This chapter covers the following topics:
Instruction sets are a convenient method to group or categorize instructions. Instruction sets are reusable and the instruction text 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.
Standard Operating Procedures (SOPs)
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.
You can use instructions and instruction sets to attach SOPs to a recipe, 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 instructions. Individual 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.
Additional Instruction Attributes and Attachments
While following SOPs, you can also capture data related to the SOPs, such as the temperature, humidity, start and end times, and so on. You might also want to attach a file, such as an in-process image of the batch. While you can always attach a file, URL, short text, long text, or comments to any instruction, you must create either clearance or process instruction attributes to capture specific types of data while completing an instruction.
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:
Recipe
Item in a formula
Operation, activity in an operation, or resource in an operation
Operation, activity, resource, or item in a recipe
Additional Information: 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
Capture attributes and attachments while completing instructions
Secure e-signature approvals for instructions
Support different types of instructions
Associate tasks and Standard Operating Procedures (SOPs) to instructions
Support instruction at the recipe, process operation, activity, resource, and material level
Copy instructions from other entities
Group instructions into reusable instruction sets
Related Topics
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.
You create or access an instruction set from the reference entity. Possible reference entities include:
Recipe
Operation
Routing
Activity
Resource
Formula
Dispense
Reverse Dispense
Prerequisites
Create SOPs.
Create reference entities such as resources, activities, operations, routings, formula recipe and dispensing setup.
To search for existing instruction sets
Navigate to the Instruction Set window.
Select an instruction set.
Select Add Existing.
Search for an existing instruction set records and select a record.
Save your work.
To create an instruction set
Navigate to the Instruction Set window.
Select Create.
Enter a name for the Instruction Set. Required.
Select an Instruction Type.
Clearance
Dispense Clearance
Dispense
Reverse Dispense
Process
Note: You can only select:
Clearance when creating an instruction set for a recipe.
Dispense Clearance when creating an instruction set for a dispense area.
Dispense or Reverse Dispense when creating an instruction set for a dispensing setup.
Enter a Description for the instruction set.
Select 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.
Select Go.
Enter a Description for the instruction set.
Select Apply to save your work.
Click Add Attachments to attach an electronic document to the instruction set. The Add Attachment window displays.
Related Topics
Adding Instructions to an Instruction Set
When creating instructions, you have the option to include custom attributes in the instructions. Examples of custom attributes include:
Recording the room temperature and humidity while dispensing ingredients.
Noting the previous batch executed.
Date of instruction completion.
Before including an attribute in an instruction, you must create the attribute.
Prerequisites
To search for a process instruction attribute
Navigate to the Process Instruction Attributes page.
Click Go.
The entire list of attributes appears, alphabetically.
In the Attribute Name field, enter a full or partial value.
Click Go.
A partial list of attributes, each beginning with the value entered, appears.
To create a process instruction attribute
Navigate to the Process Instruction Attributes page.
Click Create.
In the Create Process Instruction Attribute page, enter values in the following fields:
Code: Enter a unique code.
Name: Enter a name for the attribute.
Description: Enter a description of the attribute.
Type: Select the type of attribute from the following list:
Date
List Value: If you select List Value, the Lookup code field appears. Search for and select the lookup code which represents the list of values to use with this attribute.
Numeric: If you select Numeric, the Min Value and Max Value fields appear. Enter the minimum and maximum values permitted for this attribute.
Text
Click Apply.
Optionally, click Apply and Create Another to create another process instruction attribute.
To update a process instruction attribute
You can update an process instruction attribute's Description at any time, but you can only update an attribute's Name and Type fields before adding an attribute to an instruction.
After searching for and finding a process instruction attribute, click Update.
In the Update Process Instruction Attribute page, update the Name, Description, and Type fields.
Click Apply.
To delete a process instruction attribute
You can only delete a process instruction attribute before the attribute is added to an instruction.
After searching for and finding a process instruction attribute, click Delete.
Create instructions, identify the tasks, and add standard operating procedures (SOPs) to the instructions using the Instructions window. You can create instructions for:
Operation, activity, and resource
Routing
Formula
Recipe
Item
Tip: Create instructions at the operation level for the most flexibility.
Prerequisites
Create reference entities such as resources, activities, operations, routings, formula recipe and dispensing setup.
Create Instructions on the Instruction Create window.
Determine the structure for the instruction.
To view the list of instructions
Navigate to the Instructions window.
Select Instructions to see the existing records.
To create instructions
Navigate to the Create Instruction page by clicking the instruction set name link in the Instruction Set page.
Enter a unique value for Instruction Number.
Enter Instruction Text description.
Select a value for the Acknowledgement your choices are:
Optional indicates the acknowledgement is optional for this instruction.
Mandatory - Able to Proceed indicates 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 indicates the acknowledgement is mandatory for this instruction. You cannot proceed to the next instruction without acknowledging the current instruction.
Enter values in the follow fields:
Task: for example, Dispense
Task Attribute
Task Label, for example, Dispense
Additional Information: Task fields do not appear when defining instructions for an instruction set with a Clearance instruction type.
Select More to add the related standard operating procedures.
In the Signers tab, specify the Number of Signatures required for validating this instruction and the Role of the signer.
Click Add another row to specify the number of signatures.
Note: A role can be a user name or a responsibility. When a responsibility is used, specify the number of signers who must sign the transaction. When a user name is used, then the number of signers is not valid.
Optionally, add instruction attributes. Select the Additional Attributes tab.
Click Add Another Row: Additional Attributes.
In the Attribute Sequence field, enter an attribute sequence number.
In the Attribute Name field, search for and select an instruction attribute.
Click Apply or click Apply and Create Another to save the changes and proceed to create another instruction.
Related Topics
Creating Instruction Attributes
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.
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.
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.
In the Signers tab, update the number of signers and the role for validating this instruction.
In the Additional Attributes tab, update attribute sequences, add more attributes, or delete attributes from the instruction.
Click Apply.
Use the Update function in the Instruction Set window to modify instruction text, descriptions, and attachments to instructions.
Prerequisites
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.
Related Topics
Follow these procedures to add an instruction set and instructions to a recipe or an operation used in a production batch.
To add an instruction set and instructions to a recipe
Navigate to the Recipe Details window.
From the Process Engineer responsibility, select Recipes.
Search for and select a recipe.
From the Actions menu, select Process Instructions.
The Instruction Set: Recipe Name page opens.
To create instructions for an existing instruction set, go to step 5. Otherwise, create a new instruction set.
To create a new instruction set for a recipe
On the Instruction Set: Recipe Namepage, click Create.
On the Create Instruction Set page, enter values for the following fields:
Instruction Set: Enter the name of the set.
Instruction Type: Accept the default value, Dispense Clearance.
SOP: (Optional) Select the More link to select a standard operating procedure.
Description: (Optional) Enter a description of the instruction set.
Click Apply.
The Instruction Set: Recipe Name page now displays the new instruction set for the recipe.
A confirmation message appears: "Instruction Set created successfully."
To create instructions for a recipe's instruction set
On the Instruction Set: Recipe Name page, click the instruction set name link to create instructions for the set.
On the Instructions page, click Create.
Optional Action: Alternatively, to add an existing instruction to the instruction set, click Add Existing.
On the Create Instructions page, enter values for the following fields:
Instruction Num: Enter a unique value. Instructions are listed in numerical order.
Instruction Text: Provide instruction details.
Acknowledgement: Select one of the following values:
Optional: Indicates that the acknowledgement is optional for this instruction.
Mandatory - Able to Proceed: Indicates that 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: Indicates that the acknowledgement is mandatory for this instruction. You cannot proceed to the next instruction without acknowledging the current instruction.
SOP: (Optional) Select the More link to select a standard operating procedure.
To require signatures for the instructions (optional)
On the Signers tab, click Add Another Row: Signatures.
Specify the number of signatures required for validating this instruction and the role of the signer.
Note: A role can be a user name or a responsibility. When a responsibility is used, specify the number of signers who must sign the transaction. When a user name is used, then the number of signers is not valid.
To add instruction attributes (optional)
On the Additional Attributes tab, click Add Another Row: Additional Attributes.
In the Attribute Sequence field, enter an attribute sequence number.
In the Attribute field, search for and select an instruction attribute.
To finish creating instructions
Click Apply and Create Another to save the changes and proceed to create another instruction or click Apply once you are finished creating instructions.
On the Instructions: Instruction Set page, click the Return to Instruction Set: Recipe Name link.
Click Return to return to the Recipe Details window.
To add an instruction set and instruction to an operation
Navigate to the Process Operation Details:Activities window in the Process Engineer responsibility.
Query the desired Operation.
Select 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 an Instruction Type:
Process: Used for production-related tasks that occur after release of the operation step.
Clearance: Used for clearance checklist items, such as dispensing or production area cleanliness, calibrations, and ambient conditions, that occur before release of the operation step.
You can create only one instruction set of each instruction type per operation.
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 by clicking the instruction set name link.
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. If you acknowledge the instruction, then sign electronically if the instruction requires an e-signature.
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.
Note: Task fields do not appear when defining instructions for an instruction set with a Clearance instruction type.
Search and select a Task Attribute.
Enter a task Label.
Select the Signers tab to configure signers for approval:
Click Add Another Row in the Signers region.
Conditional Action: You can only add additional signers for the Acknowledgement types Mandatory and Manadatory: Able to Proceed.
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.
Select the Additional Attributes tab to add instruction attributes:
Click Add Another Row: Additional Attributes.
In the Attribute Seq field, enter an attribute sequence number.
In the Attribute field, search for and select an instruction attribute.
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.
Related Topics