Equipment Outages Documentation

In the rush following the discovery of a malfunctioning chamber, some of the most important information may be missed. The 483 below identifies that some of the basic information for this outage was missed.




The 483 doesn’t say what time the outage happened, but if it was 2:00 AM not everyone was prepared in advance to move the samples.

Being prepared for an emergency move should be written into your Emergency/Disaster SOP.  This portion of the SOP should discuss the allowable times, requirements for the move and the documentation required for an outage. The first step in the process is identifying the chamber to move the samples to.  The next step is inventorying the affected chamber.  In this process it can be a manual recording of the samples as they are removed, or it can be the verification at time of removal of a computer generated inventory.  On computer generated inventories any discrepancies need to be investigated and resolved, as this is a failure in the inventory process.  This failure is documented with the data being used in the exception for the outage.  This documentation needs to be included in the excursion history package.  The last step is the Impact Assessment of the samples that were stored/moved/moved.

In the assessment, a complete list of the activities such as move times, extremes and durations need to documented.  If the samples were transported to another building or facility, the Temperature Monitoring Device (TMD) data needs to be included in the package.

A discussion with the Regulatory Affairs group may be needed to determine if the outage needs to be added to any submission reports.



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