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Print Save to File Printable View of: Module 1: Introduction to QA/QC File: QAQC Introduction QA/QC Introduction Module 1: Introduction to QA/QC QA/QC Introduction Quality assurance refers to an organization's policy to prevent problems from occurring. This is a very broad definition and is applicable to any laboratory conducting testing procedures on almost every conceivable product. QA/QC QA/QC has a different meaning to different people depending upon their particular area of expertise. For example, the Federal Bureau of Investigation (FBI) provides detailed guidelines for QA/QC of a laboratory conducting forensic DNA testing and convicted offender databasing. These guidelines differ from American Association of Blood Bank (AABB) guidelines and College of American Pathologists (CAP) for genetic testing laboratories or ISO guide 17025 used by various biological testing laboratories. To further complicate matters, there are numerous International guidelines, which are becoming more and more prevalent as attempts are made to standardize quality assurance programs. Every graduate entering a career in an analytical, forensic, clinical, manufacturing, or research facility will have to abide by some type of quality assurance program. This course teaches the key components of QA/QC and helps students to understand the need to produce sound scientific data using appropriate standards and controls, written procedures, and method validation no matter what field they are employed in. This course offers a generic description of what is required in the formation of a quality system in any laboratory. This is achieved by describing the key principles in any QA/QC program with reference to the ASCLD, FBI, and ISO guidelines, together with specific examples from different specializations in those particular fields. While everyone can understand the need for a QA/QC program, it is not surprising that the process can seem daunting to the inexperienced. The program that best meets the needs of the particular laboratory and its regulatory or accrediting body is often a very difficult question to answer. Laboratories which perform a wide range of services encompassing different disciplines are faced with the choice of subscribing to more than one QA/QC program which is both time consuming and expensive, or developing their own customized program which best fits the operation of the laboratory.
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This note was uploaded on 09/01/2011 for the course VME 6766 taught by Professor Dr.grundmann during the Spring '09 term at University of Florida.

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labqaqcmod1 - Module 1 Introduction to QA/QC Page 1 of 4...

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