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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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