Quality Oracle

Location:

United States

Posted:

February 14, 2013

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Resume:

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

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.

Agenda

Oracle s Quality Solutions

Business Scenarios

Future Directions

Summary of Oracle s

Quality Solutions

Oracle s Enterprise Quality Landscape

Solutions

Oracle

ERP

E-Business Suite:

Oracle Quality and OPM Quality

Oracle Siebel Oracle Agile

CRM PLM

Customer Product

Relationship Lifecycle

Management Management

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

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

Mixed Mode Planning

Sample Analyze Adjust Quality Management

Nonconformance, CAPA, Audit, Lot/Serial Genealogy, ERES, Workflow Service

MES,

MOC,

APIs

Customers

Shop Floor Subcontractors

Laboratories

Suppliers

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 Solution

Workflow-Driven Process Management

Inspection Points Disposition

Perform incoming, in-process, and Assign lot attributes to determine

finished goods sampling availability and usage

Retest lots for expiration/stability Electronically send notifications &

initiate action on non-conformances

Monitor environmental conditions

Standardize Sample Analyze Disposition Report

Workflow-Driven Processes and Electronic Records and Electronic Signatures

Global Standards Results Compliance

Define tests, methods, and Record, calculate, and Generate Certificates of

specifications aggregate test results Analysis or Conformance

Establish sampling criteria Evaluate results against specs Inquire on lot genealogy and

and rules and determine retesting sampling history

Adjust batches

Process

Change formulation or procedures

Improvement

Continuously monitor product performance

and process compliance

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,

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 Solution

Flexible Infrastructure for Data Collection

Data Validation, Integrity, Security

Quality Analysis Tools

TRANSACTIONS

Multiple Modes of Data Entry

(Forms, Mobile

Discoverer

Devices)

Reports

Enterprise

DIRECT ENTRY

Quality Online

(Forms, HTML,

Mobile Devices) Inquiries

Data

OPEN

Actions Processing

INTERFACE Charts

(MES, Test

Equipment)

Other

actions

Send e-mail Place job

and workflow on hold

Agile PLM Product Lifecycle Compliance

Impacting Quality From Concept to Obsolescence

The PLM mission is to drive improved quality and maintain compliance at every stage of

the product life cycle

Phase View of the Product Lifecycle

Prototype Volume

Concept Design Release Ramp-up Maintenance Retirement

& Test Production

Process Quality & Compliance (PC, PPM)

Strategic

Design for

Design

Design for Release & Ramp to

Component

Quality

Quality Volume

Warranty &

Sourcing

& Compliance

& Compliance (PC, PPM, PQM)

Customer

(PCM, PQM)

(PC, PQM, PCM,

PQM,

Service

PPM, PG&C)

(PC, PQM, PCM)

Manufacturing

Manufacturing Sustaining

Readiness

Readiness Production

PQM)

(PC, PQM) (PC, PQM, PCM)

Collaborative Issue Management

Agile Product Quality Management is the quality process glue that ties the enterprise

quality

quality landscape directly to the Product Record

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.

Escalate Aggregate Analyze Act

Agile PLM Product Quality Management Solution

Capabilities Customer Benefits

Problem Reports & Issues Best Practice Design for Quality

Tracking Auditable Design for

Closed Loop Corrective Action Compliance

NCR Tracking for Outsourced Improved Customer Service and

Context Retention

Regulatory Process Compliance Reduced Warranty and Service

Costs

Quality Control of PLM

Processes Proactive Response to Quality

Variation

Quality Focused Dashboards

Outsourcing Quality Controls

Quality Business Intelligence

Focused on Design and

Innovation

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.

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.

HOW ORACLE ADDRESSES IT

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.

HOW ORACLE ADDRESSES IT

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.

HOW ORACLE ADDRESSES IT

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 Analytics

Global Visibility of Quality Information and Event Management

Across Multi-Enterprise Operations

Oracle

E-Business Suite

Production

Service

OBIEE

ing

gin

Oracle Oracle

Siebel CRM Agile PLM

Proposed Content for OBIEE-Based Quality Analytics

Enterprise Quality View and Trends

Nonconformances Cost of Quality

Enterprise CAPA Recalls

Quality Quality Audits MTBF/MTBR

Customer Complaints First Pass Yield

Analytics *

Product Trends,

Cross-Plant View,

Service Service Levels, Customer

Cycle Time Analysis

Agile Mfg Historical

Historical Trends Satisfaction

Satisfaction Trends

Item Complaints

BI BI * Analytics Service Requests

Scrap

Item NCRs

Rework Service Orders

Item CAPA

Defects Assets

Item Audits

% Products to Spec

Product Line Performance

Agile EBS Siebel

PLM ERP CRM

* Proposed Product

For More Information

E-Business Suite: OPM or Oracle Quality:

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

E-mail: ******.***@******.***

Agile Product Quality Management:

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

management.html

E-mail: *******.*******@******.***

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