Articles by Ben Locwin

1. SOPs, The Modern Worker & How Pharma Companies Must Evolve The “Read & Understand” Model 6/1/2022

   Pharma companies have used “read and understand” approaches with standard operating procedures (SOPs) as a core component for staff training for many years. However, what is the percentage of people who are completing their read and understand assignments without truly understanding them? We need to evolve our model of SOPs.

2. FDA's Drug Shortages Root Cause Report: Does It Miss The Mark? 2/7/2020

   At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” but there's a lot more to the story.

3. “Human Error” Deviations: How You Can Stop Creating (Most Of) Them 10/9/2017

   In the time it takes you to read this article, the industry will generate (conservatively) about 115 new process deviations, and about 65 of them will be misclassified as having something related to “human error” as either the principal causal factor or one of the proximal causal factors.