Working with Continuous Improvements (QMS)

QMS supports both proactive and event-driven process improvements. Using the Continuous Improvement object:

  • You can create a proactive Continuous Improvement to identify opportunities for broad, systemic process improvements.
  • You can create a standalone CAPA Continuous Improvement when dependent CAPAs created from a quality event record do not sufficiently address the specific issue. A standalone CAPA is particularly useful when the original quality event record is closed, but you still must carry out an investigation or root cause analysis. Instead of reopening the original quality event record, you can create a standalone CAPA.

The following table outlines the conceptual process differences between proactive continuous improvements and standalone CAPAs.

Continuous Improvement Standalone CAPA
Trigger A proactive improvement to an existing process, even if it's working well, to increase efficiency, improve quality, or drive cost reduction. When event-dependent CAPAs do not sufficiently address a specific problem that poses a threat to product quality, patient safety, or regulatory compliance, and the quality event that identified the need for the CAPA is Closed.
Objective Enhance and optimize processes for long-term excellence, often with a focus on efficiency and productivity. Perform additional investigations to find the root cause of a specific problem and fix it to ensure it never happens again.
Scope Broadly targets an entire process or system to find opportunities for improvement that may not be immediately obvious. Narrow in scope and focused on a specific issue and its direct and immediate impact.

Use of Proactive Continuous Improvements & Standalone CAPAs

You can use the Source field on Continuous Improvement records to distinguish between proactive continuous improvements and standalone CAPAs. This field describes how the need for a standalone CAPA was first identified, and determines if an Investigation or Root Cause Analysis should be executed as part of a given Continuous Improvement record. If configured by your Admin, depending on the value you provide for the Source field, Vault might encourage you to reference appropriate related records and provide other information that is specific to either a proactive continuous improvement or a standalone CAPA.

Depending on your organization’s process, you can create Investigations from a standalone CAPA and initiate a Root Cause Analysis from the related Investigation record, or directly from the standalone CAPA. When you initiate a Root Cause Analysis from a standalone CAPA or related Investigation record, the resulting Root Causes identified are associated with the standalone CAPA record.

To use standalone CAPAs, you must activate the Standalone CAPA field on the Investigation, Root Cause Analysis, and Root Cause objects and add the field to the layout for these objects.

We recommend configuring related object sections on the Continuous Improvement object layout for the Investigation and Root Cause Analysis objects. Alternatively, you can add a Root Cause Analysis related object section to the Investigation object layout. With either configuration, Vault automatically relates any Root Cause Analyses and associated Root Causes to the originating standalone CAPA record.

You can add values to the Source picklist for use on the Continuous Improvement object for users to describe the purpose of a Continuous Improvement. Use the Source field to account for any differences in validation, required fields, layout presentations, or lifecycle operations between proactive continuous improvements and standalone CAPAs. For instance, you may wish to configure the Continuous Improvement object layout to display the Investigation and Root Cause Assessment related record sections for standalone CAPAs, and hide these sections for proactive continuous improvements.

To configure root cause analysis for a Continuous Improvement or an Investigation related to a Continuous Improvement, you must follow the configuration steps outlined in Configuring Root Cause Analysis.