In absence of a Certified Reference “AOAC International Material (CRM) for any analysis, is an appropriate Reference Material Guidelines April determined that can provide a measure “ of accuracy? 2015” Is its suitability justified and documented? Proficiency Testing “AOAC Does the laboratory have a International Guidelines International “AOAC documented proficiency testing plan March Guidelines “ for all test methods on the technology 2010” April 2015” “ scope of accreditation? Proficiency Testing NOTE: FDA scope of accreditation is based upon technology; not method Is proficiency testing rotated among “AOAC International qualified analysts? Guidelines 2015” “ When a relevant external PT is not available, is there an alternative means “AOAC of evaluation used? International Guidelines April “ 2015” Does the Laboratory have at least one “AOAC PT event annually for each technology International on the scope of accreditation? Guidelines “ 2015” Does the Laboratory have pre-defined 5.9.2 acceptability criteria for quality control data? “AOAC Is the laboratory’s SPC data reviewed International on a regular basis to ensure it is Guidelines reporting reliable data? April 2015 2015”
“AOAC International Guidelines “ April 2015” In absence of a Certified Reference Material (CRM) for any analysis, is an appropriate Reference Material determined that can provide a measure of accuracy? Is its suitability justified and documented? Proficiency Testing “AOAC International Guidelines “ March 2010” Proficiency Testing “AOAC International Guidelines “ April 2015” Does the laboratory have a documented proficiency testing plan for all test methods technology on the scope of accreditation? NOTE: FDA scope of accreditation is based upon technology; not method “AOAC International Guidelines “ 2015” Is proficiency testing rotated among qualified analysts? “AOAC International Guidelines “ April 2015” When a relevant external PT is not available, is there an alternative means of evaluation used? “AOAC International Guidelines “ 2015” Does the Laboratory have at least one PT event annually for each technology on the scope of accreditation? 5.9.2 Does the Laboratory have pre-defined acceptability criteria for quality control data? “AOAC International Guidelines April 2015 2015” Is the laboratory’s SPC data reviewed on a regular basis to ensure it is reporting reliable data?
technical_internal_audit_checklist_section_5.docx