Automated Equipment Risk Management and Software Validation
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.