Living Out Of Debt

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.

Step number two is the appraisal. This, like many other CAPA procedures, will require some strategic thinking. A quality personnel member in charge of the CAPA case should be the one to appraise the situation and determine how the problem will impact costs, product quality, safety, function, reliably, or customer satisfaction. When they have determined the impacts and risks, they will have to assign a level of seriousness. This is important because it will act as a guideline to decide if immediate, remedial, or long-term corrective and preventative actions are necessary.

The discovery phase is the third step. This only needs to be done if long-term action is required. A detailed investigation will take place and it the final goals of the CAPA action must be determined since this is what you will measure the resolution against in stage six. This is also a good time to develop a set of specific instructions to root out the actual problem.

The fourth step is the examination stage. This is where you should really get to the root of the problem. You should collect all your data to support or refute any possible causes and then document and organize everything you have. It doesn?t matter if the data is from testing processes or a review of your records, what matters is that you find and expose the fundamental source 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.