5 replies to this topic

[bogummy]

When answering a CAPA or CAR, is "not applicable" allowed if there is no identified immediate action? What are the provisions?

Thank you!

[MOHAMMED ZAMEERUDDIN]

Immediate action or correction is always present for any deviation or non conformity. If you specifically explain the non conformity then i can reply more clearly.

[Scampi]

The short answer is NO

 

If it's been identified as a non conformance, you must have a plan to address it

[Setanta]

If it is a legitimate CAR, you have to have a plan to remedy it.

[jfrey123]

 

Well in this case, replace money with a corrective action.  And if it's part of your formal audit, you'll likely need a full root cause analysis and a plan to eliminate it from repeating in the future.

[SHQuality]

When answering a CAPA or CAR, is "not applicable" allowed if there is no identified immediate action? What are the provisions?

Thank you!

The only possible way I see that working, is if the CAPA or CAR has already been addressed by an action related to something else.

That said, I would still list the previously taken action as the corrective action to solve the issue.