Welcome to Release 12.1 of the Oracle Manufacturing Execution System for Process Manufacturing User's Guide.
This guide assumes that you have working knowledge of your business area’s processes, tools, principles, and customary practices. It also assumes that you are familiar with Oracle Process Manufacturing. If you have never used Oracle Process Manufacturing, we suggest you attend one or more of the Oracle Process Manufacturing training classes available through Oracle University.
See Related Information Sources for more Oracle E-Business Suite product information.
To reach Oracle Support Services, use a telecommunications relay service (TRS) to call Oracle Support at 1.800.223.1711. An Oracle Support Services engineer will handle technical issues and provide customer support according to the Oracle service request process. Information about TRS is available at http://www.fcc.gov/cgb/consumerfacts/trs.html, and a list of phone numbers is available at http://www.fcc.gov/cgb/dro/trsphonebk.html.
Our goal is to make Oracle products, services, and supporting documentation accessible to all users, including users that are disabled. To that end, our documentation includes features that make information available to users of assistive technology. This documentation is available in HTML format, and contains markup to facilitate access by the disabled community. Accessibility standards will continue to evolve over time, and Oracle is actively engaged with other market-leading technology vendors to address technical obstacles so that our documentation can be accessible to all of our customers. For more information, visit the Oracle Accessibility Program Web site at http://www.oracle.com/accessibility/.
Screen readers may not always correctly read the code examples in this document. The conventions for writing code require that closing braces should appear on an otherwise empty line; however, some screen readers may not always read a line of text that consists solely of a bracket or brace.
This documentation may contain links to Web sites of other companies or organizations that Oracle does not own or control. Oracle neither evaluates nor makes any representations regarding the accessibility of these Web sites.
This topic discusses the setup tasks required for Oracle MES for Process Manufacturing.
Instruction sets are a convenient method to group or categorize instructions. Instruction sets are reusable. Instructions are the text that becomes part of the batch record. Standard Operating Procedures (SOPs) are documents, images, or other files containing information that give detailed instructions on a specific step such as setting up a blender or other plant equipment, and cleaning of equipment. You access a link to an SOP from an individual instruction. An SOP link can be a URL, a document, or another file stored in the Oracle Applications attachments repository. Individual instructions can reference one or more SOPs.
The Operator Workbench guides you through a set of predefined instructions created to complete operations required for a production batch.
Dispensing the right materials to the right batches prior to the manufacturing process is a key activity in life sciences and other process industries. The process is critical when working with potent active pharmaceutical ingredients (APIs) in drug manufacturing. Decimal errors in API calculation can be life threatening. Companies preweigh materials to avoid these errors and to assure rapid delivery at the critical stages of the drug formulation process.
OPM MES Dispensing lets you deliver material in several modes of operation with full label printing capabilities. Functionality supported includes:
Unexpected events that adversely affect the manufacturing process and quality of the finished product can occur in any controlled production environment. These nonconformances must be tracked in the Control Batch Record (CBR). Quality departments analyze nonconformances as part of for their Corrective Action and Preventive Action initiatives (CAPA). To document the complete manufacturing batch record, evidence of nonconformances must be included in the CBR. Oracle Manufacturing Execution System (MES) for Process Manufacturing helps you manage nonconformance in the batch manufacturing process.
Labels are used to mark contents of containers. They are used to mark raw materials, products, and samples, namely material labels, product labels, and sample labels, respectively. Retain copies of labels affixed to containers and archive them as a part of the batch record.
Oracle Manufacturing Execution System (MES) for Process Manufacturing provides comprehensive electronic Master Batch Record (MBR) and Control Batch Record (CBR) documents that contain critical batch information from the product recipe and each production batch respectively.
The batch validator functionality lets you validate the correctness of data during a batch progression. You can close the batch only if there are no pending instructions.
Oracle Manufacturing Execution System (MES) for Process Manufacturing supports the acquisition of electronic signatures on electronic records. Electronic documentation replaces paper with a seamless interface of business activities that improves manufacturing throughput and enhances the overall quality of operations in the supply chain. The following provides information for events that are e-record and e-signature enabled in the Oracle Manufacturing Execution System (MES) for Process Manufacturing application. A brief discussion of each event is provided.
Oracle Alert User's Guide
This guide explains how to define periodic and event alerts to monitor the status of your Oracle Applications data.
Oracle E-Business Suite Concepts
This book is intended for all those planning to deploy Oracle E-Business Suite Release 12, or contemplating significant changes to a configuration. After describing the Oracle Applications architecture and technology stack, it focuses on strategic topics, giving a broad outline of the actions needed to achieve a particular goal, plus the installation and configuration choices that may be available.
Oracle E-Business Suite Flexfields Guide
This guide provides flexfields planning, setup, and reference information for the Oracle Applications implementation team, as well as for users responsible for the ongoing maintenance of Oracle Applications product data. This guide also provides information on creating custom reports on flexfields data.
Oracle Application Framework Personalization Guide
This guide covers the design-time and run-time aspects of personalizing applications built with Oracle Application Framework.
Oracle E-Business Suite Installation Guide: Using Rapid Install
This book is intended for use by anyone who is responsible for installing or upgrading Oracle Applications. It provides instructions for running Rapid Install either to carry out a fresh installation of Oracle Applications Release 12, or as part of an upgrade from Release 11i to Release 12. The book also describes the steps needed to install the technology stack components only, for the special situations where this is applicable.
Oracle Application Server Adapter for Oracle Applications User's Guide
This guide covers the use of OracleAS Adapter in developing integrations between Oracle applications and trading partners.
Oracle E-Business Suite System Administrator's Guide Documentation Set
This documentation set provides planning and reference information for the Oracle Applications System Administrator. Oracle E-Business Suite System Administrator's Guide - Configuration contains information on system configuration steps, including defining concurrent programs and managers, enabling Oracle Applications Manager features, and setting up printers and online help. Oracle E-Business Suite System Administrator's Guide - Maintenance provides information for frequent tasks such as monitoring your system with Oracle Applications Manager, managing concurrent managers and reports, using diagnostic utilities, managing profile options, and using alerts. Oracle E-Business Suite System Administrator's Guide - Security describes User Management, data security, function security, auditing, and security configurations.
Oracle E-Business Suite User's Guide
This guide explains how to navigate, enter data, query, and run reports using the user interface (UI) of Oracle Applications. This guide also includes information on setting user profiles, as well as running and reviewing concurrent requests.
Oracle e-Commerce Gateway User's Guide
This guide describes the functionality of Oracle e-Commerce Gateway and the necessary setup steps in order for Oracle Applications to conduct business with trading partners through Electronic Data Interchange (EDI). It also contains how to run extract programs for outbound transactions, import programs for inbound transactions, and the relevant reports.
Oracle e-Commerce Gateway Implementation Guide
This guide describes implementation details, highlights additional setups for trading partner, code conversion, and Oracle Applications as well as provides the architecture guidelines for transaction interface files. This guide also contains troubleshooting information and how to customize EDI transactions.
Oracle Report Manager User's Guide
Oracle Report Manager is an online report distribution system that provides a secure and centralized location to produce and manage point-in-time reports. Oracle Report Manager users can be either report producers or report consumers. Use this guide for information on setting up and using Oracle Report Manager.
Oracle iSetup User Guide
This guide describes how to use Oracle iSetup to migrate data between different instances of the Oracle E-Business Suite and generate reports. It also includes configuration information, instance mapping, and seeded templates used for data migration.
Oracle Workflow Administrator's Guide
This guide explains how to complete the setup steps necessary for any product that includes workflow-enabled processes. It also describes how to manage workflow processes and business events using Oracle Applications Manager, how to monitor the progress of runtime workflow processes, and how to administer notifications sent to workflow users.
Oracle Workflow Developer's Guide
This guide explains how to define new workflow business processes and customize existing Oracle Applications-embedded workflow processes. It also describes how to define and customize business events and event subscriptions.
Oracle Workflow User's Guide
This guide describes how users can view and respond to workflow notifications and monitor the progress of their workflow processes.
Oracle Workflow API Reference
This guide describes the APIs provided for developers and administrators to access Oracle Workflow.
Oracle XML Gateway User's Guide
This guide describes Oracle XML Gateway functionality and each component of the Oracle XML Gateway architecture, including Message Designer, Oracle XML Gateway Setup, Execution Engine, Message Queues, and Oracle Transport Agent. The integrations with Oracle Workflow Business Event System and the Business-to-Business transactions are also addressed in this guide.
Oracle XML Publisher Report Designer's Guide
Oracle XML Publisher is a template-based reporting solution that merges XML data with templates in RTF or PDF format to produce a variety of outputs to meet a variety of business needs. Using Microsoft Word or Adobe Acrobat as the design tool, you can create pixel-perfect reports from the Oracle E-Business Suite. Use this guide to design your report layouts.
Oracle XML Publisher Administration and Developer's Guide
Oracle XML Publisher is a template-based reporting solution that merges XML data with templates in RTF or PDF format to produce a variety of outputs to meet a variety of business needs. Outputs include: PDF, HTML, Excel, RTF, and eText (for EDI and EFT transactions). Oracle XML Publisher can be used to generate reports based on existing E-Business Suite report data, or you can use Oracle XML Publisher's data extraction engine to build your own queries. Oracle XML Publisher also provides a robust set of APIs to manage delivery of your reports via e-mail, fax, secure FTP, printer, WebDav, and more. This guide describes how to set up and administer Oracle XML Publisher as well as how to use the Application Programming Interface to build custom solutions.
Guides Related to This Product
Oracle Process Manufacturing Cost Management User’s Guide
The Oracle Process Manufacturing Cost Management application is used by cost accountants to capture and review the manufacturing costs incurred in their process manufacturing businesses. The guide describes how to set up and use this application.
Oracle Process Manufacturing Process Execution User’s Guide
The Oracle Process Manufacturing Process Execution application lets you track firm planned orders and production batches from incoming materials through finished goods. Seamlessly integrated to the Product Development application, Process Execution lets you convert firm planned orders to single or multiple production batches, allocate ingredients, record actual ingredient usage, and then complete and close production batches. Production inquiries and preformatted reports help you optimize inventory costs while maintaining a high level of customer satisfaction with on-time delivery of high quality products. The Oracle Process Manufacturing Process Execution User’s Guide presents overviews of the tasks and responsibilities for the Production Supervisor and the Production Operator. It provides prerequisite setup in other applications, and details the windows, features, and functionality of the application.
Oracle Process Manufacturing Product Development User’s Guide
The Oracle Process Manufacturing Product Development application provides features to manage formula, routing, recipe, and validity rule development within process manufacturing operations. Use it to manage multiple laboratory organizations and support varying product lines throughout the enterprise. Characterize and simulate the technical properties of ingredients and their effects on formula performance and cost. Simulate and optimize formulations before beginning expensive laboratory test batches. Product Development coordinates each development function to provide a rapid, enterprise-wide implementation of new products in your plants. The guide describes how to set up and use this application.
Oracle Process Manufacturing Quality Management User’s Guide
The Oracle Process Manufacturing Quality Management application provides features to test material sampled from inventory, production, or receipts from external suppliers. The application lets you enter specifications and control their use throughout the enterprise. Customized workflows and electronic record keeping automate plans for sampling, testing, and result processing. Compare specifications to assist in regrading items, and match customer specifications. Aggregate test results and print statistical assessments on quality certificates. Run stability testing with unrivaled ease. Several preformatted reports and inquiries help manage quality testing and reporting. The guide describes how to set up and use this application.
Oracle Process Manufacturing System Administration User’s Guide
This guide provides information on the few tasks that are specific to Oracle Process Manufacturing. It offers information on performing Oracle Process Manufacturing file purge and archive, and maintaining such things as responsibilities, units of measure, and organizations.
Regulatory Management User's Guide
Oracle Process Manufacturing Regulatory Management provides solutions for document management that help meet the FDA 21 CFR Part 11 and other international regulatory compliance requirements. Regulatory information management is facilitated by use of electronic signatures. Manage hazard communications by collaborating with Oracle partners to dispatch safety documents, attached printed documentation sets such as the MSDS to shipments, and set up workflows to manage documentation revisions, approvals, and transmittals. The Oracle Process Manufacturing Regulatory Management User's Guide provides the information to set up and use the application.
Oracle Engineering User’s Guide
This guide enables your engineers to utilize the features of Oracle Engineering to quickly introduce and manage new designs into production. Specifically, this guide details how to quickly and accurately define the resources, materials and processes necessary to implement changes in product design.
Oracle Inventory User’s Guide
This guide describes how to define items and item information, perform receiving and inventory transactions, maintain cost control, plan items, perform cycle counting and physical inventories, and set up Oracle Inventory.
Oracle Bills of Material User’s Guide
This guide describes how to create various bills of material to maximize efficiency, improve quality and lower cost for the most sophisticated manufacturing environments. By detailing integrated product structures and processes, flexible product and process definition, and configuration management, this guide enables you to manage product details within and across multiple manufacturing sites.
Oracle Work in Process User’s Guide
This guide describes how Oracle Work in Process provides a complete production management system. Specifically this guide describes how discrete, repetitive, assemble–to–order, project, flow, and mixed manufacturing environments are supported.
Oracle Quality User’s Guide
This guide describes how Oracle Quality can be used to meet your quality data collection and analysis needs. This guide also explains how Oracle Quality interfaces with other Oracle Manufacturing applications to provide a closed loop quality control system.
Oracle Shipping Execution User’s Guide
This guide describes how to set up Oracle Shipping to process and plan your trips, stops and deliveries, ship confirmation, query shipments, determine freight cost and charges to meet your business needs.
Oracle Purchasing User’s Guide
This guide describes how to create and approve purchasing documents, including requisitions, different types of purchase orders, quotations, RFQs, and receipts. This guide also describes how to manage your supply base through agreements, sourcing rules and approved supplier lists. In addition, this guide explains how you can automatically create purchasing documents based on business rules through integration with Oracle Workflow technology, which automates many of the key procurement processes.
Oracle interMedia User's Guide and Reference
This user guide and reference provides information about Oracle interMedia. This product enables Oracle9i to store, manage, and retrieve geographic location information, images, audio, video, or other heterogeneous media data in an integrated fashion with other enterprise information. Oracle Trading Community Architecture Data Quality Management uses interMedia indexes to facilitate search and matching.
Oracle Self–Service Web Applications Implementation Guide
This manual contains detailed information about the overview and architecture and setup of Oracle Self–Service Web Applications. It also contains an overview of and procedures for using the Web Applications Dictionary.
Installation and System Administration
Maintaining Oracle E-Business Suite Documentation Set
Use this guide to help you run the various AD utilities, such as AutoUpgrade, AutoPatch, AD Administration, AD Controller, AD Relink, License Manager, and others. This guide also provides information on maintaining the Oracle applications file system and database.
Oracle Applications User Interface Standards for Forms-Based Products
This guide contains the user interface (UI) standards followed by the Oracle Applications development staff. It describes the UI for the Oracle Applications products and how to apply this UI to the design of an application built by using Oracle Forms.
Oracle eTechnical Reference Manuals
Each eTechnical Reference Manual (eTRM) contains database diagrams and a detailed description of database tables, forms, reports, and programs for a specific Oracle Applications product. This information helps you convert data from your existing applications, integrate Oracle Applications data with non-Oracle applications, and write custom reports for Oracle Applications products. Oracle eTRM is available on My Oracle Support..
The Oracle Integration Repository is a compilation of information about the service endpoints exposed by the Oracle E-Business Suite of applications. It provides a complete catalog of Oracle E-Business Suite's business service interfaces. The tool lets users easily discover and deploy the appropriate business service interface for integration with any system, application, or business partner.
The Oracle Integration Repository is shipped as part of the E-Business Suite. As your instance is patched, the repository is automatically updated with content appropriate for the precise revisions of interfaces in your environment.
Oracle STRONGLY RECOMMENDS that you never use SQL*Plus, Oracle Data Browser, database triggers, or any other tool to modify Oracle E-Business Suite data unless otherwise instructed.
Oracle provides powerful tools you can use to create, store, change, retrieve, and maintain information in an Oracle database. But if you use Oracle tools such as SQL*Plus to modify Oracle E-Business Suite data, you risk destroying the integrity of your data and you lose the ability to audit changes to your data.
Because Oracle E-Business Suite tables are interrelated, any change you make using an Oracle E-Business Suite form can update many tables at once. But when you modify Oracle E-Business Suite data using anything other than Oracle E-Business Suite, you may change a row in one table without making corresponding changes in related tables. If your tables get out of synchronization with each other, you risk retrieving erroneous information and you risk unpredictable results throughout Oracle E-Business Suite.
When you use Oracle E-Business Suite to modify your data, Oracle E-Business Suite automatically checks that your changes are valid. Oracle E-Business Suite also keeps track of who changes information. If you enter information into database tables using database tools, you may store invalid information. You also lose the ability to track who has changed your information because SQL*Plus and other database tools do not keep a record of changes.