Overview
A Nonconformance (NCR) is a documented deviation from an expected product, process, or result. It signifies that something did not meet a defined standard. This could be due to an internal error, supplier issue, quality defect, or food safety concern. Managing NCRs effectively ensures continuous improvement and maintains compliance with quality standards.
See the Sources and Examples of Nonconformance Issues below:
Logging a New Complaint Record
One of the most common starting points for a nonconformance record (NCR) is a complaint. To create an NCR from a complaint record, navigate as follows:
Step 1: Click the Hamburger Menu > CAPA > Complaints, then select your complaint record by clicking the edit pencil icon.
Step 2: Once inside the complaint record, click Nonconformances in the left-hand pane. This action creates a new nonconformance record automatically linked to that complaint.
Then, click + Create New.
Step 3: A new NCR record number will automatically generate. Click on the blue edit pencil.
Step 4: Fill in all required fields marked with an asterisk (*), including key details in these sections:
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General Information
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NCR Status & Data
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NCR Evaluation & Analysis
Be thorough—accurate information ensures proper tracking and resolution.
Step 5: Click Save. A blue "Save Successful" message will confirm that the NCR has been recorded.
Internal Review: Validating the Nonconformance
Now that the NCR has been logged, it moves into the internal review phase.
This step is important as it determines whether the issues requires further investigation or can be closed.
Next, we’ll walk through how internal teams validate and asses each nonconformance.
Step 1: From the dropdown menu, choose the appropriate NCR Review Status:
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Additional Analysis Needed – More investigation is required before next steps.
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Internal CAR – A corrective action is needed within your organization.
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No CAR – No corrective action is needed; the issue is minor or already resolved.
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SCAR – The supplier is responsible; a corrective action request will be issued to them.
Step 2: Enter a comment in the Complaint Approver Comment field—this is required and should briefly explain the rationale for the selected review status.
Then, fill out the Verified By field and select the appropriate Review Date.
Step 3: Complete the NCR Follow-Up section. After addressing the nonconformance with a completed CAR (IF an internal CAR was previously selected), update the Follow Up Status:
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If resolved without a CAR, select Closed.
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If a CAR is linked, select Pending until the CAR is complete, then update the status to Closed.
Step 4: Enter a brief Comment summarizing the resolution.
Fill in the Closed By and Close Date fields.
Finally, click Save.
When Nonconformances Lead to Corrective Actions
Some nonconformances can be resolved directly, while others—especially recurring or systemic issues—should result in a Corrective Action Request (CAR).
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Resolve Internally: Use this for isolated, easily corrected issues.
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Escalate to CAR: Use this when the issue has a broader impact or involves a root cause requiring formal action.
To learn how to create and manage a CAR, read Corrective Action Requests (CARs) in CAPA Management.