Processes & Documents of myStandards GmbHTuesday, August 10, 2021
Since the company was founded, we have been involved in the development and implementation of our quality management system (QMS). A series of articles in the company news highlights this topic, thus increasing the visibility of our QMS and creating transparency.
The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle […] with an overall focus on risk-based thinking […] aimed at taking advantage of opportunities and preventing undesirable results. DIN EN ISO 9001:2015-11, Quality management systems – Requirements
In order to capture the existing processes, we performed a state analysis during the start-up phase and evaluated all previous experiences from the laboratory. In particular, the resources and processes, the input and output, and the risks and opportunities of our production were considered.
The identified processes were then summarized in our process map. We classically distinguish between management processes, core processes and support processes. Management processes serve to implement the tasks and duties of the company; these include personnel management, organizational management and quality management. Support processes regulate resources, process environments and operational procedures, such as maintenance and repair, quality assurance, marketing and customer satisfaction, accounting or information technology.
The core processes comprise all activities that serve to create value for the company. The focus here is on the production process in which nano-pellets are manufactured from various starting materials and distributed all over the world. However, our core processes also include research & development. This enables us to constantly expand our product range and open up new market segments.
To define a process, it helps to illustrate it in the form of a turtle diagram. This gives you an overview of the most important process parameters. The inputs to the process form the head, the process itself the shell, and the outputs and results the tail of the turtle. By looking at resources, process participants, documents and measurement indicators, the process is further specified. These points are then represented as legs in the figure. In addition, opportunities and risks should also be considered and included as a fifth leg in the illustration.
By preparing turtle diagrams, we collected data that we subsequently used to create process descriptions. We also used flowcharts to represent the workflows of the processes and to include them in the process descriptions.
In addition to the process descriptions and the process map, the documentation of our QMS follows the usual hierarchical structure and consists of the quality manual, work instructions and forms. The quality manual provides an overview of all processes and structures in the company and is an integral part of the training period for new employees. In many higher-level documents, there are references to corresponding accompanying documents. The work instructions are manuals for carrying out recurring work, the forms have a work-supporting function, e.g. in the type of checklists.
The preparation or amendment of a document is regulated in our process description for the control of documented information. If there is a need, a draft is created by the responsible employee and reviewed by a supervisor. The QMB's task is then to release the finished document. For this purpose, it is saved in the appropriate folder, recorded in a list and all employees are informed accordingly.
In this way, the QMS has been constantly reviewed and adapted according to the principles of the continuous improvement process since its official introduction last year. And this is to be continued in the future.
More articles from our series on the quality management system: