Checklist Phase 4 - Process Management

Is there an SOP that covers all the more simple procedures for which it is too laborious/inefficient to make separate SOPs but that are critical for proper functioning of the laboratory?

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Is correct transportation of samples monitored on a continuous basis by the laboratory by checking whether the transportation requirements in the SOP for Sample Collection are met?

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If problems arise in transportation of samples, does the laboratory investigate these problems to find the cause?

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If problems arise in transportation of samples, is a nonconformity form always completed?

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Are corrective and preventive actions undertaken to solve problems in sample transportation?

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Is the effect of the preventive/corrective actions to solve problems regarding sample transport evaluated to see if they worked?

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Does the laboratory monitor correct performance of all its processes using quality indicators?

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Is action undertaken upon detection of a sudden change in the value of a quality indictors to identify and solve the problem and prevent it from reoccurring?

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Have limits of acceptability been set for each quality indicator?

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Are actions undertaken to optimize the laboratory processes such that the limits of acceptability for each quality indicator aren’t exceeded any longer?

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