Equipment Measurements Which Result in Borderline Values
For the equipment measurements portion of inspections, a range of numerical values is possible for the calculated results. While results above or below a certain value will clearly be noncompliant, other values will "just pass" the test with a "borderline value." While facility personnel may want to know how their facility performed on this part of the inspection, some inspectors may be tempted to point out that they "just passed" and ask them to "keep an eye on" certain areas that are borderline and close to the point of being noncompliant. While this may seem like innocent advice that could help a facility, many people are nervous during an inspection and will hang on every word the inspector says. Some may decide to schedule service calls to investigate the borderline test result, only to find that the service engineer cannot identify a problem. If you identify borderline test results during an inspection, please make sure you indicate clearly to the facility personnel that they passed the inspection with regard to that item and that the FDA is not requiring them to take action regarding the test result found.
Many States have more stringent requirements than MQSA (example: dose limit in California is less than MQSA's 300mrad for film-screen). In these cases, it is appropriate for the inspector to follow routine State procedures and indicate that the facility failed to meet the State law with respect to the test result in question.
Reminder for State Inspectors:
When performing an MQSA inspection along with a mammography inspection for your State, and your findings reveal a noncompliant item(s) with your State's requirements, please carefully distinguish between the State's requirements and MQSA's requirements [i.e., the State's noncompliant item(s) versus noncompliant MQSA item(s)] during the close-out interview with facility personnel. It is important that facilities understand whether noncompliance items are State requirements or MQSA requirements.