Management Review

Management Review is a formal procedure in which the highest levels of leadership (often referred to as management with executive responsibility) periodically review the overall performance of the organization’s Quality Management System (QMS).

In essence, it is a mandated meeting or process designed to evaluate the QMS to ensure it remains suitable, adequate, and effective. The results of these reviews serve as the foundation for future improvements

Management review is critical because it ensures that top management remains engaged with the QMS and that the quality system continues to be aligned with the organization's strategic objectives.

Key Requirements and Documentation

In regulatory contexts such as the FDA’s Quality System Regulation (21 CFR Part 820) and the ISO standards, the following structured requirements must be met:

Mandatory Reviewers:

The review must be conducted by management with executive responsibility. This refers to senior employees who have the authority to establish or change the manufacturer's quality policy and quality system.

Frequency and Documentation:

The review must be carried out at defined intervals and with sufficient frequency according to established procedures. The dates and results of these quality system reviews must be documented.

Purpose:

The review aims to ensure the quality system satisfies the requirements of the governing regulations (e.g., QSR) and the manufacturer’s established quality policy and objectives.

Continuous Improvement Input:

Information related to identified quality problems and corrective and preventive actions (CAPA) must be submitted for management review. This review process is where management determines whether the QMS is suitable and effective.

Inputs to the Management Review

To ensure a comprehensive evaluation of the QMS, top management must take into consideration several critical inputs:

Status of Previous Actions

The results and effectiveness of actions implemented following past management reviews.

Relevant Information/Trends

Information on the performance and effectiveness of the QMS, including trends in: Customer satisfaction and feedback; The extent to which quality objectives have been met; Process performance and conformity of products and services; Monitoring and measurement results; and the performance of external providers.

Quality Problems/Audits

Nonconformities and corrective actions. The results of internal audits.

Risks and Opportunities

The effectiveness of actions taken to address risks and opportunities, and opportunities for improvement.

Resource Adequacy

An evaluation of the adequacy of resources.

External/Internal Changes

Changes in external and internal issues that are relevant to the QMS.

For example, findings from trending and continuous review related to the Corrective and Preventive Action (CAPA) management process are submitted for management review. This data drives product or process enhancements through informed decisions. The output from ongoing risk management reviews should also be fed into the management review process.

Outputs of the Management Review

The outputs of the management review must be documented and include all decisions and actions related to:

1. Opportunities for improvement.
2. Any need for changes to the quality management system.
3. Any necessary resource needs.

The organization is required to retain documented information as evidence of the results of these management reviews.

Analogy for Understanding

You can think of a Management Review like a CEO's quarterly or annual review of the entire business health report card. The CEO doesn't just check the final profit number (product quality); they look at all the underlying metrics—employee performance (audit results), customer complaints (nonconformities/CAPA), supply chain reliability (external provider performance), and financial projections (risks and opportunities)—to decide if the company is running efficiently, meeting its goals, and where it needs to invest resources for future success (outputs). This structured review ensures strategic decisions are based on the documented facts of the system's performance

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