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Oracle Process Manufacturing Quality Management User's Guide
Release 12.1
Part Number E13689-05
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Oracle Process Manufacturing Quality Management User's Guide

Contents

Title and Copyright Information

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Preface

Understanding Quality Management

About This Guide
About Quality Management
Tasks and Responsibilities
Process Flow
Understanding the Interface to Other Applications
Understanding Navigation
Using the Navigator Find Window

Setting Up

Setting Up in Other Applications
Setting Up Quality Tests
Setting Up Test Classes
Finding Test Classes
Setting Up Test Groups
Setting Up Test Units
Finding Test Units
Setting Up Sampling Plans
Finding Sampling Plans
Setting Up Parameters

Tests

Requirements
Entering Test Methods
Finding Test Methods
Understanding Tests
Entering Tests
Entering Customer Display Information
Entering Experimental Error
Finding Tests

Specifications

Requirements
Understanding Specifications
Using Lot UOM Conversions Based on Quality Results
Understanding the Status Approval Workflow
Adding and Editing Status Codes
Entering Status Details
Finding a Status Code
Understanding Specification Version Control
Understanding License Plate Numbers for Containerization
Entering a Specification
Copying a Specification
Finding an Item Specification
Entering an Item Specification Validity Rule
Displaying the Item Specification Validity Rules Summary
Entering a Monitoring Specification Validity Rule
Displaying the Monitoring Specification Validity Rules Summary
Displaying Specification Summaries from the Navigator

Samples

Requirements
Understanding Sampling
Entering Item Samples
Entering Monitoring Samples
Finding Samples
Displaying Sample Groups
Displaying Sample Summaries from the Navigator
Displaying the Samples Summary Window

Results

Requirements
Understanding Results
Entering Results
Selecting Samples and Tests for Mass Results Entry
Using the Mass Results Entry Window
Displaying Test Details from Mass Results Entry
Displaying Experimental Errors from Mass Results Entry
Finding Samples from the Results Window
Compositing Test Results
Viewing Samples for Composited Results
Adding Tests to Composited Results
Comparing Specifications
Finding Samples for Specification Comparison
Changing Quality Disposition
Associating Results to Another Sample

Reports and Inquiries

Requirements
Running the Item/Location Required Analysis Report
Item/Location Required Analysis Report Description
Running the Item/Location Test Results Report
Item/Location Test Results Report Description
Running the Customer/Supplier Test Results Report
Customer/Supplier Test Results Report Description
Running the Production Test Results Report
Production Test Results Report Description
Running the Certificate of Analysis or Conformance Report
Certificate of Analysis or Conformance Report Description
Making a Sample Storage Summary Inquiry
Finding a Sample Storage Summary
Generating Sample Labels

Stability Studies

Requirements
Understanding Stability Studies
Example of a Stability Program for Product X
Managing the Stability Study Lifecycle
      Setting Up for a Stability Study
      Planning a Stability Study
      Performing Initial Sampling and Testing
      Approving a Stability Study Plan
      Launching a Stability Study
      Performing Stability Study Testing
      Evaluating a Stability Study
Understanding the Stability Study Change Status Workflow
Creating Test Interval Plans
Generating a Series of Testing Periods
Finding Test Interval Plans
Creating a Storage Condition Plan
Finding Storage Condition Plans
Defining Storage Packages
Finding Storage Packages
Creating and Managing a Stability Study
Finding Stability Studies
Assigning Stability Study Material Sources
Editing Stability Study Variants
Finding Stability Study Variants
Editing Variant Time Points

Quality Management Navigator Paths

Quality Management Navigator Paths

Quality Management Responsibilities

Quality Management Responsibilities

Quality Management Business Rules

Specification Matching Business Rules

Quality Management Workflows

Basic Business Needs
Technical Overview
Understanding Workflow Processes
Understanding OPM Quality Management Workflows
Setting Up OPM Quality Management Workflows
Using OPM Quality Management Workflows
OPM Quality Sample Creation Workflow
OPM Quality Test Workflow
OPM Quality Sample Disposition Workflow
OPM Quality Composite Results Workflow
OPM Quality Sample Group Disposition Workflow
OPM Quality Spec Status Change Approval Workflow
OPM Quality Spec Customer Validity Rule Status Change Approval Workflow
OPM Quality Spec Inventory Validity Rule Status Change Approval Workflow
OPM Quality Spec Supplier Validity Rule Status Change Approval Workflow
OPM Quality Spec WIP Validity Rule Status Change Approval Workflow
OPM Quality Spec Monitoring Validity Rule Status Change Approval Workflow
OPM Quality Sample Group Rejection Workflow
OPM Quality Stability Study Change Status Workflow
OPM Quality Stability Study Lot Sample Workflow
OPM Quality Stability Study Batch Creation Workflow
OPM Quality Stability Study Testing Workflow
OPM Quality Stability Study Time Point Test Workflow
OPM Quality UOM Conversion Workflow
Approval Management Engine (AME) Approval Matrix

Oracle E-Record Events in Quality Management

Events
Subscriptions
Approval Matrix
Approval of Quality Specification
Samples Creation
Results
Sample and Sample Group Disposition
Stability Study Change Status

Glossary

Index