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CAPA

Corrective and Preventative Action (CAPA)
What is CAPA?  

First off, it is important to understand what corrective and preventative actions are, as well as to understand what a correction is. Here are a few definitions to help distinguish between the three terms:
  • A correction is any action to eliminate a detected nonconformity.
  • A corrective action is any action to eliminate the cause of a detected non-conformity or other undesirable situation.
  • A preventative action is any action to eliminate the cause of a potential non-conformity or other undesirable situation.

A great way to think of it is that corrective actions prevent recurrence, while preventative actions prevent occurrence.
 
CAPA = An Essential Part of Any Quality System

Per 21 CFR Part 820.100(a), companies must establish and maintain procedures for implementing corrective and preventative actions. Compliant ISO 13485 quality systems also require CAPA procedures to be in place. 


A non-conformance can arise from all sorts of different sources, including (but not limited to): Internal audits, training records, test/inspection data, adverse event reporting (MDR), customers, complaints, or supplier controls. The big question then is how to appropriately handle the non-conformance, and Fang Consulting can help your company each step of the way. Our staff has experience in a wide range of CAPA related work, including generating CAPA procedures and implementing and executing CAPAs from start to finish. 

CAPAs are an unavoidable part of the medical device industry, and we at Fang seek to help you with whatever your CAPA needs may be. Contact us to see how we can help you with whatever your CAPA needs may be.

Sources:
https://www.fda.gov/downloads/training/cdrhlearn/ucm421767.pdf
http://asq.org/quality-progress/2005/03/problem-solving/corrective-vs-preventive-action.htmlNew Paragraph
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