The requirements in this section of the standard refer to the controls to be exercised over two of an organization's main processes: production and service delivery. These are both processes that are repeated continuously to replicate products and services that consistently meet the same quality standard.
If the design process is a real journey into the unknown, the production and provision of a service can be considered a journey along a proven path, with a result that should be predictable. The design process, in fact, requires continuous control to keep it on track toward a specific objective, while the production and service delivery processes require control to maintain production within an established standard.
Production and service delivery are controlled in two different ways. Product quality can be controlled by directly verifying the product at different stages of production or by controlling the processes through which the product passes, i.e., by controlling those factors that influence the results of the process.
To control a service, on the other hand, one must rely solely on process control since, in each phase, there could be an interaction with a customer and an opportunity to improve their satisfaction (or worsen their dissatisfaction). The result is that, at the end of the service delivery process, we may have an accumulation of satisfaction or disappointment, and that, therefore, with services, especially those aimed at the customer, there are fewer opportunities to hide errors.
In the latest revision of the norma ISO 9001 standard, the control of production and service delivery is discussed in paragraphs 8.5 and 8.6. The standard requires implementation of production and service delivery under controlled conditions, and this means there must be:
- known inputs (i.e., we must know what inputs to expect);
- known outputs;
- well-known customer needs of the outputs;
- sequence of process activities and their interaction known (i.e., we must know in what order the individual activities of the processes must be carried out and with which processes each individual part of the system interacts to obtain the inputs it needs and to provide the outputs that are expected);
- known methodologies for the preparation, execution, control, and release of the work performed;
- known criteria (it must be established in advance how well the work should be done and what results should be achieved);
- known and made available resources;
- known responsibilities and authority of each actor in the process;
- known process capability (i.e., it is necessary to know in advance what the process will produce in terms of quantity and quality and according to what timescales);
- influences on the process that must be managed to minimize the risks to its known capacity
Having made this long premise, which is fundamental for fully understanding what we are going to talk about, in this article we will examine seven requirements of paragraph 8.5.1, namely:
- Availability of documented information (8.5.1)
- Availability and use of adequate monitoring and measurement resources (8.5.1e)
- Monitoring and measurement activities (8.5.1c)
- Use of adequate infrastructure and environments (8.5.1d)
- Competence and qualification of personnel (8.5.1e)
- Validation of processes (8.5.1f)
- Actions to prevent human error (8.5.1g)
Availability of documented information (8.5.1)
The informazioni documentate documented information that is required in this paragraph of the standard is intended to define what must be produced or supplied, what requirements must be met, and what work - overall - must be carried out. These requirements are expressed in terms of:
- characteristics of the products to be manufactured;
- characteristics of the services to be provided;
- activities to be carried out;
- results to be achieved
The organization has the possibility to choose which documented information is applicable because some may not be necessary if the personnel have the training, experience and, above all, possess the knowledge necessary to know how to proceed. A competent plumber, for example, will not need to have available the information that defines the basic criteria for the sequence of activities to be followed in the installation of a central heating system because they will have already learned it during training.
However, it would be good to have a checklist to support the work so that the plumber can make sure that they have not forgotten any important steps. The documented information, in this case, becomes the input for the production or service delivery process and usually comes from the planning process even if it can be provided directly by customers.
They can take the form of definitive specifications, agreements on the level of service to be provided, drawings, layouts or any information that specifies the physical and functional characteristics that the product or service must possess. This requirement is necessary because, without information that specifies the product to be produced or the service to be provided, there is no solid basis on which to control the work.
The people who carry out the operational work, in fact, must know exactly what is required of them and by when it must be completed. To guarantee the availability of correct information, it is necessary to open a communication channel between the planning process and the production and service delivery processes. All the information necessary to create the product and provide the service must pass along this channel.
At a minimum, there should be documented information defining the work to be performed, when it is to be completed, and for whom it is being worked, so that the customer is known and any relevant information can be accessed. It is also necessary to provide for the transmission of any changes to this information, so that recipients can promptly determine the correct information to use and what changes are required.
To demonstrate that the documented information that defines the characteristics of the products and services is complete and available, you can:
- present proof of the existence of a process designed to make available to personnel who need to know it the information that defines the product or service to be provided;
- select a representative sample of people involved in production and service delivery and present proof that the information they need to create products and services is available to them according to the dictates of the process described above
Availability and use of adequate monitoring and measurement resources (8.5.1e)
Monitoring and measurement are key factors needed to control processes. This means providing the equipment necessary to measure the characteristics of the product, monitor process performance, and provide adequate training and instructions so that this equipment can be used as intended.
This requirement is necessary because the quality of the product and service can only be determined if the equipment necessary to carry out the expected measurements is available and used as intended.
When designing the process for producing the product or providing the service, you should have an indication of the stages in which the characteristics of the product or service are verified. In these stages, it may also be necessary to install monitoring devices that indicate when standard operating conditions have been reached and if they are maintained.
To demonstrate that adequate resources for monitoring and measurement are available and usable, you can:
- present proof of the existence of a process for carrying out monitoring and measurement that has planned and made available the necessary resources;
- present evidence of a process for training personnel in the use of monitoring and measurement tools;
- select a representative sample of people involved in production and service delivery and present evidence that the monitoring and measurement resources specified in the documented information have been made available and that they have been trained to use them correctly