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 on the CAPA system during their inspection at 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 around 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 investigation, even if the cause of the problem is clear. 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, 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 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.
Now that you've learned about the steps to ensure CAPA compliance, learn about, the “ Top 6 CAPA Software of 2021 Based on Rating and Customer Reviews”.
Written by Romeo Elias
Romeo Elias is the President and Chief Executive Officer (CEO) of Intellect, an award winning leader in the SaaS enterprise software industry with a focus on enterprise Quality Management Software and Business Process Management (BPM). Romeo is a visionary executive, thought leader and advocate for business friendly software that requires No Programming and empowers everyone to innovate. Romeo has overseen Intellect's growth from its founding in 2000 to a high growth software company with hundreds of happy customers. Romeo is a patented inventor, entrepreneur advisor, and board member of Intellect. Prior to Intellect, Romeo worked in the consumer electronics space, overseeing the engineering design and development of handheld electronics, and previously was the founder of a web development firm. He received his BS in Mechanical Engineering from the University of California, San Diego and MS in Manufacturing Engineering from UCLA.