A corrective and preventive action (CAPA) process is an essential part of a quality management system. This process can be divided into seven key steps.
7 steps in the CAPA process
Benefits of a CAPA system for businesses
An effective CAPA system ensures that no defect, non-conformance or other problem is overlooked or left unresolved.
It also ensures that where an issue occurs, steps to address it are fully documented – and records of actions taken are easy to retrieve (and to show authorities, if necessary).
Regulated businesses – such as medical device manufacturers – are required by law to include CAPA in their quality management systems.
However, a CAPA system has advantages for all businesses. It can help companies…
- ensure regulatory compliance
- comply with quality standards and pass audits
- protect themselves in the event of product defects and/or product recalls
- drive continuous improvement in processes, products, and customer service.
Details of the steps in the CAPA process
Like many other quality management processes, the CAPA process has an iterative aspect.
It involves analysis of a problem and its root cause, planning, action, and then verification of effectiveness – followed by a return to analysis and planning if the problem hasn’t been fully resolved.
1. Identify and record the problem
The first step is to identify and record the actual or potential problem. This step needs to include a detailed description of the issue and any supporting evidence.
This information could come from an internal or external source, such as a customer complaint, service request, risk assessment or internal quality audit.
2. Evaluate risk and impact
After recording the problem, it must be evaluated to assess the potential or actual impact. In this step, explain why the problem is concerning and the possible impact on costs, product quality, safety, or reliability.
This will help the business establish the level of priority for the problem. Issues that present serious risk to the function or safety of a product should be resolved first.
3. Establish a procedure for investigating the problem
The next step is to write a procedure for thoroughly investigating the problem. At minimum, the procedure should include a defined objective for the investigation, the investigative steps, a timeline, responsible parties and required resources.
The investigation should detail the circumstances surrounding the problem and what might have led to it.
4. Analyze the problem and determine its cause
The investigation step will help you to analyze the problem and determine how and why it happened. All the gathered information must be documented and organized as part of the CAPA process.
There are established analysis techniques that can be used to determine root causes, such as failure mode and effects analysis (FMEA), the 5 Whys or Fishbone diagrams.
5. Create an action plan
This analysis will help you to create an action plan to resolve the issue and prevent it from reoccurring.
The plan should detail the steps to be completed, such as changes to documents, production methods, specifications, and processes, to correct the issue. It should list the responsible personnel, required training or upskilling, and a completion date or timeline.
6. Implement corrective/preventive action
Once the action plan is established, it should be implemented strictly according to the steps in the plan to correct the problem.
This step needs to be thoroughly documented and recorded, so that its effectiveness can be gauged. Ideally, this record should be stored centrally in a cloud-based system so it can be accessed in real-time by the necessary personnel.
7. Verify effectiveness
Once the action plan has been implemented in full, its effectiveness must be verified. First, verify that all the steps were completed correctly. Then evaluate if the problem has been solved.
Any issues or shortcomings must be recorded so that the CAPA process can be tweaked if necessary. This step must be thoroughly documented.
CAPA software from isoTracker
isoTracker’s quality management software includes a set of modules, making it possible for companies to choose only the functionality they need. (The modules can also integrate seamlessly to provide a comprehensive QMS).
The following modules all include a built-in CAPA system:
- Complaints Management
- Audit Management
- Training Management
- Non-Conformance Management.
The CAPA system ensures that corrective actions are implemented; automates workflows and notifications; and stores real-time records.
Contact isoTracker for more information about our software or sign up for a 60-day free trial, with full access to the software, support and more.
