Root Cause Analysis of Medical Devices

FDA expects medical device manufacturers to determine root cause during investigations. Under 21 CFR 820.100(a)(2), manufacturers are required to investigate to determine root cause by investigating what led to nonconformities involving the product, processes, and the quality system. 

This requires determining if proper failure investigation procedures were followed. On the FDA website, it states: “Determine whether the depth of the investigation (where possible) is sufficient (root cause) to determine the corrective action necessary to correct the problem. Select one significant failure investigation that resulted in a corrective action and determine if the root cause had been identified so that verification or validation of the corrective action could be accomplished.”

At last year’s FDA/Xavier MedCon conference, an FDA Office of Regulatory Affairs investigator explained that when it comes to root cause investigations into medical device manufacturing deviations, investigators are concerned about “scope, use of appropriate statistical methodology, and inclusion of all shared processes, equipment, and procedures.”

In a guest article on the Redica site last year, Pharmatech Associates’ Stephanie Gaulding identified Failure to Get to Root Cause as the No. 1 common deviation investigation pitfall. 

She writes:

“The reality is that the root cause of a deviation is rarely a result of human error; often, the first thing that comes to mind is part of the symptoms of the issue and not the actual cause. Searching for root cause involves digging through evidence collected during the investigation, reviewing historical data, and analyzing them for root causes.”

As a best practice, she recommends collecting information at the time a deviation occurs. Trying to recall specifics after the deviation is challenging due to the fallibility of human memory. 

Root Cause Investigation Lessons from Pharma

In one case involving a pharmaceutical firm that also offers lessons for medical device manufacturers, FDA investigators evaluating a company’s failure to conduct adequate deviation investigations of a malfunctioning autoclave found that different investigations identified different root causes for the issue. This, among other observations, resulted in a Warning Letter. 

For an example of a more effective root cause investigation involving a supplier, a firm found blue particles in granulated product. Initially, it was assumed that an operator had dropped a ballpoint pen during formulation. One of the individuals involved with quality operations at the firm conducted an onsite investigation at the calcium carbonate supplier. There, they found blue dynamite caps on the ground that matched the blue particles. The supplier’s metal filters had holes that allowed the blue particles to pass through. 

Effective root cause investigations are a critical part of medical device manufacturing operations. Increasingly, FDA investigators are focusing on inadequate root cause investigations. This is a key area to stay on top of when it comes to evaluating a quality system.

Redica can help you prepare for your next FDA inspection. Find out what the latest trends are when it comes to deviation investigations. Contact us to schedule a walkthrough of the platform.