Management Review of Process Performance and Product Quality Management review:
should provide assurance that process performance and product quality are managed over the
lifecycle. Depending on the size and complexity of the company, management review can be a series
of reviews at various levels of management and should include a mely and effec ve communica on
and escala on process to raise appropriate quality issues to senior levels of management for review.
(a) The management review system should include: (1) The results of regulatory inspec ons and
findings, audits and other assessments, and commitments made to regulatory authori es; (2)
Periodic quality reviews, that can include: (i) Measures of customer sa sfac on such as product
quality complaints and recalls; (ii) Conclusions of process performance and product quality
monitoring; (iii)The effec veness of process and product changes including those arising from
correc ve ac on and preven ve ac ons. (3) Any follow-up ac ons from previous management
reviews. (b) The management review system should iden fy appropriate ac ons, such as: (1)
Improvements to manufacturing processes and products; (2) Provision, training and/or realignment
of resources; (3) Capture and dissemina on of knowledge.