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Quality Assurance Records and Standard Operating Procedures (SOP)

 

The Quality Assurance Policy is addressed in MQSA as the following:

21 CFR 900.12 (d)(2) Quality assurance records.  The lead interpreting   physician, quality control technologist, and medical physicist shall ensure that records concerning employee qualifications, mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions and the effectiveness of the corrective actions), safety, and protection are properly maintained and updated in the mammography facility’s quality assurance manual.  These quality control records shall be kept for each test specified in 900.12(e) and (f) until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.  

Comments:

The quality assurance (QA) records that must be maintained are the following: 

§         Personnel Responsibilities: qualified mammography personnel assigned appropriate QA tasks

§         Technique Charts/Tables: the mammography techniques and procedures used in conducting mammograms

§         Quality Control (QC) test Records: including QC test procedures, test performance and monitoring, data analysis and timely corrective actions for each.

§         Procedures for safety and protection of patients and person 

Facilities have the flexibility to use procedures that best enable them to meet the required QC test criteria and outcomes (tests to be done, frequency, and especially the action limits to be met), just as long as they are consistent with the MQSA regulations. The inspector will look for the written standard operating procedures for the QC tests.  If the facility has not written their standard operating procedures, then they must document what they use for their standard operating procedures.  If a facility has adopted the ACR manual for their QC test procedures, they must adhere to it. 

 

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