Q: Are FDA investigators trained to analyze various quality data sources to help them identify other areas to audit?
At my company, it’s common that an individual department will track and trend quality data metrics within its own area and provide the data to an auditor if requested. Does FDA then add these metrics to data provided by other company departments and thus spot potentially “unknown issues” through data mapping?
A: The answer is yes, to some extent. First, FDA uses historical quality data about a company to better understand its previous issues, including deaths, injuries, court cases, injunctions, Warning Letters, etc. Next, FDA teaches investigators how to ask initial and then probing follow-up questions.
FDA used to — although not as much these days — send new investigators out with experienced investigators to help learn good follow-up questions and see the interconnectedness of things, including the regulations. There is some training in investigative tools, especially things like field exams and data analysis (with or without a computer), although those tools aren’t used as much by new investigators.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]FDA investigators may not always “connect the dots” as much as they should — but you definitely should.[/pullquote]
So FDA investigators may not always “connect the dots” as much as they should — but you definitely should. In our training course called The CAPA Clinic, we emphasize the importance of looking across various data fields to identify potential problems before they become major ones.
Here’s a real-world example: Recently at a client site, we looked at some product complaints, compared investigations of similar complaints for similar products, and then reviewed what changes had been made in response to those complaints. We traced the problem back through design transfer, its impact on supplier management and controls, and finally to incoming inspection data. Looking at all these various data sources, we discovered the company’s overall quality system wasn’t in a good state of control. We demonstrated how easy it would be for an FDA investigator to weave a story of an out-of-control company — based on what at first seemed like a few minor errors on the company’s part.
But in fact, our data mapping efforts showed that the company had failed to follow its own procedures, failed to document its design transfer activities relative to its suppliers, failed to maintain documented evidence, and failed to ensure — at the incoming inspection stage — that it was receiving the appropriate product from its supplier. The company was totally unaware of these problems because it had performed a very poor initial complaint investigation.
That’s why we don’t recommend doing audits of just one part of your quality system. You should find a string and keep tracing it into all the various areas. You need to look at the product, process and system levels. Most companies don’t like to audit this way — but that’s one of the biggest reasons they can’t find the fundamental issues causing their quality problems and compliance failures.
Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator and co-editor of FDA’s Investigations Operations Manual) and instructor of EduQuest’s 12-hour training class called The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management.