You may already have a CAPA system in place, but is it getting the job done in the case of non-conformances? Short for Corrective and Preventive Action, CAPA forms part of an overall quality management plan for many companies. This tool aims to simplify the process of dealing with employee misconduct, mistakes, misunderstandings and other instances of non-compliance where action is required. Having some CAPA process is of course better than none at all, but if your system is proving more hindrance than help, you may want to take a closer look at the characteristics needed for a truly effective system. Is Your Corrective Action System Doing its Job? In order to get the best results from a corrective action system, you need to ensure that you have all of the most essential elements in place. Some of the top traits that your system needs include the following:
1. Clear workflow for all CAPA processes Essential when you are automating these processes, workflow enables you to keep everything on track so that processes are kept on deadline and on scope with the non-conformance at hand. Some companies use a single workflow to manage the process, while others prefer multiple workflow types that are based on the type of corrective action. While both options work well, it is important to consider additional aspects that are tied to CAPA processes, such as audits and even customer complaints. Using a software system that allows routing for different types of conformance issues – quality versus safety for instance – will ensure a greatly simplified workflow.
2. Functionality for initial investigations and instant corrections Often, corrective actions are created for even the smallest of issues, which leads to a bottleneck effect with far more corrective actions than are needed. CAPA is used to correct the problems and process inconsistencies that arise from serious negative events, not for sporadic nominal events. Many events can be investigated and resolved on the spot and then closed. As such, it is good to incorporate the ability for such ‘on the spot’ resolution that allows you to review the event in question and then decide whether it demands further investigation or instant correction. This will cut down on bottlenecks in the system, and save a great deal of time all round too.
3. Filtering by priority or risk Timelines are often the most common metric used when addressing CAPA processes, but there are many other metrics to consider too. The problem with this is that critical actions that need immediate review can be left to sit when filtering by due date. A filtering process that allows you to organise corrective actions by priority or risk will help to resolve the most urgent actions first. Risk assessments are useful for this too, in order to determine the issues that are most critical to the welfare of the company.
4. Integrated action plans More often than not, many different people within your company are involved in each CAPA process. As such, project management is often used to help streamline the various tasks, individuals and roles that are involved in each process. A system that integrates action plans for the completion of each process will prove very useful indeed – especially if you are able to set deliverables, actions, roles and policies for each process. This will allow for greater organisation of each issue, and as such, a more effective way to manage the process from start to finish.
5. Traceability and reporting Tracking and reporting is another vital factor when it comes to a good CAPA system. If you imagine how much data passes through the system in terms of paperwork, you will see just how important it is to have reporting tools that make things simpler to track. Managers will need to draft final recommendations and reports, and will need data to get adequate insight into the process. Visibility is also essential when it comes to any compliance issue. This makes reporting even more essential to ensure that the event is tracked from start to finish, with visible processes throughout the way. Of course, every company has its own methods in place on how to manage the process. Even if you prefer a simpler approach, having the right factors in place goes a long way in getting the most from your CAPA system.