MedTech companies operate within a complex regulatory landscape characterized by stringent rules and evolving compliance requirements. These regulations, including process equipment operations and maintenance, are designed to ensure the safety and quality of manufactured goods – medical devices.
The main challenge is to maintain and track the entire shop floor process machinery’s operational readiness. Avoiding functional errors and unnecessary production delays is key, but also, in a possible worst-case scenario, effective containment of unexpected downtimes must be ensured.
As a first consequence, all maintenance activities must be identified, for example, vendor specifications and recommendations are planned thoroughly. Maintenance plans are a great tool to manage and execute all types of proactive and preventive procedures. Maintenance activities are conditional, based on time or usage. Therefore, as a second conclusion, value-added planning should consider and evaluate historic and real-time data to dynamically produce the most efficient schedules.
Corrective maintenance activities cannot be planned in advance, but a maintenance planning module will provide proper guidance in unexpected situations and document all the performed steps. The same is true for deferred or missed planned activities.
Maintenance Planning with Manufacturing Execution Systems (MES)
Comprehensive state-of-the-art maintenance management modules provide all the necessary functionalities to create and execute maintenance plans along with all their associated activities. And it does not stop at processing the equipment, it includes maintenance planning for all manufacturing assets such as transport or storage systems, facilities and amenities, as well as tool sets and other commodities.
Where does MES fit in?
By definition, an MES is a computer system that monitors, tracks and controls the process of manufacturing goods from raw materials to finished goods. Manufacturing assets and resources are essential entities in MES that all fall under the scope of maintenance. Providing the digital model, or the digital twin, of the complete manufacturing processes, MES serves as the perfect foundation for the implementation of a maintenance management module. Furthermore, it consolidates the additional information needed for successful planning and scheduling. This includes the work in progress, planned dates, shift calendars, personnel and qualifications, warehouse inventory and stock.
MES makes sure that maintenance plans are followed as defined and keeps track of the complete history for every asset and activity including traceability data of executed steps, personnel involvement, materials consumed, and expenses based on time and efforts. The system also automatically checks other important criteria like availability of spare parts or qualification checks of maintenance technicians.
Planned maintenance activities can be based on pre-defined parameters such as time and usage. The schedules will be due whenever the conditional criteria are met. Once due, all involved assets become restricted, and are only released for production again after all related activities have been successfully completed. Activities can involve the execution of a set of tasks, as defined in a checklist or protocol, or the collection of data for historical or verification purposes.
Conclusions
Maintenance plans are thoughtfully designed to maximize an asset’s efficiency while extending its lifetime.
Unplanned maintenance must be avoided at all costs. It results in unexpected breakdowns that require quick, reactive or corrective actions to be carried out. Unplanned downtime is just one of the consequences. The same is true for unscheduled maintenance which is probably one of the most common challenges for maintenance managers until today. Within the MedTech industry it is critical to assure, track and trace all manufacturing assets’ operability to safeguard product quality and, consequently, patient safety. Therefore, it is essential to have the maintenance activities not only planned but also scheduled. Maintenance management software can do all of that for you and even more: it helps to streamline, automate and remove manual processes, assist with all related planning of resources, time and efforts and ultimately, increase asset efficiency and productivity.
Another key take-away is that MES and maintenance management go very well together. MES serves as the underlying digital model, the digital twin, supporting the planning and scheduling of maintenance activities across the shopfloor. In reverse, having the scheduled downtimes times planned and followed, the production planning and scheduling processes in general can be further optimized. Providing your digital twin with historical and present data, the ultimate step towards predictive maintenance might be just closer as you think.
