Setting Up CAPA (Phase III): Investigation

When it comes to resolving a CAPA, the investigation is critical. The FDA will not allow medical manufacturers to simply run a cursory review and call the matter resolved. An Enterprise Resource Planning (ERP) system makes the CAPA investigation process easier by giving manufacturers the resources they need to understand the systematic issue of the CAPA. In this blog, we will outline what needs to happen during the CAPA investigation phase and how an ERP can support the process.  

Phase III: Investigation

The CAPA investigation should start with resolving any corrections vital to your organization. Yes, you need to address every aspect of the CAPA, but you must identify and immediately respond to the issues that are essential. If unsold product is potentially compromised by the CAPA issue, for instance, you are expected to quarantine and find out if it is safe before it can be sold. If product that was sold is found to be dangerous to customers, then you will likely have to issue an immediate recall to protect consumers. Essentially, you must contain the CAPA issue as much as possible right away, giving your team the time to come up with a long-term solution.

When it comes to investigating a long-term solution to the CAPA, you must return to the sources. Learn everything about how they are involved in the issue, and how issue arose in the first place. To meet CAPA requirements, you must demonstrate that you considered every component of the issue thoroughly and have all your findings documented. An ERP makes documenting CAPA data simple, if you have the right software. As a one-stop shop with 25 years’ experience, Datix has the expertise to support medical manufacturers in finding the right ERP for their business. Learn what Datix can do for you.  

By the end of the investigation, you should come up with the root cause of the CAPA, as well as every aspect that impacted it. The root cause of the CAPA is not simply the problem restated, although this is what many manufacturers mistakenly put in their CAPA documentation. It is the core and fundamental cause of the issue, and if you don’t identify it correctly, you will probably have to open another CAPA request.

To determine the root cause of a CAPA, you can use many different analysis tools like the Pareto Chart, The 5 Whys, a Fishbone Diagram, a Scatter Diagram or Failure Mode and Effects Analysis (FMEA). Your team should determine what tool they will use for this CAPA, and then use it to find the required answers. Fortunately, the right ERP can track and document data using any of these tools from within the software. If you need support finding and setting up an ERP that will work with CAPA analysis tools, look to an ERP partner like Datix. As a business-first consultant, we learn what tools and features our clients need from their software, so we can deliver the best possible ERP solution for them.

Wrap Up

In our next blog, we will review the next phase of CAPA: planning and execution. Stay tuned!

Read Phase I of CAPA: Inquiry and Assessment

Read Phase II of CAPA: Pre-Investigation

About Datix

For medical manufacturers, Datix is the ERP consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.

Learn More About How We Support Our Clients

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