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Section i 1 ONSITE Environmental Laboratories, Inc Revision 0 ' Quality Assurance Plan Februan 15, 1996 Page 1 of 4 11.0 OUT OF CONTROL EVENTS AND CORRECTIVE ACTIONS i Out of Control Events (conditions adverse to quality) are reported, documented and corrected at ONSITE Out of Control Events may arise from the failure of a process, human error, non- compliance with requirements, inadequate controls, or sample matrix problems Out of Control Events may include (but are not limited to) the following ' > Instrument failure ' > Sample holding time exceeded > Incorrect sample preparation or analysis techniques used ' > Calibration criteria not met > QC sample data (blank, spike, duplicate, surrogates, LCS) outside acceptance criteria ' > Data recording errors, transcription errors, calculation errors > Data verification errors > Any situation that might affect the final data quality 11 1 Roles and Responsibilities for Responding to an Out-of-Control Event ' When an out-of-control event is recognized, each individual involved with the analysis in question has an interactive role and responsibility 11 1 1 The Mobile Laboratory Chemist Must be able to recognize QC failure and immediately notify the supervisor ' and work with the supervisor and QA Director to solve the problem 11 1 2 The Mobile Laboratory Manager Must review all analytical and QC data for reasonableness, accuracy and clerical errors The Laboratory Manager must report the nonconformance to ' the Laboratory Director within 72 hours and works with the chemist and the Laboratory Director to solve the problem The Laboratory Manager prevents the reporting of suspect data by stopping work on the analysis in quesnon and insures that all results that are suspect are repeated, if possible, after the source of the error is determined and remedied Word 6 0 lodEsec 11 doc