Reporting Deviations

When any departure from approved procedures, specifications, or standards is identified, it must be documented as a deviation. This page covers how to report a new deviation, use form templates, review AI suggestions, and handle delayed reporting.

Report a new deviation

1. On the left sidebar, select Deviations.
2. Select Report New Deviation.
3. Optionally, select a form template (see below).
4. Complete the deviation details.
5. Review AI suggestions if available.
6. Select Report Deviation.

The system creates the deviation record, uploads any attached files, and redirects you to the new deviation’s detail page.

Select a form template (optional)

The Form Configuration section lets you choose a template or use the basic form.

1. In the template selector, select a template from the dropdown to load pre-configured sections and fields.
2. To create a new template, select the create button to open the template builder.
3. To use only the standard fields, deselect the template.

Tip

Form templates let your organization standardize deviation reporting. Templates can include custom sections, required fields, file upload areas, and linked document/CAPA selectors. Ask your administrator to create templates for common deviation types.

Complete deviation details

Fill in the required fields in the Deviation Details section:

Field	Required	Description
Title	Yes	A concise, descriptive title (for example, “Temperature excursion in freezer unit”).
Description	Yes	Detailed account of what happened, when, where, and any immediate actions taken.
Severity Level	Yes	Select from Low, Medium, High, or Critical.
Related SOP/Document	No	Link the deviation to the relevant procedure or document.
Date Detected	Yes	When the deviation was first identified. Cannot be in the future.

Complete template fields (if using a template)

When a form template is active, additional sections appear below the basic fields. These may include:

• Custom text fields, dropdowns, and checkboxes.
• File upload areas for evidence and photos.
• Linked document and CAPA selectors.
• Image caption fields for uploaded photos.

Note

When using a template, you may see similar fields (for example, Title, Description, Severity) in both the basic section and the template sections. The basic fields are used for submission; template fields add supplemental data.

Review AI suggestions

As you type the title and description, the system automatically analyzes your input and provides:

1. Suggested Severity Classification — an AI-recommended severity level with an explanation of the reasoning. Select Use Suggestion to apply it.
2. Similar Historical Deviations — a list of up to 3 similar past deviations with similarity percentages.

Tip

AI suggestions appear after a short delay while you type. They update automatically as you refine your description. These are recommendations — you always have final control over the severity classification.

Provide a delay reason

If the Date Detected is more than 24 hours before the current time, a Reason for Delayed Reporting field appears.

1. In the highlighted panel, enter an explanation for why the deviation was not reported within 24 hours of detection.
2. The delay reason is recorded in the audit trail and associated with the deviation record.

Caution

Deviations detected more than 24 hours ago require a delay justification before the form can be submitted. This is a regulatory requirement to ensure timely incident reporting.

Reset or cancel the form

• Select Clear Form to reset all fields and start over.
• Select Cancel to return to the deviation list without saving.

Validation rules

The form enforces the following validations before submission:

• Title is required and cannot be empty.
• Description is required and cannot be empty.
• Date Detected is required and cannot be in the future.
• Delay reason is required when reporting more than 24 hours after detection.
• All template fields marked as required must be completed.

Practical example: reporting a manufacturing deviation

Scenario: An operator on the tablet compression line notices that the hardness readings for the last 30 minutes are trending below the lower specification limit (6 kP vs. the 8-12 kP range). The batch is CBT-2026-0455.

Step-by-step

1. On the left sidebar, select Deviations.
2. Select Report New Deviation.
3. In the template selector, choose Manufacturing Process Deviation (if your organization has configured this template).
4. Fill in the deviation details:
   • Title: Tablet hardness below specification — Batch CBT-2026-0455
   • Description: Tablet hardness readings from compression machine CM-02 have been trending below specification for approximately 30 minutes. Recent readings: 5.8, 6.1, 5.9, 6.0 kP against a specification of 8-12 kP. Compression was halted at 14:30. Approximately 12,000 tablets produced during the affected period have been segregated and quarantined in Hold Area B.
   • Severity Level: High
   • Related SOP/Document: SOP-TAB-010 Tablet Compression Operations
   • Date Detected: 2026-03-07
5. The AI suggests High severity and flags a similar deviation from 2025-11 involving compression force drift on the same machine. Review these suggestions.
6. Select Report Deviation.

The deviation is created in Open status. From the detail page, add a comment tagging the maintenance team to inspect CM-02 compression rollers.

After reporting

Once submitted, the deviation enters Open status and appears on the deviation list. From the detail page, you can:

• Update the status (with appropriate permissions).
• Create a CAPA to drive corrective and preventive actions.
• Add comments to collaborate with your team.
• Submit a delay reason if the system detects the deviation is overdue.
• View the audit timeline to track all changes.