The second and third ISO 9001:2015 requirements related to the environment (providing and maintaining the environment necessary for the operation of processes) aim to create and maintain the environment that has been determined to be necessary for the operation of processes to achieve the conformity of products and services.
This may involve not only maintaining the status quo, but also keeping pace with any internal changes and external modifications that affect the environment. Why is all this necessary?
If the environment in which processes must operate is not properly determined, provided exactly as hypothesized, and maintained over time, the identified risks can materialize and the products may be non-conforming. The logical consequence, of course, would be reduced customer satisfaction. To provide and maintain the environment necessary for the proper functioning of processes, managers must create, monitor, and adjust conditions so that the physical and human factors of the work environment act positively to achieve the planned results.
Some of the factors that influence the work environment are constraints rather than objectives; that is, they exist only because we have an objective to achieve. Noise in the workplace occurs because it is necessary to operate machinery to produce products that satisfy the customer. If we did not need to operate the machinery, there would be no noise.
However, some of these constraints are of our own making. If management were able to create a work environment conducive to a good professional climate, the workforce would be more productive. Providing the environment necessary to protect products means understanding what we need to produce and adapting accordingly.
For example, to achieve high performance from electronic components, it is necessary to minimize particles and chemical contamination during their manufacture and assembly. To produce food and medicines, on the other hand, it is necessary to ensure adequate levels of cleanliness and hygiene, which must be maintained throughout the production and preparation of food or medicines.
For these and many other reasons, the work environment must be controlled. If these conditions apply, you must:
- Document the standards to be maintained;
- Prohibit unauthorized personnel from accessing production areas;
- Provide training to personnel who must work in such areas;
- Provide alarm systems to signal malfunctions in the environment;
- Provide procedures for maintaining equipment operation within these standards;
- Keep records of conditions as a means of demonstrating that standards have been met
Providing, instead, the environment necessary to support worker productivity means offering an environment in which the psychological and social factors that influence people are considered. Temperature, for example, can have a significant impact on worker performance, although each of us differs from others in terms of subjective tolerance to high and low temperatures. These differences can also lead to real internal conflicts.
Even where it is not necessary to control the temperature to ensure a conforming product, it is appropriate to guarantee workers a range of temperatures that enables them to maintain those performance standards that are expected of them. Noise, even within legally permissible values, can be a real distraction and, therefore, lead to errors. Finally, the space provided to workers must not only meet the standards required by the activities that are carried out in that environment but also meet the social needs of everyone, since people also need a certain degree of privacy to carry out their work without intrusion from nearby colleagues.
Placing workers too close to each other can induce some distraction and induce them to participate in discussions that are not relevant to the work they are doing. The fear factor in the workplace should not be overlooked, as it is extremely damaging to quality because people will tend to hide their mistakes to avoid being scolded. Managers should be able to create working conditions such that employees are comfortable seeking help from their supervisor if they have doubts and not be afraid of reprisals in the event of an error. How do you demonstrate that you have fulfilled the requirement?
Explaining that the environment necessary for the operation of the processes has been provided with the characteristics that can be found because:
- Compliant with applicable environmental legislation;
- Studies have been done on how environmental factors can have a detrimental effect on the product and service conformity, and all necessary precautions have been taken