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The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
Hazardous chemicals present physical and/or health threats to workers in clinical, industrial, and academic laboratories. Laboratory chemicals include cancer-causing agents (carcinogens), toxins (e.g., those affecting the liver, kidney, and nervous system), irritants, corrosives, sensitizers, as well as agents that act on the blood system or damage the lungs, skin, eyes, or mucous membranes.
The operations manual is the documentation by which an organisation provides guidance for members and employees to perform their functions correctly and reasonably efficiently. [1] It documents the approved standard procedures for performing operations safely to produce goods and provide services. [ 2 ]
Business process re-engineering (launched by Michael Hammer in 1993 [34]): a business management strategy focusing on the analysis and design of workflows and business processes within an organization. BPR seeks to help companies radically restructure their organizations by focusing on the ground-up design of their business processes.
The CDC Good laboratory practice guidelines for newborn screening recommends that "laboratory specimen retention procedures should be consistent with patient decisions." [ 49 ] Researchers have described the NBS samples as a gold mine representing a patient population that would otherwise be impossible to get. [ 46 ]
A time and motion study (or time-motion study) is a business efficiency technique combining the Time Study work of Frederick Winslow Taylor with the Motion Study work of Frank and Lillian Gilbreth (the same couple as is best known through the biographical 1950 film and book Cheaper by the Dozen). It is a major part of scientific management ...
However, BMETs do specialize and focus on specific kinds of medical devices and technology management—(i.e., an imaging repair specialist, laboratory equipment specialist, healthcare technology manager) and works strictly on medical imaging and/or medical laboratory equipment as well as supervises and/or manages HTM departments.
The Automotive Industry Action Group (AIAG), a non-profit association of automotive companies, has documented a recommended measurement system analysis procedure in their MSA manual. [6] This book is part of a series of inter-related manuals the AIAG controls and publishes, including: The measurement system analysis manual [7]