Detroit Meeting - Day 2 (Quiz 2)

Even though the TrackWise record is assigned to only one-person, investigative activities can be carried out by any qualified person.

CLIA-related TrackWise records must be reviewed by the Laboratory Director.

Immediate actions taken to stop the problem and prevent the deviation from continuing.

Immediate actions taken to repair, rework, or adjust the effects of the deviation. For example: re-performing the task according toprocedure, rejecting plasma units, re-testing samples.

The deadline for completion of Risk Analysis and Containment/Remedial Actions, and advancing the event record to “Pending Investigation,” is ___day(s) from opening the record.

Michigan is home to one of only four ice luge tracks in the nation

For trend analysis, investigate whether there has been a trend of this type of deviation over the last ____ months.

When determining duration of the effectiveness plan and monitoring, fewer checks and shorter timeframes are acceptable when there is high probability for occurrence / high probability for detection.

RCA is most effective when performed within a group, formed by people familiar with the underlying process.

A _____________ must be completed as quickly as possible and should drive the actions you take to contain the problem.