Setting Up CAPA (Phase II): Pre-investigation

As we discussed in our previous blog, the CAPA process requires extensive forethought, tracking, and careful execution in order to maintain FDA compliance. Having a tracking tool like an Enterprise Resource Planning (ERP) system allows you to follow these strict guidelines and record every step of the process. During the initial inquiry and assessment, medical device manufacturers establish if there is a systematic issue that requires the CAPA process for resolution. After identifying a CAPA, it is important to be patient and prepare rather than immediately jumping into the investigation. In this blog, we will discuss Phase II of the CAPA process: pre-investigation.

Phase II: Pre-Investigation

Identifying your CAPA sources was an important part of assessing issues initially. Even so, it is worthwhile to cement and research all the sources of a CAPA before you start investigating. You may have found a few sources to start, but there could be others that have gone unnoticed so far. Accordingly, the next step of CAPA is reviewing anything related to the issue to identify every relevant source. These sources could be from processes, product, or other quality problems (like customer complaints). In addition, you should also identify the individuals and departments associated with the CAPA from your organization and from third-party entities such as your suppliers.

With an ERP, it is possible to look through this data quickly and see every entry that may help understand the issue. Because an ERP can be integrated into your business processes, you can be confident that you are seeing the whole picture of your enterprise rather than just bits and pieces. For support setting up an ERP, look to an ERP expert with a business-first approach like Datix. With 25 years’ experience, we have the expertise to tailor your system to your organization so that you get the most out of your software.

Once you are sure that you have found all the sources and relevant parties for the CAPA, you can establish a cross-functional team to oversee the investigation. This team could include some of the people who oversaw assessing CAPA requests, but your sources should point you to the appropriate individuals to support resolving the issue. With these people in mind, it is possible to officially begin the CAPA investigation.

Wrap Up

In our next blog, we will be reviewing the heart of the CAPA process: the investigation. Stay tuned!

Read Phase I of CAPA: Inquiry and Assessment

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