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Assessor Technical Training: Microbiology
This course provides examples of the assessment process for microbiology, based on The NELAC Institute (TNI) Environmental Laboratory (2009 and 2016) standard. The principles for assessing specific technical disciplines within the laboratory operations are presented. The rationale for assessing is based on proven quality principals that allow the determination of adherence to the defined system for the technical operations. The system standards used during this course are the 2009 and 2016 TNI Environmental Laboratory (EL) standard. Personnel with a basic science background in this technical area assess operations by conducting an assessment of a laboratory system and technical operations to assure conformance to the stated quality system and where applicable the mandated methods.
This technical training course provides, identifies and reviews the following:
- Critical steps and processes of the analytical technology or technique that must be executed to ensure quality data, including critical quality control (QC) measures and QC criteria.
- Major sources of error for the analytical technology or technique and how to evaluate them as part of the assessment.
- Inappropriate procedures or practices for the analytical technology or technique.
- Key information required for assessing the laboratory results and procedures.
- Essential elements for assessing data generated.
- Exercises in the assessment from raw data to reported results.
- Writing findings or non-conformances to the standard requirements and recording observations.
The course presents the fundamentals of how to assess technical operations for the following microbiology techniques:
- Chromofluorogenic
- Multiple Tube Fermentation
- Membrane Filtration
- Heterotrophic Plate Count
- Safe Drinking Water Act and Clean Water Act Methods
- Cryptosporidium, Giardia (overview)
Accreditation of laboratories is based on a single set of standards developed by The NELAC Institute (TNI). Members represent federal agencies, state programs and the private sector. This single standard is a uniform standard for all laboratories.
The standard developed by TNI incorporates current state program requirements and the International Standards Organization (ISO) standard ISO/IEC 17025:2005, “General Requirements for the Competence of Calibration and Testing Laboratories.” The standard includes all quality assurance (QA) policies and quality control (QC) procedures that must be presented in either a QA Manual or laboratory procedures to help ensure and document the quality of the data produced.
Laboratories seeking accreditation under NELAP must assure implementation of all QA policies and the essential applicable QC procedures specified in Volume 1 of the TNI standard. The QA policies are applicable to environmental laboratories regardless of the size and complexity.
This course has been revised and materials updated to meet the requirements of the 2009 & 2016 TNI Environmental Laboratory Standard for technical assessor training.
The TNI standards may be purchased on the web at www.nelac-institute.org.
Personnel successfully completing the course will acquire the following:
- Knowledge sufficient to assess the implementation of the technology by the laboratory.
- An understanding as to how the technology is used in the various methods.
- An understanding of the key elements of data packages, and raw data to review and check effectively.
- How to write non-conformances and track corrective actions, evaluate root cause analysis