MES makes it possible
Software | Fast, efficient, cost-effective – The introduction of a fully validated MES solution serves a Tuttlingen-based medical technology manufacturer as the basis for adapting its quality management to the new ISO 13485:2016
Digitization at the production level is no easy undertaking for artisanal manufacturers of medical instruments. LA2 GmbH from Erlangen supports medical technology manufacturers with its MES solution DOQ as they enter the Industry 4.0 era. Small and medium-sized enterprises in particular face immense challenges today: To become more competitive, globally operating manufacturers must reduce product launch times, better utilize their own resources, comply with regulations and legal requirements, and improve product innovations. The modeling, implementation, and documentation of special processes such as rework, sample testing, special releases, or pilot series production are among the key tasks.
the common challenges.
In addition, the sharp increase in audits and inspections by German and European authorities, as well as by the American health authorities,
The MES solution DOQ supports medical technology manufacturers in optimizing their production processes in the Industry 4.0 era
The FDA is increasing regulatory pressure. Both new regulations such as the MDR and ISO 13485:2016, as well as existing American laws such as GMP or 21 CFR Part 11, must be complied with. The number of 244 FDA observations in 2016 alone in the areas of Device History Records (DHR), Device Master Records (DMR), and CSV (Computer System Validation) shows that many companies have gaps in the legally compliant representation of their production processes, including traceability.
YOUR KEYWORD
- Digitalization and Industry 0
- New regulations and FDA
- MES software controls and documents the manufacturing process
- Can be integrated into existing QA systems
The Tuttlingen-based medical technology manufacturer was already using an ERP system to record and manage its business processes. Two quality-relevant systems, along with CAQ software, were in use in the production area without appropriate validation. The regulatory-compliant implementation of DOQ and the validation of the interfaces to the existing systems reduced the otherwise necessary, complete revalidation of the existing systems to a minimum.
The MES solution communicates with the ERP system, from which it receives order-related data, as well as with the machine or work level. The received data or inputs, in turn, form the basis of the product development file in electronic form. Each process step is thus documented and archived in compliance with regulations.
The fact that an MES can be used on a large scale shortly after its introduction
Another example, explained by LA2 Managing Director Marc Holfelder, demonstrates how cost savings can be achieved: „A major customer from Bavaria was able to document a savings of 1,400 working hours in the first year of installation. This was achieved through reduced error costs and shorter lead times.“
Keep an eye on the production process in real time at all times
Mapping and documenting the entire manufacturing process in real time facilitates the timely detection of emerging problems. This results in fewer finishing operations for defective parts and saves on costly quality controls. The graphical representation of special processes or special approvals allows the QM manager to maintain an overview at all times. The result is a significant improvement in product quality while simultaneously reducing costs.
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In Tuttlingen, a significant focus was also placed on time recording in production. Clocking in and out of numerous work processes repeatedly led to inaccuracies because the clock-in systems were too far from the workstation. Reliable subsequent calculations were therefore impossible. Thanks to DOQ’s tablet capability, time recording is now documented at every individual workstation. Automatic evaluations with comparisons of target and actual times now provide information about productivity.
Every work step is logged and approved. At each process step in production, the forms to be completed are displayed to users. Data from machines or measuring instruments automatically fills the corresponding fields, with preset value limits controlling the data records. The system’s form-based structure easily enables a 1:1 mapping of existing paper processes, facilitates rapid implementation, and thus ensures high levels of acceptance among employees. At the end of each work step, the responsible employee authorizes the subsequent process with their electronic signature.
The web-based, fully 21 CFR Part 11-compliant software also offers the possibility of integrating supplier manufacturing processes through special role/user concepts, thus ensuring seamless documentation of the product development process. The modern database structure also allows for free scalability of the system, regardless of whether 5, 50, or 500 employees are registered.
The support during the implementation of the software was faster than expected, recalls LA2 project manager Jakub Dydowicz: “The two-part training for administrators and users in production enables us to provide all the necessary information in a targeted manner in a short time, so that the customer is able to further configure his system himself.” The independent configuration has helped the
The Tuttlingen-based company saved a significant amount of follow-up costs compared to competing DOQ software products. The necessary data for production orders could be easily transferred to DOQ in advance via an interface between ERP and MES.
To ensure compliance with regulatory requirements during implementation, LA2 subsequently conducted a separate 21 CFR Part 11 training session and provided the necessary procedures and work instructions. Integration into the existing QM system proceeded smoothly and, three months later, was the prerequisite for a successful audit of the entire CSV.
The MES solution was initially installed on the medical technology company’s servers. According to Holfelder, the next step is already being considered: moving to the cloud, including long-term archiving. ■
Andreas Hoff
LA2, Erlangen
