TGFR Consulting LLC CAPA Investigations – The “Is/Is-Not” Exercise
Is/Is-Not analysis is the first step in a CAPA investigation. A good definition of the problem is key to finding the root cause.
Category «Quality Management»
Designing a Quality Management System – Detailed versus Directive Control
As organizations work to design and develop a quality management system (QMS), how to establish compliance becomes a key consideration. The choice of structure represents a continuum between two types of control Many factors influence the choice of control, and the right choice requires considering all of these factors. This choice may be a hybrid, …