**Source URL:** https://quality.veevavault.help/en/lr/1227598/

# Identifying Impacted Materials for Change Controls (QMS)

Veeva QMS allows you to identify the downstream materials impacted by a change control. When the _Identify Impacted Materials_ action runs on a _Change Control_ record, Vault creates _Downstream Change Control Material_ and _Regulatory Change Item_ records for impacted materials and products, and relates the created records to the _Change Control_. This allows you to easily view and manage impacted materials and products directly from a _Change Control_, eliminating the time-consuming process of manually identifying downstream materials impacted by a change control.

Depending on your Admin's configuration, object, field, and section labels may appear differently than the labels mentioned in this article.

## Best Practices for Material & Product Data

Before running the _Identify Impacted Materials_ action on a _Change Control_, we recommend ensuring that the product and material data in your Vault is up-to-date and accurate. If you rerun the action after updating relevant data, Vault creates records to reflect the new data but does not delete any existing records, even if downstream materials and products were removed. For instance, if an impacted _Material_ had a related _Product_ that was removed since the action last ran, running the action again does not delete the previously-created _Regulatory Change Item_ record for that product.

This feature assumes your organization is using the following _Material_ object types and product hierarchy objects to store the following information:

* **Raw Material**: An unprocessed ingredient used to make a product.
* **Intermediate Material**: A blend of raw materials or processed materials.
* **Finished Material**: A material in its final iteration. _Finished Materials_ are typically associated with _Product Families_, _Products_, and _Product Variants_, but this may vary depending on your organization's processes.
* **Product Family**: A general category of products.
* **Product**: A product formulation.
* **Product Variant**: The variation of a product, such as size or region.

You can manage the relationship between _Materials_ and _Products_ from a _Material_ record by:

* Adding a material to the _Related Materials_ section.
* Adding a product to the _Material - Products_ section.

### Material Data Example {#example-data}

Consider the following example. A manufacturing process for Cholecarb Tablets includes the following materials: 

| Material | Related Material |
| -------- | ---------------- |
| **Raw Material**: Carbolin | **Intermediate Material**: Trihydrate Granulated Blend |
| **Intermediate Material**: Trihydrate Granulated Blend | **Intermediate Material**: Multihydrate Granulated Blend |
| **Intermediate Material**: Multihydrate Granulated Blend | **Intermediate Material**: Multihydrate Final Blend |
| **Intermediate Material**: Multihydrate Final Blend | **Finished Material**: Cholecarb Tablet 1 mg 10 Pack US

**Finished Material**: Cholecarb Tablet 1 mg 10 Pack CA |

The _Finished Materials_ above are related to _Products_ through the following _Material - Product_ records:

| Finished Material | Material - Product |
| ----------------- | ------------------ |
| Cholecarb Tablet 1 mg 10 Pack US | **Product**: Cholecarb Tablets
**Product Variant**: Cholecarb Tablet 1mg |
| Cholecarb Tablet 1 mg 10 Pack CA | **Product**: Cholecarb Tablets
**Product Variant**: Cholecarb Tablet 1mg |

## Identifying Impacted Materials

Depending on your Admin's configuration, you may be able to trigger Vault to search for impacted materials in the following ways:

* From the **All Actions** menu of the relevant _Change Control_, select the **Identify Impacted Materials** action.
* Move a _Change Control_ record to a lifecycle state or workflow step configured to automatically identify impacted materials.

Vault identifies impacted _Materials_ by first looking for _Related Material_ records associated with the records in the _Materials_ section of a _Change Control_. The _Materials_ specified in those _Related Material_ records are considered impacted materials. If the impacted materials have _Related Materials_, Vault also identifies them as impacted materials. Vault continues this process, identifying _Materials_ that are up to 10 relationship levels removed from the _Materials_ directly related to a _Change Control_.

## Downstream Change Control Material & Regulatory Change Item Record Creation

After identifying the impacted materials, Vault creates a _Downstream Change Control Material_ for each impacted material. If multiple impacted materials share the same downstream material, Vault creates one _Downstream Change Control Material_ for that downstream material. 

Additionally, Vault uses _Product_ and _Product Variant_ information from _Material - Product_ records related to the impacted _Materials_ to determine the _Regulatory Change Item_ records to create:

* If an impacted _Material_ has both a _Product_ and a _Product Variant_, Vault creates a _Product Change Regulatory Change Item_ for the _Product Variant_.
* If multiple impacted _Materials_ have the same _Product_ or _Product Variant_, Vault creates a _Product Change Regulatory Change Item_ per unique _Product_ or _Product Variant_.
* If an impacted _Material_ does not have a _Product_ or _Product Variant_, Vault creates a _Material Change Regulatory Change Item_ for the impacted _Material_.
* If an impacted _Material_ has multiple _Products_ or _Product Variants_, Vault creates a _Product Change Regulatory Change Item_ per unique _Product_ or _Product Variant_. 

Vault creates _Downstream Change Control_ records for each impacted _Material_, regardless of the impacted _Material's_ object type. Vault only creates _Regulatory Change Item_ records for _Materials_ and their related _Products_ and _Product Variants_ if the impacted material is of an object type specified in the action's configuration.

When this process concludes, Vault sends the initiating user a notification with a CSV file containing details of successfully created records and any failures. Vault also notes any records that were skipped to avoid creating duplicates.

In a Vault with material and product data set up as in the [example above][1], Carbolin is listed as a material on a _Change Control_. In a Vault configured to create _Regulatory Change Items_ for _Finished Materials_ only, the _Identify Impacted Materials_ action creates the following records:

| Created Downstream Change Control Materials | Created Regulatory Change Items |
| ------------------------------ | ------------------------------- |
| **DCCM-000001**
**Material Type**: Intermediate Material
**Material**: Trihydrate Granulated Blend | N/A |
| **DCCM-000002**
**Material Type**: Intermediate Material
**Material**: Multihydrate Granulated Blend | N/A |
| **DCCM-000003**
**Material Type**: Intermediate Material
**Material**: Multihydrate Final Blend | N/A |
| **DCCM-000004**
**Material**: Cholecarb Tablet 1 mg 10 Pack US
**Material Type**: Finished Material
**Product**: Cholecarb Tablets
**Product Variant**: Cholecarb Tablets 1mg

**DCCM-000005**
**Material**: Cholecarb Tablet 1 mg 10 Pack CA
**Material Type**: Finished Material
**Product**: Cholecarb Tablets
**Product Variant**: Cholecarb Tablets 1mg | **RCI-000001**
**Regulatory Change Item Type**: Product Change
**Product**: Cholecarb Tablets
**Product Variant**: Cholecarb Tablet 1mg |

## Reporting on Change Control Products

The _Identify Impacted Materials_ action does not populate the _Products_ section on a _Change Control_. If your process requires reporting on _Change Controls_ by product, you can update your reports to use _Regulatory Change Items_ to capture product information for _Change Controls_. 

## Related Permissions

To run the _Identify Impacted Materials_ action, you must have a security profile with a permission set that grants _Execute_ permission for the _Identify Impacted Materials_ action on the _Change Control_ object.

To manage _Downstream Change Control Material_ and _Regulatory Change Item_ records created by the action, you must have _Read_, _Create_, and _Delete_ permissions for the _Downstream Change Control Material_ and _Regulatory Change Item_ objects.

[1]: #example-data