Manage CAPA process

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	23.04.2014 16:27:49
Modified:	27.02.2018 10:38:46

Diagram Elements :

Manage CAPAs

Inform staff related to the CAPA

Nonconformity of processes

Implement lesons learned in methods and procedures

Define CAPA activities, responsibilites and timeline

Process-FMEA (PFMEA)

Nonconfority and compaint report

FSCA required?

Design-FMEA (DFMEA)

Device Hazard Analysis (DHA)

FSCA customer notice

Define FSCA notice

CAPA required?

Verify / Validate CAPA effectiveness

Create CAPA

Senior CS Specialist

RCB Risk Control Board

CAPA assessment complete

Execute field safety corrective action (FSCA)

Do root cause analysis

QA Specialist

CAPA Corrective and preventive action

Evaluate noncompliances and complaints regarding required CAPA measures

New feed into issue tracker