A Corrective and Preventative Action (CAPA) must present a solution to the issue from which the CAPA is generated, or else it is a waste of time and resources. Regulatory agencies see the CAPA as the center of all control points including design control, production and process control, records and documents change control, material control, and facility and equipment control. And it is evident that the FDA (Food and Drug Administration) investigators look first at the CAPA system during their inspection of the company. And recently the FDA has been recommending the implementation of a closed-loop CAPA system in which the CAPA is the tool that drives reports and keeps management informed.
So, how to ensure CAPA compliance?
Here are 5 steps to follow:
1- Implement a CAPA process and document CAPA procedures
This step might seem obvious, but you would be surprised how many cases have been reported by the FDA as failed on this one.
For small firms, failing to establish a CAPA system often results from a lack of knowledge about FDA and EU requirements, or a product’s questionable regulatory status.
For large firms, the problem can center on contract manufacturers or failing to integrate new sites into the quality system. In this case, a partnership with a contract manufacturer or company acquisition is recommended.
2- Use statistical methodologies to analyze quality data and identify quality problems
Types of data that can be useful:
– Process data
– Work operations data
– Returned product
– Quality audit reports
– Quality records
– Service records
Keep in mind that it’s important to include both internal and external data sources, and never ignore complaints. Because for the FDA they are always considered as a primary indicator of problems and should be analyzed through the lens of your CAPA system.
Also, since most investigators judge the quality system by reviewing the CAPA log, it is crucial to record all changes. It’s important to evaluate the number of CAPAs generated and review that information for quality assurance.
3- Investigate and identify the root causes of quality problems
The causes of the problem should be immediately investigated by experienced investigators and never ignored. The objective of the investigation is to find the root of the quality problem through a well-organized methodology.
A typical CAPA investigation is made following these four steps:
– State the problem clearly.
– Implement the documented investigation procedure and evaluation.
– Document the investigation process as conducted.
– Analyze the root cause of the issue and identify corrective actions.
Warning! Stay away from these two common mistakes.
Do not use training as a cure-all solution, it rarely satisfies the FDA
Do not skip the investigation, even if the cause of the problem is clear. The investigation should be conducted and communicated, skipping it can impact both product quality and regulatory compliance.
4- Verify or validate CAPAs for effectiveness
After investigation, any corrective action needs to be validated to make sure it will solve the problem without creating a new one.
5- Record changes in methods and procedures
All changes made to methods and procedures need to be reviewed by quality professionals, and management should always be informed of any change. If management is unaware of quality issues, it’s a clear indicator to investigators that quality control is not being reviewed as frequently as it should. It is also recommended to include a follow-up report to all CAPA issues that lists the actions implemented and the validation of those actions.
One last useful piece of advice, develop key performance indicators (KPIs), they are very important for communicating the effectiveness of your CAPA system to the organization’s management. KPIs help find non-conformity and reveal areas that require in-depth investigation. They help prevent problems and take anticipatory actions.
If you are interested in CAPA or any other QMS App, contact us today or request a free demo.