Selasa, 07 Juli 2009

Quality Assurance Plans and Standard Operating Procedures

Quality assurance plans (QAPs) and standard operating procedures (SOPs) are not required by many universities or nongovernmental institutions; nevertheless, the concepts upon which these documents are based are recommended as useful tools for maintaining overall research quality.
The QAPs and SOPs usually are required if research data and conclusions will be submitted to certain regulatory agencies, such as the Food and Drug Administration (FDA) or the U.S. Environmental Protection Agency (USEPA). Specific benefits that can
result from the establishment and use of QAPs and SOPs include the following: consistency in repeated procedures, limiting unneeded replications, obtaining the most
information possible from the fewest fish and staff, and developing sets of data that can
withstand legal challenges.
The QAP is a written document that describes the principles, policies, organizational responsibilities, objectives, implementation actions, and accountability procedures that
will ensure appropriate quality throughout a research project. The QAPs document management procedures and ensure that the data collected will qualify for meeting study objectives. The QAPs should be detailed enough to provide clear descriptions of every aspect of the project. They facilitate communications and help to keep projects on
schedule and within budget. An important matter that is overlooked frequently in QAPs is tracking and limiting access to research facilities and animals. The quality of research, and even the welfare of experimental animals, can be compromised if access is not controlled and tracked. Posting signs and providing signin and signout sheets help to ensure that other provisions in the QAPs are followed.
Typically, QAPs are prepared by the principal investigator and are subject to approval by that individual’s supervisor(s) and the IACUC. Copies of QAPs should be kept in designated, readily accessible locations in the office of the principal investigator and the
department or section where the study will be conducted.
Standard operating procedures document routine or repetitive technical activities, ensuring that work is done correctly the first time, thereby reducing unnecessary repetition and costs. Examples of specific technical tasks that may be used to conduct
research with fishes include the following: blood sampling, vaccination protocols, procedures for electrofishing, or techniques for collecting meristic data. The SOPs promote consistency in quality and integrity of data and are useful for maintaining consistency when there are changes in personnel. They also can form an essential part of effective training programs. General SOPs, not specific to individual studies, may be
established as basic procedures for entire research institutions or laboratories. Additional information on SOPs and QAPs is available from regulatory agencies such as USEPA or FDA and from various manuals or texts that address quality assurance.

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