Understanding Oracles Quality Solutions Process Manufacturing Special Interest Group February 2010

Elaine Wan Product Strategy Director, EBS Michael Caveney 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. The development, release, and timing of any features or functionality described for Oracles products remains at the sole discretion of Oracle.

Copyright 2010 Oracle.

Agenda

Oracles Quality Solutions Business Scenarios Future Directions

Copyright 2010 Oracle.

<Insert Picture Here>

Summary of Oracles Quality Solutions

Oracles Enterprise Quality Landscape

Solutions
Oracle ERP Suite: E-Business Oracle Quality and OPM Quality

Production

Service

g rin e e in g En

Oracle Siebel CRM Customer Relationship Management

Oracle Agile PLM Product Lifecycle Management

Copyright 2010 Oracle.

Executive Summary
Oracles 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

Copyright 2010 Oracle.

E-Business Suite Quality Solutions

Product Lifecycle Management

Mixed Mode Manufacturing Discrete Flow

Planning

CTO ETO MTS

Warehousing / Transportation Shipping Asset Maintenance

Receiving

Process

Lot-Based

Sample

Analyze

Adjust

Quality Management Service

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

APIs

MES, MOC, APIs

Suppliers

Laboratories

Shop Floor

Subcontractors

Customers

Copyright 2010 Oracle.

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

Copyright 2010 Oracle.

OPM Quality Solution

Workflow-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

Results
Record, calculate, and
aggregate test results Evaluate results against specs and determine retesting

Compliance
Generate Certificates of
Analysis or Conformance Inquire on lot genealogy and sampling history

Process Improvement

Adjust batches Change formulation or procedures Continuously monitor product performance

and process compliance

Copyright 2010 Oracle.

10

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

Copyright 2010 Oracle.

11

Oracle Quality Solution

Flexible Infrastructure for Data Collection

Data Validation, Integrity, Security

Multiple Modes of Data Entry

TRANSACTIONS (Forms, Mobile Devices)

Quality Analysis Tools

Discoverer Reports

DIRECT ENTRY (Forms, HTML, Mobile Devices) OPEN INTERFACE (MES, Test Equipment)

Enterprise Quality Data

Actions Processing

Online Inquiries

Charts

Other actions Send e-mail and workflow Place job on hold

Copyright 2010 Oracle.

12

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 Lifecycle Phase View of the Product

Concept

Design

Prototype & Test

Release

Ramp-up

Volume Production

Maintenance

Retirement

Process Quality & Compliance (PC, PPM) Design Design for for Quality Quality & & Compliance Compliance (PC, PQM, PCM, PPM, PG&C) Strategic Component Sourcing (PCM, PQM) Manufacturing Manufacturing Readiness Readiness (PC, PQM) Release & Ramp to Volume (PC, PPM, PQM)

Sustaining Production (PC, PQM, PCM)

Warranty & Customer Service (PC, PQM, PCM)

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

Copyright 2010 Oracle.

13

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

Customer

Call Center Operations QA Design

Manufacturing Field Service Field Enterprise Systems Supplier Mfg

Copyright 2010 Oracle.

14

Agile PLM Product Quality Management Solution

Capabilities Problem Reports & Issues Tracking Closed Loop Corrective Action NCR Tracking for Outsourced Context Regulatory Process Compliance Quality Control of PLM Processes Quality Focused Dashboards Quality Business Intelligence Focused on Design and Innovation

Customer Benefits Best Practice Design for Quality Auditable Design for Compliance Improved Customer Service and Retention Reduced Warranty and Service Costs Proactive Response to Quality Variation Outsourcing Quality Controls

Copyright 2010 Oracle.

15

<Insert Picture Here>

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 suppliers corrective action implementation.

Copyright 2010 Oracle.

17

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.

Copyright 2010 Oracle.

18

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.

Copyright 2010 Oracle.

19

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.

Copyright 2010 Oracle.

20

<Insert Picture Here>

Future Directions

Oracles Vision for Quality Analytics

Global Visibility of Quality Information and Event Management Across Multi-Enterprise Operations
Oracle E-Business Suite

Production

Service

OBIEE
g rin e ine g En

Oracle Siebel CRM

Oracle Agile PLM

Copyright 2010 Oracle.

22

Proposed Content for OBIEE-Based Quality Analytics

Enterprise Quality Analytics *

Enterprise Quality View and Trends Nonconformances Cost of Quality CAPA Recalls Quality Audits MTBF/MTBR Customer Complaints First Pass Yield

Agile BI

Product Trends, Cycle Time Analysis Item Complaints Item NCRs Item CAPA Item Audits Product Line Performance

Mfg BI *

Cross-Plant View, Historical Trends Scrap Rework Defects % Products to Spec

Levels, Customer Service Service Satisfaction Trends Analytics Service Requests Service Orders Assets

Agile PLM

EBS ERP

Siebel CRM

Copyright 2010 Oracle.

* Proposed Product

23

For More Information

E-Business Suite: OPM or Oracle Quality:

Visit oracle.com/applications/manufacturing/intro.html E-mail: Elaine.Wan@oracle.com

Agile Product Quality Management:

Visit oracle.com/applications/agile/agile-product-lifecyclemanagement.html E-mail: Michael.Caveney@oracle.com

Copyright 2010 Oracle.

24