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What is a Management Review and is it mandatory?

* (Section 1.4 of the Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01), 5 November 2013, states:

Senior management must have formal processes in place to periodically review the quality system. The review must include:

i) Evaluation of the extent to which the objectives of the quality system have been achieved;
ii) Assessment of performance indicators that can be used to monitor the effectiveness of processes within the quality system, such as complaints, deviations, CAPAs, process changes, feedback on outsourced activities, self-assessment procedures including risk assessments and audits, and external assessments such as inspections, findings, and customer audits;
iii) New regulations, guidelines, and quality issues that may impact the quality management system;
iv) Innovations that may enhance the quality system;
v) Changes in the business environment and business objectives.

The outcome of such reviews of the quality system must always be documented in a timely manner and communicated effectively within the organization.

What is the purpose of a Management Review?

The Management Review should encourage the organization to reflect on the effectiveness of its quality system. It is a moment to step out of the daily operation of the quality system and ask:

• Is our quality system truly effective?
• Is it doing what it is supposed to do?
• Does our organization contribute to the safe distribution of medicinal products?
• Does the quality system clearly show where improvement is needed or possible?

Why is there often little enthusiasm for the Management Review?

The pitfalls of a Management Review

A Management Review is not always received with enthusiasm because the expectations of the different stakeholders may differ or be unclear.

For the Quality Department, it is a significant effort to collect all relevant information and translate this data into clear summaries and metrics. After substantial work, the Management Review is finally ready to be presented. Unfortunately, the audience may show only moderate enthusiasm.

On the other hand, the quality system can sometimes feel somewhat distant from senior management. Each member of senior management has their own area of expertise. They may not be entirely sure what to do with this quality report or how to interpret it from a strategic perspective.

As a result, the presentation of the Management Review risks becoming a polite annual obligation without real added value for the organization. A missed opportunity.

Does this situation sound familiar?

By Hadewych Van Brecht