Introduction

The Dispensing functionality is essentially pre-weighing ingredients before they are

issued for consumption in a Batch. This functionality is available from the new moduleMES Process Operations.
The main areas in this module are
Operator Workbench
Dispensing / Pre-Weigh
Electronic Master and Control Batch Record
Nonconformance Management
LabellingDevice Integration
This note provides an overview and some functional highlights of the Dispensing
function in R12, as well as, the basic setup and process needed for Dispensing.
Functional Overview
The Dispensing function (also known as pre-weigh) in the MES Process Operation
module is a key requirement in many process industries, including pharmaceutical,
biotechnology, food and beverage and chemical manufacturing. This function controls the
measurement, containerization and labeling of precise quantities of specific materials to
the right batch steps prior to, or during the manufacturing process. All the stages are
tracked, including, material identification from the point of issue in Inventory to the point
of delivery in the Batch manufacturing process. This tracking is especially critical when
working with the active pharmaceutical ingredients (APIs) in a drug product formulation
(per FDA Code of Federal Regulations Title 21 Part 211.10) with pigments when
formulating paints and when working with materials that may become explosive or
otherwise hazardous when not blended in precise ratios in chemical processing.
The production batch process for such materials requires the right materials to be
dispensed to production batch steps with specific quality parameters and in right
quantities to ensure safe manufacturing process and a consistent quality product. Since
the formulation quantities may run into decimals, the accuracy of the quantities is critical.
Thus, standard weigh-scale integration has been provided to minimize the risk of data
entry error. Oracle MES for Process Manufacturing also provides configurable container
and dispensed material holding cage label printing, which may be automatic or userinitiated and includes details such as ingredient, lot no., qty, batch no. and the step in
the batch operation - for full traceability throughout the manufacturing process.
A user friendly Workbench is available for Dispensing Operators to query and view the
list of materials weighed in Dispensing. During the Dispensing process, the system gives
online access to Standard Operating Procedures (SOPs), detailed acknowledgeable work
instructions and simplified E-signatures processes.
Salient Features

The following modes of Dispensing are supported Full Container, Source Container and
Target Container however, customers can limit the modes that they want to be able to
use. In the Full Container mode, the entire container of material is used in the Batch. This
Dispensing process involves re-weighing the container to make sure that the net weight is
what is required, the container is labelled and sent to the shopfloor. The Source Container
mode involves taking some material out of the original container and then weighing and
labelling the original container for usage in a Batch. In the Target Container mode,
material is taken out from the original container and placed in a Target Container which is
then weighed, labelled and then consumed on the shopfloor. In some industries, there
maybe regulations against using material which is not in its original container, thus
prohibiting this Dispensing mode which may then be disallowed in the Dispensing.
Dispensing can be done not only for ingredients used in a Batch, but also for materials
issued for a process, for example, filters maybe dispensed for filtration process in a
Biotech environment.
Once Dispensing has been done, the dispensed material cant be used in any other batch,
it has to be used in the particular Batch or Operation it was dispensed for. Thus, checks
are put in the system so that once an ingredient in a Recipe is defined for Dispensing,
there is a check to ensure that there is a Dispensing record associated with that ingredient
before it allows it to be consumed in the Batch. When a Batch is cancelled, ingredients
dispensed for it can be used in another batch provided regulation permit. To do this, the
batch must be reversed dispensed and the ingredients re-dispensed for the other batch.
Dispensing does not create an Inventory transaction and happens at the same
subinventory that the ingredients are being consumed from in a Batch. The Dipensing
operation does not decrement Inventory although a Dispense record is associated for that
quantity. The inventory is decremented only when the material is consumed in the Batch.
Currently, the Dispensing functionality does not support Dispense Areas comprising of
Dispense booths having their own subinventory where ingredients would be moved from
the Stores to the Dispense area/ booth for Dispensing and then to the shopfloor. This is
earmarked for furure releases. Also, Dispensing currently supports only pre-weighing a
single ingredient. Although, mixing two or more ingredients and then dispensing them
out in a formulation, maybe presently modelled as a Phantom in the main batch, this is a
future enhancement known as Pre-Mix Dispensing. Some of the other future
enhancements in the Dispensing area are
Dispensing supervisor workbench
Reusable container management
The Batch Process Flow

The process flow for a Batch between the existing OPM Process Execution functionality
and the new Dispensing functionality can be depicted in the responsibilities of the
different Users as follows Process Engineer/Formulator - Creates and maintain recipes and advanced process

instructions.

Production Supervisor - Creates batches, Reserves materials, Release batches / steps

Modifies batch ingredients, steps, resources, Logs nonconformances, Prints product

labels, Completes and Closes batches / steps
Production Operator - Progresses batch steps, Performs process instructions, Records

actual material transactions, Records process parameter actual values, Creates quality
samples
Dispensing Operator - Performs dispensing tasks, Performs reverse dispensing

Dispense Example
In this Note, the setup and processing illustrating the Dispensing functionality is done for
Organization LA1 and thus all the setups are done in this organization. The Dispense
ingredient is Item 8804 (Stearic Acid) for Recipe 8301.

Setups Required for Dispensing

(1) Basic Setup of MES Operations
The concurrant program: "Enable MES for Process Manufacturing Functionality" needs
to be run once on an instance when the MES Process Operations product is first installed
to enable the MES Operations functionality integration with OPM Process Execution in
that instance.
This is a generic step needed to enable the MES Operations functionality and can be run
from the 'MES for Process Manufacturing Administrator' Responsibility.
Prior to running this concurrant prgram, the profile: GMO: MES for Process
Manufacturing is Enabled is set to No, this is changed to Yes once the concurranrt
program is successfully completed.

(2) Dispensing Setup

(i) Document Numbering Rules One can Search for existing rules, or, create new ones.
Resp: 'MES for Process Manufacturing Administrator> Setup> Document Numbering> Create:
There are two types of Dispense transactions that
can be created Dispense and Dispense
Reversal.
The format for the unique numbers generated for
each Dispense transaction can be setup here.
The Format Example field displays the number
format as each attribute is populated in this setup
screen,

(ii) Dispensing Setup One can Search for

existing rules, or, create new ones.
Resp: 'MES for Process Manufacturing
Administrator> Setup> Dispensing Setup

One can Search for existing rules,

The Dispensing rules have
the following statuses:
Not In Use There are no
Active batches for these
rules and they can be
changed.
Past Dues These are no
longer effective and can be
useful in an Audit.
Used Indicate the rules
that are used in an Active
batch and cannot be
changed.

Or create new ones >

The Dispensing
rules can be
setup specific to
an Item, ItemOrg or for ItemOrg-Recipe
combination.
In the rule
hierarchy, a
more specific
rule takes
precedance over
higher level
rules.
The Dispense
UOM needs to
be convertible to
the formulation /
batch UOM.
The Dispense Required field would be Yes. However, this can be No when doing a
data load initially and be changed later on.
When dispensing, the system allows multiple partial dispenses below the lower tolerance,
but over-tolerance dispensing is not allowed.
The start-date needs to be specified to indicate when the rule becomes effective.
(iii) Setting up a Container Item
When performing Dispensing, a Source and Target Container needs to be selected. Thus,
at least one Container Item type needs to be setup in order to define a tare weight for the
container. Container management (e.g, container status- whether clean or not, reusable
etc.) is not available currently, but is earmarked for the future.

Container - checked.

Weight UOM = Igredient

dispensable UOM
Unit Weight = Tare Wt.
If there is a mismatch
between the Container
Item UOM and the UOM
in which the ingredient is
being Dispensed, then the
Container Item will not be
available for selection in
the Dispensing screen.
The Container item needs
to be assigned to the organization where dispensing would happen
On the Master Items form: Tools > Organization Assignment :

Container Item
DKPCONT1 is
assigned to
Orgn: LA1.

(iv) Defining a Device

It is necessary to define at least one Device so that Dispensing transaction can be
initiated. A Device should be created for every Scale equipment that is present.
Resp: MES for Process Manufacturing Administrator: Setup> Defining Devices

For Dispensing,
Device Type =
Scale.
The Subinventory
defined here is
where the
ingredients will be
consumed from.
An Output Method of API also needs to be specified for the Device for it to be used
for Dispensing.
Although the Device definition is a part of the Warehouse Management System (WMS), a
separate license is not needed to access this form. The WMS User Guide would have
further details on the other fields on this form.
(v) Assigning Device to Business Events
This Device needs to be associated with the following Business Event in the Dispensing
organization Process Dispensing Event. (The other Business Event used by the MES
Operations module is Process Parameter Event.This is used to capture process
parameters e.g, temp., pressure, r.p.m, etc.). These are the two events for which the
device integration has been enabled to capture actual values.
The Device has
to be Enabled,
Auto Invoked
and have the
Verification
Level Required
set to
subinventory

Production Supervisor Responsibility: Create, Reserve and Release Batch

(i) Create a Batch 54003 with the Dispense material that has Dispensing rules setup using
the Production Supervisor responsibility.

In the current
example Recipe
8301 has a dispensable ingredient 8804.

Note the Dispensable flag checked for the ingredient 8804. This checkbox is not
updateable and is based on the Dispensing rules setup.
(ii) Dispensing currently requires that a detailed reservation exists prior to Dispensing,
i.e., a Lot needs to be specified for the ingredient. Only the Production Supervisor
currently does this, in future releases, a new responsibility Dispense Supervisor
would be available for this.

Creating a detailed reservation for the ingredient lines could be done either individually
for each line via Reservations or for the entire batch via Auto Detail Batch which
reserves all the ingredient lines on the batch by assigning their qtys to lots.
On the Tool bar: Inventory > Auto Detail Batch

This Reserves all the

ingredient lines on the
Batch

(iii) Next, Release the Batch: Actions > Release

Since all the ingredient have Consumption Type as Automatic, they are all consumed
on the Batch except for the dispense material 8804 which needs to be dispensed before it
can be consumed.
If one clicks on the Transact check box on the Material Exceptions form to consume
this Dispendable ingredient, the following error is got Transactions cannot be created
as material has to be dispensed before creating transactions. Scrolling to the right on the
Material Exceptions form the Item 8804 is indicated to beDispensable and having
Pending Reservations.

Continue by clicking Proceed.

All the
items
except the
Item 8804
have been
consumed
on the
Batch.

The View Material Transactions screen (Tool bar: Inventory > View Material
Transactions) is as follows -

(iv) Next, Release the first few Steps on this Batch so that the Operators can work on
them.
On the Batch Detail form: Steps > Actions > Release Steps:

Steps 10, 20 and 30 have been released to the Shopfloor.

Dispensing Operator Responsibility: Dispense Material

(i) Dispensing Search >
The Dispensing function can be carried out from within the Dispensing Operator or the
MES for Process Manufacturing Administrator Responsibilities.
Resp: Dispensing Operator > Dispensing > Dispendable Material
This screen brings up the material that has to be dispensed.
Specify the Organization that Dispensing has to be done in and click [Go].

Once the organization

context has been enabled
various critera can be used
to Search for material to
be be Dispensed, e.g., by
Batch, Product etc.
The Status defaults to
Detail Level
Reservations as only
these ingredients can be
Dispensed.
The Dispense Area is the
subinventory where the
ingredients are being consumed.
The checkbox Show Partially Dispensed within Tolerance if unchecked (default setting)
would not list any Dispensable ingredients which has already been partially dispensed to
above its Lower Tolerance level. If checked, it would list out Dispensable ingredients that
are between the Upper and the Lower Tolerance levels.

(ii) Dispense >

Searching by the Batch No.: 54003, brings up the material to be dispensed.

Select the Dispense Item via the radio button and click on Dispense. This brings up the
Dispensing screen.

The Dispense Mode can

be Full Container, Target
Container or Source
Container as described
earlier.
The Source Device field is
needed for reading from a
Device automatically and
is not reqd. for manual
data entry,

Entering in the Source Container, populates the Container Tare wt. and the Gross wt. of
dispense material.

The full qty reqd. is

dispensed in this
example for simplicity.
In case of hazardous
goods, the Container
maybe sealed with a
Band that has a unique
code on it. This maybe
entered as the Security
Tag and printed on the
Dispense Label.
Labels maybeselected to
be printed as reqd.
A Pallet Label will
always default to be
printed the first time any
ingredient is Dispensed
for a Batch and has the Batch No.on it. All the subsequent materials that need to be
dispensed for that Batch would go on the Pallet
The Dispense Label goes on the Dispense material and has the Batch No., Operation No.
The Material Label is for the material that is not dispensed but is going back to the
Inventory Stores. Thus, is for a mode other than a Full Container mode and has the
new qty or weight on it.
[Apply] to Dispense the material.
(iii) Label Printing >
The next screen indicates the Labels that will be printed for the Dispense transaction
(these are the ones that were selected in the Dispense transaction). In this example, these
are: Dispense Pallet and Process Dispense Material.
The Label Printing can be ERES controlled to control their printing.
[Apply] to print the Labels.

(iv) Dispensing Confirmation >

This screen provides a confirmation of the Dispensing as follows
1.

Item 8804 Quantity: 149.68546 was dispensed. Dispense Number is DKP00004-TST.

2.

Label print request IDs 1053 and 1054 were submitted successfully.

The Label
Print request
Ids are output
files that are
available for
3rd party
labelling
software to
print labels.
This screen
also shows
that the
Pending
Dispense
Quantity for
Item 8804 is
now zero.
Production
Supervisor Responsibility: Transact Dispense Mtl. / Complete Batch
Now that the Item 8804 has been dispensed on the Batch 54003, this material can now be
transacted on this Batch and the Batch completed.
(i) Query up the Batch using Production Supervisor Responsibility >

This screen shows that Item 8804 has a Reserved Qty of: 330 LB.
This qty has now been dispensed to this batch and can be consumed in it.
(ii) [Transact Material] brings up the Material Transaction form indicating
that Item 8804 still has qty 330 LB yet to be transacted.

(iii) Checking the Transact check box and Transacting the Item 8804 consumes it in the
Batch 54003.

This Batch can now be Completed using the existing standard Process Execution
functionality.

REFERENCES

1. R12 Field Readiness Workshop Oracle MES Operations John Danese.

2. Functional TOIs for MES Operations.