitution

• Least cost formulation, formula analysis

Benefits• Secure and manage data• Accelerate recipe development• Manage variability and product

consistency• Reduce costs and optimize formulas

Page 37: 001 OPM Concepts, Overview & Drivers

40

Recipe & Formula Development

Recipe & KnowledgeRepository

SecureAccessSecureAccess

Schedule

Produce

Test &Maintain

Formulate

Validate

Approve & Release

Re

tire

Co

nc

ep

t

DocumentMgmt

(MSDS)

Electronic Digital

Records

ProcessMfg Records

Testing(Stability Studies)

Web-BasedAccess

Requirements

Specifications

Studies

Schedules

Defects

Orders

Web-BasedAccess

ProcessImprovement

Workflow

Driven

SOPs

Process Product DevelopmentReducing Time to Market and Costs

Service Finance

Internal

External

Sales & Mktg Purchasing

Suppliers Customers

Engineering Manufacturing

Page 38: 001 OPM Concepts, Overview & Drivers

41

• Supplier Mgmt

• Production Planning

• Multiple Plants

• Collaborative Research

• Formula / Recipe Mgmt

• What-If Analysis

• Least Cost Formulation

• Computer Aided Formulation

• Production Recipes

• Change Control Processes

• Workflow Driven

• Least Cost Formulation

• Computer Aided formulation

• Lab Batches / Pilots

• Master Batch Records

• Tracking & Reporting

• Parent Lot, Child Lot, Contaminant Tracking

• Special Packaging / Toxicity Insert Included in Bill of Materials

• MES

• Lot Quality / Consistency

• Cert. of Analysis

• Cert. of Conformance

• Specification Matching

• Lot Genealogy

Formulate Approve& Release

Schedule Produce TestValidate

End-to-End Multi-Mode Execution Process Management

Complete Supportfor FDA 21 CFR Part 11

EU &TGA Gap GuidelinesS88

ISA 95

Monitor & Adjust Performance• Process Repeatability

• Yield Performance

• Product Data Management

• Role-Based Responsibilities

• Lot Costs

Manage ingredient and process

variability

Page 39: 001 OPM Concepts, Overview & Drivers

42

Recipe

Recipe & Formula DevelopmentRecipe Structure

Costing Quality

Processing

InstructionsText / Parameters

MES for Process

RoutingResources

Requirement

Validity Rules

Complete Support

for FDA 21 CFR Part 1

1

INPUTS

•R/M

•Int

•PKG

Operations

Activities

Resources

•Recipe Types

•Effectivity Dates

•Planning Rules

OUTPUTS

•FG

•By

•Co

Step/Material Association

•Capture Simultaneous Cost Methods

•Least Cost Formulation

•Evaluate / compare costs by method

•Specifications

•Samples

•Results

Formula -

Material List

•Graphical Recipe Designer

Page 40: 001 OPM Concepts, Overview & Drivers

43

Collaborative Access to Product DetailsQuickly Develop New Formulations

Easily view complete / modify product details

Search, retrieve and copy from existing formulas

Drag and drop items, operations, and

process instructions

PLM for ProcessPLM for Process

Graphical Recipe Designer

Complete Supportfor FDA 21 CFR Part 11

• Formulas, Recipes & Routings

• Ingredients and Operations

• Process Instructions

• Documents (e.g., MSDS)

• Issues and Changes

• Customer Specs & Reqts

Automatically compute material quantities and anticipated yield

Define conditions for recipe component use

Initiate status change and approval process

Page 41: 001 OPM Concepts, Overview & Drivers

44

Computer-Aided Formulation Model Production Requirements to Target Specifications

Product RecipeTarget Product /Customer Specs

• Recalculate Materialand Yield Quantities

• Compute Batch Characteristics (e.g., fat content, potency, etc.)

• Automatically Revise Lot Allocations

Computer-Aided Formulation

In-ProcessQC Metrics

InventoriedLot Properties

• Model & analyze impact of formulation change before producing expensive and time consuming laboratory test batches

• Perform ‘what if’ new or revised formulations without interfering with production

• Optimize using specify product target properties and allow software to reformulate ingredients

Page 42: 001 OPM Concepts, Overview & Drivers

45

Least Cost FormulationSpeed Innovation though Quality and Cost Optimization

INNOVATION & COMPETITIVENESS• Leverage existing architecture• Meet product specifications every time• Eliminate guesswork from formulation process

COST & COMPLIANCE PRESSURES• Select price-optimal formulas and batches• Reduce costs by using least cost ingredients• Fulfill regulatory requirements for products

VARIABILITY & QUALITY• Optimize variability of material characteristics• Select alternative ingredients for use-up• Formulate based on product target attributes

Page 43: 001 OPM Concepts, Overview & Drivers

46

Least Cost Formulation Optimize Costs while Complying with Product Requirements

• Generate formulations based on material, compositional, and technical requirements

• Analyze formulations using Product Requirements

• Load cost from any source

• Create formulas or production batches directly

Least Cost FormulationItem Weight Cost Brix

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

• Quality• Regulatory• Chemical• Nutrients• Costs

ProductRequirements

Formula

Batch

AlternateIngredient

Listing

Page 44: 001 OPM Concepts, Overview & Drivers

47

Focus on Product TargetsAssure customer satisfaction at target cost

•Water

•Grapefruit Juice

•Apricot Juice

•Ingredients

•55

•25

•5

•Qty

Least Cost Formulation Process – Start with Product

Typical Formulation Process – Start with Ingredients

Fruit Juice Product

•Product: Fruit Juice

•SWEETNESS

•%MOISTURE

•BRIX

•COST

•Water

•Grapefruit Juice

•Apricot Juice

•Ingredients

•0•100•0•.75

•29.5•70•27•8.00

•30•70•28•10.00

•SWEET•%MOIST•BRIX•COST

Page 45: 001 OPM Concepts, Overview & Drivers

48

Recipe & Formula Development

Recipe & Formula Development Recipe & Formula Development Process Manufacturing Product Development deliverscomprehensive and powerful tools that allow process manufacturersto manage the product lifecycle from inception through production.With OPM Product Development, you can accelerate innovation tomarket, assure consistent, quality products, and minimize costs andcompliance risks.

Enables• Compliant approval authorization, e-

records & e-signature, mass search and replace

• Change management, recipe designer, least cost formulation

• Process details, computer-aided formulation, item substitution

• Least cost formulation, formula analysis

Benefits• Secure and manage data• Accelerate recipe development• Manage variability and product

consistency• Reduce costs and optimize formulas

Page 46: 001 OPM Concepts, Overview & Drivers

49

Supply Chain Planning

Supply Chain PlanningSupply 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• Access real-time information from sales,

production and inventory to make quick and accurate decisions.

• Perform “what if” calculations to view and react to the effects of unanticipated orders or shop floor problems such as resource breakdowns and overloading.

• Evaluate Firm Planned Orders before implementing by checking ingredient and resource loading availability then commit FPO’s to production.

Benefits• Material and rough cut capacity planning • Enhanced co-product planning • Ability to perform on-line simulations • Perform “what if” calculations to view the

effects of unanticipated orders • Access real-time information from sales,

production, inventory

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Supply Chain PlanningOptimize Inventory by Location and Quantity

EnterpriseLevel

RegionLevel

Plant Level

• Leverage current enterprise-wide data

• Optimize inventory and resources across supply chain in one step

• Customize planner-specific views

• Planner workbench enables drag and drop rescheduling, “what-if” simulations

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• Model SDS directly and schedule activities to reduce changeover time

• No need to reduce resource efficiency or utilization as a surrogate for changeover time

L H M H L

L HM HL

ProductionBatch

DemandQuantity & Date

Route 1, v. 3Route 1, v. 3

Recipe X Formula X, v. 5

Validity Rules

v1 v3v2

• Specify Recipe Conditions for Seasonality, Equipment capacity, Plants: global vs. local data, Preferences and Use

• Products May Have Multiple Valid Recipes

• Alter Recipe for Each Production Run

Rule-Based Recipes Accommodate Seasonality, Variability

Support Sequence-Dependent Setup (SDS)

Planning in Process Industries

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Distribution PlanningOptimize Supply Allocation to Distribution Centers

• Fair share allocation

• Inventory policy

• Circular sourcing

• Shipping method selection and load consolidation

• Global forecast local allocation of supply across distribution network

Automatically generate transfers• Create internal transfers

• Create consolidated shipments

• Integrated with Transportation Mgmtfor carrier and mode selection

Determine optimal supply allocation from plants to distribution centers

Multi-Plant Planning

Demand Planning

Demand

Supply

Distribute

Distribution Planning

DC

RDC

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Enterprise-Wide Purchasing AutomationDrive Compliance and Manage Spending Behavior

Configurable, Pre-modeled Best Practice Purchasing Workflow

Services

Designed Equipment

Products

Indirect& MRO

Online Catalogs & Contracts

Receive & Reconcile

Approval Policies(e.g., Funds Checking)

Review / Approve

Create & Route PO

Pay Supplier

Matching Rules

Accrue / RelieveTax Encumbrance

Requisition

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Oracle Sourcing & Procurement

DemandCollection

IndirectGoods

DirectMaterials

EngineeredGoods

Services ApprovalRouting

TouchlessBuying

Automated Payment

Enforce Policy Compliance

Budget-BasedProcurement

ContractManagement

SupplierPerformance

Reduce Spend on Goods and Services

CategoryManagement

OnlineSourcing

SpendAnalysis

Streamline Procurement Processes

SupplierCollaboration

Settlement

Orders

ProfileManagement

SupplierNetwork

Logistics

SupplierPortal

Source

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Supply Chain Planning

Supply Chain PlanningSupply 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• Access real-time information from sales,

production and inventory to make quick and accurate decisions.

• Perform “what if” calculations to view and react to the effects of unanticipated orders or shop floor problems such as resource breakdowns and overloading.

• Evaluate Firm Planned Orders before implementing by checking ingredient and resource loading availability then commit FPO’s to production.

Benefits• Material and rough cut capacity planning • Enhanced co-product planning • Ability to perform on-line simulations • Perform “what if” calculations to view the

effects of unanticipated orders • Access real-time information from sales,

production, inventory

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Inventory Management

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• Multi-purposed single item, dual & multiple

UOM, auto lot allocation, grade control, divisible lot control

• Dual UOM, shelf life management, grade control, lot level status control, physical and cycle counting, APIs

• Parent / child lot tracking and traceability• Audit trail, strong security, ERES,

Inventory tied to Regulatory

Benefits• Satisfy customer demand quickly and

accurately• Reduce costs with efficient Inventory

Management• Reduce risk with rapid lot genealogy

analysis• Ensure Regulatory compliance

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Inventory ManagementCapture Location & Composition thoughout Lifecycle

Multi-Level Where Used /

Lot Source

Multi-Level Where Used /

Lot Source

Product Attributes Shelf life Retest interval Potency Dual units of measure User-defined classifications

Plant

Item

Inventory Org

Locator

Parent Lot

Child Lot

Grade

Company ABC Company

Manufacturing Location

Product

Inventory Location/Warehouse

Batch ID / Pallet #/Billet

Traceable Quantity of Material/Heat

Area, Tank, Zone, etc.

Grade A,B,C w/in a Spec

• Improve Recall Responsiveness / Cost

• Trace Materials Enterprise-Wide to Analyze Vendor Quality

• Comply with International Regulations

Lot Status Released, Hold, Quarantine

Sub-inventory

Row/Rack/Bin

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Single Source of Truth for Inventory Availability Summary of Business Gains for Process Users

• Vendor-Managed and Consigned Inventory to reduce on-hand inventory

• Improve picking and putaway process with Warehouse Management• Leverage Mobile Supply Chain Applications to improve productivity• Flexible account mapping with Subledger Architecture• Real-time Lot Management Transactions

• Lot Merge• Lot Split• Lot Translate• Flexible Attribute Definition• Attribute Inheritance

• Advanced Unconstrained Advanced Supply Chain Planning replaces Oracle Process Manufacturing MRP

• Subledger Architecture replaces Manufacturing Accounting Controller

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OPM Multiple Units of Measure

• Package / Liquid / Solid contents can vary by containers • Track onhand inventory in two units of measure simultaneously• Formulate and Transact in any convertible UOM

• Unlimited types of UOMs associated with item (lb, cases, rolls, bags, trucks)

• May record different quantities for each lot (Each case, may have different amount of Gallons

• Unlike other software, works with Purchasing, Order Management, and Costing

• Not a modification, inherent to entire application

L0t 0012 Case = 20 Ltr 20.0 Ltr

vs

Lot 001- A1 Case = 8 Ltr

Lot 001- B1 Case = 12 Ltr 20.0 Ltr

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Automatic Lot Allocation

OPM selects ingredient lots based on FIFO or FEFO methods

2/1/20082/1/20082/5/20082/5/2008Creation Date

1/1/20081/1/2008FIFO

2/15/20092/15/20093/5/20093/5/2009

Lot ALot A Lot CLot CLot BLot B

Expiration Date

Production batchProduction batch

ShipmentShipment

2/10/20092/10/2009

FEFOAdditionally, for customer shipments:• Preferred Grade• Match on Quality Specification• Remaining Shelf Life

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Inventory Management

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• Multi-purposed single item, dual & multiple

UOM, auto lot allocation, grade control, divisible lot control

• Dual UOM, shelf life management, grade control, lot level status control, physical and cycle counting, APIs

• Parent / child lot tracking and traceability• Audit trail, strong security, ERES,

Inventory tied to Regulatory

Benefits• Satisfy customer demand quickly and

accurately• Reduce costs with efficient Inventory

Management• Reduce risk with rapid lot genealogy

analysis• Ensure Regulatory compliance

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Comprehensive Process MFG Solutionwith MES

Comprehensive Process MFG Solution 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 ManufactringMES 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• Model complex process flows, rule based

recipes, scaling• Automated reservations and lot

allocations, incremental backflush, dispensing / pre-weigh, operators workbench

• Operators workbench e-records and e-signature, non-conformance

• Computer-aided formulation, least cost formulation

Benefits• Maximize production flexibility• Drive efficient, compliant shop floor

production• Streamline production and compliance

reporting• Manage variability and product

consistency

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• 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 tothe last one

10

20

30

40

50

60

70

80

90

110

100 120

Product A

Product B

Yields co-product D to routing Y

Yields co-product C to routing X

Production Scheduling in Process Industries

Standard Delay Max Delay

A1

B1 B2

OP 20

Act 1 Act 2 Act 3 Act 4

OP 10

Act 1 Act 2 Act 3 Act 4

A2

• Support minimum and maximum time offsets between operations

• Apply minimum and and maximum offsets to charges

• Respect shelf life of items purchased from suppliers

• Respect on hand lot expiration date when planning the use of the lotto meet demands

Schedule Complex Routings

Schedule Operations with Hard Links

Mixer

Packaging

Single activity, multiple charges

Schedule Charges

• Schedule a charge as a continuous process

• Apply operation dependencies to charges

• Overlap operations by incremental feeding to and from chargeable resources

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Comprehensive Process Mfg Solution Manage Production to Ensure Optimal Conditions

• Record process parameters

• Automatically calculate step quantities

• Capture electronic signatures as required

• Compare and report planned vs.work in process vs. actual

• Make iterative real-time adjustments

• In-process samples and tests

40 Test

10 Weigh

30 Blend 50 Package

20 Heat

E-Sign Resource+ActivityUsage/Qty

Resource+ActivityUsage/Qty

Resource+ActivityUsage/Qty

Resource+ActivityUsage/Qty

E-Sign

E-Sign E-Sign E-Sign

Start to Start

Finish to Start

Ingredient 1 Ingredient 2

Ingredient 4 Ingredient 5

Ingredient 3

Product 2By-Product 1 Product 1

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Computer-Aided Formulation Model Production Requirements to Target Specifications

Product RecipeTarget Product /Customer Specs

• Recalculate Materialand Yield Quantities

• Compute Batch Characteristics (e.g., fat content, potency, etc.)

• Automatically Revise Lot Allocations

Computer-Aided Formulation

In-ProcessQC Metrics

InventoriedLot Properties

• Model & analyze impact of formulation change before producing expensive and time consuming laboratory test batches

• Perform ‘what if’ new or revised formulations without interfering with production

• Optimize using specify product target properties and allow software to reformulate ingredients

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MES for Process ManufacturingControl Demand-Driven Mfg with Integrated Shop Floor Execution

System Automation & Control

Deliver Real-Time Shop Floor Visibility to Multiple Layers of Management

Reduced TCO / Complexity via Integrated Mfg Mgmt & Production Execution

MESMES

ERPERP

Corp Mgmt

Shop Floor Control

Production MgmtProduction Mgmt

Process Engineer• Manage recipes & advanced process

instructions

Production Supervisor• Create & manage batch status• Log non-conformances

Dispensing / Prod Operator• Pre-weigh designated ingredients• Process batch operations

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Enforce Manufacturing Best Practices New MES Product Guides Operator through Operations

ERP

MES

Process

Controls

Corporate Management

Plant Management

Process Management

OPM + MES for Process

Mfg

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Model Actual Scenario of Shop Floor Improve inventory visibility at each stage of the Supply Chain

• Reservation supply to assure inventory meets customer needs• High level• Detail Level

• Model plant areas so that stock is readily available• Dispensing Locations• Staging Locations

ProductionOperator

Materials ManagerProductionSupervisor

DispensingOperator

Review andApprove Schedule

Schedule FPO / Batch& Reserve Materials

Dispense Ingredients with

Detailed Reservations

Move IngredientsTo Staging

Location

ReverseDispense

Ingredients

Complete & Close Batch

Log Nonconformances

Review ControlBatch Record

Consensus forecast and

production plan

Lock Operation, Follow PI,

Execute Tasks

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Supervisor Workbench Graphical Dispense Planning View

Dispense Planning details at Area/booth,

Resource, Storage Area

Dispense Capacity Plan Vs Actual

Display Bucket (Daily / weekly)

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Complete Process Support for Work Instruction Display, Dispensing, Batch Progress Tracking, and Ingredient Consumption Reporting

Dispensing WorkbenchImprove Accuracy & Compliance While Reducing Risk

• Touch Screen enabled

• Improve accuracy by removing human interaction

• Generate Labels

• Enforce compliance- Configurable level of

control on process instructions enforce best practices and regulatory compliance

• Reduce complexity & risk- Simplified task- based

operator interface

- Consolidate systems

Multiple methods Multiple methods supportedsupported

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Complete Process Support for Work Instruction Display, Batch Progress Tracking, and Ingredient Consumption Reporting

Focus on the Operator

• Touch Screen enabled

• Process guides operators through everything to complete their work

• Configurable level of acknowledgement

• All responses logged in Electronic Batch Record

Links to SOPs

Online Process Instructions

Operator Workbench Provides Next Task Forces Compliance with mandatory acknowledgment rules

Configurable acknowledgement:Configurable acknowledgement:• OptionalOptional• Required AcknowledgementRequired Acknowledgement• E-Signature(s)E-Signature(s)

One-Click Access to One-Click Access to Transactional Forms Transactional Forms

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Operator Certification

Certification Setup for

Organization, Transaction

Criteria for Enabling Operator

Certification

Override Status

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Oracle MES for Process Mfg.Additional Benefits

• Board Room to Shop Floor Visibility• Process Repeatability • Enforce Best Practice SOPs• Reduce Labor - Remove a Level of Approvals • Eliminate Massive Amounts of Paper• Advanced Search Capability• Eliminate Errors• Lower Training Costs• Lower Cost of Compliance

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Comprehensive Process MFG Solutionwith MES

Comprehensive Process MFG Solution 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 ManufactringMES 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• Model complex process flows, rule based

recipes, scaling• Automated reservations and lot

allocations, incremental backflush, dispensing / pre-weigh, operators workbench

• Operators workbench e-records and e-signature, non-conformance

• Computer-aided formulation, least cost formulation

Benefits• Maximize production flexibility• Drive efficient, compliant shop floor

production• Streamline production and compliance

reporting• Manage variability and product

consistency

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Electronic Batch Record/E-Signature

Electronic Batch Record/E-SignatureElectronic Batch Record/E-SignatureE-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• Built-in Compliance • One-step e-signature with optional e-

record view • Manages critical information related to

production orders, quality records, or other information key to conformance with FDA Good Manufacturing Practices (cGMP),

Benefits• Reduced cost of compliance • Increased speed • Improved collaboration • Enforced best practices • Advanced search and analysis for audit • Controlled document printing

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Operation details, including Process Instructions and

Operator Comments

Electronic Batch Record

Dispensing detailsNonconformances

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Eliminate Massive Amounts of PaperCompletely replace paper batch recordswith Electronic Batch Records

• Master Batch Record is comprised of all Recipe info• Control Batch Record is the record of each batch

• Documents all events & data generated during a batch’s life cycle

• Materials, resources, steps, deviations, QC samples, labels, process instructions, e-signatures,etc.

• As events occur, they are appended to the CBR

• PDF format, securely stored in the E-Records Evidence Store

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Electronic Batch Record/E-Signature

Electronic Batch Record/E-SignatureElectronic Batch Record/E-SignatureE-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• Built-in Compliance • One-step e-signature with optional e-

record view • Manages critical information related to

production orders, quality records, or other information key to conformance with FDA Good Manufacturing Practices (cGMP),

Benefits• Reduced cost of compliance • Increased speed • Improved collaboration • Enforced best practices • Advanced search and analysis for audit • Controlled document printing

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Quality-Oriented Process Management

Quality-Oriented Process Management Quality-Oriented Process Management Process Manufacturing Quality Management empowersProcess companies to achieve product consistency, enforce proactivequality assurance, streamline quality lab productivity, and assurecustomer and regulatory compliance.

Enables• Stability studies, lot expiration

management, process control points, quality throughout the supply chain

• Standardized inspection methodology, workflow, e-records and e-signature

• Automated test/lab assignment, quality workbench

• Customer spec matching, CofA / CofC, lot traceability

Benefits• Achieve product consistency• Enforce proactive quality assurance• Streamline quality lab productivity• Assure customer and regulatory

compliance

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Pre-defined Workflow-Driven Processes and Electronic Records

Standardize Sample Analyze Disposition Report

Inspection Points• Receipt, WIP, shipping

• Lot expiration/retest

• Environmental monitoring/testing

• Input APIs

Global Standards• Tests & methods

• Sampling plans

• Specifications

Compliance• Certificate of analysis

or conformance

• Lot genealogy

Results• Mass results entry

• Composite result statistics(min/max, std dev, average)

• Stability studies

• Output APIs

Attributes• Lot status (quarantine, available)

• Order allocation (based on specs)

• Material usage decisions

• Adjust batches• Change formulation or procedures

ProcessImprovement

Quality-Oriented Process ManagementManage Variability and Assure Product Consistency

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Suppliers Customers

Inventory ShippingReceiving

ProductionAutomatic Workflow Notificationsat Each Quality Check Point for:

• Sample Creation

• Assay Testing

• Sample Disposition Decision

Pre-Defined Quality WorkflowsCheck Quality Throughout the Supply Chain

Quality check points

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Nonconformance ManagementCapture 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

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

“Any deviation from the written pro-

cedures shall be recorded and justified.” -- 21 CFR Part 211.100, Written procedures for deviations

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• Define internal and customer products specifications

• Match available inventory to customer specifications

• Provide Certificate of Analysis (COA) with each shipment

Specifications ManagementCapture and Meet Unique Customer Specifications

CustomerSpecification

ItemSpecification

Min Max

Match

In-Spec Out-of-SpecOut-of-Spec

Page 81: 001 OPM Concepts, Overview & Drivers

Lab Technician

Study Owner

Lab Supervisor

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

ProductionBatch

Stability Samples

Overlay Monitoring Specification (1)

Base Monitoring Specification

Overlay Monitoring Specification (n)

0 1 3 6 9 12 18 24 months

0 1 2 3 6 months

0 months12

Work Flow Notices

Study Execution• 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

Stability StudiesMeasure the Effects of Environmental Aging

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

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Compliant Approval AuthorizationEnsure Participation by All Stakeholders

Packagingitem

Intermediate

FinishedGood

Ingredient 3Ingredient 2Ingredient 5 Ingredient 4

By-product

Version 2

Approved

• Mandatory Version Control

• Automated Approval Cycle

• Define Conditions for Recipe Component Use

• Route Approvals to Groups / Individuals

Formulator Requests ‘Approved for Lab Use’

Approved

For

Lab Use

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Quality-Oriented Process Management

Quality-Oriented Process Management Quality-Oriented Process Management Process Manufacturing Quality Management empowersProcess companies to achieve product consistency, enforce proactivequality assurance, streamline quality lab productivity, and assurecustomer and regulatory compliance.

Enables• Stability studies, lot expiration

management, process control points, quality throughout the supply chain

• Standardized inspection methodology, workflow, e-records and e-signature

• Automated test/lab assignment, quality workbench

• Customer spec matching, CofA / CofC, lot traceability

Benefits• Achieve product consistency• Enforce proactive quality assurance• Streamline quality lab productivity• Assure customer and regulatory

compliance

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Cost Management

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• Multiple cost methods: standard, actuals,

lot, composite• Co-products, by-products, unlimited cost

elements, cost allocations• Cost monitoring, cost analysis• Flexible account mapping, sub-ledger flow,

drilldowns

Benefits• Optimize profits and margins• Capture precise product costs• Facilitate proactive cost management• Assure proper accounting of resources &

materials

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Cost ManagementAnalyze and Control Product Costs

• Maintain multiple cost methods simultaneously

• Measure direct and indirect labor costs

• Capture resource and utility costs

• Least Cost Formulation

• Include all material costs, (e.g. direct, contract)

• Evaluate / compare costs by method

- Standard vs Actual- Weighted Avg vs Budget- Period vs Standard- Standard vs Actual Lot

IndirectAcquisition Overhead ResourceMaterial

ActualActual StandardStandard PeriodPeriodLotLot

CostDevelopment

Monitoring& Analysis

Allocation Valuation

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Cost Management

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• Multiple cost methods: standard, actuals,

lot, composite• Co-products, by-products, unlimited cost

elements, cost allocations• Cost monitoring, cost analysis• Flexible account mapping, sub-ledger flow,

drilldowns

Benefits• Optimize profits and margins• Capture precise product costs• Facilitate proactive cost management• Assure proper accounting of resources &

materials

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Performance Analysis

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.

DBI for Manufacturing provides reliable information directly from mission-critical business applications in a self-service fashion freeing executives from hard-to-use, error-prone custom solutions. Using DBI for Manufacturing, managers have rich, integrated and up to the day information to improve manufacturing execution and meet strategic objectives.

Enables• Reliable information directly from mission-

critical business applications• Manufacturing management, plan

management

• 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

Benefits• Make better faster business decisions• Improve manufacturing execution• Meet strategic objectives• Manage by exception

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Performance Analysis through Oracle’s Daily Business Intelligence for Manufacturing & Supply Chain

Daily Business Intelligence for Manufacturing

Comprehensive presentation of real time Manufacturing Data in form of graphs, reports, etc

Capability to view and analyze costs related to manufacturing

Manufacturing Plans comparison, Resource Utilization tracking

Performance Analysis

Reports

Real-TimeResults

Graphs

PerformanceMeasures

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Performance Analysis

• Manufacturing Management KPIs :• Production To Plan• Production Value •On-Time Production•Manufacturing Cost Variance•Material Usage Variance•Resource utilization•Resource Variance

• Manufacturing new reports :•On-Time Production•Current Production Delayed

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Performance Analysis

• Inventory Management KPIs :• Inventory Value•Annualized Inventory Turns •Hit/Miss Accuracy•Gross Adjustment Rate•Exact Match

• Inventory new reports :•Inventory Days on-Hand•Current Inventory expiration Status•Current Inventory Status

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Performance Analysis

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.

DBI for Manufacturing provides reliable information directly from mission-critical business applications in a self-service fashion freeing executives from hard-to-use, error-prone custom solutions. Using DBI for Manufacturing, managers have rich, integrated and up to the day information to improve manufacturing execution and meet strategic objectives.

Enables• Reliable information directly from mission-

critical business applications• Manufacturing management, plan

management

• 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

Benefits• Make better faster business decisions• Improve manufacturing execution• Meet strategic objectives• Manage by exception

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Integrated Warehousing and Logistics

EnterpriseIntegration

Supply ChainPlanning

Order Management

Production

Continuous Improvement

• Inbound

• Supply

• Source

• Outbound

• Demand

• DestinationCarrierAnalysis

On-TimePerformance

CustomerSatisfaction

Continuous Planning

Collaboration& Event Mgmt

Portal / Messaging

Procurement /Financials

GlobalCustomers

Carriers /3PLs

Book /Tender

Receive &

Putaway

Manage Whs

Pick & Label

Pack & Ship

Plan Loads / Moves

Select Modes & Carriers

Track & Trace

Audit / Settle

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Multi-Level Material/Resource Traceability

Multi-Level Material/Resource TraceabilityMulti-Level Material/Resource TraceabilityOPM Quality Management offers comprehensive lot genealogy capabilities to tracematerials from receipt through customer shipment. It provides an easily accessible,online record that indicates when lots were sampled for quality inspection and wereused in production, moved, or shipped as end products—the information needed toprove compliance with government regulations, ISO 9000 requirements, or yourown internal quality standards.

Enables• Reduce risk with rapid lot genealogy

analysis• Lot Genealogy with Sampling History

Benefits• Better Customer Responsiveness• Parent / child lot tracking and traceability• End to End Tracking

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Multi-Level Material/Resource TraceabilityComply with Stringent Regulatory Requirements

Where UsedWhere Used

Lot SourceLot Source

Supplier Ingredients CustomersIntermediate orBulk Products

Finished Product

Resources /Equipment

• Improve Recall Responsiveness / Cost

• Comply with International Safety Regulations

• Trace Materials Enterprise-Wide to Analyze Vendor Quality

                                      

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Multi-Level Material/Resource Traceability

Multi-Level Material/Resource TraceabilityMulti-Level Material/Resource TraceabilityOPM Quality Management offers comprehensive lot genealogy capabilities to tracematerials from receipt through customer shipment. It provides an easily accessible,online record that indicates when lots were sampled for quality inspection and wereused in production, moved, or shipped as end products—the information needed toprove compliance with government regulations, ISO 9000 requirements, or yourown internal quality standards.

Enables• Reduce risk with rapid lot genealogy

analysis• Lot Genealogy with Sampling History

Benefits• Better Customer Responsiveness• Parent / child lot tracking and traceability• End to End Tracking

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Pre-Built Process Manufacturing Mobile Transactions

• Mobile Create Reservations • Mobile Update Reservations • Mobile Issue Ingredients • Mobile Return Ingredients • Mobile Complete Product • Mobile Return Products • Mobile Create Pending Lot • Mobile Update Pending Lot • Mobile Backflush• Mobile Product Completion by LPN

• Mobile Product Completion by LPN with directed drop

• Mobile Product Completion By LPN with load

• Mobile menu for Process Execution LPN Product Completion

• Mobile Resource Usage • Mobile Start Resource • Mobile End Resource • Mobile Release Step • Mobile Complete Step

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Pre-Built Inventory Transactions

• Receiving Transactions (Receive PO, RMA, In-transit Shipment, Internal Requisition & Receive any document)

• Quality Inspection• Inventory Delivery• Miscellaneous Inventory

Transactions (Receipt & Issue)• Subinventory Transfer• Inter-organization Transfer• On hand balance inquiry• Locator inquiry

• Cycle Count Entry • Physical Inventory Count Entry• Consume Consigned Inventory• Pick Confirm (sales orders,

replenishments & move order requisitions)

• Ship Confirm• Replenish Kanban Cards• Kanban Card Status Inquiry• Replenishment Count Entry• Label Reprint Request

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Manufacturing Operations Center

Manufacturing Operations CenterManufacturing Operations Centeris 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

• 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

Benefits• Contextualize Plant Floor Data and

Synchronize with ERP• Provide Real-Time Intelligence for Plant

Operations• Leverage Next Generation Manufacturing

Operations Architecture

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Mfg Integration & Intelligence Opportunity

Source: AMR Research, 2003

Production efficiency improvement -- 25%

Cycle time improvement -- 13 to 20%

Increase in asset utilization -- 10%

Annual payback potential -- 10x

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

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Leverage Next-Generation Manufacturing Operations Architecture

“It is often more expedient to install an abstraction layer built on a plant-level data store than to reengineer the plethora of existing applications to achieve normalization. We see this approach rapidly emerging as a best practice.” -- Alison Smith, February 2008

• Built on a common abstraction layerof production / equipment data

• Leverage existing investments in plant IT infrastructure – no rip & replace

• Allows for gradual upgrade of plant systems

Next-Generation Architecture

AbstractionLayer

ERP

Distributed Plant Systems

Automation & Control

Manufacturing HubManufacturing Hub

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Oracle Manufacturing Operations Center

The Foundation for Continuous Improvement in Manufacturing

Operations

Automation& Process

ControlSystems

ERPSystems

Users

PLC CNCMachines

DCS SCADASystems

AdvancedProcessControl

HumanMachineInterface

- MES- Quality- Cost Mgmt…

ManufacturingOperationsData Model

(ISA-95)

ManufacturingOperationsData Model

(ISA-95) Role-BasedDashboards

Contextual-izationEngine

Corporate BI

Cross-PlantKPIs

HistoricalTrends

Plant-SpecificKPIs

Real-TimeUpdates

Device-Generated Data

Production ActualsSchedules

Item Master Data

ProductionManager

Plant Mgr /VP of Mfg

Distributed Plant Systems Shop Floor Communication Drivers

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Single Repository for Mfg Operations DataProvide Consistent Information forAll Manufacturing Users

• Generic data model supports hierarchical structure for reporting or building KPIs and metrics

- Support for industry standardssuch as S-95

- Out-of-the-box hierarchical dimensions: time, product, and equipment

- Flexible and configurable

• Open and extensible to meet the requirements of different industries

- Capture process variables

- Capture additional parameters for Item, Equipment, and Work Orders

Manufacturing

Operations

Data Model

Manufacturing

Operations

Data Model

Gra

nula

rity

Enterprise Level- Products- Orders- Plans / Schedules

Plant Level- Work Orders- Batches- Mfg Routing

Equipment Level- Availability- Status- Output- Quality- Parameters

Device Level- I/O Tags- Sensor ID

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Role-Based Dashboards and KPIsDeliver Performance Measures by Responsibility

• Pre-built role-specific dashboards, reports, and alerts

• Graphical views

- Trend charts- Graphs- Tables

• Embedded best-practice calculations and KPIs

• Analytic workflows to drive actions

• Drill-downs into details forroot-cause analysis

• Leverages OBIEE+

• Configurable and customizable

Are we achieving our costand productivity targets?

What is happening now?What happened last shift?

How is the machine performing?

VP of Operations

Plant Manager

Production Manager

Production Supervisor

Operator

QA Engineer

- Red-yellow-greenindicators

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Extensible Analytical Engine

and Dashboarding Tool

Most standard Most standard KPIs availableKPIs availableout-of-the-boxout-of-the-box

• Accelerate deploymentand adoption

• Easily adapt dashboards and metrics

• Provides a comprehensive Operational Intelligence framework

Easily identify, select, modify, Easily identify, select, modify, and format relevant KPIsand format relevant KPIs

Build a Decision Support System Unique to Your Environment

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Deploy Based on Business PrioritiesGenerate Value Regardless of Implementation Scope

Line-by-Line or Work Center

Plant-Wide Performance

Network of Plantsand/or Contract Manufacturers

ScopeLocal Global

Val

ue

Identify opportunities for streamlining operations

Focus on line and machine performance

Provide decision support for executives and supervisors

Move emphasis to service levels and on-time delivery

Build common manufacturing operations architecture

Move from emphasis on local execution to global coordination

Manage

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Manufacturing Operations Center

Manufacturing Operations CenterManufacturing Operations Centeris 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

• 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

Benefits• Contextualize Plant Floor Data and

Synchronize with ERP• Provide Real-Time Intelligence for Plant

Operations• Leverage Next Generation Manufacturing

Operations Architecture

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API Interfaces

API InterfacesAPI InterfacesOracle® 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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Standard Process Manufacturing APIsIntegrate Plant Devices and Legacy Systems

Production / POC• Start Resource Usage• End Resource Usage• Close Batch• Cancel Batch• Release, Certify, and Close Step• Post Resource Transaction• Incremental Resource

Transaction• Timed Resource Transaction

Recipe Development• Formula• Insert Ingredients, (By)Products• Formula Usage Rules• Resource• Routing• Operation• Activity

Costing• Item Cost • Resource Cost• Allocation Definition• Burden Details

Inventory• Create Item• Create Lot• Create Item/Lot UOM Conversion• Create, Adjust, or Move Inventory• Change Lot Status or QC Grade• Lot Split, Merge, Translate

Quality• Tests• Specifications• Samples • Sample Labels• Results

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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 InterfacesAPI InterfacesOracle® 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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For More Information

http://search.oracle.com

Process Manufacturing

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Additional Resources

• Vivian Lewis – AGSS – SCM Solution [email protected]

Mobile 972-672-0254

• Andrew Hyers – AGSS – SCM Solution [email protected]

Mobile 502-836-1465

• David Ballin – AGSS – SCM Solution [email protected]

Mobile 201-218-3245

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Course Agenda

• Welcome & Introductions• Process Manufacturing Drivers, Concepts, &

Overview• Inventory for Process• Process Quality• Product Development• Product Execution with MES• Process Costing and DBI • Process functions in other SCM applications• Wrap up and Course Evaluation

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