This chapter covers the following topics:
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.
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:
Associate SOPs to a group of instructions, or use them at the unit instruction level
Specify operator acknowledgement for an instruction
Specify signatures for an instruction
Associate a batch action to an instruction
Navigate actions using instructions
Copy instructions from an existing group
Define various instruction types for an entity such as process, dispensing, reverse dispensing
The Operator Workbench lets you:
Identify tasks based on a specified set of search criteria
Identify batch status at the instruction level
Lock a task to complete instructions and associated tasks at the operation, activity, and resource level
View instructions interactively
Acknowledge instructions
Navigate to tasks and related actions that use the instructions
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 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:
Synchronous device responses
Resource-to-device mapping
Device selection capabilities
Multiple device interface support using RS232C, USB, RS485 and other common protocols
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:
Nonconformance capture
Unique identifier for nonconformance
Classification and disposition of nonconformance
Corrective actions and preventive actions (CAPA)
Availability of nonconformance records in the Control Batch Record (CBR)
MES for Process Manufacturing offers the following label printing features:
Automatic label printing with reprint capabilities
Configurable label content using XML
E-signature control
Label printing history
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:
Master recipes to define how a product is made in a specific process manufacturing cell.
Site recipes to define how a specific site makes the product, or some portion of the product. A site recipe has the same structure as a general recipe, but may be modified for the local language and unit of measure. It may also be modified to take into account local material availability, or it may only define a part of the general recipe that is actually performed on the site.
General recipes to define in an equipment-independent manner, the material and process dependencies required to make a product. The general recipe is usually created during or after the pilot plant scaleup of a research and development recipe.
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:
Control the printing of the MBR and CBR with e-signature control
Monitor production status
Modify the format and content of the MBR and CBR
Monitor external events
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:
Streamlined navigation flow to complete signatures
Support for custom approvers and flexible signature rules
Optionally, use the Oracle Approval Management Engine (AME) to specify users, responsibilities, and the number and hierarchy of signers.
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 |
|
| Creation and Maintenance of Instructions |
|
| Using the Operator Workbench |
|
| Dispensing |
|
| Viewing the Master Batch Record |
|
| Viewing the Control Batch Record |
|
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.
Define formula, routing, operations, activities and select resources in the Oracle Process Manufacturing (OPM) Product Development application.
Define the instruction sets and instructions.
Design a recipe.
Create recipe and define process instructions.
Create recipe validity rules and review the master batch record.
Set up dispensing.
Define dispensable items, dispensing rules, and instructions for the dispensable items.
Schedule and release batches.
Reserve the material.
Schedule the shop floor.
Release the batch.
Dispense material.
Preweigh designated ingredients.
Dispense material and print labels.
Execute batch steps.
Lock steps using the Operator Workbench.
Follow instructions and perform tasks to manage batch operations.
Manage quality.
Take samples for testing.
Print quality sample labels.
Log nonconformances.
Monitor the batch progress.
Use the interactive batch progression inquiry and report.
Print product labels.
Complete the batch.
Complete the tasks.
Resolve and sign off on nonconformances.
Validate the control batch record.
Optionally, print the batch record for reference.
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.
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:
Defining e-record events to generate the Control Batch Record (CBR)
Triggering nonconformance tracking
Acknowledging the instructions
Material consumption using dispensing
Oracle Process Manufacturing Product Development for:
Viewing Master Batch Record (MBR)
Defining instructions
Oracle E-Records for:
Retrieving XML with e-signature from the E-Records Evidence Store for batch records
Accepting signers at run time for instructions
Accepting signers for dispensing setup
Accepting signers for CBR
Dispensing and reverse dispensing material
Printing labels
Setting the signing rules
Oracle Quality for tracking nonconformances
Oracle Warehouse Management System for:
Integrating devices
Printing labels
Oracle XML Publisher for printing reports and electronic records in a human-readable format