Checklist Phase 4 - Continual Improvement
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Have failure mode and effect analyses been performed on all the procedures routinely performed in the laboratory to identify potential sources of nonconformity? |
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Have preventive actions, control steps and corrective actions appropriately been implement to prevent and control nonconformities? Look into the reports of failure mode effect analyses and see if failure modes have reasonably been prevented and controlled by preventive actions, control steps and corrective actions in practice. With reasonable is meant that the implementation of preventive actions, control steps and corrective actions weighs up against the probability of failure modes in combination with the severity of the consequences. |
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Has the effectiveness of control steps and preventive/corrective actions implemented in the laboratory routine procedures following the Failure-Mode-Effect-Analysis been evaluated? |
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When control steps and preventive/corrective actions of the Failure-Mode-Effect-Analysis appeared to be ineffective, have they been replaced by more feasible ones? |
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Has the effectiveness and feasibility of the control steps and preventive/corrective actions that were optimized based on the first audit been evaluated in subsequent audits? |
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