Introduction:

In R12, OPM Inventory as known in earlier releases, is no longer available for current transactions. Historical information can be viewed in OPM Inventory, but current balances reside in Oracle Inventory and transactions are executed in Oracle Inventory, also now known as Common Inventory.

The main feature of Common Inventory is the centralization of all inventory tracking.

One central item master becomes the source of item maintenance – creation and update – as well as the repository of all item attributes. New item attributes to control Process Manufacturing functionality have been added. Process Manufacturers may also take advantage of “organization-specific” items that enable changing the item definition by inventory organization.

This note assesses the impact of the replacement of OPM Inventory by Oracle Inventory on OPM Quality. Several concepts or terminology in OPM Quality have been changed or introduced because of Common Inventory and these are discussed below.

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

In 11i release, an OPM Organization marked with the organization type of Lab served both the Product Development and Quality areas. Now, designating a Quality Lab on the Process Quality Parameters window makes a further distinction.

In Release 12, a Quality laboratory is a Process Manufacturing-enabled inventory organization, where sample analysis takes place. It can have its own inventory, such as test kit items, and resources, like testers and instruments, so that costs can be tracked against it.

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

This way, one can differentiate between product formula or recipe development from inspection transactions and activities. Also, resources and costs can be tracked separately for the Product Development and Quality Inspection activities.

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

The Quality Lab flag is only visible on the above Quality Parameters form and this what allows that organisation for Quality testing. (The ‘Plant’ and ‘Lab’ indicators default from the Product Development Parameters screen and can’t be changed on this screen).

One can still create Specifications against any Organization, but when it comes to putting the Quality Lab on the Samples, the organization should be flagged as Quality Lab. The list of values on Quality Lab field on the Samples form will not have this Organization if this flag is not checked.

Further, Items need to be setup as Process Quality Enabled for them to be used in OPM Quality, e.g, on the Specifications, Samples screen etc. This is done on the Item Master screen in the ‘Process Manufacturing’ tab by checking the “Process Quality Enabled” flag.

Responsibility: Inventory Super User.Nav: Inventory > Items > Master Items.

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> select PROCESS_QUALITY_ENABLED_FLAG from MTL_SYSTEM_ITEMS where SEGMENT1 = '8301' and ORGANIZATION_ID = '7249'; PROCESS_QUALITY_ENABLED_FLAG -----------------------------------------------------Y

Item Revisions

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.

Revison control for an Item is defined on the Item Master under the ‘Inventory’ tab:

Parent Lot and Lot

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: Revison 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 revison, 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 an 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) On the Specification form the changes mainly are for the Item, which can be revision controlled. A Specification with different tests and targets for a particular item and revision can be created, so that on the Item Samples window, the item revision entered is

used to retrieve the proper specification and consume the sample quantity from the inventory balance of this item revision.

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

Sample Quantity Transaction Type

The sample quantity deduction out of inventory is now a seeded new transaction type – “Deduct Sample Quantity” – instead of a Miscellaneous adjustment. This provides better traceability.

This transaction type is setup in: Oracle Inventory > Setup > Transactions > Source Type = Inventory >

This Transaction type has configurable options for:

•Material Status control – to enable material status control for this transaction type.•Inactivation

SQL> select STATUS_CONTROL_FLAG from MTL_TRANSACTION_TYPES where TRANSACTION_TYPE_NAME like 'Deduct Sample Qty'; STATUS_CONTROL_FLAG ------------------- --------------- 1

The shortage alerts and notifications are not enabled for this transaction type as they are essentially valid only for Receipt transactions.

If the Transaction Type - Deduct Sample Quantity – is setup with ‘Status Control’, then it is possible to allow or disallow this transaction for certain Material statuses. It is also

possible to specify whether material with this Status is ATP-able, Nettable and Reservable.

This is done via – Inventory > Setup > Transactions > Material Status form.

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.

One possible scenario in using this feature maybe to disallow the sample quantity from being subtracted from customer shipments that have a confirmed ship quantity by having the ‘Deduct Sample Qty’ transaction disallowed.

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.

A cost can also be associated to the sample quantity transaction by setting up a cost account on the Process Quality Parameters window. If required, once assigned, this Account field can be made non-updateable using Forms Personalization.

Responsibility: Quality ManagerNav: Setup > Process Quality Parameters.

Lot Genealogy

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 Collection’which 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.

Lot Expiry and Retest Workflows

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

The ‘Date Context’ field is left blank to find all attributes.Date Type = 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, Action Codes, Reason Codes

Navigation: Oracle Inventory > Setup > Grades / Action Codes /

The setup of quality grades, action codes, and reason codes is now moved to Oracle Inventory, although the Quality Manager can still access the Grades and Actions windows from the menu. The functionality for using these fields has not changed in R12.

- A default grade for an item can be defined in Oracle Inventory, and specifications for a grade can drive an update to lot grade through a final sample disposition.

The grade field is now expanded to 150 characters from 8 characters in all quality tables.

- Action codes are used for notification of lot expiration actions and for evaluation of quality results.

- Hold reasons in OPM are now obsolete, though reason codes can still defineed to further classify inventory transactions.

REFERENCES

1. R12 TOI – OPM Quality Functional Overview: Common Inventory for OPM Quality

2. R12 Field Readiness Workshop – OPM Quality: Elaine Wan, Rajesh Kulkarni