Disconnect Between Management, QCU Possible Source of Warning Letters

A recent survey showing that device company executives are often unaware of problems faced by their quality control units may point to an overlooked contributing factor in FDA warning letters, an expert says.

The most common FDA Form 483 observations during the past decade have related to QCU failings, says Crystal Mersh, an executive partner at QxP. To understand why that is, the consulting firm surveyed 400 industry executives about their QCU departments. The results revealed a telling split in understanding of QCU capacity and performance among executives, quality assurance staff and regulatory staff.

For example, executives were far more likely to believe the QCU had adequate resources and sufficient support to fulfill its mission than QA staff, Mersh says.

“Executive management … thinks everything is really OK and good,” Mersh told a recent FDAnews webinar. “And the FDA has a bit of a different opinion.”

That discrepancy can lead to warning letters if executives fail to provide QCUs with needed resources, rendering them unable to properly perform their duties, Mersh says.

Lack Of Leadership Or Resources?

Two common trouble spots are lack of technical and leadership skills within QCU and lack of resources. Of those surveyed, 61 percent agreed or strongly agreed that the QCU has the required skills, both technical and leadership, to fulfill its responsibility. While that’s encouraging, Mersh says the 28 percent who disagreed and 10 percent who strongly disagreed suggests there is work to be done.

Critical skills for QCU staff include the technical background to understand the company’s manufacturing process, strong analytical and reasoning ability and the leadership skills to influence upper management, Mersh says.

On the issue of resources, respondents varied widely, with 65 percent saying their QCUs didn’t have adequate resources and 35 percent saying they did. This could indicate a great deal of variation in how resources are allotted or respondents’ opinions as to how resources are appropriate for the QCU, Mersh says.

“In general, the majority of folks agreed that the QCU is not adequately resourced,” she says. “And as you can see in the warning letters, the FDA is starting to realize this and call this out.”

The survey also found some wins for QCU staff. Seventy-nine percent of respondents strongly agreed that the QCU’s reporting structure should be isolated to ensure independent decisions.

On the other hand, only 39 percent agreed that the decisions of the QCU are fully independent from all company operations.

Seventy-four percent of respondents said that the QCU gets authority and support from executive management. This may indicate that companies are taking note of the FDA’s relatively recent attention to executive management on quality system matters and are responding with greater support to their QCUs, Mersh says.

For the past 10 years failure to properly manage quality control units (QCU) has been at the top of the FDA’s Form 483 and warning letter citations. Protect yourself with FDAnews’ How to Make Your Quality Control Unit Produce Quality Work - Webinar CD/Transcript. You’ll learn the nine critical expectations of the QCU; an eight-year historical breakdown of CFR 211.22 citations so you can learn from the mistakes of others; the four best practices for ensuring you’re managing an effective QCU; and much more!