Stopping Normalization of Deviance: A Safety Program with Astronaut Mike Mullane - Available at CharlieMorecraft.com
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Normalization of deviance is a sociological concept, coined by Diane Vaughan, describing how unsafe practices slowly become accepted norms within an organization because they don’t immediately cause disaster, leading to eventual failure, famously seen in the Challenger space shuttle disaster. It’s a gradual drift where deviations from standards are rationalized as acceptable due to pressure, efficiency, or lack of immediate consequences, making serious risks invisible until it’s too late. | Step
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Understanding how a process can deviate from its intended design is one of the most effective ways to prevent fires, explosions and toxic releases. A HAZOP study provides a structured method to examine equipment, instrumentation and operating parameters, identify credible deviation scenarios and evaluate existing safeguards. This approach supports compliance with OSHA’s Process Safety Management standard (29 CFR 1910.119) by helping facilities meet process hazard analysis requirements. It also s
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Protocol deviations don’t stay “minor” when they repeat or aren’t documented cleanly. In 2026, deviation management is inspection readiness: protect participant safety, preserve data integrity, and keep oversight defensible under FDA/EMA scrutiny.⁠ ⁠ This guide breaks down how to capture, categorize, analyze, and prevent deviations with GCP-aligned systems—so teams reduce rework and avoid findings.⁠ ⁠ This article breaks it down by:⁠ - What counts as a deviation and why “small” ones escalate⁠ -
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Keynote Speaker: Mike Mullane • Presented by SpeakInc • Stopping Normalization of Deviance
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