Business Process Maps SM - WD - RR

CorrectiveAndPreventiveActionProcess (CAPA)

NRWWTP

Fill out CAPA form fields Date, Requestedby, ProblemStatement, Correction Immediate Action, ProbableCause, ContributingFactors

Nonconformance Noncompliance Emergency Other Problems

Evaluation if CAPA is necessary

Start

Yes

No

Requestor (Anyone) Issued (Assigned) Employee EMSCoordinator CAPAManager

End

Move “opened” CAPA form fromOpen toArchive folder.

Review, add info, assign, copy&paste CAPA into appropriate program folder on sharedrive

Copy&Paste closed CAPA into appropriate program folder on the sharedrive

Reviewand signoff onCAPA. This actionwill close the CAPA

Requirean MOC?

No

Yes

MOCProcess

Senda copyof the completedCAPA form toCAPA manager.

Completeappropriate solution. Documents asneeded.

E-mail notification

Managesentireprocess. Updatesmanagement teamatmonthlymeetings. MaintainsCAPAStatus Tracking Log.

Of CAPA creation

END