Deviation Investigation

Effective deviation management requires thorough investigation to identify root causes and prevent recurrence. InnoQualis EQMS provides AI-powered root cause analysis tools and a comprehensive timeline view to support your investigation process.

What You Can Do

• Generate AI root cause analysis using 5 Whys or Fishbone (Ishikawa) diagram methodologies.
• View root cause findings including identified causes, contributing factors, and recommendations.
• Regenerate analysis to refine findings as new information becomes available.
• Review the deviation timeline with a complete audit trail of all events.
• Track linked CAPA events alongside deviation events in a unified timeline.

AI Root Cause Analysis

The Root Cause Analysis panel uses AI to analyze deviation data and generate structured investigation findings.

Selecting an Analysis Type

Before generating, choose one of two methodologies:

Method	Best For
5 Whys	Linear cause-and-effect chains where successive “why” questions reveal the root cause.
Fishbone Diagram	Complex deviations where multiple categories of factors may contribute to the problem.

Generating an Analysis

1. Open the deviation detail page.
2. Navigate to the Root Cause Analysis panel.
3. Select the analysis type from the dropdown: 5 Whys or Fishbone Diagram.
4. Click Generate Analysis.
5. The AI processes the deviation data and produces a structured analysis.

Note

Root cause analysis generation requires appropriate permissions. If the Generate button is not visible, contact your system administrator.

Understanding 5 Whys Results

The 5 Whys analysis presents:

• Sequential “Why” questions — Each level drills deeper into the cause chain, displayed as Why 1 through Why 5 (or fewer if the root cause is reached earlier).
• Root Cause — The fundamental cause identified at the end of the chain, highlighted in a summary box.
• Recommendations — Actionable suggestions for addressing the root cause, listed as bullet points.

Understanding Fishbone Diagram Results

The Fishbone analysis organizes contributing factors into categories:

• Categories — Factors are grouped by type (e.g., People, Process, Equipment, Materials, Environment, Management). Each category is displayed in its own section.
• Contributing Factors — Individual factors within each category are listed as bullet points.
• Root Cause — The primary root cause identified across all categories.
• Recommendations — Suggested corrective and preventive actions.

Regenerating Analysis

If new information becomes available or the initial analysis needs refinement:

1. Scroll to the bottom of the existing analysis.
2. Click Regenerate Analysis.
3. The AI produces an updated analysis incorporating the latest deviation data.

Tip

Consider regenerating the analysis after updating the deviation description, adding comments with new findings, or completing an initial investigation. The AI uses all available deviation data to produce its analysis.

Deviation Timeline

The timeline provides a chronological audit trail of all events related to a deviation, including linked CAPA events.

Viewing the Timeline

1. Open the deviation detail page.
2. The timeline panel displays events in chronological order.

Note

The timeline is only visible to users with trail viewing permissions. If the timeline is not displayed, contact your administrator.

Timeline Events

Each event in the timeline includes:

Element	Description
Event Icon	Visual indicator of the event type (create, update, approve, reject).
Event Title	Describes what happened (e.g., “Deviation Created”, “Status Changed to approved”).
Timestamp	Exact date and time of the event.
User	Email of the user who performed the action.
Description	Additional context such as the previous status or added resolution.

Linked CAPA Events

When a CAPA is associated with the deviation, CAPA-related events are merged into the timeline and sorted chronologically alongside deviation events. This provides a unified view of the complete investigation and resolution process.

The timeline displays:

• CAPA creation events
• CAPA status changes
• CAPA action updates

CAPA Information Section

Above the timeline, a Linked CAPA section shows:

• CAPA ID and title
• Current CAPA status
• CAPA creation date

If no CAPA is linked, the section displays “No CAPA linked.”