Checklist Phase 4 - Equipment

Have all pieces of equipment that have a direct influence on the outcome of examinations been validated?

Activity

Are all findings of validations (both validation of examination methods and validation of equipment) documented in validation reports?

Activity

Is there an standardized procedure in place assuring that the laboratory determines and corrects the negative influence of defective equipment on laboratory testing after a piece of equipment has been discovered to be defective?

Activity

Is the procedure for determining and correcting the negative influence of defective equipment documented in an SOP?

Activity

Has procedure for determining and correcting the negative influence of defective equipment routinely been performed in the past when equipment appeared to be defective?

Ask the interviewee to show an example.

Activity