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Medical Devices

Medical device manufacturers are held up to the highest standards of quality and face rigorous regulatory oversight because medical errors can be costly and deadly. TME automates data capture throughout the supply chain process, giving medical device manufacturers complete control and visibility into their operations. Real-time, accurate data is easily accessible so that manufacturers can easily release traceability reports, respond rapidly to product recalls, and comply with FDA guidelines. TME provides affordable solutions for manufacturers to streamline their operations, improve quality control, minimize risk and liability, and most of all stay, competitive.

WIP Tracking

TME MES monitors work-in-process at each defined step in the production cycle. TME MES can track many products and revisions simultaneously and monitor which products are entering each phase of production.

TME leverages barcode and RFID technology to easily collect information on wafers, dies, raw materials, and components, providing complete WIP tracking and product traceability. All steps, stations or processes can be monitored throughout the entire workflow to provide real-time information on WIP inventory, lots on hold, reworks and scrap, and helps reduce WIP cycle times and increase productivity, quality and yield.

Key Features:

  • Production/Operations scheduling
  • Rule-based flexible routing with multiple products, routes, and revisions
  • Resource Allocation, Labor Efficiency
  • Recipe Management
 

Production Schedule Viewer

TME Production Schedule Viewer gives manufacturers the scheduling tools to deliver high quality product on time, every time. Manufacturers can expedite orders or prioritize jobs to meet customer demand. TME's Production Schedule Viewer helps manage work cells, work-in-process, and adjust production schedules based on delays or limited capacity. The Production Schedule Viewer also generates realistic production sequences, analyzes the effects of schedule changes, and provides accurate delivery dates to achieve Just-In-Time manufacturing.

Benefits include:

  • Prioritize lots and batches to meet product delivery dates
  • Maximize asset utilization
  • Reduce cycle times and increase throughput
  • Route optimization to eliminate bottlenecks
  • Manage multiple constraints and delivery schedules for Just-In-Time (JIT) manufacturing
  • Optimize inventory consumption for JIT inventory and reduce costs carried with warehousing excess inventory

Rule-Based Flexible Routing

TME MES is a cost-effective, easy-to-use system that easily adapts to rapidly changing production demands. TME tracks and monitors the production of multiple products and multiple revisions that require simple or complex routes. You setup the rules to manage rework, engineering change orders or other process demands. This feature ensures the work in process is in the right place at the right time.

TME utilizes inventory and equipment more efficiently to reduce scrap and improve throughput. Subassemblies and consumables can be scanned to verify assembly and packaging. Data collection on selected parameters is tracked for analysis.

With TME, all inventory, receiving, production, assembly, quality control and operations can be routed and monitored throughout the entire production process.

Resource Allocation, Recipe Management, Labor Efficiency

TME MES provides the tools needed for line managers to monitor raw materials, consumption rates, labor and work-in-process. TME helps define standard production procedures and recipes for increased productivity and ensures consistent product quality. With TME, you can accurately forecast labor, material, and inventory requirements for current and future jobs.

Electronic Traveler

The electronic traveler provides a paperless production order management solution designed to replace paper travelers at each work station. The e-traveler follows the lot through each stage of production and optionally requires that each operator verify and sign off that the work is complete and ready to go on to the next step in manufacturing. Each manufacturing step is recorded providing detailed information about the product and process thereby increasing throughput, accuracy and eliminating errors.

Feature include:

  • Color-coding to provide current status at a glance
  • All required information is supplied to operators such as quantity, products, procedures, instructions and operator sign-offs
  • Automatic or manual verification of step completion
  • Effectively uses barcode and RFID technology

Data Collection

TME manually or automatically collects all data related to the manufacturing process. Product data is collected for traceability, performance and quality, as well as, production personnel, work stations, parts, assemblies, lot, and work orders. TME MES has the ability to add calculations to collected values and display all data on charts and reports for analysis. TME collects data from the users, equipment, PLCs, test equipment, and other sources.

Non-Lot Data Collection

All non-lot production data parameters can be configured and collected throughout the manufacturing process providing more insight into the infrastructure and related variables that indirectly support production.

Statistical Process Control (SPC/SQC)

TME's Statistical Process Control (SPC) provides real-time data collection and analysis on any type of data that has been collected from the plant floor. TME MES uses proven algorithms to conduct real-time quality analysis to help shop-floor personnel minimize defects and errors before they occur. The result is a significant reduction in waste, scrap, defects, cycle times, rework, and costs.

TME's SPC solution provides early detection and prevention of problems, minimizing the potential for product recalls and negative brand exposure. With TME SPC, manufacturers can take proactive measures to reduce errors, take corrective action, and continuously improve upon manufacturing processes.

Feature includes:

  • Configurable data collection
  • Customizable interface (i.e. data entry fields, display of part drawings)
  • Customizable Data Entry/Import Functions
  • Customizable Analysis and View Options for the following:
    • Chart type
    • Subgroup size
    • Error conditions on Western Electric Control Limits
    • Query on selected date or subgroup ranges chart size
    • X Bar / Range X Bar / Sigma Individual-X Chart
    • Process Capability

Engineering Analysis

Engineering analysis can be used to identify more efficient methods of production and determine if current yields meets defined parameters. All data can be sorted and viewed in the engineering analysis window or in SPC Charts or Pareto Charts. You can create queries to view the data you need to make decisions to make your product better.

Traceability & Genealogy

With TME MES, every product is tracked down to the component level to detect defective components and incorrect tolerances so that they can be identified and eliminated.

All data is collected and managed through a powerful SQL database for the product's lifecycle. This provides genealogy and traceability information to meet compliance for commercial and governmental regulations, particularly for manufacturers in the automotive, aerospace, food & beverage, and healthcare industries.

Metal and plastic parts can be permanently marked with UID serialization or 2D barcodes to provide detailed traceability throughout the supply chain. This data can be correlated with the data stored in TME MES for warranty claims, product returns, recalls and engineering analysis.

Inventory Management

TME Inventory Management provide real-time data on all inventory and assets used during the manufacturing process. From raw materials to finished goods, items can be tracked by serial number, lot number, batch, and job number. Shop-floor personnel can easily retrieve real-time data on available quantity, quantity consumption levels, location, and expiration dates to ensure optimal inventory levels, minimizing costs associated with insufficient stock or excess stock.

 TME's inventory tracking module also tracks non-lot consumables. Non-lot consumables are materials used during the manufacturing process, but due to testing, prototyping or defects are not counted as final product. Non-lot consumables may end up as samples or scrap.

See TME Inventory Management for more information.

Asset Management

With TME Asset Management, you can build and maintain a comprehensive record of key production equipment, tools, vehicles, HVAC, and more. You can track thousands of assets across multiple locations, such as storerooms, building, and even countries. TME integrates barcode and RFID tracking technology so that you can locate asset by serial number. You can easily track asset transfers, movements, locations, and any user-specified field.

See TME Asset Management for more information.

Maintenance Management & Equipment Utilization

TME MES seamlessly integrates TME CMMS to help you manage your key equipment and ensure that it operates at peak performance. Equipment availability and capacity can be determined based on real-time equipment status, allowing more efficient scheduling of production resources. CMMS provides preventative maintenance scheduling and work order management ensuring equipment is available for production when it is needed. Equipment utilization reporting also provides detailed information on all equipment used in a production facility.

See TME CMMS for more information on maintenance management solutions.

Overall Equipment Effectiveness (OEE)

TME provides complete visibility and increased production efficiency for all equipment, assembly, and production operations in your facility.

TME tracks real-time data on equipment utilization and overall plant efficiency. By integrating your production and maintenance data, TME CMMS calculates OEE and tracks Key Performance Indicators (KPIs). OEE allows plant managers, operations managers, and production line managers to reduce setup and changeover time, reduce downtime, and boost productivity by collecting and analyzing OEE plant performance data directly from the plant floor.

Capabilities:

  • Generate OEE Reports
  • Collects data from multiple applications such as MES, PLC, equipment, manual input to provide a clear picture of plant OEE
  • Measures equipment availability & operational utilization

Quality Control and Product Grading

Product grades and defect codes can be assigned at predetermined stations to aid product quality control and determine yields. With the auto-grade function enabled, all work that passes preset parameters can automatically move to the next step. A lot can also be sent for rework or placed on hold. Split Lot allows a more efficient workflow on high demand products allowing for better utilization of available equipment.

Reports

TME MES reports are available through a web browser to all personnel on the production team. TME provides rich statistical reports to analyze genealogy and traceability, equipment maintenance, inventory, work orders, cycle times, production yield, and overall production performance.

Reports include detailed information on WIP data and other defined parameters that help visualize how changing equipment or processes in manufacturing can affect output levels, cycle time and product quality. Report on lots that have been scrapped or that are on hold and determine the reason why. Detailed equipment utilization and real-time equipment status are also included.

Types of reports include:

  • OEE Reports
  • Genealogy Reports
  • Traceability Reports
  • Production Reports
  • Yield Reports
  • Quality Reports
  • TME MES provides a multitude of customized reports for any type of data collected

Built-In Alerts and Notification Systems

Real-time data collection will immediately send notifications via emails or text messages when data goes out of specification. Lots can be put on hold at that time as well. Notifications can also be triggered by low inventory, future holds being reached, and equipment downtime events.

Contact Management

TME MES Contact Manager provides a convenient way to organize all your contacts, repair and maintenance contractors, suppliers, vendors, emergency numbers and personnel contacts from a centralized location.

Key Benefits:

  • Manage maintenance contracts more accurately
  • Track equipment repair response
  • Automatic vendor notification when equipment requires repair
  • Email alerts can be sent to maintenance personnel, managers, vendors, customers, etc.

Electronic Document Manager

TME MES enables you to upload and electronically manage ISO/QS/FDA requirements, equipment manuals, operational procedures, warranty documents, training manuals, shcedules, maintenance records, and emergency procedures from a centralized platform. This gives all shop-floor personnel fast, easy access to the most relevant information concerning appropriate protocol and procedures.

TME MES document manager handles almost any file type, including video and images. Employees can easily view a maintenance video on a specific asset to properly make repairs every time.

Compliance

TME MES supports industry standardization for manufacturing and process compliance (i.e., ISO/QS/FDA etc.) Electronically upload any requirements or regulations to TME's Document Manager to ensure that all personnel have easy access to the right information.

Integrates Barcode Technology (i.e. RFID, UID, 2D) and Laser or Inkjet Marking

1D, 2D, vision systems and RFID labels of Lots, Stations, Raw Materials, Serial Numbers and Assets can be scanned for instant entry into MES via fixed mount or hand held scanners.

Parts can be laser or inkjet marked with serial information at any time during manufacturing to provide better traceability, reduce keystrokes, and keying errors. Marks can be made directly on substrates, dies, or carriers and can be controlled directly from MES and printed in 2D and/or human readable.

Interfaces with 3rd party, External systems

MES integrates with supply chain management and ERP systems such as SAP, MAS, and SYSPRO. Import or export of data from third party programs such as Excel can save hours of manual input.

Easy-to-Use Web-based Software

TME is a cloud-based system allowing you to securely access vital information from any computer with a web browser or mobile device. TME software is deployed via the Internet (or Intranet), eliminating the need for costly IT infrastructure and delivering up-to-date upgrades to access the latest technology.

Mobile/Wireless Compatible

TME provides compatibility with tablet PCs, rugged PDAs and wireless area networks to improve repair response time, provide critical asset information in real-time for maintenance, inspection, repair, overhaul, and procedures.

Customer Support & Service Available 24/7

Expect exceptional customer support and service. Live, qualified technicians provide timely, effective assistance.

  • Ensure compliance to ISO/QA/FDA requirements

  • Minimize product recall and brand exposure

  • Detect defects and errors before they occur and improve quality control

  • Reduce waste, scrap, rework and increase cost-savings

  • Reduce cycle time and time-to-market

  • Move from reactive mode to a preventive and proactive maintenance program

  • Increase equipment lifecycle, utilization, RAM, and OEE

  • Identify root causes of asset downtime, and track equipment for repair and replacement

  • Accurately forecast labor and resources for current and future jobs

  • Track and maintain optimal supply levels for spare parts, replacements, and raw materials

  • Assign tasks to qualified maintenance personnel and track work order status through to completion

  • Increase employee communication, information sharing, and collaboration