Implementing the two functions of CAPA FDA
, the Corrective Action Preventive Action, approach are as follows:
When an issue is identified or communicated, a structured set of activities are initiated to describe the problem in detail so that the team can identify a root cause path. After selecting a root cause path, a permanent corrective action is identified, implemented and validated. The steps for Corrective Action are detailed below:
Problem Statement is formed by using the 5 Why approach and the Fishbone diagram to identify the possible causes of the Problem Statement.
Problem Description is written based upon further analysis of the What, When, Where, and How Big data was collected.
Possible causes on the fishbone diagram can then be reduced by using data from the Problem Description.
The root cause is verified and permanent Corrective Actions are determined for the root cause and the inspection process.
Validation and Implementation of the Corrective Action.
Preventive Action occurs after the root cause has been found out and permanent corrective action has been validated. Preventive Action recognizes the value of the information and the actions taken during the Corrective Action function. The steps for Preventive Action are detailed below:
Capture the Problem Statement as an Object-Defect for available databases.
Connect the root causes to the Problem Statement with the Permanent Corrective Action
Failure Mode and Effects Analysis (FMEA)
Control Plan Methodology
Document information for future retrieval including supporting information.
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