Sep 30 2009
CAPA Software – Your Quality System In Six Steps
Many different processes have to function together in order to get the most from your quality system. Some of those processes include Corrective and Preventative Action (CAPA) management, change control procedures, audits, customer complaints management, and others. CAPA is very important. There are six basic steps to 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 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 third step is the discovery phase. This is only undertaken if a long-term action is required to resolve the issue. This step is called a discovery phase because an investigation is required. You must determine your goals for the CAPA action because they will act as the guidelines for whether or not the action is resolved by step six. Next, you should develop a strategy, or a set of specific instructions to determine 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.
The fifth step requires action and implementation. This is where the real progress starts within the quality system. This is where you should really consider using some CAPA software to automatically track and store all the related records and forms. A CAPA software solution has the ability to save a company months or even years of valuable time. Once installed, the implementation can take place, and the software will track who was in charge and who took care of the problem.
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.
Once you?ve reviewed all this steps, you may come to the realization that a good CAPA process can really improve a company?s quality system. Not only will a streamlined, automated system save you time, but it will improve your efficiency and make you more competitive.
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