KMCO CAPA System Training QA030

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

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.

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.

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

CAPA-ISO 9001:2008 Requirement ISO 9001:2008 8.5.2 “The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.” ISO 9001:2008 8.5.3 “The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.”

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.

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.

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.

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

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.

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.

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

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

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

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

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.

KMCO CAPA Timeline

HOW TO CREATE A CAPA

HOW TO VIEW A CAPA

HOW TO MODIFY A CAPA