Corrective Action & Preventive Action

Dear Forum,

If I propose a Corrective & Preventive Action for a deviation initiated and the same thype of deviation is getting repeated after quite some time what is the stand on the CAPA proposed earlier? Is not an appropriate CAPA for that deviation?

In this case how to proceed further?


C. Suresh

A CAPA is raised when a deviation is obeserved by QA with in the company Or by External auditor or Regulatory authorities or for that matter by any subject matter Expert.

A repeated CAPA failure for the same repeated deviation gives a signal that
-it not tight enough
-Root cause analysis is not effective --Rather I would say Inefficient
-Controls are not proper
-In one word I would say Its a management failure.CAPA is a management commitment.

The whole episode refelcts to a CAPA system which failed to identify the cause and implement or look into implementation system.

In this specific case some one who is looking after CAPA system in your setup do not know the fundamentals.He should ensure the Deviations are minimized and controlled.

My suggestion is please review your CAPA system.Do not use old system.Talk to concerned people and try to sort out if that repeated deviation is Intentional or Machine problem or if the procedure itself is wrongly written or understood wrongly by person who joined new to this organization.

If CAPA fails that means " a training is required how to implement CAPA system and also a trianing is required at that particular point of process where repeated deviations are observed."

[b]PI-cubed methodology is an important technique.

Problem: First step in this PICCC methodology is to find out what has gone wrong.

Investigate : Once the problem has been identified, investigators can gather the data that can be used for comparisions and determinations of what is not a problem.

Comparision : Asking “is not” questions (comparing time periods, locations,types of defects,etc.) further refines the investigation

Clues: The clues that are undercovered during investigations are inferences of facts.As this stage, the investigations are finally able to formulate a semi solid answers as to why the problem has occured.

Cause: Investigators can now take the clues and build a cause that can explain the problem or deviation. An assessment can be made regarding the impact of the event and preventive measures, if necessary, can be identified and implemented.

At this problem prevention stage FEMA can be used as an effective tool.This model consist of 4 basic rudiments


How do you mean “deviation?” Do you mean “non-conformity”? Not sure understand what you mean “deviation???” However, regards CAPA, I agree that the root cause(s) nor the “most likely” root causes were identified and steps taken to remove them. Recommend you also develop a formal failure investigation/failure analysis process where you isolate possible causes as method, machine, man, measure, etc. BTW, “Training” mentioned above may not necessarily be the cause but more likely a symptom.


What will a company do when there are repeated DEVIATIONS at a particular point even when CAPA is initiated?
In the above a Tight CAPA means-- such deviations should be plugged.
If you see the original post it said the deviations are repeating.
This shows the CAPA process is not completed.Once CAPA is completed there will be no such reoccurences of this sort of a Deviation or Non-Confirmity.
In simple word I would say “Its not plugged”.

Hi All,

In a simple statement…If deviations are still repeated even after CAPA…Route cause was not diagnost properly.
It may be possible the deviations are resulting as a consequence of CAPA…one thing which really required in such situation is “Thourough INVESTIGATION” followed by CAPA & effectiveness verification.

Happy Reading !

Dear Mr. Prasad,

Thanks for your reply and suugestions towards effective CAPA…

[b]Global Harmonization Task Force

Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes

Date: 4 November 2010[/b]

QMS-CAPA.pdf (318.6 KB)

thanks and nice post,
i am also facing the same problem of repetition of CAPA