003 OPM r12 Quality v1.0

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Quality for Oracle Process Manufacturing

AGSS Process Manufacturing Sales Support Team

Agenda

• General concepts• Process Quality Solution

• Key Functionality

• Additional resources


General Concepts

Manufacturing Building Blocks

Quality

Costing

Analysis

Inventory

Product

DevelopmentPlanning Produce

Order

ManagementPurchase

Quality Management

Quality

Costing

Analysis

Inventory

Product

DevelopmentPlanning Produce

Order

ManagementPurchase

• Tests and Methods

• Sampling Plans

• Specifications

• Tests and Methods

• Sampling Plans

• Specifications

Standardize Sample Analyze Disposition

• Certificate of Analysis

• Lot Genealogy

• Certificate of Analysis

• Lot Genealogy

Report

• Result Statistics

• Stability Studies

• Result Statistics

• Stability Studies

• Receiving, In Process, Shipping Inspection

• Lot Expiration/Retest

• Environmental Monitoring

• Receiving, In Process, Shipping Inspection

• Lot Expiration/Retest

• Environmental Monitoring

• Material Usage Decisions

• Batch Adjustments

• Order Allocation

• Material Usage Decisions

• Batch Adjustments

• Order Allocation

Workflow-Driven Processes and Electronic RecordsWorkflow-Driven Processes and Electronic Records

Process Improvement

Process Manufacturing Quality FlowQuality Characteristics of Material


Process Quality Solution

Process Quality Solution

Enables you to:

• Achieve product consistency• Enforce proactive quality assurance• Streamline quality lab productivity• Assure customer and regulatory compliance

Key Functionality

• Standardized inspection methodologies• Stability studies• Workflow driven quality management• Customer specification matching at order• Parent / Child lot traceability• Certificate of Conformance and Analysis• Quality driven lot usage decisions• Expired lot management

Standardized Inspection Methodology

Quality Setup

Specifications Definition

Samples Creation

Results Entry& Evaluation

Specification / Validity Rule Approval

ERES

ERES

ERES

ERES

Sample/Sample Group Disposition Approval, Sample Group Rejection

Composite Results

WIP Sampling InformationWF

WF

WF

Sample Creation Notification Workflow

WFTesting Notification Workflow

WF

WFItem/Lot UOM Conversion

Stability StudiesDetermine Product Shelf Life and Market Conditions

• Stability study management:• Assess environmental aging effects on product quality • Capture recommended shelf life and storage condition• Support research and development activities• Comply with FDA guidelines in regulated industries

• Implementation methodology via workflow and project-oriented interface

0 months40°C75% relative humidity



Batches

Stability Samples

Lab Technician

Study Owner

Lab Supervisor

Study Definition• Sample Numbering• Monitoring Specs• Storage Conditions• Storage Packaging• Testing Intervals• Item Specs

ProductionBatch

Stability Samples

Overlay Monitoring Specification (1)

Base Monitoring Specification

Overlay Monitoring Specification (n)

0 1 3 6 9 12 18 24 months

0 1 2 3 6 months

0 months12

Work Flow NoticesStudy Execution• Ensure Timely Execution of All Data Points• Assess Product Quality Over Time and Varying Environment• Capture Recommended Shelf Life and Storage Condition• Support Research and Development Activities• Comply With FDA Guidelines in Regulated Industries

Stability StudiesMeasure the Effects of Environmental Aging

Suppliers Customers

Inventory ShippingReceiving

ProductionAutomatic Workflow Notificationsat Each Quality Check Point for:

• Sample Creation

• Assay Testing

• Sample Disposition Decision

Pre-Defined Quality WorkflowsCheck Quality Throughout the Supply Chain

Quality check points

• Define internal and customer products specifications

• Match available inventory to customer specifications

• Provide Certificate of Analysis (COA) with each shipment

Specifications ManagementUnique Customer Specifications

CustomerSpecification

ItemSpecification

Min Max

Match

In-Spec Out-of-SpecOut-of-Spec

Global TraceabilityReduce Time to Resolve Issues

• Improve recall responsiveness / cost

• Comply with FDA, GMP, and other regulations

• Trace materials enterprise-wide to analyze supply chain quality

Ingredients& Resources

Intermediate or Bulk Products

Finished Product

Supplier Customers

Where Used

Lot Source

Certificate of Conformance or AnalysisAssure Product Quality Through Documentation

• Certify material for conformance to manufacturer’s or customer’s specification

• Print specification requirements and/or results• Run separately or

attach to shipment document set

Quality-Driven Lot Usage DecisionsManage Ingredient Variability for Consistent Products

• Shelf life• Retest interval• Potency• Dual units of

measure (UOM)

INVENTORY

• Expiration date• Lot status• Grade• Hold date• Lot UOM

conversions

AVAILABILITYQUALITY

• Sample lots• Evaluate for

conformance to specification

• Accept or reject

Expired Lot ManagementValidate and Manage Date-Sensitive Goods

• Notify when lots expire or require retesting• Change expired lot status to prevent usage• Manage retesting

• Lot retest sample • Lot retest tests from the specification

Process Quality SolutionEnables you to:

• Achieve product consistency• Stability studies, lot expiration management, process control

points, quality throughout the supply chain

• Enforce proactive quality assurance• Standardized inspection methodology, workflow, e-records

and e-signature

• Streamline quality lab productivity• Automated test/lab assignment, quality workbench

• Assure customer and regulatory compliance• Customer spec matching, CofA / CofC, lot traceability


Additional Resources

Additional Resources

• Vivian Lewis – AGSS – SCM Solution [email protected]

Mobile 972-xxx-xxxx

• Andrew Hyers – AGSS – SCM Solution [email protected]

Mobile 502-xxx-xxxx

• David Ballin – AGSS – SCM Solution [email protected]

Mobile 201-218-3245

Office 201-794-6221

003 OPM r12 Quality v1.0

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