Exploring Basic Concepts, Compliance Objects, and Processes

Compliance Data Foundation (CDF) on the one hand frames the conceptual basis of Product Compliance with its solution areas. On the other hand, CDF provides essential processes for

• Managing Compliance Requirements and Compliance Purposes, which constitute regulations or policies as the basis for compliance assessments.
• Managing Substances Compliance - Company substances linked to legal listed substances. Listed substances represent the chemical basis for compliance assessments of raw materials and products for substance related regulatory obligations.
• Managing Basic Compliance Data - applicable for Products and underlying Raw Materials. This data sets the stage for assessments and compliance calculations specific per solution area. An important aspect here is the calculation of composition data along the product hierarchy, finally providing a substance-related perspective, which is key for almost any compliance subject.

Let us look at some major objects, we deal with in product compliance:

• Compliance view - this is the focal point of product compliance. The compliance view comprises of basic compliance data and it relates to the compliance assessments, according to the assigned compliance requirements. To integrate with the value chain, the compliance view relates to products in product master.
• Compliance Requirements - these are the digital representation of regulations, legal obligations, or policies. Compliance requirements can be specific for legal areas, means valid for dedicated countries/regions but can also be globally valid.
• Compliance purposes combine compliance requirements for assignment to compliance views.
• Company substances - are essential to image the chemical level of products, which is addressed by numerous regulations. Since affected substances are frequently published as lists, assigned to regulations, the term listed substance is used for any published chemical substance. Company substances are the representation of these substances, which are required to model raw materials and products. Business data coming with raw materials or products in product master does not reach this special level of detail. Such a breakdown is an important part of the basic compliance data of compliance views - for products as well as for raw materials.

Compliance data foundation provides basic processes to:

• Create company substances, which are essential to represent the chemical level of raw materials and products in their analytical compositions. Substances are subject to marketability assessments when it comes to ensuring compliance with substance lists, for example restriction lists of prohibited substances.
• Create compliance views of raw materials and products and edit basic compliance data. Major parts herein are:
  • Compositions and composition calculations
  • Properties, describing for example physical-chemical properties, ecological or toxicological hazards
• Manage and activate compliance requirements and combine them in compliance purposes for assignment to compliance views, which makes related compliance assessments available.

Understand the concept of compliance requirements and compliance patterns being the digital representation of regulations or policies.

With the compliance view being the focal point of the data model for product compliance, a flexible concept for assignment of regulatory aspects to the compliance view is a key element in the concepts of product compliance.

Compliance Requirements are the objects to flexibly assign regulatory aspects to the compliance view.

Compliance Requirements are the digitized versions of regulations or legal obligations but also industry or company-specific standards can be modeled, based on the available compliance patterns.

Compliance Patterns define data structures necessary for processing and documenting compliance assessments, which finally results in a compliance status. Beside the assessment logic, specific compliance patterns also include logic to calculate the compliance status.

Numerous compliance requirements relate to the chemical level of products. Listed substances represent this part of regulations or policies.

According to the fundamental model of Compliance Requirements, it comprises of at least the initial Compliance Requirement Version (CRV) with the following version-related details, keeping each compliance requirement version self-contained:

• Header data and regulation details, supplemented with attributes specific for each solution area, for example product marketability;
• The Compliance Requirement Pattern (CR-pattern) of the CRV, for example:
  • • Substance List Check for Product Marketability or 
    • Dangerous Goods Assessment for unpackaged and packaged products;
  • Data structures - for example, data for assessing the compliance requirement version like a list of regulated substances or product information, which must be retrieved in the assessment. These data structures may also include for example
    • phrases
    • regulatory graphic collections
    • substance lists
  • Logic - for example, how to determine affected subordinate (intermediate) products, raw materials or substances along with compliance calculation or to calculate the compliance status;
  • The app to assess the Compliance Requirement.

Learn how you make compliance requirements available for assessment in a compliance view.

The compliance purpose groups compliance requirements for assignment to compliance views of products or raw materials.

Grouping criteria can be:

• Business processes, such as Sell In, Produce In, Transport In;
• Regional or organizational aspects.

With the grouping of compliance requirement in compliance purposes, you can also prevent missing the assignment of an applicable compliance requirement.

With the assignment of a compliance purpose to a compliance view, the compliance requirements included in the compliance purpose become available for assessment.

The assessment of a product is processed against an active compliance requirement version. The compliance pattern specifies applicable data structures and assessment or calculation logic.

For example, the compliance status of an unpackaged product can be calculated from the following:

• The compliance statuses of the underlying raw materials as given in the material-based composition (after production);
• The substance level of the analytical composition (globally valid or legal-area-specific).

Understand, how the compliance view bridges from the product master to regulation-based compliance data.

The compliance view is the focal point of the data model for product compliance. The compliance view supplements the commercially based product master with the legal data.

The compliance view contains the compliance information for one or multiple products in product master.

The compliance view is the single source of compliance information for assigned products in product master.

Linking a product master to a compliance view, the product logically inherits the compliance information from the compliance view.

Depending on the logistics role, the compliance view has specific objectives and details assigned:

• Purchased: raw materials are typically purchased. The role purchased allows supplier information to be added to the compliance view. This role may also be applicable for trade goods.
• Produced: products, or intermediates; the role produced allows to maintain a material-based composition for the compliance view. This role is typically assigned to the compliance view of an unpackaged product; it must not be assigned to the compliance view of a packaged product.
• Sold: The role sold typically comes with the assignment of a packaged product to the compliance view of the unpackaged product.

  The assignment of the role Sold is vital when it comes to selling and shipping the product in sales and delivery.

• Transported: This role cannot be assigned solely, there must be one of the other logistics roles assigned as prerequisite. Upon assignment of the role sold, the role transported is assigned automatically.

  The role transported is prerequisite for dangerous goods assessments.

For product compliance, it is essential to differentiate the product master assigned to the compliance view into:

• Unpackaged products, in general unpackaged products are not ready to be sold. To sell a product, it requires a packaging or another kind of enclosure. Assignment of product master for unpackaged products is optional - the compliance view "by itself" represents the unpackaged product.
• Packaged products, which are ready to be sold. Assignment of product master for packaged products is mandatory - the compliance view of a packaged product is identified by the assigned product master.

When it comes to purchased goods, raw materials, or trade goods, the situation is quite similar - you purchase packaged raw materials or trade goods, but in product compliance, the primarily focus is on unpackaged products or raw materials.

If required, there can be more detailed compliance views for assigned packaged products. This is, for example, essential for dangerous goods.

• Raw Material - means a Compliance View with the logistic role Purchased. The compliance view with the logistic role Purchased has an analytical composition. This can be manually created or calculated from the underlying supplier raw materials, which also come with the logistic role Purchased.
• Unpackaged Product - means a Compliance View with the logistic roles Produced and / or Sold and Transported.

  The compliance view with the logistic role Produced has a material-based composition. This is derived from the production bill of materials, stating the components used to produce the product. The material-based composition differentiates before production and after production, which is important in case of chemical reactions or physical changes - such as solvents being removed by drying or new substances being produced by chemical reactions. The analytical composition is derived from the material-based composition after production.

• Packaged Product - means a Compliance View with the logistic roles Sold and Transported but not Produced. This Compliance View must be related to an unpackaged product (see previous item). It is automatically created upon assignment of a packaged product in product master to the compliance view of the unpackaged product.

From time to time, compositions, properties or compliance assessments may need to be changed. To manage such changes and to safeguard consistent compliance data, the following status sequence ensures that only one dedicated set of compliance data is in status Released and is consumed for output on documents, checks or any other process.

The access to a composition‘s history is a vital element for compliance management.

The above example shows the history of the material-based composition of a product.

The option to view version history is available for:

• Compositions, as applicable for unpackaged products or raw materials;
  • Unpackaged product
    • Material-based composition for products
    • Analytical composition, also legal area specific analytical composition
    • Confidential business information
  • Raw materials
    • Analytical composition and
    • Supplier raw material analytical composition
• Properties
• Compliance assessments

From the compliance view, you navigate to thecompliance assessments, where you process the assessment of compliance requirements being assigned

• Using the assigned compliance purposes;
• By propagation, for example from the unpackaged product to the related raw materials.

From the compliance assessment, navigation leads you to the market assessment, where you consolidate the individual assessment results for a market or production country/region and business processes Sell In or Produce In.

The assessment of a product is processed against an active compliance requirement version. The compliance patterns specifies applicable data structures and assessment or calculation logic.

For example if the compliance status of an unpackaged product can be calculated from

• the compliance statuses of the underlying raw materials as given in the material-based composition (after production);
• the substance level of the analytical composition (globally valid or validity-area-specific).