About Root Cause Analysis

Root cause analysis is a process that is used identify the root of the problem for which the CAPA is created. Root cause analysis is a key aspect of the CAPA process that helps to identify and address the root cause and stop the recurrence of the problem.

This page discusses:

Defect Causes

A defect cause object is created from the known cause of the problem and then iterated to identify more causes until the root of the problem is identified. A newly created defect cause is in the Identified state. Multiple child causes can be created under the parent cause.

A task is created for the CAPA and associated with a defect cause to address the root of the problem. After the task is completed, the corresponding cause is promoted to the Addressed state. After all the child causes under a parent are addressed, the parent cause is promoted to the Addressed state.

Defect causes can be primary or non-primary based on the type of cause identified. A primary parent cause can contain primary and non-primary child causes. However, a non-primary parent cause can only contain non-primary child causes. A primary defect cause must have a task associated to it. Child causes inherit the cause factor from the parent, but can have a different sub-factor.

Lifecycle states

Refer Content Lifecycle.