Monitoring and measurement are the means by which the characteristics of the product and process are determined, and this requirement refers to the performance of planned monitoring and measurement activities.
The specifications define the target values to be kept as a reference, while the process description (or its planning) defines when the measurements must be made to ascertain whether the objectives have been achieved. The requirement is necessary because, to control the quality of the product, it is necessary to measure the characteristics obtained and the operating conditions of the process must be monitored. All controls require a verification phase and a feedback loop.
It is not possible to controllare i processi di produzione control the production or service delivery processes without performing a verification. To perform the planned monitoring and measurement in the appropriate phases, it is necessary that:
- the monitoring arrangements provide for how the collected data reaches the person responsible for monitoring and measurement in the designated phases;
- the equipment for measurement is available where the measurements are to be made;
- the physical and psychological environment is suitable to guarantee the validity and reliability of the results;
- the people are competent with regard to the operation of the measuring and monitoring equipment and in the interpretation of its data;
- the acceptance criteria are available;
- the people perform the planned monitoring and measurement work at their best and are not put under pressure to skip the steps of the planned plan, perhaps due to tight deadlines
Demonstrating that monitoring and measurement activities are implemented in the appropriate phases can be evidenced by:
- evidence of the plans for carrying out monitoring and measurement;
- a representative sample of the planned monitoring and measurement activities and proof that they have been carried out in the designated phases using the acceptance criteria provided
Use of adequate infrastructure and environments (8.5.1d)
The standard, in this paragraph, requires that the infrastructure and the environment in which production or service delivery is carried out comply with the provisions of points 7.1.3 and 7.1.4 (Paragrafo 7.1 Ambiente di Lavoro Paragraph 7.1 Work Environment). The outputs of the process, in fact, cannot be achieved unless the essential physical resources for carrying out the work are used.
Under different conditions, in fact, people would be employed to compensate for the inadequacies of the infrastructure and the environment - a state that can be sustained in some circumstances but not for long without degrading the quality of the work.
The necessary infrastructure and environment are determined during process planning. To ensure that the personnel involved in production and service delivery processes know which equipment and facilities to use, they can be:
- identified in work orders, instructions or other process documentation;
- designated areas provided for the production of specific products or for the provision of specific services Demonstrating that the infrastructure and environment are suitable for the operation of the processes can be done:
- presenting documented information that identifies any special infrastructure and environment to be used in production and service delivery processes;
- selecting a representative sample of production and service delivery activities and providing proof that they were carried out using the designated infrastructure and environment
Competence and qualification of personnel (8.5.1f)
People who carry out production and service delivery activities must have the ability to achieve the desired results. The requirement is necessary because, by not appointing competent people to carry out production and service delivery activities, there is a risk of making mistakes and obtaining non-conforming outputs.
Demonstrating that people are competent and in possession of the qualifications required to carry out the tasks that have been assigned to them is possible:
- presenting proof of the existence of a process for the appointment of personnel suitable for undertaking the work in the production and service delivery processes;
- presenting evidence that the appointments are made on the basis of competence and any necessary qualifications;
- selecting a representative sample of personnel and presenting evidence that their appointments were made according to the designated process
Validation of processes (8.5.1g)
Many processes do not present any difficulty in verifying the resulting output before delivery or delivery to the customer, however, there are some processes in which the output depends entirely on the competence of the personnel, on the capacity of the equipment and facilities and whose performance cannot be fully verified by examining the output in any way.
These processes are identified as special processes and, among them, we mention the welding process, bonding, forging, etc. These are, in essence, processes in which any deficiencies would become evident only after delivery and commissioning of the product.
Even in service companies there are many cases in which it is not possible to verify the service before providing it, just think - for example - of medical, financial or legal services.
Normally, the characteristics of the product or service are verified before their release to the customer but, when this is not possible without destroying the product, the process must be qualified as capable of producing a compliant product or of providing a compliant service. To limit the possibility that any deficiencies escape before the product is released or that the service is used, measures must be taken to ensure the suitability of all equipment, personnel, facilities, etc.
A thorough assessment of the processes should be made to determine their ability to maintain or detect the conditions necessary to consistently produce compliant products or services. It is necessary to draw up and maintain a list of processes that have been validated and of personnel qualified to use them. In this way, you can easily identify an unqualified process and an unauthorized person.
Where the capacity of the process is based on the competence of the personnel, the personnel operating on these processes must be adequately istruito e formato trained and educated. If you subcontract production processes outside, you must ensure that the supplier employs only qualified personnel and has qualified process equipment and facilities.
Demonstrating that special processes are subject to validation and periodic revalidation can be done:
- presenting evidence of the analysis carried out to determine which processes qualify as special processes;
- selecting a representative sample of special processes and presenting evidence of validation of their ability to produce consistent results;
- presenting evidence of planned and unplanned changes and demonstrating that following the changes a new validation of the special process affected by the change has been carried out
Actions to prevent human error (8.5.1g)
The system is subject to influences outside the control of management and, therefore, any action taken to address the risk of human error should be proportionate to the potential impact on the conformity of products and services.
A requirement of this type is necessary because modern production processes have reduced the possibilities of human error thanks, mainly, to the use of robotics, but many other opportunities for error remain in the service sector. Furthermore, the consequences of human error can vary considerably between different sectors.
A human error in the production of a component could be detected before the component is released for delivery to a customer, but a human error in the operation of a nuclear power plant, an oil production platform or in a surgical intervention could cost many lives.
Human error is a conclusion that is determined with hindsight, a social assessment of behavior after the fact, so actions to prevent error tend to be actions derived from experience. The standard requires that the actions to prevent human error are implemented but, before we can do so, we must have determined what actions are necessary and what are the possible risks.
Demonstration that actions are implemented to prevent human error can be realized:
- presenting evidence of an analisi dei rischi risk analysis in production and service delivery, which identifies the actions to be taken to reduce the probability of human error;
- selecting a representative sample of planned actions and presenting evidence that they have been implemented;
- recovering records of non-conformities and customer complaints and demonstrating that none was caused by human error or violation of the rules;
- recovering records indicating the result obtained from production and service delivery, demonstrating that no performance failure was deemed to be caused by human error