Considering Human Factors Requirements in ISO 9001 and AS9100

Foster a no-blame culture so all employees feel comfortable reporting an issue

Published: Tuesday, November 29, 2016 - 14:49

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?

This is especially important in aerospace, where it is estimated that more than 70 percent of commercial airplane hull-loss accidents and maintenance errors can be attributed to human factors.

Fortunately, the aerospace industry has long been cognizant of the need to address human factors, and there are several good resources available to the public on the internet:
• The Federal Aviation Administration’s Aviation Maintenance Technician Handbook, which added an addendum on human factors
• The SAE’s Supply Chain Management Handbook, which added an update on human factors in 2014

Considering human factors involves gathering information about human abilities, limitations, and other characteristics, and applying that information to tools, machines, systems, tasks, jobs, and environments to produce safe, comfortable, and effective human use.

For example, when investigating nonconformances, we need to recognize that people performing tasks are affected by a number of issues. Twelve human factors have been identified as the most common that lead to failures:
• Fatigue
• Lack of concentration
• Complacency
• Lack of knowledge
• Distraction
• Lack of teamwork
• Lack of resources
• Pressure
• Lack of assertiveness
• Stress
• Lack of awareness
• Negative norms

The resources cited contain in-depth talking points on these 12 factors and ways that they can be mitigated. Much of it is cultural. We need to promote and embrace team excellence, with additional safety nets in error prevention. We should understand how the actions of one will affect others, and establish and promote a culture of quality and prevention of errors, without fear or criticism. In aerospace parlance: “Anyone can stop the launch!”

By objectively considering human factors, we can foster a no-blame culture so that all employees feel comfortable with reporting an issue. We need to ensure competence to perform any task assigned so it can be done correctly, safely, and effectively.

Communication and the right attitude are essential to ensure a safe interface between employees and all other environmental elements such as other people, equipment, facilities, procedures, and data.

About The Author

Tristan Buser-Molatore and Marcia Buser

Tristan Buser-Molatore and Marcia Buser are preferred providers for OMEP specializing in implementing and auditing quality management systems for ISO 9001, AS9100 and ISO 13485.