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What is CAPA and why is it important?

CAPA is the abbreviation for corrective and preventive actions. The term refers to the improvements to an organisation’s processes to mitigate undesirable situations like product nonconformities and is typically used in connection with quality assurance. 

CAPA can provide a structure for organisations to follow to find the cause of a problem, solve it, and identify ways to prevent the problem from occurring in the future. Thus, organisations correct the issue and prevent it going forward.


Corrective Action (CA) vs Preventive Action (PA)

 

Corrective action is a kind of extension to the Root Cause Analysis (RCA) approach. Step 1 of CA is to identify the root cause of the issue following a report of a nonconformity. Step 2 is to eliminate the root cause to prevent the nonconformity from recurring.  

Preventive action is when you identify and remove potential sources of nonconformities before an undesirable situation has the chance to occur. 

PA follows a similar design to the lessons learned/read-across approach. It emphasises the sharing of information across the organisation so that problems can be taken care of efficiently. 

To put it simply, you could describe corrective as reactive, and preventative as proactive. 

Because the two terms are lumped together in the same abbreviation, many assume that CA must precede PA. However, the two are not necessarily linked.

If anything, organisations should focus on PA first. Preventing undesirable incidents from occurring in the first place will eliminate the need for CA. 

 

Where To Utilise CAPA Principles?

 

The CAPA method is relevant in multiple disciplines including: 

  • Manufacturing
  • Product Design
  • Testing Verification and Validation
  • Distribution, Shipping, Transport, and Packaging

The food processing, medical device development, and pharmaceutical industries are some of the industries in which CAPA is of particular importance. 

CAPA is also hugely important in the context of quality management. Certain quality control systems and standards require meticulous documentation of these processes.

 

Phases In CAPA

 

Adherence to an effective Corrective Action and Preventive Action process is essential in certain industries. It is a useful tool for companies to identify unconformities, resolve them, and prevent them from happening again. 

A good CAPA process consists of several key phases. These include:

  • Problem Identification and CAPA Initiation. In this phase, organisations will identify the problem at hand. The first step is to document the problem and describe it in as much detail as possible. 
  • Risk Analysis. Performing a risk analysis will help to identify the severity of the problem, which will determine the timeline for resolution. 
  • Root Cause Analysis. This step helps to identify exactly what caused the nonconformity. 
  • Corrective/Preventive Action Implementation. Next, organisations need to resolve the problem and implement measures to ensure that it won’t happen again in the future. 
  • Verification of Implementation and Effectiveness. After resolving the issue, it’s important to verify whether the solution works and is effective or not. If not, organisations will need to come up with a new solution.
  • Closure. After verifying that the problem is resolved successfully and won’t happen again, the CAPA process can be closed.
 

Final Thoughts

 

CA and PA provide key industries with a step-by-step approach to dealing with nonconformities. Meeting the key objectives of CAPA is essential for proper quality management. 

A great way of managing this process in a simple and strategic fashion is to use mobile-friendly audit and inspection tool. Such a tool can be used to document any and all observations (both of reactive and proactive nature) made during a CAPA process inspection, and will help to provide organisational transparency on issues spotted, as well as how to prevent them going forward. 

Are you looking for a tool to monitor quality or any other standards in your organisation? Audits.io ticks all the boxes for issue management, is easy to customise, enables real dialogue and is a lot more. Book a demo to discuss your specific needs or take advantage of our 30-days FREE TRIAL to see how it can help your organisation:

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Quality Management CAPA

Kaarle Parikka

Head of Marketing