The video below is a sample taken from our webinar, The Complete Guide to Root Cause Analysis & CAPA, available free and on-demand here.
The FDA Group's Larry Stevens discusses strategies for determining when Corrective and Preventative Action (CAPA) is appropriate. See transcript below.
The following is a paraphrased transcript, formatted for clarity and readability.
Under-using CAPA
Okay, so let's look into the CAPA program now. Many companies either overuse or underuse CAPA. I've seen—mostly as a consultant—the other use of CAPA that virtually every problem that occurs in a company is handled by another system, whether it's the complaint system, or the nonconforming material system, or the supplier quality system, and they would have four or five CAPAs a year and it would be huge things like the development of a paperless system or a new staffing plan. Clearly they were not using the CAPA program as it was intended for and obviously we're going to talk about that.
Overusing CAPA
The other issue is overuse. At one company I was with—every complaint, they opened a CAPA. They literally had hundreds of CAPAs open and it was totally shielding the real problems. So, it's really important to basically identify what your criteria is to open your CAPA and use it to deal with systemic or potentially systemic issues—the things that represent a system-wide failure.
Criteria for Opening a CAPA
We're going to look at four things to consider when you run your CAPA program as to know when a CAPA should be opened or not.
1. Did an incident cause injuries or death? Definitely open a CAPA.
In those cases, if it was a product failure, obviously a CAPA is going to be opened.
2. Have there been multiple occurrences of the same event?
This is a little more subtle in that "multiple" could mean "two," or "thirty" and the key is your risk assessment. So, we know you do a formal risk assessment with each of your CAPAs. FDA expects to see that. And that risk assessment essentially lets you determine what level of investigation you're going to do, how broadly you're going to apply it, and determining not to open a CAPA should be for something that poses minimal risk. Handle those things another way.
3. Can issued be managed another way?
We know basic change management is a model for finding things and improving things. The design control, too, as long as they're not implemented to fix a significant, systemic problem. Now, so, criteria in your CAPA procedure that allows you to you review all your potential CAPAs and make decisions as to which ones actually go into the CAPA program and which ones should be handled another way.
4. Does the issue appear to be critical after conducting a risk assessment?
The bottomline with the risk assessment is the higher the risk—even if it's one high risk report—will require a CAPA to determine the appropriate actions.
Watch our free webinar to learn more about conducting thorough root cause analysis and establishing effective, compliant CAPA procedures.
