Oracle Quality User's Guide

Contents

Title and Copyright Information

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Preface

Overview of Oracle Quality

Introduction to Quality Management

Overview of Oracle Quality

Track and Monitor Quality Results

Analyze Product Defects Using Charts and Reports

Identify Nonconformances and Implement Corrective Actions

Audit Your Quality Management System

Quality Business Flow Diagram

Quality Process Flow Diagram

Oracle Quality Command Center

Quality Command Center Overview

Collection Results Dashboard

Nonconformances Dashboard

Corrective Actions Dashboard

Track and Trace Dashboard

Setting Up

Related Product Setup Steps

System Administrator Setup

Alert Setup for Quality

Security Functions

Other Products Setup

Device Integration Setup

Quality Setup Considerations

Profile Options

Oracle Quality Command Center Setup

Setting Up Oracle Quality Command Center

Setup and Configuration Steps

Setting Up Quality Command Center Access Role

Publishing Quality Collection Metadata to Enterprise Command Center

Loading Oracle Quality Data

Collection Elements

Overview of Collection Elements

Collection Element Types

Predefined Collection Elements

      Reference Information and Context Collection Elements

      Quality Specific Collection Elements

      Reserved Words

Defining Collection Elements

Defining Collection Element Specification Limits

Collection Element Values

Defining Collection Element Values

Quality Actions

      Types of Actions

      Action Rules and Invoked Actions

      Action Details

      Action Rule Sequencing

Defining Collection Element Actions

Defining Collection Element Alert Actions

Defining a Launch a Workflow Action

Associating Output Variables with Actions

Viewing Collection Elements

Specifications

Overview of Specifications

Specification Types

Specification Collection Elements

Defining Specifications

Defining Specification Collection Elements

Collection Plans

Overview of Collection Plans

      Quality Data Collection Structure

Collection Plan Types

Collection Plan and Import Results Database Views

Collection Elements in Collection Plans

Creating Collection Plans

Defining Collection Plan Elements

Defining Collection Plan Element Values

Associating Specification Types with Collection Plans

Dependencies Between Context Elements and Actions

Defining Collection Plan Element Actions

Defining Collection Plan Element Alert Actions

User-Defined Formulas

Defining Assign A Value Actions: User-Defined Formulas

Business Examples: User-Defined Formulas

Quality Data Collection During Transactions

      Collection Triggers

      Context Element/Collection Trigger Relationships

Associating Collection Plans with Transactions

Updating and Deleting Collection Plans

Viewing Collection Plans

Parent-Child Collection Plans

Collection Plan Security

Data Collection

Overview of Data Collection

Data Collection Fundamentals

Transactional Data Collection Fundamentals

Entering Quality Results Directly

Finding Specifications While Entering Results Directly

Results Entry Folders

Viewing Attachments Associated with Quality Results

Action Processing

Updating and Deleting Quality Results

Posting Action Log Entries

Specifications for Transactional Data Collection

Collection Import

Updating Collection Import Records

Quality Workbench

Overview of the Quality Workbench

Data Collection Using the Quality Workbench

Nonconformance Management

Corrective Action Management

Finding Skip Lot Inspections

Manage Supplier Quality

Supplier Quality Collection Points

Quality Data Collection in Oracle Purchasing

Collection Plans for Receiving Inspections

Collection Plans for Receiving Transfers and Deliveries

Entering Quality Results: Receiving Transfers and Deliveries

Entering Quality Results for Receiving Inspections

Oracle Purchasing Business Example

Setting Up Oracle Quality for Use with iSupplier Portal

Entering and Viewing Supplier Quality Results in iSupplier Portal

Performing Skip Lot Inspections

Performing Inspection Sampling

Manage Manufacturing Quality

Manufacturing Quality Collection Points

Collection Plans for Managing Manufacturing Quality

Quality Data Collection in Work in Process and Shop Floor Management

Inline Quality in Manufacturing Execution System

Setting up Quality Data Collection

Work in Process Business Examples

      Defect Code Pareto Analysis

      Yield and Quality Cost Reporting

      Process Capability Study

Quality Data Collection in Project Contracts

Quality Data Collection in Oracle Process Manufacturing

Manage Order Fulfillment Quality

Viewing Quality Results Using the Order Information Portal

Manage Customer Service Quality

Customer Service Quality Collection Points

Quality Data Collection in Oracle TeleService

Oracle TeleService Business Example

Quality Data Collection in Oracle Depot Repair

Oracle Depot Repair Business Example

Manage Material Quality

Integration With Oracle Mobile Warehouse Management

Manage Regulatory Compliance

21 CFR Part 11 Overview

E-records and E-signatures for Oracle Quality

Viewing Oracle E-Records and E-Signatures

Charts, Views, and Custom Reports

Quality Results Analysis

Copy Settings Function

Copying Settings

Functional Grouping and Processing

Quality Results Folders

Pareto Charts

Histograms

Trend Charts

Control Charts

Cp and Cpk Indexes

Viewing Descriptive Statistics

Viewing Quality Results

Viewing Quality Results Details

Entering, Updating, or Viewing Related Child Quality Results

Viewing Quality Results by Lot Number

Viewing Quality Results by Serial Number

Using the Quality Results ReportWriter

Viewing and Deleting Action Log Entries

Exporting Quality Results

Reports and Processes

Overview of Reports

Collection Element Action Rules Report

Collection Element Usages Report

Collection Elements Report

Collection Plan Action Rules Report

Collection Plan Details Report

Collection Plan Summary Report

Manage Collection Element Indexes Process

Quality Results Report

Quality Specifications Report

Sequence Element Audit Report

Collection Plan Transactions Report

Quality to AK Plan Mapper

Quality Shipping ERES Collector

ISO 9000 Compliance

ISO 9000 Compliance

Windows and Navigator Paths

Quality Windows and Navigator Paths

Attachments

Attachments for Collection Plans, Specifications, Result Lines

Attaching Collection Plans, Specifications, Results Lines

Results Queries

Finding Quality Results

Query Operators

Creating In and Not In Lists

Tools Menu Options

Tools menu

Context and Reference Information Collection Elements

Context and Reference Information Collection Elements

Pre-Seeded Collection Plan Templates

Pre-Seeded Collection Plan Templates

Glossary

Index