Configuring APQR (QMS)

QualityOne Vaults support management of the APQR (Annual Product Quality Review) process, an annual evaluation of the quality standard of a product to determine the need for adjustments in product specifications, manufacturing, and control procedures. The final APQR report generated as the output of this process compiles data from multiple sources, along with the summarized results of the review and the recommendations from distinct subject matter experts.

APQR is part of the Periodic Reviews offering that provides shared functionality to enable users to perform different types of periodic reviews in Vault. See Periodic Reviews Overview for more details.

APQR Objects

QualityOne uses the following core objects to support the APQR process:

APQR (apqr__v): This object stores information about an annual product quality review.
APQR Item (apqr_item__v): This object represents the supporting items for an annual product quality review.
- Document (document__v): This APQR Item object type represents a supporting document in an APQR.
Periodic Review Template (periodic_review_template__v): This object defines the template for a periodic review.
- APQR (apqr__v): This Periodic Review Template object type stores information about APQR type Periodic Review Templates.
Periodic Review Template Item (periodic_review_template_item__v): This object defines the individual supporting items to create with each APQR record created.
- Document (document__v): This Periodic Review Template Item object type represents a supporting document in a periodic review.

Setup Preparation

You can create a list of requirements for your organization’s APQR process to refer to while configuring APQR functionality, including:

Documents and data included in the final report
Order of documents in the final report
Document types for included documents
Lifecycle states for creating and finalizing data and documents

Configuration Overview

Configuring your Vault to use APQR involves the following steps:

Configure Teams for the APQR and APQR Item objects
Activate APQR document types
Configure APQR document fields
Configure the APQR Lifecycle
Configure the APQR object
Configure the Periodic Review Template object
Add document, binder, and record actions to the appropriate object lifecycle states
Configure user permissions

Note: Depending on your Vault’s creation date and which features are currently enabled and configured, some of the steps described in this article may be unavailable or already complete in your Vault.

Activating Document Types

To use the APQR functionality, you must activate the following document types:

APQR
APQR Binder
Final Report

Configuring Document Fields

Before configuring document generation actions, you must add an object field referencing the APQR object to each document type to be included in the final report. When a user performs the document generation action, Vault populates this field with a link to the originating APQR record.

To configure an APQR object reference field on a document type, do the following:

Navigate to Admin > Configuration > Document Setup > Document Fields.
Select the Document Type under Field Location. This should be one (1) of the APQR document types.
Click Add.
Select Existing Shared Field.
Select either the APQR or APQR Item field.
Click OK.

Note: Conflicting field requiredness between the APQR object and document types can cause the binder and final report generation actions to fail due to incomplete data. Ensure that you reconcile document field requiredness on your target document types to fields on the APQR and APQR Item objects for the Generate APQR Binder action to complete successfully.

You can optionally add the QMS Organization (qms_organization__v) field or the Internal Facility (internal_facility__v) field to APQR document types as needed to map field values referencing the Organization (qms_organization__qdm) or Facility (facility__v) objects from the APQR object onto supporting documents. Do not use the Organization (organization__v) field to map field values referencing the Organization object from the APQR object.

Configuring Document Lifecycle

Add the Generate Merged PDF Document action to an appropriate state in the APQR Lifecycle document lifecycle. This action generates the APQR final report and should be added to a state in which all documents and data for the APQR have been finalized.

Configuring the APQR Object

Make the following changes to the APQR object to support the APQR process:

Add the Generate APQR Binder user action.
Insert an APQR Item related object section into the APQR object layout.
Optionally add the Organization (qms_organization__v) field or the Internal Facility (internal_facility__v) field to the APQR object layout if you wish to map field values onto supporting documents. This lets users track the performance of an Organization or Facility as part of an APQR process. Do not use the Owning Facility (owning_facility__v) field for field value mapping purposes.

Configuring the Periodic Review Template Object for APQRs

Make the following changes to the Periodic Review Template object to support the APQR process:

Add the Create Record From Template user action.
Insert a Periodic Review Template Item related object section into the Periodic Review Template object layout for the APQR object type.
Optionally add the Organization (qms_organization__v) field or the Internal Facility (internal_facility__v) field to the Periodic Review Template object layout for the APQR object type if you wish to map field values onto generated APQRs. This lets users select an Organization or Facility value when creating a Periodic Review Template for use in an APQR process. Do not use the Facility (owning_facility__v) field for field value mapping purposes.

You can optionally configure fields as required to transfer data from the Periodic Review Template object and into a new APQR record when users create APQRs using the Create Record from Template action. If you do this, you must also add identical custom fields to the APQR object.

Configuring Object Lifecycles

The APQR process relies on several actions configured on the appropriate object lifecycle states.

APQR Lifecycle

Add the Generate APQR Binder user action to a state in the APQR object lifecycle after you have created all APQR Items.

APQR Item Lifecycle

Add the Generate Document from Report action to the APQR Item lifecycle in the appropriate states. Depending on the expected content of the resulting documents and availability of the sourced data, you can add the Generate Document from Report action as a user action to the Initial or In Progress state, or in other combinations as required by your organization.

Periodic Review Template Lifecycle

Add the Create Record From Template user action to the Periodic Review Template Lifecycle in an appropriate state so that users can create APQRs from established templates.

Limitations

The following limitations apply to APQR functionality:

You can only configure the Generate Merged PDF action on the APQR Lifecycle document lifecycle, and can only run it from the APQR Binder.
The document output of the Generate Merged PDF action can only be of the Final Report document type.

Configuring User Permissions

You must ensure users have the appropriate read and create permissions to access the appropriate objects and object fields in addition to the permissions outlined below:

For the Periodic Review Template object and its object types: Create, Edit, and Delete permission.
For the Periodic Review Items object and its object types: Create, Edit, and Delete permission.
For the APQR object and its object types: Create, Edit, and Delete permission.
For the APQR Items object and its object types: Create, Edit, and Delete permission.

Configuring Document Type Permissions for APQR

You must ensure users have the appropriate document type permissions to use the APQR feature in addition to the related permissions outlined:

Type	Permission	Controls
Document Types created by QualityOne Document Generation Actions (APQR)	Create Document	Ability to create documents for APQR Items
Document Type (APQR Binder)	Create Binder	Ability to create an APQR Binder with the Generate APQR Binder action
Document Type (Final Report)	Create Document	Ability to create a Final Report document using the Generate Merged PDF action

You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:

Type	Permission	Controls
Security Profile	Admin: Configuration: Document Lifecycles: Edit	Ability to modify document lifecycles.
Security Profile	Admin: Configuration: Document Types: Edit	Ability to modify document types.
Security Profile	Admin: Configuration: Object Lifecycles: Edit	Ability to modify object lifecycles.
Security Profile	Admin: Configuration: Objects: Edit	Ability to modify Vault objects.