System validation by Kraemer Elektronik
Are you prepared for Total Quality Management (TQM) and audits?
- In many companies, equipment qualification as part of quality management or validation is an indispensable prerequisite for selecting suppliers
- Final test reports and adjustment and calibration reports are included with all testing units
- We are happy to provide you with IQ/OQ documentation to assist in your own in-house IQ/OQ processes
IQ – Installation Qualification
The Installation Qualification IQ is documented proof that testing units have been supplied and installed in conformity with the requirements in the design qualification and legal safety regulations. The Installation Qualification documentation consists of an IQ inspection plan and IQ report.
Scope of the Installation Qualification IQ:
- Inventory of delivered components and inspection to ensure conformity with the order form
- Inspection of manufacturer’s documentation to ensure conformity (nameplate, delivery note)
- Inspection of assembly and correct installation based on system diagrams (if required)
OQ – Operational Qualification
The Operational Qualification OQ is an inspection process that assesses the correct function of the testing device. During the Operational Qualification OQ, all the points in the inspection plan are checked and documented in writing. Under certain circumstances, OQ inspections may be performed with customer products only (as is usually only the case with the Performance Qualification PQ).
Passing the Operational Qualification OQ is a precondition for the technical acceptance of a testing device. The Operational Qualification can only be performed if the Installation Qualification IQ has been passed. The Operational Qualification documentation consists of an OQ inspection plan and OQ report.
The Operational Qualification OQ includes the
identification and checking of the following alarm, control and switching functions, which have an influence on quality:
- Testing unit initialization
- Weight adjustment and calibration
- Thickness adjustment and calibration
- Hardness/fracture strength adjustment and calibration
- Diameter adjustment and calibration
- Length and width adjustment and calibration
- OZB adjustment and calibration
- Adjustment and calibration report
- Product setup
- Verification of test results
- Documented proof of operating personnel induction
Your Kraemer Elektronik Service Team
Do you need our technical support?
Would you like a service agreement, do you have questions about calibrations or repairs?
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