CAPA Best Practices – Getting the Most From Your CAPA Process

CAPA Best Practices – Getting the Most From Your CAPA Process
July 8, 2013 seouser
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When it comes to CAPA software (Corrective And Preventative Action), not following a best in class system can make all the difference between a clear outcome and one that is far more muddled than ever. You may think that the process of dealing with non-compliance is only as complicated as it’s made out to be, but in actual fact, skipping steps or not adhering to a clear, consistent process is what adds complications in the first place. If you are not sure whether your CAPA system is working as it should, have a look at these best practice tips below to find out whether there is room for improvement.

Can Your CAPA System Be Improved?

A great many factors are at play from the moment a non-conformance is logged. From that point onwards, each part of the process helps towards reaching the final conclusion. The following tips will give you a better idea on whether your CAPA system needs to be improved.

  1. Implement your strategies across the entire company. Non-compliance affects the entire company, across each department and can be found at any level. In this way, CAPA should be developed across the board, to monitor and control incidents that happen at each and any level of the organisation, rather than just in a single department.
  2. Make sure that senior management is on board. Support for your strategies of this nature need to be given from the top down. Resources should be allocated properly, authority on various sign-off policies should be granted and there should be a management of overall procedures from a higher level.
  3. Tie in training and competency testing. In many cases, non-conformances are linked to lack of training, lack of understanding or even a skills gap. In this way, it is essential to aim for a more holistic approach that integrates these quality areas into your CAPA strategies to get the best results.
  4. Keep things simple and consistent. Best of breed is generally the only route to take with strategies of this nature. Customising programmes too much adds unwanted complications, leading to more risk of poor practices creeping in when set guidelines are ignored over heavily revised actions.
  5. Get your documents in order before automating. If you are using CAPA software, it is important to note that documented procedures should be in order before getting started. It is entirely possible to automate processes that are full of errors and other problems. Your policies should be clearly defined, and accessible to everyone in the organisation so that every person understands the process before they have to go through it personally. For that, you may want to consider document control tools.

At the end of the day, dealing with non-conformances need not be a complicated, stressful affair for all involved. By adhering to best practices and having a clear CAPA system in place, you can keep things in order to prevent added stresses and potential issues.

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