Too often, companies are alerted of weaknesses or problems but fail to take effective action – or wait too long to respond.
Just some of the potential consequences are damaged customer relations, publicity scandals, loss of business, and penalties for failing to comply with regulatory standards.
Corrective and preventive action (CAPA) software is designed to ensure that non-conformities, defects, and other undesirable situations are properly recorded and addressed.
What makes a CAPA system a closed-loop system?
A CAPA system is also sometimes called a Failure Reporting Analysis and Corrective Action System (FRACAS).
It becomes a “closed-loop” system when it includes built-in features to ensure that when problems are identified, suitable responses are determined and put into effect. In other words, it helps make sure that problems don’t slip through the cracks, even once reported.
CAPA software does this using functionality like required fields, automated workflows, and automatic notifications.
7 steps for an effective CAPA system
CAPA systems are a requirement for compliance with regulatory standards in many industries, particularly manufacturing.
An effective closed-loop CAPA system includes the following steps.
1 | Identification
The first step is to identify and define the problem. Include a detailed description of the problem, how the problem was brought to light, and any evidence to support the identification of the issue.
At this point, sources of information may be internal or external.
2 | Evaluation
Based on the evidence that has been collected, evaluate the problem to determine any risks it poses to the company or the consumer.
The reason for concern should also be detailed. For example, consider the potential impact of the problem in terms of cost, quality, safety, reliability, and overall customer satisfaction.
3 | Investigation
The goal of investigation at this stage is to outline what steps must be taken to determine the cause of the problem.
The procedure used to do this will vary depending on your company and the process or product in question. General areas to investigate are equipment, materials, staff, procedures, design, training, and software.
4 | Analysis
Based on the results of investigation, the root cause of the failure needs to be determined. Generally, this involves documenting data such as records, processes, service information, design controls, and operations.
The root cause of the problem could stem from one or more steps in a procedure or manufacturing process, so proper data collection and analysis is essential.
5 | Plan of action
Arguably, the most important step in CAPA is to facilitate action. A successful system swiftly corrects or eliminates identified problems.
The plan of action needs to include any changes to processes or procedures. These should be described in detail so they’re properly understood. Expected outcomes should also be made clear.
6 | Implementation
Implementing the action plan needs careful overview. Follow up to ensure that planned steps are taken. Also make sure that personnel are aware of any changes that affect them.
During this stage, ensure a record is kept of all actions taken to correct the problem. This is vital for assuring regulatory authorities that the problem won’t reoccur. Include changes to procedure, preventative measures, updates to training processes, and any other pertinent information.
7 | Follow-up
After implementation, follow up to ensure that the agreed changes are being implemented and are having the desired effect.
Document evidence that the problem hasn’t recurred following the corrective action that was taken. Alternatively, if the problem has recurred, return to the start of the loop.