Managing Compliance Requirements and Compliance Purposes

Get an overview on the process steps for activation of compliance requirement versions and compliance purposes.

Taking care of the regulatory basis for product compliance is task of the product stewardship specialist - product compliance.

Compliance requirements are the digital representation of regulations or legal obligations. As product stewardship specialist, you must identify the compliance requirements you need to assess for your products. You activate these compliance requirements by activating applicable compliance requirement versions.

To make a compliance requirement, in fact the activated versions, available for assessment in a compliance view, you must assign them to compliance purposes. Then you assign the compliance purpose to products and raw materials.

You deactivate outdated compliance requirement versions, but when doing so, you must be aware, that

• Existing released compliance assessments are set to status historic.
• Existing compliance assessments in status in process are deleted.

Have a closer look at the details of a compliance requirement and the version concept.

Compliance requirements (CRs) are the regulatory foundation for product compliance. The system comes with numerous compliance requirements. Most compliance requirements represent legal regulations, you just need to activate these CRs to make them available for use.

In addition to these regulation-based compliance requirements, you can create company-specific compliance requirements for example for company policies. The Manage Compliance Requirements apps, which are specific per solution area, allow you to create a new compliance requirement by creating a first version. When required, you can update the compliance requirement by creating a new version.

Activating a compliance requirement version makes it become available for assignment to compliance purposes. Only active compliance requirements can be used in compliance purposes and are then available for compliance assessments.

A compliance purpose is a group of compliance requirements, defined to meet a common objective and/or a specific area of competence. This grouping eases the assignment of relevant compliance requirements to a compliance view.

Header and details of a Compliance Requirement provide the following information:

• Compliance Requirement Version, identified by its specific name, assigned to the Compliance Requirement. This comprises i.e.
  • Compliance Pattern
  • Maintenance Status
  • Effective Date
  • Validity
• Details, providing editorial information

Information provided as Process Integration of a Compliance Requirement vary by Compliance Pattern. Some samples:

• Business Processes
• Affected or Exempted Applications
• Assignment of the Compliance Requirement Version to, for example:
  • Unpackaged Products and Raw Materials
  • Packaged Products

Information provided as Object-Related Details of a Compliance Requirement vary by Compliance Pattern, for example, statements used to document the assessment along with available texts.

All tab-pages except the Regulation / Policy Details tab are specific per Compliance pattern.

You can create a new Compliance Requirement (CR) using Create First Version – select the applicable type Policy (for example in case customer-specific) or Regulation (legal source).

The second option is Create New Version for an existing CR – this is appropriate in case you received a new edition of the underlying regulation or policy.

You can update an existing version by setting it to Under Revision and applying necessary changes.

When you can create a new Compliance Requirement, be aware, that the Compliance Requirement Name shall be more generic, since it is common for any version to come.

The Version Name is the specific name for a particular version.

The Compliance Patterns and the Manage Compliance Requirement app are specific per Solution Area.

On the overview of new or updated compliance requirements, you have two actions available:

1. Activate – This is applied to a new version, to make it available for assignment to Compliance Purposes, similar for the first version of a new compliance Requirement.

   Depending on the Compliance Pattern, there can be specific additional steps to be processed upon activation – e.g. for Product Marketing’s Substance List Check, you need to specify the applicable substance based composition.

2. Confirm – This is applied in case an existing version was revised.

   Only after confirming the updated version, the revision is used in compliance assessments or calculations.

Activation of an earlier version is no longer possible, if a succeeding version has been activated.

Deactivation of version is only possible, if a succeeding version has been activated.

Check the following example:

• Since version 3 is activated, you no longer can activate version 2.
• Versions 4 or 5 can now be activated.
  • In case you activate version 5, you no longer can activate version 4.
  • In case you activate version 4, you can also activate version 5.

• Since version 3 is activated, you can deactivate version 1.
• In case, you activate versions 4 or 5, you can deactivate version 3.

For further information on deactivation of compliance requirement versions, see later section.

In this example, version 2:

• neither can be activated since the succeeding version 3 is already activated;
• nor can it be deactivated since it was not activated.

Understand the concept of compliance purposes and how to utilize for assignment of compliance requirements to products and raw materials.

The overview of Compliance Purposes gives you insight on your company’s Compliance Purposes.

In the search, you utilize the activation status to identify new or inactive compliance purposes.

You see the number of product and raw materials assignments from the total number of products and raw materials for each compliance purpose.

Additionally, you find the number of assigned compliance requirements.

You create a new Compliance Purpose by first defining the name along with required translations.

Second, you assign required Compliance Requirements.

Finally, when you finished maintenance of the Compliance Purpose, you activate it to make it available for assignment to Compliance Views – for unpackaged products or raw materials.

In case you have the need to modify the Compliance purpose, switch to Edit → apply changes, e.g. change assignment of Compliance Requirements or add a translation … → re-activate the compliance purpose.

If the Compliance Purpose is not needed any more, you deactivate it, so it is no longer available for assignment to compliance views.

Default Compliance Purposes combine Compliance Requirements to be assessed for any product or raw material in your company. Default Compliance Purposes are defined by their name:

• Product Default ... - names a Compliance Purpose to be assigned to unpackaged products
• Raw Material Default ... - names a Compliance Purpose to be assigned to Raw Materials

By default, it means these compliance purposes are automatically assigned upon saving of a new compliance view.

Get to know how you can deactivate an obsolete compliance requirement version.

In the App Activate Compliance Requirement, you identify the Compliance Requirement Version (CRV) to be deactivated. Be aware, that there must be an activated newer version of the CR, before you can deactivate a predecessor version.

This formal prerequisite is checked by the system and if it is not met, you will not be able to deactivate the CRV.

Be aware of the following:

• That any released assessment result related to this CRV will be set to historic in the deactivation process, means it can no longer be used in compliance calculations or checks and any assessment being in process will be deleted.
• That in the Analytics Apps, you do not see assessments of Raw Materials or Substances.

Prepare and organize deactivation utilizing the Analytics Apps to ensure, that is, that assessments for the succeeding CRV are available and you will not run into blocks caused by missing or not yet released assessment results.

Deactivate the obsolete CRV in the App Activate Compliance Requirement.

Check deactivation in the Analytics Apps - check that all related assessments are set to historic.