What’s New and Why Is It in MY Standard? Part 2

Last time we talked about the problem. Now, we’ll put it together…

Inclusion of each “requirement” brings with it their own unique set of challenges and therefore their own unique ways of dispensing of it, but, however unique, we can identify some universal truths and in doing so, glean understanding into risk treatment – these are:

  • Etymology – the origin of the word and the historical development of its meaning.
  • Implication – auditor’s interpretation, perception of etymology.
  • Mitigation – What the hell are we going to do about it?

Let’s take Human Factors, for example… The elephant in the room.

Clause 7.1.4 says:

“Environment for the Operation of Processes

The organization shall determine, provide, and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.”

Then adds:

“NOTE: A suitable environment can be a combination of human and physical factors, such as:

  1.  social (e.g., non-discriminatory, calm, non-confrontational);
  2.  psychological (e.g., stress-reducing, burnout prevention, emotionally protective);
  3.  physical (e.g., temperature, heat, humidity, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.”

Without the Note, this clause is very much the same as the old clause 6.4. but with the Note, suddenly all the bells and whistles go off.

How is an auditor going to reasonably assess if a company has provided a proper “social and psychological environment” – non-discriminatory, calm, non-confrontational, stress-reducing, burnout prevention and emotionally protective? A ‘touchy-feely’ world?

Clause 10.1 goes on to say…

“The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

These shall include:

b) correcting, preventing, or reducing undesired effects

This might be construed as requiring us to recognize that humans are prone to errors. But, if so, must we design the process and environment to prevent and reduce human errors? Could be, except to me, it sounds more like Poka Yoke – Mistake Proofing. Hey, what do I know?



Anyway – This is especially important in aerospace, where it is estimated that 80% percent of 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

Human Factors is defined as:

Human Factors: The study of human behavior (physically and psychologically) in relation to particular environments, products, or services and the potential effect on safety. Recognition that personnel performing tasks are affected by physical fitness, physiological characteristics, personality, stress, fatigue, distraction, communication, and attitude in order to ensure a safe interface between the personnel and all other environmental elements such as other personnel, equipment, facilities, organizations, procedures, and data.”

Note: Keep in mind that what began as a Health and Safety practice (hence the ergonomics part) and also more popular on the ‘other side of the pond’ has morphed into a completely different discipline.

Enter ISO 9001:2015 and for all the evidence that TC 176 ignores the rest of the world, this odd requirement seems to have crept in. You can’t tell because the requirement isn’t named as such, but it appears to be the same “Human Factors” requirement from AS 9110, the aircraft repair station standard.

In AS 9110, the requirements for “Human Factors” (HF) are:

“The organization shall determine and manage the work environment needed to achieve conformity to product requirements. The work environment shall give consideration to human factors and human performance, and ensure that the effectiveness of personnel is not unduly impaired.”

So, how did an Aerospace requirement, “Human Factors,” end up in ISO 9001:2015?

OMG – It’s ISO 9000!

The answer is that it wasn’t an aerospace requirement after all. If you go back to ISO 9000:2000 we find that HF has slept unnoticed and dormant for the past 16 years.

Here’s the definition of “work environment” provided by ISO 9000:

3.3.4 work environment: set of conditions under which work is performed

NOTE Conditions include physical, social, psychological and environmental factors (such as temperature, recognition schemes, ergonomics and atmospheric composition).”

Then, we need to look at ISO 9004 for more of the same:

6.6 Work environment:

The organization should provide and manage a suitable work environment to achieve and maintain the sustained success of the organization and the competitiveness of its products. A suitable work environment, as a combination of human and physical factors,should include consideration of

  • creative work methods and opportunities for greater involvement to realize the potential of people in the organization,
  • safety rules and guidance and the use of protective equipment,
  • ergonomics,
  • psychological factors, including workload and stress,
  • workplace location,
  • facilities for people in the organization,
  • maximization of efficiency and minimization of waste,
  • heat, humidity, light, airflow, and
  • hygiene, cleanliness, noise, vibration and pollution.

The work environment should encourage productivity, creativity and well-being for the people who are working in or visiting the organization’s premises (e.g. customers, suppliers, and partners).

At the same time, the environment complies with applicable statutory and regulatory requirements and addresses applicable standards (such as those for environmental and occupational health and safety management).”

Remember, neither 9000 or 9004 contain auditable requirements but this is where the insidiousness creeps in. If you remember part 1, I said to “Hold that Thought?” Here it is! ISO 9001 gives us the news today… ISO 9000 and 9004 show us tomorrow’s news. And, it’s been this way almost from the beginning…

So the bottom line is, someone took what had previously been an optional, advanced best practice of ISO 9004, defined in a non-binding ISO 9000 definition, and made it an auditable, mandatory requirement in 9001.

(Yes, it’s a “note” — but that doesn’t stop auditors from trying to enforce it!)

In this part, we have discussed Etymology and Implication, next time we’ll look at Mitigation. See you next time…

Note: The Kilpatrick Group would like to express thanks to Oxebridge Quality Resources International and their Senior V.P. Christopher Paris for his contribution to this series.

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