Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all,

How do you handle a complaint that is associated with a Corrective Action? A complaint was initially received for an issue with a product and it was decided that a CAPA should be opened to address the root cause and determine the corrective actions, but can the complaint then be closed to the open CAPA? Or does the CAPA need to close before the complaint can be addressed?

Thank you

Greetings Anon,

The idea with a corrective action initiated from a complaint is there is further actions which need to be taken beyond the complaint investigation process.  Such as an identified issue has arisen, maybe a safety concern, or maybe a systemic issue.  Typically the complaint investigation is a shorter and the corrective action is longer.  So in essence the customer complaint could be closed out well before the corrective action is closed.  It does not mean the complaint can stay open, but usually the complaint is addressing one instance and the corrective action would be addressing the systemic issue.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 01-Dec-2021 14:12
From: Anonymous Member
Subject: Complaints associated with CAPAs

This message was posted by a user wishing to remain anonymous

Hello all,

How do you handle a complaint that is associated with a Corrective Action? A complaint was initially received for an issue with a product and it was decided that a CAPA should be opened to address the root cause and determine the corrective actions, but can the complaint then be closed to the open CAPA? Or does the CAPA need to close before the complaint can be addressed?

Thank you

I agree with Richard. The Complaint can be closed by referencing the CAPA. One issue I have found with this approach is when the customer is waiting for a reply regarding the corrective action you will be taking, as the CAPA process may not be set up to consider whether further information is to be sent to the customer. If the customer is expecting more information about the investigation, I typically leave the Complaint open as a tracking mechanism to assure they receive their feedback, and so that all customer communications are included in the Complaint file. However, if the customer is satisfied, or if you have another mechanism for tracking the customer response, or your CAPA process addresses customer responses, then I would close the complaint.

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Candy Beck RAC
Regulatory Specialist
Ringwood NJ
United States
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Original Message:
Sent: 01-Dec-2021 14:12
From: Anonymous Member
Subject: Complaints associated with CAPAs

This message was posted by a user wishing to remain anonymous

Hello all,

How do you handle a complaint that is associated with a Corrective Action? A complaint was initially received for an issue with a product and it was decided that a CAPA should be opened to address the root cause and determine the corrective actions, but can the complaint then be closed to the open CAPA? Or does the CAPA need to close before the complaint can be addressed?

Thank you

Agreed with Richard and Candy.  I would add that the fundamental purposes of the complaint handling regulation/clause are different that the fundamental purpose of the CAPA regulation/clause (though there is somewhat of a Venn relationship between the two regarding the "investigation" step).  Those fundamental differences are what provide the basis for closing the complaint once the issue has been handed off to the CAPA system.

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Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 01-Dec-2021 14:12
From: Anonymous Member
Subject: Complaints associated with CAPAs

This message was posted by a user wishing to remain anonymous

Hello all,

How do you handle a complaint that is associated with a Corrective Action? A complaint was initially received for an issue with a product and it was decided that a CAPA should be opened to address the root cause and determine the corrective actions, but can the complaint then be closed to the open CAPA? Or does the CAPA need to close before the complaint can be addressed?

Thank you