CAPA Chapter V: Reviewing The CAPA System and Actions

Rami.Azulay October 19th, 2019 Posted by Rami Azulay( ) Requirements Management Tool


The FDA and the ISO13485 both demand that the management reviews the status of all PAs and CAs. People tend to ignore the importance of review, and that can be costly for the management. It is up to the management to take responsibility for the CAPA review process.

Reviews should not be restricted to the management alone since it can be done at several stages of the CAPA process. For instance, a weekly review will help the management get a better understanding of the CAPA status. Needless to say, it is crucial that there is a review to ensure success. Orcanos system allows the organization to proactively send alerts regarding the review process and keep the management up to date in real-time.Management Review

Inputs for Management Review

There is a significant difference between data for management and data for day-to-day management. Below are some of the duties of a manager when reviewing the status of CAPA. They are;

  • It is the duty of the management team to provide sufficient resources.CAPA Resource Allocation Review
  • Ensure that all actions are following the set plan. That way support is made available for CAPA activities.
  • To produce a form that allows for the closure of CAPAs. Ensure that actions are complete and there is data to support it.CAPA eForm

Orcanos CAPA eForm


Actions that Yield Effectiveness

Closure can sometimes be mistaken for completion. However, completion means that the actions taken were effective. One of the few ways to fall into a non-compliance trap is to set a fixed date of CAPA action completion. Obviously, fixed deadlines are a bad idea, especially for actions that will require auditing reviews. Not with the Orcanos CAPA system. It allows you to separate between the CAPA completion to the PA/CA completion.

Perhaps, there could be an assumption that one audit is sufficient, but that may simply be one consideration point. There could be multiple measure points that will need for multiple reviews. Well, multiple data points tend to yield better results. An example is dealing with registration audits that often require at least 2 audits that span roughly two years.

Another reason to have multiple action points is that you get to see the result of actions outside that of CAPA. Deadlines for completion are within control when there is a good relationship between the assigners and assignees. Unless your system can proactively prompt the assignee with messages on its upcoming commitment for completion, exactly what the CAPA system will generate automatically.

It is important to distinguish between the closure of CAPAs and the closure of actions. Always leave room to be flexible, that way you can see the completion of action within a reasonable schedule. Remember that the completion of actions is a way to determine effectiveness.


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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