What is a CAPA form and why is it important?
CAPA (corrective and preventative action) management is the most crucial component of a strong and compliant quality management system.
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.
Keeping a thorough record of CAPA’s is key to ensuring that your organisation is compliant with ISO 9001 Clause 10.2 and evidences your commitment to the continual improvement of your processes, operations, and products.
How to create your own CAPA form
When planning your CAPA for, you should first consider the specific information you want to collect using the form.
Think about all the data you need to record to evidence that a non-conformance has been successfully investigated and effective solutions to prevent its reoccurrence decided.
Your CAPA form should include a section to include information about the non-conformance and any quick corrections that were applied to fix the NCF.
You should also include a section where the user of the CAPA form can detail the outcome of the root cause analysis.
This section is important as it will help evidence what caused the occurrence of the non-conformance so that you can avoid it from happening again by improving your processes.
There should also be a section on the CAPA form where both the corrective action and preventive action plans can be thoroughly detailed.
It is important to clearly record the steps your organisation will take to prevent the reoccurrence of non-conformances and ensures you can evidence your commitment to improvement to auditors.
With an important document like a CAPA form it is important to seek approval from management especially regarding the approval of the corrective and preventive action plans.
Therefore, in our free example we include a section specifically to be filled out by management where they can approve or reject the CAPA plans submitted.
This ensures accountability and traceability so if the non-conformance were to reoccur in the future review you can easily locate those responsible.
Finally, it is crucial to include a section on your CAPA form that should be filled in once the corrective and preventive action has been implemented.
This should include a section to record the date both were completed and the signature of the individual who implemented it.
Recording this information is particularly important for both audits and management reviews.