(Continued from previous page)

The first formal risk assessments to be performed in the life of a product are the Process and Production Rationales.  The ‘living’ Production Rationale is the definitive record of all parameters that can have an impact on product quality, and all subsequent risk assessments should evaluate the possible impact on these parameters of any proposed production solutions such as premises, utilities, equipment, operating systems, environment and procedures.  The ultimate result should be the identification of all necessary functional testing to demonstrate control of these parameters and of the ongoing support mechanisms and documentation needed for their monitoring and upkeep.

Whatever you need, we can help.   CONTACT US  to find out how.