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