![]() ![]() ![]() While management delegates responsibilities to the QA officer, laboratory supervisor, and laboratory analyst so they may effectively carry out their individual job duties, management is ultimately responsible for the QA/QC program.ī. Management has overall responsibility to the end-user or customer for the QA/QC program and activities performed by laboratory analysts. Management should meet with the laboratory supervisor and staff to develop and maintain a comprehensive program to establish specific responsibilities for management, laboratory supervisors, and analysts and to maintain awareness of conditions through periodic and systematic review of laboratory functions. ![]() Management responsibilities: Management must evaluate the risks associated with errors, recognize the need for and actively support the QS, involve staff in QS development and operations, commit monetary and personnel resources, and assume a leadership role. The laboratory must develop, document, and implement its processes to result in controlled experimental conditions that meet its specific needs and the planned use of the data.Ī. 1 AOAC International has developed a document 2 to address, using the EPA terminology, the 10 essential QC elements for microbiology laboratories: Environmental Protection Agency (EPA) published 12 essential QC elements for chemical pollutants analyzed under the Clean Water Act that need to be incorporated when the analytical method lacks QA/QC procedures. Therefore, different statistics and probability distributions are also used to evaluate chemical and microbiological data.ĭocumented QSs will vary among laboratories as a result of differences in organizational mission, responsibilities, and objectives laboratory size, capabilities, and facilities and staff skills and training. Discrete variables have only integer values continuous variables are not limited to particular values but rather the accuracy of the measuring tool used. Several of the QC tools available to microbiologists are different from those routinely used by chemists because many of the microbiologists' measurements involve discrete variables rather than continuous ones. Microbiological analyses are inherently variable because they measure dynamic living organisms. When properly administered, a balanced, conscientiously applied QS will optimize data quality, identify problems early, and increase satisfaction with analytical results without affecting laboratory productivity. That said, more time may be needed for crucial analytical data (e.g., data for enforcement actions). Staff should spend about 15% of overall laboratory time on the various aspects of an established QA program. It also clearly defines responsibilities and duties to ensure that the data are the type, quality, and quantity required. The document denotes the laboratory's commitment to the QA program for integration of intra- and inter-laboratory QC activities, standardization of laboratory operating procedures, and management practices. A laboratory documents its QS's policies and objectives in a quality management plan or quality manual. Safe Drinking Water Act, standard-setting organizations, and laboratory certification or accreditation programs).Įach laboratory develops its own QS suitable for its needs. ![]() These practices may be required by regulatory agencies (e.g., under the U.S. The laboratory practices set forth in Section 9020 represent best practices to ensure high-quality data, so use of these procedures is highly recommended for both stand-alone and mobile laboratories. These are designed to substantiate the validity of analytical processes and data and ensure compliance with regulatory requirements, customer and project quality objectives and requirements, and applicable standards of accreditation or certification. quality control (QC) operational techniques and practices.a quality assurance (QA) policy or program and. ![]()
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