Overview
A Complaint is an external report from a customer or consumer expressing dissatisfaction or concern with a product or service. Each complaint signals that something may not be working as intended, and thorough documentation is the first step toward resolving underlying issues.
See the Types of Complaint Reports below for examples. These categories are fully customizable based on your organization's needs - what's shown here represents just a few common examples.
Logging a New Complaint Record
To log a new Complaint:
Step 1: Click on the Hamburger Menu > CAPA > click Complaints > click New.
Step 2: Select one of the five Reference Types displayed. Click Continue to proceed.
What is a Reference Type?
In TraceGains, a Reference Type connects your Complaint to a related record from another part of the system (e.g., an Audit, COA, Item Supplied, or Supplier/Site). This link helps provide context, traceability, and a clearer picture of the issue’s origin.
If you're unsure at the time of creation, you can select "No Reference" and add one later.
Only 1 reference can be assigned per record.
Step 3: Fill in all required fields marked with an asterisk (*) in the following sections:
- General Information
- Complaint Status & Details
Be thorough—accurate entry here ensures proper tracking and resolution.
Step 4: Optional - You can also upload any supporting photos. Once your Complaint record is saved, you can upload supporting documentation as well.
Step 5: Click Save. A blue "Save Successful" message will confirm that the complaint has been recorded.
Internal Review: Validating the Complaint
Now that the complaint has been logged, it moves into the internal review phase.
This step is critical—it determines whether the issue warrants further investigation or if the complaint can be resolved and closed.
Next, we’ll walk through how to complete an internal review and validate the complaint.
Step 1: In the Internal Review section, use the dropdown menu to select the appropriate Complaint Approval Status:
- Approved – NCR Needed: The complaint is valid and requires a nonconformance record to be created.
- Approved – No NCR Needed: The complaint is valid, but no further corrective action is necessary.
- More Information Needed: Additional details are required before a final decision can be made.
- Rejected: The complaint is not valid or does not require further action.
Step 2: Now, navigate to the Complaint Follow-Up section.
You can complete this section at any point, depending on your internal process.
In the Follow-Up Status field, select the appropriate status from the dropdown menu as shown below:
Step 3: Complete the remaining fields listed below. Then, click Save.
- Comment
- Closed By
- Close Date
When Complaints Lead to Next Steps
Not all complaints will escalate to further actions, but some may require additional investigation:
- Monitor Only – Track the complaint for trends or recurring patterns over time.
- Link to Nonconformance – Escalate when internal validation confirms a legitimate issue that needs to be formally documented.
- Initiate a CAR – Take corrective action when systemic or recurring problems are identified.
To learn more:
- Read Nonconformances in CAPA Management to see how to start a Nonconformance.
- Read Corrective Action Requests (CARs) in CAPA Management to learn how to initiate a CAR when needed.