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How to Create a Quality Activity

Step-by-step guide to creating a Quality Activity (such as a deviation, CAPA, or change control), generating its documents, linking related records, and closing it out.

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Written by Casey Huxtable

Required Roles: Quality Manager or Document Manager

Required Permissions: Edit access to the Quality Activity subtype you are creating (for example, Deviation or CAPA) and to the Controlled Documents cabinet where its records are filed

Quality Activities are the records your quality system runs on: deviations, CAPAs, change controls, complaints, audits, risk assessments, and more. This article walks through creating an activity from start to finish.

Overview

Each activity combines structured metadata (for tracking and trending) with controlled documents (the forms, investigations, and approvals). Activities can be linked to form a traceable chain, for example from Deviation to CAPA to Change Control to Effectiveness Check, supporting a full audit trail and traceability. For a conceptual overview, see Quality Activities Overview.

Create and manage a quality activity

Step 1 – Create the activity

  1. Navigate to Quality > Quality Activity.

  2. Click + Create Quality Activity.

  3. Select the Subtype (for example, Deviation).

  4. Enter a Name. If your workspace uses auto numbering, Kivo applies the subtype code and next sequence number (for example, DEV-2026-0042).

  5. Click Create. The activity record opens.

  6. Complete the required metadata (marked with an asterisk) and any additional fields, such as date of occurrence, area or site, classification, owner, and description.

Note: If you see Cannot create activity. No subtypes configured or accessible., ask your Workspace Manager to grant you access to the subtype or to configure it. See Managing permissions for sites and activities.

Step 2 – Add the activity to a cabinet

Adding the activity to a cabinet creates the folder where its documents are filed.

  1. On the activity, click Add to Cabinet.

  2. Choose the Cabinet Type and Cabinet (usually Controlled Documents).

  3. If prompted, select the folder Template for this subtype.

Kivo builds the folder using your configured naming convention and links it to the activity under Cabinets.

Step 3 – Generate the form

  1. On the activity, click Generate Document.

  2. Choose the template (for example, Deviation Report Form) and the destination Folder.

  3. Kivo creates a new document from the latest approved template and fills in activity metadata such as the activity number, title, dates, and owner.

  4. Complete the form in Microsoft Word or the browser, then route it through the workflow for review, approval, and e-signature.

To attach documents that already exist (for example, a batch record or an SOP referenced in the investigation), use Link to Existing Document.

Step 4 – Link related activities

When one event leads to another, keep them connected rather than starting from scratch.

  1. On the activity, click Create Related Activity to open a new linked activity (for example, a CAPA arising from this deviation). Relevant metadata is carried forward.

  2. To connect two activities that already exist, use Link to Existing Activity.

Related activities appear under Related Activity on each record, giving you a traceable chain such as Deviation to CAPA to Change Control to Effectiveness Check.

Step 5 – Update and close

  1. As work progresses, update status and dates (for example, investigation complete, root cause, CAPA plan approved).

  2. When all documents are approved and any related actions are complete or tracked separately, record the closure date and set the status to closed.

Tracking and reporting

  • The Quality Activity list is filterable by subtype and metadata for day-to-day tracking.

  • In Reports, activity reports show open and closed items, aging, and trends. CAPA reporting includes views such as CAPAs per Month and CAPAs by Risk Level.

  • Activities deleted in error can be found under View Deleted Activities and restored by a user with the appropriate access.

Best practices

  • Open the record promptly. Most quality systems require events to be documented as soon as they are identified (often within one business day), even if the investigation comes later.

  • Classify consistently. Use the configured classification and risk fields rather than free text so trending is meaningful.

  • Investigate to root cause. Use a structured method (for example, 5 Whys or a fishbone diagram) and record the root cause category, not just the narrative.

  • Link, do not duplicate. Create CAPAs and change controls as related activities so the full story is visible from any record.

  • Verify effectiveness. For CAPAs, plan an effectiveness check with defined success criteria before closing.

  • Watch aging. Review open items and due dates in reports at a regular quality meeting.

Linking a Quality Project to this activity

For complex activities that involve multiple people, sequential tasks, or a defined timeline, you can create a Quality Project and link it to this activity. A Quality Project gives you a structured plan with events, milestones, tasks, a Kanban board, and a Gantt chart alongside the activity record.

To create a linked project, open the activity and navigate to the Projects tab. From there you can create a new project or attach an existing one. See Quality Projects overview for a full introduction to the feature.

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