QAQC in Lab Performance

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
Faecal coliforms 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