Equipment Qualification

Analytical Instrument Qualification

Analytical Instrument Qualification (AIQ), also known as IQ/OQ/PQ is used by test, pharmaceutical and medical laboratories to give documented proof that equipment used in the laboratory is fit for purpose.  This documentation may be requested during audits by healthcare regulatory authorities.

AIQ = IQ/OQ/PQ

IQ – Installation Qualification

Tests are conducted that show that the equipment was installed correctly and that all controls, displays and safety features are operational.

Correct installation of machinery is crucial to maintain industry standards

equipment installation
store products correctly loaded

OQ – Operational Qualification

The equipment is operated, usually without load, to show that it meets the manufacturer’s specification.  Various tests may be performed and measurements taken to show that the equipment meets the specified criteria.

PQ – Performance Qualification

The equipment is operated as normal to ensure that it performs correctly in a production environment and will continue to do so between maintenance cycles.

Operator training, operational instructions and maintenance planning documents are also examined and reviewed where applicable.

QSR – QUALIFICATION SUMMARY REPORT

  • IDENTIFYING HOT AND COLD SPOTS
  • DIAGRAMS WITH LOGGER LOCATIONS
  • MINIMUM, MAXIMUM AND AVERAGE TEMPERATURES FOR EACH
    LOCATION AND RUN
  • RESULT CONCLUSIONS
  • TEMPERATURE GRAPHS FOR EACH TEST /RUN
  • SANAS MAPPING CERTIFICATES IF APPLICABLE
  • RAW DATA

QSR – QUALIFICATION SUMMARY REPORT

The final qualification report shows summaries of the critical data collected, compares it to the specified criteria and states if the equipment meets the criteria and if the equipment is thus qualified.

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