QA/QC in Lab Performance Renu Joshi, Ph.D. CAEAL Assessor Certified by the National Quality Institute, Canada

Components influencing QA/QC Facilities Administration Standard Operating Procedures Personnel

Facilities and equipment Adequate space separation between incompatible activities condition of floors, walls, ceiling & benches adequate storage space availability of all necessary equipment and functioning properly air quality logs maintained

Sample history Sample bottles Sample transportation Holding time Handling & storage in the lab

Media quality control All SOPs available for preparation of various media Control stock cultures maintained with logs +ve and -ve cultures used to ensure that media are functioning properly non-selective medium used to evaluate selective media all media and reagents properly labeled and stored

Faecal coliforms on selective and non-selective media

Method quality control Method used is current, authorized and validated Method blanks to monitor contamination Duplicate analysis performed to monitor precision within a run Parallel analyses to monitor inter-technician method precision Confirmation of organisms done routinely

Personnel Administration Lab staff qualifications Continued education and monitoring of competency Good lab practices Standard operating procedures

Responsibilities of an Assessor To apply the standard Unbiased Not to judge the lab Provide a comprehensive report based on assessment against the standard

Assessment Team Selection of the assessment team Not a pass/fail approach Explain the process to the lab being assessed Create an informal atmosphere and an open approach

Assessment process Tour of the facilities Trace of tests Assessment of the quality system Assessment of the methods Stage meetings Reporting all the findings

Sample CAEAL Report Citations divided into 3 categories: A, B & C followed by a completion deadline Appendix No Faecal Coliforms Implement a procedure to monitor air qualityADate 0701 Maintain calibration records of thermometers and incubators used in ADate the analysis of faecal coliforms 0701 Include the calibration correction factor on thermometers used to monitor FCADate 0501 Implement the use of BS spores to monitor the performance of the autoclavesADate 0701 Ensure the balances are checked daily or as used and maintain logsADate Ensure there is a backup plan in case of equipment failureADate 0305 Develop and implement a procedure to monitor inter technician analytical B----- performance 0701 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