Market and Investment

To get the most from your quality system, many different processes have to effectively function together. These processes include CAPA (Corrective and Preventative Action) management, audits, change control procedures, customer complaints management, and much more. CAPA is a very important part of this process, and there are six basic steps that can describe the procedure.

The first step is the definition. When a company seeks to implement a CAPA process, they must have identified and defined a problem within their quality system. The definition phase requires clear reporting on how the problem information was gathered and documentation that explains the problem in detail. There must also be proof that the problem exists.

The next step is the appraisal. Like most of the CAPA procedures it requires some strategic thinking. During the appraisal stage a quality personnel member in charge of a CAPA case should determine the impact that the problem will have on costs, function, product quality, safety, reliability, and/or customer satisfaction. Once impacts and risks are pinpointed the level of seriousness is determined, which will act as a guide to decide which actions (immediate, remedial, or long-term) are necessary for to implement corrective and preventative actions.

The discovery phase is step three. You only have to do this if long-term action is required in order to resolve the issue. This is where a detailed investigation takes place, and you must determine the final goals for the CAPA action, because this will be how you decide if there was a resolution in stage six. You should also use this step to develop a set of specific instructions to discover the root of the problem.

The examination stage comes fourth. In this stage the cause of the problem is rooted out. This takes place after the data has been collected to support or refute any possible causes. Every aspect of the data needs to be documented and organized during this stage and may come from a variety of sources, including the testing processes, a review of the records, service information, and anything else that may expose the fundamental cause of the problem.

Step five is about action and implementation. This is where progress starts to happen within the quality system, and this is where CAPA software can really help. A good CAPA system can automatically track and store the records and forms you need, and that alone can save the company months if not years of valuable time. When it is installed, implementation can happen, and the software will also track who did what and when.

The final step is about closure. Finishing a CAPA investigation will only happen after every action has been evaluated. This step should verify the completion of the necessary tasks and if the actions taken were appropriate and effective. In the end, this will be valuable information for the next time you take problem solving steps.

After reviewing the phases required during a CAPA investigation it is easy to see the power that a good CAPA process can have on a company’s quality system. A streamlined, automated system will save you time and improve overall efficiency no matter how competitive the market is.