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labqaqcmod12 - Module 12 Inspection Compliance Page 1 of 11...

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Print Save to File Printable View of: Module 12: Inspection & Compliance File: Overview Overview Module 12: Inspections and Compliance Overview This module covers how to prepare for an inspection by a regulatory agency. General considerations for ensuring compliance are also discussed. Regular laboratory inspections (or audits) are a necessary tool for ensuring the maintenance of a first class laboratory. During these audits, all aspects of the laboratory program, especially those involving quality assurance, may be examined. Accreditation can only be obtained after a laboratory has successfully passed inspection by a regulatory agency and has demonstrated its capability by means of proficiency tests. To maintain accreditation, a laboratory must continue to pass periodic audits. This lesson describes the accreditation process and how one prepares for laboratory audits. Objectives At the end of this module students should: Know what comprises an audit Understand how a laboratory prepares for accreditation and that audits are an important part of this process Know how to prepare for laboratory inspections Understand what happens during an audit Be aware of what happens after an audit Assignment Please note: The assignment is listed below and again on the final page of this module. You should consider the assignment questions as you read through the module content, then submit your assignment using the assignment submission form on the final page of this module. Prepare a pre-inspection checklist for some aspect of your laboratory program other than sample handling. 1. After you read the FBI Audit Document - http://www.fbi.gov/hq/lab/fsc/backissu/july2004/pdfs/seubert.pdf ;Read the following dialogue from an interview portion of a DNA audit. List 5 things that could be potential problems for the lab being audited. 1. David is an auditor. Bob is a DNA analyst with the ABC Crime Lab. Position your mouse over the up/down/reset buttons to scroll through the dialogue between Bob and David below: Page 1 of 11 Module 12: Inspection & Compliance 8/2/2009 https://elearning.courses.ufl.edu/webct/urw/lc2793842980071.tp2801654586071/selectItem...
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File: Introduction Introduction Module 12: Inspections and Compliance Introduction By following the guidelines presented in the previous modules, one should be able to establish and run an excellent analytical laboratory that provides prompt service as well as precise and accurate analyses. The validity of the data that are generated would be accepted without question in a court of law. Because even the best laboratory is managed and run by humans, however, continual vigilance must be used to ensure that deviations from the established laboratory procedures are corrected. Small deviations can readily occur without the personnel even being truly aware of them. Although some deviations may not change the "correctness" of the analytical results, others may significantly change a study's outcome.
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