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Oracle Process Manufacturing Regulatory Management User's Guide
Release 12.1
Part Number E13693-04
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Setting Up Regulatory Management

These topics explain setting up OPM Regulatory Management for reporting product hazard information based on your particular requirements. OPM Regulatory Management lets you manage information to describe qualities and hazards in all supported languages.

This chapter covers the following topics:

Defining Disclosure Code

Use the Disclosure Code Details window to define and maintain logical groupings for items with similar legislative or recipient reporting levels. You can then link these groupings to the appropriate recipients, items, or both. You can add, edit, delete, and report on disclosure codes.

  1. Navigate to the Disclosure Codes window.

  2. Enter the disclosure Code that identifies the ingredient exposure reporting levels. Required.

  3. Enter the Description for the disclosure code. Required.

  4. Save the window.

To find disclosure codes

  1. Navigate to the Find Disclosure Codes window.

  2. Enter the following criteria to narrow your search:

  3. Click Find to search or Click New to enter a new disclosure code.

Viewing Properties

Use the Properties window to view the property IDs and their associated types, descriptions, and values. You can then link these properties to the appropriate field names.

Properties assist in field name maintenance by letting you modify language translations, information, and values as necessary. A basic set of properties is seeded into Regulatory Management. You can view report on property IDs and information.

In addition, properties determine the data entry fields that display for each field name on the Regulatory Information navigator. Properties are assigned to field names before those properties display for the field names on the Regulatory Information navigator.

The following shows the flow of information on the Regulatory Information navigator:

Item Information

Prerequisite

Define languages before defining properties.

See: Oracle E-Business Suite User's Guide

To view properties:

  1. Navigate to the Properties window.

  2. Choose Find from the View menu.

  3. Select the property. The following fields display:

  4. Close the window.

Viewing Field Name Classes

Use the Field Name Classes window to view the logical groupings of field names that pertain to similar information. You can then link field name classes to the appropriate field names. A basic set of field name classes and field names are seeded into Regulatory Management.

In addition, field name classes and field name class responsibilities determine the primary categories of item information that display on the Item Information navigator. Field name classes are assigned their responsibilities before those field name classes display on the Regulatory Information navigator. All field names assigned to the field name classes that you have field name class responsibilities for, display under those field name classes on the Regulatory Information navigator.

Field Name class responsibilities provide security options for accessing information. You can omit field name classes from group or individual responsibilities to prevent sensitive information from being available to those responsibilities. You can also limit the access that group and individual responsibilities have to a specific field name class on the Regulatory Information navigator. Select the Create check box to create and update information that is linked to the field names within the specific field name class. If you select the Query check box, then you can only view information that is linked to the field names within the specific field name class.

The following shows the flow of information on the Regulatory Information navigator:

Item Information

Field Name Classes (primary node). For example, Physical Data.

Field Name (secondary node). For example, Boiling Range.

Properties (data entry window for secondary node). For example, Low Number, High Number, and Scale. Once properties are defined, you can then enter data, such as 200 - 215 Fahrenheit on the properties window.

Prerequisite

Define languages before defining field name classes.

See: Oracle E-Business Suite User's Guide

To view field name classes:

  1. Navigate to the Field Name Classes window.

  2. The following information displays:

  3. Click Responsibilities to access the Field Name Class Responsibilities window and view the responsibilities for the field name class.

  4. Responsibility is the name of the responsibility that has security access to the field name class. The field name class is then accessible to the person with this responsibility on the Regulatory Information navigator.

  5. Display Sequence is the sequence in which the field name class displays in, on the Regulatory Information navigator. For example, a field name class with a display sequence of 10 displays after one with a sequence of 5.

  6. Create is selected if the responsibility can query and write access to the field name class. You can then create and update information that is linked to the field names within the specific field name class on the Regulatory Information navigator. Default.

  7. Query is selected if the responsibility has query-only access to the field name class. You can then only view information that is linked to the field names within the specific field name class on the Regulatory Information navigator.

  8. Click OK.

Defining Field Names

Use the Field Names window to define and maintain the field names. The field names are a grouping of properties used to capture data against an item. Field names are organization specific.

A basic set of field names is seeded into Regulatory Management. You can add, edit, delete, and report on field names. You can enter field names in every language. Enter field names in your base language and all installed languages. Other languages are optional.

In addition, field names determine the secondary categories of item information that display on the Item Information navigator. Define field names and assign them to field name classes before those field names display for the field name classes on the Regulatory Information navigator.

The following shows the flow of information on the Regulatory Information navigator:

Item Information

Field Name Classes (primary node). For example, Physical Data.

Field Name (secondary node). For example, Boiling Range.

Properties (data entry window for secondary node). For example, Low Number, High Number, and Scale. Once properties are defined, you can then enter data, such as 200 - 215 Fahrenheit on the Properties window.

Prerequisites

Define properties before defining field names.

Define languages before defining field names.

See: Oracle E-Business Suite User's Guide

To define field names:

  1. Navigate to the Field Names window.

  2. Enter the 5-character Field Name Code. This is user-definable. The first 2 digits are designated to group related field names together systematically. The last 3 digits of the 5 character numeric code identify the field name. Field names ranging from 001-499 for each section are reserved for system use. You can create field names from the available 500-999 field names for each section. Required.

  3. Select a Field Name Class from the list. The field name displays under this field name class on the Regulatory Information navigator. Required.

  4. Enter the Safety category. The safety category identifies the type of safety phrase that is applied for European hazard classifications. For example, when Consumer Use is the selected safety category, the safety phrase "Keep out of reach of children" is applied. The default safety category is "Not used." Required.

  5. You can retrieve information from laboratory Technical Parameters.

    To retrieve technical parameter data, create field names. The field name descriptions must match the Technical Parameter Names identically, including case. The appropriate properties are retrieved on the Field Names window and displayed on the Regulatory Information navigator, along with the data from Item Technical Data and, if the technical parameter is linked to a quality test, from quality specifications.

    Following are the property values that are retrieved into Regulatory Management:

    Seeded properties to use with the technical parameter data:

  6. Select the brackets ([ ]) to enter descriptive flexfield information. This descriptive flexfield lets you add your own information to the field name.

  7. Enter a valid Language Description. Base and installed languages required.

  8. Enter a Field Name Description in the language selected in the language description. The field name description that you enter displays as a secondary node on the Regulatory Information navigator.

  9. If you are entering a heading field name for ingredient information, then the description displays as the heading field name in place of the original field name. Required.

  10. Enter a valid Property ID for the field name. Property information is not used for ingredient names. They use properties from the base field name. Required.

  11. Select Required to make the specified property required on the Regulatory Information navigator. For example, for the field name Boiling Range, you can select Required for high number, low number, and scale. Then, those are required fields during data entry. Clear Required to make the specified property not required. Default.

  12. View the Property Type associated with the selected property.

  13. View the Length associated with the selected property.

  14. View the decimal Precision associated with the selected property, if applicable.

  15. View the Range Min associated with the selected property, if applicable.

  16. View the Range Max associated with the selected property, if applicable.

  17. If you want to exclude field names from one or more product classes, then click Product Classes to access the Field Name Product Class Exclusions window.

  18. Enter the Product Classes that you want the field name to be excluded from.

  19. Click OK to accept the Product Class exclusions and to navigate back to the Field Names window.

  20. Save the window.

Editing Field Name Class Assignments

Use the Field Name Class Assignments window to display and edit all field name classes assigned to a responsibility and the associated sequence number for display on the navigator.

Note: Field Name Class Assignments can also be viewed and edited from the Field Name Class Responsibilities window.

Prerequisite

Define field name classes.

Define responsibilities.

See: Oracle E-Business Suite User's Guide

To edit field name class assignments:

  1. Navigate to the Field Name Class Assignments window.

  2. Enter the Responsibility Name that you want to view field name class assignments for.

  3. View the Description for the selected responsibility.

  4. View all Field Name Classes assigned to the responsibility.

  5. View the Field Name Class Description. The field name class descriptions display as the primary nodes on the Item Information navigator.

  6. View the Display Order that the field name class is displayed in on the Regulatory Information navigator. For example, a field name class with a display sequence of 10 displays after one with a sequence of 5.

  7. Select Create to allow the responsibility query and write access to the field name class. You can then create and update information that is linked to the field names within the specific field name class on the Regulatory Information navigator. Default.

  8. Select Query to allow the responsibility query-only access to the field name class. You can then only view information that is linked to the field names within the specific field name class on the Regulatory Information navigator.

  9. Click the up and down arrows to move the selected Resequence Display Order. Save your changes, then click Resequence Display Order to resequence the field name classes so all of the numbers are in sequence. For example, if you move 20 in the current display, which is Multilingual Descriptions, down to 30, then Physical Data is sequenced, and Multilingual Descriptions displays after Physical Data both on the Field Name Class Assignments window and on the Regulatory Information navigator.

  10. Save the window.

Viewing Hazard Classification Codes

Hazard classifications let you maintain risk categories for items. Standard hazard classification codes and descriptions are seeded into Regulatory Management. Use the Hazard Classification Codes window to view the hazard classifications.

To view the hazard classification codes:

  1. Navigate to the Hazard Classifications window.

  2. The following field display:

  3. Close the window.

To find a hazard classification code:

  1. Navigate to the Find Hazard Classifications window.

  2. Enter the following information to narrow your search:

  3. Click Find.

Defining Risk Phrase Details

You can add, edit, delete, and report on risk phrases. You can enter risk phrases in every language required on your documents. Enter risk phrases in your base language and all installed languages. Other languages are optional.

To define risk phrase details:

  1. Navigate to the Risk Phrases window.

  2. Enter a risk phrase Code or combination. Required.

  3. Additional Information is used to denote that additional information would be required for a document. Select one of the following:

  4. Select the brackets ([ ]) to enter descriptive flexfield information. This descriptive flexfield lets you add your own information to the Risk Phrases block.

  5. Enter a valid Language Description. Base and installed languages required.

  6. Enter the Phrase Description in the selected language.

  7. Save the window.

Defining Safety Phrases Details

You can add, edit, delete, and report on safety phrases. You can enter safety phrases in every language required on your documents. Enter safety phrases in your base language and all installed languages. Other languages are optional.

To define safety phrase details:

  1. Navigate to the Safety Phrase window.

  2. Enter a safety phrase Code or combination. Required.

  3. Additional Information is used to denote that additional information would be required for a document. Select one of the following:

    You can enter the specified additional information for risk phrases as phrases on the Phrase Library window. Select the additional risk phrase information in European Data on the Regulatory Information navigator. Required.

  4. Select the brackets ([ ]) to enter descriptive flexfield information. This descriptive flexfield lets you add your own information to the Safety Phrases block.

  5. Enter a valid Language Description. Base and installed languages required.

  6. Enter the Phrase Description in the selected language. Required.

  7. Save the window.

Setting Up Profile Options

During your implementation, you set a value for selected profile options to specify how your Regulatory Management application controls access to and processes data. Oracle Process Manufacturing (OPM) Regulatory Management uses the listed profile options:

You can set up these profile options when you set up other applications prior to your OPM Regulatory Management implementation. Refer to the other product user's guides for more details on how these products use these profile options.

Your System Administrator sets user profile options at one or more of the following levels: Site, Application, Responsibility, and User. Use the Personal Profile Options window to view or set your profile options at the user level. Consult your Oracle E-Business Suite System Administrator's Guide for a list of profile options common to all Oracle Applications.

GR: Document Rebuild Required Workflow Enable

This profile option lets you send a notification to the partner application using the XML Gateway, whenever a regulatory property or a technical parameter of an item is updated.

Default

Null

Options

Recommended Change Level

Site

GR: Default Organization Code

This profile option lets you use the owner organization of formulas, as the default organization, while migrating standalone regulatory formulas to formula, recipe and validity rules windows.

GR: File Exists Action

This profile option lets you check while uploading a document, if there is a regulatory document of the same name existing in the OPM Regulatory Management database.

Default

Dont Overwrite

Options

Recommended Change Level

Site

GR: Partner Application Site ID

This profile option provides the site identification of the partner application, that communicates with OPM Regulatory Management using the XML Gateway.

GR: Sales Order Check for Hazardous Flag

This profile option lets you send a notification to the partner application using the XML Gateway, whenever hazardous material is ordered on a sales order.

Default

Yes

Options

Recommended Change Level

Site

GR: Soapaction

This profile option lets you specify the server/address for the Trading Partner soap server service. For example, http://xmlns.oracle.com/apps/fnd/XMLGateway/ReceiveDocument

Default

Null

Recommended Change Level

Site

GR: Ws Service Namespace

This profile option lets you specify the server/address for the Trading Partner web service. For example, http://xmlns.oracle.com/apps/fnd/XMLGateway

Default

Null

Recommended Change Level

Site

Setting Up Territory Profiles

The Territory Profiles window lets you set up and maintain defaults for the language, document type, and standard or nonstandard disclosures required for each territory entered. The territory profile is used to determine which document is attached to the shipment line. Add, edit, delete, and report on territory profiles.

Prerequisites

To set up territory profiles:

  1. Navigate to the Territory Profiles window.

  2. Enter the Territory code for this profile. The description displays. Required.

  3. Enter the Default Language to use on documents for the territory entered. The description displays. Required.

  4. Enter the Default Document to send for the territory entered. The description displays. Required.

  5. Enter the Disclosure code required for the territory entered. The code determines the ingredient reporting levels for the territory. The description displays. Required.

Defining Item Relationships

Use the Item Relationships window to define the regulatory relationships between the inventory items in your organization.

Refer to the Oracle Inventory Management User's Guide for more information.

Editing Organization Items

Use the Organization Item window to view and edit the inventory items in your organization.

Refer to the Oracle Inventory Management User's Guide for more information.

Using the Formulator Workbench

Use the Formulator of the Oracle Process Manufacturing Product Development to view the formula details.

Refer to the Oracle Process Manufacturing New product Development User's Guide for more details.