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1 <br /> ' Section 11 <br /> ONSITE Environmental Laboratories, Inc Revision 0 <br /> ' Quality Assurance Plan February 15, 1996 <br /> Paye 3 of 4 <br /> 11 3 Documenting an Out-of-Control Event <br /> ' An Out of Control Event (OOCE) Form is initiated by any ONSITE employee <br /> discovering a deviation from accepted laboratory operations that may affect the quality <br /> ' of the data The report will describe the analysts involved, the date, analyst, the <br /> identification of all affected or suspect samples, probable cause, the corrective action <br /> measure(s) taken, and the final disposition/resolution of the problem The OOCE form <br /> ' (Figure 3) then routed to the Mobile Laboratory Supervisor or responsible manager for <br /> review, and any additional corrective action Within 72 hours of identification, the <br /> Laboratory Director must be notified and determine whether the deviation is a <br /> deficiency or a nonconformance <br /> The report is signed by the chemist, the Mobile Laboratory Manager and the <br /> Laboratory Director The original, signed OOCE is filed in the appropriate project <br /> ' file, with copies on file in the analytical batch file and with the Laboratory Director <br /> 11 4 Out of Control Events are evaluated to identify potential adverse trends so that the <br /> corrective actions is taken to avoid the escalation of the trend into significant problems <br /> Data is not released until corrective actions have been taken and proven successful <br /> 11 S When significant or repetitive conditions occur, ONSITE will perforin root cause <br /> analysis to determine the appropriate corrective action to prevent the reoccurrence of <br /> the conditions if necessary, a "stop work" order will be implemented until the <br /> ' condition is corrected <br /> Word 6 0 loelsecI l doc <br />