Are there other metrics that should be incorporated, e.g., measuring process control?
The members felt that companies with a high turnover of personnel might be a helpful indicator to include but that it may be difficult to obtain good data on this factor. One member stated that expert testimonies are a positive step in the agencys risk-based analyses, but wanted to ensure that such testimonies would be formally incorporated into the analyses. The members highlighted that understanding of high-risk areas is a helpful tool for both FDA and industry in allocating resources. The members emphasized that FDA needs to help industry understand the model ranking factors with appropriate transparency, to allow firms to improve their ranking by moving toward the desired state, and to allow them to appropriately allocate their internal resources. The meeting was adjourned at approximately 4:00 p.m. on July 21, 2004.
