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What Are the Critical Elements in the Microbiology Laboratory?
Oral Presentation
Prepared by M. Hunt
USEPA (Retired), 516 Lawson Way, Rockville, MD, 20850
Contact Information: snowball02h@yahoo.com; 240-683-1369
ABSTRACT
Microbiology is the study of dynamic biological processes involving bacteria, fungi, viruses, and protozoa. In terms of microbiology, the US Food and Drug Administration (FDA) talks about Quality by Design (QbD) where quality is built into the product with an understanding of the final product and the process by which it is developed based on a systematic approach of sound science and risk management. In the water testing industry, the quality process design is set in place to prove that appropriate regulations are being followed and that the water is safe. The process design is formulated into a Quality Management Plan that is supported by both management and analysts. It is their efforts to maintain a system where all activities are supported by appropriate quality control activities and fully documented.
Microbiological analytical methods must be scientifically sound (e.g., specific, sensitive, and accurate) and provide results that are reliable. There should be assurance of proper equipment function for laboratory experiments. Procedures for analytical method and equipment maintenance, documentation practices, and calibration practices supporting process-development efforts must be documented. The microbiological process is reviewed both within the laboratory on a routine basis and by external reviewers (auditors, accreditation officials) at periodic intervals such as annually or biannually.
The critical elements in the microbiology laboratory are the following:
1. Facility,
2. Equipment and supplies,
3. Personnel, both management, supervisors, and analysts,
4. Analytical Methods, and
5. Documentation
Each will be discussed with an emphasis on analytical methods in response to both the US Environmental Protection Agency’s (EPA) final rule, published in 2012, “Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act: Analysis and Sampling Procedures (77FR: 29758) and the draft AOAC International’s “Microbiology Water Methods, Quality Assurance and Quality Control.”
Oral Presentation
Prepared by M. Hunt
USEPA (Retired), 516 Lawson Way, Rockville, MD, 20850
Contact Information: snowball02h@yahoo.com; 240-683-1369
ABSTRACT
Microbiology is the study of dynamic biological processes involving bacteria, fungi, viruses, and protozoa. In terms of microbiology, the US Food and Drug Administration (FDA) talks about Quality by Design (QbD) where quality is built into the product with an understanding of the final product and the process by which it is developed based on a systematic approach of sound science and risk management. In the water testing industry, the quality process design is set in place to prove that appropriate regulations are being followed and that the water is safe. The process design is formulated into a Quality Management Plan that is supported by both management and analysts. It is their efforts to maintain a system where all activities are supported by appropriate quality control activities and fully documented.
Microbiological analytical methods must be scientifically sound (e.g., specific, sensitive, and accurate) and provide results that are reliable. There should be assurance of proper equipment function for laboratory experiments. Procedures for analytical method and equipment maintenance, documentation practices, and calibration practices supporting process-development efforts must be documented. The microbiological process is reviewed both within the laboratory on a routine basis and by external reviewers (auditors, accreditation officials) at periodic intervals such as annually or biannually.
The critical elements in the microbiology laboratory are the following:
1. Facility,
2. Equipment and supplies,
3. Personnel, both management, supervisors, and analysts,
4. Analytical Methods, and
5. Documentation
Each will be discussed with an emphasis on analytical methods in response to both the US Environmental Protection Agency’s (EPA) final rule, published in 2012, “Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act: Analysis and Sampling Procedures (77FR: 29758) and the draft AOAC International’s “Microbiology Water Methods, Quality Assurance and Quality Control.”