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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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Understanding MES for Process Manufacturing

This chapter covers the following topics:

About Oracle MES for Process Manufacturing

Oracle Process Manufacturing closes the gap between conventional Enterprise Resource Planning (ERP) and Manufacturing Execution Systems (MES) for process manufacturers with MES for Process Manufacturing. Batch execution is simplified by paperless record keeping and support for dispensing and pre-weigh operations. Devices are integrated to the manufacturing process. Nonconformances are captured during process execution.

Oracle MES for Process Manufacturing adds additional capabilities to Oracle E-Business Suite applications so that costs, data replication, and risk of error are reduced. Data accuracy, process repeatability, and information visibility are improved by managing all information in a single, real-time database.

MES for Process Manufacturing is designed for use in many process industry plants, especially those looking to move to electronic batch record keeping and those that previously opted to purchase a third-party MES. MES for Process Manufacturing offers the advantage of providing true, enterprise-wide information from the shop floor to the boardroom.

Standard Operating Procedures

Managing Standard Operating Procedures (SOPs) ensures access to the current versions of procedures, thereby reducing the risk of nonstandard manufacturing and quality practices.

The instruction setup lets you:

Operator Workbench

The Operator Workbench lets you:

Dispensing

Dispensing the proper materials to batches prior to the manufacturing process is a key activity in pharmaceutical, chemical, and food and beverage process industries. The Production process during the manufacture of products in these process industries requires allocation of the right materials with specific quality parameters and precise quantities. Accuracy of these quantities is critical. To enable this, the dispensing functionality is integrated with weigh scale devices.

Dispensing is usually performed in dedicated locations such as environmentally controlled clean rooms that must be maintained in strict accordance with documented procedures.

Proper labeling of containers that hold dispensed material is also a critical requirement for the positive identification of material and all its related production components.

Device Integration

Device readings are captured directly from the manufacturing equipment during the dispensing process from weighing devices such as scales and balances and as process parameters during batch production.

Device reading capabilities include:

Nonconformance Tracking

Nonconformance is defined as the difference between the observed conditions and acceptance criteria as stated within an approved protocol such as a master batch record, or if the testing performed deviates from the approved procedure.

Features provided for nonconformance tracking are:

Label Printing

MES for Process Manufacturing offers the following label printing features:

Master Batch Record

The Master Batch Record (MBR) is the approved and documented set of instructions for manufacturing a specific product, in a specific plant, using specific resources, during a specified date range, to produce a specific batch size. The required elements of MBR are described in the United States Food and Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21 Part 211.186. The recipe created in Oracle Process Manufacturing Product Development application includes material requirements, equipment and resource requirements, instructions, sampling requirements, and notes related to batch manufacturing processing. This recipe is the template that is used repeatedly to manufacture a consistent product.

The three recipe types that can be built in the Oracle Process Manufacturing Product Development application are:

Control Batch Record

The Control Batch Record (CBR) document records all events in the life cycle of a production batch order.

Oracle Manufacturing Execution System (MES) for Process Manufacturing offers the abilities to:

Streamlined Electronic Signatures

During the production process, completed tasks are verified on the shop floor using electronic signatures. Oracle E-Records offers a paperless signing process for capturing the requisite electronic signatures on specific events, such as dispensing, reverse dispensing, controlling the progression of business processes and a specific quality result, or creation and modification of key setup data.

Transactions under consideration for approval are listed on the e-signature window. Event signoff status displays on the CBR, and includes the individual who signed, date, time (and time zone), and the reason for signing. Initialing is used to confirm signer identity by entry of an approved user name and password.

The initialing process does not replace the requirement for full signatures on more complex events that require review of information spanning several application windows. Examples of events that require the full signature process include recipe approval, production, batch record closing, and sample results disposition.

Streamlined electronic signatures provide:

Tasks and Responsibilities

Following is a representative work breakdown structure for managing a manufacturing execution system for process manufacturing within the enterprise. It lists many of the key tasks and the job titles usually responsible for these tasks:

Tasks Responsibilities
Setting Up Oracle Manufacturing Execution System (MES) for Process Manufacturing
  • MES for Process Manufacturing Administrator

  • Dispensing Supervisor

Creation and Maintenance of Instructions
  • Process Engineer

  • Formulator

  • Production Supervisor

  • MES for Process Manufacturing Administrator

Using the Operator Workbench
  • Production Operator (OPM Process Execution)

  • Production Supervisor

  • Process Shop Floor Operator

  • MES for Process Manufacturing Administrator

Dispensing
  • Dispensing Operator

  • MES for Process Manufacturing Administrator

Viewing the Master Batch Record
  • Production Operator

  • Production Supervisor

  • MES for Process Manufacturing Administrator

  • Formulator

  • Process Engineer

  • Production Auditor or Regulatory Manager

Viewing the Control Batch Record
  • Dispensing Operator

  • Production Supervisor

  • MES for Process Manufacturing Administrator

  • Production Auditor or Regulatory Manager

Process Flow

The Oracle Manufacturing Execution System (MES) for Process Manufacturing process flow documents the batch life cycle. The business process permits a product designer to define processing instructions and associate them to an operation, routing, or recipe. By defining individual attributes of these entities and associating them to tasks, the operator can use processing instructions at runtime to act on the instruction and enter data against it based on its definition. The overall process is controlled by e-signatures that are captured and become part of a permanent record in the Evidence Store.

  1. Define formula, routing, operations, activities and select resources in the Oracle Process Manufacturing (OPM) Product Development application.

    Define the instruction sets and instructions.

  2. Design a recipe.

    Create recipe and define process instructions.

  3. Create recipe validity rules and review the master batch record.

  4. Set up dispensing.

    Define dispensable items, dispensing rules, and instructions for the dispensable items.

  5. Schedule and release batches.

    Reserve the material.

    Schedule the shop floor.

    Release the batch.

  6. Dispense material.

    Preweigh designated ingredients.

    Dispense material and print labels.

  7. Execute batch steps.

    Lock steps using the Operator Workbench.

    Follow instructions and perform tasks to manage batch operations.

  8. Manage quality.

    Take samples for testing.

    Print quality sample labels.

    Log nonconformances.

  9. Monitor the batch progress.

    Use the interactive batch progression inquiry and report.

    Print product labels.

  10. Complete the batch.

    Complete the tasks.

    Resolve and sign off on nonconformances.

  11. Validate the control batch record.

    Optionally, print the batch record for reference.

  12. Close the batch.

Oracle Process Manufacturing (OPM) Product Development is the design source for assembling recipes, formulas, routings, operations, and activities. OPM Process Execution is the production application used to process recipes into batches. Oracle Quality provides the structure for nonconformance tracking. Oracle Warehouse Management System (WMS) provides label printing and device integration infrastructure. Oracle MES for Process Manufacturing uses Oracle XML Publisher to generate its reports and formatted electronic records.

Interface to Other Applications

Oracle Manufacturing Execution System (MES) for Process Manufacturing interfaces with other product applications in the Oracle E-Business Suite to accomplish proper and complete functioning of some of its features. Following are examples of application interfaces:

Oracle Process Manufacturing Process Execution for:

Oracle Process Manufacturing Product Development for:

Oracle E-Records for:

Oracle Quality for tracking nonconformances

Oracle Warehouse Management System for:

Oracle XML Publisher for printing reports and electronic records in a human-readable format