Reporting Deviations

When any departure from approved procedures, specifications, or standards is identified, it must be documented as a deviation. This page walks through the full reporting process, from choosing a form template to submitting the record.

What You Can Do

• Report a deviation with a structured form including title, description, severity, and detection date.
• Use form templates to standardize reporting across your organization.
• Link to SOPs/Documents to connect the deviation with the relevant procedure.
• Receive AI severity suggestions powered by machine learning based on your description.
• View similar historical deviations to understand patterns and prior resolutions.
• Attach files such as photos, documents, or evidence through template-based fields.
• Provide delay reasons when reporting more than 24 hours after detection.

Step-by-Step: Report a New Deviation

1. Navigate to the Form

1. Go to Deviation Management from the main navigation.
2. Click Report New Deviation.

2. Select a Form Template (Optional)

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

• Select an existing template from the dropdown to load pre-configured sections and fields.
• Create a new template by clicking the create button to open the template builder.
• Use basic form by deselecting the template to work with only the standard fields.

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.

3. Fill in Deviation Details

Complete the required fields in the Deviation Details section:

Field	Required	Description
Title	Yes	A concise, descriptive title (e.g., “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.

4. 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 (e.g., Title, Description, Severity) in both the basic section and the template sections. The basic fields are used for submission; template fields add supplemental data.

5. Review AI Suggestions

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

• Suggested Severity Classification — An AI-recommended severity level with an explanation of the reasoning. Click Use Suggestion to apply it.
• Similar Historical Deviations — A list of up to 3 similar past deviations with similarity percentages, helping you identify patterns.

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.

6. Provide a Delay Reason (If Required)

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

• Explain why the deviation was not reported within 24 hours of detection.
• 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.

7. Submit the Deviation

1. Review all entered information.
2. Click Report Deviation.
3. The system creates the deviation record and uploads any attached files.
4. You are automatically redirected to the new deviation’s detail page.

Use Clear Form to reset all fields if you need to start over. Use 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.

After Reporting

Once submitted, the deviation enters the 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