Introduction:

InR12,OPMInventoryasknowninearlierreleases,isnolongeravailableforcurrent
transactions.HistoricalinformationcanbeviewedinOPMInventory,butcurrent
balancesresideinOracleInventoryandtransactionsareexecutedinOracleInventory,
alsonowknownasCommonInventory.

ThemainfeatureofCommonInventoryisthecentralizationofallinventorytracking.

Onecentralitemmasterbecomesthesourceofitemmaintenancecreationandupdate
aswellastherepositoryofallitemattributes.NewitemattributestocontrolProcess
Manufacturingfunctionalityhavebeenadded.ProcessManufacturersmayalsotake
advantageoforganizationspecificitemsthatenablechangingtheitemdefinitionby
inventoryorganization.

This note assesses the impact of the replacement of OPM Inventory by Oracle Inventory
on OPM Quality. SeveralconceptsorterminologyinOPMQualityhavebeenchangedor
introducedbecauseofCommonInventoryandthesearediscussedbelow.

The Process Manufacturing Organization

The OPM organization in R12 is an Inventory and is setup as follows -

Inventory > Setup > Organizations > Organization.

This form is the same as available from the HR Organization menu option under the
OPM System Admin responsibility in pre-R12 releases. In R12, the HR Organization is
not available in the standard OPM All responsibility. The Organization option in
System Admin menu under the OPM All responsibility holds the pre-migration
Organization setup information and is no longer used for setting up OPM Organizations.

This Inventory Organiszation is defined in the MTL_PARAMETERS table. A new column

called OWNER_ORGANIZATION_ID stores the values of the owning organizations for
specifications, recipes and routings and the column ORGANIZATION_ID for all other
quality entities.

SQL> select ORGANIZATION_ID, PROCESS_ENABLED_FLAG

from MTL_PARAMETERS
where ORGANIZATION_CODE = 'LA1';

ORGANIZATION_ID P
--------------------- -
7249 Y

It is pertinent to note a migration consideration here. During migration of existing

Warehouses to R12, there is now the option of migrating a Warehouse to either an
Inventory Org or a Subinventory. This leads to the possibility of transforming the
associated Sample data incorrectly, if the Warehouse to which the Sample data belongs is
migrated as an Inventory Organization, rather than a Subinventory belonging to an
Inventory Organization.

Thus, the need to ensure that during migration to R12, the sample source Warehouse and
Location are migrated to Subinventory and Locator in the same Inventory Organization,
as otherwise, it can lead to violation of FDA regulation since the Organization code is a
part of Sample No.The Convergence Migration setup window allows the administrator
to decide whether a Warehouse being migrated is a Subinventory or an Organization.

Resp: OPM All > System Admin > System Setup > Convergence Migration Setup

Please refer - Note 376683.1: OPM Release 12 Migration for further details.
OPM Plant and Laboratory

Whether an Organization is a Plant or a Lab is now defined in the Product

Development Parameters screen.

Responsibility: Product Dev Security Manager > Product Development Parameters:

Here, Organization LA1 is marked both as a Plant and a Lab.

SQL> select LAB_IND, PLANT_IND

From GMD_PARAMETERS_HDR
Where ORGANIZATION_ID = 7249;

LAB_IND PLANT_IND
-------- ----------
1 1

The column Organization_Id has been added to most of the tables to essentially
supercede orgn_code for quality entities.

For existing Organisations, the Convergence Migration setup window allows the
administrator to decide whether an Organization being migrated is also a Plant and/or a
Lab.
Resp: OPM All > System Admin > System Setup > Convergence Migration setup:

Quality Laboratory and Items

In11irelease,anOPMOrganizationmarkedwiththeorganizationtypeofLabserved
boththeProductDevelopmentandQualityareas.Now,designatingaQualityLabonthe
ProcessQualityParameterswindowmakesafurtherdistinction.

InRelease12,aQualitylaboratoryisaProcessManufacturingenabledinventory
organization,wheresampleanalysistakesplace.Itcanhaveitsowninventory,suchas
testkititems,andresources,liketestersandinstruments,sothatcostscanbetracked
againstit.

A Laboratory, on the other hand is where one would do Product Development activities
such as Formulation, Simulation and Optimization etc.

Thisway,onecandifferentiatebetweenproductformulaorrecipedevelopmentfrom
inspectiontransactionsandactivities.Also,resourcesandcostscanbetrackedseparately
fortheProductDevelopmentandQualityInspectionactivities.

Note: An Inventory Organization must be designated as a Quality Laboratory before

creating Samples.

Whether an Orgn is Quality enabled is defined on the Process Quality Parameters screen
under Responsibility: Quality Manager > Setup
SQL> select ORGANIZATION_ID, QUALITY_LAB_IND
From GMD_QUALITY_CONFIG
Where ORGANIZATION_ID = 7249;

ORGANIZATION_ID QUALITY_LAB_IND
--------------- --------------------
7249 Y

TheQualityLabflagisonlyvisibleontheaboveQualityParametersformandthiswhat
allowsthatorganizationforQualitytesting.(ThePlantandLabindicatorsdefault
fromtheProductDevelopmentParametersscreenandcantbechangedonthisscreen).

OnecanstillcreateSpecificationsagainstanyOrganization,butwhenitcomestoputting
theQualityLabontheSamples,theorganizationshouldbeflaggedasQualityLab.The
listofvaluesonQualityLabfieldontheSamplesformwillnothavethisOrganizationif
thisflagisnotchecked.

Further,ItemsneedtobesetupasProcessQualityEnabledforthemtobeusedinOPM
Quality,e.g,ontheSpecifications,Samplesscreenetc.ThisisdoneontheItemMaster
screenintheProcessManufacturingtabbycheckingtheProcessQualityEnabled
flag.

Responsibility:InventorySuperUser.
Nav:Inventory>Items>MasterItems.

All the Item fields in the quality management screens have been implemented as key flex
fields referring to the common Item Master. The associated Quality tables have a new
column called INVENTORY_ITEM_ID to store the reference to the item defined in
MTL_SYSTEM_ITEMS.

SQL>selectPROCESS_QUALITY_ENABLED_FLAG
FromMTL_SYSTEM_ITEMS
WhereSEGMENT1='8301'
andORGANIZATION_ID='7249';

PROCESS_QUALITY_ENABLED_FLAG

ItemRevisions

OPM can now leverage revision control to help track item changes and maintain on-hand
balances by item revision without changing the item code. An example would be
creating a new item revision for promotional packaging. OPM Quality supports revision-
controlled items to differentiate quality characteristics in specifications and stability
studies. In addition, the transaction for deducting the sample quantity (discussed later)
can also be taken against a particular item revision.

Revision control for an Item is defined on the Item Master under the Inventory tab:
ParentLotandLot

The concept of a Lot and Sublot in OPM Inventory becomes a Parent Lot and Lot in
Oracle Inventory, where an item is defined as child lot-controlled on the Item Master also
under the Inventory tab:
The Lot functionality on the Item Master has Child Lot and Child Lot generation
attributes. However, on all transaction screens, there is only Parent Lot and Lot
mentioned - there is no mention of Child Lot. Users need to be aware of this terminology
difference.

There is no zero padding in the starting number for Lots. Thus, if the starting no is given
as 00001, it becomes 1. For consistency it maybe therefore advisable to provide a high
starting number, e.g 1 million.

The Child Lot Generation has two options Parent+Child and Child. If
Parent+Child is chosen, then the Lot no generated is a concatenated field as follows -
(Parent Lot no)(Lot no.)

Nav: Inventory > On-hand Availability > Lots

In pre-R12 releases, it was not necessary to inspect every single sublot, one could just
inspect a lot and that would update the attributes for the sublot. The same concept is
carried forward in R12, it is only a difference in terminology. If a Parent lot is sampled,
that would update the lot status and grade for the sublot underneath that Parent lot.

A Lot number is unique for every Org, Item and Lot no. Combination.

Note: Revision control is at the Item level and not at the Lot level.
Quality Workbench, Specification, Validity Rules and Sample forms

The business process for Quality Sampling remains the same, it is only the touch points
to Inventory that are changed.

Thus, in the setting up of Grades and Action codes, or the setting up of Item revision, and
then following through to Disposition for Lot changes, not too much has changed on the
OPM Quality screens, its only the touch points to Inventory that has changed, which are
now in Common Inventory (Oracle Inventory) rather than in OPM Inventory.

(a) On the Quality workbench, the Organization context is always shown with the Item,
so the Organization is seen right before the Item code as reflected on each of the nodes of
the Quality Workbench. It is possible to query up a specification for a different
organization than one is in, if one has access to it, by just clicking on that specification
The screens will make the dynamic change when the form is opened

Responsibility: Quality Manager.

On the Quality Workbench - View Specifications by Item

The Specifications and the Samples forms are changed to reflect Item revision and Parent
Lot and Lot features.

(b)OntheSpecificationformthechangesmainlyarefortheItem,whichcanberevision
controlled.ASpecificationwithdifferenttestsandtargetsforaparticularitemand
revisioncanbecreated,sothatontheItemSampleswindow,theitemrevisionenteredis
usedtoretrievetheproperspecificationandconsumethesamplequantityfromthe
inventorybalanceofthisitemrevision.

The table GMD_SPECIFICATIONS holds the Specification information.

The Item and the Owner Organization information is linked to the Common Inventory
tables as follows -

GMD_SPECIFICATIONS . OWNER_ORGANIZATION_ID = MTL_PARAMETERS.

ORGANIZATION_ID

GMD_SPECIFICATIONS.INVENTORY_ITEM_ID = MTL_SYSTEM_ITEMS. INVENTORY_ITEM_ID

(c) The changes in the Validity Rules form relate mainly to Inventory.
A Parent Lot and Lot can be set instead of Lot and Sublot, Subinventory and Locator
replace Warehouse and Location. Most of the other flags are the same except that the
Material Status fields (In-Spec and Out-Spec values) are shown where the Lot Status
fields were shown in pre-R12 releases.

(d) The Item Samples form is quite similar to the pre-R12 form excepting that Item
Revisions are honored.

Subinventory and Locator replaces Warehouse and Location, Parent Lot and Lot replaces
Lot and Sublot and Material Statuses replace Lot Status, however the functionality for
these features has not changed.

If a Sample is taken against only the Parent Lot (and the Lot no is left blank), the Grade
and Statuses of all the lots linked to this Parent Lot would be updated. However, to
update only a single lot, one would just enter the Lot no. In this case, a Change
Disposition would apply only to the specific Lot.

In pre-R12 release, Quality Lab would default from the profile option GMD: Default
Lab Organization. This is now to be selected from the list of values on the Samples
form. Only Inventory organizations that have Organization Type specified as Quality
in the Process Quality Parameters form can be selected here. (It maybe possible to use
Forms Personalisation to default the Quality Lab in this field.)

The functionality behind the Quality Lab field has not changed. The Quality Lab
specified here would default on every Test on the specification for the sample, implying
that the Test has to be done in the specified Lab.

Responsibility: Quality Manager: Navigation: Samples > Item Samples

SampleQuantityTransactionType

Thesamplequantitydeductionoutofinventoryisnowaseedednewtransactiontype
DeductSampleQuantityinsteadofaMiscellaneousadjustment.Thisprovidesbetter
traceability.

Thistransactiontypeissetupin:OracleInventory>Setup>Transactions>
SourceType=Inventory>

ThisTransactiontypehasconfigurableoptionsfor:

MaterialStatuscontroltoenable material status control for this transaction type.

Inactivation

SQL>selectSTATUS_CONTROL_FLAG
fromMTL_TRANSACTION_TYPES
whereTRANSACTION_TYPE_NAMElike'DeductSampleQty';

STATUS_CONTROL_FLAG
------------------- ---------------
1

Theshortagealertsandnotificationsarenotenabledforthistransactiontypeastheyare
essentiallyvalidonlyforReceipttransactions.
IftheTransactionTypeDeductSampleQuantityissetupwithStatusControl,thenit
ispossibletoallowordisallowthistransactionforcertainMaterialstatuses.Itisalso
possibletospecifywhethermaterialwiththisStatusisATPable,Nettableand
Reservable.

ThisisdoneviaInventory>Setup>Transactions>MaterialStatusform.

On this form, one can indicate whether this status is used at the subinventory, locator, lot,
or serial level. For example, if subinventory is selected, then the system allows you to
assign the material status at the subinventory level.

In case all the three Material Usage flags - Subinventory, Locator and Lot - are different
for items held in stock, then the Allowed Transactions will follow the Material Status
defined for the combination, and in case of a conflict, the overriding hierarchy will be
Lot, then Locator and then Subinventory.

Onepossiblescenarioinusingthisfeaturemaybetodisallowthesamplequantityfrom
beingsubtractedfromcustomershipmentsthathaveaconfirmedshipquantitybyhaving
theDeductSampleQtytransactiondisallowed.

The Material Status for on-hand inventory can be changed on the Material Workbench as
follows: Inventory > On-Hand Availability > On-Hand Quantity query up the Item >
Tools > Status Update.
Acostcanalsobeassociatedtothesamplequantitytransactionbysettingupacost
accountontheProcessQualityParameterswindow.Ifrequired,onceassigned,this
AccountfieldcanbemadenonupdateableusingFormsPersonalization.

Responsibility:QualityManager
Nav:Setup>ProcessQualityParameters.

LotGenealogy

The Lot Genealogy now points to Oracle Inventory. This is accessible from both the
Quality Manager (Nav: Inquiries > Lot Genealogy) and the Inventory Super User
(Nav: Inventory > On-Hand, Availability > Lots) responsibilities. However, with the
Quality Manager responsibility, one cannot access the On-Hand and the Transactions
from the Item Lots screen, these are accessible only from the Inventory Super User
responsibility.

Lot genealogy for sample records that refer to a particular lot, warehouse, and location
can be traced to other organizations, subinventories, locators, and lots. Even though
through the Warehouse Management (WMS) functions a Lot can be processed as lot split,
lot merge, and lot translate, through Lot Geneology one can view the OPM Quality
Samples that are listed for it.

The Lot Genealogy has a screen for Quality Collectionwhich is now used to display
Quality Collection Plan and its results for process items that have had an inspection
requirement, as a part of the Enhanced Receiving Inspection functionality in R12.

LotExpiryandRetestWorkflows

The OPM Lot Expiry and Lot Retest workflow is now initiated from Oracle Inventory
via a concurrent program Lot Serial Date notification. The previous triggers on the
OPM Inventory table have been replaced by this concurrant request that checks whether
lots have reached their Expiration or Retest dates. This concurrant program can be set to
run periodically to raise a business event for Lot Expiry or Retest that subsequently sends
a workflow notification to take an Inventory sample against the lot in question.
Responsibility: Manfacturing Distribution Manager (Process Ops)
Nav: Inventory >Requests

TheDateContextfieldisleftblanktofindallattributes.
DateType=EXPIRATION_DATE

The OPM Lot Expiry and Lot Retest workflow is invoked by running the above
concurrent program if the Inventory organization is process enabled and the Item is
process quality enabled.

Note: There also needs to be at least one specification and an inventory validity rule
defined without revision for the Item, otherwise the workflow will not be initiated. This is
because revision control is for an Item and not a Lot and currently this concurrant request
does not have the ability to run for a specific revision.

Grades,ActionCodes,ReasonCodes

Navigation: OracleInventory>Setup>Grades / Action Codes /

Thesetupofqualitygrades,actioncodes,andreasoncodesisnowmovedtoOracle
Inventory,althoughtheQualityManagercanstillaccesstheGradesandActions
windowsfromthemenu.ThefunctionalityforusingthesefieldshasnotchangedinR12.

AdefaultgradeforanitemcanbedefinedinOracleInventory,andspecificationsfora
gradecandriveanupdatetolotgradethroughafinalsampledisposition.

Thegradefieldisnowexpandedto150charactersfrom8charactersinallqualitytables.
Actioncodesareusedfornotificationoflotexpirationactionsandforevaluationof
qualityresults.

HoldreasonsinOPMarenowobsolete,thoughreasoncodescanstilldefineedto
furtherclassifyinventorytransactions.

REFERENCES

1. R12 TOI OPM Quality Functional Overview: Common Inventory for OPM
Quality
2. R12 Field Readiness Workshop OPM Quality: Elaine Wan, Rajesh Kulkarni