IQ/OQ

Fit for TQM and Customer Audits

Equipment qualification in the context of quality management or validation processes is an essential pre-requirement for a large number of companies in deciding on a specific supplier. Apart from the factory calibration certificate, which is included by default for the Excellent and Perfect classes, Memmert also issues IQ and OQ certificates on request. To support the customers' own IQ/OQ certifications, we can offer IQ/OQ documentation.

 

Installation - Qualification  IQ

Is documented proof that the facilities and equipment have been delivered and installed in accordance with the requirements and statutory safety regulations stipulated in the qualification. The documentation for an Installation Qualification normally consists of

 

IQ - Test Plan

contains detailed information of the tests to be formed on the respective equipment in the context of the Installation Qualification

IQ - Report

After completion of the IQ, the results are summarised, evaluated and compiled in a report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new report

 

The IQ contains the following activities:

  • Stocktaking of the components delivered, together with a check of the order documents
  • Examination of manufacturer documentation for conformity (rating plate, delivery note)
  • Examination of operator documentation for conformity (rating plate, operating instructions)
  • Examination of assembly and ensuring installation was performed correctly, based on various plans (insofar as is necessary)
  • Creating a list of supply and disposal connections (electrical, energy, communication, interfaces etc.)
  • Documented evidence of operating personnel being given instruction on operating equipment
  • Proof of test data for the initial inspection in accordance with DIN VDE 0700 Part 1 and EN 60335-3

After a successfully completed IQ, this is released by the signatures in the Qualification report of the persons responsible in the qualification team, countersigned by the user of the equipment, thus completing the process, or releasing the equipment for the next stage of qualification.  

Operation - Qualification  OQ

The OQ is a test process that evaluates a facility/appliance. During the OQ, all items specified in the test plan are processed and documented in writing, to ensure that the system functions in accordance with specifications. Tests in accordance with OQ can be performed under some circumstances (otherwise only normal for PQ Process Qualification) only with a loaded chamber. 

The OQ is carried out in order to inspect the correct functioning of a facility/appliance. This (successfully) performed inspection is a prerequisite for the technical acceptance of a facility/appliance. The OQ may only be performed after a successfully completed IQ.

The documentation for an Operation Qualification normally consists of

 

OQ - Test Plan

contains detailed information of the tests to be performed on the respective equipment in the context of the Operation Qualification This test plan contains detailed specifications on the course of the test itself

OQ - Report

After completion of the OQ, the results are summarised, evaluated and compiled in a report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new report

After a successfully completed OQ, this is released by the signatures in the qualification report of the persons responsible in the qualification team, countersigned by the user of the equipment, thus completing the process, or releasing the equipment for use.

 

The OQ contains the following activities:

  • Identification and inspection of the alarm, control and switch functions that have an influence on quality:
  • Inspection of the display units and signal lamps
  • Inspection of temperature control and control fluctuations
  • Inspection of the over/undertemperature protection alarm systems
  • Inspection of the pressure/vacuum control (if available)
  • Inspection of the CO2 control (if available)
  • Inspection of the humidity measurement and control (if available)
  • Inspection of the fan speed control (if available)
  • Inspection of the air flap position (if available)
  • Inspection of the card reader function
  • Inspection of the temperature uniformity, based on DIN 12880-2