Creating an Effective Management Review

by | Dec 16, 2021 | Compliance, Consulting Group, FDA, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards


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The idea behind the management review process is to take a step back from the day-to-day operating of an organization and review the performance of the management systems, including their continuing suitability, adequacy, and effectiveness.

Ensuring that systems remain centered on the direction of the business and to reflect changes that have occurred in the company’s perspective helps take advantage of opportunities while fully addressing any risk-concerning areas. The risks identified in a risk assessment need to be routinely monitored using the management revies as well as the following:
• Results of the performance of the company and its systems
• Data on meeting the quality objectives and key performance indicators (KPI)
• Reviewing trends in CAPA’s and working to eliminate them.
The management review requirement allows the management team to look at the business from a different angle and critically evaluate the period, improve the approach, and plan for the future.
The discussions and evaluations that take place in the review must be documented. It is usual for the review’s outputs to comprise minutes, an action plan, objectives, and targets for their achievement. It is vital to view this information with a critical eye and create an action plan to establish; what needs to be accomplished, what resources will be required, who will be responsible, what the timeframe of completion will be, and how the results will be evaluated.

Management reviews help ensure that all management teams know the organization’s focus. It helps ensure that actions are undertaken to achieve the objectives, encourage communication regarding any obstacles, and ensure that individuals have the required level of support, time, and resources available to implement actions appropriately.
For help in creating policies, presentations and including the correct statistical techniques in a management review, contact EMMA International. Experts at EMMA International have helped many clients create and hold successful management reviews. Contact EMMA by phone at 248-987-4497 or email info@emmainternational.com.

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

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