Summary
LotusWorks provides comprehensive calibration services to a leading global medical device manufacturer across five manufacturing sites in Ireland. These facilities operate under stringent regulatory frameworks including MDSAP, BSI, MDR, and HPRA, requiring high levels of compliance, traceability, and audit readiness.
Across these sites, LotusWorks manages a calibration suite of over 15,000 assets, supporting critical manufacturing and quality operations.
Client Challenge
Prior to LotusWorks’ engagement, the client experienced challenges in calibration scheduling, ownership, and visibility. Calibration scheduling lacked structure, with much of the workload building toward the end of each month. In some cases, vendors had better visibility of due dates than the equipment owners themselves.
There was a need for a partner who could provide:
- Structured scheduling and planning
- Improved control and transparency
- Full ownership of calibration activities
- Consistent compliance across multiple sites
LotusWorks Solution
LotusWorks has supported the client for over 15 years, delivering a fully integrated, end-to-end calibration service across all five sites.
Our scope includes:
- Full ownership of the calibration function, including routine, unplanned, and project-related activities
- Qualification of new assets and development of calibration strategies
- Development and maintenance of SOPs and calibration procedures
- Vendor management, including oversight of approximately 80 active vendors from a wider Approved Supplier List (ASL) of 342 vendors
- Representation during regulatory audits, providing both front-room and back-room support
- Management of calibration standards and test equipment
LotusWorks delivers these services through a dedicated team of 29 calibration professionals, with scope continuing to expand—demonstrated by the recent addition of 14 process technicians at one site.
Operational Delivery & Continuous Improvement
LotusWorks completes over 28,000 calibrations annually across the five sites, consistently achieving 100% on-time compliance.
A strong focus on continuous improvement has delivered measurable benefits, including:
- Internalisation of calibration activities previously outsourced
- Optimisation of calibration frequencies
- Cost savings through strategic spare parts procurement
- Implementation of Power BI reporting, improving visibility and automation of performance metrics
These initiatives have delivered approximately €50,000 in annual cost savings, while improving equipment knowledge, efficiency and control.
Compliance & Audit Performance
The supported sites undergo approximately four regulatory audits per year per site, with LotusWorks playing a key role in audit readiness and execution.
Our teams provide:
- Full audit representation and support
- Maintenance of audit-ready documentation and records
- Alignment with all applicable regulatory standards
This has ensured sustained compliance and strong audit outcomes across all sites.
Results & Outcomes
- Management of 15,000+ calibration assets across five sites
- Delivery of 28,000+ calibrations annually
- Sustained 100% compliance with calibration KPIs
- Approximately €50k annual cost savings through continuous improvement annually
- Scalable team structure with ongoing scope expansion
- High client confidence demonstrated through long-term partnership
Client Benefit
By taking full ownership of the calibration function, LotusWorks enables the client to focus on core manufacturing and production activities, with confidence that calibration services are controlled, compliant, and consistently delivered.
In addition, the client benefits from LotusWorks’ network of expertise, cross-site collaboration, and standardised procedures, ensuring best practices are shared and continuously improved across all locations.
Key Differentiator
What sets LotusWorks apart is how the teams operate across sites. Site leads are in regular contact, sharing solutions, improvements, and lessons learned.
As highlighted during the engagement, if this support was removed, the client would miss not just the service, but the people, the network and the way knowledge is shared across sites.