For at least the last 20 years, the CAPA systems have been the leading cause of audit findings (nonconformities) and FDA inspection findings (483s).  And there’s no sign that things are getting any better.

CAPA and CAPA-related findings include lack of documentation / documented evidence, lack of timeliness, root cause(s) not being identified, failure to show effectiveness of actions, and on and on.   Basically, every step in the process can be a potential for failure and a potential for a finding.

In general, companies are often either abusing the CAPA system or poorly applying it.

We’ll kick things off with a bit of a background discussion. We’ll discuss the standards/regulations driving this process. We’ll also touch on what the intent of the process should be. This should set the proper mindset for the remainder of the discussion.  

We’ll then look at what should be entered into the CAPA system and what should not.  We’ll describe the distinction between CAs and PAs and how to recognize the difference. We’ll discuss specific examples of situations where CAPAs are warranted in both product and process.

Due to fear, uncertainty, doubt, overhead, and resource constraints, companies often tend to shy away from CAPAs, only opening one when forced to. We’ll discuss what proper implementation of the CAPA system is and why companies should actively look for ways to improve. We’ll discuss areas to mind for new CAPAs.

Once we’re comfortable with the concepts of CAPAs and what really should be dropped into the system (and what should not), we’ll delve into the process itself.

We’ll first discuss defining the issue. This is an often overlooked, but critical step. Without properly defining the issue, we are likely to miss opportunities for improvement.

We’ll then talk about containing and correcting. There is a distinction!  Without properly considering both actions, we could wind up repeatedly seeing the problem even after we have eliminated the root cause(s).

At the heart of the CAPA system is the root cause analysis.  We’ll spend a good deal of time here, discussing tools and techniques to facilitate root cause analysis and enable identification of true root cause(s). This is probably the area where most nonconformities arising from the CAPA system come from so we want to spend a good bit of time discussing how to avoid re-stating the issue as the root cause and how to use tools to identify and document the true root cause(s).  

Actions arising from the investigation and analysis need to be verified and/or validated. We’ll discuss this aspect from both what to do and what to do if verification and/or validation fails.

A critical mistake companies make is to set artificial deadlines for CAPA closure. They often read “in a timely manner” and assume a small window. This isn’t always practical or possible. We’ll discuss planning out effectiveness evaluation and how to appropriately set evaluation windows.  

We’ll acknowledge that, despite our best plans and efforts, we may not be successful in eliminating the root cause(s) and see the problem arise again. We will discuss options on how to manage in these situations.

Finally, we’ll address closing out the CAPA. Here’s yet another point for failure as companies are eager to close CAPAs to show they are managed in a timely manner. We’ll discuss a recommended method to show CAPA status that makes sense, allowing closure to occur when appropriate.

We’ll wrap things up with a list of takeaways you can use and summarize a few key points.

Areas Covered     

Who Should Attend    

Why Should You Attend

Mention “CAPA” to folks in the medical device industry and they’ll probably look at you like you uttered a four-letter word.  For at least the last 20 years, the CAPA systems have been the leading cause of audit findings (nonconformities) and FDA inspection findings (483s).  And there’s no sign that things are getting any better.

CAPA and CAPA-related findings include lack of documentation / documented evidence, lack of timeliness, root cause(s) not being identified, failure to show effectiveness of actions, and on and on.   Basically, every step in the process can have a potential for failure and a potential for a finding.  

It needn’t be this way!  At the heart of the process is sound quality improvement concepts!  The problem generally always lies in a company’s implementation of the process.

Companies typically view CAPAs in a negative light; i.e., busy work that provides no appreciable benefits.  In these cases, management tends to minimize the efforts, often using unqualified resources and not giving them sufficient time to do the necessary work.

In other cases, some companies dump every little nonconformity into the CAPA system, improperly flooding it.  (Combine this scenario with the previous one and it’s a total train wreck!)  This is not the intent of CAPAs.

We hope to bring a little sanity back to the process with this presentation by setting the proper mindset for what should be entered into the CAPA system (and what should not), examining the ways CAPA failures arise, and discussing means to properly employ the CAPA system to do what it’s intended to do: drive quality improvement.

Topic Background    

The CAPA process is a total mess in the medical device industry.  This webinar is intended to bring a little sanity back to the process by ensuring the process is understood and giving practical advice for managing CAPAs.