Anyone able and willing to reveal the secrets of the universe concerning FSMA risk assessment?
As I analyze FSMA information, it becomes clear to me that risk assessment is not identical to hazard analysis. I am intuiting it means statistical probabilities rather than the simplistic frequency and severity exercise HACCP teams have used for so long. I took statistics at university but it’s not my passion or greatest competency. I see the FDA has offered iRisk 1.0 and very recently 2.0, calling them risk assessment tools.
Is this the right track? Are there other tools or better tools to perform a world class risk assessment for identified risks? What do we use as the dividing line between significant risks and non-significant risks? I’d really like to know what you all are thinking with respect to FSMA compliance.
The FSMA information I get is sponsored by big software companies that want to sell expensive solutions that are appropriate for large profitable companies. I am grateful for the free education and they do provide a few actionable gems for smaller companies doomed to non-automation, but really they offer such a high-level, big-picture look at FSMA and its compliance solutions that it remains slim pickings for smaller companies where managers wear many hats and resources are limited. Are there any of you FDA people converting your HACCP to HARPC and have a handle on the risk assessment yet?