Many organizations lack the structure or a procedure for correcting and preventing problems that occur in their business processes. The procedure most often used in highly regulated industries like Medical devices or automotive is the Corrective Action and Preventive Action process, commonly known as CAPA.

Corrective action and preventive action (CAPA) includes a set of actions aimed to improve your organization’s processes by eliminating the causes of recurring non-conformances and other problem situations.

The CAPA process consists of numerous steps. When embarking on the CAPA process, each step needs to be executed successfully and submissive to the CAPA program.

There are seven steps to a fully functional CAPA initiative

1. Identification – clearly define the problem
2. Evaluation – appraise the magnitude and impact
3. Investigation – make a plan to research the problem
4. Analysis – perform a thorough assessment
5. Action Plan – create a list of required tasks
6. Implementation – execute the action plan
7. Follow Up – verify and assess the effectiveness

It is necessary to ensure that each step is documented carefully because proper documentation helps in offering vital data for continuous quality improvement.

What is the difference between corrective and preventive action?

Corrective actions are reactive in nature and may include reacting to an existing product problem, customer complaint or other nonconformity and fixing it. An example to put this in perspective, “If the horses are running out of the barn the corrective action is to close the barn door.”

Preventive actions are proactive in nature and is based on detecting problems or nonconformities and eliminating them. In our horses escaping from the barn example, the preventive action may be detecting why the barn door was open in the first place and eliminate the problem of it being open.

Finally, an essential component of the CAPA process is training. Employee training is an essential part of any change that is made and should be made part of your CAPA action plan. To be effective, all modifications and changes made must be communicated to all persons, departments, suppliers, etc. that were or will be affected

To learn more about CAPA please review our thought leadership presentation.