There is no specific expectation in Q7A that cleaning records and maintenance
records have a second signature of verification. Q7A , section 2.2 tells us that quality is
responsible for making sure that effective systems are used for maintenance and calibration of
critical equipment. What that says is that it’s incumbent on quality to make sure that the system is
indeed effective, and if you are having a number of deviations or problems with maintenance or
calibration, than maybe that’s something that your quality unit would want to consider, but that is
not mandated. Further, section 8.1, Q7A states that other critical activities should be witnessed or
subject to an equivalent control.
