The new revision of AS9100D is now out, and clause 10.2—“Nonconformity and corrective action” will require us to “evaluate the need for action based on human factors to ensure nonconformities do not recur.” In addition, clause 7.1.4 of both ISO 9001:2015 and AS9100D require us to consider human and physical factors in the environment for the operation of processes, including social, psychological, and physical.

These concepts are not new to quality, but for the first time they are explicitly defined as requirements in the quality management system standards. The concept of “error proofing” gained momentum during the 1960s.

Human factors are central to many aspects of a quality management system and link back to W. Edwards Deming’s 14 Points for Management in his seminal work, Out of the Crisis (MIT Press, 2000 edition).

We recognize that humans are prone to errors, so how can we design the process and environment to prevent and reduce human errors?

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