CAPA Chapter IV: Actions To Take To Address CAPA Problems

Rami.Azulay October 11th, 2019 Posted by Rami Azulay( ) Requirements Management Tool

CAPAIf you discover a non-conformity in your CAPA system is systemic. It means that the non-conformity is realized and it will keep recurring. Then it is time to take action to both correct it and prevent it from recurring.

Hence, it is suggestive that for every CA there is a PA component. It follows the logic of definitions for Corrections, Preventive Actions and Corrective Actions.

For all actions, it is crucial to define, analyze for effectiveness, implement and document them.  

Actions (Going beyond what to do)

To get a full picture of how actions affect the CAPA process, then follow the steps below.

  • Documentation: Always document every action and if need be, refer to the documentation requirement guide.
  • Define Completion Criteria: You have to find a way to determine if an action was successful. If not, it would be impossible to know if an action was completed. 

    For instance, how will you know if an action to improve product feature or process is complete? Or perhaps your action was meant to reduce a shipping error. There should always be a way to measure your actions.

  • Verification: Using the shipping error example, how would you verify the completion of a sipping process? One way will be to contact the customer and ask if they got their item. Their answers will help verify the shipping process.
  • Effectiveness: It is not uncommon that they may be some error. In the shipping example, a way to determine effectiveness is to ask how often customers get their order correctly. The answer will provide insight into the effectiveness of your process. However, while some processes can allow for error, processes that involve risking lives have to be 100% effective.

Good Practice to Follow

We will outline a standard practice to follow for action items. They are;

  1. Always make someone responsible for the entire process. There is a chance of victim-blaming if the process becomes a group responsibility. While teamwork is essential, make sure someone heads the group.
  2. Set realistic deadlines. A deadline that is too optimistic can lead to failure. Therefore, work with the owner and ensure to pick a deadline that will allow you to complete the process.
  3. Always partner with the owner and an expert that might be needed to complete a particular step in the process.
  4. Have frequent meetings to ensure that everything is working according to the plan and on schedule. The frequency of meetings should align with the risk that comes with the process. Risky processes demand more status updates. Meetings will help you measure progress.

The Tipping Point for Actions

While Root Cause Analysis might be the most prominent issue when it comes to the CAPA system. Actions also lead to a significant amount of issues in the CAPA system. In our earlier blogs, there are hints to how actions can constitute a problem.

Sometimes when actions are set and the sequence doesn’t reach completion, it will create problems in the CAPA process. The situation is common in instances where the project demands outweigh the CAPA problems.

Furthermore, manager ignoring CAPA has a priority make taking action problematic. Although, frequent meetings can help bring the problem to light if the manager bothers to host them.

Another way for problems to arise is when there are no completion criteria despite defining the problem. The person in charge of taking action has to understand the importance of completion criteria to prevent delay. Alternatively, if the scope of the action isn’t well defined, then the same problem will arise.

Project owners can be anxious and push for quicker deadlines, it is up to the assigners to convince owners on unclear or unreasonable deadlines. Likewise, it is important that all parties are in agreement on all data collection and various deadline.


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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