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Oracle Manufacturing Execution System for Process Manufacturing User's Guide
Release 12.1
Part Number E13690-04
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Preface

Intended Audience

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.

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Accessibility of Code Examples in Documentation

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Accessibility of Links to External Web Sites in Documentation

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Structure

1  Understanding MES for Process Manufacturing
2  Setting Up

This topic discusses the setup tasks required for Oracle MES for Process Manufacturing.


3  Instruction Sets and Instructions

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.


4  Operator Workbench

The Operator Workbench guides you through a set of predefined instructions created to complete operations required for a production batch.


5  Dispensing

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:


6  Device Integration
7  Nonconformance Tracking

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.


8  Label Printing

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.


9  Batch Records

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.


10  Batch Validation

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.


11  Using the Touch Screen User Interface
12  Setting Up and Using Dispense Area and Dispensing Booths
13  Setting Up and Using Touch Screen Operator Workbench
14  Using the Dispense Supervisor Workbench
15  Setting Up and Using Operator Certification
A  MES for Process Manufacturing Navigation Paths
B  Oracle E-Record Events in Oracle MES for Process Manufacturing

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.


Glossary

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