An effective quality system may require many processes that function together to achieve the best results. These processes may include audits, change control procedures, customer complaints management, and more. They may also include a CAPA – Corrective and Preventative Action ? management process. CAPA really is a good manufacturing practice and can be summed up in six steps:
Step one is the definition. When a company is implementing a CAPA process, they first have to identify or define the problem at hand. This definition stage requires a lot of reporting on how, exactly, the information about the problem was gathered, and a lot of documentation to detail what the problem actually is. Of course, there should also be some proof that the problem exists.
Step two is an appraisal. Just like many other CAPA procedures, this requires some strategic thinking. A quality personnel manager who is dealing with a CAPA case should be able to appraise a situation and find out how the problem could impact product quality, costs, safety, functionality, reliability, and customer satisfaction. Once those risks and impacts have been determined, a level of seriousness will be assigned. This will be the guideline they will use to determine if immediate, remedial, or long-term corrective actions are necessary.
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 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 all about closure. Closing a CAPA investigation will occur only after the final CAPA actions have been evaluated. The evaluation must not only verify the successful completion of the identified tasks, but also assess the appropriateness and effectiveness of the actions taken. This way you?ll know how to improve the actions next time.
When you?ve finished reviewing all this steps, you may start to see how a good CAPA program can really improve your quality system. It will streamline your operations, automate your tedious tasks, and save you time and money which can make you a more competitive company.