Manufacturing Execution System for Process Manufacturing

Manufacturing Execution System for Process Manufacturing
ORACLE DATA SHEET
ORACLE MANUFACTURING
EXECUTION SYSTEM FOR
PROCESS MANUFACTURING
KEY FEATURES
Oracle® Manufacturing Execution System (MES) for Process
ORACLE MES FOR PROCESS
INCLUDES:
Manufacturing is an add-on application to Oracle Process
• Instruction-driven, operator-
Manufacturing that provides intensive, multifaceted shop floor
friendly user interface
• Dispensing
• Touch Screen based
interfaces
• Dispense Supervisor
Dashboard
• Electronic Batch Records for
21 CFR Part 11 Compliance
• Nonconformance
Management
execution capabilities. The application allows process manufacturers
to deploy Oracle Process Manufacturing directly on their shop floors
as the manufacturing execution system (MES) as well as use Touch
Screen based devices. For most process manufacturers, this removes
the requirement to invest in a third party or a homegrown MES
system, and helps reduce costs while eliminating integration and
• Labeling
support. MES for Process manufacturing eliminates many
• Device Integration
unnecessary and non-value-added activities by providing a structured
and standards-based shop floor execution toolset.
MES for Process Manufacturing is designed for use in process
industry plants that are looking to move to electronic batch
recordkeeping or for those that previously may have opted to
purchase a third-party MES. It offers the advantage of providing true
enterprise-wide information from the shop floor to the boardroom.
Major Features
Process-Driven Operator Workbench
The process in process manufacturing is as important as the material inputs and
outputs. The work orders or batch records are detailed, step-by-step guides, which
lead production operators through the process of making a product. The process may
vary from approvals, signatures, sequential processing of steps, specific data entry for
material, resources and Quality.
Oracle MES for Process Manufacturing puts all of the information that production
schedulers, supervisors and operators need at their fingertips. You can create
individual or unit instructions, which can be ordered into reusable procedures with an
option of attaching Standard operating procedures, documents or images.
Processing instructions may also have predefined actionable tasks that require
electronic signoff for completion. Supervisors and schedulers have access to realtime production batch status, down to the level of instruction completion status so
they know precisely what has been done and what remains to be done for any
production batches for which they have responsibility.
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ORACLE DATA SHEET
Dispensing
The management of the ingredient dispensing (also known as preweigh) process to
control the measurement, containerization and labeling of precise quantities of
specific materials to the right batch steps prior to, or during the manufacturing
process is a key requirement in many process industries, including pharmaceutical,
biotechnology, food and beverage and chemical manufacturing. This 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 211.101.
The production batch process requires the right materials to be dispensed to
production batch steps with specific quality parameters and in right quantities
running into decimals. This calls for accuracy and hence standard weigh-scale
integration has been provided to minimize the risk of data entry error.
Oracle MES for Process Manufacturing Dispensing provides dispensing operators
with on-line access to up-to-date SOPs, detailed, acknowledgeable work instructions
and electronic signatures, which provides a configurable level of control and
auditability of the completion of the dispensing process in accordance with current
good manufacturing practices as well as label printing.
The Dispensing activity is carried out in Dispensing booths with controlled
environments. Also material to and from the Dispensing booth are stored in identified
areas. Oracle MES for Process Manufacturing provides support for identifying
Dispensing Areas as well as booths within areas. You can also define storage
locations and maintain environmental specifications for the Dispensing booth / area.
Touch Screen interfaces
To have a visibility of Production information, the data needs to be captured at the
point of execution. In some cases it may not be possible to have a keyboard or
pointing devices on the shopfloor. A touch screen monitor would be of tremendous
help to the operator to enter data right at the point of activity. Also it would be easy
for an operator with secondary protective gear to enter data using a touch screen.
To help such situations, Oracle MES for Process Manufacturing has introduced
Touch screen based user interfaces. Hence companies can now deploy touch screen
devices on the shopfloor without the hassle of having pointing devices, mouse etc.
All Production Operator related activities like Material Transactions, Resource
Transactions, Process Parameters, Dispensing and Reverse Dispensing have been
incorporated into the touch screen interfaces thereby enabling the operator to perform
the transactions.
Dispense Planning
The Dispensing Supervisor needs to plan and schedule the dispensing activities based
on a set of parameters and priorities. The parameters for the planning would be the
dispensing booth where the dispensing is to be performed, the resource, the capacity
of the resource as well as the booth and priority of the activity.
A graphical dashboard helps the Dispensing supervisor to view the load vs capacity
and help him plan his activity. The Supervisor can use the Dispense Planning to
either do a mass update of several dispensing activities or an individual update.
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Nonconformance Management
Even in controlled production environments, unexpected events can happen that
impact the manufacturing process and the quality of final product. Nonconformances
that arise need to be tracked and recorded for recording in the batch record and to be
used for analysis by the Quality Department for CAPA (Corrective Action,
Preventive Action) analysis. This may also require recording the information onto
the control batch record, along with appropriate details of the event, the phase of the
batch, level of criticality as well as follow-up and signatures by the operator(s) and/or
supervisors.
Oracle MES for Process Manufacturing tracks all manufacturing nonconformances
caused by such things as batch material quantity changes, item substitutions, resource
substitutions, as well as any ad-hoc operator observations, such as a power
interruption. Notification of nonconformance’s are automatically routed
electronically to those who need to review and approve, including electronic
signature information.
Electronic Master and Control Batch Record
Most manufacturing industries keep detailed paper records of their manufacturing
records and some industries such as pharmaceutical and food and beverage
manufacturers are mandated to do so by federal regulations (per FDA Code of
Federal Regulations Title 21 Part 211.186 / 211.188). Oracle MES for Process
Manufacturing provides comprehensive electronic Master Batch Record (MBR) and
Control Batch Record (CBR) documents, which contain all of the critical batch
information from the product recipe (compiled in the MBR) and each product batch
(compiled in the CBR). You can even have the batch records automatically translated
into other languages.
Labeling and Device Integration
Labeling - Labels are used to mark contents of containers in process industries.
They are created and read, often via barcode readers for events including dispensing,
in-process sampling and when intermediate and finished products are output from
production batches.
The application can be configured to print labels automatically based on a trigger
from a business event, or label printing can be manually initiated. The reprint event
and print count indicate the number of times each label was printed. Label content is
also configurable. You may configure electronic signatures to control who has
authority to print labels.
Device Integration - Integrate shop floor equipment such as manufacturing
equipment and weigh scales in the preweigh and dispensing process with the
manufacturing execution system. This improves the speed and efficiency with which
actual data is captured during the manufacturing process, increases the amount of
data that you can capture, and removes the risk of operator data entry errors.
Oracle MES for Process Manufacturing provides the capability to capture data
directly from shop floor devices in the dispensing business flow and during batch
processing for in-process equipment data capture.
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Operator Certification
It is important that qualified and certified personnel only perform certain operations
in the production floor especially if it is a critical operation. Added to this is the
regulatory angle of FDA 21 CFR Part 211.25 which prescribes that only certified
operators need to perform the specified operations.
The Oracle MES for Process Manufacturing enables the corporation to identify the
required skills and training needs, as well as certification approvals, for an Operator
to perform production activities. You can define which operations or transaction
needs what level of certification and/or competency. Once set, all transactions would
validate if the operator does meet the set certification and competency levels.
Operator certification is seamlessly integrated with Oracle HRMS for all needs
related to skills definition, training needs and certification.
Oracle MES for Process Manufacturing Key Benefits
•
Board Room to Shop Floor Visibility –Why use disparate MES systems and
integrate each one to your ERP backbone? With Oracle, you have one source of
truth, data model, technology and system to validate.
•
Process Repeatability – This is key in validated systems. Consider the potential
for error involved in assembling a paper batch record for every production order
or batch. A fully electronic system that is validated assembles the correct
components 100 percent of the time.
•
Enforce Best Practice SOPs – Build controls into the system. For example,
make sure you have collected samples and test results were acceptable, before
completing a production batch. Oracle enforces these controls systematically,
rather than having to rely on procedural controls.
•
Reduce Labor – Consider dispensing: in a paper system, you need double
signoff. The weighing operator signs for their manual weight entries, and
another person signs that they checked the entries. With a validated electronic
system, the manual entry signature is just not needed. It’s a new paradigm in the
electronic world.
•
Eliminate Massive Amounts of Paper – Benefits are obvious when you consider
that a batch record may be 200 or more pages, and has to be saved for seven
years after product obsolescence in most pharmaceutical industries.
•
Advanced Search - Information on paper is static and standalone. Analysis to
find trends across a multitude of paper records is tedious, time consuming and
complex. Enterprise systems that run on advanced relational database
management systems excel at searching data records for the purpose of finding
trends and patterns across large numbers of records.
•
Eliminate Errors – Eliminate duplicate entry of production data. Put the data
entry in the hands of the product operators with easy to use interfaces. Achieve a
single point of data entry.
•
Lower Training Costs – The application drives the behavior of the operator,
eliminating the need to rely on manual procedures.
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ORACLE DATA SHEET
KEY BENEFITS
• Board room to shop floor
visibility
• Process repeatability
• Enforce best practice
SOPs
• Reduce labor - remove a
level of approvals
• Eliminate massive
amounts of paper
• Advanced search
capability
Oracle E-Business Suite—The Complete Solution
Oracle E-Business Suite enables companies to efficiently manage customer
processes, manufacture products, ship orders, collect payments, and more—all from
applications that are built on unified information architecture. This information
architecture provides a single definition of your customers, suppliers, employees, and
products—all important aspects of your business. Whether you implement one
module or the entire Suite, Oracle E-Business Suite enables you to share unified
• Eliminate errors
information across the enterprise so you can make smarter decisions with better
• Lower training costs
information.
• Lower cost of compliance
• Better usability
RELATED PRODUCTS
Oracle Manufacturing
Execution System for
Process Manufacturing is
designed to work together
with the following products:
• Oracle Process
Manufacturing Extensions
for Endeca
• Oracle Advanced
Planning and Scheduling
• Oracle E-Records
• Oracle Inventory
• Oracle Process
Manufacturing Process
Execution
• Oracle Process
Manufacturing Product
Development
• Oracle Process
Manufacturing Quality
• Oracle MSCA
Contact Us
For more information about Oracle Manufacturing Execution System for Process
Manufacturing, please visit oracle.com or call +1.800.ORACLE1 to speak to an
Oracle representative.
RELATED SERVICES
The following services are
available from Oracle Support
Services:
• Oracle E-Business Suite
Accelerators
• Oracle Application
Solution Centers
• Oracle University
• Oracle Consulting
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