Feb2010_EBSAgileQuality

Understanding Oracle’s Quality Solutions

Process Manufacturing Special Interest Group – February 2010

Elaine Wan Michael Caveney

Product Strategy Director, EBS Product Strategy Director, Agile

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.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.

Copyright © 2010 Oracle. 3

Agenda

• Oracle’s Quality Solutions

• Business Scenarios

• Future Directions


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Summary of Oracle’s

Quality Solutions

Oracle’s Enterprise Quality LandscapeSolutions

ERPOracle

E-Business Suite:Oracle Quality and OPM Quality

Production

PLMCRMOracle Siebel Customer

Relationship Management

Oracle Agile Product Lifecycle

Management

Engineerin

gServ

ice


Executive Summary

• Oracle’s Quality solutions are complementary in nature:

– Oracle Process Manufacturing (OPM) Quality manages

material variability with acceptance sampling to determine

conformance to specification and guide material usage

– Oracle Quality supports enforcement of quality data

collection throughout the supply chain, including raw material

procurement , equipment maintenance, warehouse procurement , equipment maintenance, warehouse

inspection, and after sales service

– Agile PLM Product Quality Management (PQM) focuses on

quality issues management and corrective actions that affect

product design and product record

Any or all of these quality solutions can be implemented

based on your quality system requirements


E-Business Suite Quality Solutions

Product Lifecycle

Management

Planning

Warehousing / Transportation

AssetMaintenance

Quality ManagementAnalyzeAnalyze AdjustAdjustSampleSample

Receiving Shipping

Discrete Flow

Process Lot-Based

CTOETOMTS

Mixed Mode Manufacturing

ServiceNonconformance, CAPA, Audit, Lot/Serial Genealogy, ERES, Workflow

Shop Floor CustomersSubcontractorsSuppliers

MES, MOC, APIs

Laboratories

APIs


E-Business Suite: OPM Quality Overview

OPM Quality Management improves product consistency and

assure customer and regulatory compliance with a proactive,

specifications-driven quality management solution.

• Quality sampling in a plant or laboratory environment

• Building quality into the product with computer-aided formulation and

integrated checkpoints

• Driving material usage decisions in planning, inventory, batch

production, shipping allocation

• Maintaining quality and lot genealogy and regulatory sign-offs

• Implementing stability studies for shelf life analysis


OPM Quality SolutionWorkflow-Driven Process Management

Inspection Points• Perform incoming, in-process, and

finished goods sampling

• Retest lots for expiration/stability

• Monitor environmental conditions

Disposition• Assign lot attributes to determine

availability and usage

• Electronically send notifications &initiate action on non-conformances

Standardize Sample Analyze Disposition Report

Workflow-Driven Processes and Electronic Records and Electronic Signatures

Global Standards• Define tests, methods, and

specifications

• Establish sampling criteria and rules

Compliance• Generate Certificates of

Analysis or Conformance

• Inquire on lot genealogy and sampling history

Results• Record, calculate, and

aggregate test results

• Evaluate results against specs and determine retesting

• Adjust batches

• Change formulation or procedures

• Continuously monitor product performance and process compliance

ProcessImprovement


E-Business Suite: Oracle Quality Overview

Oracle Quality enforces quality at source best practices with a

flexible, quality management system that collects, distributes, and

analyzes critical quality data throughout the supply chain.

• Template-based solutions for rapid implementation:

• Integrated inspections for Receiving, Work in Process, Flow

Manufacturing, Shop Floor Management, Manufacturing Execution

System for Discrete Manufacturing, Enterprise Asset Management, System for Discrete Manufacturing, Enterprise Asset Management,

Complex Maintenance Repair Overhaul, Warehouse Management

System, Service, and Depot Repair

• Supply chain nonconformance management and disposition actions

• Supply chain corrective and preventive actions management

• Internal and supplier quality audit management


Oracle Quality SolutionFlexible Infrastructure for Data Collection

DIRECT ENTRY(Forms, HTML,Mobile Devices)

TRANSACTIONS(Forms, Mobile

Devices)

Enterprise

Quality Online

Discoverer

Reports

Multip

le M

odes o

f D

ata

Entr

y

Quality Analysis Tools

Data

Valid

ation, In

tegrity

, S

ecurity

OPENINTERFACE(MES, TestEquipment)

Mobile Devices)Quality

Data

Charts

Inquiries

Multip

le M

odes o

f D

ata

Entr

y

Send e-mailand workflow

Place jobon hold

Other

actions

Actions Processing

Data

Valid

ation, In

tegrity

, S

ecurity


Agile PLM – Product Lifecycle ComplianceImpacting Quality From Concept to Obsolescence

Design for

Process Quality & Compliance (PC, PPM)

Phase View of the Product Lifecycle

Strategic Release & Ramp to

Concept DesignDesignPrototype& Test

Prototype& Test

ReleaseReleaseVolume

ProductionVolume

ProductionMaintenance RetirementRamp-upRamp-up

The PLM mission is to drive improved quality and maintain compliance at every stage of the product life cycle

Design for Design for Quality

& Compliance(PC, PQM, PCM, PPM, PG&C)

StrategicComponent Sourcing

(PCM, PQM)

ManufacturingReadiness(PC, PQM)

Release & Ramp to Volume

(PC, PPM, PQM)

Collaborative Issue Management

Sustaining Production

(PC, PQM, PCM)

Warranty & Customer Service

(PC, PQM, PCM)

quality landscape directly to the Product Record Agile Product Quality Management is the quality process “glue” that ties the enterprise

quality landscape directly to the Product Record

Design for Quality

& Compliance(PC, PQM, PCM,

PPM, PG&C)

ManufacturingReadiness(PC, PQM)


Agile PLM Product Quality Management Overview

Agile PLM Product Quality Management is an enterprise level

configurable quality solution tightly integrated into the product

record, facilitating product quality management in the PLM context

from concept through obsolescence, within a closed-loop, auditable

corrective action environment.

AggregateEscalate Analyze Act

Customer

Field

Manufacturing

Call Center

Operations

FieldService

Mfg

DesignQA

Supplier

Enterprise Systems


Agile PLM Product Quality Management Solution

Capabilities

• Problem Reports & Issues

Tracking

• Closed Loop Corrective Action

• NCR Tracking for Outsourced

Context

Regulatory Process Compliance

Customer Benefits

• Best Practice “Design for Quality”

• Auditable “Design for

Compliance”

• Improved Customer Service and

Retention

Reduced Warranty and Service • Regulatory Process Compliance

• Quality Control of PLM

Processes

• Quality Focused Dashboards

• Quality Business Intelligence

• Focused on Design and

Innovation

• Reduced Warranty and Service

Costs

• Proactive Response to Quality

Variation

• Outsourcing Quality Controls



Business Scenario Examples

Receiving Inspection

BUSINESS SCENARIO

Purchased materials that are received by a plant need to pass Quality Assurance before

becoming available for production. If the material does not meet specification, action must be

taken to classify the material and address the supplier appropriately. A few months later, the

supplier is audited on their corrective action taken.

HOW ORACLE ADDRESSES IT

• Oracle Quality skip lot rules and collection plans integrated with the receiving transaction

within Oracle Purchasing determine when incoming receipts should be held for inspection.

Receiving inspection results are recorded through the Oracle Quality collection plan. Receiving inspection results are recorded through the Oracle Quality collection plan.

• Simultaneous to the receipt, an OPM Quality workflow is sent based on the supplier

specification to create and analyze a sample of the receipt.

• The OPM Quality sample disposition communicates the material acceptance back to the

Oracle Quality collection plan to complete the receiving transaction.

• The material can be inventoried or returned to the supplier as appropriate through Oracle

Purchasing.

• If the material is rejected, a supplier nonconformance can be logged and tracked through

Oracle Quality to ensure corrective action is assigned to the supplier.

• An Oracle Quality audit is conducted to gauge the effectiveness of the supplier’s corrective

action implementation.


Manufacturing Quality

BUSINESS SCENARIO

Work-in-process is checked for quality either during production processing or upon

completion. Nonconforming material must either lead to batch adjustments or reclassification

of the product and its usage.


• The OPM Quality specification and WIP specification validity rule dictate the quality

requirements and checkpoints in the production process.

• An OPM Quality sample is collected against a batch and its test results are recorded.

• The OPM Quality sample disposition can either release or hold batch processing or update

the product lot status and grade depending on the outcome of testing.

• Manufacturing deviations can be recorded as Oracle Quality nonconformances that are

included in the Electronic Batch Record and may lead to further corrective action.


Packaging Quality

BUSINESS SCENARIO

The packing station on the line reports that there is excessive amount of cracked bottle caps

coming off the finishing line. Manufacturing engineers confirm that all machinery has been

inspected and are calibrated to the specifications defined. The problem is causing production

delays and downtime . A quality issue is entered for resolution.


• PLM launches an “issue” workflow to determine the nature of the problem. Customer and

end user complaints of cracked caps are confirmed and consolidated into a single issue.

• PLM launches a quality Corrective Action and Preventative Action (CAPA) to determine the

nature of the problem and track the resolution process. This CAPA has all the “cracked cap”

problems reports linked to it, and will be the “launch platform” for all related activities.

• CAPA launches a Packaging Change Request to redesign the cap to resist cracking. This

PCR launches a Packaging Change Order that physically changes the design of the cap,

changes the packaging bill of material, and communicates this to the ERP system with

inventory instructions. CAPA launches a Document Change Order to change the

manufacturing process to reduce the tension on the line cappers to decrease the chance of

breakage on existing inventory, and communicates this to manufacturing engineering.

• At resolution, all objects linked to the resolution processes are automatically marked as

resolved, and all processes updated, with a complete audit trail of content and process.


Customer Returns

BUSINESS SCENARIO

A customer return is received and immediately inspected by Quality Assurance. Upon

identifying a damaged container, a nonconformance report is filed and the material is moved

to a quarantined area. A Material Review Board (MRB) reviews the report and its findings

then determines the disposition of the material and recommended actions, thereby closing the

nonconformance report.


• An Oracle Quality collection plan is initiated based on the receipt of the return in Oracle

Purchasing.

• Inspection results are recorded in the Oracle Quality collection plan with an automated

action to move the material to a MRB quarantine location.

• A nonconformance is created in Oracle Quality to launch an investigation.

• Investigation findings are recorded and reviewed through the Oracle Quality

nonconformance report.

• The MRB assigns the appropriate disposition actions for the nonconformance then updates

the report status to closed in Oracle Quality.



Future Directions

Oracle’s Vision for Quality AnalyticsGlobal Visibility of Quality Information and Event Management

Across Multi-Enterprise Operations

Oracle E-Business Suite

Oracle Siebel CRM

Oracle Agile PLM

Production

Engineerin

gServ

ice OBIEE


Proposed Content for OBIEE-Based Quality Analytics

Enterprise Quality

Analytics *

Enterprise Quality

Analytics *

Enterprise Quality View and TrendsNonconformances Cost of QualityCAPA RecallsQuality Audits MTBF/MTBRCustomer Complaints First Pass Yield

Cross-Plant View, Historical Trends

MfgAgile

Product Trends, Cycle Time AnalysisItem Complaints

Service Service Levels, Customer Satisfaction Trends

EBSERP

SiebelCRM

AgilePLM

Historical TrendsScrapReworkDefects% Products to Spec

MfgBI *

AgileBI

Item ComplaintsItem NCRsItem CAPAItem AuditsProduct Line Performance

ServiceAnalytics

Satisfaction TrendsService RequestsService OrdersAssets

* Proposed ProductCopyright © 2010 Oracle. 23

For More Information

E-Business Suite: OPM or Oracle Quality:

• Visit oracle.com/applications/manufacturing/intro.html

• E-mail: [email protected]

Agile Product Quality Management:Agile Product Quality Management:

• Visit oracle.com/applications/agile/agile-product-lifecycle-

management.html

• E-mail: [email protected]


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