What is a CAPA Process?
CAPA stands for Corrective Action and Preventive Action.
- Corrective Action concerns eliminating the cause/s of an existing non-conformances to prevent its future reoccurrence.
- Preventive Action concerns identifying and eliminating the cause/s of potential non-conformities to prevent their occurrence.
Non-conformity and corrective action management are referenced under ISO 9001 Clause 10.2 and are key to both achieving compliance and engendering improvement within your organisation.
What is a CAPA Process Workflow and why is it important?
Corrective and Preventative Action management is the most crucial component of a strong and compliant quality management system. Therefore, it is extremely important to have a clearly defined CAPA process workflow within your organisation.
An effective CAPA process workflow allows you systematically identify, investigate, understand, and address any faults that may have transpired within your organisation whilst also working to prevent their future reoccurrence.
An established CAPA process workflow will help your organisation continuously improve its business operations and ultimately help contribute to increased productivity over time. CAPA management is also critical to ensuring that your organisation is compliant to both standards and regulations.
How to Create your own CAPA Process Workflow
When beginning preparations for your CAPA process workflow it is essential that firstly identify and outline the objectives you want to achieve with this process.
For a CAPA process workflow, your goal is to identify, investigate, understand, and address any issues that may have happened within your organisation whilst ensuring they do not happen again in the future.
Once you have established the main objective of your CAPA process you can now determine both the start and endpoints of the workflow.
In our free example which can be downloaded below, we begin with the identification of an NCF and end with a review of the corrective and/or preventive action that has been implemented.
However, you may wish to start and end your process at completely different points. With Jomo247’s completely customisable workflow editor you can tailor your CAPA process to your organisation’s specific needs.
Now you can begin filling in the remaining steps required to push your process through from start to finish.
Consider all the different steps your CAPA process needs to go through before the most appropriate corrective and/or preventive action can be implemented.
Next you can determine which individuals or roles will have responsibility in your CAPA process workflow. Think carefully about which employees will be involved, their duties and the information they need to successfully complete the task at hand.
In our template, we have used generic roles such as, “Investigator” or “Implementor”. We also chose to incorporate our suppliers into one section of our workflow, however, you may wish to keep the SCAR reporting process separate from your normal CAPA process.
Now that you have established a concise and clear plan you can create your workflow template.
You can create a simple image of your template using traditional methods. However, we recommend using Jomo247’s workflow editor, that will help automate your processes and eliminate your paper trail.
Once your workflow is completed you can now implement the CAPA process you have designed. It’s critical that you continuously monitor and evaluate the performance of the process in case you need to adjust.
The continual improvement of your processes especially one as integral to your QMS as the CAPA process is crucial to maintaining compliance to both standards and regulations.
What is a CAPA report?
A CAPA form records the occurrence of a non-conformance, the proceeding root cause analysis, and the advised preventive and/or corrective action that should be implemented to prevent future reoccurrence.
To download our free example and learn how to make your own CAPA report form click here.
