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

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