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Feb 12, 2014

“3 Loops in 1” as Reflected in FDA Warning Letters

Cindy Fazzi

by Cindy Fazzi, Marketing Communications, MasterControl Inc. 

Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).

Many of the citations could have been avoided, or at least mitigated, with the help of a closed-loop or “three loops in one” CAPA process.  What is it and why is it critical?

“Three loops in one” is meant to help the quality team and other CAPA professionals come up with the right solution that resolves the issue in a compliant way, according to Ken Peterson, MasterControl’s director of business development, Quality and Compliance Consulting Team (2).

3 Loops in 1
In a recent CAPA webinar, Peterson explained the “three loops in one” CAPA methodology. Let’s take a look at the different loops as explained by Peterson. I’m using examples of warning letters to demonstrate how they relate to the loops.



First Loop: A quality issue always begins with a quality event, which means that something has gone wrong and an organization needs to find out why it happened. If the problem is minor and there’s a solution that can be performed immediately and sufficiently, then you can close the complaint at this stage.

Examples of quality events that should be covered in the first loop are adverse events and customer complaints. The FDA requires adverse events to be reported. In a recent warning letter to a medical device firm, the FDA cited numerous CAPA violations, including issues pertaining to complaints that were not analyzed and trended and inadequate adverse event reporting (3).


This article is related to the Webinar: CAPA Part 3 - Effectiveness Checking and Management Review To get the full details, please download your free copy

Second Loop: If the quality issue is significant, it will then move to this phase. Typically, the quality team conducts a risk-based review process (also called risk-based filtering process) to determine if the problem needs to be escalated to CAPA. If the issue can be resolved with some containment and some trending and tracking (so it can be monitored), then it can be closed at this stage.

The abovementioned warning letter also cited the company’s failure to address CAPA problems in the second loop—it failed to conduct risk analysis and trending, which could have helped the organization escalate the quality events and fully resolve the problem.

Third Loop: If the quality team decides that a quality issue warrants a full-fledged CAPA, then a CAPA is initiated, followed by a root-cause investigation. Once the root cause is determined, a corrective action can be performed. If necessary, a preventive action should be implemented. The team will then proceed to verify and validate the corrective action to make sure that it resolves the problem. Peterson suggested performing trending, tracking, and monitoring to gain measurements for assurance that the quality issue has indeed been resolved.

The importance of a preventive action is highlighted in a recent warning letter sent by the FDA to an international medical device firm for its failure to include a component in its CAPA process that will “prevent the situation from reoccurring,” referring to nonconformances that have warranted corrective actions (4). This is exactly the kind of issue that could have been addressed in the third loop. 

Conclusion
In a nutshell, “three loops in one” refers to a quality event (issue) that goes through three loops or stages, under a large CAPA process, to ensure an effective and compliant issue resolution.

The big issue for most organizations is finding the right solution. “You need a sound methodology or process,” said Peterson, referring to a method that’s replicable and reliable and will lead to critical thinking, which in turn will lead to the right solution. “You need to ask the right questions,” he added. “If you do that, you will arrive at the right solution each and every time.”

Peterson said the greatest benefit of a closed-loop CAPA process is that it allows effective disposition of issues for a better and safer product in the marketplace. “The bottom line is, CAPA just makes good business sense and that’s the reason why we’re doing it,” he said.

Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.

Note: The views expressed in this article are those of the author and do not necessarily represent those of her employer, GxP Lifeline, its editor or MasterControl Inc.

References:
(1) The section for enforcement actions and warning letters on the U.S. FDA’s website:
(2)Ken Peterson, director of business development of MasterControl’s Quality and Compliance Consulting Team, has helped many organizations (including Abbott Laboratories, Kodak, and IBM) come up with new quality management solutions that allow them to achieve enhanced and breakthrough results. He founded PathWise, a prominent training and consulting firm that focuses on CAPA, risk management, QSR and cGMP specialties. To learn more about Ken Peterson and the QCC, go to:
(3) FDA Warning Letter issued to Hospira Inc. on May 9, 2013. Viewed on Nov. 11, 2013 at: