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Corrective and preventive action also called CAPA are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards.


Systematic Investigation

It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

Single System

The FDA considers the CAPA system a ‘single’ system.

The process requires the following:

Analysis – a thorough analysis of the issue
Investigation – a determination of the root cause(s)
Actions to correct and prevent – fix the problems and ensure they don’t happen again
Verification or validation of effectiveness of the actions – did the changes have their desired effect (more than once) and did they have any adverse effects?
Procedural changes – the means to institutionalize the changes
Communicating the changes to those directly involved – making sure everyone is aware of the changes, understands the changes, and implements the changes
Review at the management level – make management aware of and ensure they are on board with all the activities
Document everything – provide that “audit trail” of everything done

CAPA is part of your overall Quality Management System (QMS). Essentially, while remaining in compliance with the areas outlined in the FDA rules, you would follow these steps when any issue comes up:
Identify the issue.
Use root cause analysis to get to the bottom of why it has happened.
Create and implement an action plan to remedy the issue.


Concerns with CAPA

How do you improve or fix any issues that come up, either with the manufacture of your medical device or the device itself? Many people see CAPA as one of the most critical processes for medical device manufacturing, yet still there are several concerns with it.

The key is that you need to prepare early. It shouldn’t be a surprise that you get a FDA inspection because that’s part of the whole deal when you get into the medical device industry. The FDA should be expected every two years if you’re manufacturing class II or III products.

VComply can help you comply with the CAPA requirements on time with its integrated solution.

Here are a few tips for better CAPA implementation:

1. Create your CAPA process early, following recommended guidelines.
2. Keep data centralized (such as with a software system) for better control.
3. Keep your process as lean as possible to keep it easy to follow.
4. Implement risk management within the first stage of a CAPA process.
5. Make sure you clearly distinguish symptoms from causes. You need a clear definition of the problem to ensure you’re really getting to the root of it.

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