The Touchy-Feely Employee – Introduction of Human Factors

On December 13th the much awaited 2000 revision was released and the world changed forever! How significant the changes were, however, has taken sometime to fully realize. In a previous post we talked about the presence of Risk in the Standards – where it appeared and where it didn’t. Yes, 2000 was a big year… inclusion of so much but conspicuously devoid of risk (but that was then, this is now.)

Changes from 1994 to 2000

The text was reworded for easier adaptation to a wider range of organizations. Some definitions were changed. The standard had shifted from product to process-oriented thinking including a process model based on the Plan-Do-Check-Act cycle, which outlined the product and/or service cycle and the management control cycle.

The 20-element format was replaced. The text of the standard was now organized into four major processes:

  • Section 5. Management Responsibility
  • Section 6. Resource Management
  • Section 7. Product Realization
  • Section 8. Measurement, Analysis, and Improvement

Management Responsibility

  • Top management had to provide evidence of its commitment to the development and improvement of the quality management system.
  • The evidence needed to include communicating to the organization the importance of meeting customer needs, as well as regulatory and legal requirements.
  • The quality objectives were now measurable, had to be consistent with the quality policy and had to include a commitment to continual improvement.
  • Quality planning had to include continual improvement of the quality management system.
  • Top management had to ensure that customer needs and expectations were determined, converted into requirements, and fulfilled with the aim of achieving customer satisfaction.
  • Top management had to ensure communication of quality management system processes and of process effectiveness took place at all levels and functions of the organization.

Resource Management

  • The organization had to identify, provide and maintain the facilities it needed to achieve conformity of product, including: workspace and associated facilities; equipment, hardware and software; and supporting services.
  • The organization had to identify and manage the work environment with consideration of the human and physical factors needed to achieve conformity of product.

Product Realization

  • The organization had to determine customer requirements including: product requirements not specified by the customer but necessary for intended product use; and obligation related to the product, including regulatory and legal requirements.
  • The organization had to identify and implement arrangements for customer communications relating to: inquiries, order handling, or contracts (including amendments); customer feedback (including complaints).

Measurement, Analysis and Improvement

  • The organization had to collect and analyze appropriate data to determine the suitability and effectiveness of the quality management system and to identify potential improvements. Data had to be generated by measuring and monitoring quality system implementation and/or maintenance activities.
  • The organization had to analyze collected data to provide information on customer satisfaction and/or dissatisfaction and conformance to customer requirements. These methods had to confirm the continuing ability of each process to satisfy its intended purpose.
  • At appropriate stages of the product realization process, the organization had to measure and monitor the characteristics of the product to verify that requirements are met.
  • The organization had to plan and manage the processes necessary for the continuous improvement of the quality management system. The organization had to facilitate the continuous improvement of the quality management system through the use of the quality policies, objectives, audit results, data analyses, corrective and preventive actions, and management review.
  • The organization had to monitor information on customer feedback – satisfaction and/or dissatisfaction as one of the measurements of quality management system performance. The methodologies for obtaining and using this information had to be determined.

Human Factors was not expressly called out in ISO 9001:2000 Element 6.4 Work environment, which only required, “The organization shall determine and manage the work environment needed to achieve conformity to product requirements.” ISO 9004 screamed it out…

ISO 9004:2000 6.4 Work environment

Management should ensure that the work environment has a positive influence on motivation, satisfaction and performance of people I order to enhance the performance of the organization. Creation of 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,
  • workplace location,
  • social interaction,
  • facilities for people in the organization,
  • heat, humidity, light, airflow, and
  • hygiene, cleanliness, noise, vibration and pollution.

The 2008 revision of ISO 9001 continued with the same language but did add the guidance note below:

NOTE The term “work environment” relates to those conditions under which work is performed including physical,environmental and other factors (such as noise, temperature, humidity, lighting or weather).

This note then becomes the bridge between ISO 9004 (Guidance document) and ISO 9001 (Requirements) and although the term Human Factor is not specifically defined, it is categorized among ‘other’ factors such as, health & safety and environmental.

Finally, the 2009 revision of ISO 9004 took the subject to a whole new level with:

human-factorsISO 9004:2009 (current revision) 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 organization should ensure that its work environment complies with applicable statutory and regulatory requirements and addresses applicable standards (such as those for environmental and occupational health and safety management).

How do you suppose an auditor is going to assess an ‘emotionally protective’ environment? Truth…They’re not! They’re going to keep auditing the way they have done so since 2000, going merrily along ignoring the fact that it’s there. So what about now? The concept is now codified in ISO 9001 in this latest 2015 revision

ISO 9001:2015 7.1.4 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.

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

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

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

And now the fun starts…

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