QA/QC in Lab Performance

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    05-Feb-2016

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QA/QC in Lab Performance. Renu Joshi, Ph.D. CAEAL Assessor Certified by the National Quality Institute, Canada. Components influencing QA/QC. Standard Operating Procedures. Administration. Facilities. Personnel. Facilities and equipment. Adequate space - PowerPoint PPT Presentation

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  • QA/QC in Lab PerformanceRenu Joshi, Ph.D.CAEAL AssessorCertified by the National Quality Institute, Canada

  • Components influencing QA/QCFacilitiesAdministrationStandard Operating ProceduresPersonnel

  • Facilities and equipmentAdequate spaceseparation between incompatible activitiescondition of floors, walls, ceiling & benchesadequate storage spaceavailability of all necessary equipment and functioning properlyair qualitylogs maintained

  • Sample historySample bottlesSample transportationHolding timeHandling & storage in the lab

  • Media quality controlAll SOPs available for preparation of various mediaControl stock cultures maintained with logs+ve and -ve cultures used to ensure that media are functioning properlynon-selective medium used to evaluate selective mediaall media and reagents properly labeled and stored

  • Faecal coliforms on selective and non-selective media

  • Method quality controlMethod used is current, authorized and validatedMethod blanks to monitor contaminationDuplicate analysis performed to monitor precision within a runParallel analyses to monitor inter-technician method precisionConfirmation of organisms done routinely

  • PersonnelAdministrationLab staff qualificationsContinued education and monitoring of competencyGood lab practicesStandard operating procedures

  • Responsibilities of an AssessorTo apply the standardUnbiasedNot to judge the labProvide a comprehensive report based on assessment against the standard

  • Assessment TeamSelection of the assessment teamNot a pass/fail approachExplain the process to the lab being assessedCreate an informal atmosphere and an open approach

  • Assessment processTour of the facilitiesTrace of testsAssessment of the quality systemAssessment of the methodsStage meetingsReporting all the findings

  • Sample CAEAL ReportCitations divided into 3 categories: A, B & C followed by a completion deadlineAppendix No. 89 - Faecal Coliforms5.3.2. Implement a procedure to monitor air qualityADate0701 Maintain calibration records of thermometers and incubators used in ADate the analysis of faecal coliforms0701 Include the calibration correction factor on thermometers used to monitor FCADate 0501 Implement the use of BS spores to monitor the performance of the autoclavesADate0701 Ensure the balances are checked daily or as used and maintain logsADate5.5.1. Ensure there is a backup plan in case of equipment failureADate0305 Develop and implement a procedure to monitor inter technician analytical B-----performance0701 Ensure equipment maintenance logs are kept up to date ( autoclave, Milli QADate and media dispenser)0305 Develop and implement a procedure for use of a positive and a negative ADate culture to monitor media quality control

  • Now we know the significance of QA/QC and accreditation

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