Complaints and Nonconformances

The Complaints module handles the recording, evaluation, investigation, and resolution of customer complaints, internal nonconformances, and field actions. It supports full regulatory reporting workflows including FDA, MDR, adverse event, and EU vigilance tracking.

File a complaint

1. On the left sidebar, select Complaints.
2. Select New Complaint.
3. From the Type dropdown, select the record type (Customer Complaint, Nonconformance, or Field Action).
4. From the Source dropdown, select the complaint source.
5. Enter a Title (required).
6. Enter a Description (required).
7. From the Classification dropdown, select the nature of the issue.
8. From the Severity dropdown, select the severity level.
9. From the Priority dropdown, select the priority level.
10. For Customer Complaint type records, fill in the Complainant Information section:
    • Name, Organization, Email, Phone, and Customer Reference #.
11. In the Product / Lot Traceability section, enter product details: Product Name, Product Code, Lot Number, Batch Number, Serial Number, and Quantity Affected.
12. In the Dates & Regulatory section, set Date Occurred, Date Reported by Customer, and Due By (SLA Deadline).
13. Under Regulatory Reporting Flags, check any that apply: Reportable to FDA, MDR Reportable, Adverse Event, EU Vigilance Reportable.
14. In the Immediate Action section, describe any containment or corrective actions already taken.
15. Select Create Complaint.

Caution

Regulatory reporting flags should be evaluated during initial intake. Complaints flagged for regulatory reporting are highlighted with a shield icon in the list view and tracked in the Regulatory dashboard statistic.

Filter and find complaints

1. On the left sidebar, select Complaints.
2. To search by complaint number or title, enter text in the Search complaints field.
3. To narrow results, use any combination of these dropdowns:
   • All Statuses — filter by workflow status.
   • All Types — filter by record type (Customer Complaint, Nonconformance, Field Action).
   • All Sources — filter by complaint source.
   • All Severities — filter by severity level.
4. To open a complaint, select its row in the table or select View in the Actions column.

Advance a complaint through the workflow

1. On the left sidebar, select Complaints.
2. Select the complaint you want to advance.
3. In the header area, select the appropriate transition button:

Current Status	Available Transitions
Received	Start Evaluation, Reject
Under Evaluation	Start Investigation, Skip to Resolution
Investigation	Move to Resolution
Resolution	Submit for Closure
Pending Closure	Close Complaint

Note

Rejecting a complaint requires entering a reason for rejection. This is recorded for audit trail purposes.

Reject a complaint

1. On the left sidebar, select Complaints.
2. Select the complaint you want to reject.
3. In the header area, select Reject.
4. In the Reject Complaint form, enter the Reason for rejection (required).
5. Select Confirm Rejection.

Set a disposition (nonconformances only)

1. On the left sidebar, select Complaints.
2. Select the nonconformance record you want to disposition.
3. In the Disposition section, select Set Disposition.
4. From the Disposition dropdown, select one of the following:

Disposition	Description
Use As-Is	Accept the nonconforming material/product for use
Rework	Material/product can be corrected through rework
Scrap	Material/product must be destroyed
Return to Vendor	Return to the supplier
Quarantine	Hold pending further evaluation

5. Enter a Justification (required).
6. Select Save Disposition.

Document root cause and resolution

1. On the left sidebar, select Complaints.
2. Select the complaint you want to update.
3. In the Resolution & Root Cause section, select Edit.
4. Enter the Root Cause Summary.
5. Enter the Resolution.
6. Select Save.

Add a comment

1. On the left sidebar, select Complaints.
2. Select the complaint you want to comment on.
3. In the Comments section, enter your comment in the text field.
4. Select Post.

Tip

Use comments to document key decisions, communication with customers, and internal discussions. Comments form part of the permanent audit trail for the complaint.

Record types

Type	Description
Customer Complaint	Complaint received from an external customer
Nonconformance	Internally identified quality deviation (supports dispositions)
Field Action	Issue identified in the field requiring corrective action

Complaint sources

Source	Description
Customer	Directly from a customer
Field Report	Identified through field monitoring
Regulatory	Originated from a regulatory body or inspection
Internal	Found through internal processes
Supplier	Reported by or related to a supplier

Severity levels

Severity	Description
Critical	Severe impact, immediate patient risk
High	Significant quality or safety concern
Medium	Moderate impact, requires investigation
Low	Minor issue, limited quality impact

Complaint classifications

Complaints can be further classified by the nature of the issue:

• Product Quality
• Safety
• Labeling
• Packaging
• Performance
• Delivery
• Service

Regulatory reporting flags

Flag	Description
Reportable to FDA	Complaint requires FDA notification
MDR Reportable	Medical Device Report required
Adverse Event	Classified as an adverse event
EU Vigilance Reportable	Requires reporting under EU vigilance requirements

Complainant information fields

This section only appears for Customer Complaint type records:

Field	Description
Name	Customer contact name
Organization	Company or organization
Email	Contact email address
Phone	Contact phone number
Customer Reference #	The customer’s own reference number for the complaint

Dashboard statistics

The complaint list page displays four summary statistics at the top:

Metric	Description
Total	Count of all complaint records
Open	Complaints not in Closed or Rejected status
Overdue	Open complaints past their SLA due date
Regulatory	Complaints flagged for any regulatory reporting (FDA, MDR, or Adverse Event)

Linking related records

From the API, complaints support linking to related quality records:

• Deviations — link a complaint to a related deviation
• CAPAs — link a complaint to a corrective/preventive action
• SCARs — link a complaint to a supplier corrective action request

These links maintain traceability between related quality events across the system.

Practical example: handling a customer complaint for a medical device

Scenario: A hospital reports that a batch of sterile surgical drapes has packaging seal failures, with three units found to have compromised sterile barriers upon opening. The complaint needs to be recorded, evaluated, investigated, and resolved with appropriate regulatory consideration.

1. File the complaint

1. Navigate to Complaints and select New Complaint.
2. Fill in the form:
   • Type: Customer Complaint
   • Source: Customer
   • Title: Sterile barrier packaging seal failure -- SterilDrape Pro
   • Description: St. Mary's General Hospital reports 3 out of 50 units from a single case of SterilDrape Pro (Lot SD-2026-1187) had visible seal delamination along the peelable chevron seal. Units were identified during pre-operative inspection and were not used on patients. Hospital requests replacement shipment and root cause investigation.
   • Classification: Packaging
   • Severity: High (sterile barrier compromise on a surgical device, though no patient exposure occurred)
   • Priority: Urgent (requires immediate investigation due to sterility implications)
3. Complete the Complainant Information:
   • Name: Jennifer Walsh, RN
   • Organization: St. Mary's General Hospital
   • Email: j.walsh@stmarys.example.com
   • Phone: +1 555 0142
   • Customer Reference #: SMH-QR-2026-0034
4. Complete the Product / Lot Traceability:
   • Product Name: SterilDrape Pro
   • Product Code: SDP-4560
   • Lot Number: SD-2026-1187
   • Quantity Affected: 3
5. Set the Dates & Regulatory information:
   • Date Occurred: 2026-03-03
   • Date Reported by Customer: 2026-03-05
   • Due By (SLA Deadline): 2026-03-19 (14-day SLA for High severity complaints)
6. Under Regulatory Reporting Flags, check Reportable to FDA and MDR Reportable (sterile barrier failure on a Class II medical device is MDR-reportable even without patient injury, per 21 CFR 803).
7. In Immediate Action, enter: Quarantined remaining inventory from Lot SD-2026-1187 across all distribution points (42 units located). Notified affected distribution centers. Replacement shipment of equivalent lot authorized.
8. Select Create Complaint.

2. Evaluate the complaint

1. Open the complaint and select Start Evaluation.
2. During evaluation, the quality team reviews the complaint details, confirms the regulatory reporting determination, and assesses whether other lots from the same production run may be affected.

3. Investigate and determine root cause

1. Select Start Investigation to advance the complaint to Investigation status.
2. After completing the investigation, select Edit in the Resolution & Root Cause section:
   • Root Cause Summary: Seal bar temperature on Packaging Line 2 drifted 8 degrees C below the validated range during the final 30 minutes of the production run for Lot SD-2026-1187. The drift was caused by a failing thermocouple (TC-PL2-04) that was intermittently reading high, preventing the temperature alarm from triggering. Seal integrity testing during in-process checks did not catch the defect because the sample was pulled from the start of the run.
   • Resolution: Replaced thermocouple TC-PL2-04. Performed 100% seal integrity inspection of quarantined inventory from Lot SD-2026-1187; 5 additional units with marginal seals identified and rejected (8 total out of 500 units). Remaining 492 units passed and were released. Updated in-process sampling plan (SOP-PKG-012 Rev 5) to include samples from start, middle, and end of each sealing run.
3. Select Save.

4. Resolve and close

1. Select Move to Resolution to advance the complaint.
2. Select Submit for Closure after confirming all actions are complete.
3. Select Close Complaint to finalize the record.

The complaint record now shows a complete audit trail from receipt through closure. Because it was flagged as MDR Reportable, it appears in the Regulatory count on the complaints dashboard. The associated CAPA and any linked deviation maintain full traceability through the Linked Records section.