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Medical Device – Complete Calibration Solutions

Sector: Medical Device
Location:  Cork, Ireland
Project Duration: 2013 to Present 
Partnership Commenced: 2009
Service Offered: Complete Calibration Solutions

Project Description:
LotusWorks’ partnership with this world-leading medical device company first commenced in 2009 when the client recognised that there was value to be gained in consolidating calibration to one specialist company. Spanning over three sites – one in Limerick and two in Cork, the partnership has continued to grow and diversify over the last 13 years. In 2013, the client expanded its neurovascular division and appointed LotusWorks’ team to oversee calibrations within this facility. The facility itself is 110,000 sq. ft based around one substantial cleanroom totalling 33,000 sq. ft and calibration plays a pivotal role in ensuring all elements of manufacturing excellence is maintained from the temperature humidity of controlled rooms to temperature mapping of furnaces, ovens, fridges, freezers and incubators. Due to the impact of the products on patients’ health, extremely high-quality metrics are placed on calibration, something LotusWorks pride itself on consistently achieving.
A team of 24 LotusWorks technical experts manage and execute the complete calibration scope for this medical device client across its three facilities in Munster. To date the client continues to experience an improved calibration service across all three sites as a direct result of the strategic partnership approach with LotusWorks.

Project Services:

  • Management of all calibration activities for this neurovascular facility through onsite calibrations, scheduling vendors of onsite works, shipping of externally calibrated equipment to regulatory standards. LotusWorks’ calibration team is responsible for calibrating over 5,500 instruments with a wide range of calibration types and parameters
  • LotusWorks’ team identifies and corrects costly performance deficiencies in the facility resulting in cost savings and increased equipment lifecycle
  • Expert teams on-hand to coordinate and assist with planned shutdowns
  • Accurate and regular calibration of equipment/instruments highlights potential concerns which is central to ensuring product and patient safety
  • Ensure that scheduled calibrations are completed on-time (zero overdue calibrations) and respond to breakdowns to limit production downtime by providing 24/7 on-call support
  • Project management of upcoming line moves/new equipment by quoting both internal/external calibrations to be complete within the project timeline, and providing after assistance with completed certs/evidence
  • Allocation of Subject Matter Expert (calibration) on-site who is responsible for responding to all audit queries, face to face meetings, guiding auditors, ensure procedures are followed correctly and guarantee/ demonstrate conformity for all regulatory bodies
  • Detailed monthly and quarterly reporting against agreed KPI’s to the client’s Engineering Manager, Value Stream Managers and LotusWorks Directors. Report monthly quality metrics to Infrastructure Review Board. Completion of biannual report to Management Review Board including; Client Site Lead and Directors
  • Frequent implementation of proposed Continuous Improvement (CI) recommendations on-site driven by designated CI Champion. CI benefits include: (i) cost savings, (ii) efficiency, and (iii) knowledge sharing

Outcomes:

  • Consistent calibration work scope delivery meeting the client’s expectations, ensuring that reactions to breakdown are efficient and the project is never affected.
  • Client gained comprehensive calibration expertise in this facility incorporating multiple equipment types as the LotusWorks team is skilled in the calibration of all equipment & products from different providers
  • The culture of Continuous Improvement within LotusWorks means that our client experiences the best of value-add improvements from the LotusWorks team. A total of 177 CI’s with a total cost saving of €918,426 have been implemented on medical device sites since CI was implemented in 2015
  • Client experiences peace of mind that product quality and compliance is maintained resulting in reduced waste and increased productivity due to the LotusWorks team continuing to drive operational excellence
  • Since the opening of this neurovascular site in 2013 there has been a 38% increase in the number of completed calibrations without an increase in headcount on-site and the client has experienced continued time and cost-saving benefits
  • LotusWorks Calibration Optimisation model implemented has eliminated unnecessary calibration leading to financial benefit to the client
  • Complete control of costs of calibration via a one-supplier model – fast turnaround on critical instruments leads to increased equipment availability and minimizes facilities downtime 
  • The calibration team completed over 6,500 calibrations/certifications in 2021 alone
  • Accurate reporting based on real-time data analysis enables proactive and reactive decision-making, and accurate cost and task forecasting