Skip Headers

Oracle Process Manufacturing Regulatory Management User's Guide
Release 12.1
Part Number E13693-04
Go to Table of Contents
Contents
Go to previous page
Previous
Go to next page
Next

Defining Regulatory Item Information

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.

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.

This chapter covers the following topics:

Defining Prerequisites

Define the following in OPM Regulatory Management Setup before defining items:

Finding Regulatory Item Information

Use the Item Information window to view details for products and ingredients in OPM Regulatory Management.

To find regulatory item information details:

  1. Navigate to the Find Regulatory Item Information Details window.

  2. Query the existing item to view.

  3. Select the item to view:

  4. Click Regulatory Item Detail. The Regulatory Information window is displayed with the Item Information navigator active.

Viewing Regulatory General Item Information for Existing Items

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.

To view general information for existing items:

  1. Navigate to the Find Regulatory Items window.

  2. Perform one of the following:

  3. Select the item to view or edit general information for.

  4. 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.

  5. Click General Item Information to complete, view, or edit this information.

  6. View the Primary CAS (Chemical Abstracts Service Chemical Registry System) Number. The American Chemical Society's Chemical Abstract Service assigns CAS numbers.

  7. View the Regulatory Item Creator. Defaults to the name of the user who created the item.

  8. Item is the revision number of the item to reflect that changes have been made.

  9. 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.

  10. 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:

    1. Regulatory validity rule for the specific organization

    2. Regulatory validity rule with no organization specified

    3. Production validity rule for the specific organization

    4. Production validity rule with no organization specified

  11. Select the brackets ([ ]) to enter descriptive flexfield information.

  12. Save the window.

To open an item:

  1. Select Open Item from the Actions menu. The Find Regulatory Items window displays.

  2. Select the required item.

  3. Click Regulatory Item Detail.

  4. View the details on the Regulatory Information window.

To close an item:

Choose Close Item from the Actions menu.

To copy an item:

choose Copy Item from the Actions menu.

To paste an item:

Choose Paste Item from the Actions menu.

To expand the item node:

Choose Expand from the Actions menu.

To expand all the information on the item node:

Choose Expand All from the Actions menu.

To collapse the item node:

Choose Collapse from the Actions menu.

To collapse all the information on the item node:

Choose Collapse All from the Actions menu.

Viewing Exploded Components

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

To view the exploded components:

  1. Navigate to the Exploded Components window.

  2. The following fields display:

Viewing Master Item Associations

Use the Master Item Associations window to view the inventory item links to master regulatory items. You can view on master item associations.

To find master item associations:

  1. Navigate to the Find Master Item Associations window.

  2. Enter the following criteria to search for an item master association:

To enter master item associations:

  1. Navigate to the Master Item Associations window.

  2. 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.

  3. 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.

  4. 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.

  5. Select the brackets ([ ]) to enter descriptive flexfield information. This descriptive flexfield lets you add your own information to the master regulatory item.

  6. Perform one of the following:

  7. Select Item Descriptions from the Actions menu.

  8. Enter a valid Language. Enter every language that you are creating documents for. Required.

  9. Enter an item Description in the language selected in the Language field. Required.

  10. Select the brackets ([ ]) to enter descriptive flexfield information. This descriptive flexfield lets you add your own information to the master regulatory item.

  11. Click OK.

  12. Save the window

    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.