Root cause report documents

Check whether a documented system is in place, which covers the reporting, investigation, root cause analysis and corrective actions taken. 

Thorough documentation of medication errors provides information about the severity of the error as it relates to the effeet on the patient, the product(s) involved, the competence of staff handling the produet or proeessing the order, any contributing factors that may predispose a product to misuse, and the suspected root cause of the error. USP adds certain codes to MER Program data in order to characterize the error as it was reported. These codes include the type of error and the possible eause(s) of error. The following list shows some of the produet eharaeteristics that have been recorded over 9 years to have caused or eontributed to a medication error. 

If the root cause is assignable, corrective action needs to be taken and documented. If three consecutive runs over action levels occur, a problem analysis corrective action report (PACAR) must be issued. 

Information from production loss events is stored in the databases (as shown in Fig. 2). Root causes of failures and near misses are documented in offshore databases in the form of reports that include a summary of actual event(s), field observations, corrective actions and recommendations. These reports include documentation such as alarm logs, summary of personnel interviews/ observations, process diagrams and pictures etc. 

The accident analysis report determines and documents the root causes of accidents associated with the end product and includes new hazards, hazards inadequately controlled or analyzed, and new baseline information identified by the accident analysis in the system safety effort. 

A document containing the information and facts about an individual incident put in chronological order to provide a complete picture as to what happened. The report is useful for the investigation to help establish the root cause of the incident. 

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It is essential that all incidents are reported promptly, and in detail—even those that have only minor consequences or that are first aid cases or that are near misses. In the United States, incidents that meet the OSHA guidelines for recordability must also be documented and reported. (The topics of Incident Investigation and Root Cause Analysis are discussed in Process Risk and Reliability Management). 

Once the near miss has been reported, it is the supervisor s responsibility to evaluate the severity and probability of the loss. Near misses with a medium-to-extreme potential severity or a medium-to-extreme likely recurrence are required to be investigated by the supervisor. As part of the investigation, the supervisor shall identify the root/hasic causes of the unsafe act or condition, and then implement corrections to prevent recurrence. The near miss program includes a standardized investigation form that aids the supervisor in the investigation and documentation of the near miss. 

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