R12 Quality

1. QualitySetup:
Setting Up in Other Applications
Setting Up in Oracle Inventory
* Items and item attributes for every raw material,intermediate,and end item. Items must be set up as process quality-
enabled in theItem Master.
* Status and Grade control on the Item Master
* Expiration date, retest date, and retest interval
* Action and reason codes
Define Organization
Used Res. “Quality Manager”

2. Action Codes
InventorySetupAction Codes
Action codes represent user actions to perform when quality testingyields out-of-specification exception cases, such as
out-of-specification conditions,or experimental error results
Setting Up Grades
Grade is a characteristic ofan item lot and is usually a combination of inventory and quality attributes.Items must be lot
and grade-controlled to enter grades for them
Setting up MaterialStatus
The first step is to define each Material Status and its associated permissions.After you
perform quality tests,change the status of lots that do not meet quality specifications in
order to prevent them from being sold or used for production
Setup Test Classand Units
Quality Manager  SetupTest Classes

3. Setting Up Test Units
Setting up Sampling Plans
The SamplingPlan window lets you define how much and how often to sample.
Sampling plans are an optional setup, lets you define how much and how often to sample
‫التشغيله‬ ‫ف‬ ‫عينه‬ ‫كل‬ ‫وكميه‬.. ‫المطلوبه‬ ‫العينات‬ ‫عدد‬

4. Setup Parameters:
QualitymanagerSetupProcessQualityParameter
The Process Quality Parameters window lets you set up system defaults to enforce quality management business rules for
a specific organization
Select Org and Assign its type & Select Organization Type as Quality Laboratory where the sample is analyzed
Laboratory is selected if an organization is defined as a research and development laboratory organization in OPM
Product Development
Spec Validity rule

5. * Select Create Samples Automatically to enableautomatic sample creation on the Specification Validity Rules window
for an Inventory,WIP, or Supplier sample type
* Select Lot Optional to bypass theentry of a lot number whilecreatinga sample against a lot-controlled item. Deselect to
require a lot to be entered on a sample.
* Select Control Batch Step Status to control completion of batch based on Result of Test
* * Inventory Update **
- Update Inventory quantity  if check it mean sample Quantity will deduct from inventory on-hand
Means Change Material Status Based on Test Result

Control Lot Attribute
-
Enter the default In-Spec Status to update the material status when in-specification results are entered. The sample grouphas adispositionofAccept
and Control LotAttributes is selected ACC
Enter the default Out-of-Spec Status to update the material status whenout-of-specificationresults are entered. The sample grouphas adispositionof
RejectandControl LotAttributes is selected. REJ
Samples

6. - Select Manual Spec Selection to overridethe default specification and select an alternatespecification on the Item
Samples window.Select from a list of applicable specifications chosen from thespecification matchinghierarchy
- Select Consider Optional Tests Results: Optional test affect final disposition of sample or not
If selected it considered if not optional result will not affected by optional tests
Account which used if sample deduct inventory on-hand
Stability study:

7. TEST
‫اخرى‬ ‫اختبارات‬ ‫مجموعه‬ ‫من‬ ‫حسبه‬ ‫عن‬ ‫عباره‬ ‫اختبار‬ ‫اعمل‬ ‫أقدر‬
Quality managerSetup Test
Understanding Tests
determine a quality characteristic or attributeof an item or lot
Test data types you can set up:
The expression test:To buildamathematical expressionto reference
The results ofother numeric-basedtests
Non-Validated Test:resultfreetextwith no validation
Numeric Range Test:Enter a test code, description,test unit,and range of acceptablevalues for the test.If
results for the item or lot fall outside this range, then the material fails this test

8. Testunit  Percentageor any other Unit
Range:AcceptedRangeifI using Numeric Range as Data Type
Stored Precision, Report Precision:
Stored Precision as thenumber of decimals stored and displayed for this test
Report Precision as the number of decimals toreport on the Certificateof Analysis for this test
• For Expression test data types:

9. Entering Experimental Error “‫التجارب‬ ‫”خطأ‬
Accounts for inaccuracy and imprecision in test results by defining action zones around the specification limits or target
Specification (item, Monitor)
.‫الجوده‬ ‫موافقه‬ ‫متطابات‬ ‫المواصفات‬ ‫بتحدد‬ : ‫المواصفات‬
‫معين‬ ‫لمخزن‬ ‫بيئيه‬ ‫لظروف‬ ‫او‬ ‫معين‬ ‫لصنف‬ ‫المطلوبه‬ ‫الجوده‬ ‫احقق‬ ‫عشان‬ ‫معينه‬ ‫تشغيله‬ ‫على‬ ‫المطلوبه‬ ‫االختبارات‬ ‫هى‬ ‫ايه‬

10. Enter Needed Tests at Targets
To set test As Optional  Check optional Check box
Lot Retest/Expiry indicator identifies tests on the specification that need to be performed when retestingan expired lot,
or when retestingis required at specified intervals.
Recommending Lot-Specific Interclass UOM Conversions Based on Test Results:
Use quality test results toupdate a quality attributethat varies from lot to lot in inventoried material.For example, when
the activeingredient of a raw material varies across lots,despitethe standard potency established for all lots of a
particular item,you adjust for this variabilityby storinga lot conversion factor between the primary and secondary units
of measure for the material based on quality test results for the specific attribute.

11. Indicating Certificate Formatting Options on the Specification
You can specify whether to print specification targets,limits,and results on a quality certificatewhen you enter a
specification
Using Item Specification Validity Rules:
Validity ruletype as inventory, WIP, customer,or supplier for item specifications for the process-enabled
organization you select.
Select Update Inventory Quantity in theProcess Quality Parameters window toenforce an inventory transaction for
drawingthesample quantity and to decrease inventory accordingly.
Control sampleand inventory and lot Status on Validity Level

12. Certificatetype:
Select the CertificateType on the Specification Validity Rule todesignate either Certificateof Conformance or Certificate
of Analysis as the type of quality certificateto generate, and whether thecertificateis required at invoice, at shipment,or
from the supplier
Matching Customer Specifications in Oracle Order Management:

14. Understanding License Plate Numbers for Containerization:
Note: LPNs are applicableonly for WarehouseManagement System (WMS) enabled organizations.

15. Production (WIP)
Select a process-enabled inventory Organization
Optional to Select Specific Batch
At Control
You can Control Samples Created automatic,affect inventory and Control Batch Step status
Create Validity Rule for Supplier

16. Samples:
Quality inspection of materials during various points in the supply chain. This includes sample collection at events such as
receiving, batch creation, batch step release, production yield, and lot expiration. Samplinginspection also occurs for material
received from suppliers, for workin process material, for inventory, for specific customers, and for shipments. Samples are also
created as part of a stability study for a particular item.
Samples aresent to a quality laboratory organization for testing.
The organization must be process-enabled and defined a Quality Laboratory in the Process Quality Parameters window.
In theProcess Quality Parameters window set up a manual or automatic document numberingscheme for samples.
Defining and Applying Sampling Plan:
Setup: Sampling Plan

17. Creating an Item Sample:
Understanding Automatic Sample Creation, Inventory update, Control status Attribute
Automatic sample creation simplifies data entry and integrity when samplingin high volume production environments,
or at various points in the supply chain
This is based on a business event in the application.Existing business events that can trigger the sample creation
workflow include lot expiration and retest, inventory adjustment, batch or batch step creation, batch step release, and receiving
material into inventory or a receiving location
HOW to Create Automatic sample?

18. Responsibilities:
Workflow Administrator Event Manager,
AME Application Administrator,
Quality Manager
1- Set Sample numbering to automatic at Process quality Parameter
At this scenario we are using Plant org the same as lab org.
For Automaticsample creationyou musttosetnumberingtoautomaticand forinventoryupdate setAccount

19. 2-Enable the business event that triggers “automatic sample creation” and inventory deduction
Requirement :
Open “System admin” user
System administratoradministrator workflow Business Event
At
Events for createsample
1- Batch Created 2- Batch Release 3- Step release “Oracle .apps.gme.bstep.rel.wf”
Preferred to use “Oracle .apps.gme.bstep.rel.wf”
* Regarding to include Lot no. at Sample to allow transaction “automatic inventoryupdate”
* Inventory updateeffected only to byproduct with typesample
By change sample from planned to Pending will complete WIP-byproduct-completion and inventory deduct for
Quality
* Set Pending Lot for product before release Batch
At this example we are using while batch Created but preferred to use Step Release

20. Enable it and then enablesubscription
** If you need to createworkflow to notify sampler **
“AME”
Open Res. Approval Management Business analyst
Select: Process Quality Production Transaction SampleCreating

21. Create Approval Group
Create Action Type

22. Select Existing Action type
Then
Setup condition*Will Create it without Condition*
Create Rule:

23. ** Also We Can Use Transaction Type” ProcessQualityBatchStepRelease” to generate notification While Batch
Step Release
All Remaining Steps as above One
3-Define a sampling plan:
Planned Qty. to be automatic deduct as sample

24. 4- Create item Specification:
Preferred to use plant org as lab org too
Change status toapprovefor General use
Create Validity Rule for Specification

25. For Step Release make sure to do
1- Set step no. at validity
2- Before it make sure to associate by-product/product with step at Recipe
Make sure to setupDoc. NumberingforSample andSave
NowWhile ReleaseBatchPlannedSample Will automaticallyCreatedonMLP
While using Production at Lease you have to add Recipe
Save and Open Production Supervisor and createNew Document
While Step Release Sample created without notification
Open Notification

26. To view planned Sample “Automatically Created”
Set Pending Lot before Release Batch
Release Batch header  Then Release Batch Steps
Open Steps
Release Step
And Save it

27. View Sample:
Sample Will Created with Status Planned
Change Disposition of Sample by change status from Planned to Pending or Retain

28. Delaying the Entry of Lot Numbers:
This delay accommodates samplingprocesses in which thematerial is analyzed before delivery to inventory.
Accounting for Sample Quantity Drawn from a Batch:
This feature reflects the sample quantity taken from a batch by modeling the sample as a batch byproduct. An inventory
transaction for this samplebyproduct is created automatically based on thereason code defined on the Process Quali ty
Parameters window.
‫ال‬ ‫كميه‬ ‫ان‬ ‫هنا‬ ‫بتحصل‬
sample
‫عليها‬ ‫بيحصل‬
automatic transaction
‫بنعمل‬ ‫دى‬ ‫الحاله‬ ‫فى‬
formula
‫فيها‬ ‫بيكون‬
byproduct
‫انها‬ ‫ع‬ ‫هاخدها‬ ‫اللى‬ ‫الكميه‬ ‫بيمثل‬
Sample
‫ال‬ ‫وبيكون‬
byproduct type“Sample”
To update the batch with thesamplequantity:
1. Create a formula by enteringthe item to sampleas a byproduct formula line:
• Set the byproduct quantity equal to thequantity you plan to take as a sample.
• Set the Yield Type to Manual, and the Byproduct Type toSample.
Create and approvea WIP specification validity rule,specifying the recipe, formula, and formula line at which the sample
byproduct is yielded. Ensure that theUpdate Inventory Quantity indicator is selected
Example:
1- Quality  Setupprocess Quality Parameter
At Sample tab
Add Account used for automatic transaction

29. Create formula and add byproduct Line
Make Sure to be With By-Product Type“Sample” if using update inventory attribute
Create Specification “Select By product incaseFormula Contain Byproduct item else Select Product”

30. Change Validity for specification
TestScenario:
Create Batch and Release Batch

31. CheckCreatedSample fromTool  Samples
ClickOnviewSample
Change sample Disposition fromPlannedtoPending
One Sample StatusChanged

32. 2 Transactionoccur
1- WIP-Byproductcompletion
2- Sample quantityDeduction

33. If we checkmaterial Transaction
Create Sample Manual:

34. Item Samples:
Enter the Disposition as the samplestatus:
• Planned when thesample is scheduled to be taken.
• Retain when the sample is taken and put in storage. Results cannot exist for a sample with this disposition.
Retain As to indicatewhether thesample type is an Archive, Reserve, or required sample
• Pending when the sample is saved, and results areexpected, but not yet recorded. This is thedefault disposition.
• Cancel when thesample is canceled.
Click Get Spec to associatea specification for this sample. The Specification Association dialog box displays.
Enter Drawn as the date and time the samplewas taken
Result:
To enter Result for Sample
Has to be with Disposition “Pending”
Click on Result

35. Enter Resultif betweenRange willbe Inspectelseoutspec
AfterSave Sample statuschangedfromPendingtocomplete
The nextStepisAccept
Change Disposition fromComplete toAccept

37. BuiltinReports:
Item/Location Required Analysis Report
This includes process quality-enabled items that requireretestingand items that require evaluation of their expiration
dating. The report lists theitems and locators that need attention,thedate the attention is required, and the action to ta ke.
Item/Location Test Results Report: “Inventory-Test”
The Item/Location Test Results report displays theresults obtained from quality samples against inventory for a specified
organization.
Production Test Results Report “Production/WIP-Test”
The Production Test Results report displays quality test results entered for WIP samples for a specified organization

38. Certificate of Analysis or Conformance Report
The Certificateof Analysis or Certificateof Conformance report verifies the process quality-enabled items produced or
shipped comply with test procedures and quality specifications prescribed by the customer.A process manufacturer
authorizes a Certificate of Analysis or Certificate of Conformance for shipment of supplies that usually require inspection
upon receipt. The Certificateof Conformance report presents data derived from quality management information.These
reports arecreated primarily for items included on sales orders and shipped to customers.A customer may require
certification of tests performed, and results generated on specific products sold to them.Potential customers review
results certification beforeordering products. Specifications with inventory or customer specification validity rules impact
these reports.WIP and supplier specification validity rules haveno impact.
The Certificate of Analysis Report
This report shows that certain tests wereperformed on an item
Workflow “Sample Creation”