Management Reviews: A Checklist for Compliance

An effective and compliant Quality System must include periodic Management Reviews held at defined intervals of sufficient frequency.

These reviews should include assessments of your processes, products, and customer needs. In addition, they should focus on the overall health and effectiveness of your Quality System.
 
Specifically – and at a minimum – your Management Reviews should cover the following:
 
√  Appropriateness of your quality policy and objectives
√  Results of audits and other assessments
√  Customer feedback (including complaints)
√  Results of data trending analysis
√  Preventive action to avoid serious issues or recurrence of issues
√  Follow-up action from previous reviews
√  Changes to business practices or environment
√  How (and if) product characteristics are meeting customer needs
 
Outcomes of Management Reviews typically include:

√  Improvements to the Quality System
√  Improvements to products and manufacturing processes
√  Realignment of resources

You should document and date the decisions and results coming out of your Management Reviews. Then implement your planned actions using your CAPA system and a documented change control process.

For additional training on effective Management Reviews and CAPA systems, attend EduQuest’s 1.5-day class, The CAPA Clinic: Effective CAPA Systems, Failure Investigations and Complaint Management.

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