QC Records Retention Requirement for Replaced Equipment

Discussion:

Question 1: Should facilities retain QA/QC records for equipment (film processors and/or mammographic x-ray systems) which were in use for a period of time between the previous MQSA inspection and the current inspection, and has since been retired from use and replaced with new equipment?

The requirement for equipment currently being used is that these records must be maintained until the next annual inspection that would verify compliance or until an individual test has been performed two additional times at the required frequency, whichever is longer. However, for film processors and/or mammographic x-ray systems that are no longer at the facility, the records need only be kept for that equipment until the next annual inspection.

Key Words:

Equipment

Repaired Equipment

Changed Equipment

Moved Equipment