Eliminate your CAPA Headache with 6 Easy Steps

by Jayme Brace | Jul 22, 2019 | CAPA, FDA, Medical Devices, Quality Systems, Software

head outline filled with CAPA and compliance terminology

CAPAs are often the most dreaded task to complete and the words “open a CAPA” can bring audible sighs and groans, but CAPAs are an important tool in improving the quality of products and processes. A good CAPA system can alleviate a lot of the stress that comes with completing a CAPA. From Initiation to the evaluation of effectiveness, each step is as critical to completing a successful CAPA. Here are EMMA International’s Top 5 steps to improve your CAPA process.

Only initiate CAPAs with clearly defined problem statements.
Not having a clearly defined problem statement leads to wasted time and resources on unrelated or non-issues. The CAPA should be focused so the problem will truly be solved.
Assign a small cross-functional team to work on the CAPA.
Having a couple key team members from multiple areas affected by the problem will bring about different views on the problem while still being able to accomplish tasks. Having too many team members involved usually causes too much discussion without action while having a core team from the same area leads to important aspects of the problem being missed.
Ensure the actual root cause is found.
This is often the reason so many CAPAs are unsuccessful. A problem cannot be solved if the root cause is unknown. Check out our blog ARE YOU FINDING TRUE ROOT CAUSES? for more information on how to better find root causes.
Stop implementing second tier solutions.
As in math, there are always multiple solutions to any problem, but there are always good solutions and better solutions. Implementing a solution that will “work for now” without a plan in place to implement a long-term solution is not good enough. An idea without a plan will be forgotten and will lead to another CAPA attempting to solve this same issue. Investing in a quality solution the first time will save many wasted resources in the long run.
Maintain detailed CAPA records.
Occasionally, you can do everything right and the problem can still reoccur. By maintaining a detailed CAPA record, the next CAPA team will have a better starting point. This saves time as the team will not have to repeat efforts and will be able to implement a solution more efficiently.