Corrective Action Basics
This document is created to address non-conformities and ensure corrective actions are implemented.
What is a Corrective Action Preventive Action (CAPA)?
This method of asking repeated questions helps identify the root cause of a problem.
What is the "5 Whys" method?
Corrective actions are a requirement of this standard for quality management systems.
What is ISO 9001:2015?
This step ensures that corrective actions have been effective before closing the CAR.
What is verification of effectiveness?
Unlike corrective actions, preventive actions aim to address these types of potential issues.
What are potential non-conformities?
This step ensures that the identified corrective actions prevent the non-conformance from recurring.
What is implementing corrective action?
This tool uses a fishbone diagram to visualize possible causes of a problem.
What is a Cause-and-Effect (Ishikawa) diagram?
This clause of ISO 9001:2015 requires organizations to act on non-conformities and take corrective actions.
What is Clause 10.2?
Evidence of this must be documented to verify that corrective actions are working.
What is the effectiveness of corrective actions?
This action involves identifying risks and taking steps to prevent problems before they occur.
What is preventive action?
The first step in addressing a non-conformity that led to a CAR.
What is containment action?
The key purpose of root cause analysis in the CAR process is to prevent this from happening again.
What is recurrence of the non-conformance?
ISO 9001:2015 mandates that organizations ensure this before closing a CAR.
What is the effectiveness of corrective actions?
This group or individual is responsible for reviewing the effectiveness of corrective actions before closing the CAR.
Who is the CAR Coordinator or quality manager?
ISO 9001:2015 requires organizations to evaluate the need for these, to prevent future non-conformities.
What are preventive actions?
The corrective action process includes identifying the non-conformance, finding the root cause, and doing this before closing the CAR.
What is verifying the effectiveness of corrective actions?
This is the number used to grade the effectiveness of Preventive Actions with the Structure Problem Tool.
What is the Rating Number?
To maintain compliance with ISO 9001:2015, organizations must document these two elements when resolving a CAR.
What are corrective actions and their effectiveness?
A corrective action should not be closed until this has been provided to show it resolved the issue.
What is written evidence of effectiveness?
These types of actions focus on long-term solutions, rather than addressing problems that have already occurred.
What are preventive actions
The system that helps companies manage, track, and close CAPAs to maintain quality compliance
What is a Corrective Action Management System? E.g. IFS/ JIRA
This tool helps to review and analyze historical data for specific RCAs.
What is the Root Cause Code?
ISO 9001:2015 also emphasizes this type of action to prevent potential non-conformities.
What is preventive action?
This type of audit is sometimes conducted to ensure that previously closed CARs remain effective over time.
What is a SURVEILLANCE audit?
Preventive actions are part of this larger quality management concept that aims to improve overall system performance.
What is continuous improvement?