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.
This chapter covers the following topics:
Following is a requirement that customers have for instructions and instruction sets:
Yes. SOPs play an important role in assuring quality and adherence to established procedures. It is essential that they are understood and followed by all roles in a manufacturing facility. Create instruction sets and attach SOPs to them to meet your compliance standards.
Simplify SOP Management
You can use instructions and instruction sets to attach SOPs to line items of a recipe or for dispensing operations. You can also attach SOPs to a batch during batch release. Display the SOP during reporting, and provide links to an individual SOP from both the batch and its process instructions. Individual process instructions can refer to one or more SOPs.
The instruction set is an electronic folder of common instructions. Use instruction sets to group or organize a series of instructions. For example, set up individual instruction sets for pulverizing, blending, mixing, washing, and cooking. These sets serve as containers to help organize groups of instructions with common themes, maintenance requirements, or associations to responsibilities in the work breakdown structure.
Instruction sets are the containers for instructions. Use instruction sets to organize, classify, or maintain a series of instructions.
Define an instruction set for any of the following:
Item in a formula
Operation, activity in an operation, or resource in an operation
Operation, activity, or resource in a routing
Operation, activity, resource, or item in a recipe
Note: Override instructions are defined at the lowest level in the hierarchy. The progression from lowest to highest is: item, operation, routing, and recipe. It is recommended that you define instructions at the Operation or Step Quantity level in the recipe. Instructions defined at these levels are automatically presented to the production operator in the Operator Workbench. Instructions defined at other levels, such as Activity, Resource, or Material are available in the Operator Workbench, but the production operator must search for them by selecting a specific entity.
Instructions are important components of the manufacturing process that provide details on specific steps. Instructions make processing steps easier to follow. They assure a documented, repeatable process to improve productivity, quality, and consistency throughout the manufacturing process.
Instruction setup streamlines the batch execution process by letting the manufacturing engineers associate viewable characteristics to an instruction. During batch execution, production operators can navigate to the tasks using a single keystroke.
Set up instructions to:
Drive process execution at the instruction level
Acknowledge and comment on instructions interactively at the operator level
Secure e-signature approvals for instructions
Support different types of instructions
Associate tasks and Standard Operating Procedures (SOPs) to instructions
Support instruction at the process operation, activity, resource, and material level
Copy instructions from other entities
Group instructions into reusable instruction sets
Create instruction sets and add standard operating procedures (SOPs) to them. Instruction sets are used to associate several instructions into a logical grouping that can be reused.
Add instructions to the newly created instruction set. Create new instructions or search for and add existing instructions.
Define an instruction set for any of the following:
Important: You create or access an instruction set from the reference entity. For example, from an operation or dispense setup. Other reference entities are routing, recipe, formula, activity, and resource.
Create SOPs.
Create reference entities such as operations, dispense setup, routings, recipes, formulas, activities, or resources.
To create an instruction set
Navigate to the Instruction Set window.
Click Create.
Enter a name for the Instruction Set. Required.
Select an Instruction Type.
Dispense
Reverse Dispense
Process
Enter a Description for the instruction set.
Click More for SOP to add the related SOPs, or click Add Attachments to add other attachment types.
Search for attachments by Title, Description, Category, Last Updated By, Last Update Date, Type, and Usage.
Click Go.
Enter a Description for the instruction set.
Click Apply to save.
Click Add Attachments to attach an electronic document to the instruction set. The Add Attachment window displays.
Create instructions, identify the tasks, and add standard operating procedures (SOPs) to the instructions using the Instructions window.
Create instructions for:
Operation, Activity, and Resource
Routing
Recipe
Item
Tip: Create instructions at the operation level for the most flexibility in using them.
Create reference entities such as operations, dispense setup, routings, recipes, formulas, activities, or resources.
Create Instructions on the Instruction Create window.
Determine the structure for the instruction.
To create instructions
Navigate to the Create Instruction window.
Enter the Instruction Number. Required.
Enter the Instruction Text. Required.
Select a value for the Acknowledgement:
Optional indicates the acknowledgement is optional for this instruction.
Mandatory - Able to Proceed- to indicate the acknowledgement is mandatory for this instruction. You can proceed to the next instruction and acknowledge it. However, you must return to this instruction to complete it prior to closing the batch or batch step.
Mandatory to indicate the acknowledgement is mandatory for this instruction. You cannot proceed to the next instruction without acknowledging the current instruction.
Note: Approver setup and configuration is supported only for mandatory instructions.
Enter a Task. For example, Dispense.
Enter a Task Attribute.
Enter a Task Label. For example, Dispense.
Click More to add the related SOP.
Click Add another row to specify the number of signatures.
Specify the Number of Signatures required for validating this instruction and the Role of the signer.
A role can be a user name or a responsibility. When a responsibility is used, then specify the number of signers who must sign the transaction. When a user name is used, then the number of signers is not valid.
Click Apply or click Apply and Create Another to save the changes and proceed to create another instruction.
Use the Add Instructions window to add instructions to an instruction set.
Create instruction sets.
Create instructions.
To add existing instructions
Navigate to the Add Instructions window.
Search for and select an instruction set that has instructions of the same instruction type.
Click Next.
Select instructions.
Click Next.
Enter instruction numbers.
Click Next.
Review selected instructions.
Click Finish.
Create new instructions or add existing instructions to the set.
Move selected instruction up or down the displayed order.
Note: When you copy instructions from an existing instruction set, there is no linkage back to the source instructions. Subsequent changes you make to the source instruction set do not impact instructions copied from this set.
Refer to "Reordering Instructions in an Instruction Set" for details.
Use the Reorder function to reorganize instructions.
Create instructions sets.
Create instructions
To reorder instructions in the instruction set
Navigate to the Instructions window.
View the newly added instructions.
Click Reorder.
Move selected instruction up or down the list.
Use the search capability in the Add Existing function to search for an existing instruction in an instruction set.
Create instruction sets
Create instructions.
To search for existing instructions
Navigate to the Instruction Set window.
Select an instruction set.
Click Add Existing.
Search for an existing instruction set.
If you change an instruction or its characteristics for an approved entity or its nodes, then it results in a version change.
Create instruction sets.
Create instructions.
To update instructions
Navigate to the Update Instructions window.
Modify the instruction text, acknowledge, task, task attribute, and the task label information.
Click SOP to add more SOPs to the instructions.
Update the number of signers and the role for validating this instruction.
Click Apply.
View the list of instructions from the Instructions window.
Create instruction sets.
Create instructions
To view the list of instructions
Navigate to the Instructions window.
Click Instructions.
Use the Update function in the Instruction Set window to modify instruction text, descriptions, and attachments to instructions.
Create instruction sets.
Create instructions.
To update the instruction set
Navigate to the Instructions Set window.
Click Update for the instruction set to update.
Modify the instruction text and description.
Modify Standard Operating Procedure (SOP) attachments.
Click Apply.
Navigate to the Instruction Set window to view the list of instruction sets.
Following is an example of how to add instructions to an operation used in a production batch.
Set up the Process Engineer responsibility in the Oracle Process Manufacturing Process Execution application.
Set up GMO profile options.
Grant GMO access to the Process Engineer.
Grant e-signature batch e-signature permission to the Process Engineer.
Enter Standard Operating Procedures (SOPs) that you search for and add as attachments.
To add an instruction to an operation
Navigate to the Process Operation Details:Activities window in the Process Engineer responsibility.
Query the desired Operation.
Choose Process Instructions from the Actions menu. The Instruction Set window displays for the selected operation.
If the desired instruction set is displayed, then click it and proceed to step 5. Otherwise, create the instruction set as follows:
Click Create.
Enter the Instruction Set name.
Select Process as Instruction Type. Default.
Click More next to SOP to search for and add an existing SOP.
Click Add New to add the SOP as an attachment.
Enter a Description for the instruction set.
Click Apply. The instruction set is added to the list, and the SOP is attached to the set.
Navigate to the Instructions window for the desired instruction set.
If the desired instruction is displayed, then click it and proceed to step 8. Otherwise, create the instruction as follows:
Click Create.
Enter Instruction Num as the instruction number. This number is entered automatically when you set up the application for automatic numbering.
Enter the Instruction Text
Select one of the following as Acknowledgement:
Optional for an instruction that is informational. Perform this instruction in any order, or skip it. If you do not acknowledge the instruction, then batch processing proceeds without interruption.
Mandatory for an instruction that must be acknowledged and signed electronically if it is configured to require an e-signature. If you do not acknowledge the instruction, then you cannot proceed to the next instruction. The application requires that all mandatory instructions are acknowledged before the batch step and the batch can be closed.
Mandatory: Able to Proceed for an instruction that must be acknowledged and signed electronically if it is configured to require an e-signature. You can temporarily bypass this instruction and proceed to other instructions, however, the application requires that these instructions are acknowledged before the batch step and the batch can be closed.
Search and select a Task.
Search and select a Task Attribute.
Enter a task Label.
Configure signers for approval:
Select Add Another Row in the Signers region.
Add signers using only one of these methods:
Number of Signatures as 1 and Role as user name.
Number of Signatures as 1 and Role as responsibility.
Number of Signatures as the total number of signers required and leave Role blank.
Number of Signatures as 1 and Role as either user name or responsibility. Enter the lowest ranking role first, followed by any additional roles in increasing rank within the organization.
Repeat from step 1 until all signers are added.
Click Apply.
Click Reorder to reposition instructions in the list:
Select the instruction.
Click the arrow in the Move Up column to move the instruction up the list.
Click the arrow in the Move Down column to move the instruction down the list.
Click Apply.
Return to the "Note: Navigate to HTML Applications..." message.
Click OK. The process instruction is added to the operation.