003 OPM r12 Quality v1.0
Transcript of 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
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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
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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
3 months40°C75% relative humidity
6 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
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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