Prior to the 2000 version of ISO 9001, the requirement relating to the environment in which processes must take place only concerned the provision of adequate workspace for their control.
In ISO 9001:2000, the requirement to manage the work environment to ensure product conformity was introduced for the first time. The term "work environment" is defined in ISO 9000 as a set of conditions under which work is performed, and the document also notes that these conditions can include physical, social, psychological, and environmental factors.
ISO 9001:2015 refers to human and physical factors and then divides human factors into social and psychological factors, which implies that physical factors that influence humans are not human factors. There are physical factors that influence products and services (e.g., equipment and facilities) and physical factors that influence human performance (e.g., levels of light, noise, temperature, chemicals, and dust), but there are also social and psychological factors that influence human performance (e.g., fear, isolation, stress, and bullying).
Such a requirement is absolutely fundamental within the standard because the work environment is very important for all process outputs, for the product and service, and for the motivation and performance of workers. It extends beyond the factors commonly visible and audible in the workplace. Noise levels, for example, do not necessarily have to cause physical damage to be a factor that negatively affects worker performance.
It is the duty of an organization's management to first check the physical factors that must fall within the levels required by law, secondly, within the levels necessary to prevent product deterioration, and thirdly, within the levels provided for people to perform their work in the most efficient and effective way possible. It is also the management's job to create the necessary conditions so that collaborators are motivated to achieve the results expected of them.
But how do you operationally control a work environment? It's simple: environmental management is nothing more than control over the activities, products, and processes that cause or could cause environmental impacts on processes, work, and people. The approach adopted must be based on cause-and-effect management in which activities, products, and processes are the causes, and the resulting impact or potential impact represents the effect on the environment.
The effort should be focused on eliminating negative impacts and creating positive or beneficial impacts that also lead to improved performance. The register of negative effects is a risk assessment for the environment. What needs to be done, therefore, is to adopt a risk-based approach because we can never be sure of what will happen, given that every workplace is full of uncertainties by virtue of the many variables present within it.
However, some variables may have little effect, so it is important to first identify those processes for which the environment could be fundamental to the quality of the outputs. We can then ask ourselves three questions:
- What environmental conditions are maintained in the workplace, regardless of the type of work in progress? In this case, we are talking about those environmental conditions that are constantly controlled to comply with the relevant legal requirements for the workplace such as, for example, temperature, humidity, cleanliness, noise, lighting, drainage, ventilation, and emissions;
- To what extent does the quality of the process output depend on the control of environmental factors in addition to those already regulated by law?
- How likely is it that the necessary environment is already controlled by the workforce without having to introduce additional controls? An initial risk assessment should be undertaken to prioritize action, identifying those processes where further studies on the environment are needed.
Where people are an integral part of a mechanized process, the human-machine interface is of vital importance and must be carefully considered in process design. The information on the display panels should be clear and relevant.
The positioning of instruments and input, output, and monitoring devices should allow the operator to easily access information. Emergency controls should be easily reachable, and instructions for use accessible from the workstation. To demonstrate that the environment necessary for the operation of the processes has been determined, you can:
- Present the results of process risk assessments to support the decisions made regarding the necessary environment;
- Present evidence of studies conducted to identify the physical factors of the product processing environment that would increase the risk of non-conformity;
- Present evidence of studies conducted to identify the physical, social, and physiological factors of the environment that could lead to non-conformities;
- Present evidence of process descriptions that define the processing environment to be maintained;
- Present evidence that regular communication takes place with the workforce to allow them to present any problems so that they know they are being heard and understood