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Management Review for Quality Assurance

The management review of process performance and product quality ensures effective oversight throughout the lifecycle of products. It should encompass results from regulatory inspections, periodic quality reviews, and follow-up actions from previous reviews. Additionally, it identifies necessary actions for improvements in processes, resource alignment, and knowledge dissemination.
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0% found this document useful (0 votes)
6 views1 page

Management Review for Quality Assurance

The management review of process performance and product quality ensures effective oversight throughout the lifecycle of products. It should encompass results from regulatory inspections, periodic quality reviews, and follow-up actions from previous reviews. Additionally, it identifies necessary actions for improvements in processes, resource alignment, and knowledge dissemination.
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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.

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