This chapter covers the following topics:
OPM Regulatory Management Items lets you manage the items that you report hazard information for based on your particular reporting requirements. You can assign hazard information to either products, ingredients, or both.
The Regulatory Information navigator lets you maintain hazard information for products and ingredients in OPM Regulatory Management. Products and ingredients use those that exist in the Oracle Inventory Item Master.
The Master Item Association window lets you define and maintain OPM Regulatory Management generic item names and their associated Oracle Inventory item names.
Copy existing items to create new items that are not already defined in OPM Regulatory Management or create new items. You can add, edit, delete, and report on items.
Note: Regulatory Item Information can be viewed from within formulas and recipes. Refer to the Oracle Process Manufacturing Product Development User’s Guide.
Define the following in OPM Regulatory Management Setup before defining items:
Define languages before defining field names.
See: Oracle E-Business Suite User's Guide
Define field name information, including field name class responsibilities, before defining items. Field name information determines the nodes displayed on the Regulatory Information navigator and who has access to those nodes.
Use the Item Information window to view details for products and ingredients in OPM Regulatory Management.
Navigate to the Find Regulatory Item Information Details window.
Query the existing item to view.
Select the item to view:
Click Regulatory Item Detail. The Regulatory Information window is displayed with the Item Information navigator active.
Use the Regulatory Information window to define and maintain item hazard information for products and ingredients in Regulatory Management. You can add, edit, delete, and report on items.
Note: Assign responsibilities to the GR_ITEM_GENERAL field name class to allow access to General Item Information on the Item Information navigator. Do not add or delete field names assigned to this field name class because this can cause unpredictable results on the Item Information navigator.
Navigate to the Find Regulatory Items window.
Perform one of the following:
Enter a full or partial item name and click Find. All items that match your criteria displays.
Enter a specific item name.
Select the item to view or edit general information for.
Click Regulatory Item Detail. The Regulatory Information window displays. The field names classes, field names, and properties that you set up display on the navigator. Only field name classes that are assigned to your field name class responsibility are visible. And only field names without explosions for the displayed product class are visible. Edit field name classes, field names, and properties in Setup. You cannot edit them on the navigator.
Click General Item Information to complete, view, or edit this information.
View the Primary CAS (Chemical Abstracts Service Chemical Registry System) Number. The American Chemical Society's Chemical Abstract Service assigns CAS numbers.
View the Regulatory Item Creator. Defaults to the name of the user who created the item.
Item is the revision number of the item to reflect that changes have been made.
Enter the Actual Hazard percentage of the item that is hazardous. The default is 100% when you select the Explode Ingredient check box to break the ingredient into its components. To calculate the percentage from OPM Regulatory Management or OPM Product Development, leave the actual hazard percentage at 100. This is available when the Ingredient check box is selected and the Explode Ingredients check box is cleared. It is unavailable when both Ingredient and Explode Ingredients are selected or both are cleared. Required.
Note: The ingredient is reduced based on this percentage for components that are not 100% hazardous.
Select to Explode Ingredient into its components. This field is clear if the ingredient is at its lowest level in the formula and is available when the ingredient check box is selected. A formula must exist in either the Formulator or Regulatory Management applications for any ingredient that you plan to explode. Default.
Formulas are exploded based on the recipes and validity rules associated with them. The components are exploded based on the existing active Regulatory or Product Development recipe and validity rules or both. Refer to the Oracle Process Manufacturing Product Development User's Guide for details. The validity rule precedence is:
Regulatory validity rule for the specific organization
Regulatory validity rule with no organization specified
Production validity rule for the specific organization
Production validity rule with no organization specified
Select the brackets ([ ]) to enter descriptive flexfield information.
Save the window.
Select Open Item from the Actions menu. The Find Regulatory Items window displays.
Select the required item.
Click Regulatory Item Detail.
View the details on the Regulatory Information window.
Choose Close Item from the Actions menu.
choose Copy Item from the Actions menu.
Choose Paste Item from the Actions menu.
Choose Expand from the Actions menu.
Choose Expand All from the Actions menu.
Choose Collapse from the Actions menu.
Choose Collapse All from the Actions menu.
Exploded components lets you explode items into components based on formulas, recipes, and validity rules. An item must already exist in OPM Regulatory Management before you can enter it as an ingredient item code.
Assign responsibilities to the GR_EXPLOSION field name class and Explosion form block to allow access to Exploded Components Information on the Item Information navigator. You can add field names to this field name class for tracking information. Do not add or delete field names assigned to this field class because it can cause unpredictable results on the Regulatory Information navigator.
Proper access to a formula is defined through Formula Security Profiles. Access to a formula can be defined as view only or view and update.
See: Oracle Process Manufacturing Product Development User's Guide
Navigate to the Exploded Components window.
The following fields display:
Ingredient Item Code is:
Disabled if the Formula Source Indicator on the General Item Information window is set to Formula. The formula is exploded in the respective OPM application and displays here.
Disabled if the Formula Source Indicator on the General Item Information window is set to No Formula. The item displays at 100%.
Percent is:
Disabled if the Formula Source indicator on the General Item Information window is set to Formula. The percentage for each ingredient in the formula is exploded in the respective OPM application and displayed here.
Disabled if the Formula Source indicator on the General Item Information window is set to No Formula. The item displays at 100%.
Refresh Formula Explosion is available if the Formula Source indicator on the General Item Information window is set to Formula. Click to update the display to reflect the most current item explosion information from the Formulator application.
Use the Master Item Associations window to view the inventory item links to master regulatory items. You can view on master item associations.
Navigate to the Find Master Item Associations window.
Enter the following criteria to search for an item master association:
Enter Regulatory Item to search for an item master association using the name of the item.
Enter Regulatory Item Description to search for an item master association using the description of the item.
Enter Inventory Item to search for an item master association using the associated inventory item.
Enter Inventory Item Description to search for an item master association using the associated inventory item description.
Navigate to the Master Item Associations window.
Select the Master Regulatory Item that identifies the item defined in Regulatory. Required. You can only select existing Regulatory Management Items on the Master Item Associations window. Define items in Regulatory Information on the General Item Information window. The Description for the master regulatory item displays.
Enter the inventory Item from the Inventory Management Item Master that you want to associate with the master regulatory item. Required. The Description of the inventory item displays.
Select Use Regulatory Item Description to display the master regulatory item description for the selected item. Clear to display the inventory item description that you enter for the selected item.
Select the brackets ([ ]) to enter descriptive flexfield information. This descriptive flexfield lets you add your own information to the master regulatory item.
Perform one of the following:
If Use Regulatory Item Description is selected, then go to step 7.
If Use Regulatory Item Description is cleared, then go to step 4.
Select Item Descriptions from the Actions menu.
Enter a valid Language. Enter every language that you are creating documents for. Required.
Enter an item Description in the language selected in the Language field. Required.
Select the brackets ([ ]) to enter descriptive flexfield information. This descriptive flexfield lets you add your own information to the master regulatory item.
Click OK.
You can use Attachments with this window. Refer to the Oracle E-Business Suite User's Guide for detailed information on using attachments and folders.