Process flow (how to develop, phases)
Previously just described “form field content”, now includes description of how to
obtain information and some minimum expectations, including:
Frequency – if not 100 must be volume based and support containment
Reaction plan –
clarified expectation to include contain suspect product, stop process from
creating more suspect product, steps to bring process back to control
requires inclusion of owner/responsible for the reaction or reference to detailed
instruction document