It is since the ISO 9001 update of 2000, the famous "vision 2000" that the process approach has become a very important principle at the base of the functioning of a quality management system. It is using this approach, in fact, that a company has the task of identifying the processes within the management system, defining how they work and also identifying how these individual processes interact with each other forming a system.
The process approach is based on the concept that, by correctly identifying the processes and the expected results, it is easier to monitor and control the functioning of the entire quality system. Reasoning on the basis of processes, moreover, it is easier for an organization to work on continuous improvement because, by breaking down the entire quality system into smaller processes, it becomes much easier to identify areas for improvement, assess the risk of implementing the changes and validate that the changes have led to real improvements in the process. Since improvement is also one of the principles of quality management and one of the main reasons for implementing such a system, this represents a very important aspect of the implementation of the process approach.
To correctly identify all the processes, you can start from the first steps that a company takes to create and provide a product or service, that is from the marketing and commercial process and arrive, thus, until the end when the order fulfillment closes with the delivery of the product (or with the provision of the service) or with the post-delivery assistance. In the middle of these two extremes, we will find all the other processes necessary to produce the product or provide the service, therefore, for example, the design, production, storage and handling of the product, etc.
Once all these processes have been identified, which we can call "main", it will be necessary to also identify the "secondary" processes that have a support function and ensure that the flow of the order follows its course correctly (an example of support process is that relating to the preparation of documented information). Once all the processes have been identified, primary and secondary, each one should be examined as an autonomous entity, in order to be able to identify its inputs, the individual activities that compose it, who must carry out each activity, how the work must be carried out, the expected results and the outputs of the process.
A tool that can support you in this work is the turtle diagram or diagramma tartaruga which can help you to reflect on how a process is structured. Once the process has been identified, it can be controlled, monitored and continuously improved, with the consequent advantages that derive from it. In this way, the process owner can know at any time if the process is working correctly and if any changes made have led to real improvements.
Pay attention to one of the most often forgotten and extremely important elements of the process approach which is represented by their interactions. Sometimes, in fact, a process owner may tend to focus too much on the management and improvement of his own process, forgetting to pay attention also to how it interacts with others. Adopting a top view on the interaction of the processes within the system, many interesting factors can be grasped.
For example, making a change to improve a process may not be a great idea if it causes problems in other areas and this can only be seen by considering the interactions. Also thanks to the interactions, then, we see how the outputs of each process are used and concentrate, thus, on how to improve them so that they are increasingly usable by the downstream processes. Equally important is the ability to identify an output that is not required. For example, if one of the process outputs is a report that is not used by anyone, the effort to create this document is wasted and, realizing this, it is possible to use the resources elsewhere more efficiently.
By using the process approach to define, understand and control the processes of the quality system, you will find that you can better monitor the process performance, identify and implement improvements and know that you are maintaining these improvements over time, after the changes have been made. This, in fact, is the easiest way to do it and since monitoring and improving your system is one of the main reasons why you designed it according to the requirements of the ISO 9001 standard, wouldn't you want these processes to be as simple as possible?