Describing Compliance Objects for Product Marketability

Product Marketability is based on sophisticated regulatory obligations. For the purpose of demonstrating available functionalities to assess marketability, we will utilize a simplified Compliance Requirement, which resembles real legal obligations and thus allows you to focus on the logic instead of unveiling regulatory complexity. Same applies for the example products and raw materials used for the illustration.

Based on the WHO recommended alcohol-based hand rub for routine hand antisepsis, we want to produce such products. This results in the following activities:

• To easily ensure compliance, we create a Compliance Requirement for the components to be used and those being forbidden. Then we will assess compliance and prove compliance respective marketability.
• A new supplier for one raw material is proposed, here we have an impurity in the supplier analytical composition, which makes this supplier material incompliant → block supplier

Compliance Requirements (CR) are bound to model obligations originating from legal or (company) policy sources.

The Compliance Pattern (CP), assigned to a Compliance Requirement Version (CRV), defines the necessities to conform to the obligation. In the context of Product Marketability, this can be:

• a statement or a document to be retrieved for example from a supplier
• a list of substances to be evaluated, frequently along with limits regards concentration or production volumes

Beside calculation logic to derive, for example, the overall compliance status for a product, the Compliance Pattern also comprises statements to be used for documenting compliance, application of exemptions or actions to be taken.

When assessing a Compliance Requirement, these statements go into the Compliance Assessment (CA) of the assessed Compliance Requirement Version for the product or the raw material under consideration.

Compliance Requirements are grouped in Compliance Purposes, which frequently reflect the intention of the assigned CRs, but can also take into account organizational aspects (regional or product portfolio) - such as

• Import chemicals to the European Union
• Sell cosmetic products in North America

Only compliance purposes can be assigned to unpackaged products or raw materials.

In general, compliance requirements (CRs) are assigned to unpackaged products or raw materials via a compliance purpose - see Compliance Data Foundation. The compliance purpose combines compliance requirements for example for a market or for a product group.

For product marketability there is an additional assignment option:

You can manually assign individual compliance requirements for marketability directly to a supplier raw material.

This option serves the case, your supplier provides even more information as you need according to the currently assigned marketability CRs. Using this option, you can maintain all available compliance statements, received from the supplier to have it at hand in case needed. The assessments are on the supplier raw material and can be calculated to the superordinate raw material, as soon as the CR is assigned there.

To safeguard compliance with obligations regards Product Marketability, there are three Compliance Patterns available to model, process and document assessment results.

1. Numerous regulations regards Product Marketability relate to substances contained in a product. This assessment on the chemical level, represented of the product's substance based composition is mainly the area of the Compliance Pattern Substance List Check with the three available list types.
2. In some cases, it is essential to have evaluated and proved a product, unpackaged or packaged, or a raw material complies with given standards. The compliance pattern Simple Compliance Documentation allows to handle these cases also within the compliance view of a product, unpackaged or packaged, or a raw material.
3. In cases, where each and every supplier, whose raw materials go into a product have to provide prove on compliance are covered with the compliance pattern Supplier Information. Here the information is related to the detailed level of supplier raw materials underlying the raw materials going into production.
4. For particular products, it is required to assure, the customer fulfills specific requirements prior to shipping the affected product. The compliance pattern Customer Compliance Check is bound for such cases. Prior to first shipment of an affected product to a customer, a successful customer assessment is required proving the customer fulfills the prerequisites to receive the product.

Compliance Requirements (CR) have a common basic structure. Depending on the Compliance Pattern, not all sections of this structure are available:

• Header - defines the CR Version with the following:
  • Compliance Pattern
  • Validity Period, Effective Date, End of Transition
  • Maintenance Status
  • Name and translations
  • Validity (worldwide, one or multiple countries)
• Regulation or Policy Details:
  • Issuing Organization
  • Official Name
  • Version Name
  • Source URL
• Process Integration
• Object-Related Details
• Substance Lists (if applicable for the specific Compliance Pattern)

Manage documentation obligations utilizing the following pattern: Simple Compliance Documentation.

With Object Related Details, you define texts available as Compliance Statements to document details related to the compliance status set as the final assessment result.

Process Integration, defines the assignment of the Compliance Requirement Version (CRV).

In case, a CRV is defined to be used for unpackaged products and raw materials, the assessment level depend on the assignment of the CRV:

• The CRV is assigned to an unpackaged product, then the assessment is only this unpackaged product.
• The CRV is assigned to a raw material, then the CRV is propagated to all related supplier raw materials for assessment. The individual assessment status maintained for the supplier raw materials is aggregated to the raw material according to the "worst case" principle. This calculation is processed automatically upon saving the Compliance Status of an underlying supplier raw material.
• In case, a CRV is defined to be used for packaged products, and it is assigned to an unpacked product, the assessment is only for packaged products assigned to the unpackaged product.

Process Integration - for the Compliance Requirement Version (CRV) with the Compliance Pattern Supplier Information, you can define specific Affected or Exempted Applications related to the CRV and its assessment. Business Processes are for information.

With Object Related Details, you define texts available for documentation of the assessment. These texts are bound for use as:

• Exemptions - if the product is exempted from being assessed
• Compliance Statements - to document details related to the compliance status.
• Actions - for processing to comply with the obligations of the CRV.

Inventory list, stating the recommended ingredients:

• Ethanol
• Isopropanol
• Glycerol
• Hydrogen peroxide
• Water

Upon activation of this Compliance Requirement (CR), we will define the Analytical Composition as the substance based composition to be used for calculation.

Calculation of this CR starts automatically after the Analytical Composition is released.

In case the product contains a substance, not listed on the inventory list, the calculation result is NOT COMPLIANT.

Restriction List - here to show an example for prohibited substances: Methanol - a possible impurity in the raw material for Ethanol

Upon activation of this Compliance Requirement (CR), we will define the Analytical Composition as the substance based composition to be used for calculation.

Calculation of this CR starts automatically after the Analytical Composition is released.

In case the product contains a substance, listed on the restriction list, the calculation result for this substance is NOT COMPLIANT.

Follow a substance list check assessment along the product hierarchy.

The assessment of a substance list check for an unpackaged product is based on three key aspects:

1. The Substance Assessment – this relates to the following:
   • the constituents of the product’s substance based composition, which is basically the analytical composition after production or a legal composition derived from it.
   • the raw materials, derived from the product’s material based composition and the breakdown of the analytical compositions of all raw materials to the substance level.
2. The Raw Material Assessment – this relates to:
   • the assessment of all substances of the raw material’s analytical composition.
   • the supplier assessment.
   • the raw material in general, when setting the compliance status manually.
3. The Supplier Assessment supplements the substance assessment of a raw material, for example in case a supplier’s analytical composition does not add up to 100%.

For the substance list check, there are two assessment pillars:

1. Substance Assessment
   • This is the main focus, but it requires thorough composition information for the substance based compositions (Analytical or Legal Composition) along the complete product hierarchy, which is not available in every case.
   • It is the most efficient assessment, since you need to assess a substance only once for the compliance requirement version.
   • Automated compliance calculation is initiated by:
     • Release of compositions - a product's material based composition or a substance based composition for a raw material or a product
     • Release of a substance assessment
2. Supplier Assessment for supplier raw material - these are aggregated to the Raw Material. This is the complementary assessment pillar, it does not relate to substances directly.
   • You set the compliance status per supplier raw material based on information received from the supplier, granting compliance with the compliance requirement version.
   • The aggregation of these supplier related results for the compliance status of the Raw Material is calculated automatically. So you should assess each supplier raw material for the compliance requirement version and manually set the compliance status to have exhaustive data for the compliance calculation.

Marketability Assessments

In the Substance Assessment of an unpackaged product or raw material, you get an overview of the assessment results for all substances based on the applicable composition of the compliance requirement version (CRV). This is defined at activation of the CRV. It can be a Legal Composition or the Analytical Composition, which is also fallback when the applicable Legal Composition is not released or is missing at all.

In case there is no assessment for a substance for the current compliance requirement, you use the action Initiate Assessment.

Substance assessment results are commonly used for compliance calculations of any occurrence of the substance - raw material or unpackaged product.

Raw Material Assessment provides an overview on the compliance status of the raw materials as given in the product's material based composition. From here you can navigate into the raw materials to get more details, that is regards substance assessments based on the raw material's substance based composition(s)

Supplier Assessment are crucial for raw materials, that is you have no exhaustive composition data available but your supplier grants compliance with obligations related to specific compliance requirements.

Assessment details for substance list check on an unpackaged product provide two assessment layers:

• Substance Assessment - this is calculated from a released substance based composition which originates from the material based composition after production and assessment results for the contained substances. From here, you can initiate a substance assessment, in case it is missing for the current compliance requirement.
• Raw Material Assessment - this provides marketability status of underlying raw materials or intermediates from the product's material based composition. You can navigate into the assessment details for the current compliance requirement for a raw material.

Assessment details for substance list check on a raw material provide two assessment pillars:

• Substance Assessment - this is calculated from the released raw material analytical composition which is based on the supplier raw material analytical composition(s) and assessment results for the contained substances.
• Supplier Assessment - this is the complimentary assessment since you can only process substance assessments for disclosed substances of a raw material, supplier assessments are complementary to complete your raw material assessment. You make use of it when the supplier raw material analytical composition is not exhaustive, but the supplier grants compliance with the current compliance requirement.

Create an example substance list check to understand it's elements and functionality.

The example substance list (SLC) check follows the user story for production of an antiseptic hand rub.

To ensure compliance with WHO recommended formulations, we create 2 compliance requirements, both with the compliance pattern Substance List Check

1. Inventory list, stating the recommended ingredients:
   • Ethanol
   • Isopropanol
   • Glycerol
   • Hydrogen peroxide
2. Restriction List - here to show an example for prohibited substances: Methanol - a possible impurity in supplier raw materials for the ingredient "Ethanol"

You start creation of a new Compliance Requirement (CR) with the creation of the first version.

Doing so, you have to decide if the new Compliance Requirement is a:

• Policy – frequently used a CR based on internal obligations or requirements received from a customer
• Regulation – mainly used if the CR is a legal obligation, not available from the Regulatory Content provided with the system.

The Compliance Requirement is the description used to address any version assigned, therefore it is usually more general than the Version Name below.

You select the Compliance Pattern applicable for your new Compliance Requirement from the drop-down.

Substance List Check is the pattern we intend to assign.

You finalize entering the initial data required to create the first version of the new compliance requirement (CR):

Version Name – this is the specific name being displayed, for example, when assessing the CR. Usually the version name reflects the edition of the related source.

Each compliance requirement version has two dates assigned:

• Effective Date – this mandatory entry is the current date or a date in the future.
• End of Transition – this is an optional entry and specifies the date, the new obligation must be applied latest.

You find the information entered for creation in the header of the Compliance Requirement Version (CRV).

Here you can adapt the validity of the CRV by adding the respective countries. The CRV is valid worldwide if no countries are specified.

For any CRV you create, the Content Provider is set to Customer automatically.

On the header, you set the Maintenance Status of the CRV, following the status sequence:

New (initial status)→Released→Under Revision→Historical (final status, can not be changed).

In case the CRV is a subsequent version, you can compare the current version with the previous version.

In the Details tab, you maintain the editorial information. Same as for the name of the CRV in the header, you can add translations for these textual information.

Process Integration– for the Compliance Requirement Version (CRV) with the Compliance Pattern Supplier Information, you can define specific Affected or Exempted Applications related to the CRV and its assessment.

Business Processes are for information in the OP2022 release.

Object Related Details of the Substance List Check, you define texts available for documentation of the assessment. These texts are bound for use as:

• Exemptions – if the product is some way exempted.
• Compliance Statements – to document details related to the compliance status.
• Actions – i.e. for processing to comply with the obligations of the CRV.

Since the Substance List Check evaluates the substances contained in the product, assessment documentation relates to both levels, the product and the contained substances.

Substance Lists are the core part of the Compliance Pattern Substance List Check.

To assign substances, you have to define the applicable List Type.

Depending on the list type, the check logic and further details available for assigned substances apply.

You can even define multiple lists – but then evaluation priorities grow complex.

You can define thresholds, for a Restriction List this is also possible per each assigned substance, and you can exclude specific ingredient roles.

The substances you can assign with the action Add are the root listed substances or individual variants thereof. Also substance groups, which combine multiple substances (root or variants) can be assigned.

After finalizing the Compliance Requirement Version (CRV) and setting the maintenance status to Released, you must activate it in the app Activate Compliance Requirements – Product Marketability. You initiate the action Activate for your Compliance Requirement from the hitlist.

For calculation, the substance list check needs an assigned analytical composition. Upon the activation, you can specify a legal-area-specific analytical composition for calculation. By default, the globally valid analytical composition is used. The globally valid analytical composition is used if the legal-area-specific analytical composition is not available – means not maintained or not released.

Create an example compliance purpose for product marketability.

To make the newly created and activated Compliance Requirement (CR) available for assignment to a product’s Compliance View, you must assign the CR to a Compliance Purpose.

In this example, we create a new Compliance Purpose by defining the name of the new purpose.

With the action Add, you get a dialogue to select the compliance requirements you want to assign to the compliance purpose.

Select the compliance requirements you want to assign to the compliance purpose.

Confirm the selection.

Then, you find the selected Compliance Requirements (CR) assigned to your new Compliance Purpose.

Now, you must activate the Compliance Purpose (CP) to make it available for assignment to a product’s Compliance View.

In case you want to change an activated Compliance Purpose, you must deactivate the Purpose prior to making changes on the assigned CRs.

Make the newly created substance available for assessment.

In the Manage Basic Compliance Data – Unpackaged Product app, you assign Compliance Purposes to the product’s compliance view.

With the action Add, you get a list of available Compliance Purposes for assignment to the product’s compliance view.

You find the newly assigned Compliance Purpose, adding 4 Marketability assessments to the unpackaged product’s Compliance View.

Upon assignment of the new Compliance Purpose to the unpackaged product, the contained Compliance Requirements are propagated according to the rules, specific per compliance pattern.

In case of our new substance list checks for antiseptic products, the compliance requirements are propagated to the raw materials assigned to the product's material based composition (before production) and from there to the related supplier raw materials.

Use the specific apps for products, raw materials or substances to assess marketability requirements.

You can find the incomplete compliance assessments by searching for marketability status - for example: Not Compliant or Unknown.

Follow how you can identify changes of compliance requirement versions.

For Compliance Requirements with the pattern Substance List Check, in the app Manage Compliance Requirements – Product Marketability, you can utilize the action Compare with Previous Version. With this action, you can compare the CR you are viewing with it’s predecessor version.

The result of the version comparison is provided as a document, helping you to evaluate the impact of the changes.

Use the Compliance Information for Products app to easily retrieve latest compliance information.

Compliance Information For Products – Product Marketability provide an overview on the Sales as well as the Production View of a Product – unpackaged or packaged.

You can either view the details on the World Map or in Table View.

From this view, you can directly create a Market Request for a country.

Marketability information displayed in table view along with the current Compliance Status.

You can switch between Sales View and Production View.

With the action Create Request, you can initiate marketability request for one or multiple countries.

Compliance Information For Products – Product Marketability allows i.e. a sales representative to easily initiate marketability assessments for selling the product to new customers / countries and so to ensure compliance with legal obligations regards marketability.