1. CORRECTIVE PREVENTIVE ACTION PROCESS
Start
Non conformity
found
Potential non
Conformity found
Request Corrective
Action trough System
Or Form (By Initiator)
Request Preventive
trough System
Or Form (By Initiator) no
Define how the
Finding will be
Handled/Justify reason
Due do not open the CAR
Open
CAPA?
yes
Send Request for Acknowledgment to
Corrective/Preventive Action
Department Manager
CAPA
Accepted by
Process Owner/
Manager?
Send Request to
Quality Manager for
Evaluation and resolution no
yes
Open CA or PA
In the System
(Manager to designate
CAPA Owner)
Send CAR to CAPA
owner
CA Owner implement
Containment Action within
24 hours and answer
Into the system
Accepted? no
yes
CA Owner forms a
Multidisciplinary team
Quality
Manager
Evaluates request
CA Owner & Team
Answer request within
14/less days
Elevate issue
to Operations
Director
(If not answered within 30 days/
Extension is not accepted/
CAR can not be closed)
yes
Need
Extension
(Requested
By the owner?
Elevate issue to
Department
Manager/Quality
Manager no no
CAR
Answered Within 14/less
days?
yes
Initiator
Review plan no
Is the plan
Aceptable?
Reject Plan
yes
CA Owner & Team
Implement actions within
A timeframe of 14 days
Initiator verifies and
validates CAPA no
Aceptable?
yes
Close
End

2. CAPA Responsibility Acceptance
REQUEST TO OPEN CAPA
Request to open corrective/preventive action:
Initiator:
Date requested:
What is the problem?
When did it happen?
Who is affecting the problem?
Where the problem is happening?
Why is the problem happening?
How it is happening?
Departament Manager Acknowledgment (Sign off)
Owner of CAPA (Designated by Manager)
CAPA Responsibility Acceptance
Form XXX