Vault QMS includes standard state types to allow Admins to configure supported object lifecycles to capture cycle time metrics and report on the efficiency of their processes.
How Cycle Time Metrics Work
Cycle time metrics are captured via the use of two standard state types:
- Cycle Time Start: When an object record enters the state selected for this state type, Vault begins counting the cycle time. When this happens, Vault creates and begins populating a cycle time metric object record, storing relevant data.
- Cycle Time Stop: When an object record enters the state selected for this state type, Vault stops counting the cycle time. Vault stores relevant data in the cycle time metric object record, and calculates additional useful data.
About the Cycle Time Metric Object
Vault automatically captures and calculates the following reportable data in cycle time metric objects as records enter the metric-triggering state types:
- Cycle Time Start Date: The date and time that the record entered the Cycle Time Start state type, starting the cycle timer.
- Cycle Time Stop Date: The date and time that the record entered the Cycle Time Stop state type, stopping the cycle timer.
- Cycle Time: The number of days between the starting and stopping of the cycle timer.
Vault captures reportable data for additional fields depending on the applicable cycle time metric object.
Supported Objects
Cycle time metrics are currently supported for the the following objects and object types.
Quality Events
Vault supports use of the Quality Event Cycle Time Metric object for the Quality Event object, custom Quality Event object types, all custom and standard object types of standalone event objects, and for the following standard Quality Event object types: Change Control, Complaint, Continuous Improvement, Deviation, External Finding, Internal Finding, Lab Investigation, Medtech Complaint, and Nonconformance. The following cycle time metric-related fields apply only to Quality Event Cycle Time Metric:
- Original Due Date: The value of the due date field when the cycle timer started.
- Current Due Date: The latest value of the due date field. This value is typically updated via Extension Requests.
- Cycle Time Delta from Original Due Date: The number of days an object record closes before or after the original due date. A negative value indicates a closure before the original due date.
- Cycle Time Delta from Current Due Date: The number of days an object record closes before or after the current due date, after any extensions. A negative value indicates a closure before the current due date.
- Extensions Granted: The number of extensions granted, typically updated via Extension Requests.
Standalone Event Objects
Vault supports use of the Quality Event Cycle Time Metric object for the Change Control, Change Plan, Deviation, Finding, Lab Investigation, Continuous Improvement, Nonconformance, and MedTech CAPA objects, using the same Quality Event Cycle Time Metric records and fields as with Quality Events, with the exception of the Extensions Granted field.
Audits
Vault supports use of the Audit Cycle Time Metric object for the Audit object and custom Audit object types. The following cycle time metric-related fields apply only to Audit Cycle Time Metric:
- Actual Start Date: The date that the Audit began.
- Actual End Date: The date that the Audit ended.
- Audit Preparation Cycle Time: The number of days between the Cycle Time Start Date and the Actual Start Date.
- Audit Reporting/Response Cycle Time: The number of days between the Actual End Date and the Cycle Time Stop Date.
- Planned vs. Actual Audit Duration Delta: The difference in the number of days between the Scheduled Start Date and Scheduled End Date and the Actual Start Date and Actual End Date.
- Planned vs. Actual Audit Start Delta: The number of days between the Scheduled Start Date and the Actual Start Date.
- Scheduled Start Date: The date that the Audit is scheduled to begin.
- Scheduled End Date: The date that the Audit is scheduled to end.