Scott Durlacher featured in Med Device Online
Navigant’s Scott Durlacher examines the importance of understanding your company’s quality system and recommends process mapping to generate a visual of your quality system. By breaking down the information in flow charts and process maps, you are creating a more easy-to-digest format. These charts and maps are not only helpful for those existing employees, but also provide value to new employees.
Scott says, “Process mapping is not limited to identifying issues, though. It can also be leveraged, when developing a quality system, to help ensure that all processes operate in an optimal state. Think of the quality system like the back of a pocket watch, in that all the components must fit together and work in harmony for it to function optimally.”
As an FDA Investigator told me a few years ago during an inspection, “once is an anomaly, twice is a coincidence, and three times is a trend.” If an observation escalates to the point of a 483, it is often the result of the investigator seeing a trend, which raises concerns about the adequacy of one or more quality system elements. As soon as that FDA investigator leaves, the focus must shift to addressing the 483 findings. Various approaches may be used, but each typically consists of:
Addressing a 483 observation is an involved, disruptive, and costly undertaking. Remediation activities are time consuming, requiring multiple resources to take on additional responsibilities above and beyond those normally required by their role.