OPM - Quality MGMT - R12

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OPM Quality Management, Receiving Inspection,

Process Operations Nonconformance Tracking,
Copy Specifications
David Ballin
Solution Architect, SCM – Process Manufacturing
Safe Harbor Statement
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 Oracle’s
products remains at the sole discretion of Oracle.
Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Overall Agenda and Introduction section
• Introduction
• Description
• Benefits
• R12 Enhancements
• Common Inventory for OPM Quality
• Enhanced Receiving Inspection
• Nonconformance Tracking
• Copying Specifications
• Summary

Process Manufacturing Quality Flow
Capture and Leverage Quality Characteristics of Material
• Receiving, In Process,
Shipping Inspection • Material Usage Decisions
• Lot Expiration/Retest • Batch Adjustments
• Environmental Monitoring • Order Allocation
Standardize Sample Analyze Disposition Report
• Tests and Methods • Result Statistics • Certificate of Analysis

• Sampling Plans • Stability Studies • Lot Genealogy
• Specifications
Process Improvement
Workflow-Driven Processes and Electronic Records

Pre-Defined Quality Workflows
Check Quality Throughout the Supply Chain
Receiving Inventory Shipping

 
Suppliers Customers
 
Automatic Workflow Notifications
Production at Each Quality Check Point for:
• Sample Creation
• Assay Testing
 Quality check points • Sample Disposition Decision

Specifications Management
Capture and Meet Unique Customer Specifications
Customer
Out-of-Spec In-Spec Out-of-Spec
Specification
Item
Specification
Match
Min Max
• Define internal and customer products specifications

• Match available inventory to customer specifications
• Provide Certificate of Analysis (COA) with each shipment

Nonconformance Management
Capture and Record Deviations
• Access directly from batch
• Capture and document
nonconformances / deviations
• Configurable criticality
- Informational
- Resolution required prior to
completing batch or step
- Configurable e-signatures
• Included in control batch record
- Critical nonconformances must
be reviewed and signed prior to
close of the batch
- Leverages Oracle Quality
“Any deviation from
the written pro-
cedures shall be recorded and
justified.” -- 21 CFR Part 211.100,
Written procedures for deviations

Release Overview
• Release 12 Oracle Process Manufacturing Quality

Management enables Process companies to:
• Better track quality lab inventory and activities
• Streamline receiving inspection
• Document manufacturing deviations
• Enforce consistent quality specifications across plants

New and Changed Features for
OPM Quality


Common Inventory for OPM Quality
• Introduction
• Description
• Benefits
• Setup and Process
• How to set up the feature
• How to use the feature
• Dependencies and Interactions
• Summary

• Introduction
• Description
• Benefits
• Summary

Description
• Central view of Inventory

• This functionality brings together process and other types of
materials management into one, central inventory application
• All inventory balances are maintained in Oracle Inventory
• Inventory transactions processed in Oracle Inventory
• Maintain one item master

• Item master contains all types of items
• Attributes for “Process” items
• Organization-specific items

Description
Changes in OPM Quality

BEFORE AFTER
No support for Item Revisions Item Revision support in specifications,

samples, and stability studies
Sample against a lot Sample against parent lot

updates its sublots updates its lots
Miscellaneous inventory adjustment New inventory transaction type

for sample quantity deduction for sample quantity issue
Sample history only for a Sample and results traceability through

specific lot, warehouse, and location lot split, merge, and transfer

Description
Changes in OPM Quality (continued)

BEFORE AFTER
Quality Lab and R&D Lab defined as Quality Lab and R&D Lab defined as
same Lab Organization same/separate Inventory Organizations
Lot Expiry/Retest Workflows Inventory Date Notifications

in OPM Quality in Oracle Inventory
Site-level profile options and

Site-level profile options
organization-specific parameters
Grade, Actions, and Reasons Grade, Actions, and Reasons

defined in OPM Quality defined in Oracle Inventory

OPM Quality Management
Agenda
• Introduction
• Description
• Benefits
• Summary

Benefits
• Increase visibility of quality lab organizations

• Quality labs as inventory organizations help track costs of
sample analysis
• Improve traceability of quality sample transaction
• Sample quantity deduction is tracked against an item revision
and new transaction type
• Reduce cost of inspection
• Sample and results history are retained through warehouse
transactions without requiring lot retest

Agenda
• Introduction
• Description
• Benefits
• Summary

Setup and Process
SETUP PROCESS
Oracle Inventory OPM Quality
Define Grades, Enable Determine lot

Actions, and Reasons Quality Labs expiration or retest
Perform Deduct
Define Process Set organization Create sample(s) Sample Qty
Quality-enabled items parameters Transaction
Set up Inventory Date Analyze sample(s)

Notification Workflows
Enable Transaction Update lot grade

Disposition sample(s)
Type and Material and status
Status for Samples
Automated process

Agenda
• Introduction
• Description
• Benefits
• Summary

Setup – Grades, Actions, Reasons
• Grades, Actions, and Reasons setup moved to Oracle Inventory

• Grades and Actions accessible from Quality Manager menu
• Hold Reasons replaced by Transaction Reasons
Define up to 22
characters for grade
Disable code from

appearing in LOV
Optional workflow for

transaction reasons

Process – Grade and Action on Item Master

Setup – Item Revision Support
• Revision control on items can help identify material changes

(e.g., promotional packaging) and maintain on-hand balances
without changing the item code
• Item revisions are supported in OPM Quality:
• Differentiate quality characteristics
• Tests and targets in specifications
• Study parameters in stability studies
• Track sample inventory transactions for quantity drawn

Setup and Process – Item Revision Support
Define a specification
(quality attributes) for
an item revision
Find a specification and

deduct the sample quantity
from an item revision

Setup and Process – Parent Lot Support
• Child lot control on items can

group lots in an inventory
transaction
…
• Receipt
• Batch
• Sampling against a parent lot
can represent the quality of lots
under it
• Material status updates
• Grade updates
• Genealogy for a particular lot
can find the sample against the
parent lot

Setup – Inventory Date Notifications
• Configure concurrent request parameters to check:

• Lot expiration date
• Lot retest date
• Set workflow subscriber for sending Inventory sample creation
notifications

Setup – Sample Issue Transaction
New transaction type

for Inventory source
Transaction allowed
for this material status
Specify accountfor
Cost account for
sample
sampleqty
qtytransaction
deduction

Setup – Quality Laboratory
• A Quality Lab is a Process Manufacturing-enabled inventory

organization that
• Is distinct from a Formulation Lab
• Manages sample analysis activities
• Owns test kit items, testers, and test method resources
• Can be costed
• Configure Quality Lab checkbox on the OPM Quality Parameters
Window

Setup – Parameters
• Most of the site-level profile options replaced by organization-

level parameters
• Global parameters are not supported
• Default Lab profile is obsolete
Profile Option Replaced by

GMD: Specification Version Control Flag on Process Quality Parameters
GMD: Exact Specification Match Flag on Process Quality Parameters

GMD: Include Optional Tests in Sample
Flag on Process Quality Parameters
Disposition

Agenda
• Introduction
• Description
• Benefits
• Summary

Process – Quality Traceability thru Lot Transfer
MANUFACTURING QUALITY CHECKS DISTRIBUTION
Availability Hold QA Release
Grade A
Default Grade A
Lot and Sample Traceability

Inventory Convergence Support
Genealogy Inquiry of Quality Results
• No specific setup is required

• Quality Results collected for a specific lot number or serial
number will be available in Genealogy Inquiry
• Option for quality results to be included in the genealogy report
• There are no user process changes

Genealogy Inquiry of Quality Results
List of quality
collection plans used
to collect quality data
for the item lot …
“View Results”
displays actual data
collected

Agenda
• Introduction
• Description
• Benefits
• Summary

Dependencies and Interactions
• Oracle Inventory Dependencies • Oracle Inventory Interactions

• Material Statuses • Item/lot UOM conversions
• Grades • Material status update
• Actions • Grade update
• Reason codes • OPM Costing Dependency
• Process Manufacturing- • Account for inventory
enabled inventory transactions
organizations
• Quality-enabled items
• Item revision control
• Child lot control
• Inventory Date notifications

Agenda
• Introduction
• Description
• Benefits
• Summary

Summary
• Common Inventory for OPM Quality provides:

• Definition of a quality laboratory as an inventory organization
• Measurement or recording of quality attributes for an item
revision
• Inventory tracking and traceability for quality samples
• Sample issue transaction
• Genealogy of sample history
Refer to the Oracle Inventory TOI for more information

OPM Quality


Enhanced Receiving Inspection
Agenda
• Introduction
• Description
• Benefits
• Summary

Description
• Leverage existing and enhanced features to control receiving

inspection
• Hold receipt with Inspect receipt routing until inspection
passed
• Record visual inspection results via Oracle Quality collection
plan
• Notify to take samples as required by OPM Quality
specification, validity rule, and workflow rules
• Account for final sample group disposition before receiving
material into inventory

Benefits
• Streamline communications between Receiving and Quality

Assurance
• Closed loop inspection at the dock and in the lab
• Reduce risk of nonconformance downstream in the supply chain
• Proper material classification based on sample analysis
• Prevention of rejected items in production and shipping

Agenda
• Introduction
• Description
• Benefits
• Summary

OPM Receiving Inspection - Setup and Process
SETUP PROCESS
Copy OPM Receiving

Inspection Template
Perform Receiving Inspect using
Transaction Oracle Quality
Modify Quality
Plans (optional)
Record Visual Inspection
Results in Oracle Quality
Associate with
Receiving Transaction
OPM Pass Sampling
Yes
Sampling Disposition to
Define Collection Reqd? Oracle Quality
Triggers
No
Accept or Reject
Received Material

Setup
SETUP
OPM Quality Oracle Quality Oracle Purchasing
Define specification Set QA: PO Inspection Set PO for inspection

and validity rule profile option receipt routing
Enable Receiving Define OPM

business event for receiving inspection
sample creation collection plan
workflow
Define specification for

supplier and item

OPM Receiving Inspection - Setup
SETUP
OPM Quality Oracle Quality Oracle Purchasing
Define specification Set QA: PO Inspection Set PO for inspection

and validity rule profile option receipt routing
Enable Receiving Define OPM

business event for receiving inspection
sample creation collection plan
workflow
Define specification for

supplier and item
• The Oracle Quality specific setup has been highlighted. In addition, a

separate template collection plan for OPM receiving inspection has been
provided.

Setup – Oracle Quality Collection Plan
• New template collection plan

for OPM receiving inspection
• Collection plan required by
Oracle Purchasing inspection
transaction
• New collection element for

sample group disposition
• Must be Accept, Accept
with Variance, or Reject
before completing
inspection result

Setup – Purchasing/Receiving Options
• PO Inspection profile option set to

Oracle Quality instead of
Purchasing
• Item default receipt routing set to
Inspection instead of Standard or
Direct

Process – Cross-Functional Flow
RECEIVING
CLERK
QUALITY
INSPECTOR
QUALITY
TECHNICIAN
QUALITY
MANAGER
• Receive purchase order
• Require inspection
Inspection required Workflow
• Analyze sample(s)
Purchase
order
Sample
analysis
• Create
receipt
• Test
• Disposition
Collection
plan
results
Sample
group • Enter results against
disposition:
Inventory
delivery
Accept,
Accept with
collection plan
or
Supplier Inspection
Variance,
or Reject • Enter inspection result to
return result:
Accept
or Reject
complete receipt
• Accept
• Reject

Process – Enter Inspection Result
Control inspection
result based on
lab sample acceptance
Require
inspection
upon receipt

Agenda
• Introduction
• Description
• Benefits
• Summary

Agenda
• Introduction
• Description
• Benefits
• Summary

Dependencies and Interactions
• Dependencies
• Oracle Quality
• Profile option QA: PO Inspection
• Collection Plan
• Oracle Inventory or Oracle Purchasing
• Inspect receipt routing
• Interactions
• Oracle Quality
• Final sample group disposition controls inspection result

Agenda
• Introduction
• Description
• Benefits
• Summary

Summary
• Enforce OPM Quality sampling and account for final disposition

on incoming material before inventorying
• Leverage existing features to control receiving inspection
• Hold receipt with Inspect receipt routing until inspection
passed
• Record visual inspection results via Oracle Quality collection
plan
• Notify to take samples as required by OPM Quality
specification, validity rule, and workflow rules
Refer to the Oracle Quality TOI for more information

OPM Quality


Process Operations Nonconformance
Tracking
Agenda
• Description
• Process

Tracking
Description
21 CFR Part 211.100 guideline
“…Any deviation from the written procedures
shall be recorded and justified.”
• Nonconformance tracking in Process Operations leverages Oracle

Quality:
• Capture and document batch nonconformance
• Configurable nonconformance criticality
• Informational
• Resolution required prior to completing batch or step
• Configurable e-signatures
• Included in Control Batch Record
• …
• Critical nonconformance must be reviewed and signed prior to
close of the batch
• Refer to Process Operations TOI for more information

Tracking
Agenda
• Description
• Process

Tracking
Process
Process Observe Log

Manufacturing Batch Incident Nonconformance
Material Quantity Change
Process Parameters Deviation
Item Substitution
Resource Substitution
User-Defined Deviations
Close Disposition Review

Nonconformance Nonconformance Nonconformance
= Electronic Signature

Tracking
Process – Log and Review Nonconformance
Record batch
deviation from
Process
Operations
View and track all

nonconformance by
batch

OPM Quality


Copying Specifications
Agenda
• Introduction
• Description
• Benefits

Description and Benefits
• Quickly push corporate specifications from master organization

to site organizations
• Decide which organizations inherit corporate specs
• Enable spec ownership by organization
• Speed product development process

• Mass creation of site-specific quality specifications from a
corporate template
• Quick assignment of spec owner organizations

Agenda
• Introduction
• Description
• Benefits

Setup and Process
Copy Specifications Process
MASTER ORGANIZATION
Corporate General
Specification
Copy
Specifications
FUNCTIONAL ORGANIZATIONS
Site
R&D Labs Plants Specifications

Overall Agenda and Introduction section
• Introduction
• Description
• Benefits
• R12 Enhancements
• Summary

Summary
• Quality capabilities are a strategic differentiator

• Based on industry standards
• r12 provides
• Enhanced traceability
• Enhanced integration with Discrete Quality

Q&
A
Thank You

OPM - Quality MGMT - R12

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<Insert Picture Here>

OPM Quality Management, Receiving Inspection,

The following is intended to outline our general

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Standardize Sample Analyze Disposition Report

• Tests and Methods • Result Statistics • Certificate of Analysis

Workflow-Driven Processes and Electronic Records

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Receiving Inventory Shipping

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Define internal and customer products specifications

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Release 12 Oracle Process Manufacturing Quality

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Common Inventory for OPM Quality

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Central view of Inventory

• Maintain one item master

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Changes in OPM Quality

No support for Item Revisions Item Revision support in specifications,

Sample against a lot Sample against parent lot

Miscellaneous inventory adjustment New inventory transaction type

Sample history only for a Sample and results traceability through

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Changes in OPM Quality (continued)

Lot Expiry/Retest Workflows Inventory Date Notifications

Site-level profile options and

Grade, Actions, and Reasons Grade, Actions, and Reasons

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Increase visibility of quality lab organizations

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Oracle Inventory OPM Quality

Define Grades, Enable Determine lot

Set up Inventory Date Analyze sample(s)

Enable Transaction Update lot grade

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Grades, Actions, and Reasons setup moved to Oracle Inventory

Disable code from

Optional workflow for

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Revision control on items can help identify material changes

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

Find a specification and

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Child lot control on items can

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Configure concurrent request parameters to check:

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

New transaction type

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• A Quality Lab is a Process Manufacturing-enabled inventory

Copyright © 2006 Oracle. All rights reserved. Internal use ONLY.

• Most of the site-level profile options replaced by organization-

Profile Option Replaced by