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QA/QC in Lab Performance

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

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QA/QC in Lab Performance

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

  2. Components influencing QA/QC Standard Operating Procedures Administration Facilities Personnel

  3. 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

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

  5. 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

  6. Faecalcoliforms on selective and non-selective media

  7. 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

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

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

  10. 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

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

  12. Sample CAEAL Report • Citations divided into 3 categories: A, B & C followed by a completion deadline • Appendix No. 89 - Faecal Coliforms • 5.3.2. Implement a procedure to monitor air quality A Date • 0701 Maintain calibration records of thermometers and incubators used in A Date the analysis of faecal coliforms • 0701 Include the calibration correction factor on thermometers used to monitor FC A Date • 0501 Implement the use of BS spores to monitor the performance of the autoclaves A Date • 0701 Ensure the balances are checked daily or as used and maintain logs A Date • 5.5.1. Ensure there is a backup plan in case of equipment failure A Date • 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 Q A Date and media dispenser) • 0305 Develop and implement a procedure for use of a positive and a negative A Date culture to monitor media quality control

  13. Now we know the significance of QA/QC and accreditation THE END

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