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Out-of-Specification (OOS) Investigations: Avoiding Complete Failure by Looking at All Pieces of the Puzzle
Anderson
ISBN: 978-0-470-57759-2
Hardcover
320 pages
June 2015, ©2011
Title in editorial stage
  • Description
This book helps quality professionals set up a compliant system to deal with out-of-specification (OOS) results, with good examples of the needed investigations. Relying on a puzzle analogy, the author explains how industry often races through the OOS investigation "to grab that one piece of the puzzle" when they should try instead to develop a complete picture. The book covers the history of OOS problems, importance of good OOS investigations, regulatory requirements and guidelines, and building strong OOS procedures and supporting documentation, including the investigation, evaluation, and interpretation of results.
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