Project Summary – SCADA Validation for Medical Device Assembly

A leading medical device manufacturer sought to validate a new SCADA (Supervisory Control and Data Acquisition) system to be used in support of the assembly processes for both an upgraded product line and a new product line. This project launched the client’s initiative to leverage electronic process control technologies to improve efficiency and quality control of their manual assembly operations. It also represented their first step toward establishing electronic process records to be included in a long-term data storage solution for device history records.

The system leveraged SCADA technology for:

  • security, user permissions, and electronic signatures
  • acquisition of work order and serial number data via ERP interface
  • printout of barcode and information labels for sub-assemblies and finished product
  • establishment of parent/child relationships for sub-assembly and final assembly serial numbers
  • management of sub-assembly inventories
  • tracking of sub-assembly and main assembly serial numbers throughout the process
  • enforcement and real-time monitoring of build order sequencing
  • display of operator instructions and error messaging
  • determination of calibration status for inspection instrumentation and expiration status for sub-assemblies
  • control of activation status and operating parameters for interfacing equipment assets (i.e. hand tools, fixtures, automated presses, laser markers, conveyances, etc.)
  • acquisition of specified device history data generated in execution of the build order
  • supervisory functions for handling nonconformities and intervention
  • generation audit trails records for changes to build order configuration
  • guidance and recording of operator pick parts selection

The applied SCADA system features included:

  • GE Proficy HMI and iFix SCADA software applications
  • Microsoft SQL Server
  • Citrix Server/Receiver
  • Multiple workbench dedicated PC clients and peripheral installations
  • Integrated PLC, IO, and Ethernet communication with process hardware systems

Performance Validation professionals were called upon to validate this system to ensure quality and compliance with the Quality System Regulations and the client’s procedures and practices.

The PV Advantage

Performance Validation provided a dedicated Validation Specialist experienced in the delivery and execution validation documentation for SCADA projects.  Working closely with the client’s engineering validation team and quality assurance personnel, the PV Validation Specialist followed their established validation plan and user requirements to deliver the necessary system documentation and testing.

The Solution

The Validation Strategy included:

  • A risk based approach was taken by classification of the application as a commercial-off-the-shelf (COTS) software.  A failure mode and effects analysis was completed to assess the level of testing to be conducted to ensure that any identified risk related to configuration and custom coded functions was mitigated.
  • Testing requirements for the SCADA system were developed based on the findings and recommendations of the System Risk Assessment document and input from the client’s subject matter experts.
  • Due to the high level of integration, qualification/validation testing was completed in the production environment and incorporated the functionality of interfacing production hardware and software assets.
  • Installation Qualification (IQ) verified the installation of the:
    • Database Server, Application Server, and Terminal Server platforms and software installations
    • GE iFix application server installation
    • SQL Server database installations and configurations
    • network hardware installations (PLCs, I/O modules, switches)
    • hardware configuration and software installations for 20+ workbench dedicated thin-client workstations
    • logical continuity (assets<>IO/PLC<>database<>HMI)
    • software storage and version control
  • Operational Qualifications (OQ) verified the functionality of the:
    • logical security and electronic signatures
    • permission-based HMI screen navigation
    • fully integrated end-to-end build order executions with process enforcements
    • negative testing and error handling
    • supervisor intervention functions and related accountability
    • system audit trails and process data logging for electronic device history records
  • Validation deliverables included:
    • Validation Plan (revision)
    • System Risk Assessment (integrated test planning)
    • User Requirements Specifications (revision) / Requirements Trace Matrix
    • Functional Design Specifications
    • Code Review Reports
    • development and execution of Test Scripts for: Installation Qualification for core SCADA components, Installation Qualifications specific to each (2) production lines, Operational Qualifications specific to each (2) production lines
    • Production Support Plan
    • Final Validation Reports

The Results

Performance Validation delivered System Risk Assessment and Functional Design Specifications documents that facilitated a clear approach to testing and traceability for the path forward into test script design.

The client was provided with a thorough high-quality qualification testing package that ensured ready traceability to the approved requirements and specifications.

Throughout the validation, Performance Validation positioned themselves to be flexible and responsive to allow the client to optimize their project schedules for successful timing toward meeting pre-production deadlines.

Final Validation Reports were delivered on time and the SCADA system applications were released for production as scheduled.

The Benefits

Performance Validation built upon knowledge and experience gained in serving SCADA system validation projects in the pharmaceutical industry. The application of SCADA technology for medical device assembly differed somewhat from that of pharmaceutical formulation, filling, and packaging, but Performance Validation studied the details of the manufacturing process and was able to able to design a validation package that satisfied the client’s compliance needs.

Performance Validation endeavored to not only meet a minimum set of compliance requirements, but to provide the client a high level of assurance that all aspects of their new SCADA system would function as intended. Careful attention was given to ensuring the resulting life-cycle documentation would be readily maintainable for the life of the system.  Test documentation was designed in a way that provided the client with format and content that with minimum modification could be easily repeated to maintain the validated state of the system under future change control. This medical device manufacturer now has a validated SCADA system which meets their high standards of quality and compliance.

Kevin Marcial,
CSV Services Manager
Performance Validation, LLC.
5168 Sprinkle Road
Portage, MI 49002
(269) 267-4020 Mobile