This course provides examples of the assessment process for microbiology, based on The NELAC Institute (TNI) Environmental Laboratory 2016 standard. The principles for assessing specific technical disciplines within the laboratory operations are presented. The rationale for assessing is based on proven quality principles that allow the determination of adherence to the defined system for the technical operations. 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)
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
Accredition Bodies, Laboratory Assessors
None
13.5 hours
1.4
Marlene Moore
Marlene Moore founded Advanced Systems, Inc. in February 1992 as a consulting company specializing in quality systems for laboratory and sampling operations. She brings together the needs of quality system management, measurement operations and regulatory compliance. Marlene Moore has worked and managed sampling and testing laboratories for over twenty years before providing her expertise to others. Current work includes assessing for laboratory accreditation programs to ISO/IEC 17025 and assessing to ISO/IEC 17065 for conformity assessment certification programs. Assessments are performed for A2LA, ANAB and ANSI. Additional assessor and auditor training was completed under the EPA Safe Drinking Water Program for State certification laboratory auditors for inorganic, organic and microbiology and as an ISO auditor for ISO 9000. Formerly an RAB ASQ/ANSI registered auditor.
