Leveraging a CMMS in medtech

Medical device manufacturing is highly sophisticated, demanding precision in all facets of operation. The sector must comply with several industry and statutory standards to ensure medical devices are safe, reliable, and durable. Medical device manufacturing facilities are under constant pressure to continuously enhance maintenance standards to optimize manufacturing equipment performance. These facilities strive to reduce equipment downtime and manage maintenance costs via complex and frequent maintenance schedules by implementing data-driven maintenance strategies.

Investing in a computerized maintenance management system (CMMS) helps overcome various maintenance challenges limiting a facility’s productivity and compliance with statutory regulations by entities such as the U.S. Food and Drug Administration (FDA). A CMMS solution helps medical device manufacturers centralize data management and automate routine maintenance tasks. A good CMMS program contains an asset management dashboard, a work request and work order management portal, an inventory management panel, and is a reliable reporting platform.

Medical device manufacturers must comply with quality control standards such as ISO 13485 and 21 CFR (part 820). Facilities should develop maintenance programs following these standards for consistent record keeping, better risk management, and simplified facility audits.

Here’s how to leverage CMMS programs and lessons from the successful implementation of a CMMS program by Spectrum Solutions.

Automate maintenance scheduling

Some facilities manually schedule and manage maintenance workflows, leaving room for errors and causing mix-ups due to excessive paperwork. Using paper-based systems means trading off accurate planning, exposing manufacturing equipment to frequent breakdowns, and increasing maintenance-related costs.

A CMMS streamlines maintenance planning and tracks the quality of various preventive maintenance measures. The facility assigns an identification number to each piece of equipment and recommended maintenance intervals. Facilities can customize these solutions to optimize maintenance schedules based on equipment utilization rates.

This ensures maintenance teams receive timely alerts when maintenance is due, providing enough time for maintenance managers to assemble necessary spare parts and tools, allocate workloads among technicians, and reduce unplanned downtime. Companies can customize CMMS solutions to have a drag-and-drop calendar providing a preview of upcoming maintenance tasks and a task builder to define workflows for specific equipment preventive maintenance measures.

Facilities using CMMS solutions complete more than 96% of maintenance work on time, increasing overall equipment efficiency (OEE) and ensuring optimal productivity. This is beneficial when diversifying medical device production or manufacturing advanced medical devices or prototypes pending testing and approval by relevant authorities.

Managing maintenance work orders

Facilities can get the most from manufacturing equipment by establishing total productive maintenance and engaging machine operators in equipment maintenance. Operators can report performance-related deficiencies and noticeable equipment defects, eliminating time-consuming manual inspections and filling and submitting paperwork. By leveraging the work request portal in a CMMS solution to report a problem, operators scan unique equipment QR codes or identifier barcodes and leave a comment on the status of the equipment. The system then generates and sends alerts to maintenance teams.

Once maintenance teams receive a work request, supervisors prepare a digital work order, prioritizing different maintenance tasks depending on the severity of defects and equipment importance. The CMMS solution allows technicians to automatically log maintenance tasks and update the priority of several activities.

The work order management system maximizes the visibility of various maintenance workflows. Anyone with access to the system gets a glimpse of tasks in progress, scheduled maintenance due dates, and task priority. Maintenance managers can remotely approve work requests at the tap of a finger on handheld devices. The system prioritizes and updates pending tasks, preventing mix-ups during an emergency or scheduled maintenance cycle.

Spectrum Solutions easily satisfies FDA auditors by switching to Limble

Streamline inventory management

A facility should keep adequate stock of maintenance, repair, and operations (MRO) supplies for timely and smooth equipment maintenance. Inadequate MRO inventory threatens extended equipment downtime and increased frequency of asset breakdown.

CMMS platforms are beneficial for automatically tracking spare part usage. When submitting work orders, maintenance technicians specify spares and tools used for corrective or preventive maintenance. The CMMS program automatically updates inventory records, providing accurate, real-time insights on remaining stock levels. Medical device manufacturers can specify minimum MRO stock levels with the CMMS generating an email alert when stock levels fall below specified thresholds. Companies can integrate CMMS with procurement solutions for seamless restocking.

CMMS platforms are essential for searching and tracking MRO inventories in a large storage facility. Technicians can use scanning capabilities (QR or barcode) of mobile devices containing a CMMS solution to search for the exact replacement component.

Medical device manufacturers can leverage CMMS data to monitor MRO consumption patterns, identifying frequently used spare parts and tools to predict long-term MRO demand.

Tracking maintenance workflows

CMMS platforms allow maintenance managers to monitor individual and team activity remotely. Field technicians can update the status of assigned work, keep a log of each successful activity, and provide comments on the challenges or additional workloads arising outside the assigned duties. They also update various maintenance performance metrics, including the mean time to repair assets and the mean time between failures. Managers can compare these statistics through time to improve training programs and estimate the productivity of individuals and the entire maintenance department.

Using CMMS to provide technical support to maintenance technicians is helpful when inexperienced teams encounter complex maintenance problems and can’t access relevant technical information. The platform facilitates seamless collaboration and communication between technicians and managers – they create a video link via the CMMS platform for the manager to share work instructions remotely.

Standardize equipment maintenance

Enhance the operations of maintenance teams by establishing standardized work procedures which define standards, safety measures, and work procedures technicians must follow when repairing or implementing regular maintenance on manufacturing equipment. This can be enforced by creating digital maintenance checklists.

A good CMMS program allows companies to upload detailed equipment maintenance manuals, customized standard operating procedures (SOPs), and critical safety information, building consistency by ensuring technicians implement correct equipment maintenance. Technicians can also perform maintenance faster and more accurately, minimizing turnaround times and maximizing productive time.

Centralize asset, maintenance management

Medical device manufacturers must monitor the operation and routine maintenance of all assets within their facilities. A CMMS solution provides a simplified means to track the locations of various assets and equipment-specific technical information such as model, age, serial number, and historical maintenance data. The facility also uses CMMS to define relationships between assets, making it easier to relate how particular component failures impact the operation of other equipment.

A CMMS solution provides a standardized maintenance reporting template and enables technicians performing different tasks to keep a log of activities and spent MRO supplies. The solution also offers a dashboard that tracks various maintenance performance indicators. Facilities can quantify equipment downtime, asset maintenance cost, average maintenance time, and other crucial performance indicators. Leveraging this data optimizes data-driven maintenance and initiates reliability-centered equipment maintenance strategies.

Report generation is simplified with maintenance personnel able to access historical data and pull custom records covering specific timelines – information vital for periodic facility audits by regulators.

Bringing it all together

CMMS solutions help medical device manufacturers unlock new heights in their operations, providing various tools for automating routine workflows, managing emergency and scheduled maintenance, and standardizing operations.

Companies can integrate CMMS solutions with other enterprise-grade solutions for improved productivity and centralized data management. CMMS programs help medical device manufacturers to complete mandatory audits faster and more accurately.

Choose a CMMS solution based on the existing maintenance challenges, user-friendliness, flexibility and customization, data management capabilities, and ease of integration with other manufacturing solutions. Ensure the program offers the desired reporting and analytic tools and verify if the vendor provides substantial training and support during implementation.

About the author: Bryan Christiansen is the founder and CEO of Limble CMMS, modern, easy-to-use mobile CMMS software that takes the stress and chaos out of maintenance by helping managers organize, automate, and streamline their maintenance operations.

Limble CMMS: https://limblecmms.com