20R2 Data Model Changes: Quality

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Quality data model. These data model updates are automatically included in all Quality Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 20R2.

Administrator visibility of the following components has been updated:

• The Pending Change Control Approval State, In Change Control Approval State, and Change Control Approved State Document Lifecycle State Types are now visible in the Admin section of all Quality Vaults. These State Types are only meant for use with the Multi-Document Change Control feature in QualityDocs.
• The Ready for Training Document Lifecycle State Type is now visible in admin in all Quality Vaults. This State Type is only meant for use with Vault Training.
• The Recall Controlled Copies and CC: Set Change Control to Ready for Approval Entry Actions are now visible in the Admin section of all Quality Vaults. These Entry Actions will only run on QualityDocs Vaults.
• The Update Station Document Entry Action is now visible in the Admin section of all Quality Vaults. This Entry Action will only run on Station Manager Vaults.
• The Create Training Requirement Impact Assessment Record, Issue Training Assignments, and Retire or Assess Impact on Training Requirements Entry Actions are now visible in the Admin section of all Quality Vaults. These Entry Actions will only run on Vault Training Vaults.
• The Download Controlled Copy User Action is now visible in the Admin section of all Quality Vaults. This User Action can only be used on QualityDocs Vaults where the Extensible Controlled Copies feature is enabled.
• The Generate Controlled Copy User Action has been relabeled to Download Controlled Copy (Legacy) and is now visible in the Admin section of all Quality Vaults, except QualityDocs Vaults for which the Extensible Controlled Copies feature is enabled. This User Action can only be used on QualityDocs Vaults where the Extensible Controlled Copies feature is not enabled.
• The Preview E-Learning Content and Set E-Learning Standard User Actions are now visible in the Admin section of all Quality Vaults. This User Action can only be used on Vault Training Vaults.

Added the following data model changes to support the Risk Management: Detectability Support for Qualitative & Quantitative Risk Matrices feature:

• The Detectability (detectability__v) object has been added as a child object of Risk Matrix (risk_matrix__v) to Quality Vaults, tied to the QMS Application.
• The Risk Matrix Setup (risk_matrix_setup__v) object now has the Detectability (detectability__v) field for modeling matrices with a detectability axis.
• The Risk Event object now has additional fields (detectability_before__v and detectability_after__v) for capturing values necessary to calculate an event’s Risk Levels.

These changes will not immediately affect end-users, and must be configured (fields added to types of the described objects and, if applicable, risk level formulas updated to account for detectability scores on risk events, etc.) before they will modify system behavior.

The following data model changes support the Auto-Close Completed MDCCs feature:

Added a new standard field on the Document Change Control object:

• Closure System Details (closure_system_details__v)

The following data model changes support the Synchronize MDCC & Document States feature:

Added a new standard document lifecycle state type, available when the Use Document Change Control option is enabled:

• In Change Control Approval State (in_change_control_approval_state__v)

The following data model changes support the E-Learning Standards Support feature:

Added the following new objects:

• Training Completion Criteria (training_completion_criteria__v)
• Training Completion Criteria Detail (training_completion_criteria_detail__v)
• Training Content Status (training_content_status__v)
• E-Learning Status Details (e_learning_status_detail__v)

Added the following new object lifecycles:

• Training Completion Criteria Lifecycle (training_completion_criteria_lifecycle__v)
• Training Completion Criteria Details Lifecycle (training_completion_criteria_details_lc__v)
• Training Content Status Lifecycle (training_content_status_lifecycle__v)
• E-Learning Status Details Lifecycle (e_learning_status_detail_lifecycle__v)

Added the new standard field Training Completion Criteria (training_completion_criteria__v) on the Training Content Set-Document object.

Added the following data model changes to support the QRM: Process FMEA Assessment Methodology Support feature:

• The Business Process (business_process__v) object has been added to all QMS Vaults, for the purpose of acting as an identifier for which process is being assessed in an FMEA’s scope. This object includes standard fields for use with the FMEA feature set.
• The FMEA Risk Assessment (fmea_risk_assessment__v) object has been added to all QMS Vaults, for the purpose of modeling a business processes’ risk assessment following the FMEA methodology. This object includes standard fields for use with the FMEA feature set.
• The FMEA Risk Assessment Lifecycle (fmea_risk_assessment_lifecycle__v) and relevant standard states have been added to all QMS Vaults, for the purpose of modeling the lifecycle of Vault QRM’s FMEA Risk Assessment object.
• The FMEA Process Step (fmea_process_step__v) object has been added to all QMS Vaults, for the purpose of identifying the individual steps of a process being assessed in an FMEA’s scope. This object includes standard fields for use with the FMEA feature set.
• The FMEA Risk Event (fmea_risk_event__v) object has been added to all QMS Vaults, for the purpose of modeling a business processes’ risks, as identified by process step, failure mode, failure effect, failure cause and failure controls. This object includes standard fields for use with the FMEA feature set regarding Risk Matrix definition, FMEA specific data elements and Risk Priority Number calculation.
• The FMEA Risk Event Lifecycle (fmea_risk_event_lifecycle__v) and relevant standard states have been added to all QMS Vaults, for the purpose of modeling the lifecycle of Vault QRM’s FMEA Risk Event object.
• The QRM Risk Category (qrm_risk_category__v) object has been added to all QMS Vaults, for the purpose of acting as information for the categorization of individual risks identified by the customer’s organization. This object includes standard fields for use with the FMEA feature set.
• The FMEA Risk Event – QRM Risk Category (fmea_risk_event_risk_category__v) object has been added to all QMS Vaults, for the purpose of linking identified risks in assessments with higher-level categorizations described by the QRM Risk Category object. This object includes standard fields for use with the FMEA feature set.
• The FMEA Mitigation Action Set (fmea_mitigation_action_set__v) object has been added to all QMS Vaults, for the purpose of modeling a summary of actions taken to mitigate a particular Failure Mode, Effect & Cause. This object includes standard fields for use with the FMEA feature set.
• The FMEA Risk Mitigation Action Lifecycle (fmea_mitigation_action_lifecycle__v) and relevant standard states have been added to all QMS Vaults, for the purpose of modeling the lifecycle of Vault QRM’s FMEA Mitigation Action Set object.

These changes will not immediately affect end-users, and must be configured (fields added to types of the described objects and, if applicable, Risk Priority Number (RPN) field formulas updated to account for detectability scores on risk events, etc.) before they will modify system behavior. The following data model changes support the Facilitated Training feature:

• Added the following new objects:
  • Facilitated Training Request (facilitated_training_request__v)
  • Facilitated Training Request-Training Assignment (facilitated_training_request_training_assignment__v)
• Added the following new object lifecycles:
  • Facilitated Training Request Lifecycle (facilitated_training_request_lc__v)
• Updated the following objects:
  • Training Assignment (training_assignment_v) updated with the following fields:
    • Completion Source (completion_source__v)
    • Facilitated Training Request (facilitated_training_request__v)
  • Person (person__sys) object updated with the following field:
    • Person is not a Vault user (person_is_not_a_vault_user__v)
• Updated the following lifecycles:
  • Training Assignment Lifecycle (training_assignment_lifecycle__v)
    • Added the “Person is not a Vault user is No” condition to Entry Action for the Assigned state

The following data model change supports the Training Assignment Lifecycle User Actions feature:

• Updated the Training Assignment Lifecycle (training_assignment_lifecycle__v):
  • User actions are now editable for any lifecycle state

The following data model changes support the Assignment Details Lifecycle State No Longer Updated feature:

• Updated the Assignment Details (assignment_details__v) object with the following field:
  • Training Assignment Lifecycle State (training_assignment_lifecycle_state__v)
• Updated the Training Assignment Lifecycle (training_assignment_lifecycle__v) object lifecycle:
  • Removed the Change Related Object Lifecycle State entry action for the Assignment Details object for the Assigned, Completed, Cancelled states

Added the following data model change to support the QMS application:

• The Name field on the Regulatory Impacted Country object is now editable to support auto-naming using the System Managed Field attribute for usage of the object when it is not being automatically named from the RIM Integration.

The following data model changes in QMS were added to support MedTech and Medical Devices utilizing QMS in future releases:

• Quality Event (quality_event__qdm) object:
  • Fields added for Medical Devices and their processes
  • Quality Event object types added:
    • Nonconformance (nonconformance__v)
    • Medtech Complaints (mt_complaint__v)
• Context object:
  • Fields added for Medical Devices
  • Context object type added:
    • Parts/Component (part__v)
• New objects added:
  • Correction (correction__v)
  • Product Return (product_return__v)
  • Containment (containment__v)

The following data model changes support the Classroom Training feature: Added the View Classroom Training Assignment (view_classroom_training_assignment__v) workflow. Updated the Training Assignment Lifecycle (training_assignment_lifecycle__v), adding the auto-start workflow View Classroom Training Assignment to entry actions for the Assigned state. The following data model changes support the Substitute Training feature: Added the following new objects:

• Training Rule Set (training_rule_set__v)
• Training Rule (training_rule__v)
• Related Training Assignment (related_training_assignment__v)

Updated the following objects:

• Training Requirement (training_requirement__v) updated with the following field:
  • Is a substitute Training Requirement (is_a_substitute_training_requirement__v)
• Training Assignment (training_assignment__v) updated with the following field:
  • Creation Source (creation_source__v)

Added the following new object lifecycles:

• Training Rule Set Lifecycle (training_rule_set_lifecycle__v)
• Training Rule Lifecycle (training_rule_lifecycle__v)

Updated the Training Assignment Lifecycle (training_assignment_lifecycle__v) object lifecycle, adding the Pending Substitute Completion (pending_substitute_completion_state__v) state. Relaxed many constraints around the editability of object and field attributes surrounding the QRM: Process FMEA Assessment Methodology Support feature:

• For the QRM Risk Category (qrm_risk_category__v) object:
  • Lifecycle is now editable
  • Uniqueness enforcement, Maximum Length have been made editable for the field: Description
• For the FMEA Risk Event (fmea_risk_event__v) object:
  • The ability to use object types has been made editable
  • The ability to use System Managed Naming has been made editable
  • Uniqueness enforcement has been made editable for the field: Scoring Matrix
  • Uniqueness enforcement has been made editable for the field: Process Step
  • Uniqueness enforcement, Requiredness, Maximum Length and Health Information attributes have been made editable for the field: FMEA Failure Mode
  • Uniqueness enforcement, Requiredness, Maximum Length and Health Information attributes have been made editable for the field: FMEA Failure Effect
  • Uniqueness enforcement, Requiredness, Maximum Length and Health Information attributes have been made editable for the field: FMEA Failure Cause
  • Uniqueness enforcement, Requiredness, Maximum Length and Health Information attributes have been made editable for the field: FMEA Failure Control
  • Uniqueness enforcement, Requiredness attributes have been made editable for the field: Risk Response
  • Uniqueness enforcement has been made editable for the field: Initial Severity
  • Uniqueness enforcement has been made editable for the field: Initial Occurrence
  • Uniqueness enforcement has been made editable for the field: Initial Detectability
  • Minimum Value, Maximum Value, decimal configuration attributes have been made editable for Initial RPN (initial_rpn_quantitative__v)
  • Uniqueness enforcement and Requiredness attributes have been made editable for Initial RPN (initial_rpn_qualitative__v)
  • Maximum Length has been made editable for the field: Initial RPN (initial_rpn__v)
  • Uniqueness enforcement, Requiredness attributes have been made editable for the field: Original FMEA Risk Event
• For the FMEA Risk Event – QRM Risk Category (fmea_risk_event_qrm_risk_category__v) object
  • The ability to use System Managed Naming has been made editable
• For the FMEA Risk Assessment (fmea_risk_assessment__v) object
  • The ability to use System Managed Naming has been made editable
  • Uniqueness enforcement, Requiredness and Maximum Length have been made editable for the field: Description
  • Uniqueness enforcement, Requiredness have been made editable for the field: Original FMEA Risk Assessment
  • Uniqueness enforcement, Requiredness have been made editable for the field: Business Process
  • Uniqueness enforcement, Requiredness have been made editable for the field: Assessment Scoring Matrix
• For the Business Process (business_process__v) object
  • Uniqueness enforcement, Maximum Length have been made editable for the field: Description
• For the FMEA Process Step (fmea_process_step__v) object
  • The ability to use System Managed Naming has been made editable
  • Uniqueness enforcement, Maximum Length have been made editable for the field: Description
  • Minimum & Maximum value, as well as decimal configurations have been made editable for the field: Step Order
• For the FMEA Mitigation Action Set (fmea_mitigation_action_set__v) object
  • The ability to use System Managed Naming has been made editable
  • Uniqueness enforcement, Maximum Length have been made editable for the field: Description
  • Uniqueness enforcement, Requiredness have been made editable for the field: Original Mitigation Action Set

These changes are immediately available to Administrators, but otherwise do not affect the Vault’s function unless Admins make configuration changes.