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The Great CAPA Balancing Act: Knowing How And When To Act

Corrective and Preventive Action (CAPA) processes is an important part of the ISO 13485:2016 Quality Management System, and for good reason: To correct non-conformances requires doing something different than the action that caused them. Following a set problem-solving procedures ensures that critical elements and resources will not be lost and wasted along the way. But where many CAPA processes lose steam is in either over or under responding. And that is often a function of a poor set of risk filters built into the process.

CAPA is in place to help the FDA regulate medical device manufacturing facilities. Since the FDA cannot be at every facility every day, they need a system in place that supports continuous self improvement. At a basic level CAPA requires organizations to identify the nonconformity, determine the root cause and create a plan and implement that plan into action to fix the issue. One of the challenges is correctly identifying where the nonconformity is coming from.

Tools for Corrective and Preventive Action (CAPA)

CAPA Steps of Improvement

There are many ways to address problems within the workspace, below we will discuss common steps for improvement.

  • STEP 1: Contain the problem- If you experience a problem, you should stop production and quarantine any materials, parts and inventory to prevent any additional defects or issues from expanding. Containing the problem should continue until you define the issue and feel confident it is contained.
  • STEP 2: Stop Manufacturing: Production lines that may be involved with the problem need to be shut down. This way you can avoid waste that may be affected by the nonconformity.
  • STEP 3: Understand the Cause- Understanding why the nonconformance occured is the most important part of CAPA. Using a root-cause analysis can be a very helpful tool for this process.

Being Proactive rather than Reactive

Although CAPA is great to have in place, one issue is that it is often reactive rather than proactive. CAPA was designed to address problems after they occur, as a manufacturer, you should be proactive. This will save you time, money and resources.

Deciding What Problems Need to Be Fixed

Determining what problems need to be fixed can be another challenge for companies. There are also reports of countless resources which are wasted by fixing problems that probably did not need or justify the effort. Balancing these requires a blend of front end categorizations that help all employees know when action is needed, starting with these key questions:

  • How often is the problem likely to occur? (Frequency)
  • How important is it likely to be? (Importance)
  • Has this issue been addressed before? (Re-Occurrence)
  • Are we really being open minded? (Evaluate Options)
  • Did we really solve the problem? (Verification)

We will look at each of these in more detail.

What are the differences between CA/PA?


It may be as difficult to predict the re-occurrence of a problem as the first occurrence of it. And yet, if there is at least an attempt to measure and scale a perspective can often be reached. This is particularly true if measurements exist that can compare that state of something. Poor inventory control can be a function of fluctuating customer demand, which may seem not to be controlled. But many vendors find ways to better predict the needs of a customer than they do. Starting with a simple scale of how frequently this issue is likely to occur can help determine the resources that need to be applied.

FREE ISO 9001 Corrective/Preventive Action Guide

CAPA Free OfferFor a limited time we are giving our CAPA Process Guide, a time-tested outline for developing or improving your corrective action/preventative action approach (CAPA). For instance, the guide helps you develop each phase of the process including:

  • Record Potential or Actual Non-conformance
  • Assign and Manage Request
  • Investigate Root Cause
  • Design Corrective Action
  • Implement Corrective Action
  • Follow-Up on Corrective Action to Assure Effectiveness

More About Correction, Corrective Action and Preventive Actions


As far as importance, a higher level perspective can help decide the total impact of the problem. While not a guarantee, views from varying groups that are likely to be affected can help put the situation into perspective. The person(s) observing a potential or actual non-conformance initiates the process (often is called the “Requestor”) provides critical aid in this process in describing the problem. Having a CAPA administrator is also crucial to review and then request the appropriate people in the organization to assure the necessary action is taken in a timely manner.


Maintaining a “lessons learned” database of some type can at least help with those problems that seemed to recur. Providing easy and ubiquitous access and encouraging/requiring appropriate logs are necessary actions for making this database useful in the CAPA process.

Evaluate Options

Yet, there are times when new people, technologies, production and market conditions conspire to hide solutions. In this case, a more open and interrogative style of inquiry is often needed. Being good investigators with the proper methods can lead more quickly to results in these situations than past experience with its preconceived notions (that may not have detected or fixed the problem in the first place).


Finally, verifying what actions were taken and what effects they had will help ensure that the problem will not repeat (if it had for instance, temporarily righted itself). Many times people think they have done what was asked/required only to move on a bit too quickly to the next issue without fully/correctly completing the needed actions.

In summary, no one can predict the future with 100% accuracy, and yet what CAPA teaches is that we can command our destiny to a great extent. Those who put effort into it are much less likely to repeat/experience unwanted past, or unpredictable future events.

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