The keywords “validation” and “process” are used today in different contexts and with various definitions. In the following, the term process validation is understood as the proof that a process fulfills the demands at the process results. The EN ISO 9000:2015 defines a validation as: Validation is a process. It uses objective evidence to confirm that the requirements which define an intended use or application have been met. Whenever all requirements have been met, a validated status is established. Validation can be carried out under realistic use conditions or within a simulated use environment. The definition of process in EN ISO 13485:2021 refers to EN ISO 9000:2015. A process is understood as: A process is a set of activities that are interrelated or that interact with one another. Processes use resources to transform inputs into outputs. Processes are interconnected because the output from one process often becomes the input for another process.
The combination of both of these theoretical definitions lead to 2 practical questions with respect to the production of earpieces: “Am I building the earpiece correctly?” (Verification) and “Am I building the correct earpiece?” (Process Validation). Triggered by an increasing demand of validated processes on the part of notified bodies pro3dure developed the OTOFLOW® concept. OTOFLOW® offers verified process steps which can be built up to validated production processes. By this holistic approach it is secured that not only the interactions of different materials but also the interactions of single process steps are considered (e. g. cleaning, post curing, tumbling and further surface finishing). Only on the basis of an overall analysis you can answer in the future with ”Yes” to the following question: “Am I building the correct earpiece?” The flexible OTOFLOW® concept paves the way to a validated production process.