VALIDATION AND MEASUREMENT OF UNCERTAINTY FOR MICROBIOLOGY METHODS (TESTING LABORATORIES)

Presented by Elzabé Truter

PURPOSE / OBJECTIVES

Method validation is the process that provides evidence that a given analytical method, when correctly applied, produces results that are fit for purpose. No matter how well a method performs elsewhere, analysts / technicians need to confirm that the method is valid when applied in their laboratory.

This course will give detailed information and hands-on experience of practical issues of quality control and the requirements for accreditation. The course presenter will share experiences and provide practical examples on how to establish quality assurance / control procedures and how to validate methods in preparation for accreditation or maintenance of accreditation to the ISO/IEC 17025:2017 standard. Most importantly, this course will equip delegates with the knowledge and skills to draw up method validation documents suitable for ISO/IEC 17025:2017 accreditation. It will also provide laboratories with the opportunity to determine whether their work is performed correctly and according to appropriate standards and to understand the critical areas of method validation and how to apply uncertainty of measurement in microbiology.

COURSE DURATION

The course will run over a period of three (3) days.

After the training course, participants should be able to:

1. Understand the approach of method validation and uncertainty of measurement in Microbiological methods.
2. Select test methods and develop method validation protocols and experimental design.
3. Set performance criteria for different parameters based on test methods (qualitative and quantitative).
4. Use of Proficiency Testing data in method validation.
5. Statistically evaluate data.
6. Document validation results and generate validation reports.
7. Perform on-going verification of test methods to ensure / demonstrate fitness for purpose.
8. Understand the requirements for method validation and uncertainty of measurement by accreditation bodies.

PROGRAMME

DAY 1

• • Laboratory Accreditation (ISO 17025:2017) and method validation


• • Quality assurance in the microbiological laboratory


• • Media quality control


• • Method quality control in microbiology: Internal and external


• • Proficiency test results, use and control charts


• • Calibration, maintenance and verification of equipment and interpretation of calibration certificates


• • Analyst / technician competence, criteria and evaluation


• • Examining matrix effect in microbiological analysis and how it affects method validation


• • Quantitative and Qualitative methods (requirements for validation)


• • Use of reference cultures


• • Use of Test Kits and rapid test methods in accredited facilities

DAY 2

• • Method validation requirements (ISO/IEC 17025:2017)


• • Standard methods vs. newly developed or changed methods


• • Different performance parameters and deciding which need to be characterized / evaluated


• • Method validation acceptance criteria


• • Statistical analysis of data obtained during method validation for microbiology


• • Recording and evaluation of results


• • Reporting of results


• • Validation plan and re-validation

DAY 3

• • Uncertainty of measurement in Microbiology and different approaches


• • Using method validation data in the evaluation of uncertainty of measurement and understanding the links with uncertainty of measurement


• • Interpretation, application and reporting of uncertainty of measurement


• • Practical examples and use of data obtained during method validation and uncertainty of measurement


• • Example of method validation protocol / plan / design


• • Example of method validation report


• • Ongoing (continuous) verification of microbiology methods to evaluate fitness for purpose


• • References and information to assist with the validation process