Corrective Action Requests in CAPA Management

Overview

A Corrective Action Request (CAR) is used to tackle recurring or systemic quality issues. It starts when a problem - usually identified as a nonconformance needs a thorough investigation and lasting fix. CARs help identify root causes and implement solutions to prevent the issue from happening again, improving overall quality and system reliability. 

When to Initiate a CAR

Not all quality issues require a CAR. A CAR is typically initiated when:

• The Nonconformance (NCR) is systemic or recurring
• The issue significantly affects product safety, compliance, or customer satisfaction
• An external stakeholder (e.g. a supplier) is responsible for the root cause
• Audit findings or trend data indicate the need for corrective action

Logging a New CAR

One of the most common starting points for a CAR is a Nonconformance (NCR) record. To create a CAR from an NCR:

Step 1: Click on the Hamburger Menu > CAPA > click Nonconformances > then select the relevant record using the edit pencil icon. 

Step 2: Once inside the NCR record, click CARs in the left-hand pane. This action creates a new CAR record automatically linked to that NCR.

Then, click + Create New.

Step 3: A new CAR 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:

• General Information

• CAR Information

• Financial Impact & Response 

Be thorough—accurate information ensures proper tracking and resolution.

Step 5: Click Save. A blue "Save Successful" message will confirm that the CAR has been recorded.

Internal Review: Validating the CAR

Now that the CAR has been logged, the next step is the review process, which varies based on whether your team or a supplier is responsible. 

• Internal CAR: Your team completes the response directly within the system.
• External CAR: The supplier submits their response through the system.

Internal CAR

Step 1: In the Response Approval section, determine how to proceed:

• Accept and Close: if the corrective action is sufficient and complete
• Resend to Supplier: if additional clarification or action is needed

Step 2: Complete the remaining fields of the Response Approval section, if needed.

Step 3: Click Save to record your decision - whether accepting or resending the CAR. 

• If accepted, close the related Complaint and Nonconformance records to complete the CAPA process.
• To automate this step, learn how to set up workflows in this article. 

External CAR

Step 1: Go to the CAR Response section and review the supplier's submitted response.

Step 2: In the Response Approval section:

• Accept & Close: if the CAR response is sufficient.
• Re-send for Follow Up: if it's not sufficient. This can be done repeatedly until you're ready to Accept & Close. Add comment as well, if needed. 

Step 3: If a CAR is sent back for follow-up, the supplier completes the Follow Up Response section.

Step 4: Click Save to record your decision - whether accepting or resending the CAR. 

• If accepted, close the related Complaint and Nonconformance records to complete the CAPA process.
• To automate this step, learn how to set up workflows in this article.