Case Study

Efficient validation in production processes

Dental technology: Integrated testing in the development and production process
  • Founded as a Swiss family business in 1834
  • Global market leader today
  • Over 15 000 employees
  • Specialized in application technologies
  • Network with more than 180 production and service locations worldwide

Challenge: Testing production equipment according to specific validation guidelines

Sulzer's Applicator Systems Division (APS) - a global platform - offers high-precision plastic injection molding and filling technologies. Customers benefit from a network of more than 180 production and service locations around the world.

Manufacturers of dental products must ensure that all tools used in the development and production process are tested according to specific validation guidelines and quality specifications. It becomes a "tool roulette" when physically suitable production equipment (machine, tool) or the injection element for a plastic part is replaced without being tested.

For example, the production process in which, for example, the machine injects the plastic into the mold with certain settings, must be validated at least once before the start of production because it influences the product quality and even the smallest deviations are not permitted.

Goal: The most efficient validation variant at the push of a button

Sulzer's goal was to optimize the processes while continuing to ensure quality and make the validation process simpler and more efficient.

For complex projects in a demanding quality environment, the continuous transfer of information should ensure greater transparency and reliability. Employees should be able to use consolidated data from different systems combined in the platform view of a web application. Information should be available in real time and allow a quick assessment of the situation.

The web application is intended to reduce the enormous effort normally required for manual validation via networked structures and thus relieve those responsible for development, production, quality and documentation. At the push of a button, the project manager is to find out the most efficient new validation variant with which he can also still produce.

Realized: Data and application concept & web application

The manual checking of numerous documents - including article drawings, tool concepts, test certificates, design checklists, supplier lists and even the creation of valid documentation - is associated with a great deal of effort in high quality regulations such as in the dental sector.

Master data such as product data, machine data, equipment data and tool data are available in the ERP and PDM systems. The ERP shows production the availability of the tool and whether it matches the machine. The PDM manages documents such as test certificates, tool requests, tool concepts, tool checklists and design checklists.

A data and application concept developed by Intelliact together with Sulzer, as well as an implemented web application, now brings the validation effort to an appropriate level, with optimized processes and assured quality.

Quick recognition of machine utilization

Today, project managers and quality managers are able to quickly identify machine utilization as well as non-validated and validated situations and variations they are closest to. You can display the current validation status, starting with product articles with tools or only with articles. Using a traffic light system, they can see directly which tasks still need to be completed and which have already been completed.

Evaluated data from the PDM and ERP show combinations according to validation specifications for production equipment (machine, tool) and the article such as the injection element for the plastic part.

Prerequisites

Clear documentation & organized data structure

In order to implement efficient validation of all production equipment in the development and production process in accordance with specific validation guidelines and quality specifications, the plastic injection moulding and filling technology manufacturer had to meet the documentation requirements defined in advance. It had to be clear, feasible and testable.

This also included flawless data storage (documentation of article, tool, machine). The continuous transfer of information was only possible via an optimally organized data structure.





Would you also like to efficiently check your production equipment in the development and production process according to specific validation guidelines and quality specifications?

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