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A closing meeting is held onsite at the end of the site audit so that the approval holder is aware of the overall outcome.  Subsequently, a detailed report is issued to the approval holder summarizing the result of each of the categories audited as well as the specific nonconformances which will require corrective actions. 

 

If there were no nonconformances identified, the audit is fully acceptable and there is no follow-up action required on the behalf of the approval holder.  A Provisionally Acceptable outcome indicates that there were nonconformances identified that need to be addressed; however production of respirations may continue while the approval holder works on the corrective actions.  And finally, a Not Acceptable outcome indicates that systematic quality issues have been identified that must be addressed immediately.