1. KMCO CAPA System Training
QA030

2. Corrective Action/Preventative Action CAPA SYSTEM
Training Objectives
KMCO CAPA Procedure-QA030
Responsibilities
How to use the New Corrective Action Preventive Action System
Quiz

3. Corrective Action/Preventative Action (CAPA) System
A CAPA system is used to address problems in processes.
It gives every employee a means to identify areas that need improvement.
Starting a CAPA starts an investigation to find the Root Cause of the problem.
Once the Root Cause has been identified, it can be corrected to stop the problem from occurring again.

4. CAPA System
The Corrective/Preventive Action System will be the primary tool for the documentation, investigation and disposition of Corrective and Preventive Action, and will describe the steps taken in alleviating present and future non-conformances in products and systems.

5. Corrective Action/Preventative Action Procedure
One of the most important requirements of the ISO 9001:2008 Standard
Serves as the Basis of Quality Management System (QMS) Improvement
Serves as a tool for Continual Improvement

6. CAPA-ISO 9001:2008 Requirement
ISO 9001: “The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.”
ISO 9001: “The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.”

7. KMCO Quality Policy
Our Commitment at KMCO is to partner with our employees, our suppliers and our customers to consistently provide products and services that meet or exceed our customers’ requirements, to ship products in a timely manner, and to continually improve the effectiveness of our quality management system through the assurance of conformity to customer requirements.

8. KMCO Quality Policy
KMCO continually improves the effectiveness of it’s Quality Management system through the use of the Corrective Action/Preventive Action (CAPA) process.

9. RESPONSIBILITY
All employees are responsible for recognizing and reporting non-conformances, either existing or potential, within the KMCO Quality System.
The CAPA System Administrator is responsible for administration and maintenance of the CAPA System.

10. CAPA Procedure SCOPE Applies to all areas of the KMCO Quality Program.
Includes all departments responsible for compliance to the Quality Manual.

11. Corrective Action Corrective Action: (non-technical terms):
Definition
Corrective Action: (non-technical terms):
“Action to be taken when a non-conformance occurs and following the existing procedure as written could not have a stopped it.”
The procedure – which defines how a system works or how a task is completed – must be corrected.

12. Preventative Action Preventive Action: (non-technical terms):
Definition
Preventive Action: (non-technical terms):
“Action to be taken when a non-conformance has not occurred but can if this action is not implemented”
The procedural change can prevent a non-conformance and is typically a new procedure or a new section within a procedure.

13. QA030-Corrective Action Inputs may include:
Non-conformances resulting from customer or third party audits
Findings or non-conformances resulting from internal audits
Laboratory Quality Assurance testing results that indicate a problem exits
Initiated supplier corrective actions from either KMCO or external sources
Customer complaints or suggestions

14. QA030-Preventative Action
Inputs may include:
Observations or suggestions arising from Internal or External Audits
Observations from periodic review of batch data or lab data
Customer Complaint that reveals trends
KMCO employee ideas for improvement

15. Corrective Action Procedure
Record the Nonconformity-Write CAPA
Administrator appoints Owner for each Corrective Action
Determine the Root Cause of the Nonconformity (Manager or Supervisor)
Owner will investigate to Identify Root Cause within thirty (30) days
Owner will develop an action plan to correct the root cause within ten (10) days of the investigation
When Owner and Administrator agree that the Root Cause has been eliminated, The CAPA will be closed out

16. Preventative Action Procedure
Record the Potential Nonconformity-Write CAPA
Administrator appoints Owner for each Preventative Action
Owner will investigate the suggestion to determine if Preventative Action is need and feasible.
Owner will develop an action plan within ten (10) days of the investigation
When Owner and Administrator agree that the possible Root Cause has been eliminated, the CAPA will be closed out

17. QA030-CAPA
If a non-conformance requires immediate action to prevent a more serious problem, it must be performed immediately and then recorded in the CAPA system.

18. KMCO CAPA Timeline

19. HOW TO CREATE A CAPA

23. HOW TO VIEW A CAPA

29. HOW TO MODIFY A CAPA