CAPA - corrective action and preventive action

 

What Is CAPA?

 

Ø    CAPA is the abbreviation for corrective action and preventive action. These two aspects of CAPA have traditionally been connected, but are ideally are only distantly related. Here is the main difference between the two:

Ø  Corrective Action:

Elimination of the cause or causes of an existing nonconformity or undesirable situation in order to prevent recurrence.

Ø  Preventive Action:

Identification and elimination of the cause(s) of potential non-conformities in order to prevent occurrence.

 

 

Ø  In standards such as ISO 9000 and FDA 21 CFR 820, the description of preventive action follows directly after the description of corrective action, which has led to the misconception that the two processes must work together in series. In fact, they are separate, and preventive action ideally precedes corrective action to prevent or avoid the need for corrective action.

Ø  CAPA processes are used particularly in food processing, medical device development and manufacturing, and pharmaceuticals. FDA 21 CFR 820 is the quality system regulation that requires corrective and preventive procedures to be documented in medical device manufacturing facilities.

Ø  Corrective and preventive actions also have a place in the quality management process as defined in the Project Management Book of Knowledge (PMBOK). Corrective and preventive action is also considered a tool within Six Sigma for understanding regular business operations. CAPA has strong parallels with Design for Six Sigma (DFSS), used to design new products or redesign existing products. The analytical aspects of both corrective and preventive actions also harken back to PDCA.

 

 

What Is a CAPA Report?

A CAPA report provides a consistent vehicle for recording defects and issues as well as the method of their correction. Usual details include where the problem occurred, the customer’s name and address, the details of the problem, whether there was a product breakdown, whether there was an injury, and so on. The report also states what immediate action or correction was taken. The report may walk you through the process, suggest tools for the root cause analysis (such as 5 Whys and cause and effect analysis), and provide room to record analysis results. It may also provide guidance on how to route the report depending on the outcome of the analysis.

You can use the free template below to create a CAPA report.