Automated Equipment Risk Management and Software Validation

Posted by on April 3, 2017 in Manufacturing Projects

Challenge

Client needed Risk Management, environmental, health and safety analysis, and software validation during design and development of factory automation equipment.

Actions

  • Planned and conducted complete validation for non-product software tool.
  • Assisted in performing Process FMEA for automated process including identification of risks to be mitigated by software.
  • Planned and conducted software validation for non-product software:
    • Wrote detailed software requirements specification
    • Wrote software Validation plan.
    • Wrote software Validation protocol.
    • Conducted software Validation, and prepared software Validation report.
    • Repeated software Validation testing after software updates, and prepared software Validation report.
    • Conducted software Validation during OQ and prepared software Validation report.
  • Supported Factory Acceptance testing:
    • Created structure for overall Factory Acceptance testing.
    • Wrote Factory Acceptance Test protocol.
    • Wrote Factory Acceptance Test report.
  • Completed environmental, health and safety analysis for new automated equipment.
  • Wrote Installation Qualification (IQ) protocol, Operational Qualification (OQ) protocol and draft Performance Qualification (PQ) protocol.

Result

  • Completed PFMEA and integrated risk mitigations to SRS and SW Validation protocol.
  • Implemented risk mitigations to system and software design.
  • Tested software, identified non-conformances and proposed and re-verified corrective actions.