When implemented, a company will demonstrate the use of an effective PQS
through its documentation (e.g., policies, standards), its processes, its
training/qualification, its management, its continual improvement efforts, and its
performance against pre-defined key performance indicators.
A mechanism should be established to demonstrate at a site how the PQS operates
across the product lifecycle, in an easily understandable way for management,
staff, and regulatory inspectors, e.g., a quality manual, documentation, flowcharts,
procedures. Companies can implement a program in which the PQS is routinely
audited in-house (i.e., internal audit program) to ensure that the system is
functioning at a high level.
