Follow the procedure described in the Nonconformity Management SOP (under Occurrence Management of this phase). In addition, find out if results of examinations done in the past have been influenced by the defective apparatus. If this is the case formulate and carry out corrective measures to prevent more harm. See if preventive measures are also possible.
Activities related to Phase 4 - Equipment
When equipment appears to be defective, determine and correct the potential negative influence on previous testing results.
Validate all pieces of equipment used for examination in the laboratory, including software systems.
Do this according to the procedure described in the SOP on Validation (developed in phase 3, click here). This activity is necessary to verify if the data delivered by the piece of equipment is really the data the laboratory is expecting to receive.
Store validation reports in the file called “Validations” under a specific equipment tab.