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  • Actions related to determining the root cause of the issue should be related to what information/data is already available and what is known about the issue
  • Other factors such as historical and trend data may also impact formality of actions needed to determine the root cause
  • Analysis of the root cause(s) should be thoughtful and in sufficient detail to ensure that corrective actions/improvement efforts are meaningful and effective (change policies, procedures, practices, personnel development, administration, etc.)
  • Overall, identifying root causes should ensure corrective actions are meaningful and effective to ensure that noncompliance can be verified as corrected as soon as possible, but in no case more than one year from identification