Title: Phases of CAPA Subsystem
Course: PW-Course-Import-Test > Section: Module 6: Non Conformance and CAPA

Module 6

The flow diagram below shows the phases involved in the CAPA subsystem. We will discuss each of these phases. We have already discussed the first two phases earlier in the module. As you learned, a quality inspector is expected in their role to initiate a CAPA/nonconformance and write the problem statement. These phases are outlined on red.

The other phases oultined in red below are important too but are most often not performed by the quality inspector. These phases are worked on by an engineer familiar with the product and the manufacturing process after the inspector has completed the first two phases, although a quality inspector may provide valuable input when required.

Now let’s talk about these phases. These phases are typically done in a sequential order although an engineer can start planning the other phases while actions of one phase are being completed. For example, an action plan detailing the corrective and preventive actions cannot be established before the root cause investigation is completed. The slides below will walk you through the remaining phases of the CAPA process.

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CAPA - Other Phases .mov

Now you have walked through the various phases of the CAPA process. Yes, CAPA is a time consuming and lengthy process but something that cannot be ignored. It is very essential that the company management dedicate the appropriate resources to make each CAPA and the overall system successful.

Here is additional information on CAPA from a FDA presentation

http://fmdic.org/wp-content/uploads/2012/05/Lewandowski-CAPA.pdf