Complaints

The Complaints module allows you to log, investigate, and resolve complaints from customers, distributors, field service, regulatory authorities, or internal sources. It provides a structured workflow for complaint handling that includes investigation, root cause analysis, disposition, regulatory reporting, and approval-based closure.

Overview

A complaint follows a structured lifecycle:

1. Received → Complaint is logged into the system
2. Under Review → Complaint is being evaluated for investigation need
3. Investigation → Investigation is underway
4. Root Cause Analysis → Root cause has been identified
5. Disposition → Disposition decision has been made (e.g., replace, rework, recall)
6. Pending Approval → Complaint resolution submitted for approval
7. Closed → Complaint is approved and closed

Alternatively, a complaint can be closed without investigation if justified.

Complaint Sources

Complaint Types

Severity Levels

Complaint Statuses

Logging a New Complaint

1. Navigate to QMS → Complaints from the sidebar
2. Click the Log Complaint button
3. Fill in the complaint details:

Basic Information

• Title (required) — A concise title (e.g., "Product discoloration reported by customer")
• Description (required) — Detailed description of the complaint
• Complaint Source (required) — Where the complaint came from (Customer, Distributor, etc.)
• Complaint Type (required) — Category of the complaint (Product Quality, Safety, etc.)
• Severity (required) — Critical, Major, or Minor

Product & Shipment Information

• Shipment — Link the complaint to a specific shipment (auto-fills customer if matched)
• Customer — Select the customer who filed the complaint
• Product — Select the product involved
• Batch Number — Enter the batch number of the affected product
• Serial Number — Enter the serial number (if applicable)
• Quantity Affected — Number of units affected

Contact Information

• Contact Name — Name of the person reporting the complaint
• Contact Email — Email of the reporter
• Contact Phone — Phone number of the reporter

Dates & Investigation

• Date Received — When the complaint was received
• Date of Event — When the issue occurred
• Country of Event — Where the event took place
• Investigation Required — Toggle whether investigation is needed
• Reportable to Authority — Toggle if the complaint must be reported to a regulatory authority
• Owner — Assign the complaint to a user for follow-up

4. Click Submit to log the complaint

Investigating a Complaint

Starting the Investigation

1. Navigate to QMS → Complaints and click on a complaint to view details
2. Click the Start Investigation button
3. The complaint status changes to "Investigation"

Submitting Investigation Results

1. On the complaint detail page, fill in:
   • Investigation — Detailed investigation findings
   • Root Cause Analysis — Identified root cause(s)
   • Correction — Immediate correction taken
2. Click Submit Investigation
3. The complaint status advances to "Root Cause Analysis"

Submitting Disposition

After investigation, decide on the disposition:

1. Click the Submit Disposition button
2. Select the disposition type:
   • No Action Required — No further action needed
   • Rework — Product will be reworked
   • Return — Product will be returned
   • Replace — Product will be replaced
   • Credit / Refund — Customer will receive credit or refund
   • Recall — Product recall initiated
   • Field Correction — Field correction will be performed
3. Add any additional disposition details
4. Click Submit
5. The complaint status changes to "Disposition"

Closing Without Investigation

If a complaint does not require investigation:

1. On the complaint detail page, click the Close Without Investigation button
2. Provide a Justification explaining why investigation is not needed
3. Click Submit
4. The complaint status changes to "Closed (No Investigation)"

Regulatory Reporting

If a complaint is reportable to a regulatory authority:

1. On the complaint detail page, toggle the Reportable to Authority flag
2. Click Add Regulatory Report to document the report
3. Fill in the report details:
   • Report Date — When the report was submitted
   • Authority — Which regulatory authority
   • Report Reference — Reference number of the report
   • Details — Report details
4. Click Save

You can add multiple regulatory reports and update them as needed.

Linking CAPAs

If a complaint requires corrective or preventive action:

1. On the complaint detail page, click the Link CAPA button
2. Select an existing CAPA to link, or create a new one
3. The linked CAPA will be shown on the complaint detail page for traceability

Linking Documents and Records

You can link relevant documents and records to a complaint:

• Link Document — Select a document from the Document Management system
• Link Record — Select a record from the Records system
• Unlink — Remove a linked document or record

Adding Comments

You can add comments to a complaint for ongoing communication:

1. On the complaint detail page, find the Comments section
2. Enter your comment
3. Click Add Comment
4. Comments are displayed in chronological order with the commenter's name and timestamp

File Attachments

You can upload and manage file attachments:

1. Click the Upload button in the Attachments section
2. Select a file to upload
3. Uploaded files can be downloaded or deleted

Submitting for Approval

Once the investigation and disposition are complete:

1. Click the Submit for Approval button
2. Select the Approval Workflow to use (workflows of entity type "Complaint")
3. Optionally add comments
4. Click Submit
5. The complaint status changes to "Pending Approval"

Approvers will review and either approve (closing the complaint) or reject (sending it back).

If e-signatures are enabled, approvers will need to enter their password when approving or rejecting.

Filtering and Searching Complaints

On the Complaints list page, you can:

• Search — Search by complaint title or number
• Filter by Status — Filter by any complaint status
• Filter by Severity — Filter by Critical, Major, or Minor

The list page also shows summary statistics:

• Total complaints
• Open complaints
• Critical complaints
• Closed complaints

Best Practices

• Log complaints promptly — Enter complaints into the system as soon as they are received
• Assess severity accurately — Critical complaints may have safety implications and require immediate action
• Investigate thoroughly — Document the investigation, root cause, and correction with sufficient detail
• Link to CAPAs — Ensure that complaints with systemic root causes have associated CAPAs
• Track regulatory reporting — For reportable complaints, document all communications with regulatory authorities
• Use approval workflows — Submit all complaint closures for formal approval
• Review trends — Periodically review complaint data to identify patterns and drive improvements

Next Steps

• Set up Approval Workflows for complaint closure approvals
• Learn how complaints link to CAPAs for corrective actions
• Review complaints during MRM meetings